ForumMedical

UVA Study Shows Early Success In Treating Deadly Brain Tumors

2009-05-17T04:23:00.000-07:00

New research from the University of Virginia Health System shows that, when combined, two emerging medical technologies hold significant promise for treating the most deadly and... devastating form of brain tumor, glioblastoma multiforme (GBM).

According to Jason Sheehan, M.D., a neurosurgeon and assistant professor of neurosurgery at the UVA School of Medicine, the use of controlled-released nanoparticles containing chemotherapeutic drugs and non-invasive ultrasound successfully helps to treat GBM tumors in mice.

Sheehan discussed the findings on May 4 during the annual meeting of the American Association of Neurological Surgeons (AANS). The association selected Sheehan for its 2009 Young Investigator Award in recognition of his outstanding potential as a researcher in the field of neuro-oncology.

During the study, Sheehan and his colleagues placed a cancer-killing drug inside nanoparticles affixed to microbubbles (which are the size of red blood cells) and injected the compound into the veins of immunocompromised mice. Carried by the bloodstream, the treatment travelled to the GBM tumor site. There, a 1 MHz dose of energy from the ultrasound equipment caused the microbubbles to burst and release the drug directly onto the cancer cells. Results show the treatment reduced tumor cell viability in a significant fashion and compared favorably with an anti-cancer drug, administered to the study's positive control group. The UVA study also showed ultrasound induced damage to the microvessels feeding the tumor.

"Many drugs that kill GBM cells in vitro prove ineffective in living organisms because they are not able to penetrate the blood brain barrier," noted Sheehan. "These new technologies are allowing us to overcome this challenging problem and deliver a highly targeted and sustained release of chemotherapy drugs. Although more research is needed, our findings indicate the technologies hold significant promise for patients with high grade gliomas and other malignant brain tumors."

Sheehan's research is on-going and is being performed in collaboration with his study co-authors, Caitlin Burke, BS, a graduate student in the UVA School of Engineering and Applied Science and Richard Price, PhD., a biomedical engineer in the UVA School of Medicine. Their research is funded by multi-year grants from the Hartwell Foundation.

"I'm honored to receive the 2009 AANS Young Investigator Award," Sheehan says.

Sponsored by the American Brain Tumor Association, the award is presented annually by the American Association of Neurological Surgeons to a young faculty member in neurosurgery.

Sheehan received his B.S., M.S., PhD, and M.D. from the University of Virginia. His B.S. is in Chemical Engineering with the highest honors awarded from the School of Engineering. He performed fellowships at Auckland University and the University of Pittsburgh. Sheehan won the University of Virginia Clinical Excellence Award in 2006.

Widely-published, Sheehan is author of more than 100 peer-reviewed papers as well as numerous invited manuscripts and a book. He reviews manuscripts for several medical journals and serves on a variety of professional committees. Sheehan's memberships include the American Association of Neurological Surgeons (AANS), the American College of Surgeons, Leksell Gamma Knife Society, Neurosurgical Society of the Virginias, AANS/CNS Tumor Section, and the American Society of Stereotactic and Functional Neurosurgeons.

Sheehan's laboratory team also pursues translational and basic science research in brain tumors.

Source: University of Virginia Health System

New Therapy Improves Chances Of Living Disease-free With Difficult-to-treat Childhood Cancer

2009-05-17T04:20:00.000-07:00

A phase III study has shown that adding an antibody-based therapy that harnesses the body's immune system resulted in a 20 percent increase in the number of children living disease-free for... at least two years with neuroblastoma. Neuroblastoma, a hard-to-treat cancer arising from nervous system cells, is responsible for 15 percent of cancer-related deaths in children. The researchers reported their findings - the first to show that immunotherapy could be effective against childhood cancer - online May 14, 2009 on the American Society of Clinical Oncology website in advance of presentation June 2.

"This establishes a new standard of care for a traditionally very difficult cancer in children," said lead author Alice Yu, MD, PhD, professor of pediatric hematology/oncology at the University of California, San Diego School of Medicine and the Moores UCSD Cancer Center. "High-risk neuroblastoma has always been a frustrating cancer to treat because, despite aggressive therapy, it has a high relapse rate."

The therapy targets a specific glycan (a complex sugar chain found on the surface of cells) on neuroblastoma cells called GD2, which inhibit the immune system from killing cancer cells. The antibody - ch14.18 - binds to this glycan, enabling various types of immune cells to attack the cancer.

Neuroblastoma - in which the cancer cells arise from nerve cells in the neck, chest, or abdomen - is the most common cancer diagnosed in the first year of life. Approximately 650 new cases of neuroblastoma are diagnosed in this country every year, and about 40 percent of patients have high-risk neuroblastoma. These high-risk patients are usually treated with surgery, intensive chemotherapy with stem cell rescue (in which patients' adult stem cells, removed before treatment, are returned after chemotherapy to restore the blood and immune system), and radiation therapy. Still, only 30 percent of patients survive.

Yu and her colleagues compared both the percentage of patients who were still alive without experiencing a recurrence after two years as well as overall survival in two groups of 113 patients each. Patients began the trial when they were newly diagnosed with high-risk neuroblastoma. After conventional treatment with surgery, chemotherapy, stem cell rescue and radiotherapy, one group was given the standard treatment (retinoic acid) plus immunotherapy (the antibody plus immune-boosting substances), while 113 similar patients received the standard treatment alone.

After two years, 66 percent of individuals in the immunotherapy group were living free of cancer compared to 46 percent in the standard treatment group. Overall survival improved significantly as well. The trial patient randomization was halted early because of the benefit seen, and all patients enrolled in the trial will receive immunotherapy plus standard treatment.

Yu noted that the two-year mark is especially important because past trials have shown that those neuroblastoma patients who live without disease for two years after a stem cell transplant will most likely be cured.

"This is the first time in many years that we have been able to improve the 'cure rate' for neuroblastoma patients," she said. "This new therapy can help us improve care and perhaps offer new hope to many patients and families."

Yu and her team conducted the early phase I and phase II trials at the General Clinical Research Center at UC San Diego Medical Center.

Other co-authors include Andrew Gilman, Carolinas Medical Centre; M. Fevzi Ozkaynak, New York Medical College; Susan Cohn, University of Chicago; John Maris, Children's Hospital of Philadelphia; Paul Sondel, University of Wisconsin; W. B. London, University of Florida; S. Kreissman, Duke University; H.X. Chen, National Cancer Institute; and K.K. Matthay, UCSD. Local patients were seen in San Diego at Rady Children's Hospital.

Source:
Steve Benowitz
University of California - San Diego

Physicians Offer Practical Tips On Preventing Strokes And Their Lasting Effects

2009-05-17T04:16:00.000-07:00

It takes less than a minute for a stroke to change a person's life forever, but taking the time to make a few simple lifestyle adjustments and finding out how to recognize an attack when... it happens can save thousands of lives.

"It is the third leading cause of death in the United States and the leading cause of adult disabilities, but more than half of all strokes can be prevented," says Dr. Matthew Fink, chief of the Division of Stroke and Critical Care Neurology at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.

These few lifestyle changes can greatly reduce anyone's chances of having a stroke:

- Reduce salt intake. High blood pressure is one of the leading causes of stroke. Cutting back on salt is one of the most significant steps to maintaining or lowering your blood pressure to a healthy level of 120/80 or below. Try flavoring your food with a variety of spices that may be healthier than salt.

- Eat a heart-healthy diet. Maintaining a healthy balance between your good cholesterol (HDL) and bad cholesterol (LDL) is the best way to prevent high cholesterol, heart disease and the increased risk of stroke. Your cholesterol level should remain at 200 mg/dl or below.

- Stop smoking. Smoking is not only bad for your lungs, it is bad for your brain, too. A smoker is at twice the risk of having a stroke because smoking damages blood vessels, raises blood pressure and speeds up the clogging of arteries.

- Exercise. If you are obese or overweight, your risk factors for high cholesterol, high blood pressure and diabetes increases and so does your risk for a stroke. Extra weight places an added strain on your entire circulatory system, but aerobic exercise can be a good way to lose those extra pounds and substantially improve your health.

However, there are certain populations that are still at higher risk of having a stroke even after making the proper lifestyle changes. These include adults 55 years of age or older, African-Americans and Hispanics, those with a family history of stroke, and people who have already had an attack or a transient ischemic attack (mini stroke). In addition, women are more likely to die from a stroke than men, although attacks are more common in men.

"When someone does have a stroke they may experience either slight or extremely noticeable physical changes. The most effective way to prevent the permanent damage associated with stroke is to recognize the signs of an attack and to seek medical attention immediately," says Dr. Randolph Marshall, director of the Stroke Division at NewYork-Presbyterian Hospital/Columbia University Medical Center.

The most common signs of a stroke are:

- Numbness. A sudden numbness or weakness in the face, arms or legs -- specifically on one side of the body.

- Trouble Speaking. A feeling of confusion and slurred speech or trouble speaking.

- Loss of Balance. Dizziness and trouble walking.

- Poor Eyesight. A loss of vision in one or both of the eyes.

- Headache. A sudden headache that occurs for no apparent reason.

"Eighty percent of all strokes are caused by a blood clot that blocks blood flow to the brain. Today there are many new drugs and techniques that when applied during the early onset of an attack can prevent, and in some cases reverse, the damage caused by these blockages," says Dr. Philip Stieg, chairman of the Department of Neurological Surgery and neurosurgeon-in-chief at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.

Some of the most popular techniques include:

- Revascularization. Tiny micro catheters such as the Merci Retriever and the Penumbra System are inserted into the artery and used to remove the blockages and reopen the artery.

- Clot-Dissolving Drugs. Tissue Plasminogen Activator (t-PA) is a commonly used clot-dissolving drug that is injected into the artery and dissolves the clot, restoring blood flow to the brain. This procedure is most effective when used immediately following an attack.

Source
NewYork-Presbyterian Hospital

Study Shows Relationship Between Atrial Fibrillation And Development Of Alzheimer's Disease

2009-05-16T09:31:00.000-07:00

Researchers at Intermountain Medical Center in Salt Lake City believe that they have made a breakthrough connection between atrial fibrillation, a fairly common heart rhythm disorder, and... Alzheimer's disease, the leading form of dementia among Americans.

In a study presented May 15, at "Heart Rhythm 2009," the annual scientific sessions of the Heart Rhythm Society in Boston, researchers unveiled findings from the study of more than 37,000 patients that showed a strong relationship between atrial fibrillation and the development of Alzheimer's disease.

The study, which drew upon information from the Intermountain Heart Collaborative Study, a vast database from hundreds of thousands of patients treated at Intermountain Healthcare hospitals, found:

* Patients with atrial fibrillation were 44 percent more likely to develop dementia than patients without the heart disorder.

* Younger patients with atrial fibrillation were at higher risk of developing all types of dementia, particularly Alzheimer's. Atrial fibrillation patients under age 70 were 130 percent more likely to develop Alzheimer's.

* Patients who have both atrial fibrillation and dementia were 61 percent more likely to die during the study period than dementia patients without the rhythm problem.

* Younger atrial fibrillation patients with dementia may be at higher risk of death than older AF patients with dementia.

Intermountain Medical Center cardiologist T. Jared Bunch, M.D., the study's lead researcher, presented the findings at the scientific session.

"Previous studies have shown that patients with atrial fibrillation are at higher risk for some types of dementia, including vascular dementia. But to our knowledge, this is the first large-population study to clearly show that having atrial fibrillation puts patients at greater risk for developing Alzheimer's disease," said Dr. Bunch.

Alzheimer's is a devastating brain disease affecting approximately 5.3 million Americans. It is the most common form of dementia (a general term for life-altering loss of memory and other cognitive abilities), and accounts for 60-80 percent of all dementia cases. Today, it is the sixth leading cause of death in the United States.

Currently, the known risk factors for Alzheimer's are age, family history and genetics, though injury may also be linked with the disease. Heart health has long been suspected to play a role, but has not been linked. The Intermountain Medical Center study bolsters that connection.

"The study shows a connection between atrial fibrillation and all types of dementia," said Bunch. "The Alzheimer's findings - particularly the risk of death for younger patients - break new ground."

Atrial fibrillation is the most common heart rhythm problem, affecting about 2.2 million Americans. It occurs when the heart beats chaotically, leading blood to pool and possibly clot. If the clot leaves the heart, a stroke can result.

The Intermountain Medical Center study looked at five years of data for 37,025 patients. Of that group, 10,161 developed AF and 1,535 developed dementia during the study period.

The study authors say more research is needed to explore further the relationship between atrial fibrillation and the development of Alzheimer's disease.

"Now that we've established this link, our focus will be to see if early treatment of atrial fibrillation can prevent dementia or the development of Alzheimer's disease," says cardiologist John Day, M.D., director of heart rhythm services at Intermountain Medical Center and a co-author of the study.

Source:
Jess Gomez
Intermountain Medical Center

Formulations Of Three Aspirin Types Compared By Study

2009-05-16T09:27:00.000-07:00

For many years, it has been known that aspirin is beneficial to patients suffering heart attacks and near-heart attacks. But which of the many different types of.. aspirin is likely to help the most?

A group of researchers led by Dr. Sean Nordt from the University of California, San Diego gave three different types of aspirin to a group of volunteer research subjects: regular aspirin swallowed whole, regular aspirin chewed and swallowed, and chewable aspirin chewed and swallowed. Blood levels of aspirin were then measured, to see which route led to the highest aspirin levels in the body.

The chewable aspirin consistently showed greater and more rapid absorption than the regular aspirin, whether swallowed whole or chewed. This seemingly quite simple finding could lead to improvements in the care of heart attack patients.

The presentation, entitled "Comparison Of Three Aspirin Formulations" was given by Dr. Sean Nordt in the Cardiovascular forum at the 2009 SAEM Annual Meeting at the Sheraton New Orleans on May 15. Abstracts are published in Vol. 16, No. 4, Supplement 1, April 2009 of Academic Emergency Medicine, the official journal of the Society for Academic Emergency Medicine.

Source:
Sean Wagner
Wiley-Blackwell

Heating Heart With Catheter Better Than Drugs For Common Heart Rhythm Disorder

2009-05-16T09:25:00.000-07:00

Treating a common heart rhythm disorder by burning heart tissue with a catheter works dramatically better than drug treatments, a major international study has found.

One year after undergoing a treatment called catheter ablation, 63 percent of patients with an irregular heartbeat called atrial fibrillation were free of any recurrent atrial arrhythmias or symptoms. By comparison, only 17 percent of those treated with drugs were arrhythmia-free. Results were so convincing the trial was halted early.

The ablation group also scored significantly higher on a quality-of-life scale.

The study included 167 patients at 19 centers, including 15 centers in the United States. Lead researcher Dr. David Wilber presented results at Heart Rhythm 2009, the Society's 30th Annual Scientific Sessions. Wilber is director of the Cardiovascular Institute at Loyola University Stritch School of Medicine in Maywood, Il.

Atrial fibrillation, often called A-Fib, is the most common form of irregular heartbeat. Electrical signals, which regulate the heartbeat, become erratic. Instead of beating regularly, the upper chambers of the heart quiver. Not all the blood gets pumped out, so clots can form. Atrial fibrillation can lead to strokes and heart failure.

A-Fib patient Robin Drabant, 35, of Hanover Park, Il., said the condition once "made me feel like I was 90 years old with a failing heart." She was on a maximum dose of an A-Fib medication, which caused fatigue. Despite the drug, she still had episodes almost every day, lasting from 10 seconds to an hour or longer. "I would lose my breath and could feel my heart racing and fluttering," she said.

Wilber performed a catheter ablation on Drabant in May, 2008, and she no longer has A-Fib episodes. "I had great results," she said.

A-Fib symptoms include heart palpitations, dizziness, fatigue, shortness of breath and fainting. "A lot of people are disabled," Wilber said. "They have no energy. They can't work. They have a very poor quality of life."

More than 2 million Americans have atrial fibrillation, and there are about 160,000 new cases each year. The number is increasing, due in part to the aging population and the obesity epidemic.

Drugs such as beta blockers and calcium channel blockers can slow the heart rate during an A-Fib episode. Other drugs such as flecainide and propafenone can help maintain a normal rhythm. When drugs don't work or produce unacceptable side effects, alternative treatments include a pacemaker, surgery and catheter ablation.

In the ablation procedure, an electrophysiologist destroys small areas of heart tissue that are responsible for the erratic electrical signals. A catheter (thin flexible tube) is guided through blood vessels to the heart. The tip of the catheter delivers radiofrequency energy that heats and destroys tissue. Possible adverse effects include irritation of the lining of the heart, fluid in the lungs or around the heart, bleeding, clots and stroke.

In the study, 106 patients with frequent episodes of atrial fibrillation were randomly assigned to undergo ablation and 61 similar patients were randomly assigned to receive drug therapy. All patients had experienced at least three episodes of atrial fibrillation during the previous six months and had failed at least one attempt to control the rhythm with drugs.

The study was funded by Biosense Webster, which makes the ThermoCool catheter used in the trial. Wilber is a consultant to the company.

The study was the largest to date to compare ablation to drug therapy for atrial fibrillation. Earlier studies involved single centers and smaller sample sizes, Wilber said. An additional study called CABANA is designed to determine whether ablation patients live longer than patients receiving medication. Researchers will follow about 3,000 patients for three years.

Heart Rhythm 2009 May 13-16 at the Boston Exhibition and Convention Center.

Source:
Jim Ritter
Loyola University Health System

PLC Medical Systems To Demonstrate RenalGuard(R) At EuroPCR 2009

2009-05-16T09:20:00.000-07:00

PLC Systems Inc. (OTC Bulletin Board: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, announced that it will demonstrate its RenalGuard System(TM) at EuroPCR, the annual meeting of... the European Association of Percutaneous Cardiovascular Interventions (EAPCI), May 19-22, 2009, in Barcelona, Spain. More than 11,000 clinicians and professionals are expected to attend this event.

In addition, RenalGuard(R) will be included as part of a live case transmission from Hospital Clinico San Carlos, Madrid, Spain during the meeting. The interventional cardiologists involved in the case plan to demonstrate how RenalGuard is used to help prevent Contrast-Induced Nephropathy (CIN) in a patient with impaired renal function undergoing a Percutaneous Coronary Intervention (PCI).

"Following the spirit of EuroPCR, our commitment during these live cases is to provide valuable clinical education to EuroPCR attendees," stated Dr. Javier Escaned, Consultant Interventional Cardiologist, Hospital Clinico. "I consider that creating awareness of the problem of CIN and disseminating new information on how to prevent it are very important."

Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "We are very pleased to be presenting RenalGuard to this important audience, and especially pleased that Dr. Escaned will be demonstrating a live case illustrating how RenalGuard works and how it may benefit patients. CIN is a significant and growing concern worldwide, and we are very encouraged by the prospect that RenalGuard could remedy it."

Currently, RenalGuard is the subject of an investigator-sponsored trial to study its efficacy in mitigating against CIN at the University of Milan-Centro Cardiologico Monzino (CCM). The trial is designed to provide an assessment of the potential benefits of induced diuresis with matched hydration therapy compared to standard overnight hydration, a prevalent method of treatment in the EU, in the prevention of CIN in patients undergoing cardiac catheterization procedures and percutaneous coronary interventions with baseline impairment in renal function. The CIN-prevention therapy of induced diuresis and matched hydration therapy will be provided using RenalGuard.

PLC received the CE Mark Certificate for the RenalGuard System in December 2007, and concluded its pilot safety trial in the U.S. late in 2007. The company has received full approval from the FDA to commence a U.S. pivotal trial to study the effectiveness of RenalGuard in the prevention of CIN. In March 2008, PLC signed its first international distribution agreement for RenalGuard with Artech s.r.l., Cavezzo, Italy for distribution of its RenalGuard System into Italy, and in May 2009, PLC announced its second European distributor, IZASA Distribuciones Tecnicas S.A., headquartered in Barcelona, Spain, for the distribution of RenalGuard in Spain.

About PLC Systems Inc.

PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Massachusetts, PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina. PLC's newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device.

This press release contains "forward-looking" statements. For this purpose, any statements contained in this press release that relate to prospective events or developments are deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will" and similar expressions are intended to identify forward-looking statements. Our statements of our objectives are also forward-looking statements. While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates change, and you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Actual results could differ materially from those indicated by such forward-looking statements as a result of a variety of important factors, including that we may not receive necessary regulatory approvals to market our RenalGuard product or that such approvals may be withdrawn, we may be unable to raise sufficient funds in the future to implement our business plan and/or commence our planned U.S. clinical trial for RenalGuard, the current clinical trial in Italy and the planned future U.S. clinical trial for RenalGuard as a safe and effective prevention device for contrast induced nephropathy may not be completed in a timely fashion, if at all, or, if these clinical trials are completed, they may not produce clinically significant or meaningful results, the RenalGuard product may not be commercially accepted, operational changes, competitive developments may affect the market for our products, regulatory approval requirements may affect the market for our products, and additional risk factors described in the "Forward Looking Statements" section of our Annual Report on Form 10-K for the year ended December 31, 2008, and our other SEC reports.

PLC Systems, PLC Medical Systems, PLC and CO2 Heart Laser, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.

Source: PLC Systems Inc

FDA Tells Cheerios Cereal Makers Their Health Claims Contain "Serious Violations"

2009-05-13T23:01:00.000-07:00

The US Food and Drug Administration has written a warning letter to General Mills, the makers of the popular breakfast cereal Cheerios, explaining that they have reviewed the labelling of the product and found it contains "serious violations" of federal regulations.

The details of the FDA findings are in a letter dated May 5th, from W Charles Becoat, FDA Director for the Minneapolis District, to... Ken Powell, Chairman and CEO of Minneapolis-based General Mills, who make Cheerios.

According to the FDA, General Mills is breaking federal regulations on two counts: they are marketing Cheerios like an "unapproved new drug" and misbranding the product by making "unauthorized health claims".

The FDA letter to the food company states:

"FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR)."

The FDA said that the Cheerios product label promotes it like a drug intended for use in the "prevention, mitigation, and treatment of disease". The letter drew particular attention to phrases that say the product lowers cholesterol by "4 per cent in 6 weeks", that it can also reduce bad cholesterol by 4 per cent, and that it is "clinical proven" to lower cholesterol.

The letter does not address the veracity of the claims, it addresses the point that by making such claims then the product is really a drug and should go through the proper channels for obtaining drug approval.

For example, as the letter explains, the claims indicate that Cheerios is:

"Intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia."

And by claiming that the product lowers total and bad cholesterol, then it is also claiming to treat heart disease, for which total and bad (LDL) cholesterol are known risk factors. This is what puts the product in the "new drug" category, and the letter quotes several sections of "the Act" to support their case.

The FDA said another reason that the product is considered to be a "new drug" was because under another section of "the Act", it is "not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease".

The letter acknowledged that General Mills had observed regulations correctly in respect of a health claim associating "soluble fiber from whole grain oats with a reduced risk of coronary heart disease", but the two claims about lowering cholesterol are not part of that, and goes into great detail about the positioning on the packet label and how the words are shown to make its case.

The FDA said that even if the cholesterol-lowering claim could be argued to be part of an otherwise permissible claim, the wording disqualifies it from use in the soluble fiber health claim.

On the issue of misbranding, the FDA said that Cheerios bears "unauthorized health claims in its labeling" and cites text on the company's website, which under the Act is considered to be part of the product labelling, as being faulty in this respect. The text says "heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease."

According to the FDA, the claim does not meet the requirements of the Act which requires such assertions to state that "diets low in saturated fat and cholesterol and high in fiber-containing fruit, vegetable, and grain products may reduce the risk of heart disease". The Cheerios labelling neither mentions fruits, vegetables and fiber, nor the need for the diet to be low in saturated fat and cholesterol.

Thus the label does not have enough information to "enable the public to understand the significance of the claim in the context of the total daily diet," said the FDA letter.

The letter also refers to another labelling claim about reduction in cancer risk.

The FDA said the claim, which includes the statement "regular consumption of whole grains as part of, a low-fat diet reduces the risk for some cancers, especially cancers of the stomach and colon", fails to meet the authorized format because, for example, like the other claim, it does not mention fruits and vegetables and fiber content and again denies the public the chance to see the overall context of the healthy diet.

The agency also takes issue with the added phrase "especially cancers of the stomach and colon" which goes beyond what an authorized claim is allowed to say. As the FDA letter explains:

"The claim authorized through the notification procedure does not emphasize the relationship between whole grain foods and stomach and colon cancer as compared to other cancers."

General Mills has 15 days to reply with an explanation of how they intend to "correct the violations" and to ensure that "similar violations do not occur".

New Method For Detection Of Phosphoproteins Reveals Regulator Of Melanoma Invasion

2009-04-23T22:16:00.000-07:00

Scientists have developed a new approach for surveying phosphorylation, a process that is regulated by critical cell signaling pathways and regulates several key cellular signaling events. The research, published by Cell Press in the April 10th issue of the journal Molecular Cell, describes the regulation of a... previously uncharacterized protein and demonstrates that it plays an important role in cancer cell invasion.

Many cancers, including melanoma, are associated with mutations in the gene encoding the protein kinase B-Raf. Kinases are proteins that regulate the function of other proteins by attaching a phosphate group to them. B-RAF mutations often lead to dysregulation of protein phosphorylation by the mitogen-activated protein (MAP) kinase signaling pathway. Identification and characterization of MAP kinase target proteins is critical for understanding the mechanisms involved in cancer progression.

"In contrast to targets regulated at the level of gene expression, little is known about how proteins are modified in response to oncogenic B-Raf signaling in melanoma cells. In particular, identifying cellular targets for phosphorylation is needed to gain a more comprehensive understanding of the responses to MAP kinase pathway dysregulation in melanoma," explains senior study author Dr. Natalie G. Ahn from the Department of Chemistry and Biochemistry at the University of Colorado and the Howard Hughes Medical Institute.

Current strategies to identify phosphorylated proteins require purification techniques to enrich phosphorylated from non-phosphorylated proteins and metabolic labeling procedures to quantify changes in phosphorylation. Unfortunately, these methods are not readily applied to all sample types. Dr. Ahn and colleagues developed a method for analyzing phosphorylated proteins in human cell extracts that does not depend on enrichment and can be performed quantitatively in a label-free manner.

Using their method, the researchers identified ninety phosphorylation events that were regulated by oncogenic B-Raf. The phosphorylated proteins included many known signaling molecules. However, one of the targets, MINERVA/FAM129B, belonged to a protein family with unknown function. Further investigation established a role for MAP kinase-dependent phosphorylation of MINERVA/FAM129B in cancer cell invasion within a three dimensional extracellular matrix environment.

"Our results revealed successful selection and sequencing of phosphopeptides in proteolytic digests without affinity enrichment, as well as label-free quantitation of regulated protein phosphorylation events," concludes Dr. Ahn. "Further, we demonstrated pathway-dependent phosphorylation of FAM129B and discovered its importance in controlling melanoma cell invasion."

Notes:

The researchers include William M. Old, University of Colorado, Boulder, CO; John B. Shabb, University of North Dakota, Grand Forks, ND; Stephane Houel, University of Colorado, Boulder, CO, Howard Hughes Medical Institute; Hong Wang, University of Colorado, Boulder, CO; Kasey L. Couts, University of Colorado, Boulder, CO; Chia-yu Yen, University of Colorado, Boulder, CO; Elizabeth S. Litman, University of Colorado, Boulder, CO, Howard Hughes Medical Institute; Carrie H. Croy, University of Colorado, Boulder, CO, Howard Hughes Medical Institute; Karen Meyer-Arendt, University of Colorado, Boulder, CO; Jose G. Miranda, University of Colorado, Boulder, CO; Robert A. Brown, University of Colorado, Boulder, CO; Eric S. Witze, University of Colorado, Boulder, CO; Rebecca E. Schweppe, University of Colorado, Boulder, CO; Katheryn A. Resing, University of Colorado, Boulder, CO; and Natalie G. Ahn, University of Colorado, Boulder, CO, Howard Hughes Medical Institute.

Source:
Cathleen Genova
Cell Press

New Therapeutic Target For Melanoma Identified

2009-04-23T22:14:00.000-07:00

A protein called Mcl-1 plays a critical role in melanoma cell resistance to a form of apoptosis called anoikis, according to research published this week in Molecular Cancer Research.

The presence of Mcl-1 causes cell resistance to anoikis. This resistance to anoikis enables the melanoma cells to metastasize and... survive at sites distant from the primary tumor, according to Andrew Aplin, Ph.D., an associate professor of Cancer Biology at Jefferson Medical College of Thomas Jefferson University, and a member of the Kimmel Cancer Center at Jefferson. The research was conducted at Albany Medical College in New York by Dr. Aplin and colleagues.

Mcl-1 is part of the Bcl-2 protein family, and is regulated by B-RAF proteins, which are mutated in approximately 60 percent of all human melanomas. The Bcl-2 family includes several prosurvival proteins that are associated with the resistance of cancer cells to apoptosis, or cell death. Dr. Aplin and colleagues analyzed three candidate Bcl-2 proteins: Mcl-1, Bcl-2 and Bcl-XL.

"When we depleted Mcl-1 from the tumor cells, they were susceptible to cell death," Dr. Aplin said. "Mcl-1 showed dramatic results compared to Bcl-2 and Bcl-XL, which was a surprise. Our findings show that targeting Mcl-1, which is upregulated in a majority of melanoma cells, could be a viable treatment strategy."

Dr. Aplin said there are therapeutic agents in development to target this protein family, but most specifically target Bcl-2 and Bcl-XL. There is one agent in development by Gemin X Biotech that targets Mcl-1. This agent, called obatoclax, is currently in phase I/II trials.

Source: Thomas Jefferson University

Gene Testing For Melanoma Risk Reduces Anxiety And Depression

2009-04-23T22:12:00.000-07:00

People with a family history of the skin cancer melanoma show reductions in anxiety and depression after getting tested for a high-risk gene mutation, reports a study in the May issue of Genetics in Medicine, the official peer-reviewed journal of The American College of Medical Genetics. The journal is published by Lippincott Williams & Wilkins, a part of... Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, pharmacy and the pharmaceutical industry.

"This study provides preliminary evidence for healthy psychological, behavioral, and cognitive adjustment after participation in genetic testing for melanoma risk," according to lead researcher Nadine A. Kasparian, Ph.D., of University of New South Wales, Australia.

Who Gets Tested, and What Are the Effects?

One hundred nineteen patients were offered testing for mutation of the CDKN2A gene, which has been linked to a very high risk of melanoma. All had a strong family history of melanoma, with at least three affected relatives. A wide range of factors including beliefs about melanoma and genetic testing and symptoms of anxiety and depression were evaluated to assess the characteristics of patients who opted for genetic testing, as well as the impact of being tested.

Over a three-year period, 25 patients decided to be tested. Of these, 75 percent were found to carry the CDKN2A mutation. The researchers had expected that patients with positive test results would have at least a short-term increase in psychological distress.

To the contrary, however, patients who found they carried the high-risk gene had a significant reduction in scores for anxiety at two weeks after testing. Depression scores were also decreased, and remained so at one-year follow-up.

Several factors affected the decision to undergo genetic testing. Patients who believed they were highly susceptible to melanoma were three times more likely to be tested. In contrast, those who believed that melanoma was more likely to be fatal, even if detected early, were about half as likely to be tested. The most frequent reasons for being tested were to aid melanoma research, to learn about melanoma risk in one's children, and to learn about steps to reduce personal risk.

Behavior Changes As Well As Reduced Anxiety

People who tested positive for the high-risk gene became more likely to undergo regular skin examinations by a physician a key part of recommendations for early melanoma detection. Other behaviors, including sunscreen use, were not significantly different for people with positive tests, compared to those who decided not to be tested. Because of the small number of patients with negative gene test results, the impact of testing in this group could not be evaluated.

The genetic factors affecting melanoma risk are complex, but are coming into sharper focus with the discovery of the CDKN2A mutation and other risk genes. Although the CDKN2A test could have important benefits for people with a family history of melanoma, it has yet to come into common clinical use. Benefits of testing could include knowing one's risk and taking preventive steps, such as sun protection and skin examination. The test could also have negative effects, especially psychological distress and "fatalistic" thinking about melanoma.

The encouraging new results suggest that genetic testing for melanoma risk decreases rather than increases anxiety even for patients who discover that they have the high-risk gene. The percentage of patients deciding to be tested is lower than for other genetic tests for disease risk, perhaps because patients question the value of being tested. Dr. Kasparian and coauthors hope their results will lead to "widespread discussion of, and patient education about, the benefits, risks, and limitations" of genetic testing for melanoma risk.

About Genetics in Medicine

Genetics in Medicine is the official peer-reviewed journal of The American College of Medical Genetics. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, pharmacy and the pharmaceutical industry.

About the American College of Medical Genetics

Founded in 1991, the ACMG provides education, resources and a voice for the medical genetics profession. To make genetic services available to and improve the health of the public, the ACMG promotes the development and implementation of methods to diagnose, treat and prevent genetic disease. Members include biochemical, clinical, cytogenetic, medical and molecular geneticists, genetic counselors, and other health care professionals committed to the practice of medical genetics. Genetics in Medicine, now published monthly, is the official journal of the ACMG.

About Lippincott Williams & Wilkins

Lippincott Williams & Wilkins (LWW) is a leading international publisher for healthcare professionals and students with nearly 300 periodicals and 1,500 books in more than 100 disciplines publishing under the LWW brand, as well as content-based sites and online corporate and customer services. LWW is part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals and institutions in medicine, nursing, allied health, pharmacy and the pharmaceutical industry.

Wolters Kluwer Health is a division of Wolters Kluwer, a leading global information services and publishing company. The company provides products and services for professionals in the health, tax, accounting, corporate, financial services, legal, and regulatory sectors. Wolters Kluwer had 2008 annual revenues of €3.4 billion ($4.9 billion), employs approximately 20,000 people worldwide, and maintains operations in over 35 countries across Europe, North America, Asia Pacific, and Latin America. Wolters Kluwer is headquartered in Amsterdam, the Netherlands. Its shares are quoted on Euronext Amsterdam (WKL) and are included in the AEX and Euronext 100 indices.

Source: Wolters Kluwer Health

Dark Hair? Don't Burn? Your Genes May Still Put You At Risk For Melanoma

2009-04-23T22:07:00.000-07:00

New genetic research suggests that the traditional risk factors for melanoma may not be as helpful in predicting risk in all people as previously thought, according to data presented at the American Association for Cancer Research 100th Annual Meeting 2009.

"Traditionally, a clinician might look at a person with dark hair who did not sunburn easily and classify them as lower risk for melanoma, but that may not be true for all people in the population," said Peter Kanetsky, Ph.D., M.P.H., assistant professor of epidemiology at the University of Pennsylvania.

Kanetsky and his colleagues have identified that genetic variants in MC1R could help to predict melanoma risk in people who are not usually classified as high risk. While this link previously has been observed, Kanetsky said it is now time to begin discussing genetic factors as part of the overall melanoma risk model.

For the current study, researchers analyzed 779 patients with melanoma from the Pigmented Lesion Clinic of the University of Pennsylvania and compared them with 325 healthy control patients.

Overall, the presence of certain MC1R variants was associated with a more than two-fold risk of melanoma, but this risk was largely confined to those patients who would not usually be considered to be at elevated risk.

Although those with dark hair are not thought to be at increased risk for melanoma, if they had dark hair and also inherited certain MC1R genetic variants, their risk for melanoma increased 2.4-fold. However, no elevated risk was associated with these same MC1R variants in those with blond or red hair.

MC1R was also associated with increased risk among those with dark eye color (3.2-fold increase), who did not freckle (8-fold increase), who tanned after repeated sun exposure (2.4 fold increase) or who tanned immediately without burning (9.5-fold increase). People with these characteristics are usually thought to be at reduced risk for melanoma.

Kanetsky said a clinical screening test for MC1R is not yet available.

The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world's oldest and largest professional organization dedicated to advancing cancer research. The membership includes more than 28,000 basic, translational and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and nearly 90 other countries. The AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment and patient care. The AACR publishes six major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; Cancer Epidemiology, Biomarkers & Prevention; and Cancer Prevention Research. The AACR also publishes CR, a magazine for cancer survivors and their families, patient advocates, physicians and scientists. CR provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship and advocacy.

Source: American Association for Cancer Research

New SIGN Guidelines On Stroke Upgrade Plavix® (clopidogrel) Recommendation For Secondary Stroke Prevention

2009-03-11T20:45:00.000-07:00

The Scottish Intercollegiate Guidelines Network (SIGN) have issued new guidelines for the treatment of stroke, giving clopidogrel (Plavix®) a Grade A recommendation as a monotherapy alternative to the combination of aspirin and dipyridamole in the secondary prevention of vascular events.(1)

New data has been published demonstrating the efficacy of clopidogrel in this indication since the previous guidelines were produced, such as... PRoFESS*, the largest ever trial of its kind in stroke. With the publication of these guidelines, Scotland has again shown itself to be leading the way in terms of using the most recent clinical data to inform the guidance issued for its clinicians.

Under the previous SIGN guidelines, aspirin and dipyridamole was the recommended 1st-line treatment for the secondary prevention of stroke, with clopidogrel only mentioned as a good practice point.(2) The new guidelines recommend that clopidogrel is considered as an alternative to the combination of aspirin and dipyridamole after someone has had a, ischaemic stroke, for the secondary prevention of vascular events. Both treatment options have Grade A status in recognition of the body of clinical evidence supporting their use in this indication.

Chest, Heart & Stroke Scotland Chief Executive David Clark said, "We very much welcome the new guidelines, but we must make sure that the resources are made available to provide these treatments, and that the guidelines are put into practice so that all potential Scottish stroke patients benefit. We also need to improve awareness about the signs and symptoms of a stroke and to drive home the message that stroke is a medical emergency - we are already working with the NHS through our FAST campaign to achieve this."

Stroke is the 3rd largest cause of death and the largest cause of severe disability in Scotland, as it is UK-wide.(3,4) There are an estimated 100,000 stroke survivors currently living in Scotland.(4)

The National Institute for Health and Clinical Excellence (NICE) published their most recent clinical guidelines on stroke in July 2008 (prior to the publication of the PRoFESS data in August) and are currently revising their Technology Appraisal on clopidogrel and dipyridamole for use in vascular disease (expected in 2010).(5)

Clopidogrel has been prescribed for over 10 years in a broad range of atherothrombotic patients, amongst whom it has been shown to provide early and long-term protection against future vascular events. Clopidogrel has a well-known safety and efficacy profile.(6-10)

Notes:

*PRoFESS: Prevention Regimen For Effectively avoiding Second Strokes11

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY).

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life.

Plavix® (clopidogrel) is manufactured by sanofi-aventis and Bristol-Myers Squibb.

References:

1 Scottish Intercollegiate Guidelines Network (SIGN), Management of patients with Stroke or TIA: assessment, investigation, immediate management and secondary prevention (SIGN 108) (2008)

2 Scottish Intercollegiate Guidelines Network (SIGN), Management of patients with Stroke: Rehabilitation, Prevention and Management of Complications, and Discharge Planning (SIGN 64) (2002)

3 Department of Health website, http://www.dh.gov.uk/en/healthcare/nationalserviceframeworks/stroke/index.htm (last accessed December 11th 2008)

4 The Stroke Association, http://www.stroke.org.uk/in_your_area/scotland/index.html (last accessed 12th December 2008)

5 National Institute for Health and Clinical Excellence (NICE), Clopidogrel and dipyridamole for the prevention of artherosclerotic events (Technology Appraisal 90). (May 2005)

6 CAPRIE Steering Committee. A randomised, blinded trial of Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events (CAPRIE). Lancet 1996; 348: 1329-1339.

7 The Clopidogrel in Unstable angina to prevent Recurrent Events trial investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. NEJM 2001; 345: 494-502.

8 COMMIT (Clopidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet 2005; 366: 1607-1621.

9 Sabatine MS et al. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. NEJM 2005; 352: 1179-1189.

10 Yusuf S et al. Early and late effects of clopidogrel in patients with acute coronary syndromes. Circulation 2003; 107: 966-972.

11 PRoFESS Study Group. Aspirin and Extended-Release Dipyridamole versus Clopidogrel for Recurrent Stroke. NEJM 2008; 359 1-14

Sources:
Caroline Almeida
Bristol-Myers Squibb

Jeannine Nolan
sanofi-aventis

New Data Shows Abbott's Bioabsorbable Drug Eluting Stent Is Absorbed Within Two Years - Leaving Behind Functioning Blood Vessels

2009-03-11T20:41:00.000-07:00

Abbott (NYSE: ABT) announced two-year data from 30 patients in its ABSORB clinical trial, demonstrating that its bioabsorbable drug eluting stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries. Patients who received Abbott's bioabsorbable drug eluting coronary stent and... were followed out to two years experienced no stent thrombosis out to two years and no new major adverse cardiac events (MACE) between six months and two years. These results confirmed earlier positive one-year clinical results with Abbott's bioabsorbable drug eluting stent. The results were presented today at the Cardiovascular Research Foundation's 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

"Now you see it, now you don't -- for the first time, we have data in patients showing that Abbott's bioabsorbable drug eluting stent does its job treating diseased coronary arteries and that it is absorbed by two years," said John Ormiston, M.D., principal investigator in the ABSORB trial and medical director at Mercy Angiography in Auckland, New Zealand. "Clinical safety and effectiveness were sustained at two years, and the previously stented portion of arteries demonstrated the ability to expand and contract in a manner similar to a vessel that has never been stented. These are very exciting results that represent a potential major breakthrough in the future treatment of patients with coronary artery disease."

Trends were observed in data from tests of artery movement and function, demonstrating a potential restoration of unstented artery movement to coronary blood vessels after the stent was absorbed -- something that is not possible with permanent metal-based stent implants.

Abbott also will present groundbreaking intravascular ultrasound (IVUS) and optical computed tomography (OCT) imaging data on its bioabsorbable drug eluting coronary stent platform this week at TCT in the "Best of Coronary Interventions Abstracts" session at 9:20 a.m. Eastern time on Wednesday, Oct. 15, 2008. IVUS data will reveal a decrease in plaque area in treated arteries corresponding to a similar increase in blood flow area between six months and two years: 12.7 percent decrease in plaque area (p=<0.001, n=17); 10.8 percent increase in luminal area (p=0.03, n=17). OCT imaging data will show absorption of the stent into artery walls and that the blood vessel lining of arteries treated with Abbott's bioabsorbable stent looks more uniform after two years than it did immediately post-treatment.

"The imaging technology data from the ABSORB trial indicate that Abbott's bioabsorbable stent has the potential to restore vascular integrity and endothelial function to treated vessels after two years," said Professor Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, and co-principal investigator in the ABSORB trial. "With these ABSORB data, we have come full circle in interventional time, linking the past, when balloon angioplasty was used without stents, to the future, when disappearing stents may become the new standard of care for patients with coronary artery disease."

Abbott is the only company with long-term clinical data evaluating the safety and performance of a fully bioabsorbable drug eluting coronary stent out to two years. Abbott's bioabsorbable everolimus eluting coronary stent is made of polylactic acid, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. As with a metallic stent, Abbott's bioabsorbable stent is designed to restore blood flow by propping a clogged vessel open, and to provide support until the blood vessel heals. Unlike a metallic stent, however, a bioabsorbable stent is designed to be slowly metabolized by the body and completely absorbed over time.

"The early success of our bioabsorbable stent marks the dawn of the beginning of a new era in the history of interventional medical device treatment," said John M. Capek, Ph.D., executive vice president, Medical Devices, Abbott. "Today's data show that bioabsorbable stents have become more than just a wish for patients -- they are now on their way to becoming a clinical reality."

Abbott will begin enrolling the next cohort of 80 patients into its international ABSORB clinical trial in the first half of 2009.

ABSORB Clinical Trial Results

Two-year data from the first 30 patients enrolled in the ABSORB clinical trial demonstrated a low (3.6 percent, n=28) MACE rate, which was consistent with results at one year (3.4 percent, n=29) and before six-months (3.3 percent, n=30). One patient had a minor heart attack due to lack of blood supply at six-months, another was electively lost to follow up at one year, and one patient died from a non-cardiac cause at two years. A zero percent stent thrombosis rate persisted for all patients across all time points in the ABSORB trial. Potential restoration of unstented artery movement to coronary blood vessels after the bioabsorbable stent was absorbed was revealed at two years with the drugs acetylcholine and nitroglycerin used in nine patients, showing vasodilation in the previously stented area, and methergine used in seven patients, showing vasoconstriction in the previously stented area.

About the ABSORB Clinical Trial

The ABSORB trial is a prospective, non-randomized (open label) study designed to enroll up to 110 patients in Belgium, Denmark, France, New Zealand, Poland and the Netherlands. Key endpoints of the study include assessments of safety -- MACE (defined as any event that resulted in re-treatment of the treated artery, heart attack or cardiac death) and stent thrombosis (blood clot formation) rates -- at 30, 180 and 270 days, with additional annual follow-up for up to five years, as well as an assessment of the acute performance of the bioabsorbable drug eluting stent. Other key endpoints of the study include successful deployment of the bioabsorbable drug eluting stent, follow-up measurements assessed by angiography, intravascular ultrasound (IVUS), and state-of-the-art imaging modalities at 180 days and two years.

Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.

For images of Abbott's bioabsorbable stent and other information, please visit the company's online TCT newsroom at http://www.abbottvascular.com/presskit.

About Abbott Vascular

Abbott Vascular, a division of Abbott, is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.

Abbott

AGGRASTAT(R), Lowers Incidence Of Heart Attack, In Patients Who Respond Poorly To Aspirin Or Clopidogrel, After Elective Coronary Angioplasty

2009-03-11T20:39:00.000-07:00

Antiplatelet medicine, AGGRASTAT® (tirofiban HCL), a glycoprotein IIb/IIIa inhibitor, has been shown to significantly lower the incidence of heart attack after elective coronary angioplasty, in patients with coronary artery disease who have shown poor response to standard oral antiplatelet agents such as... aspirin and clopidogrel.1 These results were announced at the Annual European Society of Cardiology Congress in Munich, Germany.

"These findings are significant in that we demonstrate a proof of concept for a new treatment strategy in a patient segment whose needs have so far remained unaddressed - managing for the increased risk of thrombotic events due to non-responsiveness of patients to standard oral antiplatelets such as aspirin or clopidogrel," said Dr Marco Valgimigli, Chair of Cardiology, University of Ferrara, Italy and principal investigator of the 3T/2R Study (Tailoring Treatment with Tirofiban in patients showing Resistance to aspirin and/or Resistance to clopidogrel).

Inhibition of platelet aggregation following an intake of aspirin or clopidogrel varies greatly among patients, and previous studies have shown that poor response to oral antiplatelet agents increases the risk of thrombotic events, especially after coronary angioplasty.1 It was previously unknown if this reflected suboptimal platelet inhibition per se which might benefit from alternative or more potent antiplatelet agents.

Enrolled in the study were 263 patients who were poor responders to aspirin and/or clopidogrel, based upon a point-of-care assay, who underwent elective coronary angioplasty at ten European sites for stable or low-risk unstable coronary artery disease. Patients were randomly assigned in a double blind manner to receive either AGGRASTAT® or placebo on top of standard aspirin and clopidogrel therapy.1 The primary end point was the occurrence of periprocedural myocardial infarction, as defined by an increase in Troponin I or T within 48 hours, and was observed in 20.4 percent of patients treated with AGGRASTAT®, compared to 35.1 percent of patient treated with placebo.1 This resulted in a significant reduction of major adverse cardiovascular events within 30 days in the AGGRASTAT® group compared to the placebo group (21.2 percent versus 36.6 percent, respectively; p=0.0065).1 The incidence of bleeding was low and did not differ between the two groups.1

"Current treatment strategies for patients with coronary artery disease ignore the individual response to antiplatelet agents, and likewise fail to identify therapeutic targets for platelet reactivity necessary to intensify treatment," said Dr Paul Gurbel, Director of Cardiovascular Research, Centre for Thrombosis Research, Sinai Hospital, Baltimore, USA. "These findings illustrate the efficacy and safety of AGGRASTAT® in treating poor responders to aspirin or clopidogrel, as compared to standard care. This study shows that by assessing response to standard antiplatelet agents by a point-of-care assay, intensity of treatment can be modulated accordingly."

Dr Gurbel further commented, "These data are in accordance with our earlier results from the CLEAR PLATELETS studies that have demonstrated the strong association between high periprocedural platelet reactivity and the risk of in-hospital myocardial infarction in patients undergoing elective stenting. The use of glycoprotein IIb/IIIa inhibitors, in patients identified as poor responders to oral antiplatelet agents by objective measurements of platelet function, makes perfect sense and deserves greater attention in future studies."

"These data findings are extremely encouraging for this patient population and we believe it reinforces the potential benefits of high-dose bolus AGGRASTAT®," said John Vavricka, President and Chief Executive Officer of Iroko Pharmaceuticals. "Iroko is committed to furthering clinical research in this area, and exploring AGGRASTAT®'s potential for patients who do not respond to oral anti-platelet therapy."

In January of 2008, Iroko Pharmaceuticals acquired all non-US commercial rights to AGGRASTAT® from Merck & Co., Inc. The 3T/2R study was initiated and conducted by the University of Ferrara, Italy with an unrestricted grant from Merck & Co., Inc. and Iroko.

About AGGRASTAT®

AGGRASTAT®, a glycoprotein IIb/IIIa inhibitor, is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 12 hours and with ECG changes and/or elevated cardiac enzymes. Patients most likely to benefit from AGGRASTAT® treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA.

In most patients, AGGRASTAT® should be administered intravenously, at an initial rate of 0.4 mcg/kg/min for 30 minutes and then continued at 0.1 mcg/kg/min. For complete information, please refer to the product's prescribing information. AGGRASTAT® is intended for use with acetylsalicylic acid and unfractionated heparin.

AGGRASTAT® (tirofiban hydrochloride) is contraindicated in patients with known hypersensitivity to any component of the product; active internal bleeding or a history of bleeding diathesis within the previous 30 days; or a history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Other contraindications to AGGRASTAT® include: a history of thrombocytopenia following prior exposure to AGGRASTAT®; history of stroke within 30 days or any history of hemorrhagic stroke; major surgical procedure or severe physical trauma within the previous month; or history, symptoms, or findings suggestive of aortic dissection. AGGRASTAT® is also contraindicated in patients with: severe hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg); concomitant use of another parenteral GP IIb/IIIa inhibitor; or acute pericarditis.

Bleeding is the most common complication encountered during therapy with AGGRASTAT®. Administration of AGGRASTAT® is associated with an increase in bleeding events classified as both major and minor bleeding events, by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with AGGRASTAT® occurs at the arterial access site for cardiac catheterization. Fatal bleedings have been reported. AGGRASTAT® should be used with caution in patients with platelet count <150,000/mm3, in patients with hemorrhagic retinopathy, and in chronic hemodialysis patients. Because AGGRASTAT® inhibits platelet aggregation; caution should be employed when it is used with other drugs that affect hemostasis. The safety of AGGRASTAT® when used in combination with thrombolytic agents has not been established. During therapy with AGGRASTAT®, patients should be monitored for potential bleeding. When bleeding cannot be controlled with pressure, infusion of AGGRASTAT® and heparin should be discontinued.

The following additional adverse reactions have been reported in post- marketing experience: bleeding, intracranial bleeding, retroperitoneal bleeding, hemopericardium, and pulmonary (alveolar) hemorrhage. Fatal bleedings have been reported; body as a whole: acute and/or severe decreases in platelet counts which may be associated with chills, low grade fever, or bleeding complications; hypersensitivity; rash and/or hives.

Please refer to the specific Prescribing Information for your country for complete warnings and precautions.

About Iroko

Iroko is a pharmaceutical company focused on acquiring, developing, and maximizing the potential of currently marketed pharmaceutical products on a worldwide basis. Iroko applies concentrated selling and marketing efforts and product life cycle management strategies focused on developing new and relevant formulations and indications that benefit patient health. For more information, visit http://www.iroko.com.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. http://www.merck.com

References

1 Valgimigli M, Campo Gianluca, de Cesare N, Meliga E et al. A double-blind randomised multicentre trial of tailored infusion of tirofiban in poor aspirin and/or clopidogrel responders undergoing elective percutaneous coronary intervention. Presented at ESC, 2 September 2008

Merck & Co., Inc

Obesity, Diabetes And Heart Risk Linked To Alzheimer's, Dementia, Cognitive Decline

2009-03-11T20:34:00.000-07:00

Four studies published in a leading journal this week suggest that metabolic disorders such as obesity and diabetes may share risk factors that affect the development of Alzheimer's disease, other forms of dementia and cognitive decline.

The studies are published in the March issue of Archives of Neurology, a JAMA/Archives journal and find that:...

1. The more components of metabolic syndrome a woman has, the more likely she is to develop cognitive impairment
Dr Kristine Yaffe of the University of California, San Francisco, and the San Francisco Veterans' Affairs Medical Center, and colleagues recruited nearly 5,000 women of average age 66 with no cognitive impairment and followed them for four years. Of the 10 per cent who had metabolic syndrome, 7 per cent developed cognitive impairment compared with 4 per cent who did not have metabolic syndrome. The risk of developing cognitive impairment went up for each additional metabolic syndrome component present. (Click here for more info).

2. A man who is obese in old age is more likely to have worse cognitive function
Dr Alka M Kanaya of the University of California-San Francisco, and colleagues studied over 3,000 elderly people enrolled in the Health ABC Study. They assessed their overall body fat (adiposity) from their their body mass index, waist size, saggital diameter (from highest point of abdomen to the back), total fat, subcutaneous fat (under the skin) and visceral fat (between internal organs). Men with higher levels of body fat performed worse in cognitive function tests taken at the beginning of the study and after three, five and eight years. But no such link was found in the women.(Click here for more info).

3. Being obese in middle age, or underweight in old age puts a person at greater risk of dementia
Dr Annette L Fitzpatrick of the University of Washington, Seattle, and colleagues followed 2,700 adults of average age 75 without dementia who reported their weight in midlife (age 50) and had their height and weight measured in late life (age 65 and over). The average follow up was 5.4 years. They found that those people who were obese in midlife (body mass index, BMI, over 30) were more likely to develop dementia than those of normal weight. However, in late life the picture was quite different. Being obese in late life appeared to protect against dementia, while being underweight (BMI under 20) put a person at increased risk, and being overweight had no effect. (Click here for more info).

4. A person with Alzheimer's disease who has a history of diabetes and higher levels of total and "bad" (LDL) cholesterol is more likely to have a faster rate of cognitive decline
Dr Elizabeth P Helzner and colleagues at the Columbia University Medical Center, New York, studied 156 patients who were diagnosed with Alzheimer's at average age 83 and followed them for an average of 3.5 years. Over this time, those with higher LDL ("bad" cholesterol) and total cholesterol before diagnosis showed a faster decline on tests of cognitive function compared to those whose cholesterol was normal. This was the same for those who had a history of diabetes compared to those who did not. (Click here for more info).

Metabolic syndrome is a group of risk factors that predisposes a person to heart disease, diabetes, and other conditions. The risk factors include: obesity, mild glucose abnormalities, high blood pressure, and adverse changes in blood fats.

Metabolic syndrome affects about one in five people and older people more. Some studies suggest 1 in 4 people in the US have the condition.

In an accompanying review titled " Insulin Resistance May Links Metabolic and Cognitive Disorders", Dr Suzanne Craft of Veterans Administration Puget Sound Health Care System and University of Washington School of Medicine in Seattle, suggested that insulin resistance, which is when the tissues in the body stop being sensitive to the hormone that controls glucose levels, may be behind dementia and metabolic disorders like diabetes and obesity.

Craft wrote:

"Considerable progress has been made in establishing relationships among metabolic disorders and late-life dementing illnesses."

"A number of challenges must be addressed as we move forward to determine the key mechanisms underlying these associations," she concluded, while emphasizing the need to have clear definitions of both metabolic and neurological conditions.

"Future research aimed at identifying mechanisms that underlie comorbid associations will not only provide important insights into the causes and interdependencies of late-life dementias, but will also inspire novel strategies for treating and preventing these disorders," wrote Craft.

Sources: JAMA/Archives.

Female Cardiovascular Patients With Depression Incur Higher Health Care Costs

2009-03-11T20:30:00.000-07:00

WHAT:

Women with suspected coronary artery disease who suffer from depression have significantly higher health care costs than those who are not depressed, according to findings from the Women's Ischemia Syndrome Evaluation (WISE), an ongoing, multicenter study funded by the National Institutes of Health.

Previous studies have shown that patients suffering from certain medical conditions and depression have greater health expenses than... those without depression. Because women are diagnosed with depression at twice the rate of men, the study of costs related to depression and women's health issues is particularly important.

WHO:

C. Noel Bairey Merz, M.D., is available to provide additional details. She is one of the journal article authors and chair of the multicenter WISE initiative, which is investigating potential methods for more effective diagnosis and evaluation of coronary artery disease in women. Bairey-Merz serves as director of the Women's Heart Center at the Cedars-Sinai Heart Institute, where she also directs the Preventive and Rehabilitative Cardiac Center at the Cedars-Sinai Heart Institute. A professor of medicine at Cedars-Sinai Medical Center, she holds the Women's Guild Endowed Chair in Women's Health.

DETAILS:

This study, conducted among 868 women undergoing evaluations for possible coronary artery disease, used three different approaches to measure depression (history of treatment for depression, use of antidepressant medications, and a standard, widely accepted questionnaire). Seventeen percent to 45 percent of the women in the study met depression criteria.

Depression was associated with 15 percent to 53 percent increases in cardiovascular costs over five years. Translated into dollar figures, annual cardiovascular costs were $1,550 to $3,300 higher for depressed women than for those who were not depressed (depending on the depression criteria used).

Several factors appear to be responsible for these increased costs, but one clear association is the fact that the depressed women experienced more cardiovascular disease events. Interestingly, relationships between depression and costs were particularly strong among women who did not have evidence of significant coronary artery disease, suggesting that depression may play a larger cost role in women who do not have traditional markers of heart disease. These results combined with prior work suggest that women with symptoms of heart disease without obstructive CAD are more prone to depression possibly secondary to misdiagnosis and misunderstanding. More research is needed," said Bairey Merz.

RAMIFICATIONS:

The findings suggest that depression is an important factor in understanding overall and cardiovascular-related costs in women who have symptoms of heart disease. Although it is not currently known whether treatment for depression can lower costs in cardiac populations, the results support future research in this area.

FUNDING:

The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health, the National Center for Research Resources, the Gustavus and Louis Pfeiffer Research Foundation, The Women's Guild of Cedars-Sinai Medical Center, The Ladies Hospital Aid Society of Western Pennsylvania, and the Edythe Broad Endowment for Women's Heart Research.

Notes:

The study abstract can be accessed

First Swiss Patients Treated With The Percutaneous MitraClip(R) System

2009-03-11T20:27:00.000-07:00

Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced that the first series of patients have been successfully treated with the MitraClip(R) system at the Cardiocentro Ticino in Lugano, Switzerland. The MitraClip(R) system is the only medical device commercially available in the European Union which provides a non-surgical mitral valve repair option for... patients suffering from the effects of functional and degenerative mitral regurgitation (MR).

Mitral regurgitation is the most common type of heart valve insufficiency in Europe and the United States, affecting millions of people worldwide. In the vast majority of patients, the MR is untreated, requiring the heart to work harder and ultimately leading to heart failure.

The first patients in Switzerland were treated by the team led by Prof. T. Moccetti, M.D., assisted by G.B. Pedrazzini, M.D.; E. Pasotti, M.D.; F.F. Faletra, M.D.; and A. Auricchio, M.D., Ph.D.

"Until now, many heart failure patients with associated functional MR had no therapeutic options except medical management when surgery was not possible either because they have already had heart surgery, or presented with important renal insufficiency or lung disease, all of which significantly increase the risk of a second or a third operation," said Prof. Moccetti, Head of Cardiology Division and Medical Director of Cardiocentro Ticino. He added "The MitraClip(R) therapy provides a valuable alternative for these patients."

Professor Auricchio, Director of the Heart Failure Clinic commented: "Heart failure is a devastating disease, significantly more common than cancer and has the same poor life-expectancy. Implantable devices such as cardiac resynchronization therapy have improved the quality of life of these patients. Now with percutaneous mitral valve repair, I am confident we can expand our treatment possibilities to many of our Swiss heart failure patients."

Evalve initiated commercial sales of the MitraClip(R) system in Europe under the CE Mark in September 2008. The company is employing a direct sales strategy and is taking a disciplined and measured approach to the initial commercial roll out. The company has worked closely with hospitals to deliver high quality training programs in preparation for the first series of implants. The MitraClip(R) device is now currently being implanted in five countries, including Germany, Italy, the United Kingdom, the Netherlands and now Switzerland.

"We are very pleased to see the successful initial use of the MitraClip device in Switzerland at this important cardiac center," said Ferolyn Powell, president and chief executive officer of Evalve. "The functional MR heart failure patient continues to be the fastest growing segment of the population undergoing treatment with the MitraClip(R) system and the initial commercial results in this population are very encouraging."

About the MitraClip(R) Procedure

Percutaneous mitral repair with Evalve's MitraClip(R) device is performed by physicians in the catheterization laboratory. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR. After treatment, patients generally recover quickly. The MitraClip(R) device may improve quality of life and may help MR patients avoid or delay surgery, having preserved surgical options (valve repair or replacement) should surgery become necessary.

About Evalve, Inc.

Founded in 1999, Evalve, Inc., headquartered in Menlo Park, Calif., has developed a proprietary system which enables percutaneous repair of cardiac valves. The company's initial products are intended to reduce the risks, trauma and costs associated with current open, arrested heart surgical options. For more information about Evalve, Inc., and for an animated explanation of the procedure using the MitraClip(R) device, visit http://www.evalveinc.com. Evalve is the first portfolio company from the medical device company incubator, The Foundry (http://www.thefoundry.com).

The MitraClip(R) system is currently undergoing clinical evaluation in the United States and Canada.

MitraClip(R) and Evalve are registered trademarks of Evalve, Inc.

Evalve, Inc.

Heart Surgeon And Cardiologist At Moore Regional Hospital Perform Nation's First Convergent Ex-Maze Procedure To Treat Atrial Fibrillation

2009-03-11T20:17:00.000-07:00

A heart surgeon and a cardiologist specializing in electrophysiology have collaborated to perform the nation's first-ever Convergent Ex-Maze procedure to correct atrial fibrillation at FirstHealth Moore Regional Hospital. Atrial fibrillation, or afib, is an often debilitating heart disorder that... affects an estimated five million Americans.

Cardiothoracic surgeon Andy C. Kiser, M.D., who led the development of the Ex-Maze procedure for atrial fibrillation, and electrophysiologist Mark Landers, M.D., combined their expertise to perform the groundbreaking Convergent Ex-Maze on Jan. 23, 2009. Each physician had performed his specialty (the Ex-Maze by Dr. Kiser and the percutaneous endocardial catheter ablation by Dr. Landers) separately numerous times before, but never together until the January collaboration.

"This case is significant because we can now treat atrial fibrillation without chest incisions and because by working with the electrophysiologist during the procedure, we can do a complete atrial fibrillation treatment," Dr. Kiser says.

"The power of this new procedure is that we have heart surgeons and cardiologists taking tried-and-true technologies and working together to provide the best option for the treatment of atrial fibrillation," says Dr. Landers.

Atrial fibrillation (afib), which affects an estimated five million people, is the most common type of heart rhythm disturbance. It is the rapid, uncoordinated beating of the atria in the two upper chambers of the heart. With afib, the atria quiver instead of beating in rhythm when the electrical impulses that cause them to contract travel through the heart in chaotic fashion.

There are three types of atrial fibrillation: paroxysmal, persistent and long-standing persistent. Paroxysmal afib occurs when the abnormal electrical signals and rapid heart rate begin suddenly and then stop on their own. Symptoms can be mild or severe and last for seconds, minutes, hours or days. With persistent afib, the abnormal heart rhythm continues until it is stopped with treatment. Long-standing persistent afib lasts for more than one year. Both paroxysmal and persistent atrial fibrillation may become more frequent and eventually result in a long-standing or permanent afib.

Some people with afib are severely debilitated by weakness, shortness of breath or pain while others have no symptoms at all.

The union of the Ex-Maze procedure and catheter ablation provides many benefits to the patient including:

Elimination of chest incisions
Quicker recovery time
Shorter hospital stay
Minimal scarring
Ablation testing at the time of the Ex-Maze to confirm appropriate treatment endpoints

During the Convergent Ex-Maze procedure, the Ex-Maze portion is performed through a small incision in the abdomen while a small catheter is inserted in the large vein in the groin for the catheter ablation.

"This eliminates the need for sometimes painful incisions in the chest and allows instantaneous confirmation of the success of the procedure," says Dr. Kiser. "This approach allows the patient to have a quicker recovery and also allows us to add new lesions to parts of the heart that we couldn't reach before. In addition, it allows patients who travel from great distances for the treatment to be able to fly to the area instead of having to drive."

Dr. Kiser recently traveled to the Texas Cardiac Arrhythmia Institute at St. David's Medical Center in Austin, Texas, to observe Rodney Horton, M.D., an electrophysiologist, and Andrew Hume, M.D., a cardiac surgeon, perform the second procedure in the United States. Andrea Natale, M.D., medical director of the heart arrhythmia program at St. David's and an internationally known heart arrhythmia specialist, was also on hand for the procedure.

Various improvements to the traditional open-heart surgery technique have been developed to block the stray electrical impulses of atrial fibrillation and guide electricity onto the correct pathways through the heart. Other traditional treatments include medication, pacemaker implantation and electrical shock, all of which are offered at Moore Regional Hospital.

For many years, the "gold standard" for afib treatment has been a surgical procedure called the Cox Maze, which requires opening the chest, stopping the heart and cutting it into sections before it is sewn back together. Dr. Kiser's Ex-Maze procedure, a novel improvement to the Cox Maze that he developed in collaboration with other surgeons, creates an extensive pattern of scar tissue on the heart's surface and controls the heart's abnormal electrical impulses without the complexity of similar procedures.

"A major advantage of the Ex-Maze is that the procedure is done while the heart is beating, so the patient doesn't have to be on a heart-lung machine," Dr. Kiser says.

Initially, Dr. Kiser performed the Ex-Maze only on patients who were having some other type of open-chest procedure, such as a coronary artery bypass. In 2007, he was invited to Krakow, Poland, where he performed the world's first minimally invasive Ex-Maze procedure using Paracardioscopy, which allows surgeons to look at and operate on the heart by using ports and small cameras. He began offering the Paracardioscopic Ex-Maze as a treatment option at Moore Regional in January 2008.

Catheter ablation, a common medical procedure to treat atrial fibrillation, uses a long, thin, flexible tube (called an ablation catheter) that is typically put into a blood vessel in the arm, groin (upper thigh) or neck. The tube is guided to the heart through the blood vessel, and a special machine sends energy through the catheter to the heart. This energy finds and destroys small areas of heart tissue where abnormal heartbeats may cause an arrhythmia to start. During the Convergent Ex-Maze procedure, the ablation catheter is inserted into the heart through the groin.

The Convergent Ex-Maze can be used to treat all three types of atrial fibrillation, but focuses on those patients who have been difficult to treat with traditional methods.

"Those difficult-to-treat patients, who have had atrial fibrillation for a long time, are the patients we are now treating with this procedure," says Dr. Kiser.

Dr. Kiser is a member of the Cardiovascular and Thoracic Center and chief of Thoracic Surgery at Moore Regional Hospital. Also, the medical director of FirstHealth's Chest Center of the Carolinas and Arrhythmia Center, he has been performing heart and lung surgeries at Moore Regional since 2000 and has performed more than 150 minimally invasive Ex-Maze procedures.

Dr. Landers is affiliated with Pinehurst Cardiology Consultants, a comprehensive cardiology practice in Pinehurst.

For more information on the Convergent Ex-Maze atrial fibrillation procedure developed by Dr. Andy Kiser and Dr. Mark Landers, please contact FirstHealth Moore Regional Hospital at (800) 213-3284 or visit http://www.firsthealth.org/afib. Additional information is also available on the Ex-Maze Web site at http://www.exmaze.com.

CUTLINE

A team of American and Polish physicians performed the world's first Convergent Ex-Maze procedure in Krakow, Poland, in January 2009. Members of that team are (front from left) Rodney Horton, M.D., an electrophysiologist with St. David's Medical Center in Austin, Texas; Andy Kiser, M.D., the Moore Regional Hospital cardiac surgeon who developed the groundbreaking procedure; and Andrew Hume, M.D., a cardiac surgeon with St. David's Medical Center in Austin, Texas; and (back from left) David Haines, M.D., a cardiologist with William Beaumont Hospital in Michigan; and cardiac surgeon Krzysztof Bartus, M.D., of Poland. Source medical update

All-Inclusive Solution For Rigid Posterior Fixation Of The Cervico-Thoracic Regions Of The Spine

2009-03-11T09:29:00.000-07:00

K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, announced the introduction of an all-inclusive solution for rigid posterior fixation of the cervico-thoracic regions of the spine. The CASPIAN™ Spinal System has received FDA 510(k) and CE Mark clearance for... domestic and international distribution, expanding the global presence of K2M technologies.

This comprehensive system provides two different polyaxial screw options, Mini MESA™ and Mini DENALI™, as well as Mini Hooks and 3.5 mm Rods. The Mini MESA screws feature K2M's flagship Zero-Torque Technology™ which applies zero torsional loads, or twisting forces, to the spine when locking the system. The Mini DENALI screws feature off-axis screw height adjustment, whereby the screwdriver does not need to be co-linear with the screw shaft to adjust the screw during surgery.

According to Dr. Pierce Nunley, Director of the Spine Institute of Louisiana, "The Zero-Torque locking mechanism and ability to do complex manipulations easily on individual screws across multi-level constructs is superior to any other posterior cervico-thoracic reconstruction system on the market."

"The CASPIAN Spinal System is an important introduction for K2M, because it addresses the increasing demand from the surgeon community to offer our innovative MESA Zero-Torque Technology for the upper regions of the spine," stated Eric Major, K2M's President and CEO. "The CASPIAN clearance moves us one step closer to our goal of providing a complete product portfolio of best-in-class systems for treating all types of complex spine pathologies."

About K2M

K2M, Inc. is an innovative spinal device company that develops simplified solutions for the treatment of complex spinal pathologies and procedures. Chief Medical Officer, Chairman and co-founder, Dr. John Kostuik, former Chief of Spine Surgery at The Johns Hopkins University School of Medicine, drives K2M's commitment to redefining the market. K2M's comprehensive line of products include: spinal stabilization systems, minimally invasive systems, and other advancements in spine solutions for Degenerative Disc Disease (DDD), as well as deformity, trauma, and tumor.

K2M, Inc

Brain Damage Found In Cognitively Normal People With Alzheimer's Marker

2009-03-11T09:27:00.000-07:00

Researchers at Washington University School of Medicine in St. Louis have linked a potential indicator of Alzheimer's disease to brain damage in humans with no signs of mental impairment.

Although their cognitive and neurological assessments were normal, study participants with lower levels of... a substance known as amyloid beta 42 (A-beta 42) in their cerebrospinal fluid (CSF) had reduced whole brain volumes, suggesting that Alzheimer's changes might already be damaging their brains. Scientists previously showed that low CSF levels of A-beta 42 mark the presence of amyloid deposition in the brain, a key diagnostic marker of the amyloid plaques that characterize Alzheimer's disease.

Evidence is mounting that Alzheimer's harms the brain for many years before physicians and family members can detect symptoms, and this has led many to conclude that successful Alzheimer's treatments may only be possible if scientists find ways to identify pre-symptomatic sufferers.

The results are an encouraging sign that this search for new indicators, known as antecedent biomarkers, may be succeeding, according to senior author David M. Holtzman, M.D., the Andrew and Gretchen Jones Professor and chair of the Department of Neurology at the School of Medicine and neurologist-in-chief at Barnes-Jewish Hospital.

"We still need to confirm with long-term follow-up studies that subjects with this biomarker and brain damage go on to develop the cognitive changes characteristic of Alzheimer's," says Holtzman. "For now, the evidence we've uncovered further proves that identification and treatment prior to the start of the symptoms of Alzheimer's disease are likely going to be essential to preventing irreversible brain injury."

The results were published in the February issue of Annals of Neurology.

A-beta 42 is a protein fragment that clumps together in the brain to form the plaques that have long been the diagnostic hallmark of the disease. In an earlier study, the same Washington University researchers showed that when A-beta 42 decreases in CSF, it begins to build up in the brain.

"The new results show that something associated with amyloid deposition in the brain - either the amyloid itself or some toxic product of it - is causing brain damage in people who are still cognitively normal," says Holtzman.

For the study, led by Anne Fagan, Ph.D., research associate professor of neurology, scientists analyzed CSF samples and brain scans of two groups of subjects at the university's Alzheimer's Disease Research Center. The first group of 29 volunteers had very mild cognitive impairment; the remaining 69 volunteers were cognitively normal. Their ages ranged from 60 to 91.

Researchers analyzed CSF samples and took magnetic resonance imaging (MRI) scans of subjects' brains. They used a computer program to analyze the MRI scans and determine whole brain volume, a measurement of the amount of space taken up by a patient's gray and white matter minus the CSF fluid circulating in the skull.

Participants with normal levels of A-beta 42 in their CSF had whole brain volumes within expected ranges. But in both the cognitively impaired subjects and in cognitively normal volunteers with decreased CSF A-beta 42, the size of the brain was smaller.

In addition to A-beta 42, researchers analyzed CSF levels of a family of proteins called tau proteins. These proteins are a component of structures called neurofibrillary tangles that increase as Alzheimer's disease progresses. Scientists believe increased levels of tangles in the brain lead to increased CSF tau levels.

Researchers found CSF tau levels did not increase until subjects became mentally impaired.

"We've thought for some time that in Alzheimer's disease, amyloid builds up first followed by an increase in tangle accumulation," Holtzman says. "This is some of the first evidence in living people that this idea may be right: large scale changes in amyloid seem to precede large scale changes in tau, which are then linked to the onset of clinical dementia symptoms."

Researchers will follow cognitively normal subjects with reduced CSF amyloid levels and brain volumes to see if they eventually become demented, potentially confirming A-beta 42 as an antecedent biomarker for Alzheimer's disease. They continue to look for additional Alzheimer's biomarkers in CSF samples and brain scans.

Notes:

Fagan AM, Head D, Shah AR, Marcus D, Mintun M, Morris JC, Holtzman DM. Decreased cerebrospinal fluid amyloid beta 42 correlates with brain atrophy in cognitively normal elderly. Annals of Neurology, online publication.

Washington University School of Medicine's 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children's hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked third in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children's hospitals, the School of Medicine is linked to BJC HealthCare.

Source: Michael C. Purdy

Is It Just Hype Or Can Mental Training Games Help Prevent Alzheimer's?

2009-03-11T09:21:00.000-07:00

The premise of brain training is simple: participants must complete a series of daily exercises such as mental calculation, memorization and enigmas to help increase cognitive ability and avoid certain neurodegenerative diseases. Some companies like Brain Center International, which produces NeuroActive, promise regular users they'll shave 10 years of brain aging after eight weeks of use. Is it surprising some 10,000 copies of... the product were sold in Quebec in the last six months?

"To my knowledge, there is no scientific research demonstrating results from such recreational programs," says Sylvie Belleville, a professor at the Université de Montréal' Department of Psychology and associate research director of the Institut universitaire de gériatrie de Montréal.

According to Belleville, the principles of intellectual stimulation aren't false, but their efficiency haven't been scientifically proven. She argues that Sudoku and crosswords could work just as well.

Yet there are programs that exist that have been proven to benefit seniors and Alzheimer's victims, according to Belleville: "These programs are based on memory strategies. They have nothing to do with the repetitive exercises offered by NeuroActive and others," she says.

While memory products can be helpful, Belleville warns against the unrealistic expectations some may provide. The advertising of these products, she stresses, "Could give false hopes. If someone doesn't see a change they could quit and it could eventually lead to depression."

In her opinion, the best way to keep one's cerebral functions is to do intellectual activities, eat well, control vascular factors, particularly in the case of diabetes and hypertension, and remain physically active.

Notes:

This release is available in French.

On the Web:

About the Université de Montréal: http://www.umontreal.ca/english/index.htm

English adaptation by Marc Tulin; original French story by Dominique Nancy can be consulted here.

Source: Sylvain-Jacques Desjardins

Cognitive Decline In Alzheimer's Disease Predicted By Simple Balance Test

2009-03-11T09:20:00.000-07:00

A simple balance test may predict cognitive decline in Alzheimer's Disease, according to a study published in the March 2009 issue of the Journal of Alzheimer's Disease.

This study was carried out in 16 university hospital departments of neurology, geriatrics or psychiatry in ten cities with 686 outpatients suffering from AD. This population is... representative of the AD population seen by clinicians in daily practice. Patients were evaluated by a geriatrician every six months for up to two years, and their degree of cognitive impairment was measured using the Mini Mental State Examination (MMSE). At the same time, a "one-leg balance" (OLB) test was given, where a participant was asked to stand on one leg for as long as possible. The OLB test was reported as abnormal when the participant was unable to stand on one leg for 5 seconds or more.

Participants with an abnormal OLB at baseline or/and during the follow-up showed significantly more cognitive decline at 12, 18 and 24 months than the participants with a OLB test normal at baseline and normal during the follow-up. The worst condition (having an abnormal OLB at baseline and during the follow-up= no improvement) was associated with a mean adjusted cognitive decline of 9.2 points. The best condition (having a normal OLB at baseline and during the follow-up = no worsening) was associated with a mean adjusted cognitive decline of 3.8 points.

Senior Investigator Yves Rolland, Inserm and the University of Toulouse, France, states, "Our results suggested that an abnormal OLB is a marker of more advanced dementia (worst baseline characteristic) and an independent predictor of cognitive decline in AD. Our results reinforce in an AD population, the growing evidence suggesting a link between physical performances and cognitive decline. If these results are confirmed by other data, the OLB test could be adopted in clinical practice to identify AD patients at high risk of rapid cognitive decline."

Notes:

The article is "An Abnormal 'One-leg Balance' Test Predicts Cognitive Decline During Alzheimer's Disease" by Yves Rolland, Gabor Abellan van Kan, Fati Nourhashemi, Sandrine Andrieu, Christelle Cantet, Sophie Guyonnet-Gillette and Bruno Vellas It is published in the Journal of Alzheimer's Disease 16:3 (March 2009).

Source: Astrid Engelen

Identification Of Risk Factors In Severity Of 'Flat Head Syndrome' In Babies: New Study

2009-03-11T09:10:00.000-07:00

A new study by physician researchers from Hasbro Children's Hospital and Children's Hospital Boston identifies risk factors for the severity of asymmetrical head shapes, known as deformational plagiocephaly (DP), or more... commonly as flat head syndrome. The study was published in the March 2009 edition of the Journal of Craniofacial Surgery.

Since the 1992 campaign by the American Academy of Pediatrics, many parents have been placing babies on their backs to sleep, as it is believed to reduce the risk of sudden infant death syndrome (SIDS). As a result, there has been a 40% reduction in the incidence of SIDS. At the same time, there has been a noted increase in the incidence of DP, affecting as many as one in six infants, which may be connected with the change to the supine sleeping position in children. DP, however, can also occur with prone positioning as well.

Many researchers have published reports of risk factors for the development of DP, which include supine positioning, firstborn infants, prematurity, developmental delay and others. While these variables seem to be associated to some extent with the development of DP, the influence of each of those variables on the degree of asymmetry in DP has not been determined to date. With this in mind, physician researchers from Hasbro Children's Hospital and Children's Hospital Boston developed a study to determine the relationship between predisposing factors for DP and the severity of the flattening.

The researchers looked at a number of factors in the infants as well as maternal variables associated with pregnancy. Of particular note in their findings is the severity of flattening was not associated with infant sleep position.

Albert Oh, MD, who is also a professor of surgery at the Warren Alpert Medical School of Brown University, says, "We found a trend toward less flattening in infants who slept prone, or in positions that were alternated. Interestingly, however, while supine positioning has been a well established risk factor for the development of plagiocephaly, we were not able to demonstrate a logical correlation to indicate more severe flattening from the supine position."

In addition, the researchers identified a relationship between gestational age and the severity of the flattening, where a lower gestational age was associated with more severe flattening. Their findings also indicate that boys in the study had significantly more cranial asymmetry than girls, and their data also indicated that males are at a higher risk for more several flattening. Also of note, the researchers found no association between the use of orthotic devices and the severity of cranial flattening, calling into question the effectiveness of the use of such devices in the treatment of or prevention of DP.

The researchers also found a link between multiple-birth pregnancies and the degree of cranial asymmetry. Oh notes, "In our study, infants with DP who were the product of a multiple-birth pregnancy were disproportionately higher than in the general population and greater than in previous studies. This was the only pregnancy-related variable we found to be associated with the severity of DP of the eight different variables we assessed."

Oh says, "This study is significant because we were able to find direct correlations between a variety of variables and the severityof DP in infants. Ultimately we have shown that there are certain clear risk factors for more severe flattening in infants."

Their findings also concur with other reports, supporting the widely accepted belief that the development of plagiocephaly is progressive, beginning during early infancy. The researchers also report that maternal demographics had little effect on the severity of DP.

For the study, infants referred to Hasbro Children's Hospital and Children's Hospital Boston for DP between January 2006 and December 2007 were recruited. Parents completed a questionnaire and a focused physical exam was performed, which included a measurement of the difference in oblique cranial lengths, known as the transcranial difference. Out of the 576 with cranial asymmetry who were prospectively enrolled, 142 were excluded, leaving 434 patients with DP enrolled in the study. There were twice as many male as female infants, and the mean gestational age was 36.5 weeks. The mean age at presentation to the craniofacial programs at the hospitals was 5.8 months. Eight-three percent of the infants were reported to have a head positional preference, with 42.6 percent of those infants diagnosed with torticollis (the head leans to one side due to contracted neck muscles on that side) as the reason for the head positional preference. Nearly all of the infants (97.5 percent) in the study appeared to be developmentally normal.

Notes:

Other physician researchers involved in the study with Albert Oh are Erik Hoy, MD, also of Hasbro Children's Hospital, and Gary Rogers, MD, JD, MBA, MPH, of Children's Hospital Boston. source : health news

Drinking Wine May Lower Risk of Esophageal Cancer

2009-03-05T06:39:00.000-08:00

Wine drinkers rejoice, your favorite glass of red or white may actually help you lower your risk of developing esophageal cancer, which is one of the deadliest and fastest growing cancers in the United States. The rates of esophageal cancer have increased over the last three decades, due to a more than 500 percent increase of esophageal adenocarcinoma, a subtype of the cancer that is linked to acid reflux disease. But beware overdoing it, as alcohol abuse is a known risk factor for... another type esophageal cancer, squamous cell esophageal cancer.

The findings from three newly published studies suggest that drinking wine in moderation may actually help protect against esophageal adenocarcinoma or a precancerous condition known as Barrett’s esophagus. All three of these new studies will appear in the March issue of the journal Gastroenterology.

In one of these studies, researchers from the Kaiser Permanente division of research in Oakland, California reported that drinking as little a one glass of wine daily was associated with approximately a 56 percent decrease in the risk for developing Barrett’s esophagus. About 5 percent of the population in the U.S. is estimated to have Barrett’s, most of them are never diagnosed. People that do have the condition have about a 30 to 40 fold higher risk of developing esophageal adenocarcinoma than the rest of the general population.

The study done in California is the largest ever to examine the connection between the condition and the consumption of alcohol. The researchers examined data from a larger trial that included detailed, self-reported information about alcohol consumption. The study included 320 people who were diagnosed with Barrett’s esophagus between the years 2002 and 2005, 316 people that had gastro-esophageal reflux disease (GERD) without Barrett’s, and 317 people that did not have Barrett’s or GERD. Even after the researchers controlled the risk factors for Barrett’s, the moderate wine consumption appeared to be protective.

Douglas A. Corley, the gastroenterologist and principal investigator at Kaiser Permanente, said, “We found no relationship between overall alcohol consumption and Barrett’s esophagus, but the risk of developing Barrett’s was lower among wine drinkers.”

In the second study, researchers in Australia examined patients drinking histories that had both types of esophageal cancer. During the study, the researcher found that:
 As to be expected, heavy alcohol consumption was associated with an increased risk of developing squamous cell cancer of the esophagus.
 There was no association seen between the amount of alcohol the patient consumed and esophageal adenocarcinoma.
 It was found that the moderate consumption of wine or spirits (no more than one drink daily) was associated with a lower risk for developing both cancers in comparison to nondrinkers.

In the third study conducted, researchers from Belfast examined the impact of the consumption of alcohol on GERD-related esophagitis, esophageal adenocarcinoma, and Barrett’s esophagus. The researchers found that there was no increase in risk associated with drinking alcohol in early adulthood for any of the three conditions. However, their findings do suggest that wine may lower the risk of reflux esophagitis, esophageal adenocarcinoma, and Barrett’s esophagus.

All of the studies suggest, but do not prove, that drinking wine in moderation protects against Barrett’s and esophageal adenocarcinoma. Corley stated that if wine is protective, the benefits may have nothing at all to do with the alcohol. “Wine is high in antioxidants and other studies have shown that people who eat plenty of antioxidant-rich fruits and vegetables are less likely to have Barrett’s esophagus and esophageal cancer,” he says.
In studies done with animals, antioxidants have also been shown to help protect against the inflammation that causes injury to the esophagus.

Because there are so many questions that are still unanswered, Corley says it is still far too soon to recommend drinking a glass of wine every day to protect against esophageal cancer. He stated that at this time the best we can say is that alcohol does not seem to be a risk factor for esophageal adenocarcinoma and Barrett’s.

One of Barrett’s researchers, Prateek Sharma, M.D. from the University of Kansas School of Medicine, agrees, saying, “It may be that people who drink wine have healthier lifestyles. They may eat more fruits and vegetables and consume less fat in their diets, The last thing you would want is for people to start drinking wine to prevent cancer.”

Even though esophageal adenocarcinoma is the fastest growing cancer today in the United States, Sharma points out that it is still relatively uncommon. Approximately 15,000 people in the United States are diagnosed with esophageal cancer annually, compared with the 150,000 that are diagnosed with colon cancer annually.source medical updates

New Drug Therapy May Improve Mobility For MS Patients

2009-03-05T06:30:00.000-08:00

Multiple sclerosis (MS) affects about 400,000 Americans and approximately 2.5 million people worldwide, according to the National Multiple Sclerosis Society. It is a chronic and often disabling disease that attacks the brain, spinal cord, and optic nerves that make up the central nervous system. Symptoms can range from... numbness in the limbs to debilitating paralysis and loss of vision. The symptoms, as well as the progression and severity of MS, are unpredictable and may vary greatly from one person to another.

MS is an autoimmune disease in which the body’s own defense system attacks a fatty substance called myelin that surrounds and protects the nerve fibers in the central nervous system. The damaged myelin forms scar tissue, or sclerosis. Nerve fibers can be damaged as well. MS patients suffer from a progressive decline in mobility and few treatment options are available beyond physical therapy. However, a new drug developed by Acorda Therapeutics Incorporated, known as fampridine, has now been shown to improve walking ability in some multiple sclerosis patients. The report on the analysis was published in The Lancet.

Andrew Goodman of the University of Rochester Medical Center in New York, and colleagues, conducted the phase III study of 301 patients ranging in age from18 to 70. Participants were randomly selected to receive either 10 milligrams of fampridine or a placebo twice daily for a period of 14 weeks. Assessments were made of the participants’ walking speeds for a distance of 25 feet after periods of two weeks, six weeks, 10 weeks and 14 weeks.

The results of the study revealed that 35 percent of the participants who received fampridine achieved a faster walking speed in a minimum of three of the four assessments compared to only 8 percent of those taking placebo. In addition, those participants taking the fampridine showed greater improvement in leg strength, improving their ability to participate in daily activities such as standing, walking outside, and using stairs.

A total of 5 percent of the participants withdrew from the study due to adverse events including two participants suffering from the severe adverse events of focal seizure and severe anxiety in connection with use of the drug. The researchers noted that in previous studies, the risk of seizure appeared to increase in accordance with dosage of fampridine.

In conclusion, the researchers wrote, “Treatment with fampridine produces clinically meaningful improvement in walking ability in some people with multiple sclerosis, irrespective of disease course type or concomitant treatment with immunomodulators.” The team also noted that more research would be necessary to confirm the study findings.

There is no known cure for MS. According to Goodman, existing drugs target slowing the progression of the disease and helping to prevent relapses, although patients may not be able to tell whether or not they are working. He explained that with fampridine pills, the patients know if it is working.

In a statement, Dr. Ron Cohen, president and CEO of Acorda Therapeutics, said, “This trial included both physician and patient assessment scales that demonstrated both improvement in walking speed and clinical meaningfulness of that improvement.” He went on to say, “The results of this study indicate that fampridine-SR could potentially represent an important new treatment option in managing MS.”

Although fampridine has shown success in the improvement of visual function, strength, walking ability, fatigue and endurance in MS patients, concerns remain as to the safety and effectiveness of the drug. Acorda submitted a new drug application for fampridine to the U.S. Food and Drug Administration on January 30th. If approved, it would be the first MS drug to reverse a symptom of the disease. source medical updates

Safer, Ethical Procedure Found to Produce Stem Cells

2009-03-05T06:02:00.000-08:00

Stem cell therapy has become the subject of huge interest and vigorous debates. Promoters believe stem cells offer great promise for new medical treatments to combat cancer, diabetes, Alzheimer’s and other regenerative diseases, while the opposition argues that research on embryos—the prime source of the most versatile stem cells, pluripotent—destroys human life. In the past year, scientists have found genes that... can transform ordinary skin cells into cells that look and act like embryonic stem cells, eliminating the use of an embryo, and the ethical concerns. The downside is that delivery of these genes requires the use of a virus, raising concerns the cells could cause tumors or other effects if placed in a patient. Now, researchers say they have discovered a new method of transporting the genes without the use of such potentially harmful viruses, thereby overcoming a major hurdle for safe, personalized stem cell therapies in the future.

In the new work, researchers in Toronto and at the University of Edinburgh instead used a piece of DNA called a transposon, which can insert itself into an organism’s DNA and carry a cargo with it, to deliver four specific genes. In this case, the transposon version used is called “piggyBac,” which has been used to genetically modify a range of organisms. After the conversion, the added DNA was removed from the transformed cells with a specific enzyme. The researchers used the technique in both mouse and human skin cells and found the reprogrammed cells—iPS cells—behaved just like embryonic stem cells. “PiggyBac carries the four genes into the cells and reprograms the cells into stem cells. After they have reprogrammed the cells, they are no longer required, and in fact they are dangerous,” explains Dr. Andras Nagy, senior investigator at the Samuel Lunenfeld Research Institute of Mount Sinai Hospital in Toronto, Canada. “After they do their job they can be removed seamlessly, with no trace left behind. The ability for seamless removal opens up a huge possibility.”

In 2005, Nagy created Canada’s first embryonic stem cell lines from donated embryos no longer required for reproduction by couples undergoing fertility treatment; research that played a pivotal role in his current discovery. One of the critical components reported in Nagy’s paper, published in the March 1, 2009 issue of Nature, was developed in the laboratory of Dr. Keisuke Kaji from the Medical Research Council (MRC) Center for Regenerative Medicine in Edinburgh, Scotland. “I was very excited when I found stem cell-like cells in my culture dishes. Nobody, including me, thought it was really possible,” Kaji said. “It is a step towards the practical use of reprogrammed cells in medicine, perhaps even eliminating the need for human embryos as a source of stem cells.”

“It’s very exciting work,” said Robert Lanza, a stem cell researcher at Advanced Cell Technology in Worcester, Massachusetts. “With the new work, we’re only a hair’s breadth away from the biggest prize in regenerative medicine—a way to create patient-specific cells that are safe enough to use clinically.”

Other scientists, however, while crediting the work as an important advance, say it remains crucial to continue work on both types of cells. “The point is, we don’t know yet what the end potential of either of these approaches will be,” said Mark A. Kay of Stanford University. “No one has cured any disease in people with any of these approaches yet. We don’t know enough yet to know which approach will be better.”

In 2001, President George W. Bush restricted federal funding for human embryonic stem cell research to prevent taxpayer money from encouraging the destruction of human embryos, which is necessary to obtain pluripotent cells. However, Senators Tom Harkin, an Iowa Democrat, and Arlen Specter, a Republican from Pennsylvania, have reintroduced a Senate bill that would allow federal funding for research using stem cells taken from human embryos left over from fertility treatments. “For too long, political interference has delayed research that holds the promise for millions of Americans who suffer from a wide range of diseases,” Harkin said in a statement. “President Obama has promised to lift the restrictions on embryonic stem cell research that were put in place by President Bush, and I hope and expect that he will do so soon, but we have to make sure that the freedom to pursue this research is also protected by federal law, not merely by an executive order that can be reversed during a future administration.” source : Medical updates

Ethical Imbroglio Faces Cyberonics Regarding Neuropsychopharmacology Article

2009-03-02T01:53:00.000-08:00

In medical school, I thought it was fascinating that electroconvulsive therapy (ECT) was useful in severe depression which was resistant to other treatments. Those memories resurfaced as I was prompted by a recent Wall Street Journal article to read an article in the journal Neuropsychopharmacology which described research showing a vagus nerve stimulator (VNS) having similar promise in treatment-resistant depression.

Who would know what would be disclosed, that every author had an undisclosed financial relationship with the... device manufacturer, Cyberonics:

Ronnie Wilkins, the executive director of the medical society that publishes Neuropsychopharmacology, says that the consulting arrangements should have been disclosed and that a correction will be published as soon as possible. He says the authors did report their financial relationships with the company in forms they are required to fill out as part of the publication process. However, he says the consulting information was not included in the manuscript of the review piece as required.

It will be interesting to see what the fallout is regarding the editor of that journal having also been an author of the article in dispute. Cyberonics tries to show it had no influence by granting an unrestricted grant to undertake the research. But the article should have clearly stated the financial arrangements -- curious how that escaped publication.

Electroconvulsive therapy has long been practiced as effective treatment for severe depression and psychotic depression. According to the Nature paper, in 2001 the FDA approved VNS as an alternative to electroconvulsive therapy which lacked evidence of long-term benefit and side effects. Since then, a limited number of patients have been studied, not many more than those reviewed by the Technology Evaluation Center of the Blue Cross Blue Shield Association in August 2005 (TEC).

At that time, the TEC stated that the "available evidence is not sufficient to permit conclusions of the effect of VNS therapy on health outcomes." Specific concerns included the study's definition of treatment-resistant depression and the lack of statistical significance of the results. Some providers define treatment-resistant depression as patients having failed to improve after 6 weeks of therapy on 2 medications, but others allow for a total of 10 to 12 weeks [1]. By defining it with this shorter duration, possibly less severely affected patients were included in the trial. What a lack of statistical significance means is that by the study's numbers you can't be sure that this treatment helped.

Sounds like ECT will continue to be used in severe depression for some time, until these ethical quandries are cleared up and more studies are done.

References:
1. Nemeroff CB. Augmentation strategies in patients with refractory depression. Depress Anxiety 1996-97;4:169-81

Peak Medical, Inc. Partners With WebOps To Manage Orthopaedic Inventory and Cases

2009-03-02T01:50:00.000-08:00

WebOps LLC. has announced that Atlanta-based Peak Medical, Inc., an independent distributor of Wright Medical’s orthopaedic products, has selected the WebOps Logistics web-based solution to manage their medical device inventory and surgical case load to ensure that needed implants and devices are accurately and efficiently available in the operating room.

“We believe we’ve found a business solution that will take our company to... the next level,” says Shawn Fobas, co-principal of Peak Medical. “Putting WebOps Logistics in the hands of our sales force and our backend operation personnel will allow us to substantially increase productivity and conduct business with much greater efficiency.”

WebOps Logistics is the industry's first medical device logistics application that brings true mobility and connectivity to an entire enterprise. It is a secure, web-based solution that manages the entire logistics cycle - from initial case planning to purchase order to replenishment - and offers up-to-the-minute schedules, case requirements and inventory usage at a glance. Moreover, the system requires no client-side software and is extremely user-friendly. With WebOps Logistics, everyone is connected - via BlackBerry, Palm or PC, in real time: sales, warehouse, purchasing, customer service, inventory, management, medical staff and customer service.

“Our solution is one that is mission-critical for medical professionals,” says Joe Carlson, VP of Operations and Customer Support, WebOps, LLC. “We see tremendous opportunity to enhance the productivity of medical device companies and we’re dedicated to exploring the ways technology can be leveraged to meet those needs.”

About Peak Medical, Inc.
Peak Medical is an independent distributor of Wright Medical - a global orthopaedic medical device company specializing in the design, manufacture and marketing of reconstructive joint devices and biologics.

About WebOps
WebOps, LLC provides integrated, real-time logistics solutions for the medical device industry. WebOps Logistics™, the company's flagship solution, provides real-time, web-based connectivity and coordination for logistics, sales support and operations – via BlackBerry, Palm or PC. The solution has been implemented by leading medical device distributors since 2005 and successfully manages over 50,000 surgeries per year. For more information klik here todays medical

Improving Pediatric Care Through Medical Device Innovation

2009-03-02T01:47:00.000-08:00

The Pediatric Medical Device Institute (PMDI), an organization aimed at the development of innovative medical devices for children, has recently expanded its capabilities to include advanced R&D and manufacturing expertise with the addition of high-tech engineering firm Schultz-Creehan LLC to its list of corporate sponsors. Charged by a special stakeholders committee mandated by Congress, PMDI was founded to overcome current barriers faced by the pediatric medical device industry such as costs, small market size, and... lack of collaborative networks by providing information to hospitals, companies, and the educational community.

Through their expertise in developing innovative solutions for industry, Schultz-Creehan is able to overcome many of these barriers with their advanced capabilities and experience in precision machining at the micro scale, conceptual design, mechanical design, CAD/CAM, prototype fabrication, and small scale manufacturing. Schultz-Creehan designs and manufacturers medical device components for industry and has partnered with organizations such as Virginia Bioinformatics Institute and Virginia Tech on bio-engineering projects.

“Schultz-Creehan is privileged to work alongside PMDI and its consortium of children’s hospitals to improve the quality of medical care for children,” says Nanci Hardwick, CEO. ”We look forward to assisting PMDI in overcoming the complex challenges faced by the pediatric medical device industry.”

About the Pediatric Medical Device Institute (PMDI): PMDI is for infants and children who have unmet needs for medical devices to improve the quality of their care, the PMDI utilizes an innovative approach to product development. Unlike the current market driven device development process, the needs-based PMDI invests professional effort and/or funds at specific points in the product development life-cycle in order to create devices at an accelerated pace, thus overcoming many barriers inherent in the traditional model. For more information about PMDI

Long-term aspirin and death risk for women: new study

2008-10-13T19:06:00.000-07:00

Women who took low to moderate daily doses of aspirin had a reduced death rate, especially from heart disease, according to decades-long research. The research, based on data from a major trial that has tracked almost 80,000 women since 1976, found women who reported using aspirin on a regular basis had a 25% lower risk of death from any cause than women who didn't take the drug.

The risk of death from cardiovascular disease was 38% lower for aspirin users, and there was also a 12% reduction in cancer deaths that... took effect after a decade of aspirin use, the researchers found in their report based on the Nurses' Health Study.

The results were published in the March 26 issue of the Archives of Internal Medicine.

However, an accompanying editorial in the journal cautioned that the results were open to debate and far from definitive.

The dissenting editorial, by Dr John A. Baron of Dartmouth Medical School, was based in large part on results of a different trial, the Women's Health Study, which followed almost 40,000 women for 11 years and found no reduction in overall deaths or cardiovascular mortality associated with aspirin therapy.

Therefore, Baron said, the new findings "cannot overcome the accumulated evidence that aspirin is not particularly effective for the primary prevention of death from cardiovascular disease in women."

"This is a complicated issue," said Dr Andrew T. Chan, an assistant professor of medicine at the Harvard Medical School, and lead author of the new report. "We understand that aspirin has potential health benefits, but who would aspirin therapy be appropriate for?" There are "areas of disagreement that need further study" before that question can be answered, Chan said. But there is information from the two large studies and other trials that can help guide women and their physicians, he said.

For starters, some studies suggest aspirin has benefits for older women and those who have cardiovascular risk factors such as high blood pressure, diabetes, high cholesterol and obesity, Chan said. "Our study and the Women's Heath Study do suggest that there is a potential role of aspirin for women who have subclinical cardiovascular disease," he added.

That statement meshes with prevention guidelines issued in 2004 by the American Heart Association. The guidelines recommend aspirin for women at high risk of heart disease or who already have cardiovascular disease, but they don't apply to women at low risk for the disease. For intermediate-risk women, aspirin can be considered if blood pressure is under control and the benefits are believed to outweigh risks, such as gastrointestinal bleeding.

But the decision to take aspirin, or any other medication, should not be made by an individual alone, Chan said. "I tell women that, at this point, the decision calls for consultation with a doctor," he said. "Aspirin does have side effects, so it is something that has to be individualized. It would be very naive to recommend that treatment for all women across the board."

The new study included information on 29,000 participants in the Nurses' Health study who took between one and 14 standard 325mg aspirin tablets a week and 5002 women who took more than 14 tablets weekly.

The reduction in cancer risk that became evident after 10 years was an intriguing finding, Chan said. The Women's Health Study found no such reduction over a decade, he said. "One important message is that the study suggests the mechanisms at play for cardiovascular disease and cancer are potentially common," Chan said. "This provides further grounds for research into these mechanisms."

Dr Jeffrey Berger, a cardiology fellow at Duke University who has done related research, said the new report describes "another very large study that tells us individuals who take aspirin live longer. You can't argue with that. We can't prove cause-and-effect, but we can say that when you take aspirin, there is a reduction in overall deaths."

It's important to remember that aspirin has benefits for both men and women, Berger added. "How it benefits men, how it benefits women, that is an important issue at this time," he said.

And anyone who is thinking about daily aspirin "should really talk with doctors about the benefits and risks," Berger said.

Copyright (c) 2007 CMPMedica (NZ) Ltd. All rights reserved.

Pregnancy mistakes even smart women make

2008-10-13T19:03:00.000-07:00

With the wealth of medical knowledge that's out there for everyone to access, it's a wonder that people still engage in patently non-healthy behavior. Millions of individuals still smoke cigarettes, for instance, despite overwhelming evidence against their use. Even the more prudent make the occasional health-care "mistake"--over-flossing, for instance (dentists recommend doing so only once every other day), or thinking that only children need vaccination (adults do, too).

Part of the problem is that there is simply too much information coming in--and too fast!--to be absorbed. Many times media reports are... either vague or ambiguous at best or, at worst, clash glaringly with conventional medical knowledge.

For most laymen, interpreting medical jargon, research scientists and anyone else who sends out health-related signals is like trying to figure out a Rubik's cube. A pregnant woman cannot escape the confusion and is, perhaps because of situational anxieties, more prone to misinformation than ordinary individuals, especially when every woman in her life--mother, grandmother, sister, aunt, cousin, in-law and friend--is anxious to dispense advice on the healthy, "proper" way of going through pregnancy and labor.

Our advice? Talk to your obstetrician. No issue should be too simple or too complicated to discuss. Ask her all your questions and explore with her all your concerns. You and your doctor are a team. Your goal is to make sure you deliver a healthy baby. The only way that can happen is if you work together and communicate regularly.

Pregnancy no-no's
For starters, we've listed a few choices and decisions we discourage pregnant women from taking: A healthy pregnancy they surely will not make. Check to see if any of the items apply to you and then go see your doctor so you can both figure out what to do about them.

1. Taking preconception folic acid for granted. Folic acid is essential for the healthy development of baby's nervous system. This occurs during the first 45 days of life, at a time when a woman doesn't even know yet that she's pregnant. If you're planning on having a baby, be sure to take a multivitamin supplement containing folic acid once you begin trying to conceive.

2. Stopping medications for pre-existing diseases. A lot of women think that all prescription drugs are teratogenic (can cause birth deformities), and the reflex is to stop taking them once the stick turns blue. This decision often does more harm than good, especially for women with pre-existing diabetes, seizure disorders or psychiatric illnesses, which have to be kept in check. The best thing to do is to ask the doctor for advice on continuing versus stopping the medication.

3. Thinking that morning sickness is always normal. Nausea and vomiting in pregnancy, which occur in 70 percent to 85 percent of women, are traditional signs of a healthy pregnancy. Severe and persistent vomiting unrelated to other causes and leading to weight loss of at least 5 percent of pre-pregnancy weight, however, is not. It strongly suggests hyperemesis gravidarum, a condition that can lead to dehydration, vitamin and mineral deficiencies, and a low birth weight. The truth is that pregnant women don't have to "grin and bear it." Many medications can help alleviate morning sickness.

4. Not screening for chromosomal abnormalities. A lot of women think that having children with chromosomal abnormalities (e.g., Down's syndrome) occurs only in pregnant women over 45, who carry a one-in-30 risk of having a Down's baby. The truth is, these abnormalities occur sporadically and, while age-related, may still strike the offspring of young women. Screening is widely available, and all women should be aware of this option.

5. Eating for two. Average weight gain during pregnancy should only be about 25 pounds. Putting on a lot more weight will increase your chances of hypertension, gestational diabetes and having a big baby (and a more difficult delivery, of course!).

6. Decreasing activity. Engaging in mild to moderate exercise is still best. It keeps you fit and prepares you for the rigors of delivery. Ask your doctor to prescribe an exercise regimen for you.

7. Suffering through low-back pain. The condition called sacroiliitis is very common in pregnancy due to the laxity of the lower back ligaments and postural changes. Physical therapy and simple exercises can help relieve sacroiliitis.

8. Abstaining from sex. Except in cases of preterm labor (or a history of preterm deliveries) and bleeding due to a diagnosed placental abnormality, it is safe to engage in sexual activity--as long as it's not too acrobatic--at all stages of pregnancy.

9. Missing the blood work. Asian women are particularly predisposed to gestational diabetes, so it's important to be screened for this condition.

10. Shunning pain relief, especially epidural anesthesia, during labor. Evidence has shown that being given an epidural doesn't necessarily lengthen labor, as was previously thought.

11. Thinking that Lamaze will work miracles. The Lamaze technique is not guaranteed to work for everyone, so don't count on pain-free labor.

12. Asking the universe for twins. Multiple pregnancies, compared to ordinary single-baby pregnancies, bring a lot more complications.

13. Asking for a C-section. A C-section will involve more difficult, more painful recuperation than vaginal delivery, believe it or not.

14. Asking for perineal repair after delivery to "make the vagina virginal again." Perineal repairs and episiotomies may cause more blood loss during delivery. Discuss your options with your obstetrician.

15. Not taking prenatal vitamins and iron. Iron is the only mineral that must be supplemented in pregnancy, but some women stop taking their iron supplement when they begin to experience side effects like nausea or constipation. A simple solution to the problem is to take the iron pill at bedtime, and increase the fiber in one's diet or take stool softeners.

16. Fretting about breast-feeding. While breast-feeding is best for babies, a woman has the right to decide whether to breast-feed or not. She should not feel guilty if she cannot breast-feed for any reason or produce milk immediately after delivery. It's perfectly normal not to have milk until the third to the fifth day, so giving a temporary bottle at this time will not cause nipple confusion

3rd Annual Cardiometabolic Health Congress, Boston

2008-09-22T21:15:00.000-07:00

The 2008 Cardiometabolic Health Congress (CMHC) will hold its third annual meeting October 15-18, 2008, at the Sheraton Boston Hotel. Over 1,000 clinicians will attend educational sessions focusing on cardiometabolic risk, including the prevention and management of diabetes, obesity, hypertension, atherosclerosis, dyslipidemia, and chronic kidney disease. The CMHC agenda, faculty, and general congress information can be found at http://www.cardiometabolichealth.org.

The congress will evaluate novel and emerging therapies that combat the epidemic of obesity, diabetes, and... cardiovascular disease. CMHC features over 50 world-renowned experts translating cutting-edge science into practical approaches to manage the problems associated with metabolic syndrome and cardiovascular risk. Physicians and allied health professionals can earn up 37.5 continuing medical education credits.

"The management of diabetes is evolving quickly, with new therapeutic agents and several landmark studies reporting this year," said John Buse, MD, PhD, CDE, chief of the Division of Endocrinology at the University of North Carolina School of Medicine at Chapel Hill. "Discussing these advances in the context of cardiovascular risk management is critical for establishing best practices in patient care."

The CMHC late-breaking clinical trials data session will provide healthcare professionals with the most recent findings from large, ongoing clinical trials and discuss how the data will impact their practice.

"Cardiometabolic (CM) risk is the new paradigm that challenges us to understand patients' risk for developing cardiovascular disease and diabetes. The 2008 CMHC is the place to hear all the latest information on CM risk," said Christopher Cannon, MD, senior investigator in the TIMI Study Group at Brigham and Women's Hospital and associate professor of medicine at Harvard Medical School.

An unprecedented group of prestigious medical organizations, including the American Diabetes Association, the American Heart Association (Councils on Clinical Cardiology; Atherosclerosis, Thrombosis, and Vascular Biology; High Blood Pressure Research; Cardiovascular Nursing; Epidemiology and Prevention; and Nutrition, Physical Activity, and Metabolism); the Endocrine Society; the American Society of Hypertension, and the National Kidney Foundation, among many others, have been supporting CMHC for the past three years.

The 2008 CMHC is co-chaired by Christie M. Ballantyne, MD; Robert H. Eckel, MD; Richard W. Nesto, MD; and Jay S. Skyler, MD.

20th Annual Scientific Symposium Of The Cardiovascular Research Foundation: Oct. 12-17 In Washington, D.C.

2008-09-22T21:13:00.000-07:00

Scientists at TCT 2008 - Transcatheter Cardiovascular Therapeutics - the global annual scientific symposium of the Cardiovascular Research Foundation - will present a variety of new data that promises to advance the field of interventional cardiology. Featured trials will focus on the safety and efficacy of new devices, including drug-eluting stents and other leading edge technologies, as well as comparisons of minimally invasive therapies to either medical treatment or surgery.

The following late breaking trials will be reported:

* HORIZONS-AMI: A Prospective Randomized Trial of... Paclitaxel-Eluting Stents vs. Bare-Metal Stents in Patients with Acute ST-Segment Elevation Myocardial Infarction

* HORIZONS-AMI: A Prospective Randomized Trial of Bivalirudin vs. Unfractionated Heparin Plus Glycoprotein IIb/IIIa Inhibitors in Patients with Acute ST-Segment Elevation Myocardial Infarction: Long-Term Follow-Up and Interaction with Stent Type

* SORT-OUT III: A Prospective Randomized Comparison of Zotarolimus-Eluting Stents and Sirolimus-Eluting Stents in Patients with Coronary Artery Disease

* ISAR-Left Main: A Randomized Comparison of Sirolimus-Eluting and Paclitaxel-Eluting Stents in Unprotected Left Main Coronary Artery Disease

* FAME: A Prospective Randomized Trial of Fractional Flow Reserve Guided Stenting in Patients with Multivessel Coronary Artery Disease

* ZEST-AMI: A Prospective Randomized Comparison of Zotarolimus-Eluting Stents, Sirolimus-Eluting Stents, and Paclitaxel-Eluting Stents in Patients with Acute Myocardial Infarction

* PREPARE: A Prospective Randomized Trial of Proximal Microcirculatory Protection in Patients with Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

* BBC ONE: A Prospective Randomized Comparison of a Single Drug-Eluting Stent Provisional Strategy vs. Routine Dual Drug-Eluting Stents for Coronary Bifurcation Lesions

* ISAR-TEST-2: A Prospective Randomized Trial Comparing Polymer-Free Rapamycin-Eluting and Probucol-Eluting Stents, Polymer-Based Sirolimus-Eluting Stents, and Zotarolimus-Eluting Stents in Patients with Coronary Artery Disease

Click here to see the complete list of late breaking clinical trials and first report randomized trials and registries.

In addition, research presented at TCT will showcase breaking data in other areas of interventional cardiology:

* Drug therapies that may reduce plaque

* The differences in the ways that men and women with similar symptoms are treated by physicians

* New types of stents, including bioabsorbable devices

* New ways of detecting and reducing plaque, including vulnerable plaque that can cause sudden heart attack and death

WHEN:

October 12-17, 2008; Late-breaking clinical trials will be highlighted during press conferences scheduled on Tuesday, October 14, Wednesday, October 15, and Thursday, October 16.

WHERE:

Walter E. Washington Convention Center; Washington, DC

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Article adapted by Medical News Today from original press release.
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Microscopic Technology Improves Understanding Of Vascular Diseases

2008-09-22T21:00:00.000-07:00

For years, researchers have known that high blood pressure causes blood vessels to contract and low blood pressure causes blood vessels to relax. Until recently, however, researchers did not have the tools to determine the exact proteins responsible for this phenomenon. Now, using atomic force microscopy - a microscope with very high resolution - and isolating blood vessels outside the body, University of Missouri researchers have identified a protein that plays an important role in the control of tissue blood flow and vascular resistance. This new knowledge brings researchers one step closer to... understanding vascular diseases, such as high blood pressure, diabetes and other vascular problems.

"This study provides new insights that clarify the role of specific proteins and the vascular smooth muscle cells that control the mechanical activity of blood vessels," said Gerald Meininger, professor and director of MU's Dalton Cardiovascular Research Center. "We have identified an important receptor that is responsible for the ability of small arteries in the body. This research provides new clues for the cause of vascular diseases, such as high blood pressure and diabetes and may be used in the future as a possible therapeutic target."

The researchers isolated blood vessels from the body and used atomic force microscopy to apply a controlled force to particular proteins located on the surface of smooth muscle cells from the blood vessel wall. When force was applied to the proteins, the smooth muscle cells reacted, and constricted or contracted depending on the proteins that were targeted. Testing several proteins, researchers were able to pinpoint which proteins played a role in the mechanics of blood vessels.

In 90 to 95 percent of high blood pressure cases the cause is unknown, according to the American Heart Association. Understanding the role of these proteins in controlling blood vessel function will eventually lead researchers to better answers for treating and preventing vascular disease, Meininger said.

The study "Extracellular matrix-specific focal adhesions in vascular smooth muscle produce mechanically active adhesion sties," was published in the American Journal of Physiology Cell Physiology. It was co-authored by Meininger; Zhe Sun, assistant research professor in the Dalton Cardiovascular Research Center; Luis Martinez-Lemus, assistant professor in the MU School of Medicine and investigator in the center; and Michael Hill, professor in the school and investigator in the center.

----------------------------
Article adapted by Medical News Today from original press release.
----------------------------

Knifeless Surgery for Kids

2008-09-09T22:52:00.000-07:00

WASHINGTON (Ivanhoe Broadcast News) -- Kenny Tinsley and his mom love to play the board game Life, now that his own life isn't in jeopardy. A year ago, Kenny had an excruciating headache that left him in a coma for three weeks. The cause? A tangle of blood vessels in his brain.

"They took him up for an MRI, and came back and told me he had a bleed on the brain," says Kenny's mother, Veronica. "[They said] it was quite serious, and that... he might not make it through the night."

Kenny's brain malformation was so deep it was inoperable, so doctors suggested gamma knife treatment. The radiation treatment has been used on adults, but it's brand new for kids.

Knifeless Surgery for Kids"It's a very easy treatment for the children. They don't really experience any pain, any fear, any discomfort," Amanda Yaun, M.D., a pediatric neurosurgeon at Children's National Medical Center in Washington, tells Ivanhoe.

While the patient lies still, 201 beams of gamma radiation connect on a target. They destroy the problem area without damaging surrounding healthy tissue.

Kenny was just the second patient to receive gamma knife treatment at Children's National Medical Center.

Knifeless Surgery for Kids"It's hard to believe that one sweep of gamma knife will fix it, but if it does that really is a revolutionary way to get rid of it," Kenny says. After the gamma knife treatment, he had some brain swelling. And unlike surgery, which immediately removes a tumor, it will take months or even years for doctors to know if the gamma knife worked on him. But it has a 90 percent success rate.

Adults aren't sedated during the procedure, but children are. Side effects can include nausea and tiredness and doctors say if the first attempt at gamma knife isn't fully successful, another procedure dramatically increases a child's odds.

Kenny says, "I feel blessed. I feel lucky. I'm going to live my life to the fullest." His doctors are optimistic, and now Kenny's back to playing Life instead of fighting for it.

This article was reported by Ivanhoe.com, which offers Medical Alerts by e-mail every day of the week. To subscribe, click on: http://www.ivanhoe.com/newsalert/.

If you would like more information, please contact:

Children's National Medical Center
111 Michigan Ave., N.W
Washington, D.C. 20010
Referral and Information Service
(888) 884-BEAR (2327)

Muscles matter: Physicans advised to tell patients to build up strength

2008-09-09T22:45:00.000-07:00

Jeff Williamson, MD, a geriatrician at Wake Forest University School of Medicine in North Carolina, can be persuasive about the benefits of building muscle. "I like to say there are really only two reasons why older people end up in a nursing home. One is that their brains stop working, and the other is that their muscles stop working. Especially their leg muscles."

While the loss of skeletal muscle inevitably comes with aging, no one should just sit still and take it. In fact, sitting still would be the worst thing. People in their 40s and 50s need to... take prompt action to preserve what strength they still have, said Dr. Williamson, clinical director of the J. Paul Sticht Center on Aging and Rehabilitation at Wake Forest.

* Discuss on SermoDiscuss on Sermo
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Muscle loss probably starts around age 40 for some people and by age 50 for most. But young, sedentary people likely will arrive at later life with less muscle than those who are more physically active, said Roger Fielding, PhD, director of the Nutrition, Exercise Physiology and Sarcopenia Laboratory at Tufts University in Boston. That circumstance could set them up for more disability in later years.

"We are becoming much more aware now than at any time in the past that as people get older, the amount of muscle they have in their body becomes smaller," Fielding said.

It only has been during the past decade or so that imaging techniques have captured this muscle loss, noted Dr. Williamson. These advances have allowed physicians to quantify how much muscle people should have at certain ages and to develop outcome measures to test interventions that are intended to preserve muscle.
Most people have lost muscle mass by age 50.

General consensus surrounds the idea that physical inactivity plays a big role in muscle loss. "We see pretty large declines in strength in people because they don't maintain activity," said Barbara Bushman, PhD, a professor of health, physical education and recreation at Missouri State University. In one study, 40% of women ages 55 to 64 said they couldn't lift 10 pounds.

"We suggest that people get a dog and walk the dog for exercise, but then they can't even lift a 10-pound bag of dog food into their car," she said. The numbers are even worse for women 75 and older -- 65% said they couldn't handle that amount of weight.

"To me, that's pretty frightening," Bushman said. "They couldn't lift a grandchild or respond in an emergency situation."

Lean body mass decreases about 15% between ages 30 and 60, she said. "It comes down to about five to seven pounds of muscle lost each decade."

Although it's probably never too late to try to regain strength, the middle years -- starting at age 40 -- are a key time to pick up the weights.

"It's like saving money. In middle age, you save so you can have a good retirement. But if you save muscle mass, you'll have an even better retirement," Dr. Williamson said.

W. Jack Rejeski, PhD, a behavioral scientist at Wake Forest, warned that difficulty climbing stairs can be the first sign of functional decline. "We've shown in our research that [such problems] are one of the first signs of early disability."

"The one thing people are most fearful of losing is the ability to function independently," said Tony Marsh, PhD, associate professor of exercise science at Wake Forest. "The strength of your muscles is fundamental in maintaining your independence."
Disease fighter

It's not only functional decline that becomes evident with muscle loss. The Centers for Disease Control and Prevention poses the question on its Web site: Why strength training? The agency provides a number of answers.

For example, arthritis pain was reduced by 43% after a group of older men and women completed a 16-week strength training program. Exercise was just as effective, if not more so, than medications, based on the CDC findings.
Lean body mass decreases about 15% between ages 30 and 60.

Strengthening exercises also can improve balance and flexibility, important in reducing the risk of falls and injury. And, the pull of muscle on bone also builds bone density and helps ward off osteoporosis, which is a major problem for post-menopausal women and older men.

There even is good news in glucose control. The CDC materials include a study of Hispanic men and women who demonstrated improved glucose control after 16 weeks of strength training. The results were comparable with those produced by medication.

In another study, weight training helped to lift depression as effectively as did medications. Why this response should occur is not yet known, but speculation centers on the increased self-confidence that people build as their strength improves. Or perhaps the strength training is producing helpful biochemical changes in their brains, the CDC suggests.

Given that muscles are major reservoirs for the body's supply of fuel in the form of amino acids, having more muscle also may mean having more fuel, said C. Jessie Jones, PhD, professor of kinesiology and health science at California State University, Fullerton, and co-director of the university's Center for Successful Aging. "When recovering from an illness, a person relies on amino acids. The less muscle tissue they have, the less of a reservoir there is."

Muscles' metabolic properties also play a role in improving glucose control. More collective muscle could help control the global diabetes epidemic. CDC figures show that in the U.S. alone, more than 14 million people have type 2 diabetes, a 300% increase over the past 40 years.
New guidance

Recent guidelines also underscore the need for muscle strength. The American College of Sports Medicine and the American Heart Assn., for instance, stressed muscle strength importance in last year's joint recommendations for physical activity in older adults.

In addition to 30 minutes a day of moderately intense aerobic activity five days each week, the organizations call for muscle strengthening activity using the major muscles of the body at least twice weekly.
Weight training has been shown to improve glucose control and lessen arthritis pain.

The AHA published a separate statement last year that emphasizes resistance training's benefits for older people, especially women and those with certain heart conditions. These populations were highlighted because often they become unable to function independently.

"The purpose of the [AHA] update was to underscore the importance of the health benefits of resistance training," said Mark Williams, PhD, director of Cardiovascular Disease Prevention and Rehabilitation at the Creighton University School of Medicine in Nebraska.

"In addition, resistance training has now been reported to potentially positively impact body composition with increased muscle mass, and improve various metabolic factors such as blood lipids and blood sugar levels," he added. Williams led the team that wrote the AHA statement.

Several experts in exercise science point to the role physicians can play in persuading patients to get moving. "Research has shown that if a primary care physician is behind something, patients are more likely to respond," Bushman said.

Physicians also may intercede when patients are recovering from illness. "Just being in the hospital for a few days can dramatically affect muscle mass," Dr. Williamson said. "So physicians, in addition to thinking, 'I've successfully treated this person's heart failure or pneumonia,' need to be thinking, 'How can I help restore their muscle mass and function?' "

Assessing a patient's physical functioning should be part of an office visit, Rejeski said.

One way to conduct an assessment of lower extremity function is by the Short Physical Performance Battery, Rejeski said. It takes about 10 minutes to administer and tests balance, gait, strength and endurance. "It's a very simple test, but it has been shown in large studies to be predictive of decline in function."

Action then should be encouraged.

"The sooner you jump on any signs of decline, the better off you are," Rejeski noted. "As you get further down the slope of disability, it's more difficult to recover."

Doctors must accept arbitration in Missouri price-fixing case

2008-09-09T22:25:00.000-07:00

A Missouri court of appeals dealt a setback to hundreds of Kansas City-area physicians in their antitrust fight against some of the nation's largest health plans over their payment practices.

The court ruled unanimously that the doctors are required to arbitrate, not litigate, their claims that BlueCross BlueShield of Kansas City and... UnitedHealthcare conspired to hold down physician rates in the area.

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Kansas City Urology Care, Midwest Neurosurgery Associates, Kansas City Ob-gyn Physicians and four other physician practices argued that although the arbitration clauses in their contracts generally covered individual payment quarrels, they did not apply in the case of anticompetitive conduct.

The Western District of the Missouri Court of Appeals disagreed.

In a July opinion, judges found the arbitration provisions broad enough to cover "any dispute that [physicians] had with Blue Cross and UnitedHealthcare, even if the dispute did not involve the contract." The court said the underlying payment contracts were central to the doctors' antitrust claim and that it was unlikely they could prove their case without referring to the agreements specifically covered by the arbitration clauses.

The physicians have no plans to appeal, said their attorney, Robert Horn. The decision sends the class-action suit to arbitration to address the underlying price-fixing claims. No dates for proceedings have been set.
Market power

Doctors fear that the ruling leaves them with little remedy to challenge large insurers over low fees and gives health plans more leverage in contract negotiations.

The arbitration process can be more expensive and burdensome than going to court, particularly in large cases, said Jeffrey S. Howell, general counsel to the Missouri State Medical Assn. "This type of decision gives health plans the ability to use broad [arbitration] clauses in their contracts when they already have so much more bargaining power than physicians do," Howell said. The state medical association, along with the Litigation Center of the American Medical Assn. and State Medical Societies, are monitoring the case.

United and the Blues have a combined market share of approximately 50% in the Kansas City region, according to the MSMA. In their complaint, Kansas City-area doctors alleged that they were paid as much as 30% less than physicians in surrounding cities.

"These are pretty much take-it-or-leave-it contracts," Horn said. Those doctors who didn't contract with one plan or the other and treated Blues or United patients out of network still were forced to accept the insurer's rates, he added.

BlueCross BlueShield of Kansas City denied the price-fixing claims and praised the decision.

"Exploring and resolving differences through arbitration offers a fair and efficient process for all involved," BlueCross spokeswoman Susan M. Johnson said.

United spokesman Greg Thompson declined to comment on the pending case.

The appeals court reversed a 2006 trial court ruling in the doctors' favor.

Jackson County Circuit Judge Charles E. Atwell at that time acknowledged the broad scope of the arbitration clauses. But enforcing such agreements "would be tantamount to granting immunity to these defendants regarding any kind of claim touching upon conspiracy or relief as part of a class action," the 2006 opinion states.

Atwell also pointed to a 2006 Ohio Supreme Court decision allowing a similar physician antitrust case to go forward. Judges in Academy of Medicine of Cincinnati v. Aetna determined that the alleged conspiracy claims could be pursued independent of the physician payment agreements that were covered by arbitration clauses.

The Missouri appeals court rejected that analysis. "Under federal law, arbitrability of a claim does not turn on whether or not the claim can be maintained without referring to the underlying contract, but on whether or not the arbitration clause's scope is broad," Judge Paul M. Spinden wrote. "The physicians assert that they have suffered damages as a result of the conspiracy, which they would not have suffered had they not agreed to the reimbursement contracts."

The appeals court also said its ruling did not affect noncontracted doctors.

HIV/AIDS, Human Rights Charter Proposed In Zimbabwe

2008-09-07T22:48:00.000-07:00

An HIV/AIDS and human rights charter that aims to protect and promote the rights of people living with the disease was proposed recently by the Zimbabwe Lawyers for Human Rights, the ZimbabweStandard reports. Tinashe Mundawarara -- program manager for ZLHR's HIV/AIDS, Human Rights and Law Project, which was established in 2004 to create a rights-based legal response to Zimbabwe's HIV/AIDS epidemic -- said, "This charter is a result of concentrated efforts by many national partners who are committed to ensuring dignity, justice and equality for all." He added the project plans to promote the charter to the government as a means to "formulate legislative laws" to protect those living with HIV/AIDS.

South African Justice Edwin Cameron pointed to denial in Africa regarding men who have sex with men. He added that Zimbabwe has one of the... lowest life expectancy rates -- age 35 for men and age 37 for women -- and that he is "shocked by the fact that" 45% of people are malnourished. According to Cameron, the charter was launched at an opportune moment given the "extraordinary political situation" in Zimbabwe. He said the current governmental situation in Zimbabwe is "linked" with poor health services in the country(Standard, 9/1).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Apobec3 Gene And Neutralizing Antibody Response To Retrovirus Linked By Study

2008-09-07T22:43:00.000-07:00

Scientists have uncovered new evidence that strengthens the link between a host-cell gene called Apobec3 and the production of neutralizing antibodies to retroviruses. Published in the Sept. 5 issue of Science, the finding adds a new dimension to the set of possible explanations for why most people who are infected with HIV do not make neutralizing antibodies that effectively fight the virus.

Antibodies are key to warding off viral infections, and most vaccines against viral diseases stimulate the body to... make antibodies against the target virus. Yet no one knows how to make a vaccine that artificially stimulates the production of antibodies that can readily neutralize HIV, largely because so few HIV-infected people naturally exhibit this immune activity. The new finding about Apobec3 suggests that this gene may influence anti-HIV antibody production and may help explain why some people who are repeatedly exposed to the virus never become infected.

HIV is a retrovirus, a type of virus that incorporates its genetic material into the DNA of its host cell. Retroviruses infect many mammals, and mice are susceptible to a retrovirus called Friend virus. A single gene controls the ability of mice to make neutralizing antibodies against this retrovirus and to recover from the viral infection. New research sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, demonstrates that this single, powerful gene is Apobec3, a gene found in matching locations in mice and humans. The scientists who conducted the study hypothesize that Apobec3 in humans might play a similar role in helping shape the neutralizing antibody response to human retroviruses such as HIV. Their thinking is supported by previous studies showing that human Apobec3 proteins exert anti-HIV activity and that the human chromosomal region containing Apobec3 genes influences the ability of the virus to establish infection.

"This research delineates a potential genetic mechanism behind the production of neutralizing antibodies to HIV, which are critical to preventing HIV infection," says NIAID Director Anthony S. Fauci, M.D. "Further research on the function of human Apobec3 could yield promising insights that inform the discovery of HIV drugs and vaccines."

Scientists from the Gladstone Institute of Virology and Immunology, which is affiliated with the University of California, San Francisco, and from NIAID's Rocky Mountain Laboratories in Hamilton, Mont., conducted a series of genetic experiments by mating mice with different genetic profiles of Apobec3 and Rfv3, a gene critical to recovery from retroviral infection in mice. The researchers demonstrated that Apobec3, like Rfv3, contributes to the early control of retroviral infection in mice and also influences specific retroviral antibody responses. In addition, the scientists discovered that versions of Rfv3 that fail to make antibody responses correlate with a natural defect in Apobec3. These results provide convincing evidence that Rfv3 and Apobec3 are the same gene.

"These findings add a new and quite unexpected dimension to our understanding of Apobec3 biology that might help us attack the HIV neutralizing antibody problem, an area where scientific progress has been slow," says Warner C. Greene M.D., Ph.D., director of the Gladstone Institute of Virology and Immunology and the study's principal investigator.

The idea that Apobec3 can influence not only the ability of HIV to cause infection but also antibody responses to the virus is supported by a previous study demonstrating that the human chromosomal region containing several Apobec3 genes is linked to anti-HIV antibody responses in a group of Italian subjects who were repeatedly exposed to the virus by their HIV-infected partners but remained uninfected.

The new research by the Gladstone Institute and NIAID is also intriguing in light of an earlier study demonstrating that HIV uses one of its own proteins, Vif, to destroy two human Apobec3 proteins. Given that Apobec3 seems to help the immune system make neutralizing antibodies against retroviruses, the destruction of Apobec3 proteins by Vif might help explain why most people do not make neutralizing antibodies against HIV.

"Our mouse studies suggest that neutralization of Vif could provide the unexpected benefit of better antibody responses to HIV and therefore better control of HIV infection," says Dr. Kim Hasenkrug, chief of the retroviral immunology section at NIAID's Rocky Mountain Laboratories and the study's lead NIAID investigator. "We knew that Apobec3 had very interesting antiviral properties, but this new discovery that it affects antibody responses will generate even greater interest in both Apobec3 and Vif."

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Article adapted by Medical News Today from original press release.
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NIAID conducts and supports research--at NIH, throughout the United States, and worldwide--to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov/.

The National Institutes of Health (NIH)--The Nation's Medical Research Agency--includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases.

For more information about NIH and its programs, visit http://www.nih.gov/.

Reference: ML Santiago et al. Apobec3 encodes Rfv3, a gene influencing neutralizing antibody control of retrovirus infection. Science DOI 10.1126/science.1161121 (2008).

Source: Laura Sivitz
NIH/National Institute of Allergy and Infectious Diseases

Viral Process That Prepares Cells For HIV Infectionbiology Decoded By Researchers

2008-09-07T22:40:00.000-07:00

With the publication of a study led by Yuntao Wu, assistant professor in George Mason University's Department of Molecular and Microbiology, the medical community is one step closer to understanding how the human immunodeficiency virus (HIV) attacks cells in the immune system. AIDS, which is caused by HIV, affected more than 33 million people worldwide in 2007 according to World Health Organization statistics.

In the Sept. 5 issue of the journal Cell, Wu and his collaborators from the National Institutes of... Health reveal the covert methods that the virus uses to break a barrier present in human CD4 T-cells, the primary immune cells targeted by the virus. HIV-1 infection causes CD4 T-cell depletion that leads to immunodeficiency and AIDS.

During the six-year study, a team largely comprised of research associates and graduate students, analyzed CD4 T-cells taken from blood and infected with HIV. The researchers found that when HIV binds to the cell surface, it uses a molecule called chemokine coreceptor CXCR4 to send a signal that activates a cell protein known as cofilin. The protein is then used to cut through the cortical actin cytoskeleton (the circular layer that lies just beneath the cell's outer membrane).

"Similar to a human skeleton, every cell has a cytoskeletal structure that supports the cell, gives it its shape, and provides a force that allows the cell to migrate. For the virus, this layer also presents a barrier," says Wu. "We never understood how the virus overcomes this barrier to gain access to the center of the cell. Now we know that HIV triggers the mimicking of a cell process that activates cofilin, which cuts and modifies the cortical actin cytoskeleton and permits the virus to cross it."

Wu notes that the goal of his research was to attain a fundamental understanding of how the virus interacts with cells and the immune system in order to identify new ways to treat the disease. There is still much basic research left to be conducted before the findings from this study produce a clinical benefit. However, he believes that this discovery may later be used to develop a new treatment that could block viral interaction with, or viral alteration of, the cortical actin cytoskeleton.

"Now we have a basic understanding of the parts that cortical actin and cofilin play in all of this. This study really opened avenues for us and we hope to use this information as a foundation for more detailed studies that could lead to the development of new therapeutic tools," says Wu. "For Cell to publish our findings is a great acknowledgment of the dedication and hard work demonstrated by my students and our group."

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Article adapted by Medical News Today from original press release.
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Toward Improved Antibiotics Using Proteins From Marine Diatoms - Biomacromolecules Journal

2008-09-07T22:37:00.000-07:00

Researchers in Florida are reporting an advance toward tapping the enormous potential of an emerging new group of antibiotics identical to certain germ-fighting proteins found in the human immune system. Their study, which may help fight the growing epidemic of drug-resistant infections, is in the current (August) issue of ACS' Biomacromolecules, a monthly journal.

In the new study, D. Matthew Eby, Glenn Johnson, and Karen Farrington point out that scientists have long eyed the germ-fighting potential of... antimicrobial peptides (AMPs). These small proteins fight a wide range of bacteria and fungi in the body and have the potential to be developed into powerful drugs to overcome infections that are resistant to conventional drugs. But scientists report difficulty producing effective AMPs because the antibiotics are fragile and easily destroyed in the body. An effective way to stabilize them is needed, they say.

The scientists discovered that some AMPs have properties similar to a shell-building protein derived from marine diatoms, microscopic algae, and that these protective properties may fit the bill. When an AMP was combined with certain minerals, the antibiotic developed a coating of silica nanoparticles. - MTS

"Synthesis of Bioinorganic Antimicrobial Peptide Nanoparticles with Potential Therapeutic Properties"
D. Matthew Eby, Karen E. Farrington, and Glenn R. Johnson
ASAP Biomacromolecules, ASAP Article, 10.1021/bm800512e
Download Full Text Article

American Chemical Society

Marijuana Ingredients Show Promise In Battling Superbugs - Journal Of Natural Products

2008-09-07T22:34:00.000-07:00

Substances in marijuana show promise for fighting deadly drug-resistant bacterial infections, including so-called "superbugs," without causing the drug's mood-altering effects, scientists in Italy and the United Kingdom are reporting. Besides serving as infection-fighting drugs, the substances also could provide a more environmentally-friendly alternative to synthetic antibacterial substances now widely used in personal care items, including soaps and cosmetics, they say. Their study is scheduled for the Sept. 26 issue of ACS' monthly Journal of Natural Products.

In the new study, Giovanni Appendino and colleagues point out that scientists have known for years that... marijuana contains antibacterial substances. However, little research has been done on those ingredients, including studies on their ability to fight antibiotic resistant infections, the scientists say.

To close that gap, researchers tested five major marijuana ingredients termed cannabinoids on different strains of methicillin-resistant Staphylococcus aureus (MRSA), a "superbug" increasingly resistant to antibiotics. All five substances showed potent germ-killing activity against these drug-resistant strains, as did some synthetic non-natural cannabinoids, they say. The scientists also showed that these substances appear to kill bacteria by different mechanisms than conventional antibiotics, making them more likely to avoid bacterial resistance, the scientists note. At least two of the substances have no known mood-altering effects, suggesting that they could be developed into marijuana-based drugs without causing a "high." - MTS

"Antibacterial Cannabinoids from Cannabis sativa: A Structure-Activity Study"
Giovanni Appendino, Simon Gibbons, Anna Giana, Alberto Pagani, Gianpaolo Grassi, Michael Stavri, Eileen Smith, and M. Mukhlesur Rahman
J. Nat. Prod., 71 (8), 1427-1430, 2008. 10.1021/np8002673
Download Full Text Article

American Chemical Society

PITT Receives $10 Million NIMH Grant For Schizophrenia Research

2008-09-07T22:31:00.000-07:00

The University of Pittsburgh has received a $10 million grant from the National Institute of Mental Health to support a new Conte Center for the Neuroscience of Mental Disorders (CCNMD). The center will focus on developing new treatments for schizophrenia, a disease that affects over two million adults in the United States alone. The grant will enable Pitt researchers to gain a better understanding of the disease process and to identify pathophysiology-based molecular targets for novel therapeutic interventions for this devastating mental illness.

"The center provides a multidisciplinary approach to understanding the neurobiology of schizophrenia and includes specialists in molecular neurobiology, systems and... computational neuroscience, brain imaging and clinical psychiatry. Our goal is to understand how schizophrenia affects brain function, to identify new treatments and to develop better ways to assess the effectiveness of those treatments," said David A. Lewis, M.D., director of the CCNMD and UPMC Endowed Professor of Translational Neuroscience, Western Psychiatric Institute and Clinic, University of Pittsburgh.

Schizophrenia is a complex and challenging mental illness with clinical features that include difficulty thinking logically, and inability to recognize and express emotions, to relate to others and to interpret reality. It is a chronic condition that can be difficult to manage with medication. Schizophrenia has been identified by the World Health Organization as one of the leading causes of years of life lost to disability and premature mortality.

The center's research is based on the widely-replicated observation that expression of a gene that synthesizes the neurotransmitter GABA is reduced in the brains of individuals with schizophrenia. GABA, or gamma-aminobutyric acid (GABA), is an important neurotransmitter essential for core cognitive processes such as working memory. CCNMD investigators are working to understand how reduced GABA could lead to impairments in brain function that are typical of schizophrenia.

The CCNMD offers a highly interactive scientific environment linking investigators from the University of Pittsburgh Schools of Medicine and Arts and Sciences as well as the Pitt-Carnegie Mellon University Center for the Neural Basis of Cognition.

Project and core leaders on the grant include Raymond Cho, M.D., Guillermo Gonzalez-Burgos, Ph.D., Gordon Frankle, M.D., Mary Phillips, M.D., Department of Psychaitry; Chester Mathis, Ph.D., Department of Radiology; Allan Sampson, Ph.D., Department of Statistics; and Bard Ermentrout, Ph.D., Department of Mathematics, all of the University of Pittsburgh; and Carl Olson, Ph.D., Center for the Neural Basis of Cognition, Carnegie Mellon University.

The University of Pittsburgh School of Medicine is one of the nation's leading medical schools, renowned for its curriculum that emphasizes both the science and humanity of medicine and its remarkable growth in National Institutes of Health (NIH) grant support, which has more than doubled since 1998. For fiscal year 2006, the University ranked sixth out of more than 3,000 entities receiving NIH support with respect to the research grants awarded to its faculty. The majority of these grants were awarded to the faculty of the medical school. As one of the university's six Schools of the Health Sciences, the School of Medicine is the academic partner to the University of Pittsburgh Medical Center. Their combined mission is to train tomorrow's health care specialists and biomedical scientists, engage in groundbreaking research that will advance understanding of the causes and treatments of disease and participate in the delivery of outstanding patient care.

University of Pittsburgh Medical Center

An Advance On New Generations Of Chemotherapy And Antiviral Drugs

2008-09-07T22:29:00.000-07:00

Researchers are describing progress toward developing a new generation of chemotherapy agents that target and block uncontrolled DNA replication - a hallmark of cancer, viral infections, and other diseases - more effectively than current drugs in ways that may produce fewer side effects. Their article is scheduled for the Aug. 27 issue of ACS' Biochemistry, a weekly journal.

In the article, Anthony J. Berdis updates and reviews worldwide research efforts to develop drugs that target DNA polymerases, the enzymes responsible for... assembling DNA from its component parts. Several promising strategies are already in use that inhibit uncontrolled DNA replication, particularly in anticancer therapy, but most produce severe side effects and are hampered by drug resistance, the researcher notes.

Berdis says that one of the more promising strategies to date involves the use of so-called nucleoside analogues, artificial pieces of DNA that inhibit replication by substituting for natural segments. Most nucleoside analogues directly target the active site of the polymerase enzyme, a non-specific approach that can also harm healthy cells which contain the enzyme. Berdis describes an alternative approach in which the drugs directly target damaged DNA while avoiding healthy DNA, side-stepping the polymerase enzymes of normal cells. The development, which shows promise in preliminary lab studies, could lead to improved nucleoside analogues with fewer side effects, he says. - MTS

"DNA Polymerases as Therapeutic Targets"
Biochemistry, 47 (32), 8253 - 8260, 2008. 10.1021/bi801179f
Download Full Text Article

American Chemical Society

Advice For Muslims With Asthma During Ramadan

2008-09-07T22:20:00.000-07:00

Although Islamic rules state that people with chronic conditions are permitted not to fast, some Muslims with asthma still chose to observe Ramadan and many may consider using an inhaler to be breaking the fast.

People from South Asian communities are three times more likely than white people to have an emergency hospital admission for their asthma, despite the fact that the incidence of.. asthma in South Asian communities is actually lower than in the white population. Because of this it is especially important that South Asians look after their health over Ramadan.

Muslim people with asthma tell us that there is not enough information available about how they should alter their treatment during this time so Vikki Knowles, Clinical Lead at Asthma UK, offers the following advice for people with asthma who are observing Ramadan:

- You should discuss your plans for Ramadan with your doctor or asthma nurse before making any decisions. Do not stop taking your asthma medicine without speaking to your doctor first.

- Speak to your Imam for advice, if you choose not to use your inhalers in daylight hours it may be reasonable to take your preventer inhaler before sunrise and after sundown.

- Even if you do not plan to use your inhalers, it is vital that you carry your blue reliever inhaler with you at all times as if you have an asthma attack it could save your life.

- To help you monitor your asthma you should have a personal asthma action plan. This is a written plan, which you fill out in discussion with your doctor or asthma nurse, containing the information you need to control your asthma; details of your asthma medicine, key things to tell you when your asthma is getting worse and what to do if it does, as well as emergency information if you have an asthma attack.

- If you have adjusted your medicines for Ramadan and you begin to feel worse, please see your doctor or asthma nurse as soon as you can.

Vikki continues: 'If you have any concerns about how observing Ramadan may affect your asthma you should contact your doctor or asthma nurse or you can call the Asthma UK Adviceline on 08457 01 02 03 and speak in confidence with one of our asthma nurse specialists.'

Notes

1. Asthma UK is the charity dedicated to improving the health and well-being of the 5.2 million people in the UK whose lives are affected by asthma.

2. If you are worried about your asthma or would just like to talk confidentially to a specialist asthma nurse, the Asthma UK Adviceline offers independent advice about asthma and provides a translation service in more than 100 languages. It is open weekdays from 9am to 5pm on 08457 01 02 03 or alternatively you can email an asthma nurse at http://www.asthma.org.uk/adviceline.

3. Our website http://www.asthma.org.uk also provides useful information including frequently asked questions in a number of South Asian languages including Arabic, Hindi, Gujarati, Urdu and Punjabi

Asthma UK

Smoking Cessation Reduces Cardiovascular Risks In Patients With CKD

2008-09-07T22:17:00.000-07:00

Nearly 47.5 million Americans currently smoke, and the habit is one that increases the risk and progression of chronic kidney disease (CKD). Patients with CKD also develop cardiovascular issues as the disease worsens, and researchers are calling for more studies that will help reduce cardiovascular mortality in this patient group.

Smoking cessation may decrease cardiovascular disease as well as slow the progression of CKD. In the July-August 2008 issue of Nephrology Nursing Journal, Harold J. Manley and Nicole M. Stack describe smoking cessation therapies for... the CKD population, an area in which little guidance exists.

Because nicotine use is an addiction, Manley and Stack say it requires pharmacologic as well as behavioral interventions. They review a variety of drug therapies, including nicotine replacement therapies (NRT), which supplement the need for nicotine; buproprion, a non-nicotine-containing medication which reduces a patient's craving; and varenicline, which targets tobacco dependence by reducing cravings and blocking the pleasurable sensations of nicotine. The authors say clinicians should use reduced doses of bupropion and varenicline and recommended doses of NRT.

Manley and Stack report only three studies to date have investigated how quitting smoking preserves kidney function and say more research in this area is needed. They advise making concerted efforts to encourage CKD patients to stop smoking.

"Smoking Cessation Therapy Considerations for Patients with Chronic Kidney Disease."
Harold J. Manley, FASN, FCCP, BCPS; Nicole M. Stack, PharmD
Nephrology Nursing Journal; July-August 2008; http://www.annanurse.org/journal

Nephrology Nursing Journal is a refereed clinical and scientific resource that provides current information on a wide variety of subjects to facilitate the practice of professional nephrology nursing. Its purpose is to disseminate information on the latest advances in research, practice, and education to nephrology nurses to positively influence the quality of care they provide.

Nephrology Nursing Journal

Living Donor Liver Transplants May Drastically Decrease Mortality From Liver Failure

2008-09-07T22:15:00.000-07:00

Patients with acute liver failure (ALF) could be saved by a transplant from a living donor (LDLT), according to a new study in the September issue of Liver Transplantation, a journal by John Wiley & Sons. The recent experience of U.S. patients shows that recipient mortality rates and donor morbidity rates are acceptable. The article is also available online at Wiley Interscience (http://www.interscience.wiley.com/).

Acute liver failure occurs more than 2,000 times per year in the United States and can quickly lead to coma and death. While spontaneous recovery can occur, for many patients the... only effective therapy is liver transplantation. One-year survival for these transplant recipients is about 82 percent (just slightly less than for other indications) however, because of the shortage of donor livers, many patients with ALF die on the waiting list.

While other countries frequently use living donor liver transplantation for ALF patients, the treatment is rarely considered in the United States because of concerns about high post-operative mortality rates, risks to the donors, and whether donors can be appropriately evaluated during the rapid progression of ALF. The Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL) provides a chance to study LDLT for ALF in the U.S. because it includes data from a large cohort of LDLT candidates at 9 U.S. transplant centers.

Researchers, led by James F. Trotter of the University of Colorado, report the outcomes of recipients with acute liver failure and their donors from the A2ALL study. It includes information from 1201 potential LDLT patients from January 1998 and April 2007. Just 14 (1 percent) of the patients had acute liver failure. Ten of these received LDLT, three received a liver from a deceased donor (DDLT), and 1 improved enough to be removed from the waiting list.

Survival rates were 70 percent after LDLT, compared to 67 percent of DDLT. Over a median of five years follow-up post-transplant, the nine surviving patients experienced 39 complications, a rate similar to other patients who'd undergone LDLT in the A2ALL study. Furthermore, the risks to the donors were acceptable�"none died, while 50 percent experienced complications.

"This study demonstrates that LDLT may be performed safely in patients with ALF," the authors report. While the data was limited, and the patients may have been predicted to have more favorable outcomes than typical ALF patients, the findings are similar to the global experience with LDLT for ALF.

"In summary, these preliminary findings suggest that LDLT is a safe treatment option in selected patients with ALF," the authors conclude. "These results provide a rational basis for the continued, careful application of LDLT in patients with ALF."

An accompanying editorial by Chung Mau Lo of the University of Hong Kong, commends the authors for evaluating the role of LDLT for ALF in the United States. "The most striking finding was the rarity for patients with acute liver failure to be considered for LDLT in the United States," he writes.

"The concerns with the added donor risk and inferior recipient outcome which have led to the proscription of acute liver failure as an indication for LDLT in the New York Department of Health's guidelines were not borne out in the A2ALL study," Lo points out. Still, he suggests LDLT will continue to take a limited role in the United States, despite the potential for optimally timed liver transplant for patients with ALF.

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Article adapted by Medical News Today from original press release.
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In Liver Disease Patients Normal ALT Levels May Mask Advanced Fibrosis

2008-09-07T22:13:00.000-07:00

Patients with nonalcoholic fatty liver disease (NAFLD) may have normal alanine aminotransferase (ALT) levels in spite of having advanced fibrosis, according to a new study in the September issue of Hepatology, a journal published by John Wiley & Sons on behalf of the American Association for the Study of Liver Diseases (AASLD). The article is available online at Wiley Interscience (http://www.wiley.com/wiley-blackwell).

NAFLD is the hepatic expression of the metabolic syndrome and it can progress to cirrhosis, portal hypertension and even liver cancer. Most studies of NAFLD only include patients with... elevated ALT levels, since that is a reason for referral to liver units. However, studies have not shown a systematic association between elevated ALT and severe NAFLD, leading to the question of whether NAFLD patients with normal ALT levels should also undergo liver biopsy and be examined for other manifestations of the metabolic syndrome.

Researchers, led by Anna Ludovica Fracanzani of the University of Milan, aimed to compare NAFLD patients with and without increased ALT to determine whether ALT is a valuable criterion to exclude patients from liver biopsy. They examined data from 458 consecutive patients who underwent liver biopsy between January 2003 and June 2006. Of these, 395 had abnormal liver function tests, while 63 had normal ALT.

The researchers found no difference in the prevalence and number of the components of the metabolic syndrome and in the prevalence of severe fibrosis between the two groups of patients. However, those with normal ALT had significantly milder inflammation and milder steatosis.

Nonalcoholic steatohepatitis (NASH) was diagnosed in 59 percent of patients with normal ALT and in 75 percent of patients with elevated ALT. For the latter group, serum ferritin and diabetes were independent predictors of more severe fibrosis. Only HOMA-IR independently predicted it in patients with normal ALT.

"The present study confirms that also NAFLD patients with normal ALT are at risk of progressive and severe hepatic disease, as well as of extrahepatic manifestations," the authors report. Doctors might consider liver biopsy for these patients, because a less-invasive way to assess liver disease is not yet available. However, the cost/effectiveness of this policy, given the extremely large at-risk population, would be a concern.

The recently proposed NASH score, which is a non-invasive assessment of severity developed by Angulo et. al., identified patients in the current study with advanced fibrosis with a negative predictive value of nearly 90 percent and a positive predictive value of 100 percent. "Our data support the hypothesis that this score could also be used in the general population, including subjects with normal ALT," the authors report.

This study was limited by the small number of NAFLD subjects with normal ALT, the sample variability of liver biopsy, and the high number of subjects referred to the liver units for hyperferritinemia.

Still, the authors conclude: "Our data indicate that more than half of NAFLD patients with persistently normal ALT have a potentially progressive liver disease. In the absence of biopsy or of an adequate score able to identify subjects at risk, these patients could miss careful follow-up."

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Article adapted by Medical News Today from original press release.
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Neuroinformatics 2008, Sept. 7-9: The First Congress Dedicated To The Emerging Field Of Neuroinformatics

2008-09-07T22:12:00.000-07:00

The first INCF Congress of Neuroinformatics will convene September 7-9 at the Stockholm City Conference Center in Stockholm. The emerging neuroinformatics field combines neuroscience and informatics research to develop advanced tools and approaches to understanding the structure and function of the brain. The tools may also be applied to brain disorders and diseases. With a broad international outreach, the meeting will bring together experts from all disciplines contributing to neuroinformatics.

Until recently, datasets revealing such details as gene expression, electrophysiological properties, neurotransmitter activity and receptor distribution, have been far too vast for standard data processing approaches. In the new neuroinformatics field, neuroscientists and... computer scientists have teamed up to develop efficient data processing tools so less data is wasted. The meeting, called "Neuroinformatics 2008," aims to facilitate dissemination of recent progress and the building of a strong and vibrant community.

"The INCF Congress is the largest outreach activity of the INCF. It provides a new venue for presentations and discussions of neuroinformatics projects and initiatives from around the world. The INCF is planning to continue with a series of congresses to further promote the field of neuroinformatics", said Jan Bjaalie, executive director of the INCF.

More than 260 researchers from nearly 30 countries - including all INCF member countries and Russia, and China - are expected to attend the single track meeting, which includes a series of keynote speakers, workshops, poster sessions and live demonstrations of neuroinformatics tools.

Chaired by Rodney Douglas, head of the Institute of Neuroinformatics in Zurich, the congress will feature keynote lectures covering topics such as synaptic nanomachines, digital age perspective of neuro-research, and brain-robot function translations.

Some highlights

* Sunday, Sept. 7, 19:00: Reception at the City Hall of Stockholm, hosted by the City of Stockholm

* Monday, Sept. 8, 08:30: Computational neuroscientist Mitsuo Kawato will present his brain-controlled robots

* Monday, Sept. 8, 15:40: Neuroscientist Henry Markram will discuss the latest progress in the Blue Brain Project that aims to simulate a model of the brain using a supercomputer.

* Monday, Sept. 8, 13:30: Kathie Olsen, NSF deputy director, and Wolfgang Boch, head of the Future and Emerging Technologies unit at the European Commission, will hold a special session on funding neuroinformatics research. They will focus on success stories and opportunities in the United States and Europe.

Click here to access the full program.

In its inaugural year, the INCF Neuroinformatics Congress is anticipated to be an annual meeting. The meeting is supported by:

* European Union Special Support Action INCF

* the Swedish Foundation for Strategic Research

* the INCF Central Fund.

* the Frontiers Research Foundation

* the Bernstein Network

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Article adapted by Medical News Today from original press release.
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New Evidence On The Robustness Of Metabolic Networks

2008-09-07T22:09:00.000-07:00

Biological systems are constantly evolving in ways that increase their fitness for survival amidst environmental fluctuations and internal errors. Now, in a study of cell metabolism, a Northwestern University research team has found new evidence that evolution has produced cell metabolisms that are especially well suited to handle potentially harmful changes like gene deletions and mutations.

The results, published online this week in the journal PNAS, could be useful in areas where researchers want to... manipulate metabolic network structure, such as in bioengineering and medicine, and in the design of robust synthetic networks for use in energy production and distribution networks and in critical infrastructures, such as transportation networks.

The research was led by Julio M. Ottino, dean of the McCormick School of Engineering and Applied Science and Walter P. Murphy Professor of Chemical and Biological Engineering. Other authors of the paper, titled "Cascading failure and robustness in metabolic networks," are Luís A. Nunes Amaral, associate professor of chemical and biological engineering, and lead author Ashley Smart, who recently received his doctoral degree from Northwestern and is now a postdoctoral fellow at the California Institute of Technology.

Cell metabolism is essentially a large network of reactions whose purpose is to convert nutrients into products and energy. Because the network is highly interconnected, it is possible for a single reaction failure (which may be precipitated by a gene deletion or mutation) to initiate a cascade that affects several other reactions in the system. This event could be likened to disturbing a small area of snow that may trigger a large avalanche or the failure of a single transmission line in an electric power grid that may cause a widespread blackout.

By measuring the size of these "cascade" events in simulated metabolic networks, the Northwestern researchers were able to develop a quantitative measure of metabolic robustness: the more robust the network, the less the probability that small disturbances produce large cascades.

They found that the likelihood of large failure cascades in a metabolic network is unusually small, compared to what they would expect from comparable, randomly structured networks.

In other words, these metabolic networks have evolved to be exceptionally robust, adopting organizational structures that help minimize the potentially harmful impacts of gene deletions and mutations. Ottino and his colleagues developed a mathematical model describing the cascading failure phenomenon as a percolation-like process.

The cascading failure model opens up new possibilities for developing math- and statistics-based descriptions of how network structure affects metabolic function in biological systems. The relationship between metabolic structure and function is an important, lingering question for researchers in areas such as bioengineering and disease treatment in medicine, where one goal is to manipulate metabolic network structure in order to obtain desired behaviors.

The Northwestern team concludes it is possible that nature, in this case, is the best teacher: improved understanding of how cell metabolisms have evolved to handle failure cascades may provide clues as to how one might design synthetic networks for similar robustness.

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Article adapted by Medical News Today from original press release.
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Tips For Parents Of Middle Schoolers From AAAS About Alcohol

2008-09-07T22:07:00.000-07:00

The first few weeks of middle school are a frenzy of friends, parties, and school events. It's also time for parents to start talking with their kids about the dangers of drinking alcohol, according to The Science Inside Alcohol Project of the American Association for the Advancement of Science (AAAS).

Nearly twenty percent of 14 year-olds say they've been drunk at least once, according to the U.S. Surgeon General, and recent news points out dangers of alcohol use by the young:

* The Partnership for a Drug-Free America released a study in August, 2008 of... 6,500 teens in which 73% said school stress caused them to drink and take drugs.

* A Columbia University study, also released in August, found that "problem parents," those who let their kids stay out past 10:00 p.m. on school nights in particular, are putting them in situations where they are at risk for drinking and drug use.

* About 100 university leaders called for a national discussion of lowering the drinking age back to 18, saying it's not clear that 21 works.

The middle school years are crucial in the battle to prevent early alcohol use. Young adolescents' bodies and friendships are changing. They start pulling away from parents; yet seek out other adults for guidance. It's the most vulnerable time, specialists say, but also one of the last times they still can be influenced by adults.

No one sets out to be a disengaged parent. But it's hard to be vigilant and talk to your kids about complicated topics when you are constantly on the go. "As parents better understand the physiological effects of alcohol on the body and the fact that their children might be starting younger, it can motivate them to have this sometimes awkward conversation," says Shirley Malcom, head of the Education and Human Resources office at AAAS. "That's where the science can help."

Members of The Science Inside Alcohol Project at AAAS are writing a book for middle school parents and developing an interactive Web-based science and health curriculum explaining how alcohol affects adolescents' brains and bodies. Based on extensive research, the AAAS team suggests five steps parents can take to talk with their kids about alcohol.

1. Find Teachable Moments -- We live in a culture of celebrity. If a celebrity your child admires admits to a drinking problem, or an instance of alcohol abuse occurs in your community, talk about it. Ask your middle school student if she knows anyone who drinks alcohol and whether it is at parties or has been brought into her school. Answer questions. Have this conversation often.

2. Talk to Your Kids When Everything is Fine -- Middle school students are volatile, hormonal beings. They are sweet and wonderful one moment, and blow up the next. Pick a time when things are quiet and they're a captive audience such as in the backseat of your car. Don't take no for an answer.

3. Engage Your Kids in the Science of Alcohol -- Adolescents are incredibly self-involved. Alcohol can cause memory loss, impair sports performance, incite embarrassing behavior and affect how they feel and look. Make them aware of these facts. If there is a history of alcoholism in your family, explain about genetic predispositions towards alcohol abuse.

4. Be Vigilant -- There's no alternative to monitoring your kids. Have an early curfew. Know where they are at all times. Even if you are not home on a weeknight, make sure you can reach your kids by phone. Get to know their new friends and their parents. Find out what their rules and level of engagement are.

5. Learn to Trust Your Child -- Now's the time when all the work you've put into creating a value system for your child begins to pay off. Set limits and enforce rules, but remember to give your child room to make his or her decisions, within your comfort zone. Praise them when they do well. It's worth a thousand words.

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Article adapted by Medical News Today from original press release.
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Serious Injury In Children Prevented By Both Child Safety Seats And Lap-And-Shoulder Seat Belts

2008-09-07T22:04:00.000-07:00

For young children, all states currently require the use of child safety seats, and the minimum age and weight requirements to graduate to seat belts has been increasing over time. A new study in the journal Economic Inquiry reveals that lap-and-shoulder seat belts perform as well as child safety seats in preventing serious injury. However, safety seats tend to be better at reducing less serious injuries.

Steven D. Levitt of the University of Chicago and author of the book Freakonomics and Joseph J. Doyle of the Massachusetts Institute of... Technology analyzed three large representative samples of crashes reported to the police, as well as linked hospital data, among motor vehicle passengers aged 2-6 years of age. Researchers used the data to compare seat belts and child safety seats in preventing injury.

Results show that lap-and-shoulder seat belts perform as well as child safety seats in preventing serious injury. Safety seats were associated with a statistically significant 25 percent reduction in less serious injuries. Lap belts are somewhat less effective than the other two types of restraints, but far superior to riding unrestrained.

"Our comparisons across restraint types incorporate the way they are used, or misused, in practice," the authors conclude. "Because many child safety seats are, in actual use, improperly installed, our estimates are likely to understate the benefits associated with their proper use. From a public policy perspective, however, understanding how safety devices work in practice, as opposed to under ideal circumstances, is of great importance."

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Article adapted by Medical News Today from original press release.
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Link Found Between Bisphenol A And Metabolic Syndrome In Human Tissue

2008-09-07T22:00:00.000-07:00

New research from the University of Cincinnati (UC) implicates the primary chemical used to produce hard plastics - bisphenol A (BPA) - as a risk factor for metabolic syndrome and its consequences.

In a laboratory study, using fresh human fat tissues, the UC team found that BPA suppresses a key hormone, adiponectin, which is responsible for regulating insulin sensitivity in the body and puts people at a substantially higher risk for metabolic syndrome.

Metabolic syndrome is a combination of risk factors that include lower responsiveness to insulin and higher blood levels of... sugar and lipids. According to the American Heart Association, about 25 percent of Americans have metabolic syndrome. Left untreated, the disorder can lead to life-threatening health problems such as coronary artery disease, stroke and type 2 diabetes.

Nira Ben-Jonathan, PhD, and her team are the first to report scientific evidence on the health effects of BPA at environmentally relevant doses equal to "average" human exposure. Previous studies have primarily focused on animal studies and high doses of BPA.

They report their findings in the Aug. 14, 2008, online edition of the journal Environmental Health Perspectives. This scientific data comes just before a key Federal Drug Administration meeting about the safety of the chemical in consumer products scheduled for Sept. 16, 2008.

"People have serious concerns about the potential health effects of BPA. As the scientific evidence continues to mount against the chemical, it should be given serious attention to minimize future harm," says Ben-Jonathan, a professor of cancer and cell biology at UC who has studied BPA for more than 10 years.

"Experimenting with human tissue is the closest we can come to testing the effects of BPA in humans. It's a very exciting breakthrough because epidemiological studies looking at BPA effects on humans are difficult since most people have already been exposed to it," she adds.

Scientists estimate that over 80 percent of people tested have measurable BPA in their bloodstream. The UC study was designed to mimic a realistic human exposure (between 0.1 and 10 nanomolar) so that a more direct correlation between human exposure and health effects could be drawn.

To conduct this study, the UC team collected fresh fat tissue from Cincinnati patients undergoing several types of breast or abdominal surgery. These samples included three types of fat tissue: breast, subcutaneous and visceral (around the organs).

Tissue was immediately taken to the laboratory and incubated with different concentrations of BPA or estrogen for six hours to observe how the varied amounts of BPA affected adiponectin levels. The effects of BPA were then compared to those of estradiol, a natural form of human estrogen.

They found that exposing human tissues to BPA levels within the range of common human exposure resulted in suppression of a hormone that protects people from metabolic syndrome.

"These results are especially powerful because we didn't use a single patient, a single tissue source or a single occurrence," she adds. "We used different fat tissues from multiple patients and got the same negative response to BPA."

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Article adapted by Medical News Today from original press release.
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Delaying Evolution Of Drug Resistance In Malaria Parasite Possible - Study

2008-09-07T21:50:00.000-07:00

There's no magic bullet for wiping out malaria, but a new study offers strong support for a method that effectively delays the evolution of drug resistance in malaria parasites, a University of Florida researcher says.

David Smith, associate director of disease ecology at UF's Emerging Pathogens Institute, said the study will guide scientists and policy makers in extending the longevity of current artemisinin-based malaria drugs combined with partner drugs. Smith is a co-author of a report on the study, online in the... Proceedings of the National Academy of Sciences and in print on Sept. 16.

Smith collaborated with lead author Maciej Boni of Resources for the Future and Princeton University, and Ramanan Laxminarayan, also with RFF, to create mathematical models assessing the strategic effectiveness and clinical outcomes of using one, two and three first-line drug therapies to treat malaria within a population over a 20-year period. Their results show that using two or three drugs simultaneously reduced the total clinical cases and number of failed treatments , and slowed the rate at which drug-resistant genes spread within the parasites that cause malaria: Plasmodium falciparum, P. vivax, P. malariae and P. ovale.

"The models indicate that we can slow the evolution of resistance to current artemisinin-based therapies if nations use them in combination with two or more partner drugs," Smith said. "Currently, most nations don't do this. They use one therapy at a time, wait for it to fail, and then switch to a different therapy."

Artemisinin-combined therapies, or ACTs, are currently not widely implemented due to operational challenges and expense, Smith said. But he said the study offers compelling evidence for global leaders to collaborate and overcome these issues.

"This is not to say that implementing multiple first-line therapies solves all of our malaria problems," Boni said. "Anti-malarial drug development needs to continue so that we have novel and highly effective anti-malarials that can be plugged into the recommended strategy of deploying multiple therapies."

In the past century, chloroquine and sulfadoxine-pyrimethamine were widely used to combat malaria, but the parasites eventually evolved resistance leading to the drugs' failure. Artemesinin drugs, derived from the herb Artemisia annua, are relatively new and the malaria parasite does not yet appear to have a resistance to it. They work by triggering chemical reactions which damage the Plasmodium parasite.

"We don't have anything in the pipeline after ACTs, and it's basically just a matter of time until drug resistance evolves and artemisinin also fails," Smith said. "So the question becomes how do we keep ACTs in our arsenal for as long as effectively possible?"

The researchers' models also show that cycling through single drugs accelerated the rate at which malaria parasites evolved drug resistance. Smith said this occurred because cycling a single drug degraded the parasite's average fitness, which made it easier for drug-resistant genes to spread throughout the parasite population.

The cycling models predicted a declining therapeutic value of a single drug within 3.54 years, versus a longer effective therapeutic value of 9.95 years when three drugs were used in equal proportions within a population. The research was funded in part by grants from the Bill and Melinda Gates Foundation, and the National Institutes of Health.

"Using multiple first-line drugs reduces the selection pressure for resistance to a single drug," Smith said. "This is one way to make the ACTs last longer and benefit more people."

Co-author Laxminarayan, a senior research fellow at RFF, said ACTs are the best treatment option for malaria, now as well as in the foreseeable future.

"Novel treatment strategies improve our ability to delay the emergence of drug resistance without the need to deny treatment," Laxminarayan said.

Wil Milhous, associate dean for research at the University of South Florida's College of Public Health, said the research is "clearly a superb breakthrough in mathematical modeling applied to malaria drug deployment." Milhous has worked to develop new drugs for malaria for more than 25 years and is unaffiliated with the study.

"We have done the math in drug development, but only in terms of the cost of goods for drug combinations to include advanced preclinical and clinical testing. These are extremely time-consuming and costly but critical to regulatory approval," Milhous said. "Now we have a highly quantitative reality check that poor implementation strategies doom drugs to failure."

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Article adapted by Medical News Today from original press release.
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New Research Suggests That Action As A Goal May Be Too Broad

2008-09-07T21:46:00.000-07:00

A series of experiments conducted by researchers at the University of Illinois suggest that society's emphasis on action over inaction may lead to unforeseen consequences.

"Our research highlights how the pressures of society to be active may produce fairly unregulated behavior," said Dolores Albarracín, a professor of psychology who led the work.

The new analysis appears this month in the Journal of Personality and... Social Psychology. According to Albarracín, the findings could help understand how common words used in everyday life may influence conditions such as attention deficit hyperactivity disorder and bipolar disorder. While such conditions have genetic roots, Albarracín said, the social and cultural factors that exacerbate them are not well understood.

In a series of experiments, researchers primed participants with a set of words suggesting action or inaction and then observed their behavior. The primes list consisted of words such as "go" and "motivation" that represented an active thought, or words like "rest" and "stop" that indicated inaction.

In previous studies, Albarracín said, behavior and stimulus were always tightly linked. For example, participants primed to be hungry would eat more. In this research, however, Albarracín noted that the association between the word primes and outcomes was very weak.

In the new analysis, Albarracín and colleagues subjected participants to different sets of word primes and then asked them to perform a task. The tasks ranged from doodling to eating, and in some cases, learning new information. The intensity of the behavior was measured, and in two of the studies participants could choose to do none of the tasks and instead rest.

The studies demonstrated that participants primed with an action word were more likely to choose active tasks. But what was most compelling to Albarracín was that the same stimulus triggered a diverse array of tasks that are normally not seen together, such as eating, learning and doodling. The researchers successfully reproduced this paradigm in the laboratory. In one setting, the active word prime enhanced learning, but in a different context the same stimulus encouraged participants to doodle or eat.

"What you actually end up promoting is a very general message to be active," Albarracín said. "You can be active by exercising or learning, but you can also be active by driving fast or taking drugs. That is the danger of a global message to be active."

The studies suggest that it is important to provide more specific cues about how to be active. It also rings a note of caution about how children are educated, Albarracín said.

"If you think about the number of activities that kids are engaged in these days - going to school, playing the piano, etc. - to what extent is this pattern desirable?" Albarracín said. "Are you conveying that specific activities are valuable or that being busy and active all the time is what you are supposed to be doing?"

Source: Kaushik Ragunathan
University of Illinois at Urbana-Champaign

Study Finds Neutral HIV Presentations More Likely To Be Considered Inviting

2008-09-07T21:41:00.000-07:00

A recent study by University of Illinois professor of psychology Dolores Albarracín and her colleagues at the University of Florida and the Alachua County Health Department in Florida found a method to increase enrollment among high-risk individuals in HIV prevention programs.

The study, which appeared this month in the journal Health Psychology, found that by offering an experimental introduction to a counseling session, public health institutions could increase enrollment by a significant amount.

Previous research by Albarracín found that those most likely to... engage in behavior that puts them at a high risk for HIV are also the least likely to enroll and stay in HIV intervention programs.

Therefore the researchers studied the effects of delivering different messages to participants screened for high-risk behavior as an invitation to a counseling program delivered at the Alachua County Health Department in Gainesville, Fla. They found one message that increased enrollment among participants.

All the messages informed participants who had signed up for a generic health study that they could speak to a HIV-prevention counselor. In the experimental condition, they were also told that the counseling session was not intended to change their behavior, only to provide them with the most current information. Compared with a message that indicated that the counseling increased condom use, recipients of the experimental message enrolled at a rate higher by 15 percent. This effect was particularly strong when participants had no intention of using condoms at the beginning of the study.

"This kind of research has tremendous public health implications," Albarracín said.

"Public health experts around the world are regularly in search of the most effective methods for curbing preventable health problems," she said. "HIV is a disease caused by a number of risky behaviors like unsafe sex and unsafe needle sharing, but health information is often disseminated without complete knowledge of how it will be received by audiences," she said.

"The research indicates that people will be more receptive to information when they don't believe they are trying to be influenced," Albarracín said. "This approach will be helpful in giving public health professionals effective ways to introduce the public to information without repulsing those they are trying to help most."

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Article adapted by Medical News Today from original press release.
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A study of the 2006 Chikungunya epidemic outbreak in Mauritius

2008-08-10T21:13:00.000-07:00

ABSTRACT: Chikungunya epidemic outbreaks have affected more than 1 million people in 2005-2006 in many Indian Ocean islands and in India. Mauritius experienced a major outbreak in February/March 2006 following a minor outbreak in April/May 2005. No cases have been registered on the island since August 2006. The objectives of this study were to understand the timing and development of the 2006-outbreak in Mauritius, to investigate the possibility of a future outbreak, and to propose measures to prevent the recurrence of an epidemic in Mauritius. Mauritius rainfall, temperature and humidity data were analyzed. A door-to-door household census-type survey was carried out in a... study locality on the island. A compartmental human-mosquito interaction model was integrated to understand outbreak evolutions in the surveyed locality and in a theoretical locality. It was observed that the onset of the 2006-outbreak in February followed an abnormally high rainfall in the third week of January 2006. 51% of the surveyed population was found to be suspected Chikungunya cases. Computer simulations indicated that a small number of infected humans and mosquitoes existed in the surveyed locality at the outbreak onset. From simulations in the theoretical locality, it was deduced that the level of infectivity in some localities may be below a herd immunity threshold and that the additional percentage of infected inhabitants in a follow-up epidemic would be significantly reduced with the case-reactive control of infected adult mosquitoes.

KEY WORDS: Chikungunya, Modeling, Herd Immunity, Epidemic Control.
Source : geocities

Pharmacokinetic Study of Frusemide in Healthy and Cirrhotic Indian Subjects

2008-08-10T21:10:00.000-07:00

Abstract: Liver cirrhosis is associated with various complications such as ascites and fluid retention, progressing to development of hepatorenal syndrome, further compromising fluid elimination. Frusemide, a loop diuretic is normally administered to relieve fluid retentions. The kinetics of frusemide has not been conclusively reported in the three types of cirrhosis and among Indian subjects. The aim of the current study was to evaluate the kinetics of frusemide among healthy and Child’s A, B and C cirrhosis and compare with earlier data.

24 cirrhotic were selected and classified according to the Child’s-Pugh classification. 12 healthy male volunteers were screened and included in the study. 40 mg of frusemide was administered orally to... both groups and blood samples were withdrawn at various intervals of time for a duration of 8 hrs. The amount of frusemide present in plasma was analyzed using HPLC. The volumes of distribution (Vd), area under curve (AUC), systemic clearance (CL), maximum concentration (Cmax), time for maximum concentration (tmax) in healthy volunteers were respectively 4.56 ± 0.15 L, 2258 ± 530.7, 4.97 ± 1.67 L/h, 892 ± 49.4 ng/ml, 85.20± 7.49 mins. Corresponding values in Group A were 5.00 ± 0.31 L, 2471 ± 228.6, 6.60 ± 2.90L/h, 1021 ± 47.97 ng/ml and 88.25 V 2.12 mins; in Group B 7.73 ± 1.10 L, 4038 ± 154.7, 8.84 ± 0.45 L/h, 1448 ± 43.20 ng/ml and 120 ± 1.89 mins; In group C cirrhosis 9.69 ± 1.32 L, 4085 ± 131.75, 3.49 ± 1.40 L/h, 1551± 59.02 ng/ml and 185.7 ± 2.68 mins respectively. Significant differences at 1% and 5% were observed among the cirrhotic groups and between healthy v/s cirrhotic patients.

Data from current study do not correlate with earlier reports, carried mainly in Western population, due to possibly differences in instrumentation, etc but a possible genetic interplay should not be ruled out. Data from cirrhotic patients could not be effectively compared with earlier studies as kinetics of frusemide has not been conclusively been reported in the three categories of cirrhosis.

KEY WORDS: Pharmacokinetic, Frusemide, Liver cirrhosis.

Source : geocities

Association of Helicobacter pylori with gastric carcinoma

2008-08-10T21:06:00.000-07:00

Helicobacter pylori is a nonsporing curvilinear gram negative rod of size approximately 3.5 × 0.5µm and found to be associated with the development of chronic antral gastritis, gastroduodenal ulcers, gastric cancer and mucosa- associated lymphoid tumors. In 1983, Marshall and Warren discovered this unidentified curved bacillus located on the gastric epithelium of patients with chronic active gastritis. The discovery of Helicobacter pylori and its association with a number of gastrointestinal diseases has revolutionized the field of gastroenterology.

It is well established that cancer arises in chronically inflamed tissue, and this is particularly notable in the... gastrointestinal tract. Classic examples include Helicobacter pylori-associated gastric cancer and inflammatory bowel disease-associated colorectal cancer. Helicobacter pylori infection is basically acquired during infancy and persists for decades together. The mode of transmission has not been well defined, although oral-oral transmission, fecal oral transmission and environmental spread are among the possible routes. Bacteria, which are closely associated with gastric epithelial cells and in the mucous layer, are mainly present in the antrum but also found in the patches of gastric metaplasia in the duodenum and the esophagus.

H pylori infection is proposed to be involved in the development of gastric cancer. The high prevalence of H pylori infection in early age groups increases the risk of gastric cancer. Many studies showed a significant correlation of gastric cancer with the raised concentration of IgG antibodies to H pylori. Clinical studies based on histo-pathological examination of gastric biopsy specimens showed that H pylori infection is more common in patients with gastric cancers than patients with no pathological lesions. Severe atrophy of the stomach and the foci of gastric metaplasia, which precede the development of gastric tumors result in reduced colonization of H pylori. In these circumstances a biopsy specimen may be negative while, for several years IgG antibodies would remain positive indicating evidence of past infection.

Despite a possible role of Helicobacter pylori in gastric carcinoma (GC), its pathogenesis is not clear. Integrity of tissues, including that of gastric epithelium, is maintained by a balance between cell death by apoptosis or necrosis and regeneration. This balance may be altered by H. pylori infection, since it induces apoptosis of gastric epithelial cells both in vivo and in vitro. The studies from the developed world suggest that CagA-bearing strains of H. pylori are more often associated with gastroduodenal diseases than CagA-negative strains. It is becoming clearer that H. pylori strains carrying a functional Cag pathogenicity island (cagPAI), which encodes the type IV secretion system (TFSS) and its effector CagA, play an important role in the development of gastric carcinoma. Pathomechanism of gastric carcinogenesis associated with H. pylori includes bacteria-host interaction leading to morphologic alterations such as atrophic gastritis and gastrointestinal metaplasia mediated by COX-2 overexpression, cancer cell invasion, and neo-angiogenesis via TLR2/TLR9 system and transcription factors (e.g., NF-kappaB) activation.

Long standing mucosal inflammation reduces acid secretion (hypochlorhydria) and pepsin secretion. This favors bacterial growth and sustained mucosal epithelial cells proliferation, which increases risk of genomic mutation. DNA damage is further contributed by increased oxidative stress. How a person becomes infected with H pylori is not yet fully understood. The factors that affect the risk of a subject acquiring such infection and methods of prophylaxis have also not been identified with any certainty. Further studies are required in this field that would be helpful to prevent gastric cancers. The eradication of this pathogen, in children as well as in adults, should theoretically lead to the disappearance of gastric cancer.

Dr. Smriti Agnihotri

Associate Editor

Email: smriti_agnihotri@yahoo.co.uk

GE Healthcare Announces Phase I Results With Amyloid Imaging Agent GE-067

2008-07-31T12:04:00.000-07:00

GE Healthcare, a unit of the General Electric Company (NYSE:GE), announced positive results from a Phase I clinical trial of GE-067, a [18F]-labeled PET diagnostic imaging agent being developed by the company to assist in the detection of brain beta-amyloid. The results, presented today at the International Conference on Alzheimer's Disease, Chicago, USA by the Principal Investigator, Professor Rik Vandenberghe, of the University of Leuven, Belgium, show significantly greater brain uptake of GE-067 in Alzheimer's Disease patients compared with healthy volunteers1. The two hour half-life of the [18F] labeled ligand offers the potential for greater clinical accessibility compared with the research compound [11C] PIB.

Currently, post-mortem diagnosis of Alzheimer's disease (AD) is the "gold standard" of disease confirmation, which offers no possibilities to patients and... their carers while they are alive. A key focus of AD research is to identify in vivo imaging agents that could potentially assist in the diagnosis of the disease while the patient is alive. The ability to demonstrate whether a patient does or does not have amyloid pathology might not only be used to support a clinician's diagnosis, but could in the future be used to aid treatment decisions if any of the amyloid targeted therapies now in development are successfully approved. [11C] PIB is now the most recognised and widely used research tool for imaging amyloid. A recent study2 from the Pittsburgh group of Klunk and Mathis has demonstrated that the in-vivo image seen with a PIB PET scan mirrors the distribution and intensity of amyloid pathology identified at subsequent autopsy. However, the [11C] labeled form of PIB has a short half-life (20-minutes) which hampers its potential as a routine clinical diagnostic agent. GE Healthcare has pioneered the synthesis of a PIB derivative labeled with [18F] in order to help overcome this significant barrier to potential clinical use. The [18F] form of the ligand, with a much longer half-life of 110 minutes, may offer greater clinical utility and wider accessibility to hospitals.

The Phase I study (presented using the chemical number [18F] AH1100690) consisted of 22 subjects who were injected with the agent GE-067. Initially 6 healthy volunteers had whole body scans to determine the radiation dose. A further 8 healthy and 8 probable AD) subjects had cranial scans with significant amounts of uptake being observed in the probable AD brains compared to the healthy volunteers. These initial results suggest that GE-067 could be used to detect amyloid pathology in vivo and potentially contribute towards future diagnostic and treatment algorithms, subject to performance of confirmatory studies.

Don Black, Head of R&D, Medical Diagnostics at GE Healthcare said: "We were excited to see the results from this Phase I study with GE-067 and as a result have initiated a larger study with manufacturing and scanning centres across Europe. We also plan to extend our studies to the United States of America."

Commenting on the results, Rik Vandenberghe, Principal Investigator of the trial and Professor of Neurology at the University of Leuven, Belgium said "The results of this Phase I trial are a very encouraging step forward in our quest to develop a clinically useful diagnostic imaging agent to assist in the early diagnosis of Alzheimer's Disease and directly demonstrate in vivo the presence of abnormal quantities of beta amyloid in an individual's brain. With latest estimates of the incidence of Alzheimer's Disease predicted to quadruple to 106 million by 20503 and with the potential development of amyloid - lowering therapies, there is a critical need for an effective diagnostic product to directly and reliably demonstrate the presence of amyloid deposits as early as possible during the course of the disease and ultimately improve the lives of patients and caregivers."

The PIB series of compounds are licensed by GE Healthcare from The University of Pittsburgh. In 2008, the inventors of PIB, William E. Klunk, MD, PhD, and Chester A. Mathis, PhD, from the University of Pittsburgh, were awarded the prestigious American Academy of Neurology Potamkin Prize for their significant contribution to the imaging of amyloid.

About Alzheimer Disease

Alzheimer's disease is the most common cause of dementia and a leading cause of death worldwide. Latest estimates put the global prevalence at 26.6 million and forecast that by 2050 the prevalence will quadruple, to leave 1 in 85 people worldwide living with the disease3.

References:

1. Phase I study of the 18F-labelled benzothiazole derivative [18F]AH110690 as a biomarker of AD-related brain amyloidosis Rik Vandenberghe1 et al,. Poster Presentation, International Conference on Alzheimer's Disease 2008.

2. Post-mortem correlates of in vivo PIB-PET amyloid imaging in a typical case of Alzheimer's disease Ikonomovic, M.D. et al. Brain 2008 Jun; 131(Pt 6):1630-45.

3. Forecasting the global burden of Alzheimer's disease. R. Brookmeyer, et al. Alzheimer's and Dementia 2007 ,Volume 3 ,Issue 3 ,Pages 186 - 191

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.

GE Healthcare

Anavex Presents Neuroprotective Effects Of Anavex 1-41 At The International Conference On Alzheimer's Disease 2008

2008-07-31T12:02:00.000-07:00

ANAVEX Life Sciences Corp. (OTCBB: AVXL), a biopharmaceutical company engaged in the discovery and development of novel therapeutics to treat Central Nervous System (CNS) diseases and cancer, presented data from the company's novel compound, ANAVEX 1-41, targeting Alzheimer's disease, at the International Conference on Alzheimer's Disease (ICAD) 2008, Chicago, USA, July 26 to 31, 2008. The compound has a synergistic neuroprotective and anti-apoptotic effect in Alzheimer's disease in animal models using amyloid (beta) 25-35 peptide.

"We are pleased by our continued progress in the development of ANAVEX 1-41, and are excited to be presenting data regarding its potent neuroprotective and... anti-apoptotic properties at such low doses at ICAD," said Dr. Vamvakides, Chief Scientific Officer of ANAVEX. "Based on our pre-clinical studies to date, we continue to believe that ANAVEX 1-41 may offer disease-modifying options that reverse memory and learning deficits and protect nerve cells from death."

The Anavex Life Sciences presentation is entitled: "Neuroprotective effects of activators/agonists of the sigma-1 chaperone protein against amyloid toxicity in a mouse mode". The authors are: Tanguy Maurice (1), Vanessa Villard (1), Johann Meaner (1), Emetine Keller (1), Fanny Malaria (1), Alexandre Vamvakides (2) 1. Inserm U. 710, EPHE, Univ. Montpellier II, Montpellier, France 2. Anavex Life Sciences, Pallini, Greece.

Neuroprotection was attained in the ANAVEX 1-41 compound at very low doses (0,1mg/kg) in mice. At the same doses there was synergy between Sigma-1 receptors and Muscarinic receptors, amplifying the anti-amnesic potential effects, as well as the anti-apoptotic and the anti-oxidative stress potential.

Neuroprotection is the most important component necessary to attain long-term benefits in neurodegenerative diseases. In Alzheimer's disease, neuroprotection is about shielding the neuronal cells in the brain from degeneration or death. Therefore, ANAVEX's potent neuroprotective compound may offer disease-modifying treatment and not merely symptomatic relief from Alzheimer's disease. Moreover, the compound does not target pathologoanatomic hallmarks, such as amyloid-plaques, whose role has turned out to be controversial, since approaches to inhibit them have failed to provide compelling benefit.

Anavex's approach is based on the exploitation of the multiple modulation properties of Sigma-1 receptors, which are as of yet unexploited by the existing drugs in the market. Sigma-1 receptors are proteins that regulate the activity of other different proteins (like IP3 receptors or ER stress sensors) and also of sodium and calcium channels. Moreover, through their modulatory role, Sigma-1 receptors are able to regulate cellular apoptotic processes.

Unlike the challenge of pro-amyloid and anti-amyloid theories of AD, Anavex Life Sciences' SIGMACEPTOR(TM) Discovery Platform sigma-1 activator molecules target neuronal intracellular structures with the goal of preventing neurodegenerative action of disturbed biochemical pathways and channels.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (http://www.anavex.com) is an emerging biopharmaceutical company engaged in the discovery and development of novel drug targets for the treatment of cancer and neurological diseases such as Alzheimer's, epilepsy and depression. The company's proprietary SIGMACEPTOR(TM) Discovery Platform involves the rational design of drug compounds that fulfill specific criteria based on unmet market needs and new scientific advances. Selected drug candidates demonstrate high, non-exclusive affinity for sigma receptors, which are involved in the modulation of multiple cellular biochemical signaling pathways.

ANAVEX's SIGMACEPTOR(TM)-N program involves the development of novel and original drug candidates that target neurological and neurodegenerative diseases (Alzheimer's disease, epilepsy, depression, pain). The company's lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for anti-amnesic, neuroprotective, anti-apoptotic, anti-oxidative, anti-inflammatory, anti-convulsive, anti-depressant and anxiolytic properties. The company believes that oxidative stress, not amyloid-beta, is the cause of Alzheimer's. ANAVEX 1-41 uses sigma receptors, a unique class of receptor molecules, to guard against oxidative stress and repair cells compromised by its effects. So far, through the advanced pre-clinical phase of development, the compound has performed extremely well in well-recognized animal models of Alzheimer's disease, underscoring the promise of this alternative approach to the disease.

ANAVEX SIGMACEPTOR(TM)-C program involves the development of novel and original drug candidates targeting cancer. The company's lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for selective pro-apoptotic, anti-metastatic and low toxicity properties in various types of solid cancers such as colon, prostate, breast and lung. ANAVEX 7-1037 has already demonstrated its ability to significantly delay the growth of cancerous tumors in patient-derived xenografts during advanced pre-clinical studies.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery and development, which include, without limitation, the potential failure of development candidates to advance through preclinical studies or demonstrate safety and efficacy in clinical testing and the ability to file an IND or commence clinical studies. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

Anavex Life Sciences Corp

First Ever Study On Alzheimer's Disease Treatment In Hispanics Presented At Major Medical Meeting

2008-07-31T12:00:00.000-07:00

Eisai Inc. and Pfizer Inc (NYSE: PFE) announced results from a new open-label study that showed Hispanics with mild to moderate Alzheimer's disease (AD) experienced significant improvement in cognition compared to baseline after 12 weeks of treatment with ARICEPT. This is the first clinical trial looking at an AD prescription medication exclusively in Hispanics, and is important given the high risk of AD among this large population. These results are consistent with pivotal ARICEPT studies in the general population and also in studies specific to African Americans, as seen in the 2006 Treatment of Alzheimer's in African American Patients (TAAAP) study. The Evaluating ARICEPT Treatment in Hispanics (EARTH) study was presented at the 2008 Alzheimer's Association International Conference on Alzheimer's Disease and Related Disorders (ICAD).

"We know the Hispanic community is in need of increased education on the benefits of diagnosing and treating AD early," said Dr. Oscar Lopez, professor, department of neurology, University of Pittsburgh, and the first author of the... EARTH poster presented at ICAD. "This news should serve as a call to action for Hispanic families to watch for early signs of AD among their loved ones and speak with a doctor as soon as possible if symptoms are suspected."

This multi-center open-label clinical trial enrolled 106 Hispanic men and women from across the U.S. Patients were at least 50 years of age and had a diagnosis of mild to moderate AD. In order to most accurately measure the efficacy of ARICEPT in Hispanics, unique measurement tools with little language bias were specifically selected for use in the EARTH study. For instance, the Fuld Object Memory Evaluation (FOME) assessment reduces dependence on spoken English, and it has been proven effective in detecting cognitive impairment and in the diagnosis of AD in Spanish-speaking individuals. The Symbol Digit Modality Test (SDMT) is also extremely sensitive for detecting dementia and has minimal cultural bias. A third, commonly used measurement included the Mini-Mental State Examination (MMSE).

The MMSE score, which measures cognitive function, significantly improved from baseline (p<0.0001) with a treatment effect that was similar to that seen in the pivotal studies for ARICEPT. The FOME, which assesses learning and memory through common object recognition, also showed significant improvement with ARICEPT (p=0.0042) in terms of retrieval scores. The FOME storage scores did not show statistically significant improvement from baseline. The SDMT measures speed of mental processing, attention and concentration functions, and also showed significant improvement from baseline (p<0.0001). Behavioral symptoms and associated caregiver distress were assessed with the Neuropsychiatric Inventory (NPI). A numeric improvement in NPI total score was observed but did not reach statistical significance; however, the NPI Caregiver Distress scale (NPI-D) total score significantly improved (p=0.0500).

The most common adverse events greater than or equal to five percent were insomnia (9.5 percent), dizziness (7.6 percent), diarrhea (5.7 percent) and nausea (5.7 percent).

"All too often, Hispanics dismiss the symptoms of AD as signs of normal aging and wait years before consulting a doctor," said Yanira Cruz, who has a doctorate in public health and is president and CEO of the National Hispanic Council on Aging (NHCOA), a national organization dedicated to improving the quality of life for Hispanic communities. "This study reminds us of the value of treating AD to slow symptoms of the disease, and I encourage primary care physicians with Hispanic patients to start screening for signs of dementia at a younger age, potentially at 55 or 60 years."

Dr. Cruz urges more attention to diagnosis and treatment of AD among Hispanics and advises family members suspecting AD symptoms in a loved one to visit http://www.losamigosdesumemoria.com to learn more about the disease and complete an online memory screener.

The EARTH study represents Eisai and Pfizer's leadership in understanding the benefits of ARICEPT in multiple populations. The TAAAP study, published in the Journal of the National Medical Association in 2006, found that African Americans with mild to moderate AD and treated with ARICEPT experienced significant improvement in cognition and function. ARICEPT has now been studied in two underserved populations, both with higher prevalence and incidence of AD than the general population.

Alzheimer's Disease in the Hispanic Community

-- There are an estimated 200,000 Hispanics living in the U.S. with AD today, and by 2050, it is estimated that approximately 1.3 million Hispanic Americans will have the disease.

-- Due to language differences and cultural barriers, Hispanics typically wait to see a doctor until they are in a later stage of the disease -- usually three years after symptoms emerge.

-- Many Hispanics living with AD remain undiagnosed and untreated (approximately 40 percent).

-- Hispanics start showing AD symptoms nearly seven years earlier than non-Hispanics.

-- Reasons for increased AD risk in the Hispanic community include the growing senior population (age is the number one risk for disease), higher rates of diabetes and hypertension (known risk factors), and familial risk (genetics and heredity).

-- Hispanic participation in AD clinical trials remains historically low. Information About ARICEPT Treatment in Alzheimer's Disease

ARICEPT is the only AD treatment to be approved in the U.S. for mild, moderate and severe dementia of the Alzheimer's type. While there is no cure for AD, ARICEPT can help slow the progression of symptoms. Extensive data derived from clinical studies with thousands of patients have demonstrated that ARICEPT helps cognition and function.

ARICEPT is an acetylcholinesterase inhibitor and is believed to work by inhibiting the breakdown of acetylcholine, thereby increasing available levels of this chemical in the brain. There is an established association between the loss of acetylcholine, a brain chemical involved in memory and thinking, and AD.

In a progressively degenerative disease such as Alzheimer's, improvement, stabilization or a less-than-expected decline over time is considered a positive response to treatment. These types of responses have been observed in patients treated with ARICEPT in clinical trials for AD. Individual responses to treatment vary, and some patients may not respond.

ARICEPT is well tolerated, but may not be for everyone. People at risk for stomach ulcers or who take certain other medicines should tell their doctors because serious stomach problems, such as bleeding, may get worse. Some people who take ARICEPT may experience fainting. Some people may have nausea, vomiting, diarrhea, bruising, or not sleep well. Some people may have muscle cramps or loss of appetite or may feel tired. In studies these were usually mild and temporary.

About Eisai Inc.

Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care. Established in 1995 and ranked among the top-20 U.S. pharmaceutical companies (based on retail sales), Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with fiscal year 2007 (year ended March 31, 2008) sales of approximately $3 billion, including the results of the acquisition of MGI PHARMA, Inc.

Eisai Inc. employs approximately 1,500 people at its headquarters in Woodcliff Lake, NJ, at its state-of-the-art pharmaceutical production and formulation research and development facility in Research Triangle Park, NC, and in the field. For more information about Eisai, please visit http://www.eisai.com.

About Pfizer Inc

Founded in 1849, Pfizer is the world's largest research-based pharmaceutical company. Pfizer is taking new approaches to advancing better health as it discovers, develops, manufactures and delivers quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. Pfizer also partners with healthcare providers, governments and local communities around the world to expand access to medicines and to provide better quality health care and health system support. At Pfizer, more than 85,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide. For more information visit http://www.pfizer.com.

Pfizer Inc

Diverse Approaches To Alzheimer's Therapies Continue To Show Progress At ICAD

2008-07-31T11:59:00.000-07:00

Results from clinical trials of three potential Alzheimer's therapies raise hope for new and better treatments of the disease, according to data reported today at the 2008 Alzheimer's Association International Conference on Alzheimer's Disease (ICAD 2008) in Chicago.

A related study showed that taking antidementia drugs appears to have a positive impact on extending lifespan in those with Alzheimer's.

These reports included:

Eighteen-month data from... an open-label extension of a pivotal trial of Dimebon (Medivation) in mild to moderate Alzheimer's.

-- Nine-month data from an interim analysis of the first U.S. Phase II trial of intravenous immunoglobulin, or IVIg (Baxter), in Alzheimer's.

-- Results of a Phase II study of a monoclonal antibody (LY2062430, Lilly) in mild to moderate Alzheimer's.

-- Research suggesting that persistent antidementia drug use increases survival in people with Alzheimer's.

"Therapies targeting amyloid in Alzheimer's disease must continue to be thoroughly tested," said William Thies, PhD, Alzheimer's Association vice president for Medical and Scientific Relations. "At the same time, we know that Alzheimer's is a complex disease and that better treatments and preventions will likely also be complex, so we must investigate every promising drug target looking eventually towards the possibility of a multi-strategy approach."

18-Month Data from an Extension of a Pivotal Trial of Dimebon in Alzheimer's

In a study recently reported, Dimebon (Medivation) improved cognition and memory, activities of daily living, and behavior in a one-year placebo-controlled trial of patients with mild to moderate Alzheimer's. At ICAD 2008, Jeffrey L. Cummings, M.D., the Augustus S. Rose Professor of Neurology, and Professor of Psychiatry and Biobehavioral Sciences, at UCLA, and colleagues reported on an open-label extension of the trial to 18 months.

One hundred eighty-three (183) people with mild-to-moderate Alzheimer's were initially randomized into a six-month placebo-controlled study of Dimebon. Patients completing six months of treatment were offered the opportunity to re-consent for an additional six months of controlled treatment in their originally randomized group, followed by an open-label extension (OLE). Data presented at ICAD 2008 include only the 104 OLE participants (54 Dimebon, 50 placebo). All were given Dimebon for the OLE, not placebo, at a dose of 20 mg three times per day. Ninety-two (92) (88.5%) patients enrolling into OLE completed six months of treatment.

Patients originally receiving Dimebon for 12 months who continued on Dimebon for an additional six months in the OLE phase had preservation of function close to their starting baselines on the key signs and symptoms of Alzheimer's disease 18 months after starting the study. Patients originally on placebo for 12 months who were then crossed over to Dimebon on the OLE phase also stabilized across all key measures tested. Since these patients had declined over the previous 12 months while on placebo, they stabilized at a lower level of function than those treated with Dimebon for the full 18 months.

Dimebon was well-tolerated through 18 months. Adverse events that occurred more often with dimebon compared to placebo were dry mouth, sweating and depressed mood/sadness.

"People initially treated with placebo and then crossed over to Dimebon did not show the same level of benefit as those people who took Dimebon for the full 18 months," Cummings said. "This emphasizes the benefit of earlier treatment, and suggests the possibility that Dimebon may slow of the progression of Alzheimer's. However, open-label extensions are not that same as placebo-controlled trials, and extrapolation of the treatment results should be done with caution. Patients are being screened now for the Phase III clinical trials."

"Dimebon appears to work through a mechanism of action that is distinct from currently marketed Alzheimer's drugs. Dimebon improves impaired mitochondrial function. Mitochondria are the central energy source of all cells and impaired mitochondrial function may play a significant role in the loss of brain cell function in Alzheimer's," Cummings added.

First U.S. Double-Blind Phase II Clinical Trial of IVIg (Immunotherapy) in Alzheimer's

IVIg is under investigation by Baxter International as a potential anti-amyloid immunotherapy for Alzheimer's. It contains a broad spectrum of antibodies, and is currently indicated as a therapy for people with primary immunodeficiency disorders. IVIg contains antibodies that bind to the beta amyloid aggregates that are thought to be central to Alzheimer's. In two previous open-label studies, patients with mild to moderate Alzheimer's showed cognitive improvement when treated with IVIg for six months.

Diamanto Tsakanikas, PhD, Norman Relkin, MD, PhD, and colleagues at Weill Cornell Medical College carried out a six-month Phase II double-blind, placebo-controlled study of IVIg for Alzheimer's followed by a 12-month, rater-blinded extension study. At ICAD 2008, they reported an interim analysis of uninterrupted IVIg treatment for 9 months.

Twenty-four people with mild to moderate Alzheimer's (MMSE 14-26) participated in the trial. For the first six months, eight participants received placebo and 16 received IVIg at four doses ranging from 0.2 grams IVIg per kilogram of body weight every two weeks to 0.8 grams IVIg per kilogram of body weight given once per month (four people each at the four different doses). After six months, all subjects were given IVIg with the raters blinded to dose. The primary outcome measures were two standard measures of cognition and the clinician's observation of change (a seven point scale from "markedly improved"=+3 to "marked worsening"=-3), respectively the ADAS-cog and the ADCS-CGIC, which were administered at baseline and three-month intervals thereafter.

In the total group, the researchers found statistically significant differences favoring IVIg treatment on the CGIC at three, six and nine months. At nine months, the IVIg group averaged 1.5 points higher on the CGIC. On the ADAS-cog, scores favoring IVIg reached statistical significance at nine months. The average change in ADAS-Cog score at nine months favored IVIg treatment by 5.4 ADAS points. Uninterrupted IVIg treatment also produced sustained benefits relative to initial placebo treatment in activities of daily living.

When the results for each dose were analyzed individually, subjects receiving 0.4 grams of IVIg per kilogram of body weight given every two weeks improved over baseline on ADAS-Cog, ADCS-CGIC, and a measure of daily functioning. The researchers identified this as the best dose. None of the subjects given placebo showed comparable improvements.

Treatment-related adverse events that occurred at a greater frequency with IVIg treatment as compared to placebo were rash and a transient drop in blood count. In contrast, there were more behavioral disturbances in placebo-treated patients than those who received IVIg.

"While there were relatively small numbers of participants in this study, we were nonetheless able to demonstrate that people with Alzheimer's who get uninterrupted treatment with IVIg for nine months have statistically significant and clinically relevant improvements on both cognitive and global clinical measures," Tsakanikas said. "A large-scale, 18-month, multicenter Phase III clinical trial of IVIg in Alzheimer's is now getting underway, sponsored by Baxter and the National Institutes of Health, that will test whether IVIg immunotherapy provides long-term benefits and has a disease-modifying effect. Additional studies may be required."

Phase II Immunotherapy Trial with LY2062430 in Mild to Moderate Alzheimer's

Previous research has shown that antibodies that bind to beta amyloid can be given intravenously. By binding to beta amyloid and increasing the rate of its removal from the body, these antibody infusions may slow the progression of Alzheimer's.

Eric Siemers, MD, Medical Director of the Alzheimer's Disease Research Team at Eli Lilly and Company, and colleagues conducted a Phase II trial of a monoclonal antibody, known as LY2062430, that binds to the mid-domain of beta amyloid.

Fifty-two (52) people with mild to moderate Alzheimer's and 16 volunteer subjects were studied. Alzheimer's patients received 12 weekly infusions of placebo or antibody (100 mg every 4 weeks, 100 mg once per week, 400 mg every 4 weeks or 400 mg once per week). Volunteers received a single 100 mg dose of antibody. Safety assessments included brain imaging using magnetic resonance imaging (MRI) and examination of cerebrospinal fluid (CSF, a fluid normally present around the brain and spinal cord). In an optional sub-study, 24 Alzheimer's patients and 13 volunteers underwent a type of brain imaging known as SPECT using a tracer (known as IMPY) that measures the amount of amyloid plaque present in the brain. Measures of symptom severity were obtained in all AD patients using the Alzheimer's Disease Assessment Scale - Cognition (ADAS-cog).

The researchers found that following administration of the antibody, the amount of beta amyloid in blood increased substantially after the antibody bound to the beta amyloid protein. A small amount of the antibody enters the CSF, and in the Alzheimer's patients beta amyloid also increased in CSF, similarly bound to the antibody. For patients treated with 400 mg of the antibody, the amount of the type of beta amyloid primarily found in plaque (known as AB1-42) that appeared in the blood correlated with the amount of amyloid plaque in the brains based on IMPY scans (r=0.65, p=0.02). According to Siemers, this finding suggests that some of the beta amyloid protein present in plaque moves to blood after treatment with the antibody.

Certain other types of beta amyloid thought to be primarily or exclusively found in amyloid plaque are also increased in blood and CSF of study participants. The antibody produced no change in cognitive scores or in the total amount of amyloid plaque based on IMPY scans. Siemers said that this was expected in a study of this duration.

According to the researchers, brain imaging using MRI and CSF safety assessments showed no evidence of inflammation, bleeding or other side effects throughout the trial. No side effects were identified that appeared to be related to antibody treatment.

"We saw an increase in amyloid beta, which is thought to be bound to LY2062430, in both the blood and cerebrospinal fluid of study participants," Siemers said. "Additionally, after treatment we found a correlation between beta amyloid in blood and the amount of amyloid plaque in brain as determined by IMPY imaging, as well as an increase in blood and CSF in certain types of beta amyloid found in plaques. These biomarker data suggest that amyloid plaques in the brain may begin to 'dissolve' after 12 weeks of treatment with this antibody. We're now planning a Phase III clinical trial of this drug to be started in 2009."

Antidementia Drugs Contribute to Longer Life in People with Alzheimer's

Survival (life span) in people with Alzheimer's is recognized to be shorter than what is expected in cognitively normal seniors and is recognized to be influenced by several factors including age, disease severity, general debility, and gender. Approved antidementia drugs have been shown help with the symptoms of Alzheimer's but their influence on life span is not known.

At ICAD 2008, Susan Rountree, MD, of the Alzheimer's Disease and Memory Disorders Center of Baylor College of Medicine in Houston, Texas, reported on a study of the persistent use of antidementia drugs and their influence on survival.

The researchers followed 641 people diagnosed with Alzheimer's at an academic medical clinic between 1989 and 2005. These individuals had been on drug therapy over the course of their Alzheimer's for variable amounts of time and the majority had used one or more of the commercially available antidementia drugs (donepezil, galantamine, rivastigmine, tacrine, or memantine).

Total years on medication was divided by the total years of disease symptoms to determine a persistency score for each individual. Participants were divided into four groups (1st, 2nd, 3rd, 4th quartiles) ranging from the lowest to highest persistency scores and the researchers compared life span among the groups after adjustment for a variety of factors generally recognized to influence survival. The 1st quartile took drug less than 33 percent of the time, 2nd quartile = 34-55 percent of the time, 3rd quartile = 56-70 percent of the time, and the 4th quartile = 71-99 percent of the time.

Over the entire course of the study, 12 percent of participants never took any antidementia drugs. Fifty-three (53) percent of the participants died.

The researchers found an inverse and statistically significant relationship between the overall risk of death and the persistency of drug use. Those in the lowest persistency group (1st quartile) were 2.4 times more likely to die than those in the highest persistency group (4th quartile). Those with intermediate drug exposure had increased risk of death of 2.2 times (2nd quartile) and 1.5 times (3rd quartile) compared to the most persistent users. More persistent therapy was associated with a longer median survival time; the median survival between the lowest quartile group and the most persistent users was 3.12 years.

"In our study, people with Alzheimer's who took antidementia drugs more persistently lived longer than those who took the medications for shorter time intervals," Rountree said. "In an earlier study involving this group, we reported that persistency of treatment was also associated with long term cognitive and functional benefits. Persistent drug therapy appears to help Alzheimer's patients live longer and the mechanism may be related to overall improvement of cognition and function resulting from current symptomatic therapies."

About ICAD 2008

The 2008 Alzheimer's Association International Conference on Alzheimer's Disease (ICAD 2008) is the largest gathering of international leaders in Alzheimer research and care ever convened. At ICAD 2008, more than 5,000 researchers from 60 countries will share groundbreaking information and resources on the cause, diagnosis, treatment and prevention of Alzheimer's and related disorders. As a part of the Association's research program, ICAD serves as a catalyst for generating new knowledge about dementia and fostering a vital, collegial research community. ICAD 2008 will be held in Chicago at McCormick Place, Lake Side Center from July 26-31.

About the Alzheimer's Association

The Alzheimer's Association is the leading voluntary health organization in Alzheimer's research, care and support. Our mission is to eliminate Alzheimer's disease through the advancement of research, provide and enhance care and support for all affected, and reduce the risk of dementia through the promotion of brain health. Our vision is a world without Alzheimer's. For more information, visit http://www.alz.org.

-- Jeffrey Cummings. "18-Month data from an open-label extension of a one-year controlled trial of dimebon in patient with mild-to-moderate Alzheimer's disease." (Funder: Medivation)

-- Diamanto Tsakanikas. - "Effects of uninterrupted intravenous immunoglobulin treatment of Alzheimer's disease for 9 months." (Funder: Baxter International)

-- Eric R. Siemers. - "Safety, tolerability and biomarker effects of an Abeta monoclonal antibody administered to patients with Alzheimer's disease." (Funder: Eli Lilly and Company)

-- Susan Rountree. - "Persistent Antidementia Drug Treatment and Survival in an Alzheimer's Disease Cohort." (Funders: Forest Research Institute and The Cynthia and George Mitchell Foundation)

All materials to be presented at the 2008 Alzheimer's Association International Conference on Alzheimer's Disease (ICAD 2008) are embargoed for publication and broadcast until the date and time of presentation at the International Conference on Alzheimer's Disease, unless the Alzheimer's Association provides written notice of change of date/time in advance.

Alzheimer's Association

Diverse Approaches To Alzheimer's Therapies Continue To Show Progress At ICAD

2008-07-31T11:55:00.000-07:00

Lifestyle Factors Contribute To Lowering And Raising Risk Of Alzheimer's Disease

2008-07-31T11:52:00.000-07:00

A new study suggests that those who are unmarried or not living with a partner in midlife could have an increased risk of developing Alzheimer's disease, according to research reported today at the 2008 Alzheimer's Association International Conference on Alzheimer's Disease (ICAD 2008), in Chicago.

Additional research on Alzheimer risk factors presented at ICAD 2008 indicates that people who ruminate, or repeatedly think about their problems, may be... less likely to develop the disease, while people with metabolic syndrome (a combination of cardiovascular health related symptoms) are at higher risk. Finally, a large meta-analysis of nine European risk factor surveys confirmed a well recognized group of Alzheimer risk factors, including memory complaint, severe head trauma, diabetes, stroke and low education.

"We may not be able to do anything about aging, genetics or family history, but research shows us that there are lifestyle decisions we all can make to keep our brains healthier as we age, and that also may lower our risk of developing Alzheimer's disease," said William Thies, PhD, vice president for Medical & Scientific Relations at the Alzheimer's Association.

Unmarried Life: Paving the Way for Dementia?

Research suggests that maintaining regular social interaction can contribute to maintaining brain health as we age and possibly decrease one's risk of developing Alzheimer's. When people are married they are able to have close interaction on a regular basis. This may reduce the occurrence of dementia.

Krister Hakansson, BA, of Karolinska Institutet, KI Alzheimer Research Center, Stockholm, Sweden and Vaxjo University, School of Social Sciences, Vaxjo, Sweden, conducted a first-of-its-kind evaluation of whether midlife marital status is related to late-life cognitive function. The study examined 1,449 individuals from the Finnish Cardiovascular Risk Factors, Aging, and Dementia (CAIDE) study in midlife and then again in 1998, an average of 21 years later.

At re-examination, 139 persons were diagnosed with some form of cognitive impairment: 82 with mild cognitive impairment (MCI) and 48 with Alzheimer's. Persons in the study who were living with a partner in midlife were significantly less likely to show cognitive impairment compared to all other categories (single, separated, divorced or widowed). Those in the study who were married or lived with a significant other in midlife had a 50% lower risk of having dementia in late-life compared to those who lived alone, even after adjustments for education, BMI, cholesterol, blood pressure, occupation, physical activity, smoking habits, depression, ApoE status, age at follow-up and gender.

The researcher observed that there were differences between groups of people who had been living alone for different reasons. The all-life singles had a doubled risk, whereas the ones who stayed divorced from midlife onwards had a tripled risk. The most dramatic risk increase was found for those widowed before midlife and who stayed widowed. Compared to those married at midlife and still so at late-life, they had more than a six-fold risk of developing Alzheimer's.

"Living in a couple relationship is normally one of the most intense forms of social and intellectual stimulation. If social and cognitive challenges can protect against dementia, so should living in a couple relation," said Hakansson. "This study points to the beneficial effects of a married life, consistent with the general hypothesis of social stimulation as a protective factor against dementia."

Tendency for Rumination in Midlife May Decrease Risk for Dementia Decades Later

According to Ramit Ravona-Springer, MD, of Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel and colleagues, "rumination" refers to the disposition for repetitive thinking over one's problems.

Tendency for rumination when confronting difficulties in family and work settings was assessed in about 9,000 participants in the IIHD study, a longitudinal investigation of the incidence and risk factors for cardiovascular disease among Jewish male civil servants in Israel. Tendency for rumination was assessed as 1=always forget, 2=tend to forget, 3=tend to ruminate, 4=usually ruminate.

Dementia was assessed three decades later in 1,890 participants among 2,604 survivors of the original cohort. Mean age of the participants was 82 at the time of final assessment. 308 were diagnosed as demented, 175 as having mild cognitive impairment, and 1,407 had no cognitive impairment.

The prevalence rates of dementia (adjusted for age, area of birth, and socioeconomic status) were 21% for those who always forget difficulties in familial settings, 18% for those who tend to forget, 14% for those who tend to ruminate over difficulties, and 14% for those who usually ruminate. When rumination in response to difficulties at work was assessed, prevalence rates of dementia were 24% for those who always forget difficulties, 19% for those who tend to forget, 15% for those who tend to ruminate over difficulties, and 15% for those who usually ruminate.

A total score for rumination in both family and work settings was calculated, and subjects were divided into four groups according to this score. Relative to the group with the lowest total rumination score, dementia prevalence was 30 to 40 percent less in groups with higher scores.

"Your personality traits, specifically your psychological and cognitive style when confronting distress, may be associated with your risk for dementia," said Ravona-Springer. "However, exactly how this works still needs to be determined."

Metabolic Syndrome May Lead to Cognitive Decline

Metabolic syndrome (Met.S) is a group of heart disease risk factors that includes abdominal obesity, elevated blood pressure, high triglycerides, elevated blood sugar and low HDL cholesterol. Those who have Met.S are at higher risk for developing diabetes, hypertension, and stroke, all of which increase the risk of developing dementia, including Alzheimer's disease.

Matheus Roriz-Cruz, MD, PhD, Federal University of Rio Grande do Sul State, Brazil and colleagues studied the effects of Met.S on the development of cognitive impairment in people who have not had a stroke. Researchers evaluated 422 healthy elderly men and women over age 60 in Brazil and used a battery of scales to assess cognition, depression, planning and activities of daily living. Met.S was present in 39.3% of participants.

Data from the study revealed that all neurofunctional scores were significantly lower for those with Met.S, and the difference increased with age. Older people with Met.S had an almost 35% higher level of cognitive compromise when compared to those without Met.S.

"Met.S was independently associated with lower cognitive, planning, neuromotor and functional scores, and with more depressive symptoms," said Roriz-Cruz. "The results from this study reinforce the importance of maintaining good physical health in order to reduce one's risk of experiencing cognitive decline, and possibly developing Alzheimer's disease."

Risk Factors for Progression to Dementia in General Population

In the general population, many risk factors and predictors for dementia have been identified. However, a combination of risk factors may give a more accurate prediction for dementia than each individual risk factor.

Sylvaine Artero, of INSERM, Montpellier, France; Pieter Jelle Visser, of the University of Maastricht, The Netherlands; and colleagues analyzed a pooled database constructed from nine European surveys of dementia risk factors, including a total of 16,261 participants over age 55 without dementia. Potential risk factors were evaluated at baseline and incident dementia was assessed over a follow up period of up to 15 years. Risk factors included cardiovascular disorders, endocrine disorders, depression, head trauma, intoxicants (including alcohol, smoking and drugs), physical and intellectual activities, performance in activities of daily living, Apolipoprotein E genotype, cognitive complaint, and cognitive test performance.

In total, 1,530 subjects (9%) progressed towards dementia. In order, the most predictive variables were: impairment in executive function (planning), memory problems (as measured on tests), subjective complaints about memory/cognitive failure, Apolipoprotein E (ApoE) genotype, use of psychotropic medication, severe head trauma, diabetes, stroke, and problems with language. In addition, problems with activities of daily living, smoking, no drinking, no use of hypertensive drugs, low education, and female gender all independently predicted dementia at follow-up.

"Cases of dementia in the general population can be best identified by a combination of socio-demographic, clinical and cognitive factors," said Artero. "Developing a better understanding of the factors that increase risk for Alzheimer's will help us to create more effective methods to prevent people from developing the disease."

About ICAD 2008

The 2008 Alzheimer's Association International Conference on Alzheimer's Disease (ICAD 2008) is the largest gathering of international leaders in Alzheimer research and care ever convened. At ICAD 2008, more than 5,000 researchers from 60 countries will share groundbreaking information and resources on the cause, diagnosis, treatment and prevention of Alzheimer's and related disorders. As a part of the Association's research program, ICAD serves as a catalyst for generating new knowledge about dementia and fostering a vital, collegial research community. ICAD 2008 will be held in Chicago at McCormick Place, Lake Side Center from July 26-31.

About the Alzheimer's Association

The Alzheimer's Association is the leading voluntary health organization in Alzheimer's research, care and support. Our mission is to eliminate Alzheimer's disease through the advancement of research, provide and enhance care and support for all affected, and reduce the risk of dementia through the promotion of brain health. Our vision is a world without Alzheimer's. For more information, visit http://www.alz.org.

-- Krister Hakansson - "Unmarried life: Paving the way for dementia?" (Funders: Gun and Bertil Stohne Foundation)

-- Ramit Ravona-Springer - "Tendency for rumination as a psychological cognitive style in midlife is associated with decreased risk for dementia three decades later." (Funders: Israel Science Foundation, Israel Academy of Sciences and Humanities)

-- Matheus Roriz-Cruz - "Metabolic syndrome, successful and pathological neuroaging in a stroke-free elderly population." (Funders: Ministries of Education, Brazil and Japan)

-- Sylvaine Artero, Pieter Jelle Visser - "Risk factors for progression to dementia in general population: the Descripa study (European pooled data base)." (Funder: European Commission, 5th framework programme (QLK-6-CT-2002-02455))

Alzheimer's Association

Memory Pharmaceuticals Presents Positive Preclinical Data For MEM 68626 At ICAD 2008

2008-07-31T11:49:00.000-07:00

Memory Pharmaceuticals Corp. (Nasdaq: MEMY) presented preclinical data for MEM 68626, its lead 5-HT6 antagonist drug candidate, at the 2008 Alzheimer's Association International Conference on Alzheimer's Disease (ICAD) in Chicago. The results demonstrate that MEM 68626 is effective in models of cognition that are considered predictive of efficacy in Alzheimer's disease and mild cognitive impairment (MCI). In addition, the data suggests the potential for once-daily oral dosing with a favorable safety and toxicology profile.

"We are extremely pleased with the data emerging from our proprietary 5- HT6 antagonist program. MEM 68626 produces a robust effect in key models of cognition with a favorable safety and... pharmacokinetic profile, providing a strong rationale for clinical development in a cognition indication," stated Vaughn M. Kailian, President and Chief Executive Officer of Memory Pharmaceuticals. "We look forward to advancing this program into the clinic by year-end."

The results were presented in a poster titled "Characterization of serotonin 5-HT6 receptor antagonists as putative drugs for age-related mild cognitive impairment and Alzheimer's disease." The data included the following:

-- MEM 68626 significantly enhanced object recognition in young rats, demonstrating improvements in both acquisition and consolidation memory processes in a model of episodic memory.

-- In a model of spatial reference memory, MEM 68626 restored cognitive function in aged-impaired rats, and this effect was maintained with longer- term dosing.

-- The data suggests that MEM 68626 was active in the cortical and hippocampal areas of the brain, critical regions that are compromised in Alzheimer's disease and MCI.

-- Pharmacokinetic studies of MEM 68626 demonstrated that the compound achieved plasma and brain exposure levels sufficient for once-a-day dosing.

Memory Pharmaceuticals also presented a poster titled "Working Memory Deficits in rTg4510 Tau Transgenic Mice," which was selected as a "Hot Topics" presentation.

About MEM 68626

MEM 68626 is a novel, potent and selective antagonist of the 5-HT6 receptor, a validated target for the treatment of cognitive disorders. The compound has demonstrated efficacy in multiple preclinical models of cognition and obesity and has a favorable safety and toxicology profile in animal studies. MEM 68626 is the lead compound in Memory Pharmaceuticals' 5-HT6 antagonist program.

About the Company

Memory Pharmaceuticals Corp., a biopharmaceutical company, is focused on developing innovative drugs for the treatment of debilitating CNS disorders, many of which exhibit significant impairment of memory and other cognitive functions, including Alzheimer's disease and schizophrenia. For additional information, please visit our website at http://www.memorypharma.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or Memory Pharmaceuticals' prospects, future financial position, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including the outcome of clinical trials of Memory Pharmaceuticals' drug candidates and whether they demonstrate these candidates' safety and effectiveness; the risks and uncertainties associated with: obtaining additional financing to support Memory Pharmaceuticals' R&D and clinical activities and operations; obtaining regulatory approvals to conduct clinical trials and to commercialize Memory Pharmaceuticals' drug candidates; Memory Pharmaceuticals' ability to enter into and maintain collaborations with third parties for its drug development programs; Memory Pharmaceuticals' dependence on its collaborations and its license relationships; achieving milestones under Memory Pharmaceuticals' collaborations; Memory Pharmaceuticals' dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers and consultants; protecting the intellectual property developed by or licensed to Memory Pharmaceuticals; and Memory Pharmaceuticals' ability to maintain listing on the Nasdaq Global Market. These and other risks are described in greater detail in Memory Pharmaceuticals' filings with the Securities and Exchange Commission. Memory Pharmaceuticals may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Memory Pharmaceuticals disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Memory Pharmaceuticals Corp.

Alzheimer's - Positive New Data On Dimebon's Long-Term Efficacy And Novel Mechanism Of Action

2008-07-31T11:46:00.000-07:00

Medivation, Inc. (NASDAQ: MDVN) announced new data showing that its investigational drug Dimebon continues to produce broad, clinically meaningful benefits in Alzheimer's disease patients after long-term dosing, and appears to operate through a novel mechanism of action. These data were presented recently in a podium session and two poster sessions at the 2008 Alzheimer's Association International Conference on Alzheimer's Disease (ICAD) in Chicago. The presentations are highlighted below.

Dimebon Preserves All Key Functions in Alzheimer's Patients for 18 Months in Open-Label
Extension of First Pivotal Trial

New data from a six-month open-label extension of the 12-month placebo-controlled study of Dimebon in patients with mild-to-moderate Alzheimer's disease demonstrated that Dimebon continued to... improve the clinical course of the disease. After 18 months of treatment, Dimebon preserved function in patients at their original levels upon entering the trial across all key aspects of Alzheimer's disease, specifically memory and thinking, behavior, activities of daily living and overall function. These results are noteworthy as untreated Alzheimer's patients progressively deteriorate over time in these areas. Dimebon remained well tolerated throughout the 18-month treatment period.

The open-label extension data were presented in a poster session by Jeffrey Cummings, M.D., Director of the Mary S. Easton Center for Alzheimer's Disease Research at UCLA. "To my knowledge, no other approved or investigational treatment has stabilized function across all facets of Alzheimer's disease for this length of time," said Dr. Cummings. "These data suggest that Dimebon may provide long-term benefits to Alzheimer's patients and provide further support for its potential as a promising therapeutic to treat this devastating disease."

Patients originally on placebo for 12 months who were then crossed over to Dimebon in the openlabel extension phase stabilized across all key measures tested. Since these patients had declined over the previous 12 months while on placebo, they generally stabilized at a lower level of function than those treated with Dimebon for the full 18 months, suggesting a benefit of earlier treatment.

Dimebon Benefits Both Mild and Moderate Patients in 12-month Subgroup Analyses

New data from subgroup analyses by disease severity of the Dimebon double-blind placebocontrolled trial showed that Dimebon benefited both mild and moderate patients. In both mild and moderate patients, Dimebon treatment resulted in significant benefit on the study's primary endpoint, the Alzheimer's Disease Assessment Scale-cognition subscale, or ADAS-cog. The benefit in the moderate subpopulation was particularly robust, with a 9.7 point drug-placebo difference on the ADAS-cog (p<0.0001) after 12 months of treatment.

The subgroup analyses were presented in a separate poster presentation at ICAD 2008 by Rachelle Doody, M.D., Ph.D., the Effie Marie Cain Chair in Alzheimer's Disease Research at the Alzheimer's Disease and Memory Disorders Center, Baylor College of Medicine in Houston. "A nearly 10-point improvement over placebo in moderate patients on the ADAS-cog, a well-validated cognition scale in Alzheimer's disease, is unquestionably of clinical significance, especially in light of a clinical effect seen on the clinician's assessment of global function," said Dr. Doody. "If the results we saw for both the mild and moderate patients can be replicated, I believe that Dimebon will be an important advance in the treatment of Alzheimer's disease, regardless of stage."

Dimebon's Novel Mechanism of Action

In a podium presentation at ICAD 2008, Medivation presented new data on Dimebon's novel mitochondrial mechanism of action. Mitochondria generate energy for cells and play important roles in mediating cell function and survival. Mitochondrial dysfunction has been linked in the published literature to both Alzheimer's and Huntington's diseases. Preclinical data presented showed that Dimebon improves mitochondrial function in the setting of cellular stress with very high potency. For example, Dimebon treatment improved mitochondrial function and increased the number of surviving cells after treatment with a cell toxin known as ionomycin in a dose-dependent fashion. The effect of Dimebon to improve mitochondrial dysfunction has been confirmed in the independent laboratory of Maria Ankarcrona, Ph.D., Associate Professor at the Karolinska Institutet in Sweden.

"All of the approved Alzheimer's disease drugs operate by one of two mechanisms - cholinesterase inhibition or NMDA-receptor antagonism," noted Bengt Winblad, M.D., Ph.D., Head of the Karolinska Institutet's Alzheimer's Disease Research Center. "The body of preclinical and clinical data generated thus far convinces me that Dimebon is exerting its effects through a different mechanism. The data presented today support the hypothesis that Dimebon improves mitochondrial dysfunction. This is a novel mechanism that may, in part, explain the clinical benefits seen in Alzheimer's patients treated with Dimebon."

About the Pivotal Study

Dimebon's first pivotal Alzheimer's trial was a randomized, double-blind, placebo-controlled study of 183 patients with mild to moderate Alzheimer's disease. In this study, patients treated with Dimebon experienced statistically significant improvements compared to placebo in all the key aspects of the disease: memory and thinking, activities of daily living, behavior and overall function - after both six months and a full year of treatment. Dimebon's benefit over placebo continued to increase throughout the 12-month treatment period. At the end of 12 months, Dimebon-treated patients preserved their starting level of function on each measure of Alzheimer's disease. Results of the pivotal study were published in the July 19, 2008 issue of The Lancet.

Earlier this year, the U.S. Food and Drug Administration (FDA) informed Medivation that this study can be used as one of the pivotal studies required to support the approval of Dimebon to treat mildto- moderate Alzheimer's disease, as long as a significant proportion of the sites in the confirmatory Phase 3 trial are located in the United States. The Company recently began a confirmatory pivotal Phase 3 trial of Dimebon in Alzheimer's disease known as the CONNECTION study. Patients and caregivers can learn more about the study by visiting http://www.connectionstudy.com or by calling 1-877-888-6386.

About the Open-Label Extension

All patients who completed 12-months of dosing in the first pivotal trial were eligible to enroll in an open-label extension. All participants in the open-label extension received Dimebon, including patients who had previously received placebo during the prior 12 months of the trial. Because there was no placebo-control in the open-label extension, direct comparisons versus placebo cannot be made.

About Dimebon

Dimebon is an orally available small molecule that has been shown to inhibit brain cell death in preclinical models relevant to Alzheimer's and Huntington's diseases, making it a potential treatment for these and other neurodegenerative diseases. Preclinical data generated to date suggest that Dimebon operates through a novel mitochondrial mechanism of action. On July 7, 2008, Medivation announced positive safety and efficacy results from its Phase 2 trial of Dimebon for the treatment of Huntington's disease, which was conducted in collaboration with the Huntington Study Group. The study met its primary endpoint of safety and tolerability; in addition, Dimebon showed statistically significant benefit versus placebo in cognition as measured by the Mini-Mental State Examination, a secondary endpoint in the study. Huntington's disease is a progressive neurodegenerative disease characterized by the gradual development of involuntary muscle movement, progressive deterioration of cognitive processes and memory and severe behavioral disturbances. There are currently no approved drugs in the United States to treat this uniformly fatal genetic disorder.

About Medivation

Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. The Company's current clinical development program includes a pivotal and confirmatory Phase 3 trial of Dimebon in Alzheimer's disease and a Phase 1-2 clinical trial of MDV3100 in patients with castration-resistant (also known as hormone-refractory) prostate cancer. Medivation recently announced that it plans to continue further development of Dimebon in patients with mild-to-moderate Huntington's disease based on the positive results seen in its Phase 2 trial. For more information, please visit us at http://www.medivation.com.

This press release contains forward-looking statements, including statements regarding future clinical development plans, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve risks and uncertainties that could cause actual results to differ significantly from those projected. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release.] None of the Company's product candidates has been approved for sale, significant additional animal and human testing is required in order to seek marketing approval for any of its product candidates, and Medivation cannot assure you that marketing approval can be obtained for any of its product candidates. Furthermore, as is typically the case at this stage of the regulatory review process, the FDA has not yet performed an in-depth review of Medivation's preclinical and clinical data, so its views remain subject to change. Medivation's filings with the Securities and Exchange Commission, including its current report on Form 8-K filed on June 23, 2008, include information about additional factors that could affect the Company's financial and operating results.

medivation.com

Ongoing Phase II Study Explores Potential For Detection Of Amyloid Plaque Prior To Onset Of Alzheimer's Disease

2008-07-31T11:43:00.000-07:00

Avid Radiopharmaceuticals presented clinical results on the development of a novel 18F-labeled PET amyloid imaging agent, 18F-AV-45, that may eventually provide a practical approach for routine brain imaging of people at risk for the development of Alzheimer's disease. At the ICAD meeting in Chicago, Avid presented results of the exploratory IND clinical studies of three novel amyloid plaque imaging agents. The study results demonstrated that 18F-AV-45 (AV-45) was the best of the compounds studied, and allowed for rapid (≤ 1 hour) imaging of amyloid plaque in Alzheimer's Disease (AD). Brain amyloid plaques are comprised of β-amyloid aggregates, one of the primary pathological markers of Alzheimer's disease and a key target for new therapeutic treatments under development.

AV-45, now in Phase II clinical studies, is the first F-18 PET amyloid imaging compound to enter multi-center clinical research studies in the U.S. for the detection of amyloid plaque in... patients with varying degrees of dementia. The use of the F-18 radiolabel on AV-45 allows for high quality PET imaging of amyloid plaque to be done for the first time in a community hospital or imaging clinic setting.

"The entire Alzheimer's community dreams of a day when Alzheimer's becomes a preventable disease. The only way to achieve this is through early detection and early treatment," said Daniel Skovronsky, M.D., Ph.D., CEO and President of Avid. "At Avid, we are working to make this vision a reality, and believe that AV-45 PET imaging may have the potential to detect amyloid plaque pathology in the brain prior to the development of dementia. With this in mind, we have embarked on a Phase II clinical study of AV-45 in people with mild cognitive impairment, a form of memory impairment that may eventually lead to Alzheimer's disease," added Skovronsky.

In this study reported at the ICAD meeting, AV-45 permitted the visualization of amyloid plaque - the major pathological component of AD - within as little as 50 minutes from administration and with 10 minutes of imaging time, resulting in minimal inconvenience or delay for the patient or the imaging center. These rapid imaging characteristics of AV-45 make it very convenient for brain PET imaging at both major academic research centers as well as in the community imaging center. In addition, stable levels of AV-45 were maintained in amyloid plaque for up to 90 minutes post injection, permitting high quality PET images to be obtained over an extended period of time.

About Avid Radiopharmaceuticals Inc.

Based in Philadelphia, PA, Avid Radiopharmaceuticals Inc. is a leader in the development of products with the potential for earlier and more effective detection, diagnosis and monitoring of brain disorders. The company is a pioneer in the development of molecular imaging agents for Alzheimer's disease that could lead to earlier diagnosis and better evaluation of drugs designed to prevent or reverse amyloid plaque build-up in the brain. Avid is currently enrolling patients in clinical studies of 18F-PET agents for imaging amyloid plaques in Alzheimer's disease and for imaging the vesicular monoamine transporter (VMAT2) in diseases involving dopaminergic degeneration such as Parkinson's disease (PD) and Dementia with Lewy Bodies (DLB)
Source : Medical today

Encouraging Results From Phase 2 Clinical Trial Of Bapineuzumab At International Conference On Alzheimer's Disease

2008-07-31T11:41:00.000-07:00

Elan Corporation, plc (NYSE: ELN) and Wyeth (NYSE: WYE) are presenting detailed results from the companies' 18-month Phase 2 study of bapineuzumab (AAB-001) in patients with mild to moderate Alzheimer's disease at the Alzheimer's Association's International Conference on Alzheimer's Disease 2008 in Chicago, Illinois. As previously announced, in the study, bapineuzumab appeared to have an acceptable safety profile and clinical activity in treating Alzheimer's disease. Potential efficacy signals were seen at a range of doses without a clear dose response. The study did not attain statistical significance on the... pre-specified efficacy endpoints in the overall study population. Post-hoc analyses showed statistically significant and clinically meaningful benefits in important subgroups.

The data will be presented by Sid Gilman, M.D., William J. Herdman Distinguished University Professor of Neurology, Director of Michigan Alzheimer's Disease Research Center, University of Michigan, and Chair of the independent safety monitoring committee for bapineuzumab.

"This study was limited in its size, design and goals," said Dr. Gilman, "but if the findings seen in these post-hoc analyses are replicated in the global Phase 3 program, it would be a validation of the amyloid hypothesis and could change how physicians approach the treatment of Alzheimer's disease."

Elan and Wyeth believe that the safety and efficacy findings from this Phase 2 trial of bapineuzumab in patients with mild-to-moderate Alzheimer's disease support the design of the ongoing global Phase 3 program and plan to incorporate learnings from this study into the Phase 3 program. The companies will continue to work diligently to develop much needed new treatment options for patients and physicians.

About the Phase 2 Clinical Trial

The double-blind, placebo-controlled multiple ascending dose trial was designed to assess the safety and tolerability of bapineuzumab in mild-to-moderate Alzheimer's disease and to explore efficacy at a range of doses. Two-hundred-thirty-four (234) patients were randomized1 to receive one of four doses of bapineuzumab (0.15 mg/kg [n=31], 0.5 mg/kg [n=33], 1.0 mg/kg [n=30] or 2.0 mg/kg [n=30]) or placebo [n=110] by intravenous infusion every 13 weeks. Findings were reported for 229 patients in a modified intent-to-treat (MITT) analysis. Patients were intended to receive up to six doses during the 18-month study.

The pre-specified primary efficacy endpoints were change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Disability Assessment Scale for Dementia (DAD) in the 0.5 mg/kg, 1.0 mg/kg and 2.0 mg/kg dose groups against their placebo cohorts. Other efficacy measures included change in concentrations of tau in cerebral spinal fluid (CSF), the Neuropsychological Test Battery (NTB), the Clinical Dementia Rating Sum of Boxes (CDR-SOB), the Mini Mental State Examination (MMSE) and brain volume as measured by MRI. Efficacy was assessed from baseline for 78 weeks.

Pre-Specified Efficacy Analysis

In the total study population, statistical significance was not obtained on the pre-specified efficacy endpoints of ADAS-cog and DAD.

Post-Hoc Efficacy Analyses

Modified Intent to Treat (MITT) included patients who received at least one infusion and one efficacy assessment. In analyzing the data, the following were taken into account: an assumption of non linearity of the data over time, ApoE4 carrier status, and baseline MMSE and test scores.

The clinical relevance of the results for patients receiving the full 18 months of therapy was analyzed in a completer analysis. The patients included in the completer analysis received six (6) infusions and a week 78 efficacy assessment.

Using these assumptions, trends in favor of bapineuzumab treated patients were observed in ADAS-cog and NTB in the total MITT population. Additional completer analyses reinforced these trends.

The study revealed important differences in the rate of vasogenic edema by carrier status and for this reason the total population was analyzed by ApoE4 carrier status2.

ApoE4 Non-Carrier Population

In the ApoE4 non-carrier patients, statistically significant differences from baseline to week 78 were observed in favor of bapineuzumab treated patients on both cognitive and functional efficacy endpoints:

- ADAS-cog treatment difference of 5.0; p=0.026
- NTB treatment difference of 0.35; p=0.006
- CDR-SB treatment difference of 1.5; p=0.040

A favorable directional change of 6.9, p>0.10 for DAD was observed.

The completer analysis for non-carrier patients was consistent with the above findings.

Additionally, in these non-carrier patients, MRI results showed significantly less brain volume reduction versus placebo, as measured by the Brain Boundary Shift Integral (BBSI), at 71 weeks3, with a treatment difference of 10.7 cc; p=0.004. Smaller increases in ventricular volume (VBSI) in bapineuzumab treated patients compared to placebo were observed, which were not statistically significant. Progression of Alzheimer's disease is generally associated with loss in brain volume and increases in ventricular volume.

ApoE4 Carrier Population

In the ApoE4 carrier patients, no statistically significant changes were observed in any of the cognitive or functional efficacy endpoints. The completer analysis for the carrier population showed favorable directional changes on cognitive and functional endpoints. The ongoing Phase 3 studies in ApoE4 carriers will help clarify these findings.

MRI findings in the carrier patients showed no significant change in brain volume between bapineuzumab treated and placebo patients, while a significant increase in ventricular volume in treated patients was observed, mean 2.5cc; p=0.037. The clinical relevance of this finding is still unclear and will continue to be evaluated.

"The clinically significant benefit seen with bapineuzumab treatment in the ApoE4 non-carrier subgroup is encouraging," said Dale Schenk, Ph.D., Executive Vice President and Chief Scientific Officer of Elan. "These results across multiple endpoints are consistent with what we have seen for beta amyloid immunotherapy from animal studies through to the patients."

"These data represent scientific validation of our decision to move rapidly into Phase 3 last year," said Gary L. Stiles, M.D., Chief Medical Officer, Wyeth. "In our Phase 3 program, we will learn much more since we will be able to study bapineuzumab in larger patient populations and better assess the results in ApoE4 carriers and non-carriers in separate trials. We are encouraged by these results and we'll achieve greater insight as we move forward."

Safety Findings

Adverse Events (AE) were observed in 95% of bapineuzumab treated patients versus 90% of placebo treated patients. AEs were generally mild to moderate and transient. With the exception of vasogenic edema, AEs did not appear to be dose related.

Adverse events seen in greater than 5% of bapineuzumab treated patients and at twice the rate of placebo treated patients were: back pain; anxiety; vomiting; vasogenic edema; hypertension; weight loss; paranoia; skin laceration; gait disturbance; and muscle spasm.

Three deaths occurred in bapineuzumab-treated patients, though these were not considered by the investigators to be treatment related. No deaths were reported in the placebo group. Other adverse events of interest occurring in less than five percent of patients treated with bapineuzumab included cataract, deep vein thrombosis, syncope, seizures and pulmonary embolism.

Vasogenic Edema (VE)

Twelve (12) cases of vasogenic edema were reported, all in treated patients, and all resolved over time. Ten (10) of these cases were reported in ApoE4 carriers with 2 cases in ApoE4 non-carriers. Eight (8) of the 12 cases were reported in the highest dose group, including both cases seen in ApoE4 non-carriers. Six (6) of the 12 cases were not associated with clinical symptoms and were detected on routine MRI scan. One (1) patient was treated with steroids. Re-dosing was instituted in six (6) of the 12 patients and no recurrence of VE was observed.

Phase 3 Program Implications

The Phase 2 data reinforce the design of the ongoing Phase 3 studies by ApoE4 carrier and non-carrier populations and the selected dose groups. The companies plan to continue all four ongoing Phase 3 studies. The ApoE4 carrier dose in the Phase 3 trials was selected to seek to minimize the risk of VE observed in the Phase 2 trial. The companies intend to obtain feedback from regulatory authorities in the coming months to finalize parameters for the Phase 3 program and discuss and reach agreement on requirements for registration.

About Bapineuzumab

Bapineuzumab is the first humanized monoclonal antibody in late-stage investigation as a potential treatment for Alzheimer's disease. Bapineuzumab is designed to clear toxic beta amyloid from the brain. The beta amyloid protein is a key component of the neuritic plaques that are implicated in the pathology of Alzheimer's disease. A global, 4,100 patient Phase 3 clinical program was initiated in December 2007 and is intended to provide safety and efficacy data to support the filing and approval of licensing applications for bapineuzumab as a potential treatment for patients with mild to moderate Alzheimer's disease. To learn more about this enrollment, patients or caregivers should contact clinical sites directly. Participating clinical sites can be found by visiting http://www.icarastudy.com or, in the United States by calling 1 (888) 818-MEMORY. Study site details also can be found by visiting http://www.clinicaltrials.gov.

About Alzheimer's Disease

Alzheimer's disease is a progressive brain disorder that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities, such as bathing and eating. As Alzheimer's disease progresses, individuals may also experience changes in personality and behavior, such as anxiety, suspiciousness or agitation, as well as delusions or hallucinations. As many as 5 million Americans are estimated to have Alzheimer's disease, and more than 26 million people worldwide. One in eight baby boomers, and half of all people over 85, will develop the disease.

About the Elan and Wyeth Collaboration

The Wyeth and Elan Alzheimer's Immunotherapy Program (AIP) includes investigational clinical programs for bapineuzumab. AIP is a collaboration between the two companies to research, develop and commercialize immunotherapeutic approaches that may be used to treat and possibly prevent the onset of Alzheimer's disease. AIP research focuses on the beta amyloid hypothesis, as the companies believe that enhancing the clearance of beta amyloid in the brain may provide a new treatment approach for Alzheimer's disease.

About Elan

Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit http://www.elan.com.

About Wyeth

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.

Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. For additional information about the company, please visit http://www.wyeth.com.

Safe Harbor/Forward-Looking Statements

The statements in this press release and on the related webcast regarding the companies' assessment of the Phase 2 data and its implications for the Phase 3 program and future development of bapineuzumab are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, these statements are subject to the risk that further analyses of the Phase 2 data may lead to different (including less favorable) interpretations of the data than the analyses conducted to date and/or may identify important implications of the Phase 2 data that are not reflected in these statements. Clinical trial data are subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share the companies' views of the Phase 2 data or its implications for the Phase 3 program and future development of bapineuzumab. In addition, further analyses of the Phase 2 data and discussion with regulatory authorities may lead to important modifications to the Phase 3 program. There can be no assurance that the clinical program for bapineuzumab will be successful in demonstrating safety and/or efficacy, that we will not encounter problems or delays in clinical development, or that bapineuzumab will ever receive regulatory approval or be successfully commercialized. Other risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these forward-looking statements include those detailed from time to time in the Companies' periodic reports filed with the Securities and Exchange Commission, including Wyeth's current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors" in Wyeth's Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008, and Elan's Reports of Foreign Issuer on Form 6-K and Annual Report on Form 20-F, particularly the discussion under the caption "Item 3D, Risk Factors" in Elan's Annual Report on Form 20-F for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 28, 2008. The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

1 Randomization was on an 8:7 ratio, with more patients receiving bapineuzumab versus placebo.

2 Literature estimates that 40-70 percent of Alzheimer's disease population are non-carriers of the Apolipoprotein E4 (ApoE4) allele

3 MRI results were measured through week 71

Results Of 9-Month Phase II Study Of GAMMAGARD Intravenous Immunoglobulin (IGIV) In Patients With Alzheimer's Disease Announced

2008-07-31T11:35:00.000-07:00

NewYork-Presbyterian Hospital/Weill Cornell Medical Center announced the nine-month interim results of an ongoing Phase II clinical trial of GAMMAGARD Intravenous Immunoglobulin (IGIV) for Alzheimer's disease at the Alzheimer's Association International Conference on Alzheimer's Disease (ICAD) in Chicago.

The nine-month results show significantly better global outcomes, cognitive performance and daily functioning in... patients treated with IGIV compared to initially placebo-treated patients.

Just last April, at the American Academy of Neurology (AAN) meeting in Chicago, the six-month outcomes of the double-blind, placebo-controlled Phase II trial were presented. Now, interim data from the extension of that study show persistence of benefits for Alzheimer's patients treated continuously over 9 months. This is the first study to show persistence of benefits for Alzheimer's from IGIV with continuous treatment for 9 months. Previous studies discontinued therapy after 6 months.

The lead researcher for the trial is Dr. Norman Relkin, a behavioral neurologist and neuroscientist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. Dr. Relkin is director of the Memory Disorders Program at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and Associate Professor of Clinical Neurology at Weill Cornell Medical College in New York City.

Working in collaboration with Dr. Relkin is Dr. Diamanto Tsakanikas, the neuropsychologist for the Phase II study. Dr. Tsakanikas is Clinical Assistant Attending Neuropsychologist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and an Instructor of Neuropsychology in the Department of Neurology & Neuroscience at Weill Cornell Medical College.

Baxter International Inc. supported the study and provided GAMMAGARD Liquid and GAMMAGARD S/D for the trial. GAMMAGARD contains a broad spectrum of immunoglobulins (antibodies), and is indicated as an immunoglobulin replacement therapy in patients with primary immunodeficiency disorders.

In the double-blind, placebo-controlled Phase II study, 24 patients in the United States with mild to moderate Alzheimer's disease were randomly assigned to receive GAMMAGARD LIQUID (eight patients), GAMMAGARD S/D (eight patients) or saline placebo (eight patients). In the open-label extension of this study, all patients were treated for a total of 18 months. The study included a comparison of four dosing regimens of GAMMAGARD, with doses ranging from 0.2 g/kg every two weeks to 0.8 g/kg every month.

Cognitive, behavioral and functional measures were collected at baseline and every three months thereafter. The primary endpoints of the Phase II trial were cognitive function, as measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog), and global function, as assessed by the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change rating (CGIC). Safety and tolerability of IGIV treatment in Alzheimer's patients were also assessed relative to placebo. Secondary endpoints included effects on biomarkers related to beta amyloid, a peptide related to Alzheimer's disease.

In today's presentation at ICAD, Dr. Relkin reported that subjects who received uninterrupted IGIV therapy for 9 months demonstrated significantly better cognitive and overall clinical outcomes compared to initially placebo-treated subjects. Dr. Relkin also reported that uninterrupted treatment with IGIV resulted in further improvements in activities of daily living.

Statistically significant differences favoring IGIV treatment were observed on the CGIC at 3, 6 and 9 months. After nine months, the group of patients treated with GAMMAGARD averaged 1.4 points higher than initially placebo-treated patients on the CGIC, a commonly used measure of overall outcome in Alzheimer's clinical trials. At six months, the same group of patients had averaged 1.2 points higher than placebo-treated patients on the CGIC.

On the ADAS-Cog, a test of cognition, change scores numerically favored the IGIV-treatment at 3, 6 and 9 months, with the difference reaching statistical significance at 3 and 9 months. The average change in ADAS-Cog score at nine months of treatment favored treatment with GAMMAGARD by 5.4 ADAS points. The average change in ADAS-Cog score at six months of treatment had favored GAMMAGARD by 2.6 ADAS points. In an analysis by dose arm, subjects receiving 0.4g IGIV/kg/2 weeks improved over baseline on ADAS-Cog scores in 4 of 4 cases at 9 months. None of the subjects given placebo initially showed comparable improvements.

The scientists also measured activities of daily living (ADL) - the actual performance of each subject in common daily activities, as reported by caregivers. ADL is broken down into three increasing levels of severity: 1) independence, 2) supervision/required verbal reminders or instruction, and 3) physical assistance for daily tasks - including eating, toileting, bathing, grooming, dressing, reading, travel and using common household appliances. The research team found that experimental subjects either slightly improved or slightly declined over the study period. However, subjects in the placebo group showed a greater drop in ADL score.

The IGIV group showed minimal decline in carrying out daily tasks and performed better than initially placebo-treated patients on measures of activities of daily living. On average, there was a 7-point difference (-9.6 ADL point score in the placebo group compared to -2.5 ADL point score in the experimental group) between the IGIV (at all doses administered) and the placebo group. There was an 11-point difference between the 9-month performance of the IGIV group (+2 ADL points) and that of the placebo group (-9 ADL points). "Effects on daily function of this magnitude can make a difference in the lives of Alzheimer's patients and their caregivers," Dr. Tsakanikas commented.

Last year, in August 2007, NewYork-Presbyterian/Weill Cornell announced preliminary results of the Phase II study, indicating that the study provided further encouragement for carrying out a Phase III trial.

The latest results of the Phase II trial re-affirm the decision, initially announced in August 2007, to move to a Phase III study evaluating the role of Gammagard LIQUID for the treatment of patients with mild to moderate Alzheimer's disease with a nine-month primary outcome endpoint. The decision to move to Phase III was based on the results of two completed open-label clinical studies and the preliminary six-month interim analysis of the Phase II trial.

The Phase II study follows Dr. Relkin's earlier Phase I results in eight patients that were recently published in the journal Neurobiology of Aging (Feb. 2008). Although the findings of the Phase I and II trials are encouraging, both studies were small and must be evaluated in larger, sufficiently powered studies.

The Phase III trial will be sponsored jointly by the National Institutes of Health (NIH) and Baxter Healthcare, and additional studies may be required. The study protocol was submitted to the U.S. Food and Drug Administration for review, with the intention of initiating patient recruitment later this year. The trial will include about 35 leading academic centers in the United States that are members of The Alzheimer's Disease Cooperative Study (ADCS). The involvement of the ADCS and NIH in the conduct of the Phase III trial will ensure the highest level of independent scientific evaluation of the potential role of GAMMAGARD in the treatment of Alzheimer's patients.

This study was supported by Baxter Healthcare, the Citigroup Foundation and The Clinical Translational Science Center (CTSC) of Weill Cornell Medical College.

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances - from the development of the Pap test for cervical cancer to the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial for gene therapy for Parkinson's disease, the first indication of bone marrow's critical role in tumor growth, and, most recently, the world's first successful use of deep brain stimulation to treat a minimally-conscious brain-injured patient. NewYork-Presbyterian, which is ranked sixth on the U.S.News & World Report list of top hospitals, also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian Hospital/The Allen Pavilion. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree oversees and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar.

Potassium may help lower blood pressure

2008-07-31T11:30:00.000-07:00

NEW YORK (Reuters Health) - Research shows that boosting levels of potassium in the diet may lower a person's risk of developing high blood pressure and may decrease blood pressure in people who already have "hypertension."
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High blood pressure remains the chief reason for visits to doctors' offices and for prescription drug use in the U.S., two researchers from Nashville, Tennessee note in a special supplement to The Journal of Clinical Hypertension this month.

Dr. Mark C. Houston, from Vanderbilt University School of Medicine and Dr. Karen J. Harper from Harper Medical Communications, Inc. in Nashville, also point out that a healthy intake of... potassium is thought to be one reason why vegetarians and isolated populations have a very low incidence of heart disease.

In isolated societies consuming diets low in sodium and high in fruits and vegetables, which have and therefore high levels of potassium, hypertension affects only 1 percent of the population, they note. In contrast, in industrialized societies, where people consume diets high in processed foods and large amounts of dietary sodium 1 in 3 persons have hypertension.

The typical American diet contains about double the sodium and half the potassium that is currently recommended in dietary guidelines. Low potassium intake is thought to contribute to the prevalence of high blood pressure in Americans.

Based on their review of published studies on the topic, Houston and Harper say if Americans were to boost their potassium intake, the number of adults with known high blood pressure could fall by more than 10 percent. In 2006, the American Heart Association issued new guidelines calling for Americans to get 4.7 grams per day of potassium.

"An increase in potassium with a decrease in sodium is probably the most important dietary choice (after weight loss) that should be implemented to reduce cardiovascular disease," Houston and Harper contend.

Some studies also show that diets containing at least 500 to 1,000 milligrams magnesium daily and more than 800 milligrams of calcium daily may help lower blood pressure and the risk of developing high blood pressure.

"A high intake of these minerals through increased consumption of fruits and vegetables may improve blood pressure levels and reduce coronary heart disease and stroke," Houston and Harper conclude.

SOURCE: Journal of Clinical Hypertension, July 2008.

Missing DNA chunks tied to schizophrenia risk

2008-07-31T11:22:00.000-07:00

NEW YORK - Two huge international studies show that people who lack certain chunks of DNA run a dramatically higher risk of getting schizophrenia, a finding that could help open new doors to understanding and diagnosing the disease.
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These deletions are rare, each found in less than 1 percent of schizophrenia patients. But each one boosts the risk of disease by as much as 15-fold, by one estimate.

Scientists said studying such abnormalities may help them find new medications by shedding light on what causes the disease. And if enough rare aberrations can be found eventually, they may be combined into... a test to help in diagnosis, said Kari Stefansson, chief executive officer of deCode Genetics of Reykjavik, Iceland, and an author of one of the studies.

Schizophrenia is currently diagnosed by its symptoms.

The human DNA can be thought of as a very long string of letters — about 3 billion of them — that sometimes form words (genes). Each newly identified deletion removes a section of about half a million to 2 million letters.

In the past, scientists have found specific genes and deletions linked to schizophrenia risk. But the new work is notable because two large studies independently identified the same two DNA deletions, and those aberrations have such a big impact on disease risk. Stefansson's paper also reports evidence for a third deletion.

While the DNA deletions are linked to only a tiny fraction of schizophrenia cases, it's not unusual that a very rare cause of a disease provides insights that apply more generally, said Dr. Pamela Sklar of Massachusetts General Hospital, an author of the other paper. She said such knowledge can lead to treatments for many people.

Both papers were published online Wednesday by the journal Nature. Experts not connected with the work praised the results.

"This is tremendous" for basic research into the disease, said Dr. Linda Brzustowicz of Rutgers University. But since the deletions found so far are related to such a small fraction of schizophrenia cases, she said it's too early for companies to offer to test people for them.

Stefansson's paper, which included authors from more than a dozen centers in the United States, Europe and China, reported findings from DNA tests in about 4,700 people with schizophrenia and more than 40,000 healthy people. Sklar's paper, which included scientists from 11 institutes in the United States, Europe and Australia, tested about 3,400 people with schizophrenia and 3,200 others.

Both papers found that while the deletions were rare in schizophrenia patients, they were even rarer in people without the disease. Scientists say the disease results from a combination of genetic predisposition and environmental influences.

The two deletions found by both research groups boost schizophrenia risk 12-fold and 15-fold, Stefansson's group calculated. A third deletion his group found appears to raise risk about threefold.

Sklar said she was "absolutely delighted" that the papers found the two deletions independently, using different methods.

Anne Pulver, a schizophrenia genetics expert at Johns Hopkins University, said the papers represent a welcome shift in focus for finding genetic variants that affect risk of schizophrenia.

Traditionally, that search has centered on relatively common variants, each with little effect on an individual's risk. The new approach seeks rare variants that play a larger role. The new approach should help identify subgroups of patients with different genetic causes for their disease, she said. Eventually that could lead to treatments that are tailored to the differing biological causes, with improved outcomes, she said
Source : Yahoo news

Drug gives couch potato mice benefits of a workout

2008-07-31T11:18:00.000-07:00

NEW YORK - Here's a couch potato's dream: What if a drug could help you gain some of the benefits of exercise without working up a sweat? Scientists reported Thursday that there is such a drug — if you happen to be a mouse.
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Sedentary mice that took the drug for four weeks burned more calories and had less fat than untreated mice. And when tested on... a treadmill, they could run about 44 percent farther and 23 percent longer than untreated mice.

Just how well those results might translate to people is an open question. But someday, researchers say, such a drug might help treat obesity, diabetes and people with medical conditions that keep them from exercising.

"We have exercise in a pill," said Ron Evans, an author of the study. "With no exercise, you can take a drug and chemically mimic it."

Evans, of the Salk Institute for Biological Studies in La Jolla, Calif., and the Howard Hughes Medical Institute reports the work with colleagues in a paper published online Thursday by the journal Cell.

They also report that in mice that did exercise training, a second drug made their workout much more effective at boosting endurance. After a month of taking that drug and exercising, mice could run 68 percent longer and 70 percent farther than other mice that exercised but didn't get the drug.

Both drugs have been studied by researchers for other uses. The no-exercise drug is in advanced human testing to see if it can prevent a complication of heart bypass surgery.

Evans noted the drugs might prove irresistible for professional athletes who seek an illegal edge. He said his team has developed detection tests for use by the World Anti-Doping Agency. Evans said he has no financial interest in either drug or the test.

Resveratrol, a substance being studied for anti-aging effects, has also been reported to enable mice to run farther before exhaustion without exercise training. But the drugs in the new study appear to act more specifically on a process in muscles that boosts endurance, the researchers said.

Still, it takes more than just altered muscles to turn a sedentary mouse into a distance runner, Evans said, and "honestly, I just don't know how that happens. Whether it would happen in a person, I don't know. I think it's a small miracle it happened at all."

In fact, Evans said that when the experiment with sedentary mice was suggested by an outside scientist who was reviewing the lab's research, "I didn't think it was going to work."

The no-exercise drug is called AICAR. Previous experiments suggest that it might protect against gaining weight on a high-fat diet, which might make it useful for treating obesity, Evans said. But it would have to be taken for a long time, he said, so its safety in people would have to be assured.

Experts who study muscle agreed that a drug like AICAR may prove useful someday in treating obesity and diabetes. Many drug companies are working on such drugs in diabetes because in animals, AICAR stimulates muscles to remove sugar from the blood, noted Laurie Goodyear of the Joslin Diabetes Center in Boston.

People who can't exercise because of a medical condition like joint pain or heart failure might also benefit from such a drug, experts said.

But Eric Hoffman of the Children's National Medical Center in Washington, D.C., noted that AICAR mimics only aerobic exercise, not the strength training that might be more useful to bedridden people or the elderly, for example. He also cautioned that it's not clear whether the new mouse results can be reproduced in people.

Goodyear said exercise has such widespread benefits in the body that she doubts any one pill will ever be able to supply all of them. "For the majority of people," she said, "it would be better to do exercise than to take a pill."

Obesity not a contraindication to knee replacement

2008-07-31T11:13:00.000-07:00

NEW YORK (Reuters Health) - Obese individuals with arthritic knees should not be denied knee replacement surgery, researchers conclude, based on a new study showing that obese patients benefit from the surgery almost as much as their normal-weight peers.
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Roughly 55,000 knee replacements are performed every year in England to relieve the pain and disability of knee arthritis, according to the British research team that conducted the study. But in some parts of the country the surgery is offered only to people who are not obese, on the grounds that obesity is itself a risk factor for knee arthritis.

Dr. Cyrus Cooper, at the University of Southampton, and associates monitored the progress of 325 patients for around six years after they had had knee replacement surgery. Their progress was compared with that of 363 "control" patients seen in general medical practices, matched for age and sex, who had not had knee replacements.

At the outset, physical function was markedly worse in the knee replacement patient group than in the control group. However, at follow-up, physical function had improved in the knee replacement patients, while that of controls had worsened.

When the researchers restricted their analysis to participants who were obese, the improvements with knee surgery persisted. In obese patients, physical function increased in surgery patients and deteriorated in controls.

"The long term improvement in physical function that we observed in patients who have undergone (knee replacement surgery) is striking when set against the decline that occurred in (the control group)," Cooper and colleagues say. "These benefits extend to patients who are obese."

"There seems no justification for withholding (knee replacement surgery) from patients who are obese," they conclude.

Women With Atrial Fibrillation Face A Higher Risk Of Ischemic Stroke Than Men

2008-07-21T21:25:00.000-07:00

Using a sample of 13,559 patients with atrial fibrillation, or rapid irregular contractions of the heart, researchers compared the rates of ischemic stroke between men and women and examined the efficacy and complications associated with a common blood thinner, Warfarin. Their findings are being reported in the September 20 issue of Circulation.

Warfarin is well known to be effective in reducing the risk of stroke in persons with atrial fibrillation; however prior studies have provided conflicting evidence about whether women with atrial fibrillation have a higher risk for stroke than men when not taking blood thinners. "The research from this study clearly shows that gender plays a role in ischemic stroke risk and... occurrence," said lead author Margaret Fang, MD, MPH, assistant adjunct professor of medicine, and hospitalist at UCSF Medical Center.

The higher incidence of stroke in women not taking Warfarin therapy occurred among women in all stroke-risk-factor categories, including those with prior stroke, hypertension, congestive heart failure, coronary artery disease and diabetes. Because of the significant differences in the rate of stroke between men and women, the study indicates that being a woman is an independent risk factor for stroke and should be considered when choosing treatment options for women with atrial fibrillation.

According to the researchers, atrial fibrillation is the most common cardiac arrhythmia, and a major risk factor for both ischemic stroke and peripheral embolism, an obstruction of the blood supply to an organ. Anticoagulation therapies, such as Warfarin, are well known to substantially reduce the risk of atrial fibrillation-related stroke and embolism, but also have been shown to increase the risk for hemorrhage. "Because of this increased hemorrhage risk, physicians are sometimes hesitant to prescribe the drug, and some studies have shown that women are less likely to receive warfarin therapy than men," Fang said. "However, we found that women in our study did not suffer bleeding complications related to Warfarin more often than men who were using the therapy."

Furthermore, data showed that women may actually benefit more from Warfarin because of their higher baseline risk for stroke. "Women with atrial fibrillation, particularly those with other risk factors for stroke, should be especially encouraged to take Warfarin," Fang added.
###

The researchers used data from Kaiser Permanente's AnTicoagulation and Risk Factors In Atrial Fibrillation (ATRIA) Study cohort. The study was supported by a Public Health Services research grant from the National Institutes on Aging and the Eliot B. and Edith C. Shoolman Fund of Massachusetts General Hospital.
Adapted from materials provided by University of California - San Francisco.
Source : ScienceDaily

More Women Than Men Having Mid-life Stroke

2008-07-21T21:23:00.000-07:00

For the study, researchers analyzed data from 17,000 people over the age of 18 who participated in the National Health and Nutrition Examination Survey. Of the participants, 606 people experienced a stroke.

The study found women in the 45 to 54 age range were more than twice as likely as men in the same age group to have had a stroke. There were no sex differences in stroke rates found in the 35 to 44 and the 55 to 64 age groups.

"While our analysis shows increased waist size and coronary artery disease are predictors of stroke among women aged 45 to 54, it is not immediately clear why there is a sex disparity in stroke rates among this age group," said study author Amytis Towfighi, MD, with the Stroke Center and... Department of Neurology at the University of California at Los Angeles, and member of the American Academy of Neurology. "While further study is needed, this mid-life stroke surge among women suggests prompt and close attention may need to be paid to the cardiovascular health of women in their mid-30s to mid-50s with a goal of mitigating this burden."

In addition, Towfighi says several vascular risk factors including systolic blood pressure and total cholesterol levels increased at higher rates among women compared to men in each older age group.

"For instance, with each decade, men's blood pressure increased by an average of four to five points, whereas women's blood pressure increased by eight to 10 points. Similarly, men had significantly higher total cholesterol levels than women at age 35 to 44, but men's total cholesterol remained stable while women's total cholesterol increased by 10 to 12 points with each decade, so that by age 55 to 64, women had significantly higher total cholesterol than men," said Towfighi.

Towfighi says the study also found a greater than expected stroke surge among men who were nearing the end of middle age. Men aged 55 to 64 were three times more likely than men aged 45 to 54 to have had a stroke. Towfighi says the reasons behind this increase warrant further investigation.

This research was published June 20, 2007, in the online edition of Neurology®, the medical journal of the American Academy of Neurology.
Adapted from materials provided by American Academy of Neurology.
Source : ScienceDaily

Cholesterol In Stroke Patients Exceeds National Guidelines

2008-07-21T21:21:00.000-07:00

The study of 1,040 people hospitalized for stroke or transient ischemic attack (TIA) found that 27 percent had cholesterol higher than recommended by national guidelines. TIA happens when blood flow to part of the brain is reduced for a short period of time, but then returns, resulting in temporary neurological symptoms.

"If this high cholesterol had been recognized and the guidelines been followed, then 93 percent of these people would have been treated with cholesterol-lowering drugs," said Eric E. Smith, MD, MPH, with the Massachusetts General Hospital Stroke Service in Boston, and a member of... the American Academy of Neurology. "Studies have shown that these drugs reduce the risk of stroke, so it's probable that, if the guidelines had been followed, at least some of these strokes and TIAs would never have happened."

Even people who had previously been diagnosed with high cholesterol and those who were already taking cholesterol-lowering drugs were not at their ideal cholesterol level according to the guidelines. Thirty percent of those previously diagnosed with high cholesterol and 19 percent of those taking cholesterol drugs were not at their ideal cholesterol level. The ideal cholesterol level is determined based on an individual's risk of stroke or heart disease.

"Unfortunately, we found that the people who were at the greatest risk for a stroke or heart attack were also the least likely to be at the guideline-recommended cholesterol levels," Smith said.

The results indicate that cholesterol levels should be tested in anyone hospitalized with a stroke or TIA, and any high levels should be treated, Smith said. "We can't assume that people taking cholesterol drugs are at their ideal levels for preventing stroke and heart disease," he said.

The study was based on guidelines published in 2001 by the National Cholesterol Education Program. The guidelines were modified in 2004 with even lower ideal cholesterol levels proposed as an option for people at high risk of cardiovascular disease.

The study was supported in part by grants from the National Institute of Neurological Disorders and Stroke. The study information was collected as part of the "Get with the Guidelines" stroke quality improvement program sponsored by the American Heart Association.
Adapted from materials provided by American Academy of Neurology.
Source : ScienceDaily

Guidelines Highlight Key Differences Between Child And Adult Stroke

2008-07-21T21:18:00.000-07:00

The “Management of Stroke in Children” statement provides healthcare professionals with evidence-based guidelines for prevention, evaluation and treatment.

“Children and adolescents with stroke have remarkable differences in presentation compared with adults,” said E. Steve Roach, M.D., chair of the statement writing group and professor of pediatric neurology at the Ohio State University College of Medicine. “In newborns, the first symptoms of stroke are often seizures that involve only one arm or one leg. That symptom is... so common that stroke is thought to account for about 10 percent of seizures in full-term newborns. Seizure is a much less common stroke symptom in adults.”

Roach emphasized, however, that while stroke symptoms may differ between children and adults, speedy diagnosis and treatment are still very important to minimize the risk for brain damage, disability and death. In addition to prompt treatment, age-appropriate rehabilitation and therapy is indicated for children after a stroke.

A major treatment difference between adult and child stroke is the use of the drug tissue plasminogen activator (t-PA). The clot-busting agent is the cornerstone of treating adult ischemic stroke but, in the new statement it’s not generally recommended for treating young children, especially newborns, outside of a clinical trial until additional safety and efficacy data are published. In general, the statement recommends that if any treatable risk factor is discovered in a child who has had a stroke, the condition should be treated.

“Stroke in children is uncommon but not as rare as we used to think,” said Roach, who is also chief of neurology at Nationwide Children’s Hospital in Columbus, Ohio. “Even as recently as 20 years ago, stroke was an unlikely diagnosis in a child because it was so strongly associated with adults with atherosclerosis.” The risk of stroke from birth through 18 years is 10.7 per 100,000 children per year.

He added that improvements in diagnostic techniques such as magnetic resonance imaging (MRI) and vascular ultrasound have made it possible to confirm that a stroke has occurred when it was only suspected before. Research has also helped to better define treatment protocols. Because of these advances, experts now believe that a significant number of cerebral palsy cases may be due to strokes before or right after birth.

The most common underlying risk factors for childhood stroke are sickle cell disease and congenital or acquired heart disease. However, the list of associated conditions include:

* head and neck infections;
* systemic conditions such as inflammatory bowel disease and autoimmune disorders;
* head trauma; and
* dehydration.

Suspected maternal risk factors for infant stroke include a history of infertility, chorioamnionitis (infection in the fluid surrounding an unborn baby), premature rupture of membranes, and preeclampsia (pregnancy-related high blood pressure).

According to the statement, more than half of children who have a stroke have a known risk factor, and one or more risk factors are often discovered in others after a thorough evaluation. The risk of stroke in children is greatest in the first year of life, particularly in the first two months. It decreases after that. Data from the statement shows that stroke in the first month of life (neonatal stroke) occurs in about one of every 4,000 live births. Stroke also can occur before birth.

In adults, stroke risk factors are much different, and include high blood pressure, cigarette smoking, age (over 55), artery disease, diabetes, and atrial fibrillation. Sickle cell disease is a risk factor common to both children and adults.

Prevention efforts are different for children as well. For adults, prevention often means adopting behaviors or medication to prevent a first stroke. Prevention in children is focused on reducing the likelihood of second or additional strokes.

“Primary prevention – stopping the first stroke from occurring – is sometimes possible in children when we know of an underlying risk factor such as a heart problem or sickle cell disease. Aside from those conditions, an initial stroke is difficult to prevent because the stroke is often the first sign of a problem,” Roach said. “That’s why it’s critical to promptly recognize and diagnose a stroke, because treating the cause reduces the likelihood of additional strokes.”

Recommendations for preventing a second or subsequent stroke in children include:

* Children with ischemic stroke who also have migraines may be evaluated for other stroke risks. Common migraine isn’t likely linked to stroke, but migraine with aura seems to increase risk.
* It is reasonable to counsel children with stroke and their families about the benefits of a healthy diet, exercise and avoiding tobacco products.
* It is reasonable to suggest an alternative to oral contraceptives after a stroke or cerebral venous sinus thrombosis (CVST).
* Children with brain hemorrhage not caused by trauma should undergo a thorough risk factor evaluation, including standard cerebral angiography when noninvasive tests have failed to establish a cause to identify treatable risk factors before another hemorrhage occurs.

The incidence of the two main types of stroke (ischemic and hemorrhagic) is different in adults and children. According to the statement, 80–85 percent of adult strokes in Western countries are ischemic (caused by a blood clot). In contrast, in children about 55 percent of strokes are ischemic and the other 45 percent are hemorrhagic (bleeding in the brain).

The writing committee said the new guidelines will need to be updated as new information and technology becomes available. It urged continued research to better understand the unique diagnosis and treatment of stroke in children.

Co-writers are Meredith R. Golomb, M.D., M.Sc.; Robert Adams, M.D., M.S.; Jose Biller, M.D.; Stephen Daniels, M.D., Ph.D.; Gabrielle deVeber, M.D., MSc; Donna Ferriero, M.D.; Blaise V. Jones, M.D.; Fenella J. Kirkham, M.B., M.D.; R. Michael Scott, M.D.; and Edward R. Smith, M.D. Author disclosures are available on the manuscript.
Source : ScienceDaily

Nicotine Patch Decreases Post-Surgical Pain

2008-07-21T21:16:00.000-07:00

While morphine and other opioids (narcotics) remain the most commonly prescribed post-operative pain medications, many patients fear the side effects from these drugs, which can include drowsiness, nausea, slowed breathing, vomiting, constipation, itching and dependence.

“Some patients would rather experience the pain than the potential side effects of morphine and other painkillers,” said Ashraf S. Habib, M.D., associate professor of anesthesiology and director of... quality improvement, Duke University Medical Center, Durham, North Carolina.

Dr. Habib’s study included 90 non-smoking men about to undergo a radical retropubic prostatectomy. Each received a 7-milligram nicotine patch or an identical placebo patch before anesthesia and surgery. After surgery, each patient was able to access morphine through a self-controlled device.

The patients who received the nicotine patch self-administered significantly less morphine in the postoperative period. In general, the nicotine patch was well-tolerated by patients, however, patients receiving nicotine reported higher levels of nausea.

“The study suggests that the nicotine patch has a useful effect in improving pain relief after surgery,” Dr. Habib said.

Several previous studies have shown the pain-relief benefits of nicotine. In one study, a small dose of nicotine (3 milligrams) was given post-surgically, via a nicotine spray, to hysterectomy patients. These patients reported less pain and less need for morphine.

Future studies could determine whether nicotine is better administered in a patch or spray form, Dr. Habib said, as well as the effectiveness of nicotine in “smokers versus non-smokers and women versus men.”

In addition, different doses of the patch should be tested to identify the ideal amount of nicotine to produce optimal pain relief with minimal or no side effects.
Adapted from materials provided by American Society of Anesthesiologists, via Newswise.Source : ScienceDaily

Nicotine Therapy More Effective For Men Than Women, Says Research

2008-07-21T21:12:00.001-07:00

Antonio Cepeda-Benito, an associate professor of psychology at Texas A&M who studies drug addiction and nicotine dependency and treatment, says women using NRT generally find it harder than men to quit smoking. Cepeda-Benito, along with colleagues Jose T. Reynoso and Stephen Erath, conducted an analysis of several major smoking studies and found NRT was equally helpful to men and women in the short term, but in the long term, women were less likely than men to remain smoke-free. Their research appears in the August issue of the Journal of Consulting and Clinical Psychology, published by the American Psychological Association.

"We found that NRT given with low-adjunct support was efficacious across all follow-up periods for men only," he says. "At midterm follow-up, NRT was efficacious for women if... the treatment was given only in conjunction with an intensive treatment approach. At long-term follow up, men benefited and women did not benefit from NRT regardless of whether or not they received the treatment in conjunction with high or low levels of support."

Cepeda-Benito says data from the U.S. Department of Health and Human Services indicates about 75 percent of women daily smokers are interested in quitting, but the odds are stacked against them, with less than 10 percent of those who quit remaining abstinent in a given year. Further complicating matters is the lack of assistance in quitting smoking provided to women because, as some studies suggest, physicians are less likely to ascertain women's smoking status and advise to quit smoking, he notes.

Cepeda-Benito and his colleagues say their results suggest that women looking to kick the habit use a combination of NRT and comprehensive smoking cessation programs.

Such a program, he explains, would need to address the many variables that influence smoking behavior in women, Cepeda-Benito notes. He says studies have shown that in comparison with men, women are more craving-reactive to smoking related cues, they enjoy the olfactory - taste and hand-to-mouth sensations associated with smoking and the have greater expectations that smoking will enhance or facilitate social interactions, reduce negative moods and prevent weight gain.

For these reasons, Cepeda-Benito says women may need a truly comprehensive psychological intervention that addresses these variables.

In addition, women's fast return to smoking in the low-intensity NRT group could also lead to a recommendation to prolong the prescription of NRT, he says.

"These two recommendations are not incompatible because at some point NRT needs to be discontinued, and at that point smokers still need and benefit from learned skills and increased motivation to prevent smoking relapse," he explains.
Adapted from materials provided by Texas A&M University.
Source : ScienceDaily

Nicotine Therapy More Effective For Men Than Women, Says Research

2008-07-21T21:12:00.000-07:00

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