IN THIS ISSUE:

• Breast Tumour Drug Target Found
   
• Study Finds Testosterone Helps MS Patients
   
• FluMist Seen Effective For Young Kids
   
• Daily Aspirin May Prevent Bowel Cancer New Study
   
• US Conservatives Block Cancer Vaccine For Girls
   
• FDA Issues Health Risk Alert for 'True Man' and 'Energy Max' Products
   
• NIDA Looks at Non-Injection Drug Use and Spread of HIV/AIDS

• Believe It Or Not

• News From MedWatch

• Research Update

• Recently Approved Drugs/Indications

• FDA Recalls and Safety Alerts in the Past 60 Days

• Drug Shortages

• Recommend Edmund's Newsletter

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Breast Tumour Drug Target Found

Scientists have found a potential target for treating up to 40% of breast cancers.
A team from Canada's McGill University were able to block the action of an enzyme which fuels the growth of tumours, Nature Genetics reports.
They were able to delay cancer in mice with tumours which also respond to the drug Herceptin, but say other breast tumours may respond too.
UK experts said a new drug could boost the benefits of existing treatments.

For more information CLICK HERE

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Study Finds Testosterone Helps MS Patients

A testosterone gel slowed brain deterioration and boosted thinking ability in men with multiple sclerosis, according to a small study showing a possible new way to treat the incurable disease.
Writing on Monday in Archives of Neurology, University of California, Los Angeles researchers said the study was based on the fact that men develop MS less frequently than women and the idea that the male sex hormone testosterone may be protective.
MS is thought to be an autoimmune disease -- in which the immune system attacks rather than protects the body -- that affects the central nervous system. The men in the study had a common form of MS in which periods of symptoms alternate with periods of remission.
The men applied a testosterone gel to their shoulders daily for a year. Tests of cognitive function -- the ability to think, learn and judge -- improved, and brain atrophy diminished to the level of normal aging, the study found.

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FluMist Seen Effective For Young Kids

A newer version of MedImmune Inc.'s FluMist appears effective for children younger than 5 years old, although safety data on the influenza vaccine is still under review, U.S. Food and Drug Administration staff said in a document released on Monday.
MedImmune, which last month agreed to be bought by AstraZeneca Plc, is seeking FDA approval to market the spray for children ages 1 to 5 without a history of wheezing or asthma. It is already approved for healthy people between 5 and 49 years old.
The documents were released ahead of an FDA advisory panel meeting on Wednesday to discuss whether to recommend that the agency grant wider approval. While the FDA usually follows the advice of its outside experts, it will make the final decision.
Four studies conducted by MedImmune found the drug was effective against Type A and B influenza viruses, including one trial that showed the vaccine was about 90 percent effective, according to the FDA document.
Reviewers for the FDA also said one company study of the nasal spray vaccine did not signal any widespread safety problems, but results from other studies are still being reviewed. Those findings will be presented to the panel on Wednesday.

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Daily Aspirin May Prevent Bowel Cancer New Study

A new UK study suggests that a daily dose of 300 mg aspirin reduces the occurrence of colorectal cancer by up to 74 per cent. However, doctors are not recommending it because of possible stomach problems such as bleeding, but it might be a worthwhile precaution for people at high risk of colorectal cancer.
The study is published in The Lancet.
Previous trials have shown that aspirin reduces the short-term risk of benign growths or adenomas in the bowel of patients with a history of adenomas or cancer. However, they failed to show that aspirin prevents colorectal cancer during ten years of follow up.
In this study the researchers looked at more than 10 years of follow up because the time it takes for early cancer to develop after the appearance of adenomas is at least that.
Also, previous studies were of the observational type, looking back at the use of aspirin by bowel cancer patients and healthy subjects rather than randomizing participants from the start to various doses and a placebo and then following their progress.
Professor Peter M Rothwell of the Radcliffe Infirmary, Oxford, UK and colleagues did a 10 to 14-year follow up of two large British trials that started in the 1970s and early 1980s that included more than 7,500 people.

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US Conservatives Block Cancer Vaccine For Girls

Plans to vaccinate young girls against the sexually-transmitted virus that causes cervical cancer have been blocked in several US states by conservative groups, who say that doing so would encourage promiscuity.
Advocates of the vaccine point out that the jabs work against human papillomavirus (HPV) - which causes virtually all cases of cervical cancer - and are safe.
The latest data from a large clinical trial of Merck's cervical cancer vaccine, Gardasil, found it offered 100% protection against cervical, vulval and vaginal diseases, caused by HPV (types 6, 11, 16 and 18) and 98% protection against advanced pre-cancers caused by HPV types 16 and 18 (New England Journal of Medicine: vol 356, p1915).
After around three years of the four-year trial, almost all girls who received the vaccine before being exposed to HPV 16 or 18 appear to be protected. Those who had already been exposed to the viruses received little benefit, but by vaccinating early on, perhaps at 11 years of age, most girls could be protected. Controversial care
However, the introduction of a vaccine against HPV types 16 and 18, which together cause 70% of cervical cancer cases, has been dogged by arguments. Some conservative groups complain that by cutting the risk of catching a sexually-transmitted disease, the vaccine would encourage sexual activity in young girls.

For more information CLICK HERE

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FDA Issues Health Risk Alert for 'True Man' and 'Energy Max' Products

The Food and Drug Administration (FDA) is advising consumers not to purchase or use "True Man" or "Energy Max" products promoted and sold as dietary supplements throughout the United States. Both products -- touted as sexual enhancement products and as treatments for erectile dysfunction (ED) -- are illegal drug products that contain potentially harmful, undeclared ingredients.The products contain substances called analogs that have similar structures to active ingredients in approved prescription drugs.
Consumers should discontinue use of True Man and Energy Max and consult their health care professional about approved treatments for ED.FDA encourages men who experience ED to seek guidance from a health care professional.
FDA has not approved True Man and Energy Max; therefore the safety and effectiveness of these products are unknown. Both products are often advertised as "all natural" alternatives to approved ED drugs in advertisements appearing in newspapers, retail stores, and on the Internet.
"These products threaten the health of the people using them because they contain undeclared chemicals that are similar to the active ingredients used in FDA-approved prescription drug products," said Steven Galson, M.D., MPH, director of the FDA's Center for Drug Evaluation and Research."The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure."
The undeclared analog ingredients in True Man and Energy Max may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
FDA chemical analysis revealed that Energy Max contains thione analog of sildenafil, a substance with a structure similar to sildenafil, the active ingredient in Viagra, an FDA-approved drug for ED.Substances like this are called analogs because they have a structure similar to another drug and may cause similar side effects and drug interactions.
True Man contains a thione analog of sildenafil or piperadino vardenafil, an analog of vardenafil, the active ingredient in Levitra, another FDA-approved prescription drug for ED. Neither the thione analog of sildenafil nor piperadino vardenafil are components of approved drug products.
True Man is sold in boxes containing a 10-capsule blister pack. Energy Max is sold in boxes containing two 10-capsule blister packs.Both products are distributed and packed by America True Man Health, Inc., West Covina, Calif.A review of the ingredient statements for both products revealed that neither piperadino vardenafil nor thione analog of sildenafil are listed as an ingredient, even though one or more of those ingredients is present in the products.

For more information CLICK HERE

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NIDA Looks at Non-Injection Drug Use and Spread of HIV/AIDS

More than 500 scientists, clinicians and public health specialists met today at the National Institutes of Health (NIH) to discuss the latest research on drug abuse and the evolving epidemic of HIV/AIDS. This is the first-ever two-day public meeting at NIH to include a focus on non-injection drug use and HIV transmission. The meeting was being held in collaboration with the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute on Child Health and Human Development (NICHD), and the National Institute of Mental Health (NIMH).
“Approximately one million people in the United States are living with HIV/AIDS, which disproportionately afflicts minority populations — particularly African Americans,” said NIDA Director Nora D. Volkow, who gave opening remarks at the meeting. “To address this significant public health threat, research at NIH is examining every aspect of HIV/AIDS, drug abuse, and addiction, including the risk behaviors associated with both injection and non-injection drug abuse, and how drugs of abuse can alter brain function and impair decision making.”
Participants today heard from leading scientists about how substance abuse affects HIV/AIDS risk in diverse populations, and of the importance of designing interventions that address their specific needs. Today’s session also looked at neuroeconomics — combining brain imaging and economically-based theories to better explain and predict decision making; and neuroimaging to predict relapse to methamphetamine in treated drug abusers. Also discussed were the importance of combining behavioral therapies, and medication in drug abuse treatment to reduce HIV risk behaviors as well as drug abuse.

For more information CLICK HERE

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Believe It Or Not

Wis. festival sells deep-fried testicles

Around here, it may be tough to pass up anything deep-fried.
Wisconsinites have deep-fried cheese curds, candy bars and Twinkies. They now have deep-fried livestock testicles, too.
More than 300 people paid $5 for all-you-can-eat goat, lamb and bull testicles Saturday at the ninth annual Testicle Festival at Mama's Place Bar and Grill in Elderon in central Wisconsin.
"Once you get over the mental (aspect) of what you're eating, it's just like eating any other food, and it tastes good," Buster Hoffman said.
Festival founder Nancy Fenske said the festival grew out of her late husband Roger's birthday party 12 years ago. They decided to have "a nut fry" at Mama's Place after bringing back lamb fries from a trip to Montana.
The event grew every year and now they fry up to 100 pounds of testicles, she said.
"What else can you do in a small town?" Fenske said.
Butch Joubert, 58, likes the parts sandwiched between bread with tartar sauce. They're not so different from regular meatballs also served at the festival, he said.
"After a few beers, you can't really tell the difference," Joubert said.

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News From MedWatch

Keep up-to-date on all of the recent MedWatch reports that gives you timely safety information on the drugs and other medical products regulated by the U.S. Food and Drug Administration by CLICK HERE

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Recently Approved Drugs/Indications

Keep up-to-date on all of the recently approved drugs and/or approved new indications on already FDA approved drugs CLICK HERE

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FDA Recalls and Safety Alerts in the Past 60 Days:

To see a list of all FDA Recalls and product safety alerts for the last 60 days CLICK HERE

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Drug Shortages:

As many of you are aware, many drugs in the US are either unavailable or in short supply. To view a list of these drugs CLICK HERE

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Edmund M. Hayes, R.Ph., M.S., Pharm.D.
Departments of Pharmacy and Medicine
Stony Brook University Hospital
State University of New York at Stony Brook
Stony Brook, New York, 11794
631 444-2668

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