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IN THIS ISSUE:

Diabetes Drug Shows Promise For Preventing Brain Injury From Radiation Therapy
FDA Proposes New Measures to Strengthen Drug Safety Under PDUFA Reauthorized User Fee Program
Temperature Check May Prevent Diabetic Foot Ulcer
Anti-Cancer Chicken Eggs Produced
Do Statins Raise The Risk Of Parkinson's?
Canada's Pharmacists Seek Ban On Exports To U.S.
Anesthetic Linked to Alzheimer's Risk
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
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Diabetes Drug Shows Promise For Preventing Brain Injury From Radiation Therapy

Researchers at Wake Forest University School of Medicine are the first to report that in animal studies, a common diabetes drug prevents the memory and learning problems that cancer patients often experience after whole-brain radiation treatments.
"These findings offer the promise of improving the quality of life of these patients," said Mike Robbins, Ph.D., senior researcher. "The drug is already prescribed for diabetes and we know the doses that patients can safely take."
Whole-brain radiation is widely used to treat recurrent brain tumors as well as to prevent breast cancer, lung cancer and malignant melanoma from spreading to the brain. About 200,000 people receive the treatment annually, and beginning about a year later, up to one-half develop progressive cognitive impairments that can affect memory, language and abstract reasoning.
In the current issue of the International Journal of Radiation Oncology - Biology --Physics, Robbins and colleagues report that rats receiving the diabetes drug piolitazone (sold under the trade name Actos®) before, during and after radiation treatments did not experience cognitive impairment.

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FDA Proposes New Measures to Strengthen Drug Safety Under PDUFA Reauthorized User Fee Program

The Food and Drug Administration (FDA) today proposed recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program which, if adopted, would significantly broaden and upgrade the agency's drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public. To achieve these public health benefits, the agency proposes to recommend, as part of the reauthorization of the program, that annual user fee collections be increased to $392.8 million, an $87.4 million increase over the current base line.
The user fee program, which was first authorized by the Prescription Drug Use Fee Act (PDUFA) in November 1992, adds industry's funds to the agency's appropriations to help FDA's human drug review program achieve demanding performance goals. Over the years, the PDUFA programs, which have to be reauthorized by Congress every five years, have enabled the agency to dramatically reduce its review times for drugs and biological medications while increasing scientific consultations, clarifying issues involving drug development, and increasing oversight of postmarket safety.
"The proposed recommendations would support significant improvements in FDA's ability to monitor and respond to emerging drug safety issues, as well as continuing FDA's commitment to scientific improvements and streamlining the drug approval process," said HHS Secretary Mike Leavitt. "I commend FDA for the important progress they have made and look forward to working with Congress to ensure action on these proposals."

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Temperature Check May Prevent Diabetic Foot Ulcer

Adding a daily check of foot temperature with an infrared skin thermometer to standard diabetic foot therapy can significantly reduce the recurrence of foot ulcers, doctors in Texas and Chicago report in the medical journal Diabetes Care.
The digital infrared thermometer, called TempTouch, costs approximately $150 and is powered by 9-V batteries, Don Lawson, CEO of the thermometer maker Xilas Medical, told Reuters Health.
Co-investigator Dr. Lawrence A. Lavery, at Texas A&M University Health Science Center in Temple, and his associates point out that elevated skin temperature is a sign of inflammation and tissue injury, but the signs may be too subtle to detect.
The team randomly assigned 173 diabetic patients between 18 and 80 years of age to one of three treatment groups for 15 months. One group received standard therapy, consisting of a foot evaluation every 8 weeks, therapeutic insoles and footwear, and an education program.

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Anti-Cancer Chicken Eggs Produced

UK scientists have developed genetically modified chickens capable of laying eggs containing proteins needed to make cancer-fighting drugs.
The breakthrough has been announced by the same research centre that created the cloned sheep, Dolly.
The Roslin Institute, near Edinburgh, says it has produced five generations of birds that can produce useful levels of life-saving proteins in egg whites.
The work could lead to a range of drugs that are cheaper and easier to make.

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Do Statins Raise The Risk Of Parkinson's?

Patients taking the cholesterol-busting drugs statins could be at a much higher risk of developing Parkinson's disease, a scientist claims.
Up to four million Britons are thought to be taking statins regularly because they are at risk of a heart attack or stroke, saving at least 7,000 lives a year.
The drugs are designed to reduce levels of low- density lipoproteins (LDLs), which carry cholesterol from the liver to cells in the body.
This "bad" LDL cholesterol can fur up the arteries and lead to heart disease.
A study in the United States has found that patients with low levels of LDL cholesterol are three times more likely to have Parkinson's disease.
The researchers are planning largescale trials to determine whether the drugs are the cause.

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Canada's Pharmacists Seek Ban On Exports To U.S.

Canada's pharmacists said on Monday they are banding together to fight a U.S. bill that could see a flood of brand-name prescription drugs diverted south of the border.
The group, which includes the Canadian Pharmacists Association, the Ontario Pharmacists Association, the Best Medicines Coalition and the Canadian Association for Pharmacy Distribution, warns the bill could deplete the supply of prescription drugs in Canada.
The groups are calling on Canadian Health Minister Tony Clement to introduce a ban on bulk and retail exports of prescription drugs to the United States.
The Democratic Party-controlled U.S. Congress intends to move legislation allowing prescription drug imports from Canada as a way to address the high cost of U.S. prescription drugs.
Canadian pharmacists fear passage of the bill could deplete Canada's supply.

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Anesthetic Linked to Alzheimer's Risk

The commonly used anesthetic isoflurane can lead to the death of brain cells and the production of amyloid-beta plaque, a hallmark of Alzheimer's disease, Harvard researchers report.
Their study appears in the January issue of the Journal of Gerontology, which is devoted to the problems of dementia and delirium. In the United States, delirium accounts for $7 billion per year in hospital expenses and more than $100 billion a year when rehabilitation, institutionalization and long-term care are added to the equation.
The Harvard study raises questions about the safety of isoflurane, which has been used for years for all ages of patients.
"Many people, especially the elderly, who have anesthesia suffer from postoperative cognitive dysfunction, scrambling and delirium that can last six hours or two weeks or months," said lead researcher Rudolph Tanzi, a professor of neurology at the Genetics and Aging Research Unit of the Massachusetts General Institute for Neurodegenerative Disease.
"To me, a big dose of isoflurane mimics a stroke or a bang to the head, and you don't want that as a risk factor for Alzheimer's disease at any age," Tanzi said.

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Believe It Or Not

How do hairs like those on the chest or in the nose know to grow when you trim them?

Clipping hairs on the skin surface does not actually have any effect on the growth of hair, because the hair above the surface is technically dead. The hair visible on our bodies grows out of living hair follicles within the skin. These fairly complicated "miniorgans" are made up of more than 10 different cell types geared toward generating the hair fiber that reaches the surface of the skin. More than five million hair follicles populate the entire body; one million of those cover the head, with 100,000 to 150,000 residing on the scalp.
All hair follicles go through the "hair follicle cycle," which is made up of three stages: growth, degeneration and rest--called anagen, catagen and telogen, respectively. During anagen, the rapid proliferation of cells located at the follicle's base, or bulb, results in the constant production of hair fiber through the follicle's developing shaft. At the end of anagen, the hair-producing cells begin to die, entering into the catagen stage. After regressing for a couple of weeks, the bulb rests for several weeks to months in telogen. The new lower hair follicle then regenerates from stem cells in the telogen follicle and anagen begins anew. The old hair fiber then falls out--often while you are brushing your hair--as a new strand pushes it out the top of the follicle.
Hair follicles on different parts of the body produce hairs of different lengths by staying in anagen for varying periods of time. Scalp follicles remain in anagen for many years and can produce hair fibers over one meter in length. Hair follicles on the body, which generate shorter hairs, are in anagen for only a matter of weeks or months. The hairs that appear to "know" to grow back after being trimmed just happen to be in anagen when you cut them.
Drastic changes take place in the length of the growing stage when follicles are under the influence of testosterone. In men, during puberty, as testosterone levels increase, small hairs on the face, underarms, chest, legs, arms and pubic area turn into large hairs that remain in anagen for longer periods. (Since women don't make much testosterone, the hormone doesn't have as much of an effect on their hair follicles.) To the consternation of most men, later in life, follicles in the nose and ear become sensitive to testosterone and also enlarge, thus yielding large hairs. Paradoxically, hair follicles on the scalp of genetically predisposed men respond in the opposite manner: they miniaturize and spend less time in anagen, which leads to baldness.

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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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