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IN THIS ISSUE:

New Technique Can Identify Counterfeit Drugs
Vitamin D Backed For Cancer Prevention In Two New Studies
Human Skin Hosts Zoo Of Bacteria
FDA OKs First Nonprescription Diet Pill
Dramatic Rise In Accidental Drug-Overdose Deaths Reported
FDA Clears Breast Cancer Specific Molecular Prognostic Test
Viagra Sold Over Counter In UK On Valentine's Day
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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New Technique Can Identify Counterfeit Drugs

A new method of verifying the ingredients of a pharmaceutical product without opening the package is more accurate than the conventional methods of analysis, scientists in the UK report in a study scheduled for publication in the March 1 issue of Analytical Chemistry.
"Spatially offset Raman spectroscopy" or SORS can probe deep layers of material, separating out interfering signals emanating from packaging, drug coatings, and inactive ingredients. In that way, SORS authenticates the actual content and concentration of a drug, Dr. Pavel Matousek and Dr. Charlotte Eliasson of the CCLRC Rutherford Appleton Laboratory in Oxfordshire report. It can do so without ever having to open a package, they say.
Fake drugs have become an ever-increasing problem worldwide, the authors note. Sometimes a product has the correct molecule, but its altered formulation may decrease its effectiveness or the concentration may be wrong. Other times, the product may have none of the ingredients that it claims to contain. But if a package has to be opened to verify its contents, it can no longer be marketed.

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Vitamin D Backed For Cancer Prevention In Two New Studies

Two new vitamin D studies using a sophisticated form of analysis called meta-analysis, in which data from multiple reports is combined, have revealed new prescriptions for possibly preventing up to half of the cases of breast cancer and two-thirds of the cases of colorectal cancer in the United States. The work was conducted by a core team of cancer prevention specialists at the Moores Cancer Center at University of California, San Diego (UCSD), and colleagues from both coasts.
The breast cancer study, published online in the current issue of the Journal of Steroid Biochemistry and Molecular Biology, pooled dose-response data from two earlier studies - the Harvard Nurses Health Study and the St. George's Hospital Study - and found that individuals with the highest blood levels of 25-hydroxyvitamin D, or 25(OH)D, had the lowest risk of breast cancer.
The researchers divided the 1,760 records of individuals in the two studies into five equal groups, from the lowest blood levels of 25(OH)D (less than 13 nanograms per milliliter, or 13 ng/ml) to the highest (approximately 52 ng/ml). The data also included whether or not the individual had developed cancer.
"The data were very clear, showing that individuals in the group with the lowest blood levels had the highest rates of breast cancer, and the breast cancer rates dropped as the blood levels of 25-hydroxyvitamin D increased," said study co-author Cedric Garland, Dr.P.H. "The serum level associated with a 50 percent reduction in risk could be maintained by taking 2,000 international units of vitamin D3 daily plus, when the weather permits, spending 10 to 15 minutes a day in the sun."

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Human Skin Hosts Zoo Of Bacteria

Researchers on a safari for microbes have found that human skin is populated by a veritable menagerie of bacteria -- 182 species -- some apparently living there permanently and others just dropping by for a visit.
There's no need for alarm, said microbiologist Dr. Martin Blaser of New York University School of Medicine: the bacteria have been with us for quite a while and some are helpful.
In research published on Monday in the Proceedings of the National Academy of Sciences, Blaser and his colleagues took swabs from the forearms of six healthy people to study the bacterial populations in human skin -- our largest organ.
"We identify about 182 species," Blaser said in an interview. "And based on those numbers, we estimate there are probably at least 250 species in the skin."
"In comparison," Blaser added, "a good zoo might have 100 species or 200 species. So we already know that there are as many different species in our skin, just on the forearm, as there are in a good zoo."

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FDA OKs First Nonprescription Diet Pill

The nation's ongoing battle against obesity has a new weapon - the first government-approved diet pill that can be bought without a prescription.
Intended only for people 18 and older, the drug, called alli, is a reduced-strength version of the prescription diet drug Xenical.
The Food and Drug Administration on Wednesday announced its approval of sales of the lower-dose drug without a prescription, with officials stressing that it needs to be used in combination with a diet and exercise program.
"Using this drug alone is unlikely to be beneficial," said Dr. Charles Ganley, FDA's director of nonprescription products.

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Dramatic Rise In Accidental Drug-Overdose Deaths Reported

Unintentional fatal drug overdoses in the United States nearly doubled from 1999 to 2004, overtaking falls to become the nation's second-leading cause of accidental death, behind automobile crashes, the government reported.
The number of accidental drug overdose deaths rose from 11,155 in 1999 to 19,838 in 2004, according to the Centers for Disease Control and Prevention.
The report was based on death certificates, which do not clearly detail which drugs played the greatest role. But CDC researchers said they believe sedatives and prescription painkillers like Vicodin and OxyContin were the chief cause of the increase.
OxyContin has been blamed for hundreds of deaths across the country in recent years, becoming such a scourge in Appalachia that it is known as "hillbilly heroin."

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FDA Clears Breast Cancer Specific Molecular Prognostic Test

The U.S. Food and Drug Administration (FDA) today cleared for marketing a test that determines the likelihood of breast cancer returning within five to 10 years after a woman's initial cancer. It is the first cleared molecular test that profiles genetic activity.
The MammaPrint test uses the latest in molecular technology to predict whether existing cancer will metastasize (spread to other parts of a patient's body). The test relies on microarray analysis, a powerful tool for simultaneously studying the patterns of behavior of large numbers of genes in biological specimens.
The recurrence of cancer is partly dependent on the activation and suppression of certain genes located in the tumor. Prognostic tests like the MammaPrint can measure the activity of these genes, and thus help physicians understand their patients' odds of the cancer spreading.
MammaPrint was developed by Agendia, a laboratory located in Amsterdam, Netherlands, where the product has been on the market since 2005.

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Viagra Sold Over Counter In UK On Valentine's Day

Men will be able to buy impotence treatment Viagra over the counter in Britain for the first time from Valentine's Day, chemist chain Alliance Boots said on Sunday.
Three Manchester Boots pharmacies will sell the prescription-only medication made by U.S. drugs group Pfizer in a pilot program from February 14.
Men aged between 30 and 65 suffering from erectile dysfunction will be able to buy four Viagra pills for 50 pounds ($97) without having to get a prescription from a doctor first.
Instead, they will have a private consultation with a Boots pharmacist, when their medical history will be checked and measurements taken of their blood pressure, cholesterol and blood glucose levels.

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Believe It Or Not

Gambler gives birth on NJ casino floor

A woman playing the penny slots Saturday morning left the Resorts Atlantic City casino with her own little jackpot -- a new baby boy.
Eight-months pregnant Nyree Thompson, 32, went into labor on the casino floor about 9:30 a.m.
Thompson said she mistook labor pains for gas at first, but after going to the restroom told a security guard that she might be giving birth.
Thompson said the guard thought she was joking. Then her water broke.
"A guard came over and said, 'Don't push,'" Thompson said. "I said, 'Forget you, this baby is coming right now!'"
Minutes later, a boy weighing less than 5 pounds was born. Thompson named him Qualeem.
Four security guards helped Thompson deliver the baby, wrapping the child in a jacket until paramedics arrived at about 9:40 a.m., said Steve Callender, vice president of operations at Resorts.
Despite being premature, Qualeem was doing fine.
Callender, who has worked at Resorts since it opened in 1978, said the birth was a first for the casino as far as he knew. "We've had people die here," he said, "but we've never had people born here."

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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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