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IN THIS ISSUE:

New Treatments Prevent Brain Injury Hours After Stroke In Rats
You Can Quit Smoking
Spices And Herbs May Help You Avoid Disease
A Mixed Bag: The 2007 Pipeline Promises Novel Therapeutic Classes For Some Diseases But No New Drugs In Others
Another Reason To Resolve To Lose Weight
FDA Issues Draft Documents on the Safety of Animal Clones
Popular Heartburn Drugs Linked To Hip Fractures
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 Treatments Prevent Brain Injury Hours After Stroke In Rats

Two novel treatments -- a basic compound found in every cell in the body and an extract of green tea -- may prevent brain damage caused from stroke, according to two studies in rats led by a researcher at the San Francisco VA Medical Center.
Both treatments were administered through the nose, rather than intravenously, the conventional method for delivering drugs to the brain.
In one study, rats' brains were subjected to ischemia -- severely reduced blood flow -- for two hours in a model of stroke. Researchers then administered nicotinamide adenine dinucleotide, or NAD+, immediately after "reperfusion," or resumption of blood flow. Reperfusion is the time when stroke damage actually occurs because brain cells are suddenly exposed to highly reactive and unstable oxygen molecules, which are toxic.
The researchers found that NAD+ reduced brain cell death from reperfusion by 70 to 86 percent compared with rats not given the treatment, according to lead author Weihei Ying, PhD, a research scientist at SFVAMC and an assistant adjunct professor of neurology at the University of California, San Francisco.
The study appears in the January 1, 2007 issue of Frontiers in Bioscience.

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You Can Quit Smoking

Make 2007 the year you or someone close to you quits smoking.
Smoking harms nearly every organ of the body, causing many diseases and reducing the health of smokers in general. Quitting smoking has immediate as well as long-term benefits for you and your loved ones.
You CAN quit smoking. The following information may be helpful to your efforts.
If you’re looking to quit, we encourage you to contact 1–800–QUIT–NOW or www.smokefree.gov for additional support.

For more information CLICK HERE

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Spices And Herbs May Help You Avoid Disease

Imagine going to your doctor with joint pain and leaving with a prescription for ginger.
Before the advent of synthetic drugs, that might have happened. Herbs and spices have a long history as folk medicine, and not without merit.
Today, researchers are working to quantify their health benefits.
"We don't have enough evidence to say herbs and spices are 100-percent disease-preventing, but several have positive outlooks," says Milton Stokes, R.D., a spokesperson for the American Dietetic Association.

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A Mixed Bag: The 2007 Pipeline Promises Novel Therapeutic Classes For Some Diseases But No New Drugs In Others

When it comes to impending drug approvals, these appear to be the worst of times and the best of times. While some therapeutic areas like oncology continue to draw lots of research and development activity, other areas such as infectious disease seem to be left out of the progress of modern medicine. "Essentially, we have plenty of bad bugs but no drugs," remarked Robert Adamson, Pharm.D., director of clinical services and infectious disease specialist at the Saint Barnabas Healthcare System of New Jersey.
In summarizing the current state of affairs, Adamson referred to an increasing incidence of extended-spectrum beta-lactamase (ESBL)-producing bacteria, the emergence of multidrug-resistant Pseudomonas and Acinetobacter species, and the declining bacterial sensitivity to beta-lactam agents.
"Yet there are no new antibacterials in the pipeline with activity against gram-negative organisms. And there are only five antibacterials out of the more than 500 drugs in research and development," disclosed Adamson. One of these rare commodities is dalbavancin, a lipoglycopeptide agent possessing in vitro activity against various gram-positive pathogens, including methicillin-resistant Staphylococcus aureus. Based on phase II and III clinical trials, dalbavancin appears comparable to vancomycin, linezolid (Zyvox, Pfizer), and various beta-lactam agents in the treatment of skin and soft-tissue infections and catheter-related bloodstream infections.
According to Raulo S. Frear, Pharm.D., dalbavancin, which is under development by Pfizer, is expected to emerge next year and be used mostly to treat multidrug-resistant gram-positive infections. Frear is VP of clinical evaluation and policy and is responsible for drug pipeline review at Express Scripts.

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Another Reason To Resolve To Lose Weight

Adult men who buck mother nature and lose at least 11 pounds may reduce their risk of prostate cancer, a new study shows. It is the first time a link has been shown between weight-loss and prostate cancer risk.
Led by Dr. Carmen Rodriguez, an epidemiologist for the American Cancer Society the researchers followed nearly 70,000 men who were part of a larger American Cancer Society lifestyle study called the Cancer Prevention Study II, which began in 1982.
"Our study …adds to increasing evidence of the importance of maintaining a healthy weight throughout adult life," Rodriguez said in a prepared statement. "Although our study suggests that weight loss may lower the risk of aggressive prostate cancer, given the difficulty of losing weight, emphasis should be put on the importance of avoiding weight gain to reduce the risk of prostate cancer."
Previous research has suggested that men with excess weight had a higher risk of prostate cancer and are more likely to be diagnosed with more advanced prostate cancer and more likely to have a recurrence of the disease after treatment than are men of normal weight. Until now, however, there has been little research into whether losing weight would reduce the risk of developing of prostate cancer.

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FDA Issues Draft Documents on the Safety of Animal Clones

The U.S. Food and Drug Administration (FDA) today issued three documents on the safety of animal cloning -- a draft risk assessment; a proposed risk management plan; and a draft guidance for industry.
The draft risk assessment finds that meat and milk from clones of adult cattle, pigs and goats, and their offspring, are as safe to eat as food from conventionally bred animals. The assessment was peer-reviewed by a group of independent scientific experts in cloning and animal health. They agreed with the methods FDA used to evaluate the data and the conclusions set out in the document.
The draft risk assessment presents an overview of assisted reproductive methods widely used in animal agriculture, the extensive scientific information available on animal health and food consumption risks, and draws science-based conclusions. These conclusions agree with those of the National Academies of Sciences, released in a 2002 report. Due to limited data on sheep clones, in the draft guidance FDA recommends that sheep clones not be used for human food.
"Based on FDA's analysis of hundreds of peer-reviewed publications and other studies on the health and food composition of clones and their offspring, the draft risk assessment has determined that meat and milk from clones and their offspring are as safe as food we eat every day," said Stephen F. Sundlof, D.V.M., Ph.D., director of FDA's Center for Veterinary Medicine. "Cloning poses no unique risks to animal health when compared to other assisted reproductive technologies currently in use in U.S. agriculture."
An animal clone is a genetic copy of a donor animal, similar to identical twins but born at different times. Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA; cloning does not change the gene sequence.

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Popular Heartburn Drugs Linked To Hip Fractures

Taking such popular heartburn drugs as Nexium, Prevacid or Prilosec for a year or more can raise the risk of a broken hip markedly in people over 50, a large study in Britain found.
The study raises questions about the safety of some of the most widely used and heavily promoted prescription drugs on the market, taken by millions of people.
The researchers speculated that when the drugs reduce acid in the stomach, they also make it more difficult for the body to absorb bone-building calcium. That can lead to weaker bones and fractures.
Hip fractures in the elderly often lead to life-threatening complications. As a result, doctors should make sure patients have good reason to stay on heartburn drugs long term, said study co-author Dr. Yu-Xiao Yang of the University of Pennsylvania School of Medicine.
"The general perception is they are relatively harmless," Yang said. "They often are used without a clear or justified indication for the treatment."

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Believe It Or Not

67-year-old woman gives birth to twins

A 67-year-old woman has given birth to twin sons in the northern city of Barcelona, a hospital official said.
The woman, whose identity has not been revealed, gave birth Friday by Caesarian section, according to an official at Sant Pau hospital who spoke on condition of anonymity because of hospital policy.
The mother and twins all were doing well though the newborns were both in incubators, the official said.
Originally from the southern region of Andalucia, the woman had previously undergone in vitro fertilization abroad, the official said.
A 66-year-old Romanian woman, Adriana Iliescu, gave birth to a daughter in Bucharest in January 2005.

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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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