Edmund's Newsletter
February 10, 2009
Issue: #6 Volume 9
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In This Issue
Pharmaceuticals Sold In Sweden Cause Serious Environmental Harm In India
Methamphetamine Use Cost United States About $23 Billion
Penn Study Shows How Electronic Medical Records Can Be Used to Test Drug Efficacy
Green Tea Blocks Benefits of Cancer Drug
Ritalin May Cause Changes In The Brain's Reward Areas
Rockefeller Neurobiologist Proposes 'The End Of Sex As We Once Knew It'
Mayo Clinic Study Finds Younger Men With Erectile Dysfunction at Double Risk of Heart Disease
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News From MedWatch
Recently Approved Drugs/Indications
FDA Recalls and Safety Alerts in the Past 60 Days
Drug Shortages
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Pharmaceuticals Sold In Sweden Cause Serious Environmental Harm In India
Many of the substances in our most common medicines are manufactured in India and China. Some of these factories release large quantities of antibiotics and other pharmaceutical substances to the environment. There is an obvious risk of these releases leading to resistant bacteria.
Research from the Sahlgrenska Academy at University of Gothenburg shows that Sweden is a major consumer of pharmaceutical substances from factories that fail to adequately treat their wastewater. As it is difficult to find out where the pharmaceutical substances are manufactured and how much is released, it is impossible at present for consumers to avoid contributing to this environmental harm.

These findings are presented in the medical journal Regulatory Toxicology and Pharmacology and are highlighted today in a news article in Nature. Last week the research of the Swedish group became headline news in New York Times, Washington Post and Times of India.

"We used to think that pharmaceuticals that ended up in the environment mostly came from the use of the medicines and that the substances were dispersed through wastewater. We now know that certain factories that manufacture substances release very large quantities of active substances," says associate professor Joakim Larsson of the Sahlgrenska Academy in Gothenburg, one of the research scientists behind the studies.

Methamphetamine Use Cost United States About $23 Billion
The economic cost of methamphetamine use in the United States reached $23.4 billion in 2005, including the burden of addiction, premature death, drug treatment and many other aspects of the drug, according to a new RAND Corporation study.

The RAND study is the first effort to construct a comprehensive national assessment of the costs of the methamphetamine problem in the United States.

"Our findings show that the economic burden of methamphetamine abuse is substantial," said Nancy Nicosia, the study's lead author and an economist at RAND, a nonprofit research organization.

Although methamphetamine causes some unique harms, the study finds that many of the primary issues that account for the burden of methamphetamine use are similar to those identified in economic assessments of other illicit drugs.

Given the uncertainty in estimating the costs of methamphetamine use, researchers created a range of estimates. The lowest estimate for the cost of methamphetamine use in 2005 was $16.2 billion, while $48.3 billion was the highest estimate. Researchers' best estimate of the overall economic burden of methamphetamine use is $23.4 billion.

Penn Study Shows How Electronic Medical Records Can Be Used to Test Drug Efficacy
For years controversy has surrounded whether electronic medical records (EMR) would lead to increased patient safety, cut medical errors, and reduce healthcare costs. Now, researchers at the University of Pennsylvania School of Medicine have discovered a way to get another bonus from the implementation of electronic medical records: testing the efficacy of treatments for disease.  

In the first study of its kind, Richard Tannen, M.D., Professor of Medicine at the University of Pennsylvania School of Medicine, led a team of researchers to find out if patient data, as captured by EMR databases, could be used to obtain vital information as effectively as randomized clinical trials, when evaluating drug therapies. The study appeared online last week in the British Medical Journal.

"Our findings show that if you do studies using EMR databases and you conduct analyses using new biostatistical methods we developed, we get results that are valid," Tannen says. "That's the real message of our paper - this can work."

Green Tea Blocks Benefits of Cancer Drug
"The most immediate conclusion from our study is the strong advice that patients undergoing cancer therapy with Velcade must avoid green tea," associate professor Axel H. Schönthal said.

Photo/Lauren WalserUSC researchers have found that - contrary to popular assumptions about the health benefits of green tea - the widely used supplement renders a cancer drug used to treat multiple myeloma and mantle cell lymphoma completely ineffective.

The study, which found that a component of green tea extract (GTE) called EGCG destroys any anti-cancer activity of the drug Velcade in tumor-bearing mice, will be published in a future print edition of the journal Blood. It is now available online at the journal's pre-publication First Edition Web site.

"Our finding that GTE or EGCG blocked the therapeutic action of Velcade was completely unexpected," said lead author Axel H. Schönthal, associate professor in the Department of Microbiology and Immunology at the Keck School of Medicine of USC. "Our hypothesis was that GTE or EGCG would enhance the anti-tumor effects of Velcade and that a combination of GTE with Velcade (or EGCG with Velcade) would turn out to be a superior cancer treatment as compared to treatment with Velcade alone."

Ritalin May Cause Changes In The Brain's Reward Areas
A common treatment for attention deficit/hyperactivity disorder, prescribed millions of times a year, may change the brain in the same ways that cocaine does, a new study in mice suggests. Research from Rockefeller University shows that methylphenidate, commonly known as Ritalin, causes physical changes in neurons in reward regions of mouse brains. In some cases, the effects overlapped with those of cocaine.

The study highlights the need for more research into methylphenidate's long-term effects on the brain, the researchers say. The findings were published February 3 in the Proceedings of the National Academy of Sciences.

The researchers, led by Yong Kim, senior research associate, and Paul Greengard, Vincent Astor Professor and head of the Laboratory of Molecular and Cellular Neuroscience, exposed mice to two weeks of daily injections of cocaine or methylphenidate. They then examined reward areas of the brain for changes in dendritic spine formation - related to the formation of synapses and the communication between nerve cells - and the expression of a protein called delta Fos B, which has been implicated in the long-term actions of addictive drugs.

Rockefeller Neurobiologist Proposes 'The End Of Sex As We Once Knew It'
Women are not from Venus any more than men are from Mars. But even though both sexes are perfectly terrestrial beings, they are not lacking in other differences. And not only in their reproductive organs and behavior, either, but in such unsexy characteristics as the propensity for drug abuse, fine motor control, reaction to stress, moods and many brain structures.

According to Rockefeller University's Bruce S. McEwen, who has spent over four decades studying how hormones regulate the brain and nervous system, deciphering the substantial but often ignored differences between the sexes is crucial to developing more effective personalized medicine. In an upcoming issue of Physiology and Behavior, he emphasizes that none of the findings suggest one sex is stronger or more intelligent, and in many cases, the differences discovered raise more questions than they answer.

In spite of the subject's political sensitivities, McEwen says, it is ignored at our collective peril. "It's amazing how ignorant people are about this," says McEwen, the head of the Harold and Margaret Milliken Hatch Laboratory of Neuroendocrinology. "Medicine is clueless as to how males and females really differ from one another. They have a very mechanistic view of disease and they tend to think it always works the same way in both sexes. That can be dangerous."

Mayo Clinic Study Finds Younger Men With Erectile Dysfunction at Double Risk of Heart Disease
Men who experience erectile dysfunction between the ages of 40 and 49 are twice as likely to develop heart disease than men without dysfunction, according to a new Mayo Clinic study.

"The highest risk for coronary heart disease was in younger men," says researcher Jennifer St. Sauver, Ph.D. The study was published in the February 2009 issue of Mayo Clinic Proceedings. The results suggest that younger men and their doctors may need to consider erectile dysfunction a harbinger of future risk of coronary heart disease - and take appropriate steps to prevent it, says Dr. St. Sauver.

"The importance of the study cannot be overstated," writes Martin Miner, M.D., in an editorial in the same issue of Mayo Clinic Proceedings. The results "raise the possibility of a 'window of curability,' in which progression of cardiac disease might be slowed or halted by medical intervention," writes Dr. Miner, who practices at the Men's Health Center, Miriam Hospital, Providence, R.I.

Erectile dysfunction is common, and prevalence increases with age. It affects 5 to 10 percent of men at age 40. By age 70, from 40 to 60 percent of men have the condition.

Believe it or not
Careful! These statues could get you pregnant

Starting a family might be a little easier with a trip to Ripley's Believe It or Not museum in Myrtle Beach. The museum on Thursday opens a monthlong display of its fertility statues. The 5-foot tall wooden statues were acquired on the Ivory Coast of West Africa in 1993. The company says they were then placed in its corporate headquarters in Orlando, Fla., and within months, 13 women became pregnant.

The statues have since been on display around the world. According to the company, more than 2,000 women have reported becoming pregnant after touching the statues.

They will be on display at Ripley's through the first of March. The company says couples wanting to have a baby can touch the statues for free during business hours.
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  CLICKING HERE
 
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 by CLICKING HERE
 
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
 
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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