IN THIS ISSUE:

• Scientists Unveil Piece Of HIV Protein That May Be Key To AIDS Vaccine Development
   
• Stomach Ulcers 'Prehistoric Link'
   
• FDA Alerts Consumers to Unsafe, Misrepresented Drugs Purchased Over the Internet
   
• New Oral Drug for Type 2 Diabetes Shows Promise
   
• Testing Drugs in Kids, Not Just Adults, Can Save Lives
   
• Ageless Fatherhood? Maybe Not
   
• Vasectomy May Put Men At Risk For Type Of Dementia

• 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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Scientists Unveil Piece Of HIV Protein That May Be Key To AIDS Vaccine Development

In a finding that could have profound implications for AIDS vaccine design, researchers led by a team at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), have generated an atomic-level picture of a key portion of an HIV surface protein as it looks when bound to an infection-fighting antibody. Unlike much of the constantly mutating virus, this protein component is stable and--more importantly, say the researchers--appears vulnerable to attack from this specific antibody, known as b12, that can broadly neutralize HIV.
3-D X-ray crystallographic image showing the broadly neutralizing antibody b12 (green ribbon) in contact with a critical target (yellow) for vaccine developers on HIV-1 gp120 (red). (Credit: NIAID)
"Creating an HIV vaccine is one of the great scientific challenges of our time," says NIH Director Elias A. Zerhouni, M.D. "NIH researchers and their colleagues have revealed a gap in HIV's armor and have thereby opened a new avenue to meeting that challenge."
The research team was led by Peter Kwong, Ph.D., of NIAID's Vaccine Research Center (VRC). His collaborators included other scientists from NIAID and the National Cancer Institute, NIH, as well as investigators from the Dana-Farber Cancer Institute, Boston, and The Scripps Research Institute in La Jolla, CA. Their paper appears in the February 15 issue of Nature and is now available online.

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Stomach Ulcers 'Prehistoric Link'

Prehistoric humans were infected with a bug that causes stomach ulcers, a study in the journal Nature suggests.
A UK-German team used a computer model to show that both Helicobacter pylori and humans migrated from Africa around 58,000 years ago.
The bacteria seem to have remained "intimately associated" with human populations ever since, they say.
Australian scientists won the Nobel Prize for Medicine in 2005 for showing the bacteria can cause stomach ulcers.
In 1982, Robin Warren and Barry Marshall discovered that H. pylori colonised about 50% of stomachs.
Before their research, stress and lifestyle were considered the major causes of stomach and intestinal ulcers.
It is now firmly established that the bacteria cause more than 90% of duodenal (intestinal) ulcers and up to 80% of gastric (stomach) ulcers.
In the latest study, a team from Cambridge University and the Max Planck Institute in Berlin compared the spread of early humans from East Africa around the world with that of H. Pylori.
Previous research on DNA sequences has shown the further humans migrated from Africa the more genetically distinct they became.
The same was found to be true of H. Pylori.

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FDA Alerts Consumers to Unsafe, Misrepresented Drugs Purchased Over the Internet

The Food and Drug Administration (FDA) has become aware that a number of Americans who placed orders for specific drug products over the Internet (Ambien, Xanax, Lexapro, and Ativan), instead received a product that, according to preliminary analysis, contains haloperidol, a powerful anti-psychotic drug.
Reports show several consumers in the United States have sought emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms and muscle stiffness after ingesting the suspect product. Haloperidol can cause muscle stiffness and spasms, agitation, and sedation.
Therefore, the agency is reissuing its warning to consumers about the possible dangers of buying prescription drugs online. FDA urges consumers to review the FDA Web site for information before buying medication over the Internet.

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New Oral Drug for Type 2 Diabetes Shows Promise

The first of a new class of oral antidiabetic drugs is able to lower blood sugar (glucose) in type 2 diabetes as well as Avandia (rosiglitazone) does, but without causing weight gain, according to a report in the journal Diabetes Care.
The new agent, vildagliptin, also known by the brand name Galvus, is awaiting regulatory approval in the U.S. and Europe. The new drug class, dipeptidyl peptidase-IV (DPP-IV) inhibitors, improves cell responsiveness to glucose, the authors explain.
Dr. Julio Rosenstock from the Dallas Diabetes and Endocrine Center, and colleagues compared the effectiveness and tolerability of vildagliptin versus rosiglitazone (the generic name for Avandia) in nearly 800 patients with previously untreated type 2 diabetes.

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Testing Drugs in Kids, Not Just Adults, Can Save Lives

A third of the drugs tested under a federal policy that encourages separate drug studies on children were found to work differently than they do in adults. In some cases, the drugs were found to be more dangerous in children, while other drugs were completely ineffective in children.
Congress will consider renewing the pediatric drug testing law this year, and two Duke University Medical Center researchers assert that it is good policy and should be continued because it improves children's health and even saves lives.
Pediatricians Jennifer Li, M.D., and Daniel Benjamin, M.D., analyzed financial and medical data on 59 drugs that were tested in children under the "pediatric exclusivity provision" of the Best Pharmaceuticals for Children Act, enacted in 1997.
Their findings appear in the Feb. 7, 2007, issue of the Journal of the American Medical Association. The study was funded by Duke and received additional support from the National Institutes of Health.

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Ageless Fatherhood? Maybe Not

Most women hoping to have a family are painfully aware of their biological clocks. They know their ability to bear children declines with age, even with all the innovation in fertility treatments.
Now, research is revealing that a man's potential for producing a child may not last forever, either -- at least not without health consequences for the child. And, as men age, those who don't take care of their health may fall victim to a faster, louder clock.
"Men who are overweight, whose belly fat is very bad, have a higher chance of lower testosterone levels," reducing their ability to father a child, said Dr. Harry Fisch, director of the Male Reproductive Center and professor of clinical urology at Columbia University College of Physicians and Surgeons. Cigarette smoking can also adversely affect a man's fertility.
Fisch doesn't believe there's a "cutoff" point for fatherhood. "But the sooner, the better," he said, citing recent research.
Several studies have found that older fathers risk having children with medical problems, including Down syndrome. Fisch and his colleagues evaluated more than 3,400 cases of Down syndrome, finding that if the woman and the man were both over age 35 at the time of conception, the father's age played a role in prevalence of the disorder. This effect was most pronounced when the woman was over 40, the researchers found. And, in those cases, the incidence of Down syndrome was about 50 percent attributable to the sperm, the researchers said. The study was published in 2003 in The Journal of Urology.

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Vasectomy May Put Men At Risk For Type Of Dementia

Northwestern University researchers have discovered men with an unusual form of dementia have a higher rate of vasectomy than men the same age who are cognitively normal.
The dementia is Primary Progressive Aphasia (PPA), a neurological disease in which people have trouble recalling and understanding words. In PPA, people lose the ability to express themselves and understand speech. It differs from typical Alzheimer's disease in which a person's memory becomes impaired.
Sandra Weintraub, principal investigator and professor of psychiatry and behavioral sciences and of neurology at Northwestern's Feinberg School of Medicine, began investigating a possible link between the surgery and PPA when one of her male patients connected the onset of his language problem at age 43 to the period after his vasectomy.

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Believe It Or Not

For women, nothing's like the smell of men's sweat

For women, apparently there's nothing like the smell of a man's sweat.
Researchers at the University of California at Berkeley said women who sniffed a chemical found in male sweat experienced elevated levels of an important hormone, along with higher sexual arousal, faster heart rate and other effects.
They said the study, published this week in the Journal of Neuroscience, represents the first direct evidence that people secrete a scent that influences the hormones of the opposite sex.
The study focused on androstadienone, considered a male chemical signal. Previous research had established that a whiff of it affected women's mood, sexual and physiological arousal and brain activation. Its impact on hormones was less clear.
A derivative of testosterone, it is found in male sweat as well as in saliva and semen. It smells somewhat musky.
"It really tells us that a lot of things can be triggered by smelling sweat," Claire Wyart, who led the study, said in an interview on Wednesday.
The researchers measured levels of the hormone cortisol in the saliva of 48 female undergraduates at Berkeley, average age of about 21, after the women took 20 sniffs from a jar of androstadienone. Cortisol is secreted by the body to help maintain proper arousal and sense of well-being, respond to stress and other functions.
Cortisol levels in the women who smelled androstadienone shot up within roughly 15 minutes and stayed elevated for up to an hour. Consistent with previous research, the women also reported improved mood, higher sexual arousal, and had increased blood pressure, heart rate and breathing.
YEAST
For comparison's sake, women also smelled baking yeast, which did not trigger the same effects.
This was the first time that smelling a specific chemical secreted by people was shown to affect hormonal levels, the researchers said. The women had no skin contact with androstadienone.
The researchers used only heterosexual women in the study out of concern that homosexual women may respond differently to this male chemical.
Wyart said while this marked the first time a specific component of male sweat was demonstrated to influence women's hormones, other components of sweat may do similar things.
The study did not determine whether the increase in cortisol levels triggered mood or arousal changes or whether those changes themselves caused the cortisol elevation.
The researchers also said their findings suggest a better way to stimulate cortisol levels in patients who need it, such as those with Addison's disease. Instead of giving cortisol in pill form, which has side effects such as peptic ulcers, osteoporosis, weight gain and mood disorders, smelling a chemical like androstadienone could be used to affect cortisol levels, they suggested.

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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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