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IN THIS ISSUE:
(Today Is Edmund's Birthday and this Newsletters 7th Birthday)

Folic Acid May Prevent Cleft Lip and Palate
Seeing The Medicine In Chinese Herbs Through The Random Forest
Chemicals In Brown Algae May Protect Against Skin Cancer
New Food Pyramid Offers Building Blocks to Good Nutrition
NIAID DNA Vaccine for H5N1 Avian Influenza Enters Human Trial
COX-2 Drugs May Raise Risk of Repeat Heart Attack
Study Blasts TV Drug Ads
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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Folic Acid May Prevent Cleft Lip and Palate

A new study finds that women who take folic acid supplements early in their pregnancy can substantially reduce their baby’s chances of being born with a facial cleft.
Researchers at the National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health, found that 0.4 milligrams (mg) a day of folic acid reduced by one third the baby’s risk of isolated cleft lip (with or without cleft palate). Folic acid is a B vitamin found in leafy vegetables, citrus fruits, beans, and whole grains. It can also be taken as a vitamin supplement, and it is added to flour and other fortified foods. The recommended daily dietary allowance for folate for adults is 400 micrograms or 0.4 mg.
“These findings provide further evidence of the benefits of folic acid for women,” said Allen J. Wilcox, M.D., Ph.D., lead NIEHS author on the new study published online in the British Medical Journal. “We already know that folic acid reduces the risk of neural tube defects, including spina bifida. Our research suggests that folic acid also helps prevent facial clefts, another common birth defect.” In the United States, about one in every 750 babies is born with cleft lip and/or palate.
“Folic acid deficiency causes facial clefts in laboratory animals, so we had a good reason to focus on folic acid in our clefts study,” said Wilcox. “It was one of our main hypotheses.”
The researchers examined the association between facial clefts and mothers’ intake of folic acid supplements, multivitamins, and folates in diet. The researchers found that folic acid supplementation of 400 micrograms or more per day reduced the risk of isolated cleft lip with or without cleft palate by one-third, but had no apparent effect on the risk of cleft palate alone.

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Seeing The Medicine In Chinese Herbs Through The Random Forest

Over the past several years, scientific journals have been abuzz with reports of the chemical constituents of Chinese herbs used in traditional medicine. Think ginseng, Ginkgo biloba and ginger, to name a few.
A group of researchers at King's College London decided to use a computer screening to construct a single database both to catalogue the chemical makeup of 240 species of herb and to indicate which target enzymes and receptors implicated in diseases—such as HIV/AIDS, cancer and Alzheimer's disease—those components may be able to regulate.
"The motivation for the cataloguing and the provision of tools for the data mining is really to provide a way for perhaps not the herbs themselves, but the purified constituents [that] might be discovered as new therapeutics of this disease or that disease," says King's College pharmacologist David Barlow, who credits the study's co-author, PhD student Thomas Ehrman, with the idea.
Barlow's group used a screening algorithm called Random Forest, which is a type of decision tree, to compile its database. The algorithm involves each entity being screened with a random set of questions—in this case, mostly about the herb's constituents—to tease out which of the biological targets it could possibly effect. "If you take a set of 8,000-plus constituents from herbs and get their chemical details and feed them through the system, you essentially classify them one by one and say, 'This one has a fingerprint appropriate for this target and, therefore, may have this use,'" Barlow explains.

For more information CLICK HERE

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Chemicals In Brown Algae May Protect Against Skin Cancer

Substances extracted from a marine seaweed may protect against skin cancer caused by too much sun, new research suggests.
The animal study indicates that chemicals called brown algae polyphenols (BAPs), which are found in a type of brown marine seaweed, might protect against skin cancers caused by ultraviolet B (UVB) radiation.
UVB radiation in sunlight is thought responsible for 90 percent of the estimated 1.3 million cases of non-melanoma skin cancer diagnosed in the United States annually.
Researchers applied the BAPs to the skin of hairless mice and fed it to the animals in their diet. In both cases, the substances reduced the number of skin tumors by up to 60 percent and their size by up to 43 percent. They also reduced inflammation.
The study, led by researchers at the Ohio State University Comprehensive Cancer Center, is published in the Dec. 15 issue of the International Journal of Cancer.

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New Food Pyramid Offers Building Blocks to Good Nutrition

The new and improved U.S. Department of Agriculture's food guide pyramid -- called MyPyramid -- is helping Americans, young and old, to better understand how to eat healthfully, dietitians say.
The new pyramid features vertical bands (rather than the old horizontal pyramid sections) in six different colors to represent different food groups and types. Orange equals grains, green is for vegetables, red is for fruits, blue represents dairy, purple is meat and beans, and yellow stands for oils.
Along the side of the pyramid, a drawing depicts a person climbing a set of steps to match the new slogan "Steps to a Healthier You," which is meant to encourage physical activity as essential.
Perhaps the most important feature of the new pyramid, unveiled in 2005: By plugging in certain personal information, such as age, gender, and levels of physical activity, you can get a nutrition plan that's tailored for you.

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NIAID DNA Vaccine for H5N1 Avian Influenza Enters Human Trial

The first human trial of a DNA vaccine designed to prevent H5N1 avian influenza infection began on December 21, 2006, when the vaccine was administered to the first volunteer at the National Institutes of Health (NIH) Clinical Center in Bethesda, MD. Scientists from the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), one of the NIH Institutes, designed the vaccine. The vaccine does not contain any infectious material from the influenza virus.
Unlike conventional flu vaccines, which are developed by growing the influenza virus in hens’ eggs and then administered as a weakened or killed form of the virus, DNA-based vaccines contain only portions of the influenza virus’ genetic material. Once inside the body, the DNA instructs human cells to make proteins that act as a vaccine against the virus.
VRC Director Gary Nabel, M.D., Ph.D., together with a team of scientists from the VRC recognized the potential for employing new vaccine technology against influenza, a disease for which effective vaccines have long been made, but for which the reliability of supply and manufacturing capacity has been problematic. Dr. Nabel and his colleagues previously have shown the DNA vaccine approach to be effective against influenza viruses in animal models, including highly pathogenic viruses such as the H5N1 strain and the H1N1 virus that caused the deadly 1918 pandemic. The DNA vaccine used in this study is similar to other investigational vaccines evaluated by the VRC that hold promise for controlling other viruses, such as HIV, Ebola, SARS and West Nile.
“An effective H5N1 influenza vaccine would provide a potentially life-saving advance against a global health threat,” notes NIAID Director Anthony S. Fauci, M.D. “More broadly, development of this DNA vaccine technology has the potential to improve our production capacity for vaccines to prevent seasonal influenza and other diseases.”

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COX-2 Drugs May Raise Risk of Repeat Heart Attack

A large study confirms that Vioxx (rofecoxib), but not Celebrex (celecoxib), is associated with increased risk of a first heart attack. However, people with a prior heart attack may be at increased risk for experiencing another if they use either selective COX-2 inhibitor, the research indicates.
While Vioxx was pulled from the US market due to an elevated risk of heart attacks and stroke in adults, Celebrex remains on the US market.
Previous studies looking at the harmful effects on the heart of COX-2-selective inhibitors have largely excluded patients with a history of heart attack, Dr. James M. Brophy, from the McGill University Health Center in Montreal, and colleagues note in the journal Heart.
They analyzed data on 125,000 patients, with an average age of 75, who were treated with an NSAID between January 1999 and June 2002.

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Study Blasts TV Drug Ads

In strong criticism of the pharmaceutical industry's marketing practices, new research claims that televised ads for prescription drugs are riddled with emotional appeals and lack helpful information on the disease itself.
"The ads really use emotion instead of information to promote drugs," said the study's lead author, Dominick Frosch, an assistant professor of medicine at the University of California, Los Angeles. "The question we have to ask ourselves is: (Should buying) prescription drugs be the same as buying soap?"
Pharmaceutical companies spent an estimated $1.9 billion on TV advertising in 2005. In order to figure out the most common strategies used in some of the commercials, Frosch and his colleagues reviewed a sample of 38 ads for prescription drugs that appeared on network television in June and July 2004.
Using a statistical analysis that gave ads more "weight" if they were aired more frequently, the researchers report that 82 percent of the ads made "factual claims," but many fewer provided further information about illnesses such as causes (26 percent), risk factors (26 percent) or prevalence (25 percent).
Ninety-five percent of ads made "emotional appeals," and 78 percent implied that use of the medication would result in social approval. Fifty-eight percent of the time, products were depicted as medical breakthroughs.
The drugs advertised included Allegra (allergy), Ambien (insomnia), and Cialis (impotence), among others.

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Believe It Or Not

NJ warns: Don't eat squirrels near toxic waste dump (there goes my birthday dinner)

New Jersey has warned squirrel hunters near a toxic waste dump about consuming the critters because they could be contaminated with lead.
It is the first time the state has cautioned Ringwood residents many who are members of the Ramapough Mountain Indian tribe who hunt and fish in the area about their squirrel intake, said Tom Slater, a spokesman for the Department of Health and Senior Services.
A lead-contaminated squirrel was found in the area two months ago, prompting the agency, along with the state Department of Environmental Protection, to send out letters advising that adults eat squirrel no more than twice a week and even less for children and pregnant women.
Lead, which is harmful in small amounts, can damage the nervous system, red blood cell production and the kidneys.
"We've known for a long time something was wrong here, we just didn't know what it was," resident Myrtle Van Dunk said.
Residents and many environmental activists believe the lead comes from toxic waste, including paint sludge, dumped in the area by the Ford Motor Co. during the 1960s and early 1970s, from its now-closed car manufacturing plant in Mahwah.
Ford is removing thousands of tons of waste from a 500-acre former mining property in the Ringwood area. The site was recently relisted on the federal Superfund list, a ranking of the country's worst environmental dump sites, after multiple cleanups failed to remove all the sludge.

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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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