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 President The Institute for Safe Medication Practices
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 Quackwatch
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Vitamin E's Lack Of Heart Benefit Linked To Dosage
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The reported failure of vitamin E to prevent heart attacks may be due to underdosing, according to a new study by investigators at Vanderbilt University Medical Center.
The findings, published early online in Free Radical Biology and Medicine, suggest that these earlier studies all had a fundamental flaw - the doses used weren't high enough to have a significant antioxidant effect. In fact, no studies have ever conclusively demonstrated the dose at which vitamin E can be considered an antioxidant drug, the researchers report.
This study suggests it takes at least 1600 IU per day to cause a significant reduction in oxidative stress - twice that used in some of the previous clinical trials.
Oxidant injury, or oxidative stress, occurs when highly reactive molecules called free radicals attack and damage cellular proteins, lipids (fats) and DNA. Free radicals, which are byproducts of normal metabolism, are produced in excess in certain disease states, including heart disease.
Epidemiological data and animal studies suggested that antioxidant compounds like vitamin E, vitamin C and beta-carotene might offer some protection against heart attack in individuals at risk.
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| FDA Approves Genetic Testing Labeling For Blood-thinning Drug |
The U.S. Food and Drug Administration has announced the approval of updated labeling for the widely used blood-thinning drug, Coumadin, to explain that people's genetic makeup may influence how they respond to the drug.
Manufacturers of warfarin, the generic version of Coumadin, are to add similar information to their products' labeling, FDA said.
The labeling change highlights the opportunity for healthcare providers to use genetic tests to improve their initial estimate of what is a reasonable warfarin dose for individual patients. Testing may help optimize the use of warfarin and lower the risk of bleeding complications from the drug.
These labeling updates are based on an analysis of recent studies that found people respond to the drug differently based, in part, on whether they have variations of certain genes.
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| Despite Overeating, Morbidly Obese Mice Gain Protection Against Diabetes |
The "world's fattest mice" can overeat without developing insulin resistance or diabetes thanks to a glut of a key hormone, a dichotomy that helps explain why not all obese people are diabetic, a UT Southwestern Medical Center researcher has found.
Consuming excess calories usually spurs insulin resistance and diabetes. But in a multicenter study appearing online today in the Journal of Clinical Investigation, scientists show how an abundance of adiponectin, a hormone that controls sensitivity to insulin, and a lack of leptin, a hormone that curbs appetite, enables mice to store excess calories in fat tissue instead of in liver, heart or muscle tissue - places where excess fat can lead to inflammation, diabetes and heart disease.
The mice get morbidly obese, but are insulin-sensitive with normal blood-glucose levels.
"The message isn't that it's good to be obese, but that expanded fat mass, when stored in the right places, can help prevent diabetes and reduce the risk of heart disease," said Dr. Philipp Scherer, professor of internal medicine and the study's senior author. "In fact, these are the first mice to directly show that fat-mass expansion has antidiabetic effects." Dr. Scherer directs the Touchstone Center for Diabetes Research at UT Southwestern.
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| Folate Mystery Finally Solved |
Some biochemical processes, especially those in bacteria, have been so well studied it's assumed that no discoveries are left to be made. Not so, it turns out, for Johns Hopkins researchers who have stumbled on the identity of an enzyme that had been a mystery for more than 30 years. The report appears in the May 15 issue of Structure.
"It was really quite a surprise when we realized we had discovered the unknown player in how bacteria make the B vitamin folate, a player that we've known of since 1974," says study author L. Mario Amzel, Ph.D., professor and director of biophysics and biophysical chemistry at Hopkins. "Basic research can be so serendipitous at times."
Amzel and colleague Maurice Bessman and their labs were in the middle of systematically characterizing how members of a family of related enzymes in bacteria can recognize specific molecules. With each family member, they isolated purified enzyme, grew crystals of pure enzyme, and figured out the enzyme's 3-D structure by using techniques that use X-rays.
Armed with the 3-D structure, they then used computer modeling to analyze how the enzyme binds to and acts on another molecule, its substrate. Read more..... |
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Drug Protects Brain Cells In Huntington's Disease Model |
A drug used in some countries to treat the symptoms of Huntington's disease prevents death of brain cells in mice genetically engineered to mimic the hereditary condition, UT Southwestern Medical Center researchers have found.
The research sheds light on the biochemical mechanisms involved in the disease and suggests new avenues of study for preventing brain-cell death in at-risk people before symptoms appear.
"The drug can actually prevent brain cells from dying," said Dr. Ilya Bezprozvanny, associate professor of physiology at UT Southwestern. "It's much more important than people thought." Dr. Ilya Bezprozvanny, associate professor of physiology, led research showing that the drug tetrabenazine - used in some countries to treat the symptoms of Huntington's disease - prevents death of brain cells in mice genetically engineered to mimic the hereditary condition. The study, of which Dr. Bezprozvanny is senior author, appears in the July 25 issue of The Journal of Neuroscience.
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| Research Team Finds Link Between Zinc And Macular Degeneration |
A team of scientists, including three researchers at George Mason University, found that the mineral zinc could play a role in the development of macular degeneration. In studying eye tissue samples, the researches found that deposits, that are hallmarks of age-related macular degeneration (AMD), contain large amounts of zinc.
This finding, published in the journal Experimental Eye Research, might be particularly important because zinc supplements are widely given to patients to help boost weak immune systems. In addition, a 2001 study from the National Eye Institute found that high doses of zinc supplements, combined with antioxidants, may postpone the progression to blindness.
AMD is a medical condition in which the macula, the place of central vision in the eye, experiences atrophy and in some cases bleeding. It is the primary cause of blindness in the elderly in Western society and approximately 13 million Americans suffer from the disease according to AMD Alliance International.
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FDA Proposes New Rule for Sunscreen Products
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The U.S. Food and Drug Administration today proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC) sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.
"For more than 30 years, consumers have been able to identify the level of UVB protection provided by sunscreens using only sunburn protection factor or SPF values," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "Under today's proposal, consumers will also now know the level of UVA protection in sunscreens, which will help them make informed decisions about protecting themselves and their children against the harmful effects of the sun."
Sunlight is composed of the visible light that we can see, and ultraviolet (UV) light that we can not. There are two types of UV light, UVA and UVB. UVA light is responsible for tanning and UVB for sunburn. Both can damage the skin and increase the risk of skin cancer.
The proposed regulation creates a consumer-friendly rating system for UVA products designed to help consumers identify the level of UVA protection offered by a product. The FDA proposal provides a ratings system for UVA sunscreen products on a scale of one to four stars. One star would represent low UVA protection, two stars would represent medium protection, three stars would represent high protection, and four stars would represent the highest UVA protection available in an OTC sunscreen product. If a sunscreen product does not provide at least a low level (one star) of protection, FDA is proposing to require that the product bear a "no UVA protection" marking on the front label near the SPF value.
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Believe it or not
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93-year-old charged with drug dealingA 93-year-old man was charged with cocaine-trafficking Thursday, the same day police netted three other people on charges of possessing heroine, opium and a slew of prescription drugs, police said Friday.
William C. Tinnen, also charged with possession of cocaine with intent to sell, was jailed before being released Friday on $200,000 bond, said Kammie Michael, spokeswoman for the Durham Police Department.
Tinnen also was sentenced for cocaine possession in 2001, and given a suspended sentence, Michael said.
Three others were arrested in the two raids as a part of an undercover operation, police said.
The others are Ryheme McLaurin, 25; Doris Faye McLaurin, 52; and Francisco Morales Medina, 38. Police listed Durham addresses for all three. |
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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 CLICKING 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 by CLICKING 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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