XTEND-15sec-NEWSt
9th April 2003
Click on the summary link of interest:
New England Journal denounces misuse of HGH study by marketers.n1
The New England Journal of Medicine has taken the unusual step of denouncing misuse of a scientific report it published in 1990 about growth hormone. They note that many marketers are misrepresenting the significance of that report. In their recent article which can be referenced as Drazen JM. Inappropriate advertising of dietary supplements. New England Journal of Medicine 348:777-778, 2003 the following warnings are posted:
Although the findings of the 1990 study were biologically interesting, the duration of treatment was so short that side effects were unlikely to have emerged, and it was clear that the results were not sufficient to serve as a basis for treatment recommendations.
Growth-hormone injections have not proven safe.
Studies that have followed the 1990 report by Rudman et al. confirm the effects of growth hormone on body composition but do not show improvement in function.
Amino acid pills marketed as so-called "growth hormone releasers" can't work because they are digested.
Warren Matthews comments: It is good that the Journal came out with this article because so many people are wasting their money on so called HGH products…they simply don't work! It's probably a good thing that they don't work because there is increasing evidence that long term direct administration of HGH can have many negative effects. From what I now know about HGH I wouldn't use it even if I was given a life time supply for free. If you would like to know a little more about HGH please read the updated section by clicking here. (The section on HGH is part way down the page.)
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Partnership between American Academy of Pediatric Dentistry and Coca Colan2
CHICAGO - March 3, 2003- The American Academy of Pediatric Dentistry (AAPD), the recognized leader in children's dental health, is pleased to announce a collaborative research and education partnership between the AAPD Foundation (AAPDF) and the Coca-Cola Foundation.
The AAPDF will receive an unrestricted grant to support important clinical, basic and behavioral research, which will be conducted by independent investigators. This affiliation will also create public and professional educational programs, based on science, that promote improved dental health for children.
"The AAPDF is committed to pursuing research that will speak for itself, and providing programs that guide parents to establish good dental habits for their kids," AAPDF President Joel Berg said.
A key part of AAPDF's mission is to support public education and research activities, such as its Good Health Starts Here campaign, which raises awareness about children's dental hygiene, diet and nutrition, dental visits and fluoride.
"This partnership will provide AAPDF additional and innovative approaches to communicate our messages to a broad spectrum of the general public," AAPD President David K. Curtis said.
At the upcoming AAPD Annual Meeting in New York City, the AAPDF will formally announce a new initiative involving several corporate sponsors. This latest AAPDF initiative is intended to have a major impact on public education and research activities concerning children's dental health.
Founded in 1947, the American Academy of Pediatric Dentistry is the not-for-profit membership organization representing the specialty of pediatric dentistry. The AAPD's 5,600 members are primary care providers who also provide comprehensive specialty treatments for infants, children, adolescents and patients with special health care needs. As advocates of children's oral health, the AAPD works closely with legislators, professional associations and health care professionals to develop policies and guidelines, implement research opportunities in pediatric oral health, and educate pediatric dentists, health care providers and the public regarding pediatric oral health.
American Academy of Pediatric Dentistry
211 E. Chicago Avenue, Suite 700
Chicago, IL 60611
(312) 337-2169; (312) 337-6329 fax.
Warren Matthews comments: I just had to share this with you! I think that it is ironic that Coca Cola first contributes to the poor condition of children's teeth and then supports research into improving them. I wonder if after much research and many studies that they may reach a conclusion that Coca Cola is bad for children's teeth. Somehow I don't think so!
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Public Citizen Calls on FDA to Ban Antidepressant Serzonen3
WASHINGTON, D.C. - The consumer advocacy group Public Citizen today petitioned the U.S. Food and Drug Administration (FDA) to remove from the market the popular antidepressant nefazodone, manufactured by Bristol-Myers Squibb. Nefazodone, marketed under the name Serzone, has no unique therapeutic benefit and has led to at least 11 deaths in the United States from liver toxicity, government records show. Prescribed More Than 4.5 Million Times Each Year, Drug Can Cause Fatal Liver Damage, Lead to Dangerous Interactions with Other Drugs
For more info click here.
Warren Matthews comments: I haven't studied these claims in detail so I really can't comment. But it would not surprise me if the allegations prove to be valid.
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Important notice: All material provided within XTEND-15sec-NEWS is for informational and educational purposes only, and is not to be construed as medical advice or instruction. No action should be taken solely on the contents of this publication. Consult your physician or a qualified health professional on any matters regarding your health and wellbeing or on any opinions expressed within this newsletter. The information provided in this newsletter is believed to be accurate based on the best judgment of the editor but the reader is responsible for consulting with their own health professional on any matters raised within.
March 6, 2003
Public Citizen Calls on FDA to Ban Antidepressant Serzone (Full Article)f1
Prescribed More Than 4.5 Million Times Each Year, Drug Can Cause Fatal Liver Damage, Lead to Dangerous Interactions With Other Drugs
WASHINGTON, D.C. - The consumer advocacy group Public Citizen today petitioned the U.S. Food and Drug Administration (FDA) to remove from the market the popular antidepressant nefazodone, manufactured by Bristol-Myers Squibb. Nefazodone, marketed under the name Serzone, has no unique therapeutic benefit and has led to at least 11 deaths in the United States from liver toxicity, government records show.
In January 2003, the manufacturer removed nefazodone from the European market after the Swedish Medical Products Agency announced that it would require a warning on the drug's label about the potential for liver toxicity. In the United States, more than 4.5 million prescriptions were filled for Serzone in 2001.
"There is no good reason to keep this drug on the market. It is no more effective than other antidepressants, and it presents a unique health hazard for patients," said Sidney Wolfe, M.D., director of Public Citizen's Health Research Group.
In its analysis of adverse event reports from the FDA, Public Citizen found that from 1994, when it was first marketed, to the spring of 2002, nefazodone was associated with at lease 53 cases of liver injury, including 21 cases of liver failure and 11 deaths. Worldwide, Bristol-Myers Squibb itself acknowledges 28 reports of liver failure, including 18 deaths.
Additionally, while nefazodone is not more effective at treating depression than older drugs, according to research by the federal Agency for Health Care Policy and Research, it is uniquely dangerous to patients. Further, periodic liver testing has not been shown to prevent injury and there is no way to predict which patients are at higher risk for liver damage.
An analysis by researchers in Spain found that, of 13 antidepressants, nefazodone has the highest incidence of liver injury - seven to 22 times that of the other antidepressants.
The liver toxicity dangers of nefazodone are compounded by the fact that it inhibits a key enzyme that is involved in the detoxification of about half of all prescribed drugs, so nefazodone increases the toxicity dangers of other drugs a patient is taking simultaneously. Also, by inhibiting this enzyme, nefazodone can increase its own concentration with potentially toxic results.
The FDA in December 2001 notified Bristol-Myers Squibb that it must add a "black box" warning to the package insert for nefazodone warning of life-threatening liver damage and recommending that physicians advise their patients to be aware of signs of liver problems.
But black box warning does not go far enough to protect patients, particularly because the labeling presented a confused message, the petition said. Although the black box warning recommends monitoring of patients' liver function, a second notice on the label downplays the necessity of such tests.
In the February 2002 issue of its monthly newsletter about drug safety, Worst Pills, Best Pills News, Public Citizen labeled nefazodone as a "Do Not Use" drug because of its known liver toxicity and recommended that anyone who had been taking it consider switching to a safer antidepressant. The petition and articles from the newsletter about Serzone are posted online at www.worstpills.org, a drug information service launched this winter by Public Citizen.
"Our readers have known for a year to steer clear of this drug, and now patients in Europe are protected, too," Wolfe said. "The FDA is endangering the lives of patients in this country every day that it allows nefazodone to remain on the market."
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