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NEWS: Jeanne Lenzer US government agency to investigate FDA over rofecoxib BMJ 2004; 329: 935 [Full text]

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FDA and ephedra

Anssi H. Manninen   (22 October 2004)

cosy relationship between drug companies and FDA

manan vasenwala   (22 October 2004)

Re: cosy relationship between drug companies and FDA

Lisa Blakemore-Brown   (23 October 2004)

FDA and ephedra 22 October 2004
Anssi H. Manninen, Senior Science Editor Advanced Research Press, Inc. Send response to journal: Re: FDA and ephedra	Recently, The FDA decided to ban ephedra-containing supplements. The pharmacokinetics of ephedrine following ingestion of supplements formulated as concentrated ephedra extracts is distinguishable from that of synthetic ephedrine found in conventional dosage forms. Neverthless, the FDA did not ban ephedrine. Why? Simply because they want to support pharmaceutical companies selling ephedrine-containing products? Dr. Greenway and co-workers at the Pennington Biomedical Research Center examined the effect of a supplement containing herbal caffeine and ephedrine on metabolic rate, weight loss, body composition and safety parameters (Obes Res. 2004 Jul;12(7):1152-7). Results indicated that ephedra plus caffeine promoted more weight and fat loss than placebo, and was well tolerated. According to the authors, “dietary herbal supplements containing [ephedra and caffeine] should remain available to obese individuals trying to control their weight.” Further, Dr. Soni and co-workers concluded that the adverse event reports raise concerns about the risks associated with ephedra usage, but did not establish a direct causal relationship between intake of ephedra and reported injuries (Toxicol Lett. 2004 Apr 15;150(1):97-110). They also pointed out that the published preclinical and clinical studies, and the long history of safe use of ephedra, support the safety-in-use of ephedra when used as directed. According to Dr. Soni et al., the problems associated with the adverse events appear to be the result of overuse, inconsistent potency, individual sensitivity, contaminations, etc. Competing interests: None declared
cosy relationship between drug companies and FDA 22 October 2004
manan vasenwala, consultant-cardiologist k.k.heart center, aligarh-202002.india Send response to journal: Re: cosy relationship between drug companies and FDA	the number of revelations about fatal drugs, being made in quick succession, put role of FDA in serious doubts. no longer can we assume it to be an impartial and incorruptible agency nor can we assume it to be an "angel-guardian" for the vast numbers of ailing people throughout the world. previously, a mention that a particular drug was "approved by FDA" was sufficient to silence critics. i wonder, if time is ripe to make FDA a party for claims for compensation for collusion with drug manufacturers? Competing interests: None declared
Re: cosy relationship between drug companies and FDA 23 October 2004
Lisa Blakemore-Brown, Psychologist UK based Send response to journal: Re: Re: cosy relationship between drug companies and FDA	It is about time these `cosy relationships` are starting to be exposed. The extraordinary goings on in the UK over suspected vaccine damage including: encouragement of parent blame theories to muddy the waters; removal of autism diagnoses; results of dubious epidemiology used to obliterate pure science, clinical good judgment, video evidence and a consistent pattern of evidence from parental reports whilst rights to legal aid are also obliterated, must make even the most naive readers wonder about Government links to Big Pharma and the dangers posed for the population by such spin and collaboration. Perhaps what is going on with the FDA in the US will lead to a similar expose in this country? Or is it really naive to expect that? Competing interests: Expert in Autism