US government agency to investigate FDA over rofecoxib
BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7472.935 (Published 21 October 2004) Cite this as: BMJ 2004;329:935All rapid responses
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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
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Competing interests: No competing interests