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the FDA that has no authority. Once enough of these red flags come in on a drug,
then they'll send it back to the original committee that approved the drug in the
first place. I do not feel that they have an unbiased representation when they look
at this. That’s why over 99 percent of the time all that happens is a change to the
drug label or what we call a package insert. This usually goes unnoticed even if they
send out a "dear doctor" letter warning doctors about these drugs, and that they
better be careful here. There have been studies that show doctors don’t pay much
attention to that. So it’s not a very good system.”
Dr. Ray Strand
The final studies are usually done on healthy individuals and many times not even
in the age category the drug is marketed for! For example, a clinical trial might
over-select young, healthy subjects when the drug being tested is intended for use
primarily on older patients.
"Rochon et al. found that only 2.1 percent of subjects in trials of nonsteroidal anti-
inflammatory drugs were 65 years of age or older, even though these drugs are
more commonly used and have a higher incidence of side effects in the elderly."
Bodenheimer T, "Uneasy Alliance-Clinical Investigators and the Pharmaceutical
Industry," New England Journal of Medicine, 342(20), May 18, 2000.
Critics of the FDA point out the agency's close ties to the big drug companies as one
of the problems in the drug approval process. A USA Today report found that more
than half the advisors to the FDA have "financial relationships" with drug
companies that have an interest in FDA decisions (De Angelis C, "Conflict of
Interest and the Public Trust," JAMA, Nov 1, 2000). But even if panel members
involved in approving a drug are scrupulously honest, they still depend on data
from that company's clinical trials to approve the drug as safe and efficacious, and
the data can be misleading.
"Efforts by drug companies to suppress, spin, and obfuscate findings that do not suit
their commercial purposes were first revealed to their full, lethal extent during the
thalidomide tragedy. Although government drug regulation schemes around the
world are now in place, the insidious tactics of Big Pharma have changed little."
"The Tightening Grip of Big Pharmaceutical Companies," Editorial, The Lancet,
April 14, 2001.
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