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Old July 11th 05, 05:31 PM
Angelo DePalma
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Apples and oranges. The issues of FDA approval, post-marketing safety
assessment, me-too drugs, and marketing unnecessary products are
intertangled, extremely complex, and separate from the issue of an unproven
dietary supplement.

I know that many herbs have a long history of *apparently* safe use. What
most of them lack is a rigorous study of side effects and interactions with
other herbs or drugs.

On balance, I'd bet that supplements are safe but not very effective. Natrol
is undoubtedly safer than most prescription drugs. However, the consequences
of being wrong, or being legally exposed, are so high that USCF should steer
clear.


"Vince Hart" wrote in message
oups.com...


Angelo DePalma wrote:
Vince, you hit on precisely my point. Placebo controlled clinical trials
are
the gold standard for approving medicinal substances. No-one should
accept
any less from "natural" treatments. Anything less has a much higher
chance
to expose patients or consumers to unacceptable risks.





On the other hand, Vioxx was subject to your "gold standard," and it
was still marketed and prescribed to millions of patients, most of whom
would have done just as well with over-the-counter remedies since they
were not at risk for the stomach problems that the Cox-2 inhibitors
were designed to avoid.

Many natural treatments have been around since long before the advent
of modern pharmaceuticals so the chance of unexpected side effects may
be much lower than that for a clinically tested modern drug. On the
other hand, the chance that the natural treatment has no actual benefit
is probably much higher.

Vince Hart



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