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Re: NY TIMES SLAMS ALTERNATIVE MEDICINE ON FRONT PAGE
Thanks for stating this so clearly. We do need a new way to deal with
this. I've been very disappointed that the long-term NIH meno studies
are apparently focussing on the know W.A. products (Premarin, Provera)
and ignoring (as far as I know) estrogens natural to the human body and
progesterone.
If I'm wrong about this I'd be glad to be corrected!!
Thanks in advance,
dn
leagle1140@aol.com (Leagle1140) wrote:
>
>Re: the NYT article . . .
>
> Notice that the author's real problem with alternative treatments is
>that they are "untested." By this she means that they have not been
>subject to scientifically rigorous and controlled experiments.
>
> Unfortunately, patent law and the FDA Act have an unfortunate
>intersection where natural medicines are concerned. Patent law makes it
>impossible to safeguard intellectual property rights in natural products.
>Plants, for example, are generally not patentable.
>
> At the same time, the FDA divides its regulatory structure into
>"foods" and "drugs." Foods require only a GRAS determination - a showing
>that something is generally recognized as safe. This is a low hurdle,
>and that's why most herbal medicines are sold as food supplements.
>
> Drugs require a showing of efficacy - in other words, scientific
>proof (within statistical parameters). This requires an enormous
>investment of time and money (not to mention a stable of research
>scientists and attorneys). I should know, I am a D.C. lawyer who has
>dealt with this process.
>
> Because patent law won't allow big companies to recoup the investment
>required to get something approved as a drug by the FDA, studies on herbal
>medicines and alternative therapies will NEVER take place, unless the
>public sector or charities step in.
>
> A very strange effect of two otherwise very well-intentioned legal
>regulatory schemes. Any comments?
>
>
>Tree
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