32 replies to this topic

[nameless]

I am by no means a doctor but I have been reading how some think high doses might do more harm then good. I just have to say that even with regular medicine prescribed by a doctor comes with risk. The thing about regular prescriptions is that they are approved by the FDA but the medicine is use to treat not cure. Even if something natural was proven to be a cure for a disease the FDA would not a approve it because there would be no money in it. The sad proof is that they dont want to cure any diseases because the drug companies would be out of business and the FDA cash cow would be gone.

Except in this case a special formulation of resveratrol is a drug, will go through FDA testing and Glaxo will make money.

Issue I have with resveratrol isn't necessarily just safety, although all those joint pain forum posts do give me pause. But... maybe wait until we find out if it actually does something beneficial in people first?

Edited by nameless, 13 May 2009 - 04:49 PM.

[AcaiBerry]

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Edited by niner, 03 June 2009 - 09:32 PM.

[unglued]

Even if something natural was proven to be a cure for a disease the FDA would not a approve it because there would be no money in it. The sad proof is that they dont want to cure any diseases because the drug companies would be out of business and the FDA cash cow would be gone.

No conspiracy theory is needed to explain why it's hard to get FDA approval for a natural product. Doing a carefully controlled Phase III trial to prove that something works can cost millions of dollars. A company's stockholders are unlikely to want to invest millions of dollars in proving the efficacy of a product they don't own a share of the patent for, since it's hard to get the money back even if it turns out to work. That leaves it to taxpayers in a large country such as the U.S. to foot the bill for a trial that could benefit everyone, but NIH funding isn't unlimited.

As an example, I heard somewhere that Sirtris Pharmaceuticals, which has been testing both a resveratrol formulation and new chemical entities (NCEs) for the same indications, is likely to take only the NCEs to Phase III trials. Why would they make that choice? Both resveratrol and the NCE are aimed at curing "diseases of aging" including diabetes, not making money off selling a lifetime supply of insulin, for example. Partly it's because the NCEs are predicted to be much more potent than resveratrol, but partly because they'll be able to make the money back from the NCE by selling it without competition for several years (until the patent expires and generics come out).

Sorry this is getting a little off-topic, since Phase III trials are not about safety, by definition, but about efficacy. The link above shows summaries of the safety trials, for anyone who doesn't already know about them.