Posted by Geezer on November 28, 2002, at 21:42:21
In reply to Re: Is there a medical term for AD poop-out? » Jackster, posted by Alan on November 28, 2002, at 13:18:48
> > Thanks for all your replies. It's amazing that given how common this seems to be - there's very little research/information on it out there.
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> That's because of the lack of proper oversight and ground rules of the FDA...a government agency incestuously related to the pharm industries.
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> Take oversight of clinical trials away from the FDA and give it to the NIH. That is, accept as evidence only trials designed and supervised by the NIH.
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> Failing that, ban cross-employment between the FDA and any company that it regulates for 10 or 15 years in either direction. Right now, there is a revolving door between the fox's house and the henhouse. It's bad enough that regulators are hired directly from the regulated companies. It's even worse that the FDA's "internal advocate" for a drug can and often does leave the FDA after approval of the drug to earn hundreds of thousands of dollars a year working for the maker of the drug.
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> Actually, we probably need both of the steps above.
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> And of course we need a law placing all directly or indirectly maker-funded research about a drug into the public domain when that drug receives FDA approval.
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> We need to change our laws so that as part of the price for approval of a drug, ALL studies on its use in humans (at the least) get placed into the public domain. That way it won't be as easy to make distorted claims. For instance, the public and the FDA have seen only a small fraction of SKB/GSK's studies on Paxil. In the majority of them it worked worse than placebo to a statistically significant degree*. At least that's what plaintiffs in one of the class-actions suits alleged, promising to provide supporting evidence. It just shouldn't be legal to hide things like that. And now that scandals like the HRT and cox-2 inhibitor surprises are emerging (i.e. it affects more than just us "head cases") I think there's some chance the regulatory environment may change.
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> On second thought, in the present political environment of deregulation for profit....
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> * Still, that's an average response. It doesn't negate the fact that some people respond and some of those respond extremely well. Statistical truth and statistical inference, important as they are, have considerable limits. The closer you narrow it down to an individual case, the fuzzier the picture gets until there is no statistical picture at all when dealing with a sample of one. Just because the number of people doing well on a drug is less than the number doing well on placebo does not prove that all those people are experiencing a placebo effect or spontaneous remission. Some of them may very well be experiencing a bona fide pharmacologically therapeutic effect. It's just that one can't prove it statistically. With the right tools, one could hypothetically prove it chemically or by doing repeated double-blind crossover trials on one or more individuals.
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> AlanAlan,
I like your idea here - the FDA is about as effective as the INS. I too would like to see some SCIENTIFIC testing and the inclusion of test results from Europe as part of full disclosure (that's where the significant numbers and long term data comes from).
Do you happen to know if SSRIs can regain their AD effect (after poop out) for a patient completing ECT? I have been struggling with Parnate for 3 weeks (it's like taking Thorazine, I can't even talk or walk straight), would love to go back to Prozac.....the best 18 months I ever had.
Thanks,
Geezer
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poster:Geezer
thread:129589
URL: http://www.dr-bob.org/babble/20021127/msgs/129815.html