[Conductor71]

Well, we all know that the FDA is broken but I had no idea. While this site has a clear bias, the factual history is there. They provide lots of statistics, but a key one is missing. We have all kinds of data on drugs or vaccines or procedures that have harmed for those stories tend to be plastered all over the news, but you never see or hear mortality or morbidity rates for those who quietly suffer or die because the FDA requires proof of efficacy on everything now. Those numbers are never collected and reported.

Prior to amendments in 1962, companies only had to prove drug safety in the new drug app process and new drugs might be approved in little as 7 months. With the added requirement of proving efficacy, we now wait on average 7 years. There is no reciprocity for treatments and drugs already in use with patients. I know it seems 7 months long is hardly long enough to "prove" safety, but if you look at the number of drugs now recalled or proven in long run to be harmful (look at SSDI) to some; including dopamine agonists...how are we any better off, really. We are not better off and in fact may be harmed by this.

I don't know if I agree with their entire solution, I do think that as people who live with a debilitating incurable disease we should have some sort of consent to sign off on any off label treatments or option to try a new drug in Phase III without signing on into trial- I will sign a legal waiver taking responsibility.

Anyway, I leave with your thoughts and a few quotes from economists...

okay first the site FDA Review

“The tragedy is that these regulations are not necessary. The FDA may have some expertise when it comes to drug safety and efficacy, but on the only issue that matters—your trade-offs between various risks—you are the expert, and the FDA’s scientists are rank amateurs.” (Henderson 2002, 277)

"The carnage from this regulation, I regret to assure you, will continue for a long time . . . the deaths of which I speak are counterfactual deaths, not deaths that can be directly connected to any regulatory malfeasance . . . the actual victims of the regulation did not swallow a bad FDA-approved pill. They merely failed to swallow a good one in time and never knew what they had missed.” (Peltzman 2005, 15–6)



While European officials require drugs to be proven effective relative to existing therapies, “the FDA more often uses a placebo comparator, except where placebo would imply unethical treatment of patients” (9). Sobel concludes that, due to the existence of a real placebo effect in clinical trials: “the FDA definition of effectiveness as ‘effective beyond a placebo’ is an improper policy that is detrimental to public health. The effectiveness standards deny consumers the benefit of a proven placebo treatment that would improve their condition, even when this may be the only, or at least the safest treatment available” (Sobel 2002, 478).

[krugen68]

I don't know if I agree with their entire solution, I do think that as people who live with a debilitating incurable disease we should have some sort of consent to sign off on any off label treatments or option to try a new drug in Phase III without signing on into trial- I will sign a legal waiver taking responsibility.

......there is little concern for those affected, only a rigid adherence to rules to 'protect' those that most need the new drugs. An inverted logic.
Peter

[lurkingforacure]

I don't know all the rules about this but we were told by a doc we consult with via telephone, in another state no less, that there is considerable leeway in treatment....more specifically, a doc can treat you off-label, for lack of a better way to describe it, if both of you are working towards a common goal (uh, that would be to feel better, how hard is that?) and the plan is set out and understood by all. Seems reasonable to me. Of course, that assumes that what you might want to try is available and legal, of course, if you are wanting to get something not yet available, something that is either in trials or not even on the table in this country, that's another issue.

I was very happy to hear this and was not aware of the possibilities before he explained it to us. Naturally, though, there are a LOT of doctors who won't try anything that's not absolutely mainstream, unfortunately.