Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design
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Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design
#2A family member of mine has tried to participate in a clinical trial. The trial also forces him to forgo any existing medication, basically making his illness intolerable. There is no indication in the trial if he is being served with real medication or a placebo, but his life has been extremely affected just by participation. Naturally he quit the trial. How would this statistical analysis address these common behaviors where ill people would just not participate in trials when certain illnesses are involved?
Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design
#3A good summary and commentary here
http://www.marginalrevolution.com/marginalrevolution/2015/08...
Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design
#4Also: http://fdareview.org/
"Medical drugs and devices cannot be marketed in the United States unless the U. S. Food and Drug Administration (FDA) grants specific approval. We argue that FDA control over drugs and devices has large and often overlooked costs that almost certainly exceed the benefits. We believe that FDA regulation of the medical industry has suppressed and delayed new drugs and devices, and has increased costs, with a net result of more morbidity and mortality. A large body of academic research has investigated the FDA and with unusual consensus has reached the same conclusion. Drawing on this body of research, we evaluate the costs and benefits of FDA policy. We also present a detailed history of the FDA, a review of the major plans for FDA reform, a glossary of terms, a collection of quotes from economists who have studied the FDA, and a reference section with many webbed links. A more detailed table of contents follows. We are happy to receive comments and criticisms."
Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design
#5Also: http://fdareview.org/ "Medical drugs and devices cannot be marketed in the United States unless the U. S. Food and Drug Administration (FDA) grants specific approval. We argue that FDA control over drugs and devices has large and often overlooked costs that almost certainly exceed the benefits. We believe that FDA regulation of the medical industry has suppressed and delayed new drugs and devices, and has incre…
Yes, and bureaucracy never petitions for less bureaucracy. Only more. And we see this in multiple areas, and not just the FDA.
FDA bureaucracy equals more people dying because of slowness.
FCC bureaucracy equals regressive rules on radio transmitters and receivers, contrary to what the people in the field actually use/do.
FAA bureaucracy leads to idiotic laws on quadcopters/drones/personal UAVS that affect the landscape of the technology to the point where uploading a video to youtube is "against the law".
Patent law/USPTO bureaucracy leads to inane patents like XOR patent, "Slide to Unlock", fillet and round design patents (patent a 1/4 circle), One-click, and other patents that are glaringly obvious to anyone in the field. Yet, these enact heavy transaction fees; that is if the companies play along.
Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design
#6I've been on the science side of a number of FDA clinical trials for a few years now.
The FDA is too conservative with many metrics, and too aggressive with others. The clinical trial pipeline is tortuously slow for everyone involved-- the EU equivalent agency has done a lot to accelerate the process fruitfully. Eclipsing these FDA malregulations is the problem of transparency; if the FDA forced clinical trials to publish 100% of their data rather than only the positive results, we'd have a better medicine producing industry.
Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design
#7Also: http://fdareview.org/ "Medical drugs and devices cannot be marketed in the United States unless the U. S. Food and Drug Administration (FDA) grants specific approval. We argue that FDA control over drugs and devices has large and often overlooked costs that almost certainly exceed the benefits. We believe that FDA regulation of the medical industry has suppressed and delayed new drugs and devices, and has incre…
I'm wary of relying on economists to assess the utility of the FDA. The alternative to the FDA they mention is basically self-policing. Except we already have a drug-like industry that relies entirely on self-policing: the "health supplements" industry, which the FDA is explicitly banned by legislation from regulating. And the precedent of the health supplements industry is extremely disconcerting--companies are basically legally lying through their teeth (it's not illegal if someone else, e.g., Dr. Oz, says it, cause they aren't advertising, they're exercising free speech), and they sometimes don't even bother to stuff their products with what they say the active ingredient is.
The problem with drugs is the placebo effect. Evidencing efficacy beyond the placebo effect requires large, controlled trials (the infamous Phase III clinical trial) that end up being correspondingly expensive; nothing less is sufficiently powerful. Because of placebos, you can sell expensive nothings, and it will appear to work sufficiently well that reputation wouldn't suffer.
Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design
#8So the FDA is too conservative for life-threatening conditions, and not conservative enough for relatively mild conditions. That probably fits pretty well with most people's intuitive sense of things; it's interesting to see the math works out that way.
Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design
#9My small sample size of experience with the FDA: they seem to be very receptive to novel therapies for terminal illness and it's surprisingly straight-forward to get a Phase I trial approved.
There's no static rule uniformly enforcing the initiation of trials, rather your IND (investigational new drug) application is reviewed by experts in the relevant field to determine whether (1) is there a plausible reason to believe your new therapy helps and (2) is it unlikely to kill or severely injure patients.
I can't think of a better way for things to work for late-stage cancer or other untreatable terminal illnesses.
Re: Is the FDA Too Conservative or Too Aggressive? Analysis of Clinical Trial Design
#10TriCorder X-Prize? FDA has done nothing but hobbled it's development. DNA screening for the masses? FDA shut down 23andMe. Terminally ill and willing to try an experimental drug? FDA says, "too bad" (and the Supreme Court agrees).