Biotech Values

[poorgradstudent]

gofish:

>There is a greater-good principle involved , IMO , that says it's OK to have an approval process that allows one ineffective drug to be used for a few years before it's recalled , if that same process results in 5 , 10 , or 20 drugs that do provide benefit to get on the market for the extra few years required to conclusively demonstrate that benefit.<

Certainly I have no hard statistics for this, but I think your scenario of one ineffective drug amidst 5, 10 or 20 that provide a benefit would prove a little optimistic. In fact, I think the statistic is most likely the oppposite. With all the companies and drugs reported on here, my strong impression is that lowering the bar would put 20 stinkers on the market for every effective drug. There are plenty more ineffective drugs than effective ones.


Also, I agree there is a further good involved. And to get a physician's perspective on that, I do think many would benefit from attending a grand rounds talk or two at the local academic center to see how docs vet clinical data. Although we routinely express here that a patient with disease X has no options, docs aren't putting leeches on every patients; they do, in fact, have treatment strategies. And they demand strong proof to abandon their treatment strategies, because they know the efficacy that they can expect from their established regimens.

I attend the oncology grand rounds, and there have been multiple presentations by fellows of treatment strategies from small populations that increase survival. Mostly different scheduling of drugs and novel scheduling of two established drugs into a combination strategy. But these data get vetted by the clinicians because the most frequent comment ends up being "yeah, but this sounds like treatment X from 5 years ago that subsequently failed in a larger trial." In the face of that kind of repeating scenario, docs are reluctant to experiment on their patients by abandoning their effective treatment strategies for the latest small trial that showed a benefit.

So from the two talks I've attended here where dndn was discussed, this is at the heart of the matter. One doc asked if his patients are going to respond as in 9901, or as in 9902A because for the latter he wouldn't adjust his treatment strategy for patients. His is the question that neither the sponsor or the FDA can reliably answer.