I should mention that Science is publishing some letters that it received in response to Andy Grove's proposal to rework the clinical trial system for drug development.
Sidney Wolfe and Michael Carome of Public Citizen aren't too happy with the idea, as you might expect. Their take, as I would reword it, could be summarized as "Hey, the existing system allows the drug industry to spew unsafe crap all over the market, and this would make it even worse". Actually, the language in their letter isn't far off:
A. Grove proposes returning to the era before the enactment of the 1938 Federal Food, Drug, and Cosmetic Act, when new drugs were marketed in the United States without evidence that they were safe or effective. His irrational and dangerous proposal, which would limit the Food and Drug Administration's (FDA) premarket review of new drugs to phase 1 clinical trials, is premised on the fundamental misunderstanding that such trials can provide proof of a drug's safety and on the misguided belief that it is not necessary to establish proof of efficacy. . .
Grove's proposal would subject patients on a massive scale to haphazard, uncontrolled, poorly regulated experimentation involving drugs with unknown safety and effectiveness. Such a flawed proposal does not deserve serious consideration.
Norman Marcus of the Virginia Cartilage Institute is more even-tempered, and his view is closer to my own blog post:
. . .Grove's proposed system needs some fine-tuning.
Grove correctly leaves the safety issues to the FDA, but he does not address dosage issues, which should also be determined before distribution. He does not explore how virtual clinical research organizations of the future would monitor issues of compliance and establish fair methods of measuring response. Replacing the heralded phase 3 trial with a self-administered trial would indeed save money and introduce the product much sooner to at least part of the potential market, but pharmaceutical companies would need some shielding of liability to protect them from the increased risks inherent in this plan. Because patients and third-party payers would undoubtedly see the new drugs as experimental, the pharmaceutical companies should be required to offer them at nominal cost.
That said, experimenting (carefully) is exactly what we should be doing. . .
Finally, David Borhani and J. Adam Butts (of DE Shaw Research) go right to what I've named the Andy Grove Fallacy:
. . .Compared to the semiconductor industry's gains over the past 50 years, the pharmaceutical industry's productivity must seem disappointing. There exists, however, an important distinction between engineering integrated circuits and discovering drugs. The semiconductor industry's realization of Moore's Law has always benefited from a fundamental understanding of solid-state physics. Conversely, we still don't know how living organisms work; new “components,” as well as interactions between well-known components, are discovered daily. . .This ignorance is the real reason why 90% of drug candidates fail in clinical trials: They simply don't work. The trial process is doing just what we ask of it.
None of these are unexpected reactions, and I'm sure that Grove himself has heard them before (and anticipated these). So where does this leave us? Status quo ante, with everyone having stated their positions?