This investor voiced the radical proposal that drugs and devices be tested only for safety—not efficacy. The idea is that, trusting to the wisdom of the market, ineffective drugs would soon be eliminated because they don’t work. A similar opinion was voiced in a question posed to the last FDA Commissioner, Robert Califf, in a December interview in the Washington Post.1
Clearly, an important segment of the American population believes that one should be able to market nearly any pharmacologic agent for any indication, as long as it does not make people fall over dead immediately.
My investigation to determine whether the free market really does eliminate ineffective therapies required very little effort on my part. While at a party recently, an acquaintance complained about the inadequacy of public transportation to the place where she had her back pain treated. It turns out she was going for sessions in which she was treated with cupping, a treatment that includes placing very hot glasses on her back. She said the cupping was the most excruciating thing she had ever had happen to her but that her back pain was much better after each session (a clear example of the “bang your head against a wall” class of therapy). I thought cupping had gone out in the 1840s, but it is alive and well deep in the heart of Queens, N.Y. Laetrile and high colonics are still around, too. So discredited therapies seem to take on a life of their own.
Nonetheless, nobody is suing the practitioners who use these measures because their pockets hold little more than lint. But if Merck or Amgen, to pick a couple of successful pharma companies, were to open cupping centers in storefronts around the country, there might be a little more action in court.
Actually, I think my venture capitalist friend had an ulterior motive. Think how many successful lawsuits there could be against pharmaceutical companies if they could simply market any not-immediately toxic agent for any indication they wanted. Anybody whose condition was not treated or improved could sue for false advertising, because there would be no legitimate expectation of nonresponders. The response rate would not be tallied in licensing studies and validated by the FDA.
Clearly, investment opportunities in class action lawsuits (a well-established market already) would increase dramatically with the hope of ever larger settlements and, therefore, payouts to venture capitalists. Shaking off the regulatory shackles will increase the number of drugs making it to market, although probably only for a little while.
