His lawsuits on behalf of the powerless to prevent predation by spammers, the insurance industry, the pharmaceutical industry, the tobacco industry, the consumer lending industry (+) and efforts to protect the environment and investors (+) are proof that you can make a difference within the system—even in a state as politically hide-bound as New York.
However, Spitzer’s latest adventure with the pharmaceutical industry, as well-intentioned as it is, will worsen the problem he is intending to correct. Spitzer wants to address the quasi-unethical practice by pharma, in which a company pays for studies of the effects of it’s drugs, but releases the results only from the studies that fovor the company.
He has initiated a lawsuit against the international pharmaceutical giant GlaxoSmithKline. The company, in what is a very common practice in the industry, had chosen not to release the results of a study of Paxil’s effects on children. Spitzer’s suit claims that by not releasing ALL available study data on a drug, consumers are harmed. In this case, the drug was actively prescribed to children, even though test results collectively (and this particular study) do not show that they derive any benefit from it, or that it is safe. However, it is not unreasonable for doctors to have concluded that it was safe, since another similar drug from a competitor—Prozac—had conducted tests and received approval for children.
While Spitzer’s consumer-protectionist heart is in the right place, he stands to create a bigger problem than he is out to solve. (Full disclosure here: I formerly worked for a firm that specialized in consulting for the pharmaceutical industry.) This is because it assumes that all clinical studies are equal in validity.
The pharmaceutical companies pay for these studies because they are required to show safety and efficacy by the Food and Drug Administration (FDA), who holds approval over whether the drugs can be marketed, and how. The FDA makes best efforts to look at the studies, and then to determine: if they are scientifically valid, if the benefits are as presented, which patient group actually benefits (if any), whether there are safety issues, and so on. The FDA can explicitly exclude companies from marketing a drug for a particular use, or to a particular age group. But there is such a thing as off-label use, which can be fed by word-of-mouth understanding of a drug’s effect that hasn’t formally been addressed by the FDA. Once a drug is perceived as safe for one use, doctors feel more comfortable prescribing for other uses, if there appears to be data to support that use.
The companies will naturally try to present all the scientific evidence in the most favorable light, or in a way that will not lead to the outright exclusion of certain markets. So what will happen if you require them to release all of the studies they conduct? They will have a strong incentive to produce studies that won’t really tell you much one way or the other, and to bury everyone with data. The resulting confusion will mean that there will be ten studies to sift through, without any outside measure of which ones are scientifically sound. The noise will produce a huge consumer pressure on doctors to continue to prescribe for off-label uses, based upon “results” that have no sound backing.
In the meantime, the FDA will slow to an even slower crawl than it is operating at currently, stalling truly innovative cures from coming to market.
I realize that pharma is this year’s tobacco as the big villain, and therefore, would be a politically popular target, but if Spitzer continues to pursue this course, it’s going to be bad medicine.
(Full Disclosure: I spent several years working for a consulting firm that exclusively serviced clients from the pharmaceutical industry.)
