The FDA has posted a policy draft: “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.” A better name would be: “Let’s Give Away the Shop to Industry and Encourage Bad Medical Practice.”
Here's the essence of the FDA’s reasoning:
FDA…recognize[s] the important public policy reasons for allowing manufacturers to disseminate truthful and non-misleading medical journal articles and medical or scientific reference publications on unapproved uses of approved drugs and approved or cleared medical devices to healthcare professionals and healthcare entities…These off-label uses or treatment regimens may be important and may even constitute a medically recognized standard of care. Accordingly, the public health may be advanced by healthcare professionals' receipt of medical journal articles and medical or scientific reference publications on unapproved or new uses of approved or cleared medical products that are truthful and not misleading.
This proposal to abdicate responsibility for public health didn’t fool Henry Waxman, the ever-vigilant chair of the House Committee on Oversight and Government Reform, Waxman's letter to the FDA is worth reading. Here is his conclusion:
I recognize this area of the law is complex and that FDA needs to respect the First Amendment rights of drug and device companies to communicate truthful and non-misleading information to doctors and patients. But the draft guidance…would open the door to abusive marketing practices that will jeopardize safety, undermine public health, and lead to an increase in unapproved uses of powerful drugs.
The danger to patient health should be readily apparent from the examples of journal article abuses…including anti-depressants, Vioxx, Celebrex, antiarrhythmics, Neurontin, and other False Claims Act settlements. Drug and device companies can manipulate and selectively distribute studies in order to make their products appear safer and more effective than they truly are. Where the unapproved uses are actually ineffective, patients have been denied other, more effective treatments and have been unnecessarily exposed to the ineffective products’ known side effects. Even worse, patients have suffered serious harm due to unanticipated and serious side effects of unapproved uses.
This story demonstrates how the big bucks to be made in pharmaceuticals can foster ethical degradation in major health institutions. The FDA panders to marketing. Journals publish skewed studies. Respected clinicians become industry shills.
The ethical quality of our health care system depends on checks and balances. An entrepreneurial pharmaceutical industry is a public good. But entrepreneurialism, like a rifle, has to be aimed correctly. Breakthrough drugs that meet real health needs and create mega-profits should be celebrated. Me-too drugs and spurious promotion of off-label uses should be fought against, as Representative Waxman's committee is doing.
I don't think the people in the pharmaceutical industry are any worse than those who deliver health care. We are all influenced by our environments and the incentives we encounter. What we are seeing in stories like this one is what will happen if we squander the crucial checks and balances process.
[On this topic, see also the excellent blog postings by Merrill Goozner and John Grohol. And, for a recent example of how the journal process has been corrupted, the Carlat Psychiatry Blog.]