The FDA was founded to protect consumers from bogus medicines and other problem food and drug products. To this day, it defines it’s core mission as one of defending “public health.”
But what if the proverbial fox is left to guard the proverbial henhouse?
The tenure of departing FDA Margaret Hamburg was marked by conflict of interest, particularly with respect to dental mercury amalgam. Her nominated replacement? Oh, just someone reported to be “the ultimate industry insider”: Dr. Robert M. Califf.
He has written scientific papers with pharmaceutical company researchers, and his financial disclosure form last year listed seven drug companies and a device maker that paid him for consulting and six others that partly supported his university salary, including Merck, Novartis and Eli Lilly. A conflict-of-interest section at the end of an article he wrote in the European Heart Journal last year declared financial support from more than 20 companies.
He also has a history of working with pharmaceutical and medical device companies through a company called Faculty Connection.
A promotional video posted by Faculty Connection displays images of Califf and boasts that the firm has “served over 175 different pharma, biotech medical device firms.” The video says the firm helps “faculty who want to work with industry” negotiate with health care industry sponsors, along with providing liability protection and record-keeping services.
Naturally, his close financial ties to Big Pharma are being downplayed by administration officials, even as his ability to impartially promote the stated public health mission of the FDA is questioned loudly and more often.
Recently, we came across a powerful and fascinating read on “institutional corruption” in the realm of Big Pharma, published a couple years ago in the Journal of Law, medicine and Ethics. In light of the Califf controversy, it seems more relevant than ever.
Just as a proper electoral democracy is devoted to the public good, health care systems are founded on the moral principles of benefcence, nonmaleficence (“first, do no harm”), respect for autonomy, and the just distribution of scarce resources. Based on these principles, health care workers are obliged to use the best medical science to relieve suffering and pain, treat illness, and address risks to health. The institutional corruption of health care consists of deviations from these principles.
The major patent-based research pharmaceutical companies also nominally commit themselves to improving health and relieving suffering. For example, Merck promises “to provide innovative, distinctive products that save and improve lives…and to provide investors with a superior rate of return.” Pfizer is dedicated “to applying science and our global resources to improve health and well-being at every stage of life.” Pharmaceutical companies continuously emphasize how deeply society depends on their development of innovative products to improve health. But in fact, these companies are mostly developing drugs that are mostly little better than existing products but have the potential to cause widespread adverse reactions even when appropriately prescribed. This deviation from the principles of health care by institutions allegedly dedicated to health care is institutional corruption. We present evidence that industry has a hidden business model to maximize profits on scores of drugs with clinically minor additional benefits. Physician commitment to better health is compromised as the industry spends billions to create what Lessig calls a “gift economy” of interdependent reciprocation. New research finds that truly innovative new drugs sell themselves in the absence of such gift-economy marketing.
Regulators such as the FDA and the Environmental Protection Agency arise when unregulated competition is perceived to cause serious harm to society and government regulation is needed to address the problem. The FDA was founded to protect the public’s health from the fraudulent cures peddled in the 19th century. Through a series of legislative enactments, often in response to a drug disaster, the pharmaceuti-cal regulatory side of the FDA has acquired ever-wider responsibilities to ensure that new drugs do more good than harm. Institutional corruption consists of distortions of these responsibilities, such as approving drugs that are mostly little better than existing medications, failing to ensure sufcient testing for serious risks, and inadequately guarding the public from harmful side effects. These distortions serve commercial interests well and public health poorly.
Image by Lisa Yarost, via Flickr