The nomination of drug industry-funded Robert M. Califf for FDA Commissioner is a slap in the face of every honest doctor, researcher and regulator and the public that puts its trust in the FDA. It makes a mockery of concerns about conflicts of interest, transparency and industry firewalls and the regulatory process itself. Senators Bernie Sanders and Elizabeth Warren objected to the Pharma darling in hearings this week but few doubt the nomination will sail through.
A disclosure statement on the website of the Duke Clinical Research Institute which Califf has directed lists 25 drug companies Califf receives research funds from including drug giants like Johnson & Johnson, Lilly, Merck, Schering Plough and GSK.
Califf has gone on record that collaboration between industry and regulators is a good thing. He told NPR, "Many of us consult with the pharmaceutical industry, which I think is a very good thing. They need ideas and then the decision about what they do is really up to the person who is funding the study." What?
He is known for defending Vioxx which is reported to have caused at least 50,000 heart attacks and events before its withdrawal. (Merck is said to have known about Vioxx' cardio effects but marketed the blockbuster drug anyway.)
Califf was instrumental in the Duke drug trial of the blood thinner Xarelto and a cheerleader of the drug despite medical experts' objections to its approval and 379 subsequent deaths. Duke itself is still recovering from a major research fraud scandal that resulted in terminated grants, retracted papers and a Sixty Minutes special. It is the least appropriate place from which to choose an FDA Commissioner.
The FDA already is the drug industry's handmaiden, smiling on questionable new drugs and new drug approvals only to issue warnings or withdraw them after billions were made. Remember Vioxx, Baycol, Trovan, Meridia, Seldane, Hismanal and Darvon? They are not around anymore. Why? Remember the popularity of statins, brand name asthma and psychiatric drugs and GERD drugs? Once they went off patent, the FDA "discovered" serious side effects and began to list warnings. Sorry about that. Under Califf, the Wall Street toadying at the price of public health will get worse--if that is possible.
There is a stereotype of backwoods courtroom "justice" in which prosecutors and defense attorneys who appeared to be adversarial leave arm in arm and go for a beer after a judicial decision. No hard feelings. The same collegiality oozes at FDA hearings with FDA staffers seeming to suck up to industry, perhaps for jobs in which they return to squeeze their prior colleagues. (Who remembers former Texas Governor Rick Perry's chief of staff leaning on Perry to vaccinate all the state's girls with the Merck vaccine Gardasil after he left for industry?)