The FDA has been called an arm of the drug industry because of how often it smiles on questionable new drugs and new drug approvals only to issue greater warnings or even withdraw them after the drugs made billions. Remember Vioxx, Baycol, Trovan, Meridia, Seldane, Hismanal and Darvon? They are not around anymore. Why? Remember how popular statins, brand name asthma and psychiatric drugs and GERD drugs were? Once they went off patent, the FDA “discovered” serious side effects and began to list warnings. Sorry about that.
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?)
FDA advisory panels, whose recommendations the FDA usually follows, are supposed to include “patient representatives” to see that the public’s interests are balanced against Big Pharma consultants. So many doctors and researchers now live on 5 and 6 digit drug company stipends, the FDA actually relaxed conflict of interest rules a few years ago–it could not find enough unlinked doctors!
But the “patient representatives” can be a sham. At one meeting I attended, one “patient representative” was a member of the drug industry-funded National Alliance on Mental Illness (NAMI) which was investigated by Congress for its hidden Pharma income and many consider a front group. The other so-called patient representative” had given keynote speeches at NAMI. So much for transparency.
Because of the huge amount of money to be made from a blockbuster drug like Lipitor—it was the best selling drug in the world—there is a natural tension between drug companies who want to hurry the march to Wall $treet and drug regulators who want to slow it down to protect the public.
That is why the nomination of unapologetic drug industry supporter, Robert M. Califf, for FDA Commissioner is so concerning. A disclosure statement on the website of Duke Clinical Research Institute list 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, where Califf directed clinical research, 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.
If approved as FDA Commissioner, as many expect, will Califf recuse himself from decisions on the dozens of drugs whose manufacturers pay him? Or will he rule on them anyway? Either way, his nomination is a slap in the face of every honest doctor, researcher and regulator and the public that puts its trust in the FDA. In fact, if the FDA Commissioner is funded by industry, why have an FDA?