According to Reuters, President Obama will be naming his choice for FDA Commissioner within “days.” Most sources say that he has narrowed his choices down to the following four candidates: Joshua Sharfstein, head of Baltimore's health department; Robert Califf, cardiologist at Duke University; Cleveland Clinic cardiologist Steve Nissen; and Susan Wood, former head of the FDA's Office of Women's Health. However, the rumor mill seemingly churns hourly--now, according to Drug Wonks, former New York City Health Commissioner Margaret Hamburg is also in the running (Hamburg's name surfaced too late for me to give her a mini-review).
I’m not sure who I would pick. I personally know Dr. Steve Nissen and think he would be an fantastic choice, because he amply understands the challenges and imperfections of the FDA and has clear plans for fixing the agency. And, of course, it doesn’t hurt that he has never been afraid to call out drug companies for hiding inconvenient data about drug side effects. Dr. Nissen, if you’ll recall, was the one who broke the Avandia story . But he is hardly anti-pharmaceuticals. As chair of cardiovascular medicine of the Cleveland Clinic, he has conducted industry-funded research, and he has focused on using intravascular ultrasound (IVUS) imaging for treating coronary atherosclerosis. His disclosures are listed here, but note that he receives no personal income from these relationships, insisting that companies donate all honoraria to charity.
Susan Wood is another great choice. A heroine when it comes to women’s rights, Wood was the FDA’s Director of the Office of Women's Health until 2005, when she resigned on principle over the delay in approving “Plan B,” an emergency over–the–counter contraception (not to be confused with the “abortion pill,” RU-486). She is currently a professor in the School of Public Health at GW University. You can read up on her here and here. As far as I know, she has no financial relationships with any pharmaceutical company, and she is the only candidate who is not an M.D., for better or for worse.
Josh Sharfstein, who is currently head of the Baltimore Health Department, has an interesting psychiatric connection in that his father, Steve Sharfstein, is the former president of the American Psychiatric Association. Steve Sharfstein made a splash by publishing this column in which he urged clearer boundaries between physicians and industry enticements. Josh Sharfstein has an equally strong sense of ethics, and has in the past called Pfizer onto the carpet for improper promotion (he once alerted the New England Journal of Medicine that Pfizer was inviting docs to a “rack ‘em up and toss ‘em down” event including billiards and lots of alcohol). He has also worked on the staff of Representative Henry Waxman, who is now chair of the powerful House Energy and Commerce Committee. Sources tell me that he has no financial relationships with the pharmaceutical industry.
The only truly bizarre entry on Obama’s short list is Dr. Robert Califf, vice chancellor for clinical research and professor in the cardiology department at Duke. I have no problem with his experience and extraordinary academic achievements. And I hesitate to criticize a fellow grad of UCSF Medical School. But c’mon folks, look at these industry disclosures. He took money—lots of money--from 18 different pharmaceutical or device firms. Most of this was not for research, but for consulting and speaking, including CME. If Dr. Califf believes that it is ethical for physicians to help drug companies market their products, that’s his own business. But to elevate him to a position in which he is the country’s chief watchdog over unsafe medications and foods seems a dangerous move. With money from 18 drug companies padding his bank account, he will presumably spend most of his FDA career recusing himself from crucial decisions. Not a good idea.
So, Mr. President, in my opinion you can’t go wrong with Nissen, Wood, or Sharfstein—but please keep Dr. Califf out of the running.