A doctor who once denounced Pfizer for holding a marketing event in a pool hall is leading President-elect Barack Obama's team formally assessing the troubled FDA, boosting his chances of becoming the next FDA commissioner, according toThe Wall Street Journal.
Joshua Sharfstein, now head of the Baltimore Health Department, has tangled with the pharmaceutical industry on several occasions and would likely lead the agency to get tougher on drugs, the paper writes, adding that drugmakers might just benefit from his strong support of childhood vaccinations. Just the same, several other candidates are in the running, and no decision appears imminent.
Sharfstein, 39 years old, is a former staffer for Henry Waxman, the California Democrat who recently won the chairmanship of the House Energy & Commerce Committee. He visited the FDA several times in recent weeks and discussed controversies involving the agency, according to the Journal, citing unnamed sources. He declined to comment on any current or future involvement with the FDA.
The commissioner's jobs may prove among the most hard-fought of the new administration, with members of Congress from both parties promoting their candidates in letters and talks with the transition team, the Journal tells us. Pharma's lobby donated about $10 million to Democrats this election, breaking a heavily pro-Republican giving pattern.
Drugmakers, by the way, worry about two contenders for the top job whose crusading has affected FDA policy and corporate bottom lines. And one is Sharfstein, who successfully pushed the FDA last year to block drug makers from selling over-the-counter cough and cold meds to small children (back story).
The other is Steve Nissen, the 60-year-old head of cardiovascular medicine at the Cleveland Clinic. His questions about the safety of two popular drugs, the Avandia diabetes pill and the Vytorin cholesterol pill, have given him a platform to criticize the agency.
People close to the industry have been floating the names of other candidates to run the FDA - including Janet Woodcock, a senior official at the agency - who are seen as less likely to carry out a thorough overhaul, although some Democratic aides have suggested Woodcock as a possible interim chief while a permanent leader is vetted (back story).
As a resident at Harvard University in 1997, Sharfstein wrote the New England Journal of Medicine to complain that Pfizer was offering free alcohol and billiards games to doctors in Boston while promoting its products. The drugmaker's ad for the event urged docs to "rack 'em up and toss 'em down." (Rack 'em up referred to the billiards, while toss 'em was, yes, the drinks).
"For aggressive drug-company representatives, such inappropriate promotions may be just a way of doing business. But for doctors, they violate a basic principle: that we are advocates for our patients and not on the make for ourselves," he wrote. "At a time when physicians are searching for authority and respect in a new health care system, accepting improper gifts from pharmaceutical companies seems particularly unwise."
Pfizer responded to the NEJM that its slide presentations at the pool hall "provided useful medical information to attendees," but conceded that it "created a poor impression" (see the letter; subscription may be required).
As a Waxman staffer, Sharfstein helped get a bill passed amid a Republican majority that reversed an FDA decision allowing the makers of colored contact lenses to classify them as "cosmetics." A number of people suffered blindness after wearing the lenses. The bill reclassified them as medical devices.
Nissen outlined in a speech this week specific changes he wants at the FDA. He said the agency should more often require companies to prove their drugs save lives, rather than merely show they achieve some presumed beneficial goal (see here). "The ultimate purpose of that drug should be to prolong life. So, isn't that what we should be measuring?" he said.
Nissen also said too many drugs are put on a fast track for FDA approval as ostensible life savers, even though they aren't that important. He has called for complete transparency in FDA interactions with industry and criticized it for sometimes delaying public disclosures of potential dangers based on corporate claims that "proprietary information" is at stake.
However, Nissen has also suggested giving early limited-term approval for truly life-saving and innovative drugs, an idea industry supports.
Source: The Wall Street Journal