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
22 Comments
Can't they get any pharmacy-type folks in the running?
FDA Wants To Reduce The Quality of Life Again. I have severe asthma and two of the medicine the FDA wants to ban is on the list. I am asking that anyone that has or has known someone with a lung disorder please contact the FDA and let them know that all Americans with any disorder or disease be allowed to continue living life best they can with the current medicines available and not to ban them. Banning even one of the medicines I take can reduce my daily life by as much as 50%
http://www.fda.gov/comments.html
Sierra,.. You appear to be an adult, so dont worry, you'll get your drugs!!
Ed,
OMG,..Doesnt he look like a brunnette Marcus?...
Sharfstein has been my own first choice for Commish, so I hope the WSJ has it right. His record is superb. He will be tough but fair. He is probably the only candidate who does not come with toxic baggage (of whatever kind). I believe it is the best chance we have for a new era that will be good for the FDA, for the industry, and for all of us.
I'm loving this choice!
Any nomination Obama might consider is a tough choice between an FDA insider with baggage to overcome or an outsider with credibility to earn. It’s virtually impossible to imagine a selection that would avoid both.
For those of you who do not yet know Josh Sharfstein, spend a few minutes on him.
When there are so many problems with FDA, do we really want to take a chance on a guy with so little experience? Aren't there a ton more people who have actually done things with their careers other than nuzzled up next to Waxman?
Joshua Sharfstein is the WRONG person for the job of FDA Commissioner, at least according to the results of an ongoing survey of consumers, healthcare professionals, government agency staffers, and drug industry executives.
With over 400 votes cast so far, Joshua Sharfstein is in 7th place in a field of 10 contenders.
Who's in first place?
Steve Nissen AND Peter Rost -- the latter being a former Pfizer whistleblower (who is also supported by 2 members of Congress).
I invite everyone to take the survey and vote for your choice here: http://tinyurl.com/634r47
Your response is anonymous unless you provide contact information for attribution. You can also write in your own choice.
Results of this survey will be published in the next issue of Pharma Marketing News.
Tell the drug industry who should be the next FDA Commish.
Vote for your choice here: http://tinyurl.com/634r47
Come on, John. Sharfstein is the WRONG person based on your survey of ... the limited cohort of individuals that visit your site? Do you actually believe this limited group reflects the true need of FDA and the US healthcare system? Do you sincerely believe that Peter Rost (a former pharma VP of marketing, whistleblower, and author of a few books) is better qualified?
Luckily, blog polls don't select FDA Commissioners.
Justice...they could be selecting the same way as Illinois does and John Mack's blog won out to select the next commish.... :D
Good point, CA. Could be that outfit in Alaska got involved that FDA "chose" to self-promo itself.
You betcha.
Wow - tough crowd. Are John Mack's readers any less qualified to voice an opinion on the FDA commissioner than Ed's are on preemption, regulation of pysch drugs, academic disclosure and the rest? Maybe - but it's a blog guys, not the Supreme Court.
Obviously, everyone is entitled to voice an opinion. (I don't think "qualification" is relelvant to that point.) Pharmalot doesn't choose the FDA Commish either. (Nor is it a pure blog - more in the category of the WSJ blog; newspaper first.)
Anyway, it's annointing one's blog poll as determinative of the right or wrong choice that's, to me, a little bizarre.
For a look at some of where Josh Sharfstein may be coming from, see these remarks of his father, former Prez of the APA. (Not that sons echo fathers, but lines of conviction are not uncommmon.)
http://pn.psychiatryonline.org/cgi/content/full/41/12/1-a
Hello JiM, of course they are entitled to voice an opinion: that's my point. I think John Mack's was less to state that his poll is definitive than it was to promote his own site.
Agree, Christopher. It was, indeed, a good marketing tactic - a provocative hook (mimicking a pronouncement from on high) and then on the promoting Pharma Marketing News.
I auppose the hook was so successful, I got hooked! Well done, John!
Nice idea, but how about someone who has had some experience in managing/leading an organization bigger than Baltimore's health dept. FDA is almost bigger than Alaska and deals with a lot of issues--many international--including food. Holding Pharma's feet to the fire should not be the main qualification. How about scientific knowlege?
This is one of the worst choice possible. FDA needs a reformers with a proven track rather than someone who is another David Kessler. Josh Sharfstein will only use this job as a stepping stone.
I would also like to bring to your attention potential conflicts related to Dr. Nissen, the chair of cardiology at the supercharged entrepreneurial cleveland clinic. He is typically portrayed in the media as a vigorous patient safety enthusiast. His notoriety includes being a “champion” of safety concerns surrounding Vioxx. I believe there is a potential subtext for the active role Nissen (and his predescesor, topol) played in illuminating the safety issues surrounding Vioxx (and for avandia).
The Cleveland Clinic has become a critical site for major clinical trials for Pfizer and an active “academic detailing” for the virtues of the Pfizer blockbuster drugs (Celebrex, Lipitor, Norvasc, and the upcoming Torcetrapib). I also believe they do work for takeda the manufacturer of a avandia competitor. It is also conceivable that the Nissen/Topol campaign to discredit Vioxx was in part motivated by the strong relationships between the Cardiology department and Pfizer and designed to promote the alternative use of Celebrex. I think their campaign perhaps to please Pfizer by diminishing sales of vioxx backfired because of the safety concerns that now surround the whole class of drugs including celebrex. None the less, Nissen’s complex relationships with industry may be rife with conflicts of interest and a developing fact pattern suggests he may be substantially biased by his active participation in the Pfizer promotion machine It is noteworthy that to the best of my knowledge he has not criticized a Pfizer drug and is often quoted extolling the virtues of Pfizer products. To his credit he has been critical of Merck, J and J, and BMS compounds that have concerning safety profiles. Some have argued that his concerns were voiced after the knowledge was already public and may have been part of a tactic to bolster his own credibility. Some key examples: Nissen was the Principle Investigator (PI) for the major Pfizer funded Lipitor trial REVERSAL. This trial is a critical part of Pfizer’s strategy to convince FDA that intermediate endpoints like intravascular ultrasound (IVUS) findings should be accepted by FDA in lieu of hard endpoints like mortality. IVUS is an essential component of Pfizer’s plan to accelerate approval of their pipeline of new HDL increasing drugs. Nissen active role in Pfizer funded research, his advisory board appointment at FDA, and his availability to the press has served Pfizer and his career handsomely.
Nissen was also the PI for the Pfizer funded CAMELOT Norvasc study. Nissen is the PI for the Pfizer funded Torcetrapib trial that will be a critical piece of evidence for the fda new drug application. This drug was pivotal to Pfizer’s financial future and already generated controversy for Pfizer’s decision to bundle it with Lipitor - we all know it crashed a burned. Nissen is the PI for the new 100 million dollar Pfizer Celebrex trial. The trial is a public relations prize for Pfizer. It is designed to bolster sales while the results will be unavailable for years. Nissen is an active participant is Pfizer funded national “educational program” for physicians including free continuing medical education programs. These programs include the National Lipid Education Council (www.lipidhealth.org) and the Emerging Science of Lipid Management (www.eslm.org). These highly funded programs promote aggressive use of statins (Pfizer’s Lipitor being the most highly prescribed one). Nissen does state that he does not receive industry speaking or consulting fees but this is merely a token gesture. My questions are: How do researchers like Nissen at the Cleveland clinic benefit from running major clinical trials? Clearly prestige, promotion, but does the clinic factor the trial dollars into bonuses, promotions, profit sharing, raises etc. Medical groups have powerful reward structures for bringing in revenue especially highly profitable enterprises like industry funded clinical trials. The travel and expenses perks alone are extraordinary for industry funded trials. Do these potential conflicts compromise the design, analysis, and conclusions of these studies?
What kind of revenue is the Cleveland clinic cardiology practice generating by popularizing IVUS and how does Nissen and Topol benefit from this personally. Does the clinic have any financial interests in the technology? Are Dr. Nissens financial relationships with Pfizer substantial enough to question his role in fda proceedings?
Does Dr. Nissen participate in major pharmaceutical company funded educational programs other than Pfizer? If not does lend support to the theory that he is for practical purposes a member of the Pfizer sales team.
FDA deserves and desperately needs a reformer without the baggage that Dr. Nissen has.
If you are interested in the final results of my poll here's my take-away and a link to the full text summary of results (thanks to those of you who participated and gave me your opinion):
My takeaway: "Pharma Industry Out of Touch with Their Customers When It Comes to Who They Favor for FDA Commissioner"
FDA critics like Steve Nissen and Peter Rost are the candidates of choice in the Pharma Marketing News survey that asked respondents to vote on who they think should be nominated as the next FDA Commissioner.
The survey included representatives from various stakeholders, including executives and staffers working within the pharmaceutical industry, agents and vendors to the industry, healthcare professionals, members of the general public, and staffers within government health agencies.
It is particularly interesting that former FDA Commissioner David Kessler is almost as popular as Janet Woodcock among pharmaceutical industry respondents.
Perhaps it is not surprising that the drug industry favors these “insiders” and not “change agent” outsiders like Nissen, Rost, or Susan Wood, who are favored by pharma's customers: the general public and healthcare professionals.
It’s just another indication that the industry may not be ready for changes that their customers want to see.
You can get the complete results of the survey here: http://tinyurl.com/43o6o2
For all the people who say you need EXTENSIVE scientific experience, managagement experience, industry experience, FDA experience, Washington political experience.
I disagree. The next commissioneer needs a mandate to clean up FDA and the savvy to be able to do it. Everything else he/she can have advisors for and will. It's getting those good advisors.
As an insider it's clear it's clear to me that Von Eschenbach was very successful at what his job truly is. Yet he didn't have most of those qualifications.
It's the mandate and having someone with the ability to clean things up that's important.
Salmon