Let's try picking the biggest "Whiny Whistleblower" for 2005: the person who most outrageously defied his or her employer, regardless of loyalty, science, or even common sense, by launching attacks from within. Recent battles over pharmaceuticals provide multiple candidates.
It's tempting to nominate last year's hands-down winner, Dr. David Graham of the Food and Drug Administration. Graham has been a thorn in the side of the FDA for years, calling for the withdrawal of twenty or more drugs, sometimes succeeding. He is well known for ignoring the "benefit" side of the risk-benefit equation when it comes to evaluating drugs. Any real or imagined adverse effect is reason enough for this Torquemada-like guardian of public health to issue demands for a recall. He gives little credence to the benefits side of a drug's profile, aiming at the rare side effect. Despite the fact that thousands of patients resistant to other drugs would stand to benefit, he calls for bans.
Graham has made a career out of calling for the banning of drugs, including Accutane, Arava, Meridia, Serevent, and Bextra. All but Bextra, an anti-arthritis drug similar in action to Vioxx, remain on the market. His rationale varies from drug to drug, but the song remains the same: sacrificing the many for the few. It's as if he balanced his bank account by viewing only withdrawals, not deposits.
He continues to rant against "dangerous" drugs at every opportunity. He remains certain that the FDA -- where he continues to work -- is too soft on drug safety, although the agency has dramatically increased the number of "black-box" warnings this year.
Because repeat winners are rare, the other candidates have the edge: so I vote for ex-Pfizer V.P. Dr. Peter Rost, an inept exec but a pretty good whistleblower. He provoked a federal investigation of his own company in 2003, alleging that Pfizer was responsible for the improper marketing of the synthetic growth hormone Genotropin (which had been the property of Pharmacia, taken over by Pfizer in 2002).
Rost's destructive enough to get the prize, you may think. But wait, his whistleblower credentials are even stronger: Rost tried to sabotage his benefactors at Pfizer -- not to mention the best interests of the American public -- by arguing against the company's position that importing cheaper drugs from Canada (among other places) was a bad idea for the consumer in the long run. Rost maintained that the anti-importation position was a ploy by industry to fool the public and keep profits high. His position, of course, was not unique: many politicians and demagogues held the same position, echoed by media advocates of a government takeover of all medical care. He even made it onto 60 Minutes. The fact that such imports would inevitably include counterfeit and even toxic substandard medications, and that importing cheap drugs would also be importing foreign price controls, was not mentioned in his diatribes against Pfizer.
I wondered why in the world his Pfizer employers would tolerate such perfidy and keep him on their payroll. On December 2, I found out: it was then that his attempt to get the Feds to participate in his whistleblower suit came to naught. Pfizer had hesitated to fire him for fear of being accused of interference with an investigation. With the investigation over, Rost was promptly fired.
The qualifications of the man I declare runner-up, Dr. Eric Topol of the Cleveland Clinic, just hit the news. (His candidacy is a bit more nuanced than the others, a decided electoral disadvantage.) He has advocated against the use of Vioxx -- indeed, his campaign against the Merck drug seemed inordinately vitriolic for a scientist.
He testified in the latest lawsuit against Merck, alleging heart damage as a result of Vioxx. Shortly thereafter, he was relieved of his duties as head of the Cleveland Clinic medical school -- not a coincidence, he asserts. However, he has also called for the financial disentanglement of his employers from certain medical devices from which they have profited. So which of these campaigns provoked his demotion, if either? Who knows. It is likely that nothing will stop him from blowing his whistle, though.
As always with whistleblowers, the question arises: why don't these folks resign if they feel so at odds with the policies of their employers? FDA's Dr. Graham particularly needs to be reminded of this option, as he's been in attack-dog mode longer than the others. (He should have been guided by the examples of the principled resignations of two of his FDA colleagues within the past four months over the debacle over FDA's delayed approval of the pregnancy-preventing Plan B drug -- surely on that issue, politics rather than science is driving regulatory decision-making.)
Do the whistleblowers stay in their jobs because, as such types often say, they "feel they can do more good working against the system from within"? Or, more likely, is it simply because they can get away with biting the hand that feeds them and get more attention by staying on the job?
Gilbert Ross, M.D., is Executive and Medical Director of the American Council on Science and Health (ACSH.org, HealthFactsAndFears.com).