June 06, 2007
Avandia Hearing Bust
There wasn't much new at today's House Government Reform Committee hearing on the heart attack risk associated with GlaxoSmithKline's diabetes drug, Avandia. Dr. John Buse, the incoming head of the American Diabetes Association, revealed another effort by company officials to shut him up -- this time in 1999 -- when he began raising questions about heart attack risk. It took him another two years to take those charges to the Food and Drug Administration, which did nothing.
If anything, the forum gave Republican critics a chance to launch personal attacks on Steve Nissen of the Cleveland Clinic and the New England Journal of Medicine, where last month a meta-analysis exposing those higher risks finally came to light.
The attacks began last week with Scott Gottlieb's op-ed in the Wall Street Journal attacking NEJM for politicizing the issue, and continued today with a guilt-by-association attack on Nissen's alleged conflicts of interest in the Washington Times by Peter Pitts and Robert Goldberg, who call their inappropriately named organization the Center for Medicine in the Public Interest.
The trumped up charges aired today included allegations that Nissen sought to politicize the issue by going straight to Capitol Hill without bringing his information first to the FDA. As Nissen responded at the hearing, the FDA by law is not allowed to share the clinical trial data that the company had given the agency. This is something he would know first hand since he serves on numerous FDA advisory committees.
Nissen had also tried to get source data from Glaxo for the clinical trials that had been posted on its website. When those talks went nowhere, Nissen said today, he went to Rep. Henry Waxman's committee for help, a logical place since he was already talking to Waxman about FDA reform issues.
What is the reform that Nissen is pushing? Complete transparency of clinical trial data, from the earliest pre-approval trials to all trials conducted after a drug hits the market. The Avandia case is just the latest in a long line of examples (Vioxx, anti-depressants in children) showing why this change is badly needed.
As for the ad hominem attacks, Pitts and Goldberg said Nissen had his own conflicts of interest because his boss at the Cleveland Clinic, an interventionist cardiologist who has been raked across the coals for his inappropriate investments in companies whose devices he's testing, is also a limited partner in a firm that Nissen is doing drug studies for. They also claimed Nissen has a conflict of interest because one company he consulted for donated the money he would have otherwise earned to the American College of Cardiology, which Nissen later headed, for employee gym memberships.
This would be a serious charge if it were for Nissen's gym membership. And, frankly, I have never felt comfortable with the "I give it all to charity" dodge. It's especially dicey if you're naming the charity. Memo to Nissen: Give it all up, or at the least, let the donor name the charity.
But, that said, even I, whose day job involves policing conflicts of interest, would never accuse flacks like Pitts and Goldberg of being on the take if they decide to give all the money they receive from Big Pharma (I'm just guessing here) to charity.
You see, I have to guess. When Nissen writes an article for NEJM or another journal, he discloses the names of the companies from which he received money before donating it to charity. Here's the disclosure from his article on Avandia:
Dr. Nissen reports receiving research support to perform clinical trials through the Cleveland Clinic Cardiovascular Coordinating Center from Pfizer, AstraZeneca, Daiichi Sankyo, Roche, Takeda, Sanofi-Aventis, and Eli Lilly. Dr. Nissen consults for many pharmaceutical companies but requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction.
On the other hand, I noticed that the Washington Times piece had no conflict of interest disclosure. What about it guys? Do you want to let my readers know who funds the so-called Center for Medicine in the Public Interest?
Posted by gooznews at June 6, 2007 05:29 PMMerrill,
I think it's important to put the personal attacks by Gottlieb, Pitts, and Goldberg in historical context. When the West German pediatrician Widukind Lenz described the association between thalidomide and birth defects, the drug's manufacturer accused him of everything from being a Nazi to being insane. So these tactics are nothing new.
It is rather amusing to see the hysteria exhibited by these individuals over Nissen's article; their basic position is that Nissen has no right to publish a scientific article on drug safety, which is ironic given their lack of scientific credentials (despite Goldberg's description of himself as a "medical researcher," and the frequent references to him as "Dr. Bob", he has no medical or scientific training - his Ph.D. is in political science; Gottlieb was revealed by the Seattle Times to have inflated his clinical credentials and at the time of his appointment to a senior FDA position, had no substantive experience in clinical trials, drug regulationstatistics, molecular biology, or clinical pharmacology; and Pitts, of course, has his primary expertise in PR.)
For Gottlieb's ties to the pharmaceutical industry, and to a public relations firm that has many pharma clients, see:
http://hcrenewal.blogspot.com/2007/05/did-new-england-journal-of-medicine.html
For Pitts' major ties to the same PR firm, see:
http://hcrenewal.blogspot.com/2007/05/stealth-health-policy-advocacy-for.html
For these folks to accuse Nissen of politicizing the issue is just laughable