AvandiaGate: FDA Smears Steve Nissen “They’re Barking Up The Wrong Tree!”
6 CommentsBy Ed Silverman // May 31st, 2007 // 3:54 pm
The controversial cardiologist is outraged over an e-mail written by an FDA spokesman, who sent his missive to several journalists. Entited “What are St. Steven’s feed made of? Clay, perhaps?”, Doug Arbesfeld forwarded a critical news story that included an anonymous blog accusing Nissen of playing favorites among drugmakers, ABC News reports.
And the bespectacled Nissen, who co-authored a recent study in the New England Journal of Medicine suggesting that Avandia may increase the risk of heart attacks, is pretty angry. He considers the message a direct attack on his personal integrity and professional reputation.
“I’m a pretty tough guy,” the slightly built, bespectacled Nissen told ABC News, “but I’ll tell you, having this kind of an e-mail that questions my motives, broadcast to the major journalists with whom I work and have established a reputation, is - it’s an outrage. Using taxpayer dollars, a federal agency’s press office, rather than responding to the scientific questions that I raised, attempting to smear me individually. It’s unacceptable.”
Arbesfeld, who previously worked at Johnson & Johnson, acknowledged sending the e-mail to a handful of reporters but denied he was attempting to impugn Nissen’s reputation. And the FDA is hanging him out to dry. The agency told ABC: “The content of the e-mail from an FDA consultant was his own words and does not represent an FDA position.”
Arbesfeld included in his e-mail a comment on a blog posting, originally published in the Wall Street Journal, that accuses Nissen of primarily criticizing drugmakers that don’t support drug trials at the Cleveland Clinic: “Wake up, pharmaceutical companies … if you don’t hire the Cleveland Clinic for your big trials then you face the firing squad from Nissen and Company.” The comment’s author is identified only as “Brian A.”
Nissen calls the anonymous blogger’s accusation an example of “the big lie.” “The idea that I would somehow be selective in my criticism to those companies that don’t bring clinical trials [to the Cleveland Clinic] is…extremely offensive…and absolutely untrue.” And he points to his outspoken criticism of Cox inhibitors including Celebrex, a Pfizer product, at the time he was the principal investigator for a Pfizer clinical trial.
But Nissen said he is even more infuriated that a top FDA spokesman distributed articles including the blog disparaging his reputation and that of the Cleveland Clinic, instead of confronting the Avandia study itself. “They’re barking up the wrong tree,” he barks back. “While I did spend a sleepless night about this, I’m not backing down. What counts here is the truth. What counts here is the health of our patients. And if they think they can intimidate me by doing this…they have another thing coming.”
In the study, Nissen and his co-author report that diabetes patients who took Avandia were 43 percent more likely to have a heart attack than patients who took other medications or a placebo. Glaxo “strongly disagrees with the conclusions” in Nissen’s article, which the company contends “are based on incomplete evidence and a methodology that the author admits has significant limitations.”
The FDA responded to the study by issuing a safety alert, recommending that docs “continue to carefully make individualized treatment decisions” for diabetes patients who take Avandia. At least three congressional committees are planning to investigate Avandia and the FDA approval process in the coming weeks.
ABC’s Nightline plans to air a segment about this tonight at 11:35 EST.
Source: ABC News
reality
So Nissen, a man who has made a name for himself attacking others’ integrity and professional reputations is upset because someone attacked his integrity and professional reputation? That’s rich.
Had Glaxo done a meta-analysis with similar data that showed a reduction in CV events, Nissen would’ve been apoplectic over the study design.
The Nissens of the world, while doing much good, have also nicely set things up to be “okay for me, but not for thee.” For instance, Nissen’s ASTEROID trial was published in JAMA last year, and JAMA requires independent statistical analysis for all pharma-sponsored studies (in this case, AstraZeneca). Who did the statistical analysis? The Cleveland Clinic. Now really, how independent is that? If you ask me, not very. And frankly, I’m surprised it passed JAMA’s muster. Likewise, had someone else done an IVUS study with no control group, Nissen’s letter to JAMA would’ve been fast-tracked to the website.
Rick Longenhagen
Rikenhagen@aol.com said…
Please do not short sell the comment made about Nissen having a bias against pharmaceutical companies that do not choose his institution as a study site.
I have first hand knowledge of one of the top experts on thrombolytic therapy, also from the Cleveland Clinic, who used his academic standing, and any medical journal who would publish him to disparage a novel lifesaving new therapy because he was approached in an inappropriate manner (not first) to investigate the drug in phase IV trials. I have also personally seen this addle minded behavior at smaller teaching institutions where phase IV and aftermarket trials were held in neighboring or competetive institutions. The physician specialists involved would react the same way and blackball the drug regardless of efficacy and safety. I started to feel I was dealing with children, taking their bat and glove and going home.
N Smith
Dr. Nissen is not the issue. There will always be doctors criticizing new drugs, and large drug companies fighting back. Sometimes they will be right and other time not so. We all expect that.
What we don’t expect is that the FDA will organize a smear campaign on behalf of a drug company to influence the press.
If all this is correct then I do believe that Doug Arbesfeld should be fired, and, if Andrew von Eschenbach wants to show that there is still a small amount of integrity left in the FDA, he should accept where the buck stops and resign.
The odd thing is how little reported this has been. Earlier today there were over 800 Google news hits on the FDA vs Avandia story, but hardly anyone mentioned the FDA smear despite the fact that this all came out to the House oversight committee on Wednesday (according to UK Guardian newspaper)
Dr. Mike
Whew! The FDA is attacking someone with a smear campaign? This neo-con, rogue, thug, Bushfraud behaviour is rampant now. Arbesfeld should be fired, now.
Rick Longenhagen,
I have also seen this behaviour in the thrombolytic field first-hand and had to have my hands dirtied dealing with the individual from the Cleveland Clinic that you referred to. Disgraceful.
Clarisse
Keep up the smears. It is so helpful to us in the real world who have to be subjected to this “scientific” discussion while my husband died 7 months ago of CHF because nobody in a top cardiac hosp recognized early enough what happened too fast when the symptoms appeared. Why don’t you get out of your sandboxes and follow your oath to do no harm. Or at least give people a fighting chance to recognize and respond to the side-effects before they die. And don’t forget to hide as much information as possible before you get your drug on the market so that the doctors trying to help can accidently kill their patients with your help, and then everyone can engage in sophmoric political games of debating a drug that should have been adequately studied before it was brought to market. Statistics are great, they can prove anything. The only thing I know is that my husband is dead. And, yes he was on Avandia. Thank you Glaxo and all your efforts to keep your studies private and out of the hands of doctors before you were forced by those evil lawyers to at least post part of your studies but not enough to easily identify the fatal side-effects. Keep up the studies, maybe only a few thousand more families have to have a premature funeral. Have you done a cost-benefit analysis on how much it costs you when the patient dies and you no longer have that revenue. Surely there must be something important to you.
Melody
if Andrew von Eschenbach wants to show that there is still a small amount of integrity left in the FDA
And why would von Eschenbach want to do this? He is well on his way to the dismantlement of this agency. I believe the Consumer Protection Services’ end is already in sight; but FDA is doing is fine job in challenging their race to the bottom. Patients . . . consumers . . . citizens–we don’t matter; keep those corporate profits high and those stellar executives well-compensated.