Comments on: AvandiaGate: FDA Smears Steve Nissen “They’re Barking Up The Wrong Tree!”

By: Melody

Melody — Tue, 31 Jul 2007 13:15:35 +0000

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.

By: Clarisse

Clarisse — Tue, 31 Jul 2007 08:15:35 +0000

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.

By: Dr. Mike

Dr. Mike — Mon, 30 Jul 2007 19:03:53 +0000

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.

By: N Smith

N Smith — Thu, 07 Jun 2007 22:12:42 +0000

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)

By: Rick Longenhagen

Rick Longenhagen — Tue, 05 Jun 2007 14:45:55 +0000

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.

By: reality

reality — Mon, 04 Jun 2007 17:46:31 +0000

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.