Glaxo Tells Journal Editors To Censor Steve Nissen
20 CommentsBy Ed Silverman // May 3rd, 2010 // 7:18 am
The controversy over the Avandia diabetes pill has now engulfed the European Heart Journal, which revealed in an April 23 editorial that GlaxoSmithKline’s research chief, Moncef Slaoui, wrote a letter urging the editors not to publish in print an online version of an editorial written last January by Steve Nissen, the Cleveland Clinic cardiologist who has been at the center of the storm. His piece ran in conjunction with an analysis of one of Glaxo’s own clinical trials.
Why did Slaoui take such an unusual step? Glaxo, of course, has been on the defensive ever since Nissen published a meta-analysis in 2007 indicating previously undisclosed cardiovascular risks with the widely used diabetes pill (background). And shortly after the EHJ paper and editorials were published, the Senate Finance Committee issued a scathing report that detailed heated internal disagreement within the FDA and new revelations about Glaxo actions and deliberations.
In a bid to mute growing criticism, Slaoui (in photo at right) wrote that Nissen’s editorial “is rife with inaccurate representations and speculation that fall well outside the realm of accepted scientific debate. We
strongly disagree with several key points within the editorial, most importantly those which imply misconduct on the part of GSK…On this basis, GSK believes that it is necessary for the journal to withdraw this editorial from the website and refrain from publishing it in hard copy, until the journal has investigated these inaccuracies and unsubstantiated allegations” (see the complete letter).
As noted by CardioBrief, which first reported this spat, Slaoui went on to list various facts that, he contended, Nissen got wrong. Having published Slaoui’s letter, the EHJ editors then gave Nissen a chance - point-counterpoint style - to offer a rebuttal (see it here). In the end, the editors refused to grant Slaoui’s unusual demand. And they explain their position rather eloquently:
“The journal’s editorial board discussed the issue and unanimously agreed that such a demand was unacceptable…Science is an interactive process and that is why journals are optimally positioned to promote this process. Communicative reasoning within the scientific community is the hallmark of the scientific process…Scientists know what a good argument is and will consider its merits and evidence, if put forward by knowledgeable colleagues, may they work in academia or in the industry. However, we cannot suppress concerns, data or divergent opinions - we must consider them and argue with data, numbers and plausibility. Only through such a discourse can progress evolve.”
It’s hard not to agree with the approach taken by the editors. If Slaoui and Glaxo have an issue with a piece, they are, indeed, free to offer a rebuttal. But to insist that a medical journal should squelch an editorial - particularly when Glaxo once before worked overtime to persuade Nissen not to publish his meta-analysis (see here) - is not only a disservice to scientific discourse, but poor judgment.
Pharmaguy
I think the word you want in the headline is “censor” (i.e. prevent his editorial from appearing), not “censure” (i.e. reprimand).
tiffany
classy move by GSK-
Cynical
It is an editorial and represents Nissen’s opinion! GSK should get a life.
Paul
I have no interest with either GSK or Nissen. But, as an independent observer, I have to say that Nissen seems to have had a mission to embarrass GSK and other companies to the nth degree. He’s taken money from many companies and I don’t buy his effort to appear squeaky clean.
Time for him to step out of these debates - his credibility is shot. Time to let others. If there’s wrongdoing the surely there will be other critics. His stunt to carry a concealed wire and mike to tape conversations with GSK was the lowest. Nothing was said and he came out to the media with “well this is what they mean”…come on!
Your 15 minutes of fame are over. Let other experts with more credibility and objectivity pursue this.
clarkkent
Nissen’s rebuttal is weak. I agree with Paul. Nissen’s stunt where he wore a wire in order to catch GSK saying incriminating stuff came up empty. So he comes out and says I was so intimidated by them I had to wear a wire, but then nothing wrong is said? What a loser.
jah
Dr. Nissen is a hired gun. He tries to come off as being a savior of people who might be harmed by medications, but if one looks closely at his so called foundation donors, he clearly accepts funds from pharma companies that are direct competitors to the drugs he makes ‘noise’ about. He is NOT squeaky clean, unbiased or objective in any way. He profits quite nicely (in personal attention, and likely stock price increases) everytime he broadcasts his ‘opinions.’ It is time the scientific community steps up and calls out Dr. Nissen’s conflicts of interests.
pager
Having difficulty giving any credence to Nissen. He should give back all of the money he took from industry - until then a hypocrite in my book.
John
I see that GSK’s entire PR department decided to submit comments here and attack Dr. Nissen. Just know that no matter how hypocritical he may seem to you, GSK PR personnel, most of the public does not see him in that light - and very definitely sees you, GSK, as a large bucket of sleaze.
Evelyn Pringle
I recall vividly the lengths Glaxo went to to discredit Nissen when he first published his analysis in 2007. The company even had an FDA spokesman spewing out slanderous emails to journalists from his agency account in repeating comments made by anonymous bloggers and ex-FDA officials writing editorials in the MSM.
By the looks of the comments above, nothing much has changed since 2007, except now people can slam Nissen without revealing their true identities.
John
Evelyn,
Yep. It looks like the GSK spin-machine is all over this one. The thing is, no one buys their spin and I don’t think they fully realize that yet. Either that, or they are like the Little Train That Could… or the Energizer Bunny… and believe that if they just keep trying, things will turn around for them. Their behavior has jaded an entire generation of Americans. I foresee that Americans will be suspicious of drug companies and their products long after I cease to exist. And they brought it on themselves.
Paul
I am offended that you would call any dissenting message a “GSK spin machine”. I have nothing to do with GSK (or any company) and do not work for any PR company, etc. I have been watching this stuff go on for a long time.
My comments in no way absolve GSK. But I do stand behind my statement that Nissen has lost credibility and objectivity. He has got lots of money from companies and is like a dog with a bone with some arguments even after others have refuted them. Let others with more credibility make the case.
Nancy
I wish Dr. Nissen would engage in scientific discourse on the ethical justification for the PRECISION trial - ici et maintenant. See
http://www.publicintegrity.org/articles/entry/1203/
Mike
So….let me see if I get this correct. Any comment that disagrees with Nissen is from a “spin machine.” Sorry. I’ve read his meta-analysis and his conclusions don’t hold water. His comments should be removed because people without scientific knowledge (like some of those supporting Dr. Nissen in this blog) side with him and shout louder then those who disagree with his conclusions. Nissen’s comments should be removed because the data doesn’t support HIS conclusions. As a physician I can tell you that I’m suprised and saddened that my old schoolmate still gets press with this. The medical community has spoken. Those in the EHJ world diappointment those of us practicing.
Nancy
@ Pharmaguy
I think “censure” could work in the headline.
vince
Seems to be a pattern here lets see NYT June 2 2007 “Doctor Says Drug Maker Tried to Quash His Criticism of Avandia” http://www.nytimes.com/2007/06/02/business/02drug.html…….. “Yesterday, in a written statement issued by a spokeswoman, Mary Anne Rhyne, the company said: “Discussions occurred with Dr. John Buse in 1999 and 2000 regarding his views on Avandia, and we had a scientific disagreement that was later resolved. We regret if, at any time, Dr. Buse felt the conduct of any GSK employee was contrary to the spirit of open, scientific debate regarding his views on Avandia.” The statement also said that the company “does not condone any efforts by GSK’s staff to limit an individual’s ability to discuss or publish adverse events related to Avandia.”
Realistic
Hey GSK - Avandia is crap! Always has been and always will be! Hope that the lawsuits bleed you dry!
Jay
You don’t have to be in GSK PR to respect them for taking this stand. They will never win the battle in a fight couched as academic and press freedom, but…really, does anyone think Dr Nissen has written an academic and scientific editorial?? Let’s call this what it is: a self-righteous polemic intended to continue defending Dr Nissen’s campaign against Avandia. He restates all the ‘facts’ from his own meta-analysis as if they are ‘Truth’ - whereas that initial analysis has been widely critiqued as biased itself and inappropriately conducted. After he leaked the results to the congress and media and became the ‘people’s champion’ against this drug, he now needs to defend his analysis and continue painting GSK as dastardly for having the gumption to continue marketing it. Hopefully a future FDA panel will be unbiased and truly scientific and will not be overly influenced by Dr Nissen’s and Senator Grassley’s campaigns and will weigh in on the true benefit-risk the drug brings to the armamentarium.
Hap
Paul - probably because most (if not all of the complaints) about Nissen are that he’s a self-aggrandizing anti-GSK shill, and that they almost all sound like readings from the same page of the same hymnal.
GSK could have complained that Nissen has significant conflicts of interest (because of his acceptance of money from Takeda, though he disclosed it, and if that were enough to have his papers pulled, well, medical journals would have a hard time finding papers at all), or could have argued with his interpretation (which they have). If they think he and the journal libeled them, they could have sued - it would have been intimidation, but in an arena better suited for the open exchange of facts. Instead they threatened to sue, which implies that they haven’t actually got the facts to sue, and thus has all of the negative PR repercussions of intimidation without any of the potential gains. It also was likely to get the response it did - to goad the journal and Nissen into a further recounting of GSKs sins and listings of their less-than-forthright behaviors. If GSK (or drug companies in general) had any goodwill, this action would not help them any.
In addition, with their previous attempts to derail Nissen’s meta-analysis and to silence/suppress the criticisms of Buse (another person who received money from Takeda), the letter continues to reinforce their lack of reputation on the matter. If you have good data, you shouldn’t need to intimidate people from giving contrary opinions - just give your side, and make sure you have good people to explain it. The lack of a forthright response implies that they haven’t the substance to make one, and, well, that probably isn’t what GSK means to say. Oops.
Josh
Nissen vs GSK. Hmmm, who to believe… who to trust. Seems to me that the only “winner” (yes, inverted commas are back) here is the EHJ, without whom we would have no substance upon which to debate.
Paul Tremblay
Un coup bas de la part de fans qui se disent de droite mais qui dans le fond aiment juste chialier après quelqu’un ou quelque chose.
http://chialezpourvrai.wordpress.com/