Friday, April 30, 2010

Should Drug Companies Censor Medical Journals?

I have previously addressed the debate over the safety of the diabetes drug Avandia (rosiglitazone) between Steve Nissen, head of cardiology at the Cleveland Clinic, and GlaxoSmithKline, the drug's manufacturer:
http://brodyhooked.blogspot.com/2010/04/more-on-avandia-saga.html
http://brodyhooked.blogspot.com/2010/02/secret-avandia-tapes-comedy-or-smoking.html
http://brodyhooked.blogspot.com/2010/02/avandia-story-failures-of-regulation.html

So a further round of fisticuffs between these worthy opponents in the European Heart Journal (subscription required) might seem like old news--were it not for the bit of interest GSK added by calling on the journal to censor Dr. Nissen's previous editorial.

Dr. Nissen had written his editorial, "The Rise and Fall of Rosiglitazone," giving his take on the whole matter. The journal had published the editorial on line but it had not yet appeared in the print edition. GSK, in the person of Moncef Slaoui, Chair of Research & Development, wrote a long letter to the editor of the journal disputing Nissen's account point by point, and including the statement: "We strongly disagree with several key points...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."

Nissen responded with his own point by point refutation of GSK's point by point refutation. He introduced his letter: "Pharmaceutical companies have abundant resources for delivering their messages to physicians and the public. Physician-scientists essentially have only medical journals through which we communicate... If we allow a pharmaceutical company to control what we are allowed to publish, scientific discussion and debate would suffer irreparable harm. This demand from GSK constitutes an unacceptable attempt to interfere with the editorial decisions of a major medical journal."

The EHJ editors chimed in, "Scientists know what a good argument is and will consider its merits and evidence...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."

As a side matter, one of the Nissen accusations at which GSK took the greatest umbrage was that they "stole" a copy of the manuscript of Nissen's meta-analysis while it was still under review with the New England Journal. To defend their counterclaim that they were essentially innocent bystanders who received a faxed copy of the manuscript that they had never requested, they cited an earlier publication that I did not realize existed, in which the leak of the manuscript was reported as a news item in Nature by Brian Vastag about 7 months after the event occurred. Vastag offered an interview with the leaker, Dr. Steven Haffner of the University of Texas-San Antonio. At that time, and apparently later as well, the New England Journal declined to say anything about what had been done with Haffner, though they added that routinely such an offense would lead to a future ban from reviewing and from contributing editorials and review articles. Vastag quoted Haffner about his decision to fax the copy of the manuscript to a former resarch collaborator who worked for GSK, "Why I sent it is a mystery...I really don't understand it. I wasn't feeling well. It was a bad judgment." He went on to say--this is apparently the part that GSK liked and why they cited Vastag's article in their reply to Nissen--that his collaborator at GSK had not requested the manuscript (how could he if the manuscript was presumably under confidential editorial review at the time) and was "probably a bystander." No further comment.

Nissen SE. The rise and fall of rosiglitazone [editorial]. European Heart Journal 31:773-776, 2010.

Slaoui M. The rise and fall of rosiglitazone: reply [letter to editor]. European Heart Journal (advance access e-published April 23, 2010).

Nissen SE. The painful truth [letter to editor]. European Heart Journal (advance access e-published April 23, 2010).

Luscher TF, Landmesser U, Ruschitzka F. Standing firm: the European Heart Journal, scientific controversies and the industry [editorial]. European Heart Journal doi:10.1093/eurheartj/ehq127 (advance access e-published April 23, 2010).

Vastag B. Reviewer leaked Avandia study to drug firm. Nature 451:509, 2008.

2 comments:

Michael Kirsch, M.D. said...

Nissen is a well known drug company antagonist. Nevertheless, he and the EHJ have the right argument here against GSK's clumsy request for censorship. I'd like to be more enlightened on the leaker and his motivations. www.MDWhistleblower.blogspot.com

Web Allways said...

Never, never .... "Drug Companies should never Censor Medical Journals as news should be in general public as it's original form. More health related Medical Journals at MDLinx.