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Healthy Skepticism Library item: 16951

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: Electronic Source

Silverman E
Pharma, Conflicts Of Interest And Fingerpointers
Pharmalot 2009 Dec 15

Full text:

The controversy over conflicts of interest is taking a twist as a former Merck executive and a medical journal are teaming up to lash out at doctors who have criticized drugmaker behavior in published studies, and have also served as expert witnesses in product-liability litigation.
To wit, Laurence Hirsch, a former vice president of medical communications at Merck, published a lengthy essay in a recent issue of Mayo Clinical Proceedings in which he lambasted the doctors and the journals that published their work for “selective and incomplete” disclosure. He points to Yale University professor of medicine Harlan Krumholz, who has reportedly been paid $200,000 while working for attorneys who are suing Merck, and David Egilman, a clinical associate professor of family medicine at Brown University, who has reportedly collected upwards of $2 million for similar consulting work.
One example that upsets him is their April 2008 article in the Journal of the American Medical Association, which examined journal articles about Vioxx and court documents from Vioxx lawsuits – and concluded Merck employees or ghostwriters were frequently involved in various articles, but the primary authors were often academics who had little to do with the studies or didn’t always disclose financial ties to Merck (see here). While the authors of the JAMA article did make disclosures, Hirsch maintains these were insufficient.
It shouldn’t be surprising that Hirsch is upset, because he oversaw the medical communications strategy at Merck during most of the Vioxx years. The Mayo essay is, essentially, a platform to strike back. Interestingly, Hirsch readily acknowledges his tenure at Merck, but failed to disclose his current employer, preferring to say only that he works for a medical device company with no financial conflict in Vioxx or the litigation (although it appears he works at BD, see here and here).
Merck, meanwhile, is distributing copies of Hirsch’s essay, according to The Chronicle of Higher Education, which quotes the Mayo editor, William Lanier, who penned a supporting editorial last September, as saying leading medical journals are fostering an anti-business bias that will stifle “creativity and productivity,” ultimately forcing R&D to go abroad.
For their part, a couple of the JAMA authors aren’t keeping quiet. Egilman, who settled with Eli Lilly after a judge found he leaked Zyprexa documents two years ago, long before Lilly paid $1.4 billion to settle civil and criminal off-label marketing charges (see here and here), wrote us that “Merck doesn’t need a pr team they have the Chronicle. Any mention of the fact that the drug (Vioxx) killed 100,000? That Merck took it off the market? That the NEJM accused them of hiding data? That we disclosed our funding? That Hirsch didn’t point to a single error (in his essay)? Details, details, details.”
And Krumholz wrote us that “he is unable to identify anything we did wrong in our articles – and it seems quite clear that there had been misdeeds with the Vioxx data (NEJM and the FDA also made the same points), that there was ghostwriting, that there was a major seeding trial, and that Vioxx increases risk – that is essentially what we have published.
“I was paid a substantial amount for my time – but it was at the standard rate and I worked hard to understand all the documents and be able to testify at the trial – nothing I said at the trial is in dispute – and was essentially that Vioxx increases risk (Merck had experts who said it did not).
“Hirsch also suggests that I should be precluded from commenting on any Merck products – trying to neutralize my comments about ezetimibe over the past couple of years. So even though I was testifying about a drug that is off the market – and at the time, I was talking about ezetimibe I was long done with the trial and had no financial arrangements with any company or lawyer – I spent hundreds of hours on that litigation. And the time I spent made a difference at the trial and ultimately gave me access to documents upon which I could do research, at a time when I was no longer being paid.
“I don’t mind disclosing the past relationship, but it is offensive to be targeted by someone who lead the messaging that promoted a drug that was increasing risk and suggesting that journals should be wary of my participation in the trial as if they were not. Of course they knew and as a result our work was scrutinized closely. They did not want to be sued over our work and wanted to be sure it was done well. And so did we.
“Ultimately, we are scientists who are trying to positively affect public policy. We are physicians who want our patients to have access to safe medications and to know where risks exist. We are trying to use our experience in the trial – with the veil lifted – to share information with the broader community. I don’t mind the debate, but this one with Mayo Clinic seemed like a concerted effort to neutralize us – marginalize us – and suggest that we did something wrong.
“And really I have nothing against Merck…I am really trying to get better transparency and avoid the distortions of information that marketing can introduce when it intrudes on the science. Both industry and academia need to find ways to have high integrity interactions and avoid those that are not in the best interest of the public and patients.”
Hirsch, meanwhile, is out stumping for “good publication practices” for medical journals. A co-founder of the International Society for Medical Publication Professionals, he recently co-authored – along with others who work for several drugmakers – an article in BMJ that offers new guidelines (see here).


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