More Zyprexa Documents Released--Ghostwriting at Lilly

Once again, it takes court-ordered release of documents related to a lawsuit to shine daylight on previously hidden drug company practices. The present relevations come from Bloomberg News and are based on court-ordered release of internal Eli Lilly documents as a result of litigation over their antipsychotic olanzapine (Zyprexa):

http://www.bloomberg.com/apps/news?pid=20601109&sid=aVvfe.v1k_VY#

Both in HOOKED and on this blog I have documented previous accusations of ghostwriting, so I'll try to comment here mostly on what is new. Of most interest perhaps is a guide called "Medical Press: Pre-Launch Feature Outline" (unfortunately, undated) which was an internal how-to primer on preparing ghostwritten articles. It covered both what the article should say to boost Zyprexa sales and how to find a compliant putative author to put his or her name on the final published paper. As the Bloomberg reporters recount, "The guide also offered tips on how to find authors by identifying a 'key opinion leader' and providing them either an outline of the article or a finished copy. Authors could include a study investigator, an advisory board member or 'Lilly-friendly' doctor, according to the documents."

The main importance of this passage is the frank admission that the puitative author might be sent a finished copy of the article. Up until now, the company and the putative author, when confronted, have routinely defended themselves by insisting that all that was provided by the company was a rough draft and that the author listed in the journal then made extensive changes in it. Even if that were true, it is still a violation of standard authorship ethics guidelines not to list to "ghost" author who actually wrote the first rough draft. But it is also more in keeping with the assertions of insider-whistleblowers like psychiatrist David Healy that in fact, few if any modifications to the draft are routinely made.

Sadly this "guide" does not state the going price paid to the putative author whose name appears on the published article. I have only been able to document payments of as high as $1000. Colleagues in the know tell me that figure is woefully low, but I still cannot find written documentation of anything higher. It's well documented that the "ghost" writer might be paid $20,000 for an article that is successfully placed in a top-tier journal.

Another insight is provided by a passage that recounts an exchange over a paper putatively authored by Dr. John Buse of UNC-Chapel Hill, a former president of the American Diabetes Association. The paper, actually authored by Lilly staffer Patrizia Cavazzoni, took issue with another paper that stated that there was a substantial risk of Zyprexa causing diabetes--the side effect (along with weight gain) that is today prompting the spate of lawsuits against manufacturers. The skeptical paper defending Zyprexa was submitted to the Journal of Clinical Epidemiology. When the paper was not promptly published, Lilly folks became concerned and in November, 2002, Lilly's senior scientific communications coordinator, Suraja Roychowdhury, wrote the journal. The editor, Andre Knotterus (here quoting the Bloomberg article) "replied in an e-mail that it was 'a bit strange to be contacted by the Lilly product team. Dr. Buse and coauthors can contact us directly next time.'"

Okay, let's get this straight. When journal editors are criticized on the issue of ghostwriting, they routinely reply that they are not private detectives, and that if Dr. Bigname sends them a paper and swears up and down that he actually wrote it himself, how is the poor little bitty journal to know different? So here, apparently, we have a paper submitted to a journal editor, and then a production team from a drug company calls the editor to complain that the article was not published as fast as their business plan called for. Instead of wondering, "Hmm, I wonder if this could have been a ghostwritten article, which good journal ethics requires that I refuse to print?" the editor instead says, "Next time, by the way, have the fake author send me the message instead." There is here at least the appearance of full journal complicity in the ghostwriting arrangement.

For the record, Dr. Buse denied to Bloomberg that he had ever put his name on an article that he did not write. He then proceeded to tell the reporters 1) that he had no recollection of who said what to whom regarding that particular paper on diabetes; 2) that his experience showed how biased an academic physician can become who works regularly for the drug companies; and 3) that in his opinion ghostwriting used to be very common but is becoming much more rare. I must say that for somebody who has never personally been involved in ghostwriting Dr. Buse seems to know a lot.

Finally the article makes the point that several of us critics of Pharma have stressed--we know of no case where an academic physician has been fired or has received any serious sanctions after being caught putting his name to a ghostwritten paper. Given that everyone agrees that ghostwriting is a clear and egregious violation of scientific publication standards, the current track record of academic medicine in policing itself is abysmal.

Contacted by the Bloomberg reporters, Lilly protested that its legal opponents in the current wave of lawsuits are cherry-picking damaging documents, quoting them out of context, and creating an erroneously negative picture of Lilly's corporate practices. There is of course the danger of this occurring whenever tens of thousands of pages of documents are released and reporters have to paw through the pile for the juiciest bits. That's why it is so important to know the background--what has been demonstrated in previous accounts of whistleblowing that are not dependent on this same stack of documents. As HOOKED and this blog will demonstrate, the facts contained in the Bloomberg News account are believable because reasonably consistent with what we have known previously about ghostwriting practices.

A tip of the hat to Roy Poses' Health Care Renewal blog for heads-up on the Bloomberg News article.

NOTE ADDED 6/15/09: The paper by Buse that I referred to above, on further inspection, turns out to fall very questionably under the "ghostwritten" category. John B. Buse is listed as the first author, but the Lilly staffer, Patrizia Cavazzoni, is clearly listed as the second author. The paper as a whole is also clearly labeled as funded by Lilly. If indeed the paper was primarily written in-house by Lilly staff, then the most serious ethical infringement was the listing of Buse as a first author.

Buse JB, Cavazzoni P, Hornbuckle K, et al. A retrospective cohort study of diabetes mellitus and antipsychotic treatment in the United States. J Clin Epidemiol 56:164-70, 2003.