More Things That Go Bump in the Night

From ghoulies and ghosties
And long-leggedy beasties
And things that go bump in the night,
Good Lord, deliver us!

The Wall Street Journal just published an investigative report updating our knowledge about the ghost writing of medical articles. It includes some important new examples of the genre.

• The manuscript of an article in the American Journal of Kidney Diseases, whose first author was ostensibly Alex J Brown was posted on the web-site of medical writer Michael Anello as an example of his work. He had been commissioned by a medical communications company to write the paper on behalf of Abbott Laboratories, which makes Zemplar (paricalcitol), a Vitamin D analog. Anello was not listed as an author of the published article. (Brown AJ. Therapeutic uses of vitamin D analogues. Am J Kidney Dis. 2001 Nov;38(5 Suppl 5):S3-S19.) Brown claims he partially re-wrote Anello's draft, and was responsible for the final version of the article. Anello has since removed the article from his web-site.
• A medical writer paid by GlaxoSmithKline helped draft a manuscript on the safety of acetaminophen versus aspirin and other analgesics for patients with asthma. GSK makes a version of acetaminophen (Panadol) outside the US. The published article stated that the first author "performed the analysis and drafted the paper." (Jenkins C, Costello J, Hodge L. Systematic review of prevalence of aspirin induced asthma and its implications for clinical practice. BMJ 2004;328:434) The lead author said that the "structure of her work was 'suggested' by the company version but she and the other authors did their own analysis." She also denied knowing that the company paid the writer. GSK said the failure to disclose the role of the medical writer was "a lapse on the part of GSK." A rapid response was just (December 13, 2005) appended to the electronic version of the article, stating, "A medical writer assisted in sourcing the papers, summarising their content and reviewing drafts for this review of the literature, but declined to be included as an author. The authors reviewed all papers considered for the analyses. The scientific evaluation of the data and the clinical commentary contained in the review was provided by the authors. The authors have recently been made aware that, without their knowledge, the medical writer's costs had been met by GlaxoSmithKline, but are confident that the information presented in the review was accurate and reflected the authors' personal scientific opinions."

The Wall Street Journal article also recounts some cases that may be familiar to the readers of Health Care Renewal.

• There was the omission by someone at Merck, unbeknownst to the lead author, of pertinent data about adverse events afflicting patients treated with Vioxx from the manuscript of the VIGOR study sent to the New England Journal of Medicine. (See our post here.)
• How the manuscript of the Advantage trial of Vioxx was written in-house by Merck, not by its first author. (See our post here.)
• The "stealth marketing" campaign that included the authoring of multiple articles about Zoloft (sertaline) by a medical education company at Pfizer's behest. (See our post here.)
• The finished draft of a manuscript on the adverse effects of warfarin sent to Dr. Adriane Fugh-Berman by a medical communications company hired by AstraZeneca, which was starting to market a new competing drug, Exanta (ximelagatran). (See our posts here, here and here.)

Kudos to the Wall Street Journal and reporter Anna Wilde Matthews for reminding us that ghost-writing is an ongoing, unsolved problem. It would be fitting to conclude with a quote from the editorial in the Journal of General Internal Medicine that accompanied Dr Fugh-Berman's article noted just above.

Publishing biased literature is not simply "getting the message out" for the pharmaceutical client of the medical education company. It injects bias and untruth into the scientific dialogue in order to enhance corporate profits.
How much is sullying the medical literature worth in market share?

Protect us, indeed!