Newly-released court documents gathered as part of a court case against Wyeth (now part of Pfizer) brought by patients who developed breast cancer while taking its Prempro hormone replacement therapy (HT) illustrate how ghostwriting was used to distort or hide scientific evidence and lend clinical credibility to company marketing aims in medical journals and presentations. In “The Haunting of Medical Journals” in this week’s PLoS Medicine, Georgetown physician, researcher and expert witness Adriane Fugh-Berman examined the documents. She found that where company-funded trials and clinical findings are concerned, the marketing tail is still vigorously wagging the dog.

DesignWrite, a medical education and communication company (MECC) was hired by Wyeth to produce large quantities of “authored” papers that touted unproven benefits and later downplayed risks of HT proven in large randomized control trial (RCT) studies. Between 1997 and 2003, Wyeth hired DesignWrite to produce drafts of more than 50 peer-reviewed publications, including at least four primary publications on a Wyeth-funded Prempro trial.

DesignWrite’s ghostwriters also helped “manage” clinicians and thought leaders, ensuring marketing messages remained front and center in published papers, and planned CME events and journal supplements.

“Even though a 1997 DesignWrite proposal admitted that ‘HRT continues to be a drug in search of a disease’” Fugh-Berman writes, “my examination of the available documents indicates that the lack of evidence regarding the prevention and treatment of cardiovascular disease, dementia, and other diseases proved no deterrent to Wyeth/DesignWrite’s promulgation of numerous marketing messages positioning HT as a panacea.”

While this lines up with mounds of other evidence that show companies’ marketing goals running the scientific show, the casualness of the counter-science that was done to keep physicians prescribing HT is newly shocking.

When in 2002 the Women’s Health Initiative, a large RCT, disproved purported cardiovascular benefits previously associated with HT and showed increased risk of breast cancer and stroke, Wyeth commissioned the ghostwriters at DesignWrite to write papers casting doubt on hormone therapy’s role in breast cancer. One Wyeth employee suggested that a journal supplement falsely state that breast cancer associated with the treatment was less virulent. That year, Wyeth management “charged the Publication Committee with increasing the number of positive HRT/Premarin-related publications. They have asked us to publish at least 1 study per month.” The company also flooded medical publications with mini-reviews, editorials, comment, and other booster pieces that did not have to be peer-reviewed, but still packed a clinical punch with physicians.

Physicians, it’s clear from the documents, were only as valuable to Wyeth and DesignWrite as their prescribing pen and their generic credibility. As “authors” who lent their names to ghostwritten pieces, the companies saw them as interchangeable: “I moved Dr. Creasman as an author to the patient ed piece (with Blackwood, Weiss, & Speroff) and left Horwitz and Boman on the basic science manuscript,” one document stated.

This should be insulting to physicians. As a marketing tool, ghostwriting has been implicated in the physician recruitment campaigns around Vioxx, Neurontin and other high-profile drugs stripped of their mystique and safety profiles by sound science.  But as Fugh-Berman and these documents illustrate, the use–and manipulation–of medical journals and clinical evidence to support marketing aims may have become so routine that in some cases, the most reaction Wyeth’s antics stirred was confusion on the part of the token author:

“From what you have written, I would be more of an ‘editor’ rather than the major writer—that is, you guys would be writing the versions—with me ‘altering, editing, etc.? Is that correct?’”
And if this is an outrage to physicians, so should it be to the rest of us. The following is a response from Wyeth’s Gerald Burr to a ghostwriter about whether manuscripts could be reused.
“‘You can’t just put another name on the article, but you can plagiarize the way we did when we wrote papers in college. What you need to do is give your potential authors Karen’s version of the article before the author modified it. Then have your authors modify it for publication under their name. Wyeth owns Karen’s draft, not the final publication.’ Burr supplied five drafts but asked that [a DesignWrite supervisor] Karen Mittleman be notified of the plans for reuse ‘so she can advise if we are going to piss off any of the U.S. authors.’”
Read the full article here.

–Kate Petersen, PostScript blogger