Study shows ghostwriters overstated benefits of HT

Fugh-Berman A. PLoS Med. 2010;doi:10.1371/journal.pmed.1000335.

An academic analysis of 1,500 unsealed documents revealed that pharmaceutical company Wyeth used ghostwriters to insert marketing messages into medical journal articles promoting menopausal conjugated equine estrogens.

The documents were recently unsealed during litigation against Wyeth. The company is facing a class action suit on behalf of 14,000 plaintiffs who claim to have developed breast cancer while taking the conjugated equine estrogens (Prempro).

Adriane Fugh-Berman, MD, of Georgetown University Medical Center, studied dozens of the ghostwritten articles and commentaries written by DesignWrite, a medical communication company hired by Wyeth. The articles, which were published in medical journals and disseminated to physicians and pharmaceutical representatives, downplayed the risks for breast cancer associated with HT, defended unsupported cardiovascular benefits of HT and promoted unproven off-label uses of HT, including the prevention of Parkinson’s disease, dementia, wrinkles and vision loss, according to a press release. Fugh-Berman’s analysis was published Tuesday in PLoS Medicine.

Specifically, the articles questioned whether HT-induced changes in breast density were linked to increased breast cancer risk, implied that estrogen use after breast cancer was safe and suggested that HT-linked breast cancers were less aggressive.

Fugh-Berman’s analysis found that DesignWrite was paid $25,000 to produce articles reporting clinical trial results — including four summaries of the Women’s Health, Osteoporosis, Progestin, Estrogen (HOPE) study of low-dose Prempo — and received $20,000 per article to write 20 review articles about Prempo.

“Given the growing evidence that ghostwriting has been used to promote HT and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted,” Fugh-Berman wrote in the analysis.

This appears to be a classic case of ‘the pot calling the kettle black.’ That is, much of this material has been taken directly from the litigation documents prepared by the lead plaintiff attorney, James Szaller. Thus, Dr. Fugh-Berman appears to have published a semi-ghost written article herself! The substance of her paper is riddled with errors and misassumptions. I can speak to the HOPE papers, which she calls ghost written, but, as lead author of the first HOPE paper, I spent about 1 hour during a 9-hour deposition as a fact witness, explaining how the paper was developed over a period of years, and most certainly was not ghost written. In summary, this is an article written by someone trying to justify her own role as a well-paid expert plaintiff’s witness, and falling into the trap of apparently using ghost written material without attribution. The paper is riddled with scientific misinterpretations and personal assumptions. The truth, as always, lies somewhere in the middle.

–Wulf H. Utian, MD, PhD, DSc

Independent Consultant, Gynecology and Women’s Health, Cleveland Clinic

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