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  • BIOETHICS FORUM ESSAY

Ghostwriters in the Hormone Therapy Machine

Halloween is more than a month and a half away, but a newly published ghost story is a must-read for everyone – patients, doctors, medical journal editors, bioethicists, and others – concerned about how pharmaceutical companies plant lies in the medical literature. “The Haunting of Medical Journals: How Ghostwriting Sold `HRT,’” just posted on PLoS Medicine, documents how Wyeth, the maker of menopausal hormone therapies, used ghostwriters to create more than 50 journal articles with a favorable spin on the drugs after landmark randomized controlled trials showed that they increased the risk of breast cancer and stroke and did not protect against cardiovascular disease.

The PLos Medicine article was written by Adriane J. Fugh-Berman, an associate professor in the department of physiology and biophysics at Georgetown University Medical Center and principal investigator of PharmedOut, a project to educate physicians about the influence of drug companies on prescribing. Fugh-Berman was a paid expert witness in the litigation against Wyeth brought by more than 14,000 plantiffs who developed breast cancer while taking its menopausal hormone therapy drug, Prempro, a combination of estrogen and progestin. She had access to roughly 1500 documents that show how Wyeth used ghostwriters to “insert marketing messages into articles published in medical journals.” An archive ofdocuments on ghostwriting is on the PLoS Medicine Web site.

Among the key findings from the unsealed documents:

  • Wyeth worked with several medical education and communication companies, particularly DesignWrite, to have their writers produce journal articles, scientific abstracts, and continuing medical education materials about the Premarin family of products that downplayed the risks and promoted unproven benefits.
  • In 2002 Wyeth charged DesignWrite “with increasing the number of positive HRT/Premarin-related publications. They have asked us to publish at least 1 study per month.”
  • After writing the articles in house, DesignWrite persuaded doctors to “review” them and have their names appear as authors.
  • The authors were permitted to make changes, but only if they did not alter the overall marketing messages in the articles.
  • Wyeth paid DesignWrite $25,000 each for articles that reported on clinical trials and $20,000 each for 20 review articles on the unproven benefits of hormone therapy, such as that it may help protect against Parkinson’s disease and Alzheimer’s disease.
  • These articles appeared in many leading medical journals, including Obstetrics and Gynecology, American Journal of Obstetrics and Gynecology, Archives of Internal Medicine, Journal of the American Geriatrics Society, Journal of Women’s Health, International Journal of Cardiology, U.S. Pharmacist, and Fertility and Sterility.

 

“Marketing messages in credible journals have almost certainly contributed to widespread use of HT among millions of women who had no medical indication for the drug,” Fugh-Berman concludes.

In addition to menopausal hormone therapy, Fugh-Berman writes, ghostwriting has been documented to market Lexapro, Paxil, and Zoloft for depression, Neurontin for seizures and pain, and “Fen-phen” for weight loss. “Industry-funded marketing messages may infest articles in every medical journal,” she writes.

It’s easy to blame Big Pharma, but the scariest part is the apparent willingness of the medical establishment to play along. “Acceptance of ghostwriting, euphemistically termed `editorial assistance,’ may be so widespread that it is considered normal,” Fugh-Berman writes.

This frightening prospect can only be averted, she concludes, when doctors, medical institutions, and medical journals take a hard line on ghostwriting: “Patient care will benefit if physicians draw together as a profession to denormalize relationships with industry and avoid the role of corporate pawns in the future.”

Susan Gilbert is the editor of Bioethics Forum.

Published on: September 8, 2010
Published in: Conflicts of Interest in Research, Medicine & Business

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