But some medical data suggested links between HRT and cancer, so an alarmed Wyeth poured resources into addressing this hazard — by hiring ghostwriters at the publicity firm DesignWrite to promulgate the company's sales messages in the form of more than 50 articles for peer-reviewed medical journals, as well as supplements, medical abstracts and reports. From 1997 to 2003, DesignWrite scribes followed Wyeth's instructions to, as Fugh-Berman notes in an article published in PLoS Medicine, "mitigate perceived risks of hormone-associated breast cancer," to "promote unproven, off-label uses, including prevention of dementia, Parkinson's disease, and visual impairment," to "raise questions about the safety and efficacy of competing therapies (competitive messaging)," to "defend cardiovascular benefits" and to "position low-dose hormone therapy."
Eighteen medical journals published DesignWrite's HRT spin control, including the venerable American Journal of Obstetrics and Gynecology and the International Journal of Cardiology. Between the introduction of Prempro in 1995 and 2002, 13 million women, representing 38 percent of the postmenopausal women in the United States, were taking HRT, garnering $3 billion in sales a year.
But in 2002, the Journal of the American Medical Association published the unspun results of a Women's Health Initiative study of 16,000 U.S. women on HRT. The drugs in Premarin and Prempro elevated the risk of the diseases they were intended to prevent, resulting in a 41 percent increase in stroke risk, a 29 percent increase in heart attack risk, a 26 percent increase in the risk of breast cancer and a 22 percent increase in cardiovascular disease risks.
However, Wyeth persisted in "educational" efforts, such as seminars directed at doctors who had withdrawn their patients from HRT — some scripted by the ghostwriters of DesignWrite.
How to Evaluate
What help exists for doctors, who need to know the potential sources of bias in peer-reviewed articles? Several books offer clear, impeccably researched guides to sniffing out manipulation. Marcia Angell's The Truth About the Drug Companies and Abramson's Overdosed America are likely to be most helpful to a busy clinician. PharmedOut.org offers tools for detecting undue influence in medical research and publishing.
Leadership has also come from open-access journals, including the Public Library of Science publications. Their business models vary, but because they don't accept pharmaceutical advertising or funding and are usually freely accessible to all online — in contrast to journals that must maintain income to answer to stockholders — open-access publishers can keep their hands in their pockets and avoid the rest of the profession's rampant conflicts of interest.
Harriet Washington is the author of Medical Apartheid: The Dark History of Medical Experimentation on Black Americans From Colonial Times to the Present. Her new book, Deadly Monopolies: The Shocking Corporate Takeover of Life Itself — And the Consequences for Our Health and Our Medical Future, will be published in October.