At odds with a major pharmaceutical company, professor Adriane Fugh-Berman recently published a report revealing that Wyeth, a subsidiary of Pfizer, paid for ghostwritten articles promoting the use of one of its drugs for conditions not approved by the Food and Drug Administration.

According to Fugh-Berman, an associate professor in the department of physiology and biophysics, the articles suggest the use of estrogen-progestin drug Prempro for non-FDA approved conditions.

Fugh-Berman’s analysis of industry documents pertaining to the issue was published on Sept. 7 in PLoS Medicine, and she also serves as a paid expert witness for plaintiffs against Pfizer and Wyeth.

Recently banned by the Medical Center in its Policy on Industry Relationships, the ghostwriting process is a contested topic in the medical community. At least one physician at the Georgetown University Medical Center agreed in the past to publish a ghostwritten article on the supposed cardiovascular benefits of hormone therapy against cardiovascular and other diseases, according to Fugh-Berman’s report.

Prempro was approved by the FDA for treating menopausal symptoms, but Wyeth marketed the drug as a preventative method for a variety of other medical problems as well.

“Essentially, these articles claimed that Prempro reduces risks while it actually increased risks,” Fugh-Berman explained. “Ghostwriting is common. This study is really the tip of the iceberg. It proves that medical literature has been corrupted.”

A statement from Pfizer said that Fugh-Berman’s analysis neglects the review process to which medical journal articles are subject, however.

“This article completely – and conveniently – ignores the fact that the published manuscripts were subjected to rigorous peer-review by outside experts on behalf of the medical journals that published them, and that their integrity and scientific rigor has even been recognized by multiple courts,” Pfizer said in a statement.

And according to Fugh-Berman, the practice of ghostwriting is not uncommon in the medical community. Recent studies estimated that 10 percent of articles in the medical literature are ghostwritten.

“Ten percent is a big underestimate,” Fugh-Berman added. “That’s just the people who admit it.”

The ghostwritten articles were meant to diminish concerns that hormone therapy may cause breast cancer and to defend claims that Prempro offers benefits such as the prevention of cardiovascular disease, Parkinson’s disease, dementia, vision problems and wrinkles, according to Fugh-Berman. She said she feels that these claims are unfounded.

A large, federally funded trial by the Women’s Health Initiative concluded that Prempro increases the risk of invasive breast cancer and blood clots, which can cause strokes. It also reported an increase in the risk of cardiovascular disease, countering claims from ghostwritten Wyeth articles that declare that Prempro decreases cardiovascular risk.

DesignWrite, a medical education and communications company, was paid $20,000 per article for ghostwritten reviews of the drug. The company would then present the articles to physicians who would agree to “author” the reviews in medical journals.

Wyeth also allegedly paid $25,000 per article for four primary publications, or publications that report clinical trials, concerning findings by the Women’s Health, Osteoporosis, Progestin and Ed9 Estrogen (HOPE) study.

Since the FDA does not regulate medical journals, drugmakers can use ghostwritten articles to promote non-FDA approved uses of their drugs or to affect perceptions about their drugs without FDA regulation. Physicians who agree to “author” these articles are presented with complete drafts, and the original writers are often uncredited.

Physicians often rely on medical journals to keep up with changes in the medical field. Ghostwritten articles that are meant to promote a product can compromise the integrity of peer-reviewed journals.

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