Doctors Behaving Badly: Gynecologist has "excellent" adventure with pharma ghostwriter

In a fascinating piece in the New York Times, Natasha Singer detailed how Dr. Gloria Bachmann leapt at the chance to sign her name to an article she had not written.

According to the Times, DesignWrite, a ghostwriting shop in Princeton, N.J., was hired by Wyeth around 1997 to help build a body of evidence in legitimate research journals about the benefits of post-menopausal hormone therapies like Wyeth's Premarin to treat hot flashes and other ailments, part of a two-year plan that would include 30 articles.

Wyeth had overcome fears in the 1970s that Premarin caused endometrial cancer. The company claimed that if Premarin were combined with another hormone called progestin - "combination hormone therapy" - it lowered the cancer risk. Sales shot back up. In the 1990s, the company turned the two-pill therapy into one, calling it Prempro.

In July 2002, the Women's Health Initiative, a federally funded study, revealed that the risks of taking Prempro outweighed the benefits, showing that women who had taken the drug long
term had higher rates of breast cancer, heart disease and stroke.

So DesignWrite had a bit of a mountain to climb in 2003 when it started putting together a paper touting hormones for treating menopausal hot flashes and night sweats. A DesignWrite ghostwriter produced a detailed, 14-page outline. In July, the company sent it to Bachmann, the associate dean for women's health at the Robert Wood Johnson Medical School in New Brunswick, N.J. The company had to know that getting Bachmann to sign on to the article would be a coup. The board-certified gynecologist had published dozens of articles related to menopause and hormone therapy, and she had recently been given the President's Community Service Award from the American College of Obstetrics and Gynecology.

But the company did not have to do much selling. Bachmann quickly approved the outline, gushing in an email:

"Outline is excellent as written. I would like to try for publication as a review article in Obstetrics and Gynecology. We would have to change the title of the manuscript to Vasomotor symptoms: evidence based treatment options - or a title that emphases [sic] the data driven writing style. Let me know if this is acceptable to you."

Pleased, no doubt, with both the enthusiasm and the deference, DesignWrite went to work on a draft of the article based on the outline, sending it to Bachmann in September 2003. Once again, Bachmann effused.

"I reviewed the entire article and it is excellent. I only had one correction, which I highlighted in red. I don't think that it needs any more drafts. It is the best article that I have come across on this topic. The table is definitely outstanding. Overall, this is an A plus article!"

Again, the DesignWrite ghostwriters had to have been grinning from ear to ear. Any health writer would cry if an editor sent them an email like that.

The article, "Menopausal Vasomotor Symptoms: A Review of Causes, Effects and Evidence-Based Treatment Options," was submitted to The Journal of Reproductive Medicine as if it were an original piece of work authored by Bachmann. It was published in the March 2005 edition of the journal. Singer writes:

It described hormone drugs as the "gold standard" for treating hot flashes and was less enthusiastic about other therapies. The acknowledgments thanked several medical writers for their "editorial assistance," not disclosing that those writers worked for DesignWrite, which charged Wyeth $25,000 to generate the article.

Bachmann told the Times:

"There was a need for a review article and I said 'Yes, I will review the draft and make sure it is accurate.'... This is my work, this is what I believe, this is reflective of my view."

The article states clearly at the bottom of the first page, "Financial Disclosure: The author has no connection to any companies or products mentioned in this article."

This statement would not be true, of course, if the true author of the piece had been named.