Ghostwriting for Premarin: Steroids on Steroids

Today's New York Times reveals the not particularly astonishing fact that Wyeth Pharmaceuticals engaged a medical writing company to produce 26 articles pushing Premarin as Hormone Replacement Therapy (HRT) in women from 1998-2005. The articles were outlined and written by writers employed by Design Write, and then were sent to top academics in the Ob/Gyn field, who reviewed them, rubber stamped them with occasionally minor edits, and submitted them to journals under their names. In no case was Wyeth's involvement in funding the articles disclosed.



We've heard this sordid tale before. Last year, an article in JAMA revealed that Merck commissioned ghostwriters to produce dozens of articles pushing Vioxx (see the NY Times coverage here--you'd need a subscription to JAMA to read the original paper by Joseph Ross); Eli Lilly paid ghostwriters to push Zyprexa; and Pfizer-funded ghostwriters generated the majority of articles about Zoloft in the late 1990s, according to the British Journal of Psychiatry.

What to make of all this? The best analysis I've heard yet was provided by Dr. Joseph Ross of Mt. Sinai Hospital in New York, who was quoted in today's paper:

“It’s almost like steroids and baseball,” said Dr. Joseph S. Ross, an assistant professor of geriatrics at Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting. “You don’t know who was using and who wasn’t; you don’t know which articles are tainted and which aren’t.”

In this case, since Premarin is a steroid, Wyeth put its own steroids on steroids. As with baseball players on steroids, when companies pour marketing money into ghostwriting campaigns, they change the rules of the academic game. The playing field is no longer level; the drug company's version of the truth gains the upper hand. Sometimes, their truth really is the truth, but sometimes it's a carefully crafted lie. Sorting it out is difficult even for physicians who specialize in the area being written about. It's essentially impossible for the average generalist physician, to say nothing of patients who did not have the advantage of attending medical school.

As the New York Times article says, some journals now require that all authors detail precisely who wrote what and who was paid by whom before considering manuscripts. It is time for all journals to institute this policy. In addition, several academic medical centers now forbid their faculty from engaging in ghostwriting, a trend that will continue.
As I've said before, it would be nice if those who are caught with their hands in the cookie jar would have the courage to apologize. But nobody involved in this latest scandal is willing to so. Design Write, the company that did Wyeth's dirty work, said that:

[the company ] “has not, and will not, participate in the publication of any material in which it does not have complete confidence in the scientific validity of the content, based upon the best available data.”

Dr. Gloria Bachmann, a professor of Ob/Gyn who rubber stamped an article pushing Premarin for hot flashes and other symptoms, said:

“There was a need for a review article and I said ‘Yes, I will review the draft and make sure it is accurate,’ ” Dr. Bachmann said in an interview Tuesday. “This is my work, this is what I believe, this is reflective of my view.”

And Wyeth's spokesman said that "the articles on hormone therapy were scientifically sound and subjected to rigorous review by outside experts on behalf of the medical journals that published them."

Actually, the proper collective response from all of these participants should have been: "We sincerely apologize for having deceived the medical community by engaging in ghostwriting without disclosure. We have contributed to the erosion of the public's trust in medicine, and we regret it."