University of Wisconsin + Wyeth = Biased CME

In the fall of 2002, the Women’s Health Initiative stopped its NIH-funded clinical trial of hormone replacement therapy, because women randomized to receive hormone therapy (estrogen + progesterone) had more breast cancer, heart disease, and strokes than those not taking the drugs.

This presented Wyeth, the manufacturer of the implicated drug Prempro, with a problem: a potentially catastrophic loss of income.

They responded the way drug companies generally respond when their product is shown to be hazardous. They ramped up their marketing. They criticized the methods of the study. They emphasized the need to weigh risks vs. benefits.

And, according to this riveting article from the Milwaukee Journal Sentinel, Wyeth deployed an army of ghostwriters and academics to create a one-sided $12 million CME program which is under investigation by the Senate Finance Committee.

According to the article, Wyeth hired a marketing communications company called DesignWrite which teamed up with UW Medical School to create an organization they named “The Council on Hormone Education.” This council was composed of 40 academics in the field, 34 of whom had ties financial ties to Wyeth.

It is unclear if the members of the council actually created any course content or if they simply were paid to put their names on CME articles written by DesignWrite ghostwriters. At any rate, the council stamped its name on 16 CME newsletters, the stated goals of which were "to develop and disseminate balanced, accurate, timely and consistent information about hormone therapy" so doctors could "better serve women."
The newsletters included articles such as "A Perspective on WHI (the Women's Health Initiative)," "Choosing the Right Therapy for Postmenopausal Osteoporosis" and "Sexual Desire Disorder in the Postmenopausal Woman."

Sounds pretty academic.

But when John Fauber and Susanne Rust, the investigative reporters, showed the materials to independent experts in the field, here were the reviews:

--Jacques Rossouw, chief of the Women's Health Initiative branch of the National Institutes of Health said, according to the paper, that “the views expressed in the course are not those of the general scientific community and are not suitable for a university medical education course.” "There is a history of this kind of thing from Wyeth," Rossouw said. "The materials regurgitate lines that I have heard and read many times, and I have come to believe (though I do not know) that this is part of an overall marketing strategy to the profession. It is not good science because it fails to strive for any kind of balance."

--Raymond Gibbons, a professor of medicine at the Mayo Clinic and former president of the American Heart Association, “said he also found material relating to heart disease one-sided. He noted that the materials inappropriately gave observational data equal weight to rigorously done, randomized clinical trials. ‘It's a lot of post hoc analysis,’ he said. ‘I don't see the other side of the argument.’"

-- Marcia Stefanick, an investigator with the Women's Health Initiative, told the Journal Sentinel that “since the results of the first large clinical trial on hormone therapy were released in 1998, drug companies have been trying to minimize the concerns….They are very eager to keep coming up with ways to show it isn't harmful….There is this constant attempt to get women back into it."

--Anthony Scialli, an adjunct professor of obstetrics and gynecology at Georgetown University's School of Medicine, put it simply: "It is pure, undisguised marketing.”

And what is the University of Wisconsin, the ACCME-accredited sponsor of the program, saying and doing? First, they immediately pulled the program from their website after the Journal Sentinel started asking inconvenient questions. Second, an apparently very embarrassed George Mejicano, who is director of UW’s CME programs, is not giving the straightest of answers. For example, when asked if the course had received criticism, he is quoted as answering: “Yes and no. It’s complicated.”

It’s not really so complicated. UW took in $1.5 million from Wyeth to help them advertise Prempro in the guise of CME. Money clarifies the mind and sharpens incentives.

Meanwhile, UW is involved in several other ongoing big ticket CME initiatives. These include:

--Pfizer’s $12.3 million smoking cessation program. Pfizer happens to make Chantix, an embattled smoking cessation drug.

--Boehringer Ingelheim’s program on restless leg syndrome . The company happens to make Mirapex, a drug for RLS.

-- Bayer HealthCare Pharmaceutical’s course on premenstrual dysphoric disorder. Bayer happens to make Yasmin, an oral contraceptive being touted as a good treatment for…yes, premenstrual dysphoric disorder.

If you want to enjoy these advertisements, you’d better get on it. I’ll wager that the chastened university will be soon be shutting down these websites as well!