A Controversial Medical Education Program, With (Pharma) Strings Attached
In December, Sen. Charles Grassley, R-Iowa, sent a letter to Mitchell A. Leon, the president of DesignWrite Inc., the company that has now become Exhibit A in the unfolding ghostwriting scandal that has medical journal editors everywhere combing through their submissions looking for fakes.
Grassley made it clear that he was not pleased with rumors that DesignWrite may have ghostwritten at least three journal articles. It now has come to light, through legal action by the New York Times and the medical journal PloS Medicine, that the company had been hired by Wyeth to produce at least 30 journal articles that would be signed by researchers and medical doctors to give them the imprimatur of independence and scientific rigor.
DesignWrite was outed by Susanne Rust and John Fauber of the Milwaukee Journal-Sentinel in January as part of a triumvirate with Wyeth and the University of Wisconsin that had created the official sounding Council on Hormone Education to help Wyeth overcome the damaging evidence about hormone therapies that threatened to derail the sales of some of the company's top selling drugs.
The conclusions were clear: Women who took hormone therapy drugs were at increased risk for breast cancer, heart disease, stroke and blood clots.
The findings were so strong that researchers stopped a clinical trial in 2002, five years early, because it would have been unethical to continue giving the drugs to women.
But that same year, the University of Wisconsin-Madison's School of Medicine and Public Health began a medical education program for doctors that promoted hormone therapy, touted its benefits and downplayed its risks.
For the next six years, thousands of doctors from around the country took the online course that was funded entirely by a $12 million grant from Wyeth Pharmaceuticals, which makes the hormone therapy drugs used in the study, Prempro and Premarin.
The university received $1.5 million of that total, and university faculty received money as well.
Even after the course was no longer available, the Web site and course material remained on the Internet, accessible to consumers and doctors. The university dropped the site Jan. 15, one day after the Journal Sentinel began questioning UW officials about the propriety of the program.
DesignWrite is part of a vast industry of Medical Education and Communication Companies (MECC). Health writers can take some great lessons from the Journal-Sentinel in finding local stories about how these companies operate.
1. Where did that that new institute at your school come from? The University of Wisconsin is a public school, and Rust and Fauber gathered as much public information as they could about the origins of the institute, the finances behind it and its influence. One great lesson: take digital images of those pages when you find them. (Or use my favorite tool, Snagit.) The fact that the university took the site offline the day after the newspaper started asking questions was damning evidence, but it could also have undermined the story had the reporters not been thinking ahead. Instead, they were able to post a nice screen shot with their story showing the council's logo on the UW site: a book with angel's wings. What could be more reassuring than that?
2. Which esteemed faculty members are on the company dole? The Journal-Sentinel found that "Thirty-four of the 40 council member physicians have financial ties to Wyeth, including the course director, Julie Fagan, a UW doctor and associate professor of medicine." They reviewed financial disclosure forms that the faculty members had to file with the university. Honest researchers also will note their financial ties when they are publishing research. Look for the fine print.
3. Is the science solid? The Journal-Sentinel went to the leading experts in the field and had them review the course materials being used by the council. The head of the Women's Health Initiative, which was behind the clinical trial in 2002 that was halted because of concerns about patient safety, said the materials were unsound scientifically and "failed to strive for any balance." Raymond Gibbons, a Mayo Clinic professor 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." This is a great technique for any health story and one of the pillars of good medical care: a second opinion.
Is there anything wrong with drug companies producing research, publicizing it and sharing it with medical professionals? Of course not.
Drug companies, like insurance companies, are easy to vilify, but they don't deserve a fraction of the ire heaped on them. They are staffed with some of the brightest scientists in medicine. They create medications that save lives and improve lives every day. What health writer doesn't have a copy of The Merck Manual on their shelf?
Drug and device makers should be proud of their work and let people know when they are involved in research, not hide behind some Hallmark-y council. Health writers can nudge them in the right direction by keeping tabs on the studies they are funding, the courses they are overseeing, the researchers they are paying and the journal articles they are writing.