Wednesday, September 29, 2010
Menopause: The Scandal (Part Two)
In part one of this post, I introduced some of the admittedly controversial issues surrounding the use of hormone replacement therapy in menopausal women, and I pointed out that the proper forum for scientific debate and medical education is in journals and medical meetings. Furthermore, in order for us to trust the integrity of this education, it should not be funded by the pharmaceutical industry. Let drug companies fund research and advertising all they want--but scientific debate among doctors should be completely independent of a promotional agenda.
This sounds obvious but the current system of CME all too often turns a blind eye to what has become a constant stream of artful transgressions of this principal. Journal supplements have become a key promotional strategy for drug companies seeking to influence prescribing behavior. This fact is hardly news, and such corrupted supplements are a dime a dozen to this day. What is unusual about Dr. Fugh-Berman's recent article about the marketing of Premarin is that she reveals a smoking gun--that is, documentation from Wyeth and DesignWrite showing that the CME was planned with an explicitly promotional intent.
The trail of evidence begins with a proposal for Wyeth submitted by DesignWrite, entitled "Premarin Publication Program" (yes, the pdf is available from the Drug Industry Document Archive at UCSF, and it makes for pretty creepy bedtime reading). On page 3 of the proposal, DesignWrite tells Wyeth exactly what it plans to do in order to get more doctors to prescribe Premarin:
"The specific objective of this program is to 1) increase physician awareness on the multitude of benefits that hormone replacement therapy provides for postmenopausal patients, 2) diminish the negative perceptions associated with estrogens and cancer, and 3) blunt the competitive threat of raloxifene, a selective estrogen receptor modulator, expected to be approved early next year for osteoporosis."
Ghost-writing is big business. Wyeth paid DesignWrite $25,000 per Premarin-boosting article and ended up paying the company several million dollars between 1997 and 2003. They paid a particularly big chunk of cash, $413,140, for a CME meeting and journal supplement. DesignWrite apparently loves producing CME supplements for companies, because, as they say in their publication plan,
"The value of journal supplements is that it allows you to better tailor your marketing message since it is a manufacturer-sponsored publication form. Additionally, reprints of supplements may be purchased and distributed widely among health care professionals via sales representatives and direct mail."
DesignWrite put on a 2001 meeting of Wyeth's hired guns in order to provide content for the supplement. They helpfully produced this outline of what each article should say--basically, they all minimized concerns that HRT causes breast cancer.
Eventually, the supplement was published in 2001 by the journal Women's Health in Primary Care and Wyeth mailed it to 128,000 physician, bought 1,500 additional copies for its sales force, and distributed the supplement to media and “select thought leaders”. In her article, Fugh-Berman publishes a pretty damning table comparing each carefully crafted marketing message with a corresponding sentence as it was published in a CME article. And of course, each article has an identified academic "author," with the actual writer having been an employee of DesignWrite in each case.
All in all, this is a nauseating example of the use of accredited CME to manipulate doctors.