WASHINGTON -- The manner in which pharmaceutical companies market their products to people who have hemophilia appears unprecedented and direct-to-consumer marketing should be examined by regulators, say researchers who reviewed documents, including consumer-oriented materials, produced by the makers of hemophilia treatment products.
The PLOS Medicine "Policy Forum," published June 14, was written by Adriane Fugh-Berman, director of PharmedOut, and two former graduate PharmedOut interns (who are now physicians). PharmedOut is a Georgetown University Medical Center project involving physicians, researchers, students and other volunteers who promote evidence-based prescribing and educate health care professionals about pharmaceutical marketing practices.
Marketing directly to people with hemophilia, the trio reports, begins when patients are young -- through camps, school scholarships, internships, awards and career counseling -- and continues into adulthood with gifts, grants and jobs.
They say this strategy is effective because "[People with hemophilia] often make their own decisions about what product they use, which is acknowledged by factor manufacturers," the authors write.
Fugh-Berman, an associate professor at Georgetown University Medical Center, and co-authors Phillip Kucab, MD, a resident at Detroit Medical Center, and Katelyn Dow Stepanyan, MD, a resident at UCLA, say the marketing takes place against a background where optimal strategies for hemophilia treatment and prophylactic regimens remain uncertain.
The authors say personal relationships are a key factor in the marketing strategies. They say it is common practice for physicians to serve as spokesperson for pharmaceutical industry, however, "In hemophilia.... patients and their families are recruited by factor manufacturers for employment, consulting roles, or advisory boards," they write.
"We know companies focus promotional efforts on people with hemophilia because patients specifically tell their physicians which products they want to use," Fugh-Berman says. "This one-on-one marketing is extraordinary and has never before has been documented. These companies make a great deal of money from their clients, and spend millions on individual promotion to foster brand loyalty."
Demonstrating the costs involved, the authors compare the sales of a best selling drug, Lipitor, to hemophilia products. In 2011, the international market for hemophilia products was $8.5 billion, compared to $12.5 billion for Lipitor, a statin used to treat high cholesterol. The difference, Fugh-Berman says, is that there are about 500,000 people worldwide with hemophilia (20,000 in the U.S.) compared to millions of individuals who use Lipitor.
The authors call on regulators to review how pharmaceutical companies directly market to and interact with consumers -- pointing out that the U.S. regulates pharmaceutical industry marketing strategies that target physicians.
They also suggest that the federal government should require comparative research on the benefit of different blood agents (which vary considerably in price) and different regimens-- none of this research has been done, they add.
The authors report no funding for the study was received. Fugh-Berman is a paid expert witness in litigation regarding pharmaceutical marketing practices. Kucab, who has hemophilia, cited some of his personal experiences in the research. He is on the Multidisciplinary Advisory Board for Bayer Health Care, on the board of directors of the World Federation of Hemophilia USA, and is a consultant for the National Hemophilia Foundation. Stepanyan reports no disclosures.
About Georgetown University Medical Center
Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC's mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award (UL1TR001409-01) from the National Institutes of Health.