The pharmaceutical company Parke-Davis employed “the systematic use of deception and misinformation” in order to manipulate physicians into prescribing the drug gabapentin for so-called off-label uses, write two San Francisco VA Medical Center physicians in the New England Journal of Medicine.
The company’s deceptive marketing campaign was, and is, typical of the pharmaceutical industry, the authors say in the NEJM “Perspective” piece (January 8, 2009).
The authors are Seth Landefeld, MD, associate chief of staff of geriatrics and extended care at SFVAMC and a professor of medicine, epidemiology, and biostatistics at the University of California, San Francisco, and Michael Steinman, MD, an SFVAMC staff physician and an assistant professor of medicine at UCSF.
They base their opinion on a review of internal company documents made public as a result of a lawsuit brought in 1996 against Parke-Davis, a division of Warner-Lambert, by a former employee who was troubled by the company’s marketing practices. Warner-Lambert was purchased by Pfizer in 2000.
The suit alleged that the company broke the law in promoting off-label (not FDA-approved) uses of gabapentin, a seizure drug marketed under the name Neurontin. Those uses included treatment of pain, migraine and bipolar disorder. In 2004, Warner-Lambert pleaded guilty and agreed to pay over $430 million to resolve criminal charges and civil liability.
The true significance of the case, say Landefeld and Steinman, is that it brought to light pharmaceutical marketing practices “that may be widespread but remain unseen because companies are rarely prosecuted for illegal marketing.”
Some of the practices employed by Parke-Davis included hiring third parties to create continuing medical education programs designed to promote Neurontin; sponsoring meetings for which moderators and participants received honoraria and other benefits from Parke-Davis; encouraging, financially and otherwise, medical “thought leaders” to promote Neurontin to their colleagues; discouraging the peer-reviewed publication of research results unfavorable to the company’s marketing goals; and sponsoring the publication of favorable research results.
The scientists observe that the campaign was extremely successful, boosting U.S. sales of Neurontin from $93 million in 1995 to nearly $3 billion in 2004 before generic competitors entered the market and took over most of the drug’s market share. “The great majority of those increased sales were for off-label uses,” says Steinman.
The authors draw three main conclusions from the Neurontin case. The first is that because so much marketing material is disguised as education, research, or respected opinion, and is thus essentially invisible, “drug promotion can corrupt the science, teaching, and practice of medicine.”
The second is that “many people and institutions,” from drug company employees to federal agencies, either do not recognize the ethical and legal implications of deceptive drug marketing or fail to exercise oversight and enforcement – and in fact tend to view such practices as “business as usual.”
The third is a recommendation by Landefeld and Steinman, namely that the government and the drug industry work together to greatly increase openness and accountability during the drug approval process “in order to preserve the integrity of medical science and practice.”
They suggest the creation of a National Institute for Pharmaceutical Research that would support independent peer-reviewed drug trials. “This would fund important drug studies in a manner that could avoid putting the sponsor in direct conflict of interest with the outcome of the study,” says Steinman.
Documents from the Neurontin case are available online from the Drug Industry Document Archive (DIDA) at the UCSF Library. The archive, a fully searchable record of company marketing strategy reports, internal correspondence, and descriptions of company-sponsored activities, is located at http://dida.library.ucsf.edu.
The views expressed in the “Perspective” article and in this press release are those of the authors and do not necessarily reflect the official views of the Department of Veterans Affairs.
SFVAMC has the largest medical research program in the national VA system, with more than 200 research scientists, all of whom are faculty members at UCSF.
UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.