September, 2006. Recently, an unusual multimillion dollar grant was awarded to the Cecil G. Sheps Center for Health Services Research at the University of North Carolina at Chapel Hill, unusual because it was funded by a consortium of the attorneys general (AG) of eight states as part of a much larger settlement achieved with Pfizer Pharmaceuticals in a lawsuit brought by fifty states and the federal government. The suit was brought against Pfizer concerning claims of illegal marketing of the anti-epileptic drug (AED) gabapentin (Neurontin) for off-label use to treat several conditions, including bipolar disorder, by Parke-Davis, a company owned by Pfizer since 2000. The researchers at the Sheps Center responded to a request for proposals from the AG consortium, and the funding allows them to carry out a careful scientific review of the literature evaluating the evidence supporting the use of AEDs in the treatment of bipolar disorder, and then to disseminate their findings widely in order to provide fair and balanced information to prescribers about the use of AEDs for this disorder.
This litigation joins a growing public momentum leveling strong criticism at the pharmaceutical industry, questioning the industry's marketing tactics, its policies regarding public release of its sponsored research findings, and its influential role penetrating the world of academic medicine. The Food and Drug Administration, in turn, has been under fire to tighten its standards and to exert greater efforts to warn the public (e.g., with "black box" warnings) about potential dangers of selected medications.
Public safety is, of course, of paramount importance, and there can be no controversy about the need for appropriate caution, for balanced, thorough, and evidence-based information, and for ethical conduct and disclosure of any potential conflict of interest by physicians. It would be a mistake, however, to paint the pharmaceutical industry as the evil empire that seduces vulnerable researchers from the pristine world of clinical medicine. There are good guys and bad guys among us in medicine and among those in industry. I would contend that by far the majority of scientists and leaders in both worlds are attempting to carry out their work carefully and ethically, with the shared goal of improving healthcare. Pharmaceutical companies need to continue to fund the hugely expensive drug development business, while medicine needs to establish and vigilantly maintain an appropriate partnership with the industry, including appropriate safeguards, disclosure requirements, and protection against bias.
In this issue of the Journal, three articles and one clinical case discussion focus on bipolar disorder, reflecting the Journal's commitment to publishing evidence-based information to guide clinicians in their practice-these articles are particularly timely, in light of the recent concern about inappropriate marketing of an AED, described above, for off-label use in the treatment of bipolar disorder. It is only through careful analysis of published, peer-reviewed research that we can move forward to make justifiable, informed, and appropriate clinical decisions, including appropriate prescribing of medications for off-label use, in our best efforts to help our patients.
John Oldham, MD