Often, the drug company then finds an academic to accept a research grant to serve as lead author of the resulting article — and frequently as its paid “opinion leader,” who may receive honoraria for talking up the product through the company’s “speaker’s bureau,” at continuing medical-education courses, and elsewhere. Harvard, Tufts, Boston University, and other local medical schools and teaching hospitals are filled with professors receiving such honoraria; the Integrity in Science Project Web site (cspinet.org/integrity/index.html) has a searchable database of them. “The more prestigious the institution, the more likely the industry associations,” says John Abramson, clinical instructor at Harvard Medical School and author of Overdosed America. “The drug companies understand who the key opinion leaders are.”
The changing nature of research so concerned the editors of more than a dozen top medical journals — including the New England Journal of Medicine, the Journal of the American Medical Association, and Annals of Internal Medicine — that in September 2001, they wrote in a group letter that, until recently, “academic, independent clinical investigators were key players in design, patient recruitment, and data interpretation in clinical trials.... This may be a thing of the past.” As a result, they announced a new policy that required those seeking publication to disclose exactly who performed what duties on the research and authoring of each submitted paper.
But those disclosures rarely make it into the news articles, Internet forums, and doctor small talk that help increase the number of prescriptions written, boosting sales. In particular, clinical-trial results with an academic institution’s name on it do something that a drug company legally cannot: promote “off-label” use of a drug, or prescription for maladies for which it has not received FDA approval.
Yahoo.com’s Healthwise encyclopedia tells us, for instance, that Ortho Tri-Cyclen, along with other birth-control pills, “are commonly used” to treat dysfunctional uterine bleeding. The only clinical study of Ortho Tri-Cyclen’s application for that purpose — finding it to be “an effective use” — came in 2000 from Ann Davis of Beth Israel Deaconess Medical Center. Not only was Beth Israel paid by the manufacturer, Ortho-McNeill (a Johnson & Johnson subsidiary), to host the study, but Davis was also a consultant for Ortho-McNeill and a member of its speakers bureau. Not only that, but all four of her co-authors on the Healthwise article were Ortho-McNeill employees. (Davis, now at NEMC, did not return calls from the Phoenix.)
Davis is not the only medical specialist whose name and institution have fronted research — co-authored by the very same four Ortho-McNeill workers — suggesting off-label uses for Ortho Tri-Cyclen. One or more of those Ortho-McNeill employees appear as co-authors on journal articles by Mass General’s Steven Grinspoon, reporting that Ortho Tri-Cyclen may improve bone density; from the University of Pittsburgh, on the use of Ortho Tri-Cyclen to restore hair growth; from Scott & White Memorial Hospital, in Temple, Texas, on the use of Ortho Tri-Cyclen for menstrual-cycle control; and from the Center for Health Studies, in Beechwood, Ohio, and the University of Palermo, in Italy, on the use of Ortho Tri-Cyclen to treat acne.