When that happens, “the design of the study … likely is selected by the drug company to achieve the best results,” says Dariush Mozaffarian of Brigham and Women’s Hospital and Harvard Medical School.
Nevertheless, two-thirds of medical-school-research administrators accept industry-sponsored clinical-trial contracts that forbid their scientists from altering the study design, according to a survey published last year in the New England Journal of Medicine, authored by Michelle Mello of the Harvard School of Public Health. Nearly that many accept contracts that do allow the sponsoring company to alter the design. Less than a third find it unacceptable for the sponsor to store the data and “release portions” to the school’s scientists, and half think it’s okay for the sponsor to write the article, as long as the academic researcher “may review the manuscript and suggest revisions.”
With such constraints imposed by industry and embraced by so many sponsoring academic institutions, how can the work of even the best-intentioned researcher be trusted? “I think it’s reasonable to be suspicious,” says Harold Sox, editor of Annals of Internal Medicine, one of the world’s top peer-reviewed medical journals. “People don’t have the time to read the fine print, looking for evidence that the researchers had freedom to be scientists.”
Merck, for instance, appears to have controlled virtually everything about a 2002 Annals paper touting the use of alendronate, a/k/a Merck’s Fosamax, on osteoporosis. The article’s lead author was Susan L. Greenspan, then a Harvard Medical School professor and director of the Beth Israel Deaconess Osteoporosis Prevention and Treatment Center, and now with University of Pittsburgh Medical Center. But Merck paid for the recruitment and participation of 327 patients; Merck collected the data from 25 separate facilities; Merck employees took care of “coordinating the early phases of the study” — that is, the design and execution of the trials — and of “providing expertise in study conduct.” And Merck retained control and ownership of the research itself.
Most of these procedural details are revealed in the Annals article’s disclosures and acknowledgments. But such qualifications to a study’s objectivity rarely appear where many people learn about the results: in news articles or on Web sites. In 2001 — the year before Greenspan’s article appeared — Fosamax barely topped $1 billion in sales; in 2003 it made $2.7 billion. (Greenspan did not return calls from the Phoenix.)
Mozaffarian at Brigham and Women’s says he avoids involvement in studies that originate with drug companies. His article in American Journal of Cardiology last December included this disclosure statement: “Pfizer had no role in the study conception, design, implementation, analysis, interpretation, or manuscript preparation.” For that article, he and his colleagues wanted to pursue a hypothesis about the drug in Pfizer’s Lipitor. “So we contacted Pfizer and asked for their database,” Mozaffarian says. Pfizer provided it and also ponied up a grant, while agreeing to have no input or control over the research or results.