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9 Clinical Research and the Limits of Commercial Interests In an editorial in JAMA, Bruce Psaty and Drummond Rennie considered the ethical legitimacy of the decision on the part of a sponsor to stop a clinical trial before sufficient data were gathered to yield scientifically valid results. e early termination of a comparative investigation of different treatments for high blood pressure was the occasion for the editorial. No rationale except “business considerations” was given to the investigators by the sponsor for the decision to end the study early. Psaty and Rennie recognize that, though drug companies are private businesses, “the recruitment and involvement of human research participants places clinical trials in a category decidedly distinct from the customary swapping and trading of ordinary goods and services.”2 Subjects volunteer to be involved in an undertaking which, though it may not provide benefit for themselves , is expected to benefit others through the contribution it makes to medical knowledge. An Institutional Review Board (IRB) that is doing its job well would not give approval for a research project involving human subjects to proceed without a Medical research, even if it is conducted by the pharmaceutical industry, is not solely a commercial enterprise designed to maximize personal gain or company profits. The responsible conduct of medical research involves a social duty and a moral responsibility that transcends quarterly business plans or the changing of chief executive officers.1 120 Marketing to Healthcare Professionals reasonable expectation of scientifically valid results. Stopping the research prematurely prevents it from providing any useful medical information and thus breaks covenant with the volunteer participants ; it exposes them to some risk without a justifying benefit of valid medical knowledge. e authors’ argument is valid: “If the conduct of a seriously underpowered study is unethical, the willful creation of an underpowered study by the early stopping . . . seems unethical as well.”3 e legitimate reasons for stopping a clinical trial early include safety concerns and insufficient patient enrollment. ese decisions should be made by an independent data and safety monitoring board (DSMB), not by the sponsors. In the case of the blood pressure trial, the DSMB recommended against stopping. In undertaking clinical trials of medications, drug companies are engaged in a scientific undertaking, not just or primarily a commercial venture. Clinical drug trials, whether done by academic scientists or by private for-profit companies, are scientific studies and need to be conducted with a commitment to the ethical standards of research using human subjects and a commitment to scientific objectivity. In clinical research, both scientific integrity and protection of the rights of human subjects take priority over commercial interests. In a 2004 study published in JAMA that received considerable news coverage, researchers reported that even “normal” blood pressure was risky in patients with coronary heart disease and that they can benefit from medication to lower their blood pressure further.4 e New York Times article on the publication of this study is, perhaps, a signs of the times. e reporter not only described the study findings and the reactions of some medical experts but also pointed out that the study was sponsored by Pfizer, the company that makes a drug used in the study, and that the company saw the manuscript before it was submitted for publication . e story also included the statement that “Virtually all experts not employed by the government have been paid consultants for drug companies.”5 e objectivity of researchers, essential to good science, is not (or no longer) automatically assumed. As more and more people become aware of the interactions between industry and researchers, these interactions are being 121 Clinical Research and the Limits of Commercial Interests subjected to critical analysis and review. An Associated Press story followed up the report of an expert panel on cholesterol guidelines with a story entitled “Doctors’ Ties to Drug Firms Questioned.”6 Eight of the nine were making money from the companies whose cholesterol-lowering drugs they were urging upon million more Americans. Two own stock in them. Two others went to work for drug companies shortly after working on the guidelines. Another was a senior government scientist who moonlights for 10 companies and serves on one of their boards.7 e fundamental question is whose interests are being served by these financial and other ties. Practicing physicians and the public can have trust in scientific studies and literature reviews only if there are high standards to protect scientific objectivity and clear evidence that these standards are rigorously adhered...

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