Conflicts and Scientists Social Duties

Professional researchers are the public's and policymakers' most important source of scientific expertise. Government agencies that evaluate biomedical proposals and projects must rely on scientists to analyze the safety and efficacy of research and products. Scientists also serve as reviewers for governmental grant applications and as authors, editors, and referees for professional publications. Conflicts of interest arise when industry, regulatory agencies, government committees, and editors all seek out the same individuals—a likely prospect when many of the most talented researchers have already-established commercial interests (Culliton).

Few scientists will purposely present biased conclusions, but researchers' commercial interests may influence their professional life in other respects. Scientists might be hesitant to participate in the evaluation of an industry with which they maintain a financial connection. Following a large oil spill on the California coast in the late 1960s, for example, government investigators found it difficult to recruit scientists willing to testify against the oil companies. Most qualified scientists had commercial ties to the industry (Kenney). When a medical journal sought independent reviewers to judge the quality of a research study showing the lack of benefits of a popular drug—a study whose publication the company manufacturing the drug was attempting to suppress on the grounds that the study was badly designed— the editors discovered that virtually all scientific experts in that field had existing financial ties to the company (Rennie). Corporations frequently employ researchers as consultants to determine if their facilities meet governmental health standards or if their new product induces disease. A researcher's desire to please the employer and to preserve the potential of future affiliations may influence the study design and methodology selected for the investigation. A study that monitors employee health for only a short time, for example, would be less likely to uncover an occupation-related disease with a long latency period. A corporation facing liability for a suspect drug would prefer its researchers to find that the product presented no danger and was not responsible for the maladies suffered by current users (Ashford; Porter, 1992a, 1992b).

Similarly, reviewers of grant applications may have commercial interests that unconsciously lead them to undervalue a potential competitor's proposal. Journal referees may denigrate articles or reports that threaten their commercial interests or their industry employer. A researcher with a consulting arrangement or an equity interest in a new development might tend toward findings that would laud the benefits of the innovation. In one egregious case, a researcher who owned over 500,000 shares of biomedical stock altered a study design to delay the release of negative findings until he could sell his holdings for a tremendous profit (American Medical Association). Physician-researchers with commercial interests in innovative treatments or research protocols bear additional responsibilities. A central tenet of medical professionalism holds that the welfare of the patient be placed before any benefit to the physician. If a physician-researcher is testing an experimental therapy, the patient must be protected from risks of undue harm from either the experimental drug itself or from withholding standard therapy. Physician-researchers with financial interests in their protocol might tend to recruit subjects aggressively, playing down the risks and exaggerating the benefits associated with the research. In a highly publicized case in which a young man died during experimental gene therapy, both the investigator and the university had financial interests in the biotechnology firm that planned to market the drug if it proved successful, and it was charged that substantial, known risks were not disclosed to the subject (2001).

During the 1990s a considerable change in pharmaceutical research funding occurred in the United States. Companies began to shift research grants away from universities and toward for-profit contract-research organizations (CROs). The CROs promised quicker research results and hence faster licensing of new drugs, compared to the more cumbersome, bureaucratic university system. Between 1991 and 1998, the portion of pharmaceutical industry research funds going to academic medical centers fell from 80 percent to 40 percent (2000). For-profit commercial IRBs sprang up to service the CROs, creating questions as to the adequacy of ethical review when both the IRB and the investigating organization had such strong financial incentives to speed the progress of research and to produce positive results (Lemmens and Freedman). As research funds were shifted to the private sector, university investigators had to compete more vigorously for the remaining funds, increasing the likelihood that both institutions and individuals would ignore serious conflicts of interest in their eagerness to secure funding.

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