Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials

Chapter 1: Clinical Trials: Coming Soon to a Physician Near You

A woman and her son wait for the doctor to see them. The doctor, however, is no longer a clinician. Instead, the white male neurologist has transitioned from treating patients to conducting clinical trials for the pharmaceutical industry. To do so, he has converted his private practice into a research center . Running studies in diverse therapeutic areas, including Alzheimer’s disease , arthritis, diabetes, gastrointestinal disorders, and psychiatric illnesses, the doctor recruits and enrolls human subjects in drug studies through mass media advertisements. This physician is not alone. Pharmaceutical companies are increasingly contracting with private-sector physicians to conduct their studies. Clinical research responds to U.S. federal regulations mandating that pharmaceutical products be tested on human subjects to ensure safety and effectiveness before they are made available on the market. This physician, like many others, has successfully established a company to profit from drug development. On this particular day in December 2003, I am shadowing the doctor as part of an extended interview regarding his involvement with pharmaceutical clinical trials. He has invited me to observe his interactions with human subjects and their families so that I will have a better sense of his role. One of these interactions is with the woman and her son. The human subject in this case is the son, a ten-year-old boy who is enrolled in a pediatric study to test the efficacy of a treatment for attention deficit hyperactivity disorder (ADHD). Because the purpose of this visit is to assess how well the investigational treatment is working to alleviate the symptoms of ADHD, the doctor asks a 1 Chapter 1 Clinical Trials Coming Soon to a Physician Near You 2 Medical Research for Hire series of questions that are primarily directed to the mother. She explains that, from her perspective, her son seems to be noticeably more “mellow,” but she has concerns about the drug because the boy’s teacher is still complaining about his disruptive behavior in the classroom. Although the teacher’s impressions of the boy’s behavior could be construed as anecdotal or incidental to the clinical trial, they are of primary concern to the woman. This working-class family has no health insurance, so standard medical care is not an option for the woman to address her son’s disruptive behavior in the classroom. Under pressure from her son’s teacher, the woman has turned to a clinical trial as a means both to provide some sort of treatment for her son and to prove to the teacher her own commitment to addressing the problem. The situation of neither the physician nor the woman and her son is unique. In the past two decades, the pharmaceutical industry has reorganized the clinical testing of its products. Currently, about three-quarters of studies in the United States are conducted in the private sector by nonacademic physicians who recruit their own patients or local community members into drug studies.1 Over 60,000 of these studies take place in the United States each year, accounting for 75 percent of the 80,000 clinical trials conducted worldwide ; to execute these studies, more than 50,000 U.S. physicians registered with the Food and Drug Administration (FDA) as principal investigators on one or more clinical trials in 2001.2 As for the human subjects, 3.62 million Americans participated in pharmaceutical clinical trials in 2003 alone.3 What explains such staggering numbers of Americans engaged in the business of screening new drugs? The expansion of pharmaceutical clinical trials in the private sector can be seen as addressing two problems in U.S. health care: decreasing revenue for physicians and decreasing access to treatment for patients. Physicians report diminishing income due to restrictive relationships with insurers and government agencies, ever-increasing malpractice insurance premiums, and inflated overhead costs to operate private practices. As a result, many physicians are attracted to pharmaceutical contract research because it is perceived as a lucrative field. These physicians are hired as investigators to conduct predefined study protocols that have been developed by scientists and project managers at pharmaceutical companies.4 As contract investigators, they have no input on study design, inclusion-exclusion criteria dictating which human subjects can enroll in the study, or interpretation of the study results. The participation of physicians instead involves following the instructions of the pharmaceutical companies Clinical Trials 3 in administering the investigational product, collecting the...