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

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

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

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

Synopsis

Today, more than 75 percent of pharmaceutical drug trials in the United States are being conducted in the private sector. Once the sole province of academic researchers, these important studies are now being outsourced to non-academic physicians.

According to Jill A. Fisher, this major change in the way medical research is performed is the outcome of two problems in U.S. health care: decreasing revenue for physicians and decreasing access to treatment for patients. As physicians report diminishing income due to restrictive relationships with insurers, increasing malpractice insurance premiums, and inflated overhead costs to operate private practices, they are attracted to pharmaceutical contract research for its lucrative return. Clinical trials also provide limited medical access to individuals who have no or inadequate health insurance because they offer "free" doctors' visits, diagnostic tests, and medications to participants. Focusing on the professional roles of those involved, as well as key research practices, Fisher assesses the risks and advantages for physicians and patients alike when pharmaceutical drug studies are used as an alternative to standard medical care.

A volume in the Critical Issues in Health and Medicine series, edited by Rima D. Apple and Janet Golden

Excerpt

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 . . .

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