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Medical Research for Hire

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

Jill A. Fisher
Copyright Date: 2009
Published by: Rutgers University Press
Pages: 272
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  • Book Info
    Medical Research for Hire
    Book Description:

    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

    eISBN: 978-0-8135-4593-6
    Subjects: Health Sciences

Table of Contents

  1. Front Matter
    (pp. i-vi)
  2. Table of Contents
    (pp. vii-viii)
  3. Acknowledgments
    (pp. ix-xii)
  4. Chapter 1 Clinical Trials: Coming Soon to a Physician Near You
    (pp. 1-18)

    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...

  5. Chapter 2 Governing Human Subjects Research
    (pp. 19-32)

    At root and by definition, the clinical trials industry would not be possible without the participation of human subjects. Although it is a highly regulated industry, the research terrain has changed significantly since the United States enacted laws in the 1970s to protect human subjects. To date, there has been little explicit examination of how the development of a for-profit clinical trials industry might influence research practices and ethics and what regulation might be necessary under these new conditions of medical research.¹ By examining the organization of pharmaceutical clinical trials, the limitations of and problems with current federal policies governing...

  6. Chapter 3 Pursuing Contract Research
    (pp. 33-65)

    On my first visit to a large practice, I interviewed Richard,¹ a white male physician in his mid-forties who was actively involved in pharmaceutical contract research and had conducted roughly 250 studies since the early 1990s. That day, there were nearly forty studies operating out of his private practice with a dedicated research staff to oversee them. In addition to his impressive experience with drug studies, Richard had a range of organizational and business experiences in the clinical trials industry: he had worked on clinical trials in an academic setting as part of his residency training, in his private practice...

  7. Chapter 4 Coordinating Clinical Trials
    (pp. 66-96)

    Ruth,¹ a charismatic white woman in her early fifties, welcomed me into her office in the clinical research facilities of a large, successful obstetrics and gynecology private practice. Having worked at the investigative site for more than eight years and at another site for several years prior to that, Ruth had much to tell me about the clinical trials industry. Ruth juggled several roles at the site: research coordinator, recruiter, and “regulatory specialist.” At the time of my second interview with her, she had recently been promoted and was transitioning to the position of site director.

    Ruth explained to me...

  8. Chapter 5 Monitoring the Clinical Trials Industry
    (pp. 97-125)

    One Wednesday evening, I drove to an airport hotel for an interview with Evelyn,¹ a clinical research associate, or “monitor,” at a large contract research organization (CRO). Her company was based in another region of the country, and this was the last evening she was in town before returning home from a two-week trip during which she conducted three site visits in three cities in the Southwest. Because her only “office” while in town consisted of a back room at the investigative site she was there to monitor, she suggested we meet for the interview in the hotel lobby.


  9. Chapter 6 Recruiting Human Subjects
    (pp. 126-157)

    Early in 2005, I received a message on my answering machine. The call was from a company specializing in clinical trials on healthy human subjects and was part of a general recruitment campaign for their facility in the southwestern United States. The woman calling reminded me that I could earn money by enrolling in any of the company’s active recruiting studies:

    This message is for Jill Fisher. We are [a clinical trials company], calling just to advise you of current studies we have available that you are qualifying for. They are very good studies currently running, and it’s good, easy,...

  10. Chapter 7 Mobilizing Informed Consent
    (pp. 158-179)

    During my fieldwork, I had the opportunity to sit in on an informed consent visit for a study to test the safety of an experimental treatment for Alzheimer’s disease. The prospective human subject was a seventy-five-year-old Latina woman, who was accompanied by her middle-aged son. They had found out about the study through a print advertisement in a local newspaper, and the son had made the appointment for his mother to be screened. The clinical trial was being conducted out of a dedicated investigative site not affiliated with a private practice.

    The tone of the informed consent visit was educational....

  11. Chapter 8 Cultivating Pharmaceutical “Compliance”
    (pp. 180-207)

    Although the majority of my informants seemed to be people who really enjoyed their jobs in the clinical trials industry or who had positive experiences participating in drug studies, I occasionally interviewed someone who was dissatisfied with contract research. One such informant was Anne,¹ a veteran nurse turned disillusioned research coordinator. At the time of our interview, she had been working as a coordinator for eighteen months; she had been in her current position eight months, a personal record for her given that she was already on her third coordinator job. During the interview, it was obvious that she was...

  12. Chapter 9 Changing Markets in Pharmaceutical Research
    (pp. 208-216)

    The broader context of health care in the United States shapes the organization of pharmaceutical clinical trials. Physician-investigators who conduct studies for pharmaceutical companies and patient-subjects who participate in them do so largely in response to limitations in the structure of health care delivery. The majority of private-sector physicians become interested in drug studies in order to increase their income. Many patient-subjects enroll in clinical trials as their only means to access any medical attention for their illnesses, and others see drug studies as an extension of care from their own physicians. Meanwhile, healthy-subject clinical trials enroll impoverished, largely minority...

  13. Appendix: On Methods
    (pp. 217-220)
  14. Notes
    (pp. 221-244)
  15. Index
    (pp. 245-258)
  16. Back Matter
    (pp. 259-260)