In HOOKED, I cited a study by anthropologist Jill A. Fisher of Arizona State, who conducted ethnographic research in her region of the country on private practitioners who signed up to do research with contract research organizations (CROs) in order to increase practice revenue. Her earlier report was interesting mainly for how research was "sold" by the CROs to the docs ("any idiot can do it"), and how the docs immediately offloaded all the major research tasks onto their lowest-paid office assistants--who then often became very dedicated enthusiasts for the proper and ethical conduct of the trial.
In the present study, Fisher follows up with more analysis of how the physicians themselves viewed the ethics of research. Even though the reason these physicians are attractive to the CROs is that they presumably control a large population of patients, and even though the patients are their patients, Fisher describes a thinking process in which the docs come to see themselves as bound to the interests of the pharmaceutical industry, and not as protectors or advocates for the human subjects enrolled in the studies. For example, when asked why they should not fudge results, some respondents commented not in terms of the ethics of research, but how if your site got a bad reputation you'd lose future CRO business.
I find this intriguing in terms of my own expeience in practice-based research. As an academic family physician, I was for many years involved in a department where a high priority was placed on the creation and sustenance of practice-based research networks, involving private practitioners as well as academics in research, in order to assure that the population on which the study was carried out represented the "real world" of family medicine in the community. These investigators were, as a rule, not paid, and did research as part of their practice beause they thought it was a good thing to do. There were clearly ethical conflicts created by having one's personal family physician also play the role of a resarch investigator--most notably, the way patients could feel pressured to enroll in studies. On the other hand, these docs also became very avid students of research technique and methods, again mostly out of their own interest and commitment--far beyond the simple weekend seminar (with golf thrown in) offered as "training" for the private docs by the CROs in Fisher's sample. So despite the importance of the ethical concerns in both situations, the motives and general thinking of the practice-based primary care physician-investigators and the current crop of CRO recruits seem like night and day. Big surprise--if Pharma pays the piper, Pharma calls the tune; and the piper knows right away whom he works for.
Fisher JA. Practicing research ethics: private-sector physicians & pharmaceutical clinical trials. Soc Sci Med 66:2495-2505, 2008.
Showing posts with label contract reearch organizations; research ethics. Show all posts
Showing posts with label contract reearch organizations; research ethics. Show all posts
Monday, May 26, 2008
Subscribe to:
Posts (Atom)