Monday, May 26, 2008

The Private Physician as For-Profit Researcher: Ethical Problems

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.

1 comment:

Anonymous said...

Recently published on

The Human Injury of Lost Objectivity

If I were to rate the corruptive tactics performed by big pharmaceutical companies, the intentional corruption of implementing fabricated and unreliable results of clinical trials by pharmaceutical companies by hired third parties who manipulate these trials they sponsor because of their power to control others involved in such trials that is largely absent of regulation would be at the top of the list, and likely the most damaging to the requirement of authenticity and, more importantly, assuring the safety of the public health, as I understand that this does in fact occur.
Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of meds. Then, in 1980, the Bayh-Dole Act was created, which allowed for such places to profit off of their discoveries that were performed for pharmaceutical companies in the past. This resulted in the creation of for-profit research trial sites, called Contract Research Organizations, which is often composed of community research sites with questionable investigators possibly void of necessary research experience or quality regarding their research purpose and ability. Since they are for- profit, with some CROs making billions of dollars a year. The trials conducted at such places are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their med being studied in the trial. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner has been transformed into a method of marketing, which includes altered results of the trial to favor the sponsor’s med. Their activities are absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit what may be a collusive relationship between the site and the sponsor.
Further disturbing is that once the creation of the trials is completed, they are then written by ghostwriters often, although no one seems to know how often. These people are not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers, as one does not need research training or certification in order to perform this function. Rarely do trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the sponsor. Also, these hired mystery writers are known to make about 100 grand a year. This activity removes accountability and authenticity of the possibly fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to be placed on the trial that likely had no involvement with the trial, and, along with others, was paid by the sponsor for doing this deceptive act.
To have the trial published, the sponsor pays a journal to do this in various ways, I understand, such as purchasing thousands of reprints of their study from the journal. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers and research sites to support the pharmaceutical industry. So benefits of meds studied in such a malicious way potentially can harm patients and their treatment options and safety risks. The purchased reprints are distributed to the sponsor’s sales force to share the content with prescribers which may lack validity.
Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns, if in fact true based on reports by others. If so, our health care treatment with meds is now undetermined in large part with such corruptive situations, as well as the possible absence of objectivity that has been intentionally eliminated. Trust in the scientific method in this type of activity illustrated in this article is absent. More now than ever, meds are removed from the market are given black box warnings. Now I understand why this may be occurring.
Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method. More importantly, research should not be conducted in a way that the sponsor can interfere in such ways described in this article, requiring independent sites with no involvement with the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters. Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health. Knowledge is power, and is also possibly a lifesaver.

“Ethics and Science need to shake hands.” ……. Richard Cabot

Dan Abshear