On Research Ethics & Private Physician-Investigators
Jill Fisher (Women & Gender Studies - Arizona State ) has authored a fascinating, provocative new article in the latest Social Science & Medicine entitled Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials.
Here is the Abstract:
This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first on historical studies of physicians as investigators and then on 12 months of qualitative fieldwork in the Southwestern US, this paper analyzes the shifting, contextualized ethics that shape physicians' relationships with patients/subjects and pharmaceutical companies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceutical companies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities.
I agree with many of the author's arguments and conclusions, though not all of them. For example, while many scholars have noted the errors in the traditional belief that human participants research prior to WWII was not governed by norms, it hardly follows from the fact that such research was norm-governed that the norms that did govern were ethical. To infer otherwise would be a rank instance of the naturalistic fallacy. Thus, the fact that the author's research suggests a continuity in the way that "physicians continue to develop their own codes of ethics in response to their professional roles and responsibilities" does not imply that these constructions are ethically adequate.
Still, the author's conclusion seems sound to me: "Although physicians are not immune to the critiques of the bioethics community and the mainstream media regarding their work, they construct their sense of what is ethical through their everyday practices in the clinic in relation to the needs of the pharmaceutical industry and their own business bottom-lines."
Recommended.
Recently published on www.brainblogger.com
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
Posted by: Dan | May 24, 2008 at 04:14 PM