Tuesday, January 29, 2013

The Downside of the Informed Consent Juggernaut by John F. Peppin

This Academy should have no interactions with the pharmaceutical industry.” This statement paraphrases a speaker at the American Academy of Pain Medicine annual 2010 meeting. Such hubris and arrogance I have come to expect from academics, especially when we are dealing with notions of conflict of interest. It is such speakers who have caused the rush to limit Health Care Professionals (HCP) interactions with the pharmaceutical industry, apparently ignoring all other potential sources of conflict of interest—e.g., sexual orientation, political commitments, professional reputation, and religious affiliation–and arguing instead that all financial conflicts of interest should be eliminated. When presented with the story that follows the speaker above had little to say. But it was obvious he hadn’t anticipated, or didn’t care about, the negative consequences of such policies.

In January of 2002 a small group of HCPs met and formed an organization dedicated to a multidisciplinary approach to the treatment of chronic pain. This group had a desire for pain treatment education but also a drive to develop a distinctive format, multidisciplinary and interactive. The Iowa Pain Institute (IPI), a nonprofit educational organization, was born out of this desire and drive. I was one of a small group of individuals who founded the Iowa Pain Institute. Never wanting it to be “my group,” I declined to accept the presidency. I, and the other founders, wanted this group to be autonomous of its founders, something that would continue without our input and help, a goal almost achieved. Further, although some of us were academically affiliated (I consider myself a “recovering academic”) we wanted the group to be free of the conflicts of interest involved in such an affiliation.

The group and its events grew way beyond the expectations of its founders. For eight years this group operated monthly with a regular attendance of over 50 individuals. The group’s goals and mission were to develop a multidisciplinary interactive setting for education and investigation into the treatment of chronic pain. Chiropractors, nutritionist, physicians, nurse practitioners, physical therapist, nurses, physician assistants and others attended. The physician group was a mix as well–neurologists, pain physicians, anesthesiologists, surgeons, physical medicine and rehabilitation physicians, internal medicine physicians, family practitioners and others. The format for the monthly meetings consisted of a formal presentation on a disease state with case studies. These were interspersed with a journal club format.

The pharmaceutical industry funded these meetings; however, it was made clear that the content was the sole responsibility of IPI and its leadership. Not once in our eight–year history was there any pressure or pushback on content from the industry representatives who so generously sponsored our events. The industry proved generous, compliant with our group’s policies and more than willing to help our group with its goals and mission. As an example, a meeting might focus on osteoarthritis. The speaker would present an overview of the disease of osteoarthritis, then present one or more cases including x–rays. An in depth discussion would ensue suggesting different approaches, pharmaceutical and well as non–pharmaceutical.

The members would meet at a local restaurant at 6 P.M. for networking time followed by the meeting at 7 P.M. The meeting would last roughly 2–hours. There was a membership fee of $25 per–year, which allowed the members free attendance to each sponsored event. Unsponsored meetings did occur on occasion. The topics during these non–sponsored meetings were usually non–pharmacologic, e.g., the physiology behind Chiropractic Medicine. The leadership was voluntary, consisting of a President, Vice–President, Secretary and Treasurer. During the hours before the actual meeting, members were able to discuss with health care professionals with whom they might have little, if any, interaction during their work day. Cases were discussed; treatment efficacies and new treatments were reviewed during these informal discussions. The members would then sit and the meeting would begin. The meeting was focused on education, not on organizational bureaucracy. A speaker would present an overview of a disease state. This would include epidemiology, etiology, diagnosis and treatment. On occasion there would be demonstrations of diagnostic skills and findings. In discussing treatments the leadership was explicit that generic names should be used as much as possible and additionally treatment discussion should include both pharmaceutical and non–pharmacologic approaches, if possible. After this presentation, an open interactive discussion of the disease with questions and answers occurred. Frequently, case studies were included illustrating the disease state. Two similar groups started from the IPI example—one in Kansas City and one in Omaha. Both were successful, albeit with different formats and memberships. Neither is currently still in operation to my knowledge.

Helping to develop and run this organization was a tremendous event in my life. Numerous experiences occurred because of my involvement in IPI, which changed my approach to the treatment of pain and gave me a distinct appreciation for other, and in many cases very different, approaches to that treatment. For example, when the group was started, a good friend of mine who is a neurologist (the two of us were the initial impetus in starting IPI), strongly encouraged us to include chiropractors. As a physician who had osteopathic training, I was frankly skeptical. However, my friend was very persuasive and we included this group of HCPs. In doing this, I believe, many of us who had not had professional exposure to chiropractors developed a strong appreciation for the skills they had to offer. After this realization, I would routinely call these individuals, now friends, and ask their advice, on occasion even taking x–rays to their offices for review. Furthermore, the membership was completely open; if you were an HCP and had an interest in or treated pain patients, you were welcome. In addition, the IPI had a strong representation of psychologists who specialized in chronic pain patients. It became quickly apparent to me and others in the group that this resource was underutilized and necessary in the treatment of pain. Because of this realization and the utilization by club members, one group had to hire another full–time psychologist to keep up with the referrals. Medical, nursing and pharmacy students found the IPI very instructive. They would routinely attend, and those students who rotated through my clinic as part of their medical school training were required to present a short article review to the group. This would usually occur before the main presentation of the evening. These were always well done and educational for all in attendance, as well as being very good experience for the students involved. Furthermore, it gave the students an appreciation for the complexities involved in the treatment of chronic pain, as well as the professionalism and desire for quality care that existed amongst those in our group.

The success of this group is quite remarkable. There are rare multidisciplinary groups who meet regularly in any area of medicine but especially whose focus is on the treatment of pain. Furthermore, the evenings were opportunities for networking and discussing different approaches to a pain trigger’s treatment.

A major part of the success of this group was due to the financial support of the pharmaceutical industry. Unfortunately, the IPI was dissolved in 2010, almost 8 years to the day of its inception, the victim of misguided and arrogant notions of “conflict of interest.” Then came the PHARMA code and FDA oversight and one of the few multidisciplinary educational opportunities that occurred locally and on a monthly basis was gone forever.

The current notion of conflict of interest manifested in the PHARMA code and FDA requirements is a juggernaut based on political philosophies rather than good, quality evidence and is seemingly unstoppable. Unfortunately, there are casualties that have occurred because of this political juggernaut, and the IPI demise is one such example. There are no multidisciplinary pain clinics in the state of Iowa; organizations like the IPI fulfilled a tremendous need, the only potential for such a multidisciplinary interaction in the state and one of few nationwide. A format for multidisciplinary interactions, discussions, case studies and education in the treatment of pain in the state of Iowa does not currently exist. Although one could argue that committed professionals should attend such things and pay their own way, without sponsorship the reality belies such thoughts. Furthermore, many of those who attended were not wealthy or highly paid. Physical therapist, psychologist, nurses, students and many others were able to attend because of the industry sponsorship. In addition, the pragmatics of organizing meetings monthly for such a large attendance is very difficult to attempt without regular sponsorship. The government and academics are happy to make pronouncements of what we should not do and what we should think, but were certainly not forthcoming in funds to continue activities such as those illustrated by IPI. Sadly, IPI was allowed to die without comment from those in the hallowed halls of academia and government.

Copyright © 2011 The Johns Hopkins University Press. Narrative Inquiry in Bioethics, volume 1, issue 2. Used with permission.

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