My mother's last day

It was a crazy day for my mother, a newly hired physician at a clinic, where she works 3 days a week. By noon, she had already seen 14 patients in 3 hours, she felt very behind on her documentation, and she was starving with no prospect of eating lunch.  Then, a middle-aged man with asymptomatic high blood pressure arrived complaining of “cold” symptoms.  She explained to him that while he did indeed have a virus, his blood pressure was sky high and would require medications to bring it down.  She ordered clonidine for him and he sat down while she went on to see several more patients.

She returned after about an hour to find that his blood pressure was 198/124, unchanged.  Tired, hungry and frustrated, she asked the clinic manager if they had nitroglycerin.  She knew they didn’t. She asked the clinic manager, “How can you not have nitroglycerin?”  My mom then asked if the patient could have a bus token to go to the emergency room for treatment, and the clinic manager said “No, just call an ambulance.”  My mother replied, “An ambulance is unnecessary, he is perfectly stable.” 

The clinic manager proceeded to call 911 despite the doctor’s objection.  At this point, the doctor lost it.  “How can a clinic that has been around this long not be stocked with medications like nitroglycerin and albuterol.  I have never worked in such an ill prepared facility. And it is unnecessary to waste tax payer money on an ambulance for a patient who could simply take the bus.”  The clinic manager disrespectfully retorted, calling her unprofessional, inappropriate and worst of all, she said, “Your patients don’t even like you.” 

My mother, the highly educated, extremely experienced physician, then proceeded to walk out.  She said, “Since you never actually sent me a contract, I have no obligation to stay and work here.  Don’t worry. I won’t be back.  Maybe you can find a different doctor for your patients not to like.”

My mom has been practicing ambulatory primary care for decades, and she has always had one priority: that her patients like her.  She cares more about whether or not they like her than anything else, except their safety.  When I ask her why she doesn’t retire, she always says, “so I won’t go crazy at home with your dad!”

She has related many problems at this family practice in Southern California since she took the part time gig 3 months ago.  She complains regularly about the usual stuff:  “Everybody wants Vicodin and Percocet and Soma and Xanax for chronic pain that has no obvious cause.  They want a 4 month supply with 3 or 4 refills.  They are crazy.  But even when I say no and explain why it is not safe, they complain, and the medical director writes the prescriptions for them behind my back!”  She had never been so pressured to write narcotic prescriptions at this level in her career and could not believe the lengths the clinic would go to please the patients, despite safety concerns. 

She told me about the ridiculous number of unnecessary tests the medical director encouraged the physicians to order, including annual MRIs of joints causing chronic pain.  When she asked him why he had ordered an MRI of the shoulder on a patient she had seen weeks before to whom she spent a lot of time explaining why she did not need the test based on her physical exam, the medical director replied “Why are you wasting time doing a physical exam?  Just order the test, it’s what she wanted.”

My mom could retire at any moment.  She does not depend on her job for income to survive, and she certainly does not have to support a family or anyone through college at this point in her life.  I can only imagine how pervasive these dilemmas are for practicing physicians out there in the community who do.   I wonder how often physicians must submit themselves to risky, expensive practices that have questionable efficacy because some clinic manager who works for some administrator says “the patient is always right.”  I'm guessing, daily, maybe hourly.  

As physicians, we are supposed to be stewards of society’s health care resources. We hold a fiduciary duty to our patients and society.  We are to put everyone’s welfare above our own.  I mean, ultimately, many of the patients demanding narcotics are dead as prescription opioids now cause more accidental deaths in this country than car accidents.

But, how realistic is it to expect that level of sainthood from physicians?  We are human, too.  We have student loans, mortgages, spouses and children to support.  And even when we take it upon ourselves to put the welfare of society and patient safety above all else, we are often met with disrespect, disdain, and even threats to our paycheck.  And the real kicker is that our own colleagues often undermine our medical decisions just to get ahead.

All I can say is wow, this the real deal: the US healthcare system.  Good luck with your fix, feds.  You have no idea what you’re dealing with.

Komo Gursahani MD MBA

Fellow, Bander Center for Medical Business Ethics

Saint Louis University School of Medicine

Recognizing and Managing Our Conflict of Interest by Laura Jean Bierut

One day I found that I was listed as an inventor on a patent application, and this event has changed my view of conflict of interest in academic medicine and industry.

My patent grew out of my investigation into genetic contributions to the development of addiction. My colleagues and I successfully applied to a program offered through the National Institute on Drug Abuse (NIDA) for a large–scale genetic study of smoking. This project combined the skill of our academic research team with the expertise of our industry partner, a high tech genetics company, to search for genetic contributions to smoking. Our university–based academic team brought in knowledge of the disease under study (smoking and nicotine dependence) and DNA samples from subjects who consented to participate in genetic studies. The industry partner contributed the large–scale genotyping. NIDA played the role of matchmaker for this arranged marriage between academia and industry.

I entered this project with my background as a professor in psychiatry at Washington University School of Medicine. From my viewpoint in a medical school academic setting, the major products produced by professors were papers published in academic journals, research programs funded by grants, courses offered to students, and clinical training provided for residents. Though there are parallels with industry, many differences exist. The greatest contrast was in the speed of the project and the view on “products” which were to be developed. Our industry partner had clear short–term goals and milestones in this research program, and I was impressed with the pace of their work and the clarity of their vision. This speed was in contrast to the typical pace of scientific decision making in an academic medical center where many options must be carefully considered before action may be taken. With our industry partner, this project took less than two years from start to finish, which included publication.

Towards the end of our collaborative research project, our industry partner applied for a patent, “Markers for Addiction”, which described our genetic findings as a possible diagnostic test for a person’s addictive potential, and I was listed as an inventor. The patent application was initiated and submitted by our industry partner, and then my colleagues and I were informed of the application. This patent came as a surprise to me from my academic viewpoint. My academic colleagues and I considered our results in this study to be a discovery about the genetics of developing nicotine dependence, which added to scientific knowledge about addiction. We had not conceptualized the results of our study as an invention, and this patent application was a concrete example of the contrast of cultures between academia and industry. Our partner identified a potential product, a predictive test for developing a nicotine dependence that could someday be marketed, and the patent application reflected our industry partner’s logical goal of protecting the intellectual property from our discovery.

Once I was listed as an inventor, a cascade of events unfolded, which gave me further insights into the world of industry and issues in conflict of interest. After I informed my university oversight board about the patent, I was told that I had a conflict of interest. Prior to this patent, I viewed a conflict of interest as something which was improper and to be avoided. Overnight I became one of “those people” who had to add a disclaimer slide during presentations or publications. I was concerned that others would question my scientific judgment. However, my conflict of interest experience soon changed my viewpoint.

A conflict of interest is a situation where a personal interest presents a risk of influencing one’s professional duties. Once I started to examine my potential conflict of interest resulting from this patent, I began to realize that a conflict of interest was present in my academic job and did not require a connection with industry. We all know of famous cases of falsified scientific results which were published in high impact journals. The falsification of results is often the consequence of the inherent conflict of interest within research groups—a high impact publication is more likely to lead to further research funding and personal gain of the investigative team.

On a more personal level, I woke up one day to find that my own original data had been published in a prominent journal by another research team prior to the end of the NIH embargo period—the time an investigator has to publish her analysis of data before data sharing rules permit others to publish analyses of the same data (Holden, 2009). Perhaps the error was inadvertent, but it deprived me the opportunity to be the first to publish data I worked hard to collect, and it was likely driven by the same dynamics that drive data falsification: The desire to obtain the funding and recognition needed to sustain a lab in an academic environment.

Next, I came to understand that a conflict of interest may not represent a negative situation but can point to a productive research program. For example, we all hope that scientific research will lead to a new diagnostic test or treatment that lengthens life and reduces morbidity. A company may invest in this new test or treatment so that it can be marketed for patients, and a conflict of interest would arise for the investigators. The Bayh–Dole Act, adopted by Congress in 1980, is meant to encourage this entrepreneurial spirit in researchers and permits universities, small businesses, and non–profit institutions to pursue and retain ownership of inventions that arise from research funded by the U.S. government. For example, without the prospect of obtaining a patent for our discovery, it is unlikely that our industry partner would have invested time and money into this genetic study aimed at smoking prevention and cessation—important public health goals for the US.

So how have my views of conflict of interest changed? First, I believe we all have many potential conflicts of interest in our work. Secondly, instead of viewing a conflict of interest as a negative mark, I see that a potential conflict of interest can represent a successful research program that has moved out of academia into a useful product marketed by industry. One goal of academic medicine is for us to recognize and manage these potential conflicts of interest—regardless of whether they arise from collaboration with for–profit enterprises or from the competitive nature of academic medicine—and to manage them.

References

Holden, C (2009). Paper retracted following genome data breach. Science, 325, 5947: 1486–1487.

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

Crossroads: The Intersection of Personal, Professional Society, and Industry Relationships by William H. Seitz Jr. and Edward Diao

Being hand surgeons who have been researchers, educators and clinicians, responsible for the education of medical students, residents, fellows and peers, who by necessity have worked with industry to develop new products, for which we have been compensated, we have always represented our involvement and potential conflicts in all of our professional activities. As such, we have been tapped over the past ten years by The American Society for Surgery of the Hand (ASSH) to develop and expand its relationships with industry to support our mission of education, research and innovation. This work was begun long before the investigation by the Department of Justice of improper personal relationships between orthopedists and industry.

We helped provide a peer–reviewed process for education and display of industry’s new technology at our annual meetings, which financially fueled our ability to enhance the quality of the meetings. This included the development of “hands–on” skilled workshops where industry provides surgeons opportunity to physically utilize new technology in a simulated surgical environment. The industry participants were charged a fee for this opportunities, and very quickly these opportunities became highly sought after by industry and significant revenues were generated. This provided feedback for industry from the surgeon participants to improve their equipment and, at the same time, it provided surgeons with access in a single venue to become familiar with new technology. In turn, the revenues generated provided financial support to reduce the overall cost of the annual meeting to our membership. Additionally, the development of this partnership with industry lead to interest in industry providing support for education and research as well as educational grants to allow more young surgeons to attend the annual meeting. Last year industry supported fifty $1,500.00 scholarships for residents and fellows as well as armed forces surgeons to attend our annual meeting.

Thus began the formation of relationships of “no–strings–attached” philanthropy by industry to promote meaningful research, which has itself helped direct industry to pursue new frontiers of product development. For the past three years our industry partners have contributed substantially to increase the amount of available funds in our philanthropic foundation (the American Foundation for Surgery of the Hand). In turn, we have been able to substantially increase the amount of dollars awarded annually as research grants to our member applicants. This “seed money” has in turn been used to perform research which has additionally garnered substantial full–funding in the form of R01 grants from the National Institutes of Health and other similar organizations. Industry has had the opportunity to ask that their funds be used for research in certain areas (arthritis, soft–tissue, trauma, etc.). This allows them to evaluate current cutting edge research being done by our members and helps them focus on new frontiers of development as they plan their future goals and activities.

This evolutionary process has led to the development of the Corporate Advisory Council (CAC). The CAC has addressed issues of compliance and has generated a list of “Ten Commandments” of Ethical Society/Industry behavior, which can serve as a model for any professional society, and which has led to the publication of a white paper on this topic.

In these pages, we want to tell a story illustrating how potential “conflicts of interest,” if well–managed in terms of guidelines and transparency, can be used to enhance the delivery of health care by a professional society setting a very high “moral bar” and assuring strict enforcement of guiding principles as it brings physicians and industry together.

About ASSH

For over 50 years ASSH has been a leader in the advancement of the science and practice of hand surgery and upper extremity surgery to ensure competency of its members and ultimately the betterment of our patient’s lives. This has been accomplished through an extensive array of courses, meetings, development of educational materials and specialty training curricula. Dissemination of information and knowledge takes place through rigorous oversight at the ASSH Annual Meeting, on–going continuing medical education (CME) meetings throughout the year, its peer–reviewed specialty journal (The Journal of Hand Surgery), and the publication of multiple text and multi–media educational tools.

We believe education and the dissemination of information is a dynamic process as there is a constant need to find new solutions for unsolved existing problems. This requires investigation through multiple layers of clinical and bench research. The ASSH also recognizes this through its partnership with its philanthropic organization. The American Foundation for Surgery of the Hand (AFSH) has been committed to raising funds to support meaningful research in the field of hand and upper extremity surgery. Meanwhile, the practical translation of these efforts into clinical practice requires the manufacturing and marketing and dissemination capabilities of our corporate partners in industry. We, many of our colleagues who are members of the ASSH, and our patients have benefited by our partnerships with industry through the development of improved implants, instrumentation, and fixation devices intended to enhance our ability to deliver surgical care. The development of these products and systems has required the resources of industry that bring not only financial support but engineering and manufacturing capabilities. The evolution from concept to prototype to working system requires a “hand–in–hand” partnership between the surgeon and industry. The ASSH has functioned as a platform on which that partnership can be built.

Because annual member dues, journal subscription rates and attendance fees at meetings and courses are capable of raising only a fraction of the resources needed to meet this mission, outside funding and support made possible by providing a platform for industry to present its new technology through the sale of exhibit space at the Annual Meeting and advertising in the journal, is key to ASSH’s ability to provide all these benefits to its community. Non–CME skills courses allowing industry and its surgeon champions to demonstrate their new technology have also been a source of revenue to support this mission.

To monitor and develop clean and ethical relationships, in 1999 the ASSH Council Board formed the Corporate Relations Committee. All industry relations (conflicts) of any officer or any person presenting educational research data through the Society has been clearly stated and recorded for public awareness.

For example, any surgeon presenting information within any ASSH CME educational forum who gains royalties, research support, consulting fees, stock revenues, etc., must clearly declare such involvement prior to presentation. This declaration unequivocally alerts the audience to the possibility of bias in the presentation and therefore intensifies the level of scrutiny (appropriately) in evaluation of the quality and validity of the information being presented.

Recent Events

In 2005 the United States Department of Justice (DOJ) investigated the five largest orthopaedic companies regarding unethical behavior and kickbacks to surgeons, essentially as an inducement to utilize their products.

Despite having already developed a “no–strings–attached firewall” to maintain an ethical relationship with industry, the ASSH leadership and its key industry partners recognized the importance at this juncture to form a combined leadership council, the Corporate Advisory Council (CAC) to set specific guidelines as a model for all medical societies to follow in their corporate relationships. This process has been undertaken to, “enhance education, improve research for patient care; encourage fairness and consistency; enhance communication between industry groups and physicians, while managing conflict of interest” (American Society for Surgery of the Hand, 2010).

At the corporate advisory council meeting in July 2009, a working group consisting of members of the ASSH leadership, the ASSH executive staff, key representatives of multiple upper extremity device manufacturers and leaders of the American Foundation for Surgery of the Hand poured over documents and resource materials to become intimately familiar with guidelines that had previously been drawn. Many of the corporations had adopted their own guidelines to follow regarding their interactions with physicians as “the physician consultants” and in regards to physician education and marketing, which were carefully studied.

Additionally, we reviewed guidelines from the ADVAMED and PhRMA groups in response to the United States Department of Justice (DOJ) investigation of the five largest companies. The CAC also noted and studied the individual approaches each company and organization had taken on their own to be in compliance in the absence of any specific standards established by the DOJ. In our review, we found that there was no evidence of any previous guidelines, which had been established by any Medical Society or Specialty Society on a voluntary, pro–active basis for its physician membership. Nor was there any evidence that any medical society and corporate group had worked together to develop specific guidelines for the appropriate and essential interactions between the two groups.

The CAC, through all of its membership components, felt strongly that in the area of upper–extremity care, patients would benefit when physicians and industry interact on product development, surgical education and performing outcomes studies to verify the efficacy of common surgical procedures. Our goal was to involve our corporate partners in drafting a set of guidelines that would support ethical interactions between physicians and industry while improving patient care.

The outline of this labor with multiple multidisciplinary panels is the “Ten Commandments” of Society/Industry professional behavior and are listed here:

1. Industry is strongly encouraged to support educational activities to increase knowledge and the skills necessary to improve patient care through the American Society for Surgery of the Hand (ASSH).

2. Industry is strongly encouraged to provide support for research through the American Foundation for Surgery of the Hand (AFSH). The subject and content of the research will be determined by the ASSH/AFSH. Corporations will not control the content of supported research.

3. The ASSH/AFSH will clearly define research programs and methods of selection of topics and researchers receiving donated funds. The AFSH will provide annual updates to donors on the use of those funds.

4. Physicians will be consulted and involved in the development and design of new products as deemed necessary by the device company following a comprehensive review of the specific project requirements as well as the physicians’ credentials, qualifications and expertise on the subject matter by the company.

5. Consulting and design activities will be reimbursed by industry at a fair market value on a per–activity or per–time basis. No ASSH members will accept gifts, funding for companion travel, sponsorship of a recreational activity, entertainment, or sports event.

6. ASSH members and industry will be parties to explicit contracts regarding the scope of service and reimbursement for service.

7. ASSH members will not demand or accept unreasonable reimbursement for travel, meals, and lodging, for being involved in an educational activity.

8. All funding to support education and research will be controlled by the ASSH and AFSH.

9. Companies will not influence the control of educational or research activities.

10. All relationships will be disclosed and readily available to the public (American Society for Surgery of the Hand, 2009).

Evolution of “No–Strings–Attached” Support for Research and Education

Recognizing that financial resources previously set aside by industry for marketing purposes would not fit these guidelines moving forward, frank discussions have been held between the ASSH, AFSH leadership and leaders of corporate members of the CAC to discuss and develop mechanisms to ethically support future research and education in non–conflicted ways. Clearly, the potential exists for bias in research when directly funded by industry. Prior to the DOJ investigation, it was common practice for individual corporations to directly fund resident and fellowship education through grants directly to training programs. There existed a tacit “quid pro quo” of training residents and fellows in the use of that company’s products. Similarly, industry supported research had the potential for significant bias. The “ten commandments” were developed to mitigate and ideally eliminate such behavior in the future.

Through the AFSH/ASSH “future in–hand” campaign designed to raise $4 million dollars over a 3–year period, independent and non–conflicted contributions from our corporate partners added to member donations have enabled us to increase research grant awards from $75K–$100K dollars annually previously, to over $200K–$230K dollars, currently. These seed grants have translated into the realization of $2.4 million dollars of secondary R01 grants from entities such as the National Institutes of Health. In addition, corporate commitments to funding upper extremity fellowships through a totally independent, non–conflicted 501c3 entity (AFSH) has enabled us to begin the development of a new 2–year Complete Upper Extremity Fellowship pilot program.

An additional initiative taken by the ASSH to more quickly improve and enhance patient care has been a market research initiative. The ASSH leadership has recognized that industry has the resources and incentives to develop new and better technology, while the ASSH members as a collective have broad and deep insights as to how resources could best be employed to solve the “unsolved problems” in upper extremity care, using their own clinical experience to guide their opinion. In response, the ASSH has developed detailed questionnaires that delve into the areas of greatest need for hand surgery in terms of new solutions and new products to facilitate new solutions. The initial response to the survey was a 32% response rate within a 2–week time period. This extraordinary response yielded a rich collection of information that is being collated to meaningful data to be shared in the near future with our corporate partners.

At the 2010 ASSH Annual Meeting there was the first ever Symposium presentation on the relationship between ASSH and Industry, reviewing many of these points and outlining the vision we have for future collaboration, with both industry leaders and ASSH leaders presenting their views in an open forum to all attendees.

The guidelines we have developed as a society translate into a daily code of ethics for our individual members in their dealings with industry. They also provide a framework of ethical behavior for industry from its highest leaders to its local representatives. They serve as an educational tool to provide a framework of behavior for medical students, residents and fellows as they embark on their careers in Hand and Upper Extremity Surgery. Moreover, they are translatable to any realm of medicine.

References

American Society for Surgery of the Hand. (2009). Hand surgeons take ethics into their own hands: Hand surgeons take leadership role in industry relations to ensure patient care. Retrieved from Media release page Online Web site: http://www.assh.org/media/releases/Pages/HandSurgeonsTakeEthicsintoTheirOwnHands.aspx

American Society for Surgery of the Hand. (2010). Relationship between industry and hand surgery: Ethics and Code of conduct [PDF Document]. Retrieved from Annual Meeting Archives Symposium 10 Notes Online Web site: http://www.assh.org/AnnualMeeting/AnnualMeetingArchives/Symposia%20Handouts/05_011_SYMP10.pdf

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

Welcome to the Forum on Medical Business Ethics

Welcome to the Bander Center's Forum on Medical Business Ethics. The Forum will serve as a repository for stories by physicians about how business relationships affect their practice of medicine and conduct of research. The first installments are borrowed from a project that was led by several Bander Center affiliates. In 2011, we published a symposium in the journal Narrative Inquiry in Bioethics on Conflicting Interests. The "narrative symposium" included 10 stories by physicians and two commentary articles.

We thank the Johns Hopkins University Press for allowing us to reprint these stories. It is our hope that physicians will regularly contribute new stories to this Forum. We are using a Blogger technology to host the Forum to enable moderated discussion. Faculty may use these stories freely in educational programs that serve physicians and physicians-in-training.

Best, James M. DuBois

The Evolution of Conflicts of Interest in a New Subspecialty: A Case Study of the Development of Interventional Cardiology by David M. Zientek

I entered medical school four years after Dr. Andreas Gruentzig performed the first coronary angioplasty in a human, and soon became fascinated with the field of cardiology. The result of Gruentzig’s research led rapidly to the development of a new subspecialty, interventional cardiology, which attracted many young and aggressive cardiologists. Having trained and begun my interventional career in the early years of the field, I have been in a unique position to observe how conflicts of interest have evolved in the field. While many of the conflicts, which my colleagues and I have faced, are ones faced by most physicians and have remained stable throughout my career, there are several which are unique to a newly–developing field, and the nature and types of conflict evolve as the subspecialty matures. As an interventional cardiologist with an interest in medical ethics, I have struggled with many of these conflicts in private practice. I have agued that a conflict of interest occurs when a physician places him or herself or is placed in a situation in which it is likely that he or she may compromise moral obligations to an individual patient or society in general. It is important in looking at one’s individual practice to recognize that a conflict of interest is present when there is a potential to breach one’s obligations out of self–interest, rather than only when such a breach has occurred.

In a fee-for-service medical system, interventional cardiologists face many of the same conflicts of interest faced by any procedure–oriented specialty. Once Medicare and other insurance companies agreed to reimburse for coronary angioplasty, and later intracoronary stents, there was a financial incentive to perform these procedures. In a new field such as interventional cardiology in the early days, there were few guidelines for appropriate use of the procedure. Indeed, many performed large numbers of these procedures not for a monetary gain, but because of an honest belief that treating coronary artery blockages which appeared severe enough to reduce blood flow to the heart would lessen mortality and prevent myocardial infarction with a much less invasive procedure than a coronary bypass. Many have joked about the “occulostenotic reflex:” it is extremely difficult to see a severe narrowing of a coronary artery, even if it is causing no symptoms, and not feel compelled to treat the lesion. Indeed, despite being well aware of the literature, most of my colleagues and I still struggle with this tendency. Yet even as evidence mounted that angioplasty and later stenting of the coronary arteries did not reduce cardiac mortality or myocardial infarction in those with stable angina (rather than those presenting with unstable angina or acute myocardial infarction), and should be reserved for treatment of refractory symptoms on medical therapy, large numbers of procedures continued to be performed.

Financial incentives certainly contributed to the growth in interventional volumes. Two recent high–profile cases in Maryland and Texas accuse the involved cardiologists of having performed a large number of coronary stent procedures on patients with very mild lesions. In one case it was noted that after a particularly busy day in which the cardiologist implanted 30 coronary stents, the company which manufactured the stents treated the physician and his staff to a pig roast in his backyard. While financial incentives may have played a role in these most egregious cases, it is also difficult to change physician’s intellectual biases, which are ingrained early in development of a specialty, that intervention prevents infarction or death. In addition, it is hard for the interventional cardiologist to override patients’ and referring physicians’ perceptions that a significant stenosis must be intervened upon. Thus, the cardiologist who strictly follows published data has a conflict because this may cost him or her patients and referral sources. I have certainly felt pressured at times in my career to perform interventions when I felt medical therapy or coronary bypass grafting were the preferred treatment. While these types of conflicts involving financial incentives and intellectual biases may be common to all physicians, there are several conflicts which are more unique to newly emerging fields.

In the early years of interventional cardiology, the technology and techniques used in the field expanded in a rapid fashion. These were truly exciting times in which many of my colleagues were literally inventing devices in their garage, then taking them to a manufacturer for further development and marketing. Several of these devices, such as directional atherectomy, which used a directed rotating blade to cut out plaque, had brief periods of great popularity before large–scale studies demonstrated that they were no more effective than simple balloon angioplasty, and have since largely disappeared from the armamentarium of the interventional cardiologist. With many of these devices, the inventors became financially involved with the manufacturing company. They often did the initial research and initially presented the findings to national meetings. Often, even if study results were not favorable to their device, they would argue that the procedure had not been done correctly, or that the study looked at the wrong questions. These early pioneers faced many conflicts: the intellectual bias toward the device as an inventor and early investigator, the financial bias given patents and investment in the manufacturer, and the fact that many of the inventors became very high profile and respected representatives of the field. For interventional cardiologists in practice, it was often difficult to determine the objectivity of these pioneers as they presented their data and served as “cheerleaders” for their devices. There was very little guidance from professional organizations on controlling conflicts of interest for device inventors with regard to their involvement in clinical studies, or their investment in manufacturers other than a growing requirement to disclose investment or employment interests at meetings (usually by a brief slide at the beginning of a presentation).

While the inventors had clear conflicts, interventionalists in private practice had more subtle conflicts. In the rush to appear to patients and referring physicians as the most progressive cardiologist, there was pressure to quickly adopt the latest techniques before they had been validated by large–scale studies. This on occasion conflicted with patients’ best interests when a well–validated alternate therapy was available. Many of us rushed to become involved in clinical research as this gave us significant marketing potential by having access to the latest devices, and remuneration for enrolling patients in research significantly supplemented some of my colleagues’ income. In addition, even when large–scale studies were performed on a new device, the initial indications were often for a very limited patient population. When new devices were approved, however, they were often rapidly applied to different patient populations for whom the initial research did not apply. Thus, the line between “investigational therapy” and “standard care” can become blurred.

As the field has matured, there continue to be conflicts for those physicians involved in developing new devices; however, as fewer truly unique techniques are being put forward, these have become less prominent. New issues have surfaced during the evolution to a mature field. As large–scale studies were completed on the new devices driving the development of the field, professional societies recognized a need for guidelines that would lay out the appropriate indications for the use of new technology. Typically, these guidelines were and are developed by committees of experts in the field. However, as with research on new devices, the experts often have close ties to the device and drug manufacturers. Hence, concerns have been raised about the difficulty of forming a committee which will not have biases toward certain techniques or devices in which the committee members may have an intellectual or financial interest.

Beyond guidelines looking at appropriate use of devices, it has become apparent that high–volume interventional centers and high–volume interventional clinicians tend to have better patient outcomes, and there have been recommendations for minimum volume criteria to continue performance of interventional procedures. The current recommendation is that interventional cardiologist should perform a minimum of 75 cases a year to maintain competence, though there is some leeway for those performing procedures at a high–volume experienced center. Many groups and centers have not adopted a strict cutoff for intervention. However, to achieve board certification in interventional cardiology, the current procedural requirement is for 150 cases in the preceding two years, or in occasional cases a log of 25 consecutive cases may be submitted. In addition, some large group practices and hospitals are now requiring this minimum volume. While these guidelines are laudable, I have experienced and observed several potential unintended conflicts of interest that arise when volume requirements are put in place. Will the operator who has a relatively low volume now have added to the financial conflicts of fee for service procedures the incentive to intervene on cases that do not fit strict guidelines simply to keep up privileges rather than focusing on the best possible therapy for the patient? In addition, in large groups where physicians may increasingly be sub–specializing in particular techniques even within interventional cardiology, will there be competition among members of the same group for patients to keep up numbers? Or will the interventional cardiologist take on a more complex case than he or she normally would, rather than referring the case to a colleague who may be more competent for such cases, in order to maintain a defined volume?

In summary, conflicts of interest are common to all fields of medicine. While many of these conflicts are very similar in different fields, newly developing fields provide unique and changing conflicts. Having completed training and started the practice of cardiology during the development of interventional cardiology as a subspecialty has given me a unique vantage point to observe these conflicts. Early in the development of a field, the lack of guidelines and the rapid evolution of new technology lead to conflicts related to involvement in development and research on devices, as well as conflicts related to applying new technology in areas for which it has not yet been adequately studied. As the field matures, conflicts arise from the attempt to standardize care through guidelines and the difficulty posed by the relationships that experts who write the guidelines have with the industry. Finally, while well intentioned, some of the guidelines related to volume might lead to unintended conflicts of interests.

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

A Change of Heart by Andre N. Sofair

I was a resident and chief resident in the Department of Internal Medicine at the Yale University School of Medicine. Here, the relationship between physicians, the pharmaceutical industry, and particular pharmaceutical representatives was a common topic of discussion. Training and later practicing at Yale has had a large influence on how I have chosen to interact with the pharmaceutical industry as a physician.

Early in my training, which took place in the late 1980s, it was not unusual for us to have lectures or to be invited to a soiree sponsored by a pharmaceutical company. Many of us, including me, would avoid these venues for a number of reasons. First, we were concerned that any data presented would inherently be biased towards presenting the sponsor’s product in a more favorable light, even if unwarranted. Secondly, we felt that the representatives were trying to bribe us, hawking pens, books, and other wares in hopes of convincing us to preferentially prescribe their medication to our patients. Lastly, and most important to us, we felt that the companies were taking money from our patients, in the form of escalated purchase prices, in order to sponsor these affairs for physicians or physicians–in–training, a group not generally in need of subsidies.

At our department and school, these discussions progressed and ultimately evolved to a degree that two papers were published which outlined our policies for the relationship between our faculty and the pharmaceutical industry (Coleman, 2008; Coleman, Kazdin, Miller, Morrow, & Udelsa, 2006). These documents banned us from receiving any form of gift, meal, or free drug sample (for personal use) from industry, and set more stringent standards for the disclosure and resolution of financial conflict of interest in our educational programs. After my residency, I received further training in epidemiology, biostatistics, and public health and was ultimately able to procure government funding to direct several large scale population–based epidemiologic studies of domestic emerging infectious diseases. One of these was a 2–year study of new cases of fungal bloodstream infections that I conducted along with a group of colleagues from the Centers for Disease Control and Prevention as well as the Johns Hopkins Bloomberg School of Public Health, where we captured over 1100 cases from the entire State of Connecticut and Baltimore County, Maryland from 1998–2000 (Hajjeh et al. 2004). Because of the unique nature of this study, a number of local and outside researchers contacted us for permission to collaborate with us to answer a variety of clinical questions using our database.

One researcher who approached us was Steven Teutsch, MD, MPH, from Merck and Company’s Outcomes Research and Management group. His group was charged with developing evidence–based clinical management programs, conducting outcomes–based research studies, and ultimately to enhance quality of care. He was a recognized expert in this field of work, having published over 100 related articles.

At that time, Merck was working on caspofungin, a medication in a new class of antifungal medications, called echinocandins, which ultimately became FDA–approved in 2001. Teutsch’s goal was for us to use our database to assemble a group of cases with bloodstream fungal infections to then compare with a group of controls, or hospitalized patients with the same medical or surgical conditions as our cases but without known fungal infection, in order to determine the marginal impact that these fungal infections had on length of hospital stay and mortality. In Connecticut, we had a unique opportunity to design and conduct this additional study because of the existence of the Connecticut Hospital Association, which captured data on all acute care hospitalizations throughout our State. With their participation, assembling a group of control patients was feasible without contacting each individual hospital.

Merck offered to pay Yale University 10% of my overall salary, which would be proportionate to my time spent on data acquisition and analysis. This was the first time that I had ever worked with anyone in the pharmaceutical industry and I was initially reluctant to enter into this relationship given my prior background and perspective, developed as a resident. However, after several discussions with Dr. Teutsch and my other research colleagues, I decided that the research question was an important one and that, as a group, we would be able to conduct the work in a rigorous manner. Merck reserved the right to review the manuscript and to have authorship; they could not refuse to allow the data to be published. Additionally, involvement of a ghostwriter, or one who writes the paper but gives credit for authorship to another person, was never suggested by Merck.

Over the course of two years, our group worked together successfully on study design, data acquisition and analysis, as well as in the writing and publication of the manuscript (Morgan et al., 2005). Dr. Teutsch was involved at every step but never directed the process towards a pre–specified outcome. I always found him to be scientifically rigorous, unbiased, and a reliable colleague. His expertise was critical to the success of the work, especially as we encountered challenges in the assembly of control groups and as we embarked on the data analysis. Not surprisingly, we found that patients hospitalized with bloodstream fungal infections were more likely to have a longer hospitalization and to die than their uninfected controls. The unique contribution of this work was that we were able to quantify all of these attributes in a population–based, and therefore representative, manner.

Although still against the practices of gifts or meals being given from the pharmaceutical industry to physicians, my personal experience working with Dr. Teutsch reversed many of my preconceived ideas of how this interaction would proceed. Over the two years that we worked together, I can only describe our relationship as cordial, professional, and scientific. Given a similar opportunity to collaborate in unrestricted and unbiased scientific inquiry, I would not hesitate to work again with colleagues from industry as I have learned that their unique background and expertise can strengthen the collaboration. I have also found that both my prior exposure and discussions as a medical resident, coupled with this more recent research collaboration, has given me a more balanced perspective. With this I am better able to teach and counsel my medical residents and students about working productively with professionals from the pharmaceutical industry.

References

Coleman, D. L. (2008) Establishing policies for the relationship between industry and clinicians: Lessons learned from two academic health centers. Academic Medicine, 83, 882–887.

Coleman, D. L., Kazdin, A. E., Miller, L. A., Morrow, J. S., & Udelsman, R. (2006) Guidelines for the interactions between clinical faculty and the pharmaceutical industry: One medical school’s approach. Academic Medicine, 81, 154–160.

Hajjeh, R. A., Sofair, A. N., Harrison, L. H., et al. (2004) Incidence of bloodstream infections due to Candida species and in vitro susceptibilities of isolates collected from 1998 to 2000 in a population-based active surveillance program. Journal of Clinical Microbiology, 42, 1519–1527.

Morgan, J., Meltzer, M. I., Plikaytis, B. D., et al. (2005) Excess mortality, hospital stay, and cost due to candidemia : A case-control study using data from population-based candidemia surveillance, Infection Control and Hospital Epidemiology, 26, 540–547.

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

Expert Testimony at the Food and Drug Administration: Who Wants the Truth? by Joel S. Perlmutter

In this article, I describe my rather surprising experience as a guest speaker at a Food and Drug Administration (FDA) Advisory Committee meeting. It all began on June 11, 2009 when an email invitation arrived from the Division of Medical Imaging and Hematology Products at the Food and Drug Administration (FDA) requesting that I participate as a guest speaker at the August 11, 2009 meeting of the Peripheral and Central Nervous System Advisory Committee. At that meeting, according to the email, “the Committee will discuss a new imaging agent to be used in the assessment of dopaminergic neuron function,” and I was asked, “to speak on the topic of differential diagnosis of patients with movement disorders and the role of neuroimaging in the evaluation of these patients.” I had more than enough work to do, but this sounded like an intriguing opportunity. After all, I have more than 25 years experience with neuroimaging research in Parkinson disease and related conditions, with particular expertise in imaging dopaminergic pathways in the brain. I have had multiple grants from the National Institutes of Health supporting my neuroimaging research. One of these grants, entitled “Validation of Neuroimaging Biomarkers of Nigrostriatal Neurons,” is precisely designed to develop and validate neuroimaging biomarkers of dopaminergic pathways—which include nigrostriatal neurons—a major component of dopamergic pathways. Of course, it may be relevant to disclose that I originally proposed this grant since I was rather concerned that multiple national and international studies had applied neuroimaging measures of dopaminergic pathways as endpoints of clinical research studies without having, at least in my mind, adequate validation of the methods (Ravina et al., 2005). I have been a rather hard–nosed person with regard to what constitutes adequate validation. The other part of my background that is relevant to disclose is that I am head of the Movement Disorders Center at Washington University in St. Louis. In that role, I am responsible for a large clinical, teaching and research operation that focuses on Parkinson and related diseases. I have always been a rather serious clinical–educator, constantly grilling medical students, neurology residents and movement disorders fellows on how any test that they order for a patient helps with decision–making for that patient. “If the test results will not alter decision–making, then do not order it,” many trainees have heard me emphasize. Given this background and my Missouri upbringing (the Show Me state), I thought it was reasonable to respond affirmatively to this invitation. After all, this would be my chance to provide a non–industry perspective and clearly state my position on the topic at hand. And, my position was clear—I do not believe that current evidence justifies the clinical application of molecular neuroimaging of dopaminergic systems in the brain.

Let me first give you some background on the potential clinical relevance of measuring dopaminergic pathways in the brain. Abnormalities of dopaminergic pathways in the brain underlie several neurologic and psychiatric illnesses and may also be critically important to treatment of those conditions. The most straightforward example is idiopathic Parkinson’s Disease (PD), a disease that primarily affects older individuals that causes progressive difficulty with walking, stiffness, slow movement, poor balance, tremor, soft speech and trouble swallowing. Many people also develop cognitive impairment. Destruction of these dopaminergic neurons in the brain leads to many of these manifestations. Notably, any other cause that reduces function of these neurons, like drugs that block dopamine action, may produce similar symptoms. The current gold standard for diagnosis of idiopathic PD is examination of the brain after one dies, and this permits identification of the loss of dopaminergic neurons and abnormal deposition of a protein called alpha–synuclein. Other related diseases like multiple systems atrophy, progressive supranuclear palsy or cortical basal ganglia syndrome may cause similar symptoms but may progress more quickly than Parkinson disease and respond less well to medications that can provide symptomatic relief to those with idiopathic PD. People with idiopathic PD also may develop cognitive impairment leading to dementia. The dementia may be caused by underlying abnormal deposition of alpha–synuclein in higher brain regions (so–called synucleinopathy) but also could be caused by pathologic changes similar to those that occur in Alzheimer’s disease. In fact, those who develop dementia may have Alzheimer’s disease as a cause or an alpha–synucleinopathy with defects in dopaminergic pathways.

The next relevant point is how dopaminergic pathways are measured in the brain in living humans or animals. A variety of molecular imaging methods have been developed for this. Basically, each of these requires a radiolabeled chemical that is injected intravenously into a person and the radiotracer then enters the brain to more or less selectively stick to some part of a dopaminergic neuron or gets trapped in the brain by some mechanism related to the integrity of dopaminergic neurons. The goal of such scans is to measure the number or function of these neurons. Some tracers require imaging with positron emission tomography (PET)—relatively expensive but with higher resolution—or with single photon emission computed tomography (SPECT)—lower resolution and less expensive. A fair amount of work has demonstrated that these methods all can distinguish with varying sensitivity a person with PD from a normal subject.

This background information provides the basis for determining what may be the clinical utility of measuring dopaminergic pathways in the brain. Could such measures help with the diagnosis of PD by confirming a defect in the dopaminergic pathways that occurs in PD but perhaps not in some other conditions—like someone with essential tremor—a condition that causes tremor that at times is difficult to distinguish from PD? If so, would this improve patient care? In other words, could we avoid giving someone medicine for PD who is not likely to benefit from it (Stoessl, 2009)? Could the measures help provide prognostic information for individual patients and predict the rate of disease progression? Could such measures help identify those who have dementia due to alpha–synucleinopathy rather than Alzheimer’s disease? (McKeith et al., 2007) Can these techniques identify a person at risk for developing PD? Substantial controversy exists as to whether these methods can answer these questions (Serrano Vicente et al., 2009; Eerola et al., 2005). Many national and international meetings (like the International Movement Disorders Society) have forums for addressing these controversies. In fact, some of these methods have been approved for clinical application in other countries. None had been approved by the FDA for clinical application in this country.

So, this invitation was my opportunity to review the research data that I believe demonstrate no clinical utility at the current time for these molecular neuroimaging methods. After a review of the literature I did not believe that the methods helped with diagnosis of PD—the data do not support the notion that it can distinguish PD from related conditions. Some believe that less closely related conditions like essential tremor can be distinguished (Eerola et al., 2005;Ceravolo et al., 2008) but I argued that if there was clinical ambiguity that obscured confident clinical diagnosis between these two conditions in an individual, then a simple trial of treatment for PD would be a more direct and far less expensive alternative to a molecular imaging test. Similarly, the only data that supported such techniques to help distinguish causes of dementia were funded by industry that made these types of radiotracers (McKeith et al., 2007), an arrangement that may bias reporting only positive outcomes (Kelly, Jr. et al., 2006). In contrast, I do believe that molecular imaging of dopaminergic pathways may be a more sensitive means to identify a defect in these neurons before it can be detected clinically by an appropriately trained neurologist (Marek & Jennings, 2009)—however, today we have no treatment that can prevent or slow disease progression to make this a useful clinical tool. In the future, we may have such preventative treatments and then, with appropriate selection criteria, these types of scans may help identify and treat people to prevent onset of PD symptoms.

So, I decided to participate in this advisory committee meeting. I was told that the agenda would include a basic review of Parkinson disease by Dr. Ted Dawson from Johns Hopkins University and then I would review the potential clinical utility of neuroimaging dopaminergic pathways in movement disorders. After that there would be presentations by the FDA, presentations by industry and then panel discussion and committee questions.

Everyone arrived at the meeting on time in Silver Spring, Maryland. Dr. Dawson gave an excellent review of Neurodegeneration in PD and then I reviewed the literature on “Neuroimaging of Dopaminergic Neurons: Evidence for Clinical Utility.” In my talk, I also addressed the cost effectiveness of applying molecular imaging for diagnosis compared to a trial of drug—this favored a simple short testing of the response to a drug by a 10–to–1 cost differential. My final slide, entitled “Clinical Utility?” included the bullet points that these techniques were not needed for clinical utility and not necessary for treatment decisions in patients. My conclusions were straightforward.

What then happened? Dr. Dawson and I were invited to observe the remaining talks and sit in the public audience area. We were told that we could not participate in any discussions or ask any questions. The FDA had speakers and GE Healthcare had several speakers justifying their proposal for clinical application of a SPECT radiotracer to measure dopaminergic neurons. We could observe the FDA panel members ask questions of other speakers but we were not allowed to ask or answer questions from the panel or anyone else at that point. Once we sat down after giving our talks, we were prohibited from participation. I must say, I was quite surprised. This permitted several misperceptions to go unanswered. For example, one FDA panel member specifically stated that Dr. Perlmutter supports this clinical application—quite far from my position, but I was not allowed to clarify that point. One of the GE Healthcare representatives presented data from a study that they had sponsored with the conclusion that it was clinically useful to use one of their molecular imaging markers to properly diagnose dementia due to synucleinopathy—a position that I do not endorse. There were multiple questions by panel members that we could have easily addressed but again we were not allowed to respond and they were not permitted to address us. One panel member specifically asked the chair of the panel whether they could consider cost effectiveness of this drug and was told that was not to be considered in their decision to recommend or not recommend approval of the application from GE Healthcare.

I left that meeting feeling that I was window dressing rather than a considered expert on an important topic. The next week, I learned that the panel voted 11–to–2 to recommend approval of the GE Healthcare application.

What are the ethical issues raised by this experience? First, I am concerned that there was a lack of interaction between the committee and the invited experts. The playing field was not level. How come? The challenges to the FDA are substantial. There are pressures to approve new drugs that can improve health care for Americans. Frequent complaints arise from the public about delays with FDA approval. Yet, we also hear about potential bias from FDA panel members that may have relationships to industry and that the FDA receives a substantial part of its funding from industry sources—the same industry that the FDA regulates (Olsen & Whalen, 2009). These conflicts of interest exist (Kelly, Jr. et al., 2006). I believe that my experience demonstrates one example of where potential bias of information can influence a panel. In fairness, there are many other movement disorders specialists who believe that these imaging methods would help them make decisions. One such movement disorders specialist also gave a presentation for GE Healthcare at the meeting and made the point that neurologists in other countries can order these molecular imaging tests and we cannot—a deficiency that he thought should be corrected. However, my position is that when the FDA considers such applications, a more thorough and objective review of the data is warranted. The question really is “who wants the truth?”
Acknowledgement

...

References

Ceravolo R, Antonini A, Volterrani D, Rossi C, Kiferle L, Frosini D, Lucetti C, Isaias IU, Benti R, Murri L, Bonuccelli U (2008) Predictive value of nigrostriatal dysfunction in isolated tremor: A clinical and SPECT study. Mov Disord 23: 2049–2054.

Eerola J, Tienari PJ, Kaakkola S, Nikkinen P, Launes J (2005) How useful is [123I]beta–CIT SPECT in clinical practice? J Neurol Neurosurg Psychiatry 76: 1211–1216.

Kelly RE, Jr., Cohen LJ, Semple RJ, Bialer P, Lau A, Bodenheimer A, Neustadter E, Barenboim A, Galynker II (2006) Relationship between drug company funding and outcomes of clinical psychiatric research. Psychol Med 36: 1647–1656.

Marek K, Jennings D (2009) Can we image premotor Parkinson disease? Neurology 72: S21–S26.

McKeith I, O’Brien J, Walker Z, Tatsch K, Booij J, Darcourt J, Padovani A, Giubbini R, Bonuccelli U, Volterrani D, Holmes C, Kemp P, Tabet N, Meyer I, Reininger C (2007) Sensitivity and specificity of dopamine transporter imaging with 123I–FP–CIT SPECT in dementia with Lewy bodies: A phase III, multicentre study. Lancet Neurol 6: 305–313.

Olsen AK, Whalen MD (2009) Public perceptions of the pharmaceutical industry and drug safety: Implications for the pharmacovigilance professional and the culture of safety. Drug Saf 32: 805–810.

Ravina B, Eidelberg D, Ahlskog JE, Albin RL, Brooks DJ, Carbon M, Dhawan V, Feigin A, Fahn S, Guttman M, Gwinn–Hardy K, McFarland H, Innis R, Katz RG, Kieburtz K, Kish SJ, Lange N, Langston JW, Marek K, Morin L, Moy C, Murphy D, Oertel WH, Oliver G, Palesch Y, Powers W, Seibyl J, Sethi KD, Shults CW, Sheehy P, Stoessl AJ, Holloway R (2005) The role of radiotracer imaging in Parkinson disease. Neurology 64: 208–215.

Serrano Vicente, J. S., Bernardo, L. G. Barquero C. D. Silva A. C. Infante de la Torre J. R. Dominguez Grande M. I., and Rayo Madrid, J. I. Sanchez Sanchez R. Herrera C. D. Negative predictive value of the SPECT with 123I loflupane in movement disorders. Rev Esp Med Nucl 28[1], 2–5. 2009.

Stoessl, A. J. Radionuclide scanning to diagnose Parkinson disease: Is it cost–effective? Nature: Clinical Practice Neurology 5[1], 10–11. 2009.

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

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.

Why is Medicare Wasting Away? by Govind K. Nagaldinne and Erin L. Bakanas*

When I moved to the Midwest from the West coast to be with my family, I accepted a position as a home care physician for a company which provided health care services to homebound patients. The patients were elderly, most of them bedbound or with a debilitating condition which prevented them from driving. Most of these patients were on a limited income, mainly Social Security benefits, and had Medicare and Medicaid insurance.

In my new employee orientation, I was encouraged by a company physician and the local office manager (a registered nurse) to order echocardiograms and Doppler studies every six months for all patients with a history of hypertension.

In the beginning I was uncertain about the reasoning behind obtaining echocardiograms every six months, but they did quote guidelines from experts in the field. The practice owned the echocardiogram equipment and the echocardiogram technician was an employee of the company. The echocardiogram tapes were mailed to out–of–state cardiologists. The echocardiogram reports were mailed back to the office in 3–4 weeks. Being new to the job, I ordered the tests as recommended, despite my misgivings. I felt uncomfortable, as most of the tests ordered were on stable hypertensive patients. Even after reviewing the echocardiogram results, I rarely needed to change my management of the patient.

My apprehension grew when I heard patients worrying about the copayment bills they had received. One patient said, “I will pay the bill because I do not want to lose the services you are providing.” I felt no better when an acquaintance of mine mentioned that a patient had complained to her saying, “the house call doctor ordered an expensive test but I did not hear the results of the test for six weeks.” I realized that patients were worrying while waiting for their echocardiogram results, and I did not feel this burden was in any way justified by the little information the testing provided.

I started attending weekly morning physician and office manager meetings. Every physician was given weekly productivity reports and Relative Value Units (RVUs) generated were mentioned during this meeting. Medicare compensates physicians for services they provide under the Supplemental Medical Insurance program, or Medicare Part B, on the basis of a fee schedule that specifies payment rates for each type of covered service. Payment rates are calculated in three steps: First, the fee schedule stipulates relative value units (RVUs), which measure the resources required to provide a given service. Second, payments are adjusted to account for geographical differences in input prices. Third, a “conversion factor” translates the geographically adjusted RVUs for a particular service into a dollar amount.

I learned each echocardiogram generated RVUs 3–5 times higher than that of a simple physician home visit. The manager encouraged us to meet a target of a certain number of RVUs per week by ordering blood tests, echocardiograms or Doppler studies.

The director from the company headquarters would visit the local office and encourage physicians to order more tests to boost up the low Medicare reimbursements. At every meeting, the director would make it a point to mention the company was unable to support expenditures with current insurance reimbursement rates, and needed additional ways to increase the reimbursements. Many times I felt that I might lose my job if I did not keep up my RVUs with the rest of my colleagues. I began to feel pressured to generate more revenue in competition with the other physicians employed by the company. I found myself ordering more laboratory investigations and radiological investigations to keep up my productivity on par with my colleagues. Wherein the patient expected honest and appropriate advice from me, I failed them in my responsibility by ordering more investigations in order to satisfy the company’s demands and relieve my own financial and employment concerns.

Motivated out of my sense of discomfort with this process, I had discussions with my colleagues, who reassured me this approach is legal. But I did not feel this was sufficient justification for practices I was beginning to question as unethical or unprofessional and I worried whether I was providing quality care to my patients.

I decided to review the data on the utility of an echocardiogram in a stable patient who has longstanding hypertension. According to the American College of Cardiology guidelines, an echocardiogram has a Class III indication for this specific clinical situation, meaning that longstanding stable hypertension is a condition for which there is evidence or general agreement that an echocardiogram is not useful and in some cases may be harmful. It is a fact that Medicare was allowing echocardiograms every six months for patients with hypertension. From the business perspective of my employer, this fact of Medicare guidelines was enough to make frequent echocardiograms permissible. The company further supported their position by arguing this practice was saving money for Medicare as the cost of house calls made by their employees over a one year period was less than the cost of a day of hospitalization for a serious illness. The company claimed that their services prevented hospitalizations. But when I did my own investigation into this claim, I found that appropriate home care provides necessary health care services to seniors. There is no data to support that more frequent physician home visits and diagnostic tests prevent hospitalizations.

I began to realize that the practices I was being encouraged, even pressured, to adopt were not only problematic for my patients’ financial concerns, but also for the larger healthcare system. I believe that every physician has an obligation to strive for the best stewardship of health care dollars and ensure that every cent spent is for appropriate patient care. Instead, I found myself in a classic example of medical waste, wherein the tests were ordered for the benefit of the physician and the company, with very little impact on patient care. By utilizing more healthcare dollars the company was claiming a larger portion of the healthcare resources available in the limited common pool called Medicare. This in turn contributed to rising healthcare costs, experienced by patients as higher premiums and co–payments, and leading to the threatened bankruptcy of Medicare.

I was left with a decision as to how I would handle the multiple conflicts of interest I was facing. Disclosure did not seem a likely option. I had been advised to tell my patients that tests were ordered, “just to make sure,” and also to remind them, “the results may take weeks.” Deep inside I felt uncomfortable knowing that this was unnecessary. But I also realized that, given the trust my patients had expressed, they were unlikely to question my orders even if they knew that the diagnostic testing was done by the company’s technicians and that the company stood to benefit financially from this arrangement.

Education is a second option for managing conflicts of interest. Being the newest physician in the group, I found I had little influence when I tried to get my colleagues to question these practices that kept their paychecks high but added unnecessary costs to patients and to the healthcare system. (Although I always felt I might have tried harder.) Educating our patients is another way wherein questioning the necessity and benefits of every test with their physician would help curb medical waste. But this would require an open dialogue between physician and patient, which was not encouraged in this particular setting.

Avoidance is the most straightforward way of dealing with conflicts of interest. It involves recognizing that something has the potential to create a conflict of interest and eliminating it. I tried hard to justify the tests clinically and limit the number of echocardiograms and Doppler studies. Even though avoidance is the best way, it is not an easy path to ameliorate conflicts of interest as this may require confronting the company and managers with the potential of losing one’s job. Alternatively, avoidance might require leaving one’s job and the resultant undesirable position of abandoning patients. During my brief period with the company I tried to minimize unnecessary tests, and knowing that the job was just a transition job helped me achieve that. I was fortunate to leave the company and move to a different city, but many physicians may not have that opportunity.

A few years later the company opened an office in the city in which I was practicing. A potential physician employee had been given my name by the company and he called to ask about my experiences and wondered what advice I would offer as to accepting a job with them. I replied that I never felt comfortable working for the company as physicians were given the notion the company’s finances were dependent on physicians’ revenue and we were pressured to order more tests than patients’ conditions justified.
Footnotes

* Nagaldinne is the primary story teller; Bakanas assisted with the writing of the story.

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