What I Told The Students About Navigating Corporate Conflicts Of Interest
- Allen Jacobs DPM FACFAS
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The New York State Podiatric Medical Association meeting this year included a two-day lecture series for junior and senior students at the podiatry colleges. The sessions were well attended. I was honored that the seminar committee asked me to present one of the sessions to the students.
For my topic, I decided to lecture on managing conflicts of interest and corporate influence in podiatry education and practice. Consistent with my concerns, every student had already been outfitted with a bag featuring a corporate name, which was filled with products and advertisements.
We discussed potential conflicts of interest in future practice including financial, professional, personal and prejudicial conflicts.
I pointed out to the students that corporations have a substantial influence in research, publication practices, marketing disguised as "education" and sponsorship of opinion, promotion of drugs, products, and providing "guidelines" for the treatment of various problems.
We discussed the fact that continuing medical education (CME) is now a greater than a $3 billion a year industry. Although doctors and residents will insist that corporate-sponsored lectures, dinners and gifts do not influence the manner in which they practice, I asked the students to consider why companies keep spending great deals of money doing so. I also noted that multiple studies have demonstrated that even small, insignificant gifts influence the prescribing habits of doctors, who denied that they were influenced by corporate gifts or dinners.1,2 Studies have demonstrated that doctors attending corporate-sponsored events are more likely to utilize the products discussed even when there is no scientific evidence of efficacy and that promotional activities lead to the increased use of products, and importantly the non-rational use of products, with the acceptance of the company rather than scientific view.
We discussed the fact that the responsibility of industry is first to the shareholders to optimize returns and optimize use of its resources, and lastly to the public or to the protection of the podiatrist using the product or prescribing the product. We discussed the fact that patient care and protecting the podiatrist from product-associated liability was not a primary goal of the corporations and their promotional activities. I used as an example the $311 million in fines for bribes and kickbacks leveled against Biomet, Smith and Nephew, Zimmer, DePuy and Wright Medical (Stryker avoided a financial penalty).3
I pointed out that many of the products endorsed by "thought leaders" in our profession are expensive, provide profits to corporations and have little if any scientific evidence of superiority. By using such unproven devices, we make money for the corporations and perhaps make a little bit of personal profit by gaining favors with such corporations. But in the end, this raises the cost of medical care and the utilization of such devices and therapies in patients who are trusting us to make the best decision for them as individuals, not to satisfy some corporation.
I discussed the fact that the future of these students would likely be grounded in the accountable care organizations, acute care event systems, captive professional corporations, co-management agreements with hospitals or other healthcare providing organizations, or employment in a hospital-based healthcare system. We discussed the fact that under future circumstances, these future doctors would be evaluated to no small extent by cost-effectiveness as much as any other parameter.
I asked the students if they can do a surgery with 95 percent success, do they really need to add a widget costing $800 to that surgery? Does the average bunion or hammertoe correction really require extensive implants over Kirschner wires? Does the average patient really require a locking plate for treatment of a bunion or arthrodesis of the great toe joint? Does the average patient really require use of an orthobiologic material in the performance of surgery?
The answer is yes if you are a speaker for the company, yes if you are a consultant for the company and yes if you are a sales rep for the company paying for dinner or for a free room at a seminar for this student or resident.
A Reminder Of The Responsibilities Of The DPM Degree
I discussed with the students the fact that the DPM degree carries with it privileges, responsibilities and self-regulation. The DPM degree is recognized throughout the 50 states as a degree that will entitle these future graduates with a certain trust. I reminded the students that the first responsibility they should always maintain is the well-being of the patient. They will carry the power to recommend limb amputation or, conversely, extensive and expensive therapies for limb salvage. Individuals will approach them wanting to know what is best for their health and relief of pain. They will be in a position to recommend surgical correction of deformities, to recommend the optimal manner in which to correct such deformities or to recommend that the patient not undergo surgical interventions. They will be in a position to diagnose and treat a variety of disorders that may first manifest in the foot or treat disorders such as rheumatoid arthritis that have significant effects on the lower extremity.
They will be given a trust. The responsibility of this trust will rest solely on the future graduates. This is not a small concession to the DPM degree. It is recognition that the DPM degree is of tremendous value, such that society will trust those bearing that degree to make appropriate, honest and ethical decisions regarding the need for treatment including surgery, the need for diagnostic testing and the need for therapeutic interventions.
Furthermore, I reminded the students of a more general responsibility. The DPM degree allows time and self-regulation for defining expertise required for certification and for recertification as well as for licensure at the state level.
We discussed the facts that the responsibility that these young individuals will carry in the future is first to the public. However, I reminded them that as podiatrists, they also have responsibility to the podiatric profession to advance the science of podiatry.
I reminded the students that corporations will attempt to capture their loyalty by creating conflicts and potential conflicts in the decision making, interpretation of results, and reporting of results to fellow DPMs. I reminded the students that they have a responsibility to disclose any conflicts in reporting the interpretation of results to fellow DPMs.
The students also got a reminder that they were entering the world of healthcare reform. Whether one agrees with the basic tenets of the Affordable Care Act or not, the fact is that healthcare costs in United States are higher than anywhere in the world, and some correction in the current fee for service process and the continued reliance on expensive technology was required in some manner.
We discussed the influence of corporations on their future education both as students and residents, and reminded the students that the first responsibility of any corporation is that of corporate profit and not the provision of healthcare to the public. For example, I made it clear to the students that one only has to look at the majority of podiatry seminars, at which the speakers are sponsored by some corporation in some manner, whether obvious or sub rosa. Typically, when I get an invitation to speak at a meeting, I pointed out that the first question organizers ask of me after I agree to speak is "Who will sponsor you?" This cannot help but raise the issue of potential bias.
A Revealing Conversation With A First-Year Student
Several years ago, I had a conversation with a first-year student at one of the podiatry colleges. I had done some rather extensive surgery on her mother and she was returning home to St. Louis for her Christmas vacation. Her mother asked if I would be willing to meet with her daughter and answer questions about podiatry practice, and I agreed to do so. She was a nice enough individual. However, her questions surprised me, given the fact that she had only been in podiatry school for the months of September, October and November, a total of three months.
Her first question to me was "How many external fixators do you use in a year?” I was surprised and asked her why she would have such a question.
She told me, "Well, I know the use of external fixation is controversial." I asked her why she would think it was controversial and she informed me that they had already had two courses in external fixation in her first three months of podiatry school. Of course, companies manufacturing external fixation devices sponsored the courses. I responded to her question, surprised that the subjective external fixation, let alone training in external fixation, would be part of the curriculum of a student in his or her first three months.
Her second question? “How many ankle fractures do you do a year?”
At that point, I asked her what she thought she would be doing as a podiatrist. Three months into her first school year, not even knowing how to correct an ingrown toenail or care for a painful callus, she was already involved in large external fixation and ankle fracture considerations.
I pointed out that this was an example of corporate influence in podiatry and students must be careful not to allow corporations to take priority over patient care.
I pointed out that there are many inducements to "play ball" with corporations. It starts when students and residents accept free food, free lodging at meetings and free samples. Later on, they will get payment for lecturing and money for "consulting." When students and residents witness the inappropriate use of implants or fixation devices by their residency directors or teachers, there is an implied acceptance of primary loyalty to a corporation rewarding that residency director’s work over patient care.
I pointed out to the students that publications in peer-reviewed journals, sponsored by corporate support, were far more likely to demonstrate positive outcomes endorsing the utilization of the product or pharmaceuticals studied in that particular report. I also reminded the students that transparency regarding the influence of corporations in journals is not always obvious.
Similarly, we discussed the influence of in-office product sales on decision making, and the fact that as residents and future practitioners, they will have the option to recommend and sell for a profit various devices and pharmaceutical products. These future practitioners will have to determine whether their primary goal is profit or the well being of their patients’ health.
In summary, I asked the students to look at the American Podiatric Medical Association (APMA) Code of Ethics, to think about the APMA Code of Ethics and to think about the trust that every patient is placing in them seeking their advice and guidance for the treatment of foot and ankle problems.
The students will receive a degree that carries a great deal of responsibility. Hopefully, they will carry that responsibility in an appropriate, ethical manner and minimize the aggressive influence that corporations have attempted to place upon them.
1. Grande D, Frosch DL, Perkins AW, Kahn BE. Effect of exposure to small pharmaceutical promotional items on treatment preferences. Arch Intern Med. 2009;169(9):887-893.
2. Campbell EG, Weissman JS, Ehringhaus S, et al. Institutional academic industry relationships. J Am Med Assoc. 2007; 298(15):1779-1886.
3. Available at http://www.healthpointcapital.com/research/2007/09/27/zimmer_depuy_biome... . Published Sept. 27, 2007. Accessed Feb. 14, 2014.