Should industry have a role in resident education?

Phelan Piehota, DO, and Andrew T. Strand, DO, offer their takes on industry, influence and education.

Welcome to CEDARS-ASPENS Debates, a monthly feature in Ocular Surgery News.

CEDARS (Cornea, External Disease, and Refractive Surgery Society) and ASPENS (American Society of Progressive Enterprising Surgeons) is a joint society of cornea, cataract and refractive surgery specialists, here to discuss some of the latest hot topics in ophthalmology.

One of our missions is to promote resident education, including introducing residents to the process of speaking from the podium and contributing as authors in medical journals. This month, Phelan Piehota, DO, and Andrew T. Strand, DO, residents at the Ohio University Heritage College of Osteopathic Medicine Doctors Hospital in Columbus, discuss interaction with the pharmaceutical and medical device industry in a residency program.

While certainly there is always a concern about naïve residents being subject to undue influence by industry and therefore biasing the way they practice, there is also the reality of residency programs. Often, these residents are not exposed to the latest drugs and devices, and therefore they are still inexperienced when they go into practice. In addition, they often struggle with patient compliance in the clinic population and are unable to provide these needy patients with samples to truly act in the best interest of the patients. This is a complex issue with no easy answer. We hope you enjoy the discussion.

Kenneth A. Beckman, MD, FACS
OSN CEDARS-ASPENS Debates Editor

Truce needed between medical education vs. industry

My education and training have prepared me well as both a clinician and surgeon, but I will have a learning curve waiting for me after graduation. This curve lies in the real-world clinical knowledge of the newest medications available. In 2009, a committee on Conflict of Interest in Medical Research, Education, and Practice developed a set of recommendations that combined the recommendations of the Association of American Medical Colleges and the Pharmaceutical Research and Manufacturers of America. The recommendations:

• Prohibit the acceptance of items of material value from pharmaceutical, medical device and biotechnology companies, except in special situations.
• Prohibit educational presentations or scientific publications that are controlled by industry or that contain substantial portions written by someone who is not identified as an author.
• Prohibit consulting arrangements that are not based on written contracts for expert services to be paid at fair market value.
• Prohibit access by drug and material device sales representatives to medical students, residents and fellows, except by specific faculty invite.
• Prohibit the use of all drug samples, except in special situations.

The main goal of these recommendations is to prevent undue influence by industry over the clinical decisions that we as physicians, especially residents, make. While I agree that my clinical plan should be unbiased and evidence based, there is a problem with such a strict mandate on access. We resident physicians have no personal experience with some of the newest medications. For hypothetical instance, if I am treating an open-angle glaucoma patient for an acute case of anterior iritis, I may want to use a topical steroid that has a strong anti-inflammatory effect with the least risk of steroid-induced ocular hypertension. If I were in a private practice situation, I would have a sample cabinet so I could give medication to the patient in the office and observe the effects over the next few days. However, because of overly strict regulations, residents do not have access to any samples and must prescribe a generic and hope that the patient tolerates it well.

In reality, we physicians tell ourselves a few fairy tales with each patient we give a prescription to. The first fairy tale is, “The patient heard and understood everything I said about dosage, route and frequency.” Second, “The patient can afford this medication irrespective of insurance copay.” Third, “The patient is going to go to the pharmacy right away and begin taking the medication today.” With some patients, all of these fairy tales may actually come true, but most fairy tales are deficient somewhere. With access to sample medications, we could assure that the patient has an equivalent or better medication in his hands before leaving the office.

When patients miss out, so do I. Drug sample access by residents was brought into question by a 2005 article that concluded “access to drug samples influenced resident prescribing decisions.” I agree that the 1990s campfire stories of extravagant gifts and big pharma-sponsored vacations to Jamaica were not good medicine and probably carried associated biases. However, the complete absence of newly approved drug samples and education in medical training is not good medicine either. Simply prescribing medications is not feasible due to cost, and having no access to samples prevents short trials before confirming that a certain medication is the best choice; therefore, medications are rarely brought up as an option for treatment until everything else has failed.

If my decision to prescribe a medication is influenced, it will be on its evidence-based merits, not a commercial with a bouncing cartoon or the fact that the medication is sitting in a locked drug sample cabinet. A comprehensive medical education should include reasonable clinical access to all treatment options. I know about the newest medications, mechanisms of action, side effect profiles, contraindications and indications, but some would argue the most important aspects of the medicine, its clinical efficacy and tolerance, are something I will have to wait until after I am done with my training to discover. The restriction of industry influence in medical education was needed in a time referred to as “the wild west” of the pharmaceutical industry. Today’s medical landscape is much different than 20 years ago due to these regulations; some changes were for the better, and some for the worse. Let’s bring back some balance to the issue.

• References:
• Adair RF, et al. Am J Med. 2005;doi:10.1016/j.amjmed.2005.02.031.
• Lo B, Field MJ, eds. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Press; 2009.

• For more information:
• Phelan Piehota, DO, is the OU-HCOM Doctors Hospital Chief Ophthalmology Resident PGY-VI. He can be reached at phelanpi@pcom.edu.

Disclosure: Piehota reports no relevant financial disclosures.

Current training not adversely affected by lack of industry presence

The prompt for this month’s debate came from several co-resident conversations regarding our prescription habits and occasional frustrations at a lack of access to certain medications for our patient population. These frustrations were centered on our lack of access to sample medications. The fact is that the majority of our patient population has difficulty in filling prescriptions in a timely manner for therapeutic intervention and being able to afford ophthalmic medications. Within the last decade, graduate medical education (GME) has made sweeping reforms in resident/fellow access to pharmaceutical and medical device representatives, including free samples for resident clinics. The crux of the discussion is based on outside influence from the pharmaceutical and medical device industry.

When evaluating what role the pharmaceutical and medical device industry should have in GME, we first need to define the core values or mission of these institutions. Second, we need to critically evaluate if those values are compatible with each other, and if so, in what situations? If not, how does GME protect itself from undue influence? And finally, we need to understand what this should mean for residents.

Values

The Accreditation Council for Graduate Medical Education has six core competencies used by GME to evaluate residents in training: patient care, medical knowledge, practice-based learning and improvement, interpersonal and communication skills, professionalism, and systems-based practice. To achieve accreditation, institutions providing GME must have curricula that promote the development of appropriate professional attributes; help learners at all levels think critically and appraise the evidence-based for research reports, practice guidelines and marketing materials; and provide appropriate role models and mentoring. While I cannot summarize the values or mission statement of big pharma or the medical device industry, we can agree on a general consensus: Develop high-quality products that have a positive impact on health care, maximize market share and maximize profit.

Are these values compatible?

A 2008 report by the Association of American Medical Colleges addresses these conflicts of interactions with industry as “for medicine generally, and for academic medicine in particular ... have a corrosive effect on three core principles of medical professionalism: autonomy, objectivity and altruism.” A 2009 report on Conflict of Interest in Medical Research, Education, and Practice provides substantial historical evidence for undue influence from industry and guidelines that shape the current climate in GME.

The report summarizes how, late in the last century, industry financial influence crept into GME on many levels. The ever-increasing funding cuts at academic institutions, decreasing reimbursement from Medicare and institutional costs for infrastructure all led to some institutions relying on outside assistance for funding and education. Around this time, 65% of reported clinical departments received industry support for continuing education, 37% received industry support for residency or fellowship training, and 19% received unrestricted funds for department operations. Couple this with the perceptions of entitlement among medical trainees surveyed during this time. Roughly 80% of respondents reported being “entitled” to gifts from industry. Because of their amount of medical student debt, the report suggested that residents and fellows may be strongly influenced by the pharmaceutical and medical device industry.

Empiric data on actual behavior modifications among residents and fellows regarding industry influence are lacking. Before the sweeping changes in GME, influenced by the Conflict of Interest in Medical Research, Education, and Practice report, a study reported that 17% to 82% of physicians would dispense a drug sample instead of their preferred drug of choice, based on availability and cost avoided to their patient, and that residents were more likely to use sample drugs vs. attending physicians. In this same era, residents randomized to either access to drug samples vs. no access revealed that the latter were more likely to prescribe generic medications or other counter medications. Even after reforms and a general absence of samples in resident institutions, a 2014 study revealed that among internal medicine residents prescribing statins, patients were given brand-name medications in 50% of cases.

The response of the pharmaceutical and medical device industry is that its services help in educating residents, fellows and physicians in making evidence-based medical decisions for their patients. On the surface this appears beneficial, but industry does not have the altruistic values we should embody with our patients. At the end of the day, the pharmaceutical and medical device industry is at the beck and call of the financial free market. Unchecked, we would see more influence by industry in medical education, in the aims of capturing a larger market share for their products. Each clinical decision regarding pharmaceuticals or medical devices needs to depend on the specific situation, evidence-based medicine and cost-effectiveness of treatment. As residents, we have ample access to literature regarding treatment options and the experience and expertise of our attending physicians to help guide treatment, negating the need for industry representative education in most situations.

Are there situations in which industry influence might be beneficial to resident education? Anecdotally, yes, for ophthalmic surgical products and in surgical subspecialties with limited treatment options or limited treatment products.

How should we protect from undue influence?

GME needs to adhere to the recommendations of the Conflict of Interest in Medical Research, Education, and Practice report (as outlined in Dr. Piehota’s response). Program directors and attending physicians must be conscientious of their own biases and protect their residents from undue influence.

What does this mean for residents?

Going back to the prompt for this discussion and lack of free sample medication from the pharmaceutical industry: Would we and our patients benefit from access? Yes, no and maybe. The main benefit would be convenience and cost to the patient in acute settings. There is a possible benefit for expensive medications that have no generics available, such as Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan). The responsibility is on the resident in training to keep abreast of current therapies, tailor medications specifically to our patients and maintain cost-effective care. I do not believe our current training is adversely affected by the decreases in industry presence in GME because we have the tools to make our own informed choices. I believe we are forming practice habit patterns that limit undue influence from the pharmaceutical industry while embracing transparency in patient care under the current limitations.

• References:
• Accreditation Council for Graduate Medical Education. ACGME Institutional Requirements. https://www.acgme.org/acgmeweb/Portals/0/irc_IRCpr07012007.pdf. 2007.
• Adair RF, et al. Am J Med. 2005;doi:10.1016/j.amjmed.2005.02.031.
• Association of American Medical Colleges. Industry Funding of Medical Education. https://www.aamc.org/download/157370/data/industry_funding_report.pdf. June 2008.
• Campbell EG, et al. JAMA. 2007;doi:10.1001/jama.298.15.1779.
• Chew LD, et al. J Gen Intern Med. 2000;doi:10.1046/j.1525-1497.2000.08014.x.
• Gagnon MA, et al. PLoS Med. 2008;doi:10.1371/journal.pmed.0050001.
• Lo B, Field MJ, eds. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Press; 2009.
• Sierles FS, et al. JAMA. 2005;doi:10.1001/jama.294.9.1034.
• Spurling GK, et al. PLoS Med. 2010;doi:10.1371/journal.pmed.1000352.
• Ryskina KL, et al. J Grad Med Educ. 2014;doi:10.4300/JGME-D-13-00412.1.
• Ryskina KL, et al. J Gen Intern Med. 2015;doi:10.1007/s11606-015-3323-5.

• For more information:
• Andrew T. Strand, DO, is an OU-HCOM Doctors Hospital Ophthalmology Resident. He can be reached at andrew.strand@ohiohealth.com.

Disclosure: Strand reports no relevant financial disclosures.