By Mihir Gupta
Most professors at Harvard College don’t face monetary pressure to advocate certain viewpoints. The scholars teaching our classes say what they truly believe, whether it is that Reagan-era economics are fundamentally sound, or that folklore and mythology are actually relevant. Elsewhere in the University, however, monetary considerations are increasingly jeopardizing academic freedom. The most prominent example is the situation at Harvard Medical School (HMS) that has prompted University officials to review the HMS conflict of interest policy and University-wide regulations governing faculty interaction with the private sector.
The issue at hand concerns the relationship of HMS faculty to the pharmaceutical industry, and the impact of that relationship on the education of HMS students. Students felt that their professors were no longer saying what they truly believed, but instead what they had been paid, directly or indirectly, to say. The result is a significant HMS student-led movement to separate classroom from pharmaceutical boardroom. The potential for conflicts of interest arises in a surprisingly large number of cases. Faculty laboratories, clinical research, and endowed chairs are often funded at least in part by a pharmaceutical company. It is therefore easy to see how these profit-seeking firms can dilute academic purity. For example, a professor who runs a successful clinical trial of Pfizer’s latest heart-disease drug and researches its effects in his/her laboratory might be inclined to promote the drug as a treatment for the condition in his/her cardiology class.
Many medical school faculty thus find themselves having to keep their professional affiliations, and even research results, out of the classroom. Indeed, many within the HMS student movement are advocating policies that would facilitate just such a separation: they call for greater limitations on the interactions that pharmaceutical companies are allowed to have with students, whether directly or indirectly through funding educational programs. The education of tomorrow’s doctors, argue the students, should be free of the bias inherent in the private sector. The movement has led to an HMS policy that requires all faculty and teachers to fully disclose their industry ties in the classroom – a move that no other medical school has yet taken.
However, HMS may not be leading the way in regulating conflicts of interest; in fact, the school may even be far behind the curve. A recent report by the American Medical Students Association (AMSA) gave HMS an “F” grade on its conflict of interest policies. The medical school performed poorly in every single area of AMSA’s scorecard. For example, HMS has “no policy, or a policy unlikely to have a substantial effect on behavior” regarding the ability of private companies to offer gifts to physicians in Harvard’s hospitals that encourage them to prescribe a certain therapy. According to AMSA, the school has been unable to show that it promotes understanding of the impact that financial conflicts of interest make on physicians’ decision-making. Also, there is reportedly no oversight mechanism or explicit sanctions for noncompliance with current regulations.
These findings ought to concern both students and patients at Harvard-affiliated hospitals. The fact that other leading medical schools such as UPenn and Columbia received an “A” from AMSA suggests that medical schools do not necessarily face a tradeoff between institutional excellence and conflict of interest regulations. There are multiple factors explaining Harvard’s failing grade. A primary reason is that the University does not own any of its affiliate hospitals. This separation increases the difficulty of imposing or strengthening regulations, but does not make such action impossible. Harvard’s intransigence might thus be traced to an institutional culture of engaging too readily with pharmaceutical industry players: the previous dean of the medical school, for example, sat on multiple pharmaceutical company boards during his tenure, and several faculty are currently under Senate investigation for conflicts of interest.
The medical school’s response to student pressure, the AMSA report, and a flurry of media attention has been to convene a student-faculty committee under the current dean, Dr. Jeffrey Flier, to evaluate conflict of interest policy. The committee is still in session and actively soliciting input from medical students and faculty. Policy changes are expected to be implemented within the next few years, though no definite timeline has been set.
It should be noted, however, that the two sides observers expected to clash in the committee – those in favor of pharmaceutical interaction versus those opposed – agree more than they disagree. According to Vijay Yanamadala, a second year medical student at HMS and a 2007 graduate of Harvard College, “everyone agrees that there should be one-hundred percent transparency in all interactions between faculty and industry and an appropriate amount of regulation to ensure that transparency exists.” Where the two camps differ, he says, is “on the finer points of to what extent these interactions should be limited.” The media’s portrayal of the ideological clash, Yanamadala adds, puts things “in a much more dramatic light than they really are.”
While the medical school un-dramatically formulates the next generation of conflict of interest policies, it is worth considering what impact such policies could have on the education of medical students, and even undergraduates heading into the medical profession. Doing so requires recognition that pharmaceutical companies’ interactions with faculty in the research and clinical capacities do not necessarily translate into changes in classroom teaching, even though such interactions draw the most ire and earned Harvard the failing grade.
Many students are in fact calling for increased interaction between medical students and the pharmaceutical industry. Such students carefully distinguish from increased interaction between the industry and faculty, and indeed many support tighter regulations for such relations. They are instead calling for medical students to have greater exposure to industry during the first and second years of medical school, a time when students have virtually no opportunities to interact with firms. Yanamadala asserts that students begin interacting with industry representatives during clinical rotations in their third and fourth years of medical school, and will continue to do so for the rest of their careers. “Artificially limiting these sorts of interactions during the first and second years,” he says, “doesn’t really make sense.”
Yanamadala and others also advocate for continued interaction between faculty and industry, albeit with full transparency and proper regulations. The argument in favor of such interactions concerns a fact at the heart of the issue: that pharmaceutical companies produce the medicines that doctors, and ultimately patients, rely on. Yanamadala continues, “these companies have relied on interactions with doctors and with faculty whose expertise is transferred to industry in order to develop new technologies. Trying to restrict these interactions now would really jeopardize our future potential to get discoveries in academia out to the clinics for use in patients.”
The balancing act, of course, comes in regulating academic-industry interactions in ways that ensure they are ethical without stifling them altogether. However, it is also be vital to teach medical students, as early in their education as possible, how to recognize and deal with bias from all sources, including the academic literature. In judging how Harvard Medical School’s curriculum deals with bias in the context of pharmaceuticals, one need only look to the AMSA scorecard. In this area, HMS earned as low a grade as it did on every other metric on the AMSA scorecard, raising concerns about how well HMS will perform this vital task. To do so, it will need faculty to carefully guide students, especially at early stages. The school will thus have to combine increasing faculty regulations and responsibilities with an increased industry presence in the early stages of medical school.
The natural question that arises is what, if anything, will persuade leading academic institutions such as Harvard to change their conflict of interest policies. Given that pharmaceutical companies pour millions into academia (for the most part with good intentions and outcomes), the incentives seem stacked in favor of the industry. One might think that student pressure would work against this, and to an extent it certainly does. However, the students have few bargaining chips. Barring them making the radical move of withdrawing from medical school, they have few ways to exert pressure.
Also of concern is the fact that Harvard and other top medical schools will continue to attract talented pre-medical students to their ranks, regardless of their conflict of interest policies. This is primarily because pre-medical students almost never decide where to attend medical school based on such policies. Ravi Parikh ’09, who is currently deciding where he will attend medical school starting this fall, says he will make his decision based on “the strength of the education, the curriculum, accessibility of faculty, the school’s resources, and my familiarity with the school.” These factors are what most pre-medical students would (and should) consider.
However, most of these considerations – especially a school’s resources and the curriculum – are directly impacted by conflict of interest policies. The result is that pre-medical students, while making the right decision for their future, often reward the mistakes of their choice medical school’s past. No student should have to turn down a world-class education because of institutional misdemeanors, but what are pre-medical students to do when a school accumulates the resources it needs by subordinating its academic interests, and potentially its curriculum, to the private sector? The onus is thus on medical schools, especially those with high levels of funding and prestige, to self-regulate faculty-industry actions appropriately while giving students the exposure to industry necessary to make informed decisions in their clinical careers.
This is not to say that cases of misconduct in faculty-industry interactions are the exclusive fault of the medical schools themselves; the industry itself is as much to blame. Of course, the industry is an easy target: a 2005 Harris poll revealed that the public perceives the pharmaceutical industry as one of the least honest and trustworthy, better only than the likes of big oil and tobacco. The negative perception of pharmaceutical companies pervades much of academia as well, because pharmaceutical research is believed by some to be of lesser academically legitimacy.
Chemistry concentrator Jeffrey Holder ’09, however, sees things differently. After an internship in medicinal chemistry at Eli Lilly & Co., Holder believes that industry scientists, “are some of the best out there.” The chemists, he says, “have less than one-hundred days from the identification of a target molecule to devise a synthetic route with minimum steps to scale up its production to hundreds or thousands of kilograms of product.” Indeed, many of the best and brightest researchers head to industry precisely because of the scientific rigor that parallels academia in depth and competitiveness.
Another reason they go into industry, however, is to make an impact on human disease, often more directly than can be made in an academic research laboratory that is not part of a drug pipeline. Says Holder, “the way that the researchers in industry talk about the properties of a drug is always in terms of what the patient needs. It’s never just in terms of the science; it’s in terms of the patient.” Indeed, as Parikh notes, “without the pharmaceutical industry, there would be no such thing as medicine.” The implication with regards to medical school conflict of interest policies is that pharmaceutical companies, for all their shortcomings, still ought to be viewed as institutions that prioritize human well being as much as academic hospitals do – qualified, of course, by the profit motive inherent in their interactions that necessitates careful regulations. Viewing them as such will lead to the most balanced and productive policies, and guide efforts such as those at HMS – not towards excluding pharmaceutical companies entirely, but rather towards encouraging collaboration with them in ways that harness their desire and ability to make socially beneficial scientific discoveries.
The scope of these issues extends far beyond undergraduates who are headed to medical school or biochemical research. Their impact is broad insofar as doctors, whose patients will include the pre-med and non-pre-med alike, receive their education from institutions that have close ties with the private sector. Even the most prestigious of those institutions, such as Harvard Medical School, have much work to do with regards to regulating their faculty’s relationship with industry players; their approach will hopefully be based on a thorough understanding of the ways the companies interact with faculty and students, the necessity of those interactions, and the nature of the companies themselves.