“Scientific enterprise is not just a quest for knowledge and truth; it is also a fairly good reflection of the whole spectrum of human behavior: from genius, passion and jealousy, to mistakes and misconduct.” Cokol and Rodriguez-Esteban….EMBO reports 2008.
In our quest to get more impact from America’s Academic Medical Centers (AMCs) by making innovation and entrepreneurship an expected and natural academic behavior, we need to continue to discuss various system requirements that exist in AMCs that are necessary to process innovation to eventual impact. One of these system requirements is the declaring of a conflict of interest (COI) and disclosing this to the scrutiny of an institution’s COI committee. I know…it already sounds confusing, a bit nefarious, and not very fun (as in colonoscopy not fun). You might be saying, where is the conflict in coming up with an awesome life-saving idea and moving it to the bedside.
First, a small bit of history. There was once (and unfortunately still is to a significant extent) a practice where medical industry would pay medical key opinion leaders (KOLs) a lot of coin to speak to their medical brothers and sisters about products that the industry entity was producing. This could be devices, diagnostics, pharma, etc. Think of it as an endorsement of medical athletic wear by a medical superstar. What company doesn’t want that? The problem was that many times the KOLs forgot to… uhhh… mention they were being paid so that the praise they were giving the product was maybe less objective than the audience would have expected. This also led to problems when KOLs were maybe advocating that their institutions adopt the product or service.
Well…of course what could go wrong in medicine with this sports analogy of superstars endorsing the life impacting correlations of sneakers (devices), power drinks (therapeutics), etc.? Sometimes industry would put KOLs on their boards, giving them stock options and more cash, lots of travel (can you say Platinum miles member) and speaking engagements, which further muddied objectivity. For the most part these KOLs simply gave advice and advocated (we hope) for products they truly believed were transformative, but some of course had other agendas.
This doesn’t necessarily sit well in the sacred halls of the ivory tower of AMCs so on the eighth day, COI committees were formed, and they were ...well…ok at first. COI committees were designed to objectively provide some checks and balances remembering that disclosure did not necessarily represent a conflict but perhaps an appearance of conflict that should be overseen making sure that things like reimbursement for these KOL services were not out of proportion to services rendered and that the KOLs were ensuring they were disclosing relationships to the institution, their colleagues, societies, journals, patients (if the KOLs were leading studies for industry) etc. In fact, societies and journals, IRBs, grant agencies, and others jumped on board and now mandate disclosure if the individual(s) submitting have any real or potential financial skin in the game on the trial, study, or paper they are attempting to undertake or get published. However, if you are hell bent on gaming and cheating the system, stuff happens. We had such a rascal at the University of Michigan. Dr. Sid Gilman, a distinguished Professor of Neurology (classic academic career and superstar), became a bit of a poster-child for what not to do and how all the checks in the world won’t necessarily prevent a problem.
Ok…so COI committees seem reasonable, but we all know the bureaucracy of the AMC is a bit like kudzu. It sort of looks all around to see what else it can latch on to and feed off of. Hey…know what looks COI juicy…a good idea and potentially commercializable product from Dr. Smith (name changed to protect the innocent). Professor Smith has an awesome idea to develop a device that will help paramedics and doctors save more patients who experience cardiac arrest (there are approximately 350,000 cases of out-of-hospital cardiac arrest with a 90% fatality rate). She works hard to develop a prototype and shows initial proof in her lab that it works. She then works with her University’s Tech Transfer Office and files a patent to protect the idea and technology.
However, at this stage no established industry partner feels the technology has been sufficiently de-risked or perhaps had a bad third quarter and can’t make the investment at this point. Dr. Smith, however, feels she and the local entrepreneurial community might be able to leverage some early stage investment and move the technology forward. She has identified a capable CEO and some pre-seed investment and decides to start an LLC and negotiate a license for the technology from the University. This act, however, activates an internal red alert of required activities with the COI committee which in turn requires additional steps with the IRBs, review of all other research activities, and other things. Anything that is faintly connected to this technology (graduate students, future grants, speaking engagements, travel, etc.) will require more and ongoing key strokes. Sometimes an audience before the COI committee is required. It can really become hot and heavy if, heaven forbid, the faculty innovator as a company founder or other medical officer takes shares in the company even if its 0.00001 cents/share. Many times, the innovator-entrepreneur won’t be allowed to be the principal investigator on a clinical study examining the technology. They must also disclose to patient subjects in research consent forms that they are part of a company and may benefit from the results (it really sounds and makes the investigator seem sleazy). At some institutions and for some individuals, this exercise is simply too much, and I personally know colleagues who simply forgo the opportunity to engage in the entrepreneurial aspects of the enterprise and instead wait for magic to happen in the university’s Tech Transfer Office.
So, what’s wrong with this? For one thing, this can significantly suppress innovation and divorces it from the reality of the principles of entrepreneurship (see blog #4). There’s not a technology fairy that visits innovators in the middle of the night and magically refines and get transformative technologies to market, saving lives and leaving bags of cash at the University for all to enjoy. Instead, there are these beings called entrepreneurs who must raise piles of cash and risk a lot to take the technology to the next level and the next, and the next to try to get it to market. In the end, after years of blood, sweat, tears, and cash, the majority are dashed to pieces on the rocky shores of the free market. Only a very small percentage sail into the harbor of success like a luxury cruise liner impacting the thousands of patients hoped for. Yes…this is the reality innovators and entrepreneurs know about, but AMC leadership and committees have little first-hand knowledge of. For most of them, optics are the first order of business.
What makes this disclosure and management process curious is that there is, in my opinion, lack of any semblance of equipoise when applying COI principles to promotion and tenure (P&T…see blog #2) and other activities which can be argued hold much more potential for mischief. I always found it puzzling that for faculty who are in the process of P&T and are hard pressed to do research and publish (or perish), there is no obligation to disclose to patients they may be enrolling in studies, or journals they are submitting research findings to that the clinical study and publication of this new knowledge are critical to their success and required for their being promoted and/or tenured resulting in their getting significant job security, higher salaries, more power in the institution, prestige, ability to travel and promote their work, etc. Hmmmm…any conflict here? Just saying. If one looked at this objectively, there is really just as much conflict if not more. In fact, folks...there is likely to be far more potential for scientific misconduct in the timebomb-ticking race for P&T than in the pursuit of commercialization of a technology invented by a faculty member.
Let’s also not forget the poorly publicly advertised reproducibility crisis facing medicine and science in which an increasing number of studies for which we have paid billions of dollars for from the NIH and other sources can’t be replicated. And…oh did I mention the significant increase in retracted papers from journals including those with the most prestige? These should really be targets for the COI kudzu to latch onto.
In addition to the usual, IRB, journal and grant agency peer review, Dr. Smith will have to convince early investors, venture firms and industry partners of the merits of her innovation. All of these entities will in turn do their own due diligence, combing over the literature, talking to experts, etc. And wait…that’s not all…she and her company will have the pleasure of dealing with the FDA and that regulatory stuff. Dr. Smith, as an entrepreneur has essentially exposed every nook and cranny of her innovation and for that matter, her career for scrutiny putting at risk a lot of people’s time and money and even the safety of patients. So…you can see that skirting important steps driven by the nefarious motive of profit poses a bit of risk to Dr. Smith.
The process to get Dr. Smith’s innovation to market to treat victims of cardiac arrest will likely take a decade and millions and millions of dollars. Over this time, Dr. Smith will face more checks and balances than the traditional academic that ensures she doesn’t try to fool everyone and go all Theranos on us (however, remember Elizabet Holmes was never a member of the Academy). Malfeasance in the public sector can lead to financial devastation and jail time. Not so much in the world of academia if you falsify data in a paper. Maybe Dr. Smith should be allowed to put in the IRB consent form something like: Dr. Smith was bold enough to form a company to help further develop this potential life-saving technology. She is working like crazy trying to raise enough money to refine and test it. There is a chance she may be successful over the next decade and might even break even, but in reality, there's less than a 1% chance this will happen. More likely her dreams will be buried at the bottom of the ocean and more people will continue to die of cardiac arrest. If you consent to this study, sign here...
So on balance, I would say, if there is a clear and present COI danger, it's not coming from the entrepreneurial class within the AMC. What I am arguing is that innovation and entrepreneurship that moves ideas to impact involves activities that are, in essence, no different from a COI standpoint than with the traditional activities associated with P&T. The activities which lead to deserved P&T are expected of faculty hired into AMCs (discovery and transmission of new knowledge, teaching, excellent patient care, etc.). When that new discovery and knowledge gets transmitted to the outside world it sometimes requires additional activities that transform it to a form that requires entrepreneurship and commercialization. This is simply a convergence of interest of the faculty innovator and the AMC and not a conflict any more than the previously mentioned traditional P&T activities, which have beneficial consequences not just to the individual faculty member, but also to the institution and the patients it serves. In other words…both should be considered equally natural and expected. Heck…the AMC already knows this cause guess what...they are going to take an equity stake in Dr. Smith’s company in addition to getting a royalty rate. Again…this is not a conflict but simply a real-world essential business reality.
While this makes great sense to me, I had an opportunity to make this argument several years ago at the Association of American Medical Colleges Focus on Conflict of Interest Academe. Nice people, a bit of discussion (mostly the push-back kind), but a lot of deer in the headlight looks. I don’t know what the ultimate answer is. However, I know it should start with more dialogue on the realities of innovation and entrepreneurship, better communication with the public on the process and expectations and how they are actually benefiting, and some attempt to ease the burden or make the COI process more efficient for innovators wishing to engage in entrepreneurship.
Given all this and if things don’t change…if you are an academic innovator and don’t have a conflict…I would suggest you get one. Otherwise you might not truly be innovating toward full impact! Wish this was the ultimate sign of convergence but…just saying it feels like divergence. I love me some COI.