The Promethean Role of Industry in Spine Surgery Research (2010)

The days of a lone surgeon making major research breakthroughs are fading into the past. Biomedical research in the current era is an increasingly complex enterprise requiring extensive teams of specialists using sophisticated equipment.1 We need greater cooperation between networks of surgeons, basic scientists, engineers, and other specialists, to continue making advances in spine surgery. We also need practicing surgeons to contribute their data to giant national registries. And we must always remember that industry plays a major key role in research and development. Universities, hospitals, and government do great basic research on the one hand or clinical research on the other. But they do not do much translational research, and they certainly never bother to develop products that we can actually use in patient care. Maybe they should, but currently they do not. Without industry collaboration, medical progress would remain entirely theoretical. Recently, industry relations with doctors have come under scrutiny. A few highly publicized scandals, such as Merck's Vioxx and Astra Zeneca's Zoladex, have led to widespread discussions and overdue professional reforms.2,3 It is now understood that relations between physicians and industry, and any other kinds of potential conflicts of interest, need to be openly disclosed to the public.4 Surely there is no harm in greater transparency.5 Similarly, inappropriate physician-industry relations need to be replaced with appropriate physician-industry relations, as described by AdvaMed among others.6,7 For example, consulting arrangements should be a fair market-rate fee for real service and expertise, not any of those old “nudge-nudge” consulting fees. We would all like to avoid a situation where a few more national media scandals lead to widespread loss of public confidence and greatly increased government regulation. Therefore, both surgeons and our industry partners need to be proactively self-regulating about all this. Beyond these disclosures, there have been a range of opinions about which physician/industry relations to permit or restrict, but the middle-road position of the Institute of Medicine is likely to prevail.8 In brief, they call for a removal of industry influence in continuing medical education and also recusal of surgeons with conflicts of interest from research and policy committees. Some critics have gone even further and called for an end to industry-supported research,9 but fortunately, that is not the position of the Institute of Medicine. They recognize that industry plays many vital roles in the development of new therapies—roles that universities, hospitals, and governments do not, and cannot do. First, hundreds of companies, large and small, take long-shot gambles on the preclinical research of possible products, yet only a small fraction ever get all the way out of the laboratory and into the hospital. Much of this research would never get carried out if it were not for enterprising people taking risks on innovation. Second, many multicenter, multiyear clinical trials would not even exists without industry funding and logistical management. Yet, this is precisely the kind of level-1 evidence that government and insurers are always demanding. Third, a better understanding of the existing therapies, and incremental improvements of them, comes about in large part through companies diligently monitoring their own products. Dismissing industry-sponsored research as “tainted” because of industry funding is misguided. As residents learn in “Journal Club,” it is the study methods that determine the reliability of the findings.5 Conversely, companies making medical products need the input of university researchers and practicing surgeons, to improve the products they are offering. Industry is incapable of improving patient care without the input, guidance, and innovation suggested by healthcare professionals. Therefore, it makes no sense to place restrictions on that feedback loop. But, we do need a new model for research collaborations between surgeons and industry. In the old model, a company would come to surgeons and say, “Look, we have got this amazing new Spine-Widget, and we want you to do a study on it. You enroll the patients, we will provide the widgets; you do the surgeries, we will fund it.” But the public is getting increasingly skeptical of these arrangements, because of perceived conflicts of interest. In the new model,10 a university department, private foundation, or professional society will develop a portfolio of priority research themes that need to be addressed. Private donors, including industry, will contribute unrestricted sponsorship to this research program. Researchers will propose specific studies addressing the topics identified, and the foundation, university, or society will select specific studies to receive funding, based on peer-review of the proposal merits. This model will create a buffer-wall against inappropriate influence while ensuring closer dialog; and it will make precious data more widely available for the greater good of the entire spine surgery community. This new model will launch us forward into the future, all together. In summary, spine surgery is at a historic pivotal moment. Many breakthrough technologies are in the pipeline these days. Medical companies have a crucial role to play in the research and development of the surgical technology clinicians use to help our patients. ACKNOWLEDGMENT The author thanks Michael Hanna, PhD, (Mercury Medical Research & Writing) for support in preparation of the manuscript.