Working With Industry – The Downside

Neurosurgery is a technology-intensive field. New developments happen rapidly and are essential for improvements in patient care. Technological developments do not, however, occur in a vacuum. Bringing new technologies to market requires not only intellectual rigor, but also enormous investment in basic and clinical research, health policy and marketing. As part of this equation, it is absolutely essential that companies enlist actively practicing physicians in order to develop new ideas, test existing ideas, and modify strategies to achieve improved patient outcomes. Participating in this process is difficult, requiring energy and time that could otherwise be devoted to clinical or personal activities. It is generally more convenient to accept the status quo. The energy required to overcome the inertia of the status quo comes from altruism, ambition, and money.

While we all consider ourselves to be altruistic, there are few of us who would tolerate the rigors of residency, the interruptions of our personal lives, the long and late hours, and the hassles of the current medicolegal morass, for free. Sometimes, efforts are made for personal reasons: to gain fame and respect from peers, to achieve academic advancement, or to place a new plaque on the wall. These rewards do not, however, pay the bills. Similarly, there are very few corporations that are willing to invest large sums of stockholder money and spend years in the research and development process for a new device without the potential for significant financial gain. In fact, for a company whose mission is to reward its stockholders, pursuit of such a strategy would be absolutely unethical.

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Financial reward is an important driver of technical innovation. This is as true in neurosurgery as it is in personal electronics. If you build a better mousetrap (or pedicle screw or MP3 player), you are rewarded financially. Corporations have figured this out and are aggressive in recruiting physicians to act as innovators, evaluators, and advocates for their devices. While this strategy is fine when the products produced are marketed in a free market in which the consumer determines the relative worth of a product, it is problematic in the medical field. We are not simply shopkeepers who display our wares. Our customers (patients) rely upon us to provide advice and to make purchase decisions for them. We are our patients’ advocates and have a moral responsibility to recommend treatment options that make the most sense for them. The problem arises when a physician is also an advocate for a corporation that manufactures a device which may or may not be used for the treatment of a particular disorder. If the physician derives personal benefit from recommending product A versus product B, can the physician truly offer an unbiased recommendation?

I have begun to disclose my consulting arrangement with Medtronic when I offer treatment to a patient with a Medtronic product. I have never had a patient ask me to change my treatment plan based on this disclosure, yet it still is a bit of a hassle. One reason to avoid involvement with industry is simply to avoid yet one more ethical dilemma for the physician who truly may be trying to do the right thing but who works within a system that rewards him or her for doing more surgery, discourages treatment of underinsured patients, and encourages waste. Failure to disclose relationships with industry may also be relevant in a medicolegal system that punishes arbitrarily for perceptions that may have no basis in reality.

The Accreditation Council for Continuing Medical Education has determined that a physician with an industry relationship is by definition conflicted. Therefore, in order for such a physician to participate in an accredited educational event, the physician must disclose his or her relationship(s) with industry. Course directors and program directors have the responsibility to determine whether or not the conflict is substantial enough to disallow participation in the educational program. Therefore, it is possible that participation in ACCME-accredited educational activities may be limited for those who are perceived to be heavily involved in industry. This scenario is probably going to become more commonplace as degrees and definitions of conflict are adjusted in accordance with ACCME regulations and common sense. The physician who earns less than $5,000 per year primarily for teaching a series of “hands-on” courses probably does not have the same conflict as the physician who earns $5 million per year from product royalties.

Probably the most common downside to participation as an investigator or advocate for industry is the potential for loss of academic prestige. Several physician researchers/innovators have been able to maintain academic credibility despite extensive industry involvement. These physicians have contributed directly to the concept and design of innovative technologies and have participated in rigorous clinical trials to validate the relative worth of their innovations. Others have served as ambassadors, bringing established technologies to new markets and evaluating the efficacy of these technologies in new clinical scenarios. These physicians have substantially increased their academic status through their innovation and evaluation of new products.

But more frequently, physicians, particularly young academic physicians, are approached to act as product advocates by companies that have products already in the late stage of development or early stage of marketing. In return for consulting agreements or stock options, these physicians are expected to present at national meetings data derived from trials designed by the industry sponsor. The physician is encouraged to speak with venture capitalists about investing in the parent company and is sent on whirlwind tours with speaking engagements at key hospitals in order to promote the use of the new device. These same physicians tend to get involved with multiple companies, and within a very few years they are thought of more as “spokesmodels” than as academic physicians. It takes many years of thoughtful research to rid oneself of such a reputation.

The worst downside to industry relationships is the potential for real or perceived fraud. I alluded to this earlier when discussing the issue of disclosure to the patient of any financial relationships with instrumentation companies. In addition to disclosing one’s industry ties to patients, such relationships must be disclosed to the hospital and/or to the university. If a product line is endorsed by a local surgeon who is paid by the product manufacturer to promote its products, then there is at least the perception of a “kickback.”

In summary, physicians and industry must interact in order to develop new technologies that are relevant to patient needs. This interaction must be disclosed in a realistic fashion to any and all stakeholders affected by the relationship (patients, hospitals, students, etc.). In some cases, the degree of the interaction may prohibit participation in certain educational or even clinical activities. Separating clinical decisions from financial decisions is necessary to avoid fraud. Younger physicians are cautioned against endorsing products that they did not substantially help to develop.

The relationship between physicians and industry is changing due to increased complexity of regulations and because of a more saturated market. Physicians must guard their access to patients closely and must act as patient advocates and not as industry “spokesmodels.”

Daniel K. Resnick, MD, MS, is associate professor and spine surgeon in the Department of Neurological Surgery of the University of Wisconsin-Madison Medical School. Disclosure: The author has a consulting agreement with Medtronic and reports receipt of less than $5,000 for consulting activities in the past year (2007).