Opportunity abounds in the exhibit hall during the 2004 Annual Meeting of the American Association of Neurological Surgeons: opportunity to discover the latest innovations; opportunity to identify potential customers; opportunity to develop relationships that may prove mutually beneficial in the future. How to ensure that patients benefit from medical science-industry interactions is a billion-dollar question that neurosurgery, industry and society are working to address.
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As neurosurgeons, we utilize the products of the medical device industry to make our jobs easier and improve outcomes for our patients. Innovative neurosurgeons provide many of the ideas that fill the research and development pipeline of medical product manufacturers, while industry funds research that leads to the next breakthrough in neurosurgical care. The list of interactions goes on, and in each case both parties benefit from the relationship.
The Annual Meeting: A Microcosm of Interdependence
Perhaps the most visible manifestation of neurosurgery and industry’s mutually beneficial relationship is the exhibit hall at any neurosurgical meeting. These primarily educational events additionally provide a showcase for industry’s latest products and supply a large audience of “customers” who come to view products and information as well as try out the latest devices.
For example, at the recent annual meeting of the American Association of Neurological Surgeons (AANS) in Orlando, Fla., 220 companies were represented in the exhibit hall. With exhibitors outnumbering medical registrants 3,107 to 2,832, there was ample opportunity either to try new equipment with the benefit of the undivided attention of a knowledgeable company representative, or, depending upon one’s viewpoint, to develop a potentially fruitful relationship with a prospective buyer.
In addition, some companies sponsored aspects of the annual meeting, such as special lectures, the opening reception, and the scientific program CD-ROM. Perhaps less visible but of vital importance is corporate sponsorship of the practical clinics through provision of necessary equipment. Typically the course director will decide which equipment best meets the needs of a course-a certain type of spinal instrumentation for a clinic on cervical spine instability, for instance-and will make the initial contact with the equipment’s manufacturer.
Exhibition hall fees and sponsorships underwrite a large portion of the annual meeting, while the remainder is covered by participants through registration fees.
While some may believe that an annual meeting the scope of the AANS’ could not be held without the financial support of industry, in fact only about 5 percent of the annual meeting is underwritten by industry, while exhibitor fees account for just over one-third of all revenue. It would be correct to say that the annual meeting could survive without corporate support, but it would be transformed into a bare-bones format accompanied by increased registration fees; further it is unlikely that the hands-on practical clinics, so important for trying out new techniques, could continue at all without corporate support.
With regard to the annual meeting, neurosurgery and its mission of continuing medical education clearly benefit from industry support.
Sponsoring companies benefit in return through direct access to nearly 3,000 neurosurgeons and other healthcare professionals gathered in one location for the duration of the meeting. In the exhibit hall, company representatives have the opportunity to answer surgeons’ questions and provide hands-on demonstrations of their products. Throughout the week of the meeting, exhibitors have opportunities to interact with neurosurgeons in the convention center, hotels and local restaurants. This face-to-face contact is perhaps the most valuable marketing opportunity a company can get.
Companies receive educational benefits from organized neurosurgery as well. Industry representatives are allowed to attend some scientific sessions during the meetings where they have the opportunity to learn about the latest advancements in patient care and the challenges that our subspecialty currently is facing.
Beyond the Annual Meeting
Organized neurosurgery benefits from industry’s financial contributions beyond the annual meetings. Most fellowships, educational grants and achievement awards are funded either directly or indirectly by industry contributions. With few if any strings attached, these grants are largely altruistic but garner good will in return. Companies also contribute directly or indirectly to many neurosurgical residency programs in the form of research grants, fellowship funding and educational programs. Many local continuing education programs offered at private and training institutions are underwritten in part by medical product companies.
All this participation in neurosurgical education gives industry an opportunity to influence physician behavior and product utilization. Many years ago I participated in a hands-on practical course to learn how to use a new high-speed drill. I was afforded the opportunity to drill real bone with multiple bits and attachments, each designed for a specific purpose. The intense training was in a controlled environment that allowed me to develop competency with the tool without undue risk to a living patient. After drilling for a period of time with a single bit, the instructor provided a new bit of the same design saying something like “see how much difference a sharp bit makes.” In addition to providing invaluable experience with new technology, the company representatives had the opportunity to encourage the use of multiple drill bits that of course would increase sales revenues. The workshop provided a valuable service to the participants but also provided a forum for promoting the sponsor’s product.
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| Hands-on experience with new instrumentation and techniques is one of the valuable experiences offered in practical clinics held during annual meetings of the American Association of Neurological Surgeons (AANS). Industry makes these practical clinics possible by donating the instrumentation and other necessary equipment specified by each course director. |
Industry and medicine work hand in hand toward the advancement of technology. In the formative stages, industry gets ideas for product development from the physician while medicine relies on research and development expertise to bring new ideas to fruition. Large research and development coffers fund much of the basic research that precedes the manufacture of a new product. New products must undergo the rigors of approval by the U.S. Food and Drug Administration, which requires the participation of test sites and enrollment of patients into trials. Feedback from doctors and patients leads to refinements in a new product. Without mutual participation in this development process, no new product would ever make it to market.
When a company funds research, it often will request the right to review the results and control public access to any data generated by the research. This affords the company some protection against publication of erroneous results but may also keep from the medical community certain vital information that may reflect negatively on the company’s product. Surgeons frequently work with company engineers and product managers to develop new medical devices. Surgeons involved in product development often are awarded by contract a percentage of future sales in compensation for their intellectual contributions as well as endorsement. Commitments of this nature can influence the surgeon’s utilization of a new product as well as other products the company may sell. Thus, a potential for abuse and unethical behavior exists on both sides of the product development equation.
Individual neurosurgeons typically enjoy mutually beneficial relationships with local product representatives. In my operating room, some industry representatives are as much a part of the operating team as the scrub technician, circulating nurse or anesthesiologist. These reps are immediately available to deal with technical problems encountered with equipment they have provided to the hospital or to assist the scrub technician in the management of complex instrument sets with which the tech is not completely familiar. The distributors of products that I use most frequently contact me on a routine basis to ensure that my needs are met. Local representatives answer my questions about specific products, and relay to the home office any concerns that arise. It is on the local level that I have formed the closest and most enduring partnerships with company representatives, and I suspect this type of partnership is commonplace.
Competition between companies is fierce, but the battles are largely fought and won on the surgeon’s home court. Rival representatives vie for a customer’s time and the opportunity to describe, demonstrate and promote the latest company product. Competition can be good when it leads to more economical and higher quality options for our patients. But when it leads to undue influence or loses sight of the patient’s best interests, the line has been crossed. We all become accustomed to perks, some small and some not so small. We think little or nothing of the lunch a company representative has provided and a round of golf may be viewed as usual Saturday sport with friends. But at what point do these perks become bribes or kickbacks? Nobody would dispute that it is illegal to receive remuneration from a company simply for using their product in the treatment of a patient. What if a company foots the bill for a physician and a spouse to spend a long weekend at a high-end resort? Is this illegal, or if not illegal, is it not unethical?
Codes Spell Out Industry’s Commitment to Ethical Relationships
Mutualism becomes parasitism when personal gain becomes a prime motivation in the interactions between neurosurgery and industry. In order to limit the potential for abuse, industry has recently made a public commitment to ethical relationships with healthcare professionals. The Pharmaceutical Research and Manufacturers of America, PhRMA, a consortium of pharmaceutical and biotechnology companies, and the Advanced Medical Technology Association, AdvaMed, an association of medical device, diagnostic product and medical information system manufacturers, both have adopted voluntary codes of ethics that facilitate responsible interactions with the medical community. Both organizations have expressed an ultimate commitment to benefit patients and to enhance the practice of medicine through education of healthcare professionals and promotion of medical research. Both ethical codes outline appropriate interactions with healthcare professionals that relate to the marketing of their products. These documents are similar to one another in scope, but the AdvaMed code, which is more applicable to neurosurgery because it focuses on devices, is written from the perspective of companies that promote complex medical technology that requires proper education for the safe and effective use of their products.
The codes specify that product training and education that is independently sponsored by a medical device or pharmaceutical company, such as demonstration of new surgical technology, is not only ethical but necessary. However, any meeting of this type should be held at an appropriate facility that is conducive to learning. That is, the attractive location should not be the sole reason for sponsoring a training meeting in the Caribbean. The company may cover reasonable expenses of the attendees and provide hospitality such as receptions and meals so long as they are modest in value and provided only to bona fide participants. In other words, it is OK to furnish lunch for the doctor but not for the doctor’s spouse. Companies also may provide financial support in the form of educational grants, payment for advertisement opportunities, faculty expenses and hospitality for third party sponsored educational programs, such as an AANS annual meeting, as long as the same general principles regarding location and format are met. In addition, the third party conference sponsor should be responsible for and control the selection of program content, faculty, educational methods, and materials. Furthermore, it is inappropriate for a company to cover the personal expenses of non-faculty healthcare professionals attending the conference.
According to the codes, individual physicians may be paid to serve as consultants for medical product companies if they provide “bona fide consulting services, including research, participation on advisory boards, presentations at company-sponsored training, and product collaboration.” Such arrangements assume a written contract, fair market compensation and appropriate qualifications. Simply being a good customer with high utilization of company products does not warrant a consultant’s fee. Gifts are allowable as long as they are worth less than $100 and have an educational purpose or serve the patient. The Advised code also addresses how a company can appropriately assist a doctor with technical issues, give advice regarding reimbursement and make charitable contributions. The complete documents can be viewed online and downloaded from www.advamed.org and www.pharma.org.
These codes may seem too restrictive to some, but they go a long way toward preserving mutualism between neurosurgery and the medical product industry. What we must all keep foremost in our minds is our shared mission of helping patients. The patient’s well-being should always be the guiding ethical principle in the interactions between industry and the medical profession.
H. Louis Harkey III, MD, is professor of neurosurgery at the University of Mississippi
Medical Center