Perspectives on interactions between paediatricians and the pharmaceutical industry.

One of the major developments in medical history has been specific therapy – the provision of drugs targeted to specific indications for which therapy is usually efficacious and safe. Specific therapy developed as a consequence of serendipitous observations of the antibacterial effects of penicillin and sulfonamides, made in the United Kingdom and Germany in 1928 and 1935, respectively. These observations led to a series of developments that resulted in the ready provision of a wide variety of potent therapeutic agents. One of the major and unintended consequences was the change in the culture of medicine from a focus on care to a focus on cure, which is eloquently described by Lewis Thomas in his masterful work, The Youngest Science: Notes of a Medicine-Watcher (1). Another unintended, but no less real, consequence of the therapeutic revolution has been the development of the pharmaceutical industry from small, family-operated businesses to very large, polished and profitable enterprises (2). The presence of a robust pharmaceutical industry has created opportunities and challenges for physicians. The advantages of novel therapeutics must be weighed against the risk of adverse events; the cost of new drugs must be weighed against the risk of therapeutic failure. In addition, the increasing concern about what constitutes an appropriate relationship between physicians and the pharmaceutical industry has become a much-debated topic in the past decade (3). Opportunities abound for physicians to interact with the industry, such as through continuing medical education (CME) events and industry-supported research. There is a series of questions that every paediatrician should ask themselves when considering an interaction with the pharmaceutical industry. The first question is, what is the reason that I am being asked this? Why does the company in question want to send me on a CME cruise or pay me to give a talk? As part of this thought process, it is important to remember that the goals of the industry and the physician, although both legitimate, are probably different. The physician’s goal is to provide the best care possible for patients using the best available knowledge. The company’s goal is to provide reputable products and return a profit to shareholders. While these goals are not necessarily mutually exclusive, they are very different. This leads us to the next question: what would my colleagues think about this? Would another physician (a resident or student) feel that the compensation provided or the activity undertaken was appropriate? This, in turn, leads to the most important question: what would my patients and their families think about this? As an example, would the parents of children under your care be pleased to know that you were receiving compensation for enrolling children in a company-sponsored study? Is it likely that the community at large would think that it is appropriate for physicians to receive thousands of dollars of sponsorship to attend CME meetings in warm and distant climes? If the answer to either of the last two questions is no, the paediatrician should carefully consider whether to proceed. To put things in context, one can keep in mind the old adage, “would your mother be proud?” Whether the compensation or payment provided is reasonable must be considered. Is it reasonable for a company to pay a paediatrician $5,000 to give a 30 min CME talk? Unless one is a Nobel laureate, the answer is almost certainly no. Thus, having considered the above questions, the next step is to decide whether to proceed and, if the answer is yes, how to proceed. This is unlikely to occur in a vacuum. It is important to recognize that there are often provincial and institutional guidelines governing physician-pharmaceutical relations. For instance, most, if not all, Canadian university research ethics boards will not approve research protocols that involve payment of ‘finders fees’ for patient recruitment. When speaking or writing for industry, maintaining objectivity and credibility is critical. Ensuring that all therapeutic options are discussed, using generic rather than proprietary names and, as much as possible, one’s own audiovisual material rather than company-generated material, is important in ensuring that the content of the talk or manuscript provides an unbiased, evidence-based approach to a problem and is not a product endorsement. The source of support and any conflicts of interest should be identified. Many physicians participate in industry-sponsored research. Again, while researchers and company sponsors have many common goals, they also have goals that are different. Both researchers and companies wish to develop new knowledge. Researchers want to present and publish their results, enhancing the profile of the individual and their institutions. Companies have the goals of bringing products to market on a timely basis, retaining and enhancing market share, and returning a profit to shareholders. While these goals may not necessarily be mutually exclusive, it is important for both parties to recognize that some of the other partner’s goals, while legitimate, may not be theirs. Failure to appreciate this has resulted in painful and very public clashes between companies and researchers. These controversies have brought the issue of industry-supported research to the forefront and, as a result, a number of guidelines have been established to guide physicians, academic institutions and companies in the conduct of such research. The paediatrician planning to get involved in industry-supported research should ensure that they are very familiar with these policies because they apply to them and their institutions. Given the increasing concerns over the results of industry-sponsored trials, preserving academic integrity is a major issue for the paediatrician in a teaching centre. It is important, particularly for paediatricians in community practice, to consider how being involved in this research will be perceived by their patients and the families of their patients. In all cases, financial support and conflicts of interest must be acknowledged in an open and transparent manner. The astute reader will note that this author faces these issues. I have had the great good fortune to be the recipient of the GlaxoSmithKline-Canadian Institutes of Health Research Chair in Paediatric Clinical Pharmacology, an endowed Chair established at the University of Western Ontario as a result of a partnership between GlaxoSmithKline Canada and the Canadian Institutes of Health Research and awarded on the basis of a peer-reviewed competition. Thus, when writing or asked to identify conflicts of interest, it is critical that I identify the Chair and the partners involved. In dealing with the pharmaceutical industry, openness and transparency are key in ensuring that the paediatrician identifies and avoids conflicts and perceptions of conflict that can significantly impact on all parties involved.