Drug and device development requires extensive expertise, is costly, and time consuming. In particular, the need for deep expertise in many disciplines means there is a market value for those skill sets, and sometimes those exist in the private sector, but many times, in academia. The relationship between academia and industry is both praised and criticized, but unavoidable as increasingly complex diseases are tackled by both parties. As a result, many academics also have some kind of corporate relationship, be it as a trial investigator, a consulting or advisory role, or a speaker’s bureau slot, to name a few examples. As these relationships merit payment, critics feel industry payments erode away at academics’ ability to offer unbiased opinions and expertise, precipitating the need for some kind of disclosure.
Putting aside the details of the most recent example of a debate over conflict of interest (COI) out of Memorial Sloan Kettering Cancer Center (MSKCC), much of which has already been detailed elsewhere, the response suggests disclosure is not only preferred but necessary, though the who, how, and why have yet to be hammered out. Medical journals and some specialty societies may require the data, but do not have uniform criteria for the reporting of industry ties (whether by physicians or sponsors) nor a readily identifiable platform for prospective patients or industry observers to view what relationships physicians may have.
The most comprehensive source of information is the Open Payments database maintained by the Centers for Medicare and Medicaid (CMS). Applicable manufacturers and group purchasing organizations are required to annually submit relevant payment information to physicians and teaching hospitals to CMS, and CMS subsequently allows physicians and those hospitals to review the reported payments for accuracy. Payments for research, meals, travel, gifts, and speaking fees are all required to be reported.
While the most comprehensive, there are some notable exemptions to the Open Payment database, which some argue are loopholes asking to be closed. Companies that do not yet have a marketed product approved by the Food and Drug Administration do not have to report payments, meaning many small biotech companies working on their very first product are not reporting to the database. Additionally, continuing medical education (CME) payments are also exempt, though some argue CME is simply another avenue for industry to market their new launches and pipelines.
Referring to the recent MSKCC news, medical ethicist Dr. Arthur Caplan publicly commented “We have yet to figure out what COI means or how to manage it in a health care world where industry ties are everywhere” which is likely the best succinct encapsulation of the status quo. It is unknown what payment threshold might influence physician decision making (whether perceived or actual), but there is also some intangible value to physicians who serve as investigators on cutting edge clinical trials and serve on advisory boards alongside the top minds in their fields, who in turn can provide better care for their patients. It would be wrong to suggest that all interactions between industry and physicians are either unethical or inappropriate, but we can, and should, do better at reporting them.