On September 13, 2018, the Chief Medical Officer of Memorial Sloan Kettering Cancer Center resigned from his post amid reports that he failed to disclose payments from a large number of healthcare companies in research articles.
A prominent figure in cancer research, Jose Baselga, MD, omitted his significant ties to giant corporations (e.g., Roche Pharmaceuticals) and smaller biotech companies from articles that were published in the New England Journal of Medicine and The Lancet, as well as other leading journals.
An article in that day’s New York Times illuminated the reasons why this matters.
While overseeing the cancer center’s medical operations, Baselga served on the boards of Bristol Myers Squibb, Varian Medical Systems (which sells radiation equipment to Sloan Kettering), and at least four other such companies; these positions require that he accept fiduciary responsibility to protect the financial interests of the companies.
Baselga, an expert in breast cancer research, also played a key role in the development of cancer drugs such as trastuzumab (Herceptin, used to treat metastatic breast cancer), a product developed by Roche subsidiary Genentech.
The financial benefits he received in exchange for his industry relationships (2013-2017) totaled nearly $3.5 million in payments from drug, medical equipment, and diagnostic companies; several million came from Baselga’s ownership interest in a company acquired by Genentech in 2014.
Baselga declined to disclose how much he received from similar companies that are not required to report such payments; for instance, Infinity Pharmaceuticals paid him close to $250,000 in cash and stock options for serving on its board from 2015-17.
Fast forward to December 8, 2018, when another New York Times article exposed more failures to disclose industry ties — this time, it was the dean of Yale’s medical school; the director of a cancer center in Texas; and Howard “Skip” Burris III, MD, president-elect of the American Society of Clinical Oncology. Although drug companies paid Burris’s employer more than $100,000 for consulting/speaking and provided nearly $8 million in funding for his research, Burris declared no conflicts of interest in more than 50 articles in leading journals.
Concern about the influence of drug companies on medical research is nothing new; Congress held hearings on the issue as far back as the 1950s, and the early 2000s saw another spate of scandals involving physicians’ failure to reveal industry relationships.
Federal regulations can play an important role in resolving this issue, and continued improvement in reporting mechanisms is essential.
A recent study compared two sets of mandatory disclosures for physicians:
- The Centers for Medicare & Medicaid Services (CMS) requires public reporting of payments to physicians by healthcare companies; its Open Payments database relies on mandatory reporting by companies that manufacture federally covered drugs, devices, or medical supplies.
- The Securities and Exchange Commission (SEC) requires companies to disclose compensation and stock paid to physicians in exchanges for serving on company boards of directors.
The findings highlight important limitations of the Open Payments database:
- Sixty percent of physician-director relationships identified via the SEC database were healthcare companies not listed in Open Payments (i.e., companies that are exempt due to their products being in development or clinical trials, companies that manufacture only non-prescription drugs, healthcare services, health insurance, and medical equipment companies).
- The large discrepancies found in the magnitude of payments disclosed to the SEC and to Open Payments suggest that CMS should consider revising its requirements to mandate reporting of physician-director relationships.
As the chief means for communicating scientific discoveries to professional peers and the public, medical journals must be vigilant; although medical journals and professional societies have tightened their rules around reporting financial relationships with industry, medical journals tend to rely on the honor system rather than enforcement.
Especially for academic physicians, the main takeaway is that our relationships with healthcare companies can — and sometimes do — open the door to bias in the way our studies are designed, the way we prescribe drugs, and the way we practice medicine.
Failure to acknowledge industry relationships raises suspicion, leads inevitably to mistrust, and undermines the credibility of what we publish.
There are no good excuses; we can, and must, do better.
Primary investigators on clinical trials, leaders of professional organizations, and journal editorial board members can prevent the next scandal by demanding transparency in fiduciary arrangements with industry.