This blog post is the first of three examining a recent high-visibility conflict of interest (COI) problem at a major national cancer research institution, with lessons for healthcare organizations about avoiding similar compliance problems.
Avoiding and preventing conflicts of interest is an important focus of healthcare compliance. Unknown and undisclosed conflicts can threaten an institution’s tax-exempt status, reputation, research funding, and most importantly, patient safety. They can also undermine the valuable trust that a patient must have in his or her healthcare provider and the institution where care is being received. The uproar over a recent COI lapse at the executive level of Memorial Sloan Kettering Cancer Center, a preeminent New York research hospital and institution, underscores just how important COI prevention can be. The resulting scandal may help end the common, questionable situation where leaders at prominent healthcare educational and research institutions also have been affiliated with private healthcare companies, whether as members of corporate boards or advisers.
What Happened at Memorial Sloan Kettering?
The COI issue at Memorial Sloan Kettering occurred at the highest level of the organization. Dr. José Baselga, the organization’s chief medical officer, failed to report his extensive healthcare and pharmaceutical industry relationships in conjunction with the numerous research articles he has published during the past decade. This lapse was brought to light in an article by The New York Times and ProPublica that uncovered how “Dr. Baselga had received millions of dollars in consulting fees and in ownership interests in health care companies, but had often failed to disclose those ties in appearances at scientific conferences and in journal articles. His reporting failures included articles in prestigious publications like The New England Journal of Medicine and The Lancet as well as in Cancer Discovery, a journal for which he serves as one of two editors in chief” (Thomas, K. and Ornstein, C., 2018).
In addition to these lapses, Dr. Baselga was a board member of cancer drug-maker Bristol-Myers Squibb, as well as Varian Medical Systems, a seller of radiation equipment for cancer treatment. He is known to have received “nearly $3.5 million in payments from drug, medical equipment and diagnostic companies from August 2013 through 2017, according to Open Payments, a federal database that tracks payments to physicians from health care companies.” In the aftermath of these disclosures, Dr. Baselga resigned from Memorial Sloan Kettering, as well as from the boards on which he served.
As reported more recently in The New York Times, Dr. Baselga was asked to resign as editor of the medical journal Cancer Discovery, which is published by the American Association for Cancer Research. The organization stated that “he did ‘not adhere to the high standards’ of conflict-of-interest disclosures that the group expects of its leaders. Some of his omissions involved articles that were published in Cancer Discovery while he was an editor-in-chief” (Thomas and Ornstein, 2019).
Managing COI Risk
Regulatory compliance requires that healthcare organizations secure annual conflict of interest disclosures from physicians, APPs, board members, and hospital leaders at the director level and above. Why are these disclosures important? Perhaps a physician is involved in the decision process about selecting and purchasing a medical device for use in a hospital. It is important to know that the doctor is making his recommendation as the best possible choice. Or, did he make it because he receives speaking fees from the device’s manufacturer? The goal here is to remove any question about influence on this decision that would challenge its being made in the best interest of patients only.
Effective disclosure about any possible conflict of interest requires a thorough questionnaire to guide discernment of any conflicts. The questionnaire must walk individuals through all their relevant business relationships, revealing the potential for COI. Conflicts must then be reported on a disclosure form.
Not All COIs Result in Biased Decision-Making
A conflict of interest exists when a person could derive personal benefit from actions or decisions that he or she makes in an official capacity. According to Bill Sacks, co-founder of HCCS, “Relationships among physicians, hospitals and the medical industry are important. Industry contributes to medical education, funds clinical trials, and provides medications for the indigent. In short, they support the teaching, research and clinical missions of academic medicine.”
In the case of Dr. Baselga, it was reported in early January that he has been hired by the British-Swedish pharmaceutical giant AstraZeneca to lead research and development in oncology, as part of the company’s expansion in cancer treatments (Thomas and Ornstein, 2019).
Thomas, K., and Ornstein, C., “MSK Cancer Center Orders Staff to ‘Do a Better Job’ of Disclosing Industry Ties,” The New York Times, September 9, 2018, Retrieved at https://www.nytimes.com/2018/09/09/health/cancer-memorial-sloan-kettering-disclosure.html.
Thomas, K., and Ornstein, C., “Top Cancer Doctor, Forced Out Over Ties to Drug Makers, Joins Their Ranks,” The New York Times, January 7, 2019, Retrieved at https://www.nytimes.com/2019/01/07/health/baselga-sloan-kettering-astrazeneca.html.