October 23, 2018
A September 8, 2018, New York Times article reported that Dr. Jose Baselga, Memorial Sloan Kettering Cancer Center’s (“MSK”) Chief Medical Officer, failed to disclose relevant financial conflicts of interest to numerous journal publishers. Although Dr. Baselga, a world-renowned breast cancer physician, compliantly satisfied his institution-based conflict of interest (“COI”) disclosure requirements, he failed to disclose millions of dollars in payments that he received from multiple pharmaceutical companies in more than 100 publications over a period of four years. This lack of transparency through the failure to disclose industry relationships calls into the question the objectivity and validity of the results of Dr. Baselga’s research.
As one would expect, the fallout from this report has been severe. Dr. Baselga has since resigned from his position as Chief Medical Officer at MSK. He has also resigned from the Board of Directors at Bristol-Myers Squibb and Varian Medical Systems. MSK’s response to the New York Times report has thus far included distribution of a notification letter to MSK staff requesting them to “do a better job” of COI disclosure and creation of a task force to assess MSK policies and processes for reporting and managing outside activities and industry-supported clinical trials.
The New York Times report illuminates the disparate COI disclosure requirements that are set forth by medical journals and professional societies. Moreover, this case illustrates the general lack of COI disclosure enforcement by medical journals. In fact, most medical journals do not fact-check author disclosures, they in large part leave self-disclosure to the honor system. As was the case at MSK when a member of the staff fails to comply with COI disclosure requirements, the reputational damage and burden of remediation are shared by both the individual and the institution.
The events that transpired since the September 8th report have brought to light the institutional vulnerability that exists when faculty or staff fail to disclose relevant financial relationships to journals, medical societies, and at conference presentations. It is clear that the institutional risk of harm is significant, and institutions should seize this opportunity to begin to proactively review the compliance and operational effectiveness if its COI programs. Moreover, consideration to establish and implement a reconciliation process to assess COI disclosures made to external entities should be entertained.
To begin, we recommend review of current COI policies and procedures. Assuming your current policies comport with federal requirements, we then suggest that you perform an assessment of compliance with the “in-house” COI disclosure, review, management, and reporting requirements. This assessment should include review of a random sample of select COI disclosures, management plans, and required reports to federal funding agencies. Appropriate actions including revision of COI policies, procedures, education, and training should be implemented in response to the compliance assessment.
Institutional COI (“ICOI”) policies and procedures should be included as part of the policy and procedure assessment. Although not required by federal regulation, policies, and procedures that include disclosure and management of ICOIs are considered essential to promote transparency and accountability. If your institution has not yet implemented an ICOI policy, we recommend that strong consideration be given to establishing one.
COI training and education to staff and faculty should also be considered. We recommend that you incorporate the events at MSK as a case study to illustrate the potentially disastrous fallout of incomplete COI disclosures. We also suggest that you incorporate an overview of Open Payments as part of the education. Physicians should be encouraged to review, and if necessary, dispute their financial data that is posted on the open payments website.
Finally, we recommend that you, review disclosures made by staff to medical journals and other relevant entities that are outside of your institution. This assessment should include reconciliation of institution-based disclosures with those made to journals as evidenced by review of the publications. The review sample should include faculty or staff with large numbers of publications and those with multiple COI disclosures.