Policywise

The perils of partnering for profit

Editor’s note: The opinions expressed in the following blog post are the author’s own and do not reflect the views of Baylor College of Medicine.

Public trust in the biomedical research enterprise has been rocked due to a series of ethical breaches at one of the world’s top cancer research institutes, Memorial Sloan Kettering (MSK).

Its chief medical officer and clinical trialist allegedly failed to disclose millions in industry payments. Then it was revealed that MSK holds an equity stake in a big data startup, as did four hospital executive board members and three other board members, are investors.

The principal worry about conflicts-of-interest in the health care and biomedical research settings is that they bias research, and there is good evidence to support that.

The fallout has been swift. The chief medical officer and cancer trialist resigned  and several other top researchers—including MSK’s CEO—filed corrections with medical journals, revealing previously undisclosed relationships with health care companies. For its part, MSK is reviewing its conflicts-of-interest policy, including whether senior leaders should have financial or advisory relationships with health care companies.

While drug company ties and equity relationships among academic research centers, their inventors, and small companies spun out from labs are not uncommon, the sheer size and number of conflicts in the MSK case are worrisome, even compared against historical examples of conflicts-of-interest taught in courses on research ethics.

If I were teaching a case study about the MSK controversy, I’d highlight four key discussion questions:

  • Are conflicts of interest avoidable? No. Conflicts of interest are everywhere in big research institutions. The MSK case isn’t the first example, nor will it be the last. What’s important about the MSK case is the breadth of conflicts—which include board members of the hospital.
  • The media has focused on transparency (or disclosure) as a solution. Is it? Well, sort of. It’s true that people should know when reading a publication (or websites of government, companies, and universities) whether a researcher has a financial relationship with a company. But would we feel better about a properly disclosed conflict worth millions of dollars?  Thousands of dollars?  Fifty bucks and a free coffee mug?
  • Are there other solutions? We see that disclosure may not be the best way forward. As the MSK case illustrates, compliance is often voluntary and subject to interpretation. We can’t rely on journals to be gatekeepers of financial conflicts, because they have little clout when it comes to enforcement. Some propose eliminating all financial ties with companies. This is an admirable sentiment, but a tall order. Industry is needed for its drug development resources. Professional codes of conduct are good for guidance, but again, they are not much help for enforcement.
  • How might big data change the calculus? Bias, the central worry behind these types of conflicts, may be magnified by algorithms embedded in artificial intelligence (AI) tools powered by big data. Recently, two Stanford bioethicists pointed to concerns about big data bias, which can skew research results. They raised conflicting interests as something to watch for in AI applications in health care. An algorithm designed to save money (or maximize profit) might lead to inequities of care, or worse, harmful treatment decisions.

The MSK case has yet to be completely written. How the narrative goes depends on MSK itself. MSK seems sincere about changing its institutional culture around financial conflicts. This would begin with better requirements for disclosure, stringent thresholds for what constitutes a conflict, penalties for noncompliance, and robust ground level oversight.

If they can turn their troubles around, then the MSK conflicts-of-interest case will have a happy ending, ensuring public trust in science and medicine.

-By Christopher Thomas Scott, Ph.D., Dalton Tomlin Chair of Medical Ethics and Health Policy at Baylor College of Medicine

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