Tuesday, September 22, 2015

A Subtle Conflict of Interest in Obama’s Nominee for FDA Commissioner

Robert Califf, U.S. President Barak Obama’s nominee in 2015 to head the federal Food and Drug Administration (FDA), had received consulting fees of roughly $205,000 between 2009 and early 2015 from drug companies and a medical-device maker.[1] He donated the money he had made since around 2005 to nonprofit groups, and he had ceased all such work before he became the FDA deputy commissioner for medical products and tobacco. The question is whether he would have a conflict of interest in taking the helm at the regulatory agency that puts the public’s interest above those of the regulated companies. I contend that such a conflict is indeed entailed, though not on account of the money he received or any relationships he had developed with people at the companies.

As a clinical-trial researcher at Duke before joining the FDA, Robert Califf was a founder of the Duke Clinical Research Center Institute, which helped pharmaceutical companies run clinical studies. Such facilitation is oriented to helping companies, and, if ethically done, ultimately to helping the public too. In other words, he was not oriented to an area in which the respective interests of a drug company and the public are apt to be at odds. He could thus safely assume a mentality favorable to the companies. Such a mentality is at odds with that of a regulator of companies. Government regulation itself presupposes a tension between the interests of the regulated and the wider public. The mentality fitting the regulator’s role puts the public interest above the interests of the companies possibly to be regulated or already being regulated. A regulator, or an entire agency, captured by one or more of the companies being regulated, regulates sub-optimally because the public interest is valued less than a private interest (including the regulator’s own personal interests).

Public Citizen, a nonpartisan public-health group, urged the U.S. Senate to reject the nomination because “it would accelerate a trend of FDA decision-making that is more aligned with industry than with patients.”[2] Interestingly, the group did not highlight the fact that Robert Califf had received money from drug companies for consulting work, such as participating at an AstraZeneca employee-education session about cardiovascular disease. Rather, the complaint is oriented to the impact of a mentality aligned with the drug companies.

In the language of conflicts of interest, a regulator acting in line with his or her mentality assumes one role. Acting in line with the public interest above that of company interests to the contrary, can be considered another role. Both roles pertain to the regulator’s exercise of his office—for our purposes, the FDA Commissioner. The roles conflict. Robert Califf could reasonably be expected to be tempted to make decisions in line with his mentality (i.e., a private benefit to himself, and a broader private benefit to the companies involved) at the expense of his office’s duty to put the public interest above the two private interests (which include that of his mentality, or orientation). Herein lies the personal conflict of interest—personal in that he could be expected to be tempted on an ongoing basis to put his personal mentality (i.e., a personal benefit, psychologically) above the duty of his office to put the public’s welfare first.

To be sure, we cannot assume that Robert Califf would give into the temptation as Commissioner of the regulatory agency. Sanjay Kaul, a cardiologist, asserted that Califf had demonstrated his ability to act with independence. “Even though I have not always agreed with him on many issues, I respect him for his intellect and integrity. There is no doubt in my mind that he will leverage his inside knowledge of how the industry works to promote innovation without compromising public safety.”[3] Although I suspect that Kaul overstates the congruence of the respective interests of the industry and the public, we cannot assume that a predisposition to help drug companies necessarily wins out.

Even so, I contend that to have a person with a mentality or at least habit of helping companies in the regulated industry as a regulator necessarily involves an ongoing tension for the person, and furthermore that submitting said person to such a tension (or temptation) is itself unethical because of the subtle harm done on him or her. More simplistically, a regulator ought to have a mentality or bias that is aligned with putting the public interest above the interests of the regulated.

Even a subtle bias gained from substantial work-experience, which itself points to an underlying orientation and may even extenuate it, can be reckoned as a personal role. That role can be in tension with another role to be performed—a role oriented to a wider-held benefit (e.g., that going to the public). A personal conflict of interest can therefore exist even without any hint of personal financial benefits (e.g., bribery, extortion, etc.) being likely in a person’s position/office. Even as we tend to limit our recognition of personal conflicts of interest to the superficial level of money—such conflicts being much more extensive—the good news is that more of those conflicts are avoidable than we surmise. Merely in matching a mentality or predilection of a potential office-holder to the role having a wider rather than narrow distribution of benefits (i.e., acting for the public welfare), we can reduce the incidences of such conflicts.

[1] Drug companies spent an additional $21,000 reimbursing the cardiologist for travel, meals, and other expenses. Joseph Walker, “FDA Nominee Received Industry Fees,” The Wall Street Journal, September 19-20, 2015.
[2] Ibid.
[3] Ibid.