Nominee for New FDA Commissioner Derived Salary from Six Pharmaceutical Companies LAST YEAR

In President Obama's first inauguration speech, he promised to restore science to its proper place in government by shielding the regulatory process from corporate influence. One of his specific proposals to carry out this promise was to prevent anyone with a severe corporate conflict of interest from serving in the executive branch until at least one full year had gone by without the conflict in place. Thus, if you received salary from a pharmaceutical company in 2014, you would not be permitted to serve as the FDA Commissioner at least until 2016.

Unfortunately, as we have repeatedly seen campaign promises wither, this one too seems to have died a quiet death. For it was revealed yesterday by the Washington Post that President Obama's nominee for the Commissioner of the FDA - Dr. Robert Califf - received salary support from not one, not two, not three, not four, not five, but six pharmaceutical companies last year (2014). In addition, Dr. Califf was paid by eight pharmaceutical companies for consulting services and had personal equity in two pharmaceutical companies. In all, in 2014, Dr. Califf had significant financial interests in 14 different pharmaceutical companies!

To make matters worse, according to the FDA itself, a clinical trial led by Dr. Califf was sharply criticized by Public Citizen's Health Research Group for failing to quickly anti-coagulate patients treated with an experimental anti-coagulant drug who were then taken off that drug, resulting in an excess of 16 strokes among these patients. According to the FDA report: "The Division received comments from Public Citizen’s Health Research Group indicating concern that the applicant’s failure to “1) pre-specify criteria for transition to appropriate anticoagulation in the 30 days following study-drug discontinuation or 2) provide clear, standardized instructions to investigators on how to transition patients deemed eligible for further anticoagulation” exposed subjects to unnecessary harm and therefore was unethical. While it is obvious that the applicant can not have intended XARELTO subjects to have had a greater number of strokes while they were being followed because it worsens the apparent risk-benefit profile of XARELTO, it also true that lack of care in designing and conducting ROCKET could have resulted in some XARELTO subjects suffering unnecessary strokes." Recently, Project on Government Oversight (POGO) executive director Danielle Brian stated: "Dr. Califf’s handling of the Xarelto trial raises concerns about his judgment in overseeing the pharmaceutical industry."

The worst of the story, however, is that during his Senate confirmation hearings, Dr. Califf apparently defended his conflicts of interest with Big Pharma, demonstrated a misunderstanding of what conflict of interest is all about, and expressed no awareness of the severity of the problem of conflict of interest in making government regulatory decisions.

According to the Washington Post article: "President Obama’s nominee to lead the Food and Drug Administration defended his past ties to the pharmaceutical industry on Tuesday, saying that drug company dollars never influenced the outcome of his academic research and vowing to maintain the agency’s standards for ensuring that approved treatments are safe and effective. Robert Califf, a cardiologist and long-time Duke University researcher, acknowledged that pharmaceutical companies helped fund many of the clinical trials he oversaw. But the drug industry routinely funds such studies, he noted, and Duke’s contract requirements protected the independence of investigators to publish research outcomes, whatever the results."

This demonstrates a misunderstanding of the problem of conflict of interest. Conflicts of interest are a problem not because they lead to conscious manipulation of study findings by investigators, but because they could lead to subconscious bias in the conduct or reporting of the results of these studies. A conscious bias in reporting the results would represent academic misconduct, not merely conflict of interest. It is the subconscious bias produced by pharmaceutical company funding that is at issue here. That is what conflict of interest policies are designed to protect against - not the conscious manipulation of study findings, which is an ethical issue. Conflict of interest is not an issue about ethics as much as it is an issue about protecting the integrity of the research and regulatory process.

The Rest of the Story

It is difficult to understand how this nominee, who just last year had significant financial relationships with 14 different pharmaceutical companies, could - one year later - be confirmed as the head of the agency which regulates those 14 companies.

Clearly, Dr. Califf would have to recuse himself from any decisions regarding any of those 14 companies. However, since these represent some of the largest pharmaceutical companies in the nation (including Merck, Novartis, Roche, Eli Lilly, Bayer, Janssen, and Amgen, he would essentially have to recuse himself from all regulatory decisions made by the FDA. Therefore, it is apparent that because of his extensive financial conflicts of interest with Big Pharma, he is not qualified to serve as the FDA Commissioner.

Regardless of the integrity of his decision-making, the agency would always be under the public perception of a bias towards the pharmaceutical companies emanating from the Commissioner's conflicts of interest with these companies. This is simply not tolerable, and it is the precise reason why federal agencies have conflict of interest policies in the first place.

If Dr. Califf is appointed as the FDA Commissioner, I believe that he would be in violation of the Office of Government Ethics (OGE) regulations which state as follows: "a Federal employee may not personally and substantially participate in an official capacity in any particular matter which, to his knowledge, he or any other person (whose interests are imputed to the employee under 18 U.S.C. 208) has a financial interest if the particular matter will have a direct and predictable effect on that interest (5 CFR 2640.103(a))."

To avoid being in violation of this law, Dr. Califf would have to recuse himself from all FDA-related work.

Now, you might respond to this argument by pointing out that the prospective Commissioner is now divested of his financial interests and therefore, while he had financial interests in the past, he no longer holds them. So there is no violation of the government ethics regulations. Putting aside the point that this clearly violates the spirit of the law, though not the letter of the law, let's consider this further.

It is a good point. However, you are forgetting 5 CFR 2635.502(a), which clearly states that:

"Where an employee knows that a particular matter involving specific parties is likely to have a direct and predictable effect on the financial interest of a member of his household, or knows that a person with whom he has a covered relationship is or represents a party to such matter, and where the employee determines that the circumstances would cause a reasonable person with knowledge of the relevant facts to question his impartiality in the matter, the employee should not participate in the matter unless he has informed the agency designee of the appearance problem and received authorization from the agency designee in accordance with paragraph (d) of this section."

So what is the definition of a "covered relationship" with a "person?"

First, please note that according to the definition of "person": under 5 CFR 2635.102(k), a "person" includes a "corporation," "company," or "firm."

According to 5 CFR 2635.502(b)(1)(iv), a covered relationship includes: "Any person for whom the employee has, within the last year, served as officer, director, trustee, general partner, agent, attorney, consultant, contractor or employee."

Because it appears that Dr. Califf has, within the last year, served as a consultant and/or contractor for a number of pharmaceutical companies, it appears that his being appointed FDA commissioner at this time would violate 5 CFR 2635.502(a), unless he were specifically cleared for every activity he participates in by receiving authorization from the agency designee following a judgment that "the interest of the Government in the employee's participation outweighs the concern that a reasonable person may question the integrity of the agency's programs and operations." (see 5 CFR 2635.502(d)) He would have to receive such an authorization based on the above determination for each and every matter in which he participates. Obviously, this makes it clear that he is simply not in a position to be appointed as the FDA Commissioner given his extensive and recent history of Big Pharma conflicts of interest.

Finally, one might say: "Well, Dr. Siegel, I see your point but since it is almost 2016, it will be more than one year since the financial relationships so there is no problem and no technical violation of the law."

To which I would respond: "If that is the extent to which you have to go to defend this nomination and you still don't see a problem, then you are missing the forest for the trees."

The rest of the story is that the nominee for FDA Commissioner has such a severe, recent, and extensive history of financial interests with multiple pharmaceutical companies that it would violate all principles of scientific and regulatory integrity to appoint him to head the agency which regulates those very companies.