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Conflicts of Interest at the President's Bioethics Commission

(This is the second of two posts on the recent report of the Presidential Commission for the Study of Bioethical Issues regarding protections for human research participants.  The first post is available at this link.)

The Hastings Center Report, the preeminent bioethics journal, requires all contributors to disclose any potential conflicts of interest they might have regarding the subjects of their submissions. The journal defines “conflicts of interest” as “any personal or professional affiliations, any financial interests, and/or any past, present, or anticipated activities that may compromise the quality or objectivity of a manuscript or review.” It offers authors the following rule of thumb when determining what interests to declare: “Is there anything [that] would likely cause readers to second-guess your objectivity if it were to emerge after publication?” If, for example, an author argues that existing protections for human research participants are fundamentally sound and robust, a reader might find that conclusion less credible if she knows the author leads an institution that earns significant sums of money from conducting human subjects research.

In other words, if President Obama’s ethics commission (the PCSBI) had sought to publish their report on protections of human research subjects in The Hastings Center Report, The American Journal of Bioethics, or many other academic journals, the Commissioners would have been required to disclose any interests that might undermine the objectivity of their analyses and recommendations. A cursory glance at the PCSBI’s roster suggests several members would have had substantial interests to declare.

The purpose of the PCSBI’s report was to evaluate the adequacy of protections for human research participants. Several of the Commissioners either personally conduct such research or oversee institutions that do:

  • The PCSBI’s chair, Amy Gutmann, is President of the University of Pennsylvania, which conducts many clinical trials — including the 1999 gene therapy trial that suffered from “a litany of deficiencies” and resulted in the death of Jesse Gelsinger.
  • The vice chair, James Wagner, is President of Emory University, which likewise has an enormous financial interest in clinical trials. Emory is also the institution that failed to take meaningful action against Dr. Charles Nemeroff after the University’s own conflict of interest committee “detailed multiple ‘serious’ and ‘significant’ violations of university procedures intended to protect patients.”

In sum, these are quite literally the people and institutions that federal regulations are designed to protect research participants from. They are also the people and institutions that would be subject to any regulatory changes that might result from the PCSBI’s recommendations. If, for example, those regulations made clinical trials more expensive, or exposed research institutions to greater liability or other penalties, those increased expenses would likely affect the bottom lines at places like Penn, Emory and the University of Kansas. Yet I’ve been unable to find any acknowledgement of these potential conflicts in the PCSBI’s report, on its website, or in the transcripts of its public meetings.

Perhaps the Commission has thought deeply about potential conflicts among its members. Perhaps they determined there were none, or have implemented protections to guard against their influence. But without disclosing any of that information, there is no way for the public to assess the objectivity of the PCSBI’s report or the adequacy of any steps it has taken to address potential conflicts. Instead one is left to wonder whether the Commission’s general endorsement of existing protections for human subjects research, its meager recommendations for change, and its deference to the pharmaceutical industry may have been influenced by some Commissioners’ substantial institutional interests in the rules governing clinical trials.

At the very least, the PCSBI should publicly address any conflicts of interest among its members and describe the Commission’s conflicts policies. A Presidential commission — particularly a commission on ethics — should adhere to ethical standards that at least match, if not exceed, the baseline requirements for publishing in academic journals. As Dr. Gutmann herself has said, “The more transparent and open our deliberations . . . the better our recommendations will be.” Failing to heed that advice opens the door for guys like me to write posts like this.

That said, it is far from clear that merely disclosing such conflicts would be sufficient to protect against bias in the task of assessing the adequacy of protections for research participants. Paradoxically, research suggests that rather than reducing bias, “disclosure [of an advisor's conflict of interest] can increase the bias . . . because it leads advisors to feel morally licensed and strategically encouraged to exaggerate their advice even further.” Accordingly it is reasonable to ask whether conflicted Commissioners should have recused themselves from participating in the human subjects investigation, in order to promote public confidence in the objectivity of the PCSBI’s report. Simply disclosing conflicts of interest does nothing to mitigate the inherent dubiousness of entrusting the evaluation of human subjects protections to the leaders of the very institutions that are experimenting on people.

Ironically, the government originally asked the Institute of Medicine to conduct the investigation of the Guatemala syphilis study — the scandal that prompted this review of human subjects protections. The Obama administration decided to transfer that responsibility to the PCSBI because “the government learned that the Institute of Medicine had identified a potential conflict of interest owing to an historical overlapping personal relationship between its leaders and funders of the research in Guatemala.” Consequently, President Obama transferred the investigation to the PCSBI “to ensure the integrity of the investigation and to assure its independence.” In light of this history one would have expected the Commission to be acutely aware of the need to address potential conflicts of interest among its members.

The PCSBI’s Commissioners are probably well-meaning, ethical people. But the purpose of conflict of interest rules isn’t merely to police bad actors, but to help good actors police themselves against improper — and unconscious — influences. It would be nice to see some evidence that the Commissioners are doing that.

(Note: I’ve made a couple inquiries to the PCSBI’s staff about how the Commission is dealing with potential conflicts of interest, but have yet to hear back from them. If I get a response, I’ll post it in the comments below.)

Matt Lamkin
Twitter: @lawbioethics

2 Responses to “Conflicts of Interest at the President's Bioethics Commission”

  1. Adam Kolber says:

    This is an interesting post, but here are some questions it raised in my mind:

    (1) I understand your interpretation of the Hastings Center Report conflict-of-interest rules. But are those rules ordinarily interpreted to require a disclosure when a president of a research university or an actual researcher writes about regulations on experimental research? It may not be enough to find some cases where there are such disclosures because authors might be excessively cautious. To find an important omission on the part of PCSBI members, it would be more convincing if you could show that researchers rarely *fail* to make such disclosures.

    (2) Given that research universities are, in some respects, competing against each other for research dollars, if the rules got stricter, would they really have that much of a negative impact on research universities? Or would the fact that everyone would be subject to the same rules largely soften their impact on any particular school?

    (3) Could one argue that the disclosures need not be made because anyone who has the objectivity concerns that you have can see them just by looking at the bio information that (I presume) is in the report? Suppose, for example, that a catholic priest conducts an investigation into an alleged church sexual abuse case. Wouldn’t the fact that the priest makes clear that he is, in fact, a priest suffice to disclose at least some potential conflict in the investigation? In other words, might disclosures be more important in cases where potential conflicts of interest are more difficult to spot, as where a person has a non-public relationship with a pharmaceutical company that stands to profit from the publication?

    -Adam Kolber

  2. Matt Lamkin says:

    Thanks for your insightful comments, Adam. I think there are a few issues at play here. One is whether certain PCSBI members have a conflict of interest with respect to examining the adequacy of protections for human research subjects. If so, then there’s an additional question about whether they ought to have declared these conflicts in the report. And finally there’s a question about whether disclosure of the conflicts would be sufficient to ensure the objectivity — and the perceived objectivity — of the report.

    Your second point raises the possibility that leading a university that earns substantial sums from conducting clinical trials may not represent a conflict with respect to examining the adequacy of research subject protections. You suggest tougher rules might not harm research universities because the rules would apply to all universities competing for clinical trials. That seems plausible if clinical trials take place in an efficient market. But it seems equally likely that uniformly-applied, expensive new rules would simply cut universities’ margins across the board. It also seems reasonable to expect that university administrators (and their legal counsel) generally would not favor new rules that would subject them to heightened litigation risks or federal penalties, regardless of whether other universities were subject to the same increased risks. Similarly, I think we would have reason to be skeptical of, say, PhRMA’s recommendations regarding human subjects protections even if any resulting regulations were applied to all competing drug companies.

    In addition to having an interest in avoiding increased risks and operating expenses, university presidents have a strong interest in protecting their institution’s reputations. Had the PCSBI chosen to include in its report notable cases of unethical treatment of research subjects in federally-funded research, it wouldn’t have had to look far. But, incredibly, a report whose sole purpose was to assess the adequacy of research participant protections does not describe a single instance in which those protections failed or researchers acted unethically. Was that decision influenced by the fact that going down that road might have led to Penn’s and Emory’s own doors — e.g., in the death of Jesse Gelsinger and the failure to enforce ethics rules against Dr. Nemeroff? Who knows? But a reader might be forgiven for believing that the leaders of these institutions aren’t eager to keep these incidents in the public eye.

    If some Commissioners had interests that conflicted with undertaking an objective assessment of human subjects protections, should those interests have been disclosed? As I read The Hastings Center Report’s rules, I believe disclosure would be required in this case, but obviously I can’t answer on the editors’ behalf. (I’ve sent an inquiry to the journal and will post the answer here if I receive one.) You raise an interesting suggestion that the Commissioners need not disclose their conflicts because they’re obvious to readers, in the same way that one would understand the position of a priest reporting on misconduct at a church. I don’t think the conflicts of the Commissioners in this case are similarly on display. The fact that James Wagner leads a university does not make clear that he oversees an institution that conducts clinical trials (many universities don’t), let alone the fact that Emory is “the nation’s fourth leading contributor to drug discovery among U.S. public-sector institutions,” that it “has received more than $788M in licensing fees from commercialized products,” or that it “continues to receive approximately $20M a year via licensed products.”

    But ultimately the deeper problem here isn’t as much about disclosure as about whether leaders of institutions that earn millions from conducting clinical trials should be participating in — and, indeed, directing — an ostensibly independent assessment of human subjects protections. I would suggest they should not for the same reasons we shouldn’t trust oil companies to evaluate our environmental protection laws, and we wouldn’t put foxes on a Presidential Commission for the Study of Henhouse Protection Issues. In my view the historical conflicts that prevented the IOM from studying the Guatemala scandal pale in comparison to the current conflicts of several members of the PCSBI.

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