Thursday, May 26, 2016

Ellenbogen/NFL vs. US Congress: A Case of Research Misconduct?

Earlier this week the Democratic staff of the US Senate Energy and Commerce Committee released a report of its investigation (here in PDF) into the alleged role of the NFL in trying to influence research funding decisions of the National Institutes of Health. In response, one of the academic scientists who has worked with the NFL for years, Prof. Richard Ellenbogen of the University of Washington, wrote a letter in response to the Senate Committee, criticizing the report.

Here I arbitrate this dispute, which falls right into my wheelhouse - the intersection of science policy and sports governance. I conclude that the Senate Committee is spot on and Ellenbogen's objections are substantively vacuous. In fact, the Senate Committee should have been much stronger in its critique of academics who were clearly dancing around the line of research misconduct.

The allegations levied against Ellenbogen are troubling, to say the least. Here is what the Senate report says:
Dr. Ellenbogen is a primary example of the conflicts of interest between his role as a researcher and his role as an NFL advisor. He had been part of a group that applied for the $16 million grant. After his group was not selected, Dr. Ellenbogen became one of the NFL’s primary advocates in expressing concerns surrounding the process with the BU grant selection. He not only participated on a conference call with NIH and FNIH on behalf of the NFL; he also reached out to Dr. Koroshetz separately to share that he would be unable to recommend to the NFL owners that they fund the Boston University (BU) study. This series of events raises significant questions about Dr. Ellenbogen’s own bias. It is clear that he should not have been communicating directly with Dr. Koroshetz or any other NIH staff about the grant selection process.
In his defense presented in his letter, Ellenbogen cites three objections to the report.

First, he was not interviewed by the committee:
Yesterday a report from the minority staff of your committee was released to the media alleging that I and others participated in an effort to influence an NIH grant selection process. Nothing could be further from the truth. Unfortunately, I was not afforded the simple opportunity to make this plain to your staff members, despite the fact that my contact information was provided to them and my willingness to engage with them on any question was made clear to them. I find this basic lack of fairness, combined with the disregard for the opinions and reputations of the medical professionals named in this report, to be unworthy of the important committee that you lead. At a minimum, I hope you can understand my profound objection to this maligning without so much as the courtesy of a direct question to me by your staff.
As a matter of procedure, Ellenbogen is correct. The Committee should have interviewed him, simply as a matter of comprehensiveness. However, Ellenbogen does not use the letter to explain where the Committee report is factually incorrect in any way that might have been corrected by such an interview.

Ellenbogen's second objection appears to be the focus of his defense, and he states that he is not paid by the NFL:
To be clear, I am not and never have been paid by the NFL nor have I ever received funding through the research grant dollars in question. 
This is either flat out untrue or deeply misleading, and this is easily shown. It is remarkable that Ellenbogen would make such a claim, given how ridiculous it is - his financial conflicts of interest here are many.

For instance The Seattle Times explains in an article from August, 2015:
A $2.5 million donation from the National Football League (NFL) will kick off the newly formed University of Washington Medicine Sports Health and Safety Institute aimed at advancing research, education and advocacy to prevent sports-related concussions. . . The UW institute will be led by [Dr. Stanley] Herring and Dr. Richard Ellenbogen, chairman of UW Medicine’s Department of Neurological Surgery.
And that is not all, from 2013:
University of Washington neurosurgeon Rich Ellenbogen was on the sidelines at a Seahawks game last year when he got word that “the boss” wanted to see him. That would be the top boss, team owner and Microsoft co-founder Paul Allen. “I’d never met him before,” recalled Ellenbogen, who volunteers as a neurological specialist for the Seahawks and the NFL. . . During the two-year, $2.4 million study, scientists at the UW and the Allen Institute for Brain Science in Seattle will examine the brains at the structural, cellular and molecular levels, looking for changes related to traumatic-brain injury.
Want more? Ellenbogen is listed on the NFL website as being among the recipients of $40 million in research funding from the League. He was also a co-PI on a grant proposal to the NFL-sponsored competition that is at the Center of this controversy.

The cherry on top is that as a member of the NFL's Head, Neck and Spine Committee Ellenbogen receives Super Bowl tickets and travel (Source: E&C Report), which depending on where he sits, each might be worth anywhere from $5,000 to $80,000. Coincidentally, the minimum threshold for a financial conflict of interest under NIH policies is $5,000.

Any of the examples above would on their own qualify as a financial conflict of interest under NIH policies. Such a conflict would prohibit Ellenbogen from serving as a reviewer on any funding application to NIH under a research partnership with the NFL.  It is not even close. Why he chose to take a stand on his lack of conflict is puzzling.

Ellenbogen's third objection has to do with the substance of the proposed research at Boston University that he intervened to try to stop being funded:
Medical professionals can and always will discuss priorities and debate protocols; that is healthy and appropriate. I believe strongly that there is a vital need for a longitudinal study that tracks the impact concussions have over many years. 
This objection is irrelevant. Sure, we academics can complain out in public about our objections to federal agency funding decisions. We can write blogs, op-eds and sing from the mountain tops. And we do it all the time.

What we cannot do is insert ourselves into the federal agency peer review process and try to alter it in our own preferred direction.

The Senate Committee concluded:
Although he did not violate any specific NIH rule we are aware of, Dr. Ellenbogen’s participation in these discussions contravenes the spirit of the NIH conflict of interest rules, which are designed to ensure that individuals who have a financial interest in the outcome of a grant award are not involved in the decision-making process to award such a grant.
I don't think that this goes nearly far enough. Much of the attention here has been, appropriately, focused on the NFL. More needs to be paid to academics behaving badly.


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