Democratic members of the House Committee on Energy and Commerce just released the full 91-page report detailing the findings of their investigation into the NFL’s attempts to improperly influence the direction of the National Institute of Health’s concussion research. We’ve embedded the whole report below, and will highlight interesting excerpts here as we read through it.
Update (1:20 p.m.): The committee drops the hammer on the NFL:
The NFL’s interactions with NIH and approach to funding the BU study fit a longstanding pattern of attempts to influence the scientific understanding of the consequences of repeated head trauma. These efforts date back to the formation of the NFL’s now-discredited MTBI Committee, which attempted to control the scientific narrative around concussions in the 1990s.
In this instance, our investigation has shown that while the NFL had been publicly proclaiming its role as funder and accelerator of important research, it was privately attempting to influence that research. The NFL attempted to use its “unrestricted gift” as leverage to steer funding away from one of its critics. The League, its players, and the public have a vested interest in advancing our knowledge of the relationship between degenerative diseases and sports-related head trauma.
Update (1:08 p.m.): The committee concludes that the NFL’s Head, Neck, and Spine Committee needs to get the hell out of the paint:
The NFL repeatedly emphasized the “independent” nature of the HNS Committee members, and suggested that the actions of those members did not reflect the official positions of the League. The uncertainty surrounding whether scientists were reaching out as representatives of the NFL or as independent researchers led to unnecessary confusion in the relationship between NIH, FNIH, and the NFL.
Despite their expertise as researchers and physicians, members of the HNS Committee cannot approach the NFL-FNIH-NIH partnership claiming to be impartial observers. They are under the same obligations as paid NFL staff when it comes to observing guidelines for donors to FNIH.
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.
Update (12:51 p.m.): After the NFL pulled its funding from Dr. Stern’s study, the NIH went about trying to find other studies on which to spend the league’s money. They reached out to NFL executive VP Jeff Miller to see what studies the league might be interested in funding, and he sent this puzzling reply:
From the formation of the Sports and Health Research Program (“SHRP”), the NFL and the NIH have expressed a shared interest in two primary areas of scientific inquiry: 1. Improved understanding of the neuropathology around Chronic Traumatic Encephalopathy (“CTE”); and 2. A prospective longitudinal study to examine the longterm implications of closed head brain injury. These goals were set in October 2012 at a meeting where leaders from the NIH, FNIH and NFL participated. …
The second of these goals, a prospective longitudinal study on the long-term effects of concussion, was the subject of a SHRP-funded and NIH-led public workshop in Bethesda, Maryland in July 2013. At that meeting, national experts, including senior representatives of the NIH, FNIH, as well as members of the NFL’s Head, Neck and Spine Committee, reached consensus on the need to fund a prospective longitudinal study with the remainder of the NFL’s contribution to the SHRP.
As the NIH pursues its plans for concussion research, we hope you will consider the conclusions reached at the most recent workshop on the importance of a longitudinal study.
Dr. Walter Koroshetz from the NIH replied to that email and basically said, “Uhhhhh, that’s exactly what we were trying to do before you assholes pulled our funding!”:
We were puzzled by your comments asking us to consider funding a longitudinal study. Informed by the July 2013 SHRP-funded public workshop on Brain Trauma-Related Neurodegeneration that included national experts from the NIH and the NFL’s Head, Neck and Spine Committee, the NIH drafted a proposal for a prospective longitudinal study of “high risk individuals with symptoms and medical history suggestive of CTE.” NFL, FNIH and NIH agreed to pursue this longitudinal study in July, 2014 in the attached Research Plan for a “longitudinal study in high risk adults.” As you know, in December 2015, NINDS did award a grant to a consortium led by Boston University in response to the attached Funding Opportunity Announcement
Detect, Define and Measure the Progression of Chronic Traumatic Encephalopathy for a “multicenter and multidisciplinary longitudinal study of individuals with a “probable” or “possible” diagnosis of chronic traumatic encephalopathy (CTE).” The award of this longitudinal study was a direct result of the July 2013 workshop. We eagerly await the results and do not have any plans to support an additional longitudinal study for CTE at this time.
Update (12:27 p.m.): Dr. Richard Ellenbogen, co-chairman of the NFL’s committee on brain injuries, is completely shameless (emphasis mine):
On the conference call, Dr. Koroshetz proposed a potential compromise solution. He suggested the possibility that two studies could be funded, thereby increasing the number of research sites, subjects, and primary investigators. NIH had employed a similar approach on the second research plan, splitting the grant money between two institutions to explore the neuropathology of CTE. Dr. Koroshetz suggested that the two studies might address the NFL’s concerns. Dr. Koroshetz raised the possibility of revisiting the application that had been awarded the second highest score at the May Council meeting. Later, with the permission of the investigators, it was revealed that this was the UNC-led study with Drs. Guskiewicz and McCrea as principal investigators, and Dr. Ellenbogen as a co-investigator.
According to Dr. Koroshetz, Dr. Ellenbogen called him again separately soon after the June 29, 2015, conference call to reiterate his opposition to awarding the grant to Dr. Stern. At that time, Dr. Ellenbogen told Dr. Koroshetz that he could not recommend that the NFL fund the BU study, because he believed that Dr. Stern had a conflict of interest and that the grant application process had been tainted by bias.
Update (12:21 p.m.): The NFL’s excuse for not wanting to fund Dr. Stern’s study made no sense (emphasis mine):
Additionally, according to Jeff Miller, the NFL was concerned that BU’s study did not reflect the consensus they believed had been reached prior to signing the fifth research plan. Miller told Committee staff that the NFL sought a “Framingham-style” longitudinal study to examine the long-term effects of concussions. According to Miller, once Dr. Stern’s grant had been selected, members of the HNS Committee advised the NFL that his study would not accomplish what the NFL sought in a longitudinal study and did not fit into the areas they wanted to research. Miller further indicated the sentiment among HNS Committee members that BU did not do longitudinal studies and that their expertise was limited to neuropathology. Neither Dr. Koroshetz nor Dr. Freire mentioned that the NFL had raised this issue contemporaneously in connection with their other concerns regarding the award of the grant to BU. Dr. Koroshetz noted that a long-term study was discussed in 2012 during the development of the SHRP; however, both NIH and the NFL agreed then that such a study was not feasible under the time and funding constraints.
Update (12:09 p.m.): The NFL and NIH signed a letter of agreement, which very clearly stated that the NIH would maintain full control over how the NFL’s money would be spent:
The LOA made clear that NIH has exclusive control over certain areas. It states, “DONOR [NFL] acknowledges and agrees that NIH will have responsibility for and control over the scientific and administrative aspects of the Research Plans it manages under the Program, including but not limited to holding workshops, developing and posting calls for applications, reviewing applications, determining grantees, awarding grants, overseeing the grants, including the scientific and financial progress of the grantees, monitoring data sharing plans, and publication of research results related to the Program.”