Monday, May 23, 2016

Congressional Report: NFL Tried To Influence Government Research On Head Injuries

Even though the National Football League currently paints itself as a player-friendly organization that puts safety above the base thrill of seeing a dude repeatedly getting his bell rung, the league has a long history of not only ignoring the issue but actively seeking to smother scientific research linking the sport to devastating longterm brain damage. A newly released Congressional investigation appears to confirm earlier news reports claiming that the NFL isn’t done trying to insert itself into research that could have an impact on the country’s most popular team sport.

The report [PDF] from Rep. Frank Pallone (NJ) and the Democratic staff of the House Committee on Energy and Commerce, alleges that the NFL didn’t just donate millions to the National Institutes of Health — a division of the Department of Health and Human Services — but that the league then tried to influence which research applicants received that NIH money.

In 2012, the NFL donated an “unrestricted” $30 million to the Foundation for the NIH for sports-related research. The NIH, like most research facilities, is more than happy to receive donations but its policies prohibit donors from having any leverage in deciding who ultimately receives the grants funded by those donations.

So the fact that the NIH eventually awarded $16 million of that funding to Dr. Robert Stern — a Boston University researcher whose views on football and brain injury don’t paint the league in the best light — should have had no effect on the league’s arrangement with the NIH.

However, in Dec. 2015, ESPN’s Outside the Lines reported that the league suddenly balked on funding this project, leaving NIH on the hook to fund Stern’s 7-year study into Chronic Traumatic Encephalopathy (CTE), a progressive, degenerative brain disease, resulting from repetitive trauma to the brain, that can have disastrous effects on a person’s memory, mood, and behavior.

In a statement at the time, NIH claimed — without any substantial explanation — that the NFL was “willing to contribute to the Boston University CTE study headed by Dr. Stern,” but that “NIH made the decision to fund this study in its entirety” and to look for new applicants for an additional CTE study that would be funded with the NFL money.

In the wake of the ESPN report, and subsequent reports claiming that the league tried to intervene in the selection of grant applicants — including having members of the NFL’s Head, Neck and Spine Committee actually apply for funding — the Energy and Commerce Committee began its investigation.

According to the report, the NFL health officials first began to try to scuttle the funding for Dr. Stern’s research in June 2015, shortly after it became clear that his project had scored highest in a review of all candidates.

That’s when league health officials sent a letter to NIH raising vague “significant concerns” about Stern and his BU researchers’ “ability to be unbiased and collaborative.” At particular issue was the fact that Stern had previously supplied an affidavit that was heavily critical of the NFL’s concussion settlement with former players.

NIH officials and NFL doctors then had phone conversations about this issue. On that call was Dr. Richard Ellenbogen, who was not only on the league’s Head, Neck, and Spine Committee, but who had also applied for the $16 million grant that eventually went to Stern.

Dr. Ellenbogen then called Dr. Walter Koroshetz of the NIH’s National Institute of Neurological Disorders and Stroke, who had been heading the grant application review process. According to the report, the purpose of the call was to once again express concerns about awarding the grant to Dr. Stern. Ellenbogen told 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.

Dr. Koroshetz maintained that there was no conflict of interest but eventually decided to approach the NIH Council with two funding options, even though there would likely only be sufficient funds to support one. In Sept. 2015, the Council decided to only fund Stern’s study, and concluded that there was nothing hinky about the selection process, that there were no conflicts of interest that would compromise researchers’ objectivity, and that the other grant applicants had failed to justify funding.

The Council also stated at the time that this research was so important to issues of public health that NIH would fund the entire thing if need be.

This, presumably without intention, opened the door for the NFL to back away from its promise. After the NIH reminded the league that the entire grant was predicated on the NFL making funds available, a league exec replied “Didn’t you represent… that the CTE grant would be supported by NIH dollars? That’s what was stated to the group the other day.”

NIH responded by pointing out that while it would shoulder the cost if necessary, it would ultimately be a burden to taxpayers.

“[S]upporting the CTE study with taxpayer dollars means that NINDS will be unable to fund other meritorious research for several years,” reads an email to the league.

Eventually, the NFL looked like it might agree to fund only the first year of the study, at a cost of $2.58 million, though that was eventually knocked down to only $2 million, which was ultimately declined by NIH.

While this was all going on, another member of the NFL’s Head, Neck, and Spine Committee talked to NIH doctors about adding athletes to an ongoing intramural study involving patients with traumatic brain injury recruited into a protocol at the NIH Clinical Center.

This expansion of the study would be funded from the NFL money and would involve the researchers from the grant proposal that came in second to Stern’s, one of whom happened to be Dr. Ellenbogen.

Dr. Koroshetz reminded the league that the Council had agreed to fund only the one project, but the NFL took its case all the way to NIH Director Dr. Francis Collins.

Dr. Collins told the NFL that it couldn’t expand this program without going through the mandatory review process. And since they had just begun the effort of seeking out a new $16 million to replace the one that the NFL backed away from, it wouldn’t be a prudent use of the league’s donation.

With regard to the search for the new project, the NFL — in the midst of the Congressional investigation — wrote to NIH suggesting that its money be used for a long-term study on the effects of concussions… which is exactly what the Stern research is.

The Congressional report determined that the NFL acted improperly attempted to influence the grant selection process at NIH, that the league “should not have intervened in the process once it had signed the research plan,” and that “It was improper for any members of the NFL’s staff, as well as members of its Head, Neck and Spine Committee, to opine on the merits of Dr. Stern’s grant and attempt to circumvent the peer review process.”

The report singles out Dr. Ellenbogen, not for breaking any rules, but for behavior that “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.”

Rep. Pallone explains to ESPN that “Once you get anybody who’s heavily involved with the NFL trying to influence what kind of research takes place, you break that chain that guarantees the integrity.”

Not surprisingly, the NFL is denying all of the allegations.

“There is no dispute that there were concerns raised about both the nature of the study in question and possible conflicts of interest,” reads a statement from the league. “These concerns were raised for review and consideration through the appropriate channels…. It is deeply disappointing the authors of the Staff Report would make allegations directed at doctors affiliated with the NFL Head, Neck and Spine Committee without ever speaking to them.”


by Chris Morran via Consumerist

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