After nearly 12 months of setbacks, the National Institutes of Health announced that it will contribute $2.6 million to support the study of the risk factors, detection and diagnosis of chronic traumatic encephalopathy, a disease that results in long term brain deterioration.
The story leading to the eventual acceptance and support of a proposal submitted by Robert Stern, director of clinical research at Boston University’s Chronic Traumatic Encephalopathy Center, recently gained national attention when the project’s original donor, the National Football League, backed down from its previous commitment to fund the study.
In 2012, the NFL committed to an “unrestricted” $30 million donation to the National Institute of Neurological Disorders and Stroke for sports-related research. The organization signed a letter of agreement with the Foundation for the National Institutes of Health, which outlined potential research projects to be used with the promised funds. The parties ultimately came to an agreement to fund a longitudinal study involving CTE.
Dr. Pellman is currently the league’s medical director. However, some might remember him as the former chair of the NFL’s Mild Traumatic Brain Injury Committee, who resigned from the position in 1999 after facing criticism for his scientifically dubious claim that professional football players face a lower risk of concussion-related brain injuries, compared to members of the general public.
In an email to the FNIH, Dr. Pellman stated that he, along with other representatives from the League, were concerned regarding Stern’s “ability to be unbiased and collaborative.” Stern, who appeared in the CBS documentary “League of Denial” in 2013, is a vocal critic of the NFL’s policies regarding player safety.
“(The) trouble is...that the group is led by the people who first broke the science open,” NINDS Director Walter Koroshetz said in an email. “NFL owners and leadership think of them as the creators of the problem.”
However, Pellman’s concern regarding the BU researchers’ potential biases against the League are intriguing, as one of the proposals had been submitted by several researchers who were associated with the NFL. Although these researchers held unpaid positions within the NFL, the line regarding their roles as independent scientists and NFL representatives would be blurred when one of the researchers, Dr. Richard Ellenbogen, began contacting the NIH on the League’s behalf. Ellenbogen became involved in the NFL’s request for a reallocation of funds that would benefit his project.
The NFL also raised concerns about to members of the review committee, as two of the researchers, Drs. Ann McKee and Robert Cantu, are professors in the BU School of Medicine and have collaborated with Stern on several papers involving CTE as recently as 2013. To the NFL’s credit, this is, potentially, a fair objection. Although the researchers were not listed as members on Stern’s grant, they could ultimately collaborate with Stern on a paper involving the study, and their professional relationship with Stern could skew their evaluation. That is, if these committee members were involved in the evaluation of Stern’s proposal.
The NIH has a written policy regarding conflicts within review panels. According to these guidelines, Drs. McKee and Cantu could serve on the grant panel, as long as they stepped out of the room during the evaluation of Stern’s proposal. Unfortunately, the answer of whether this process actually occurred does not appear to be public record. However, the NIH did state that they had followed the appropriate guidelines in selecting and conducting the panel. Therefore, we can only assume that their own guidelines were followed.
Drs. McKee and Cantu are experts in CTE research, and were likely chosen to for their abilities to evaluate the scientific merit of the submitted proposals, not to skew the review process in Stern’s favor. As long as the proper procedures were followed, this should have been a non-issue, and appears to have stemmed from an attempt to uncover a loophole, rather than genuine concern from the NFL.
In December 2015, the United States House Committee on Energy and Commerce determined that the NFL had acted inappropriately by attempting to interfere with the NIH’s peer review system. According to the Committee’s report, NIH policy states that “donors to the NIH cannot influence the agency’s grant decision-making process….(to ensure) that applications submitted to the NIH are evaluated by scientific experts in a manner free of inappropriate influence or bias.”
When the NFL’s request to allocate part of their funding to the second-highest ranked proposal, which was the one submitted by their own researchers, was denied by NIH Director Francis Collins, the League opted to back out of the donation, leaving the NINDS to cover the cost of the project. Ultimately, they were able to cover a fraction of the previously promised funds.
This controversy raises the question of whether a for-profit organization should have a place within science research. Although some have raised concerns on the origins of funding sources on a researcher’s results, it is generally considered acceptable to receive funds from an invested party - as long as that source is clearly disclosed within any publications that result from the project. Additionally - and this should be clear - the invested party should not interfere with the grantee’s research.
The NFL was clearly out of bounds (pun intended), crossing the field and attempting to interfere with the NIH’s role in supporting science research. The NFL case serves as a perfect example of a private donor situation gone wrong. However, this situation does not necessarily indicate that for-profit organizations should be excluded from supporting research.
Much of the blame in this situation falls on the FNIH. The Foundation was meant to serve as a mediator between the NIH and NFL, to ensure that the organizations were able to cooperate while maintaining an appropriate boundary between the donor and scientists.
The NIH spoke directly with members of the League, including the researchers who had submitted a proposal for the grant money. Although the fact that these members had submitted a proposal at all might be considered ethically questionable by some, their correspondence on the NFL’s behalf regarding the money should never have been permitted.
Additionally, the NIH did not attempt to hold the NFL to their donation, despite written proof of the commitment three years prior. FNIH Director Maria Freire said she was reluctant to demand payment, as the Foundation is not permitted to solicit private donations. However, in this situation, the agreement to support the study had long since been established.
Furthermore, the NIH never should have entertained the thought of allocating the funds according to NFL’s requests, as this would have violated their own peer review policy. The FNIH failed in its duty to protect the integrity of this process. Therefore, the NFL is not fully responsible for the resulting situation. The rules had been clearly established, but were not enforced.
Hopefully these unfortunate, highly publicized events will help ensure that these situations do not occur in the future. Granting agencies and donors each have an established role in the granting process. In a time when research funding is becoming increasingly difficult to obtain, it is unfortunate to think that meritorious projects might remain unfunded due to an inability for a granting agency and a business to abide by their own set rules.
The relationship between private agencies and government departments should be mutually beneficial. This means that corporations like the NFL need federal agency studies and investigations to identify the flaws in their own product in order to improve the safety of their brand. Ironically, by trying to avoid any bad publicity that may have resulted from the outcome of this study, the NFL has created even more negative media attention towards themselves by meddling in what should be an impartial governmental process.
What is important to distinguish here is that the NIH is a federal agency made up of unelected officials. This is important because a private organization or corporation providing money to a federal study is different than giving money to politicians or studies by researchers on the particular company’s payroll, the latter group of which would potentially come with strings attached. The fact that the NFL provided money in the first place should not automatically yield the same skepticism of the study’s results that would come with, for example, a study conducted by a certain scientist on the payroll of several oil companies with results questioning the veracity of manmade climate change.
Therefore, the largest problem with stories like these is that they cast a political aura over agencies that are apolitical by design. For example, a recent examination of the political contributions received by Republican members of the House Science Committee surprised absolutely nobody. The Accountability Initiative Report found that the oil industry has donated over $2.6 million to Republican members of the committee, which yields significant influence on U.S. policy concerning climate change. Recently, the committee has launched an investigation not into a campaign from the oil companies to deliberately mislead the public about climate change but rather into state attorney generals who are launching investigations of the industry.
Unfortunately, Americans expect this kind of foolishness from Congress. But the scientific federal agencies like the NIH, NSF, NOAA, and (to a lesser extent) the EPA are viewed more favorably by the general public. Even Congressional Republicans, to no avail, tried to keep the NIH up and running during the 2013 government shutdown and wasted no energy letting the public know that they would fight for one of the most beloved government sectors.
One of the most important sources of this rare form of trust in government that has been bestowed upon the scientifically-focused federal agencies is their impartiality. Officials at the NIH, NASA, NSF, etc. are immune from worrying about being beaten in an election or from having a well-funded primary opponent. Not being beholden to special interests is what sets executive agencies apart from Congress. However, stories like this one projects the false idea that corporate money has a hold on the agencies as well. To the casual observer, this would mean that these very important agencies are no different from Congress, which is heartbreaking to those who know the great work that is possible with federal funding.
When the stench of dark money is on federally-backed scientific studies, the public loses trust in the institutions that have stood by their side for generations. When this trust is breached, it is incredibly difficult (if not impossible) to get it back. It will require several structural changes as well as several generations worth of time for Congress’s approval ratings to get anywhere close to 50 percent. Even though the NFL was most at fault here and not the NIH, this makes the latter seem dependant to the casual news follower. The point here is that, in a way, the negative public perception towards government is not largely the government’s fault. It is the fault of those that wish to benefit monetarily from government policies and punish those officials, elected or unelected, that produce results that they do not like.
This does not mean that studies should not be funded by industries that would be affected by the outcome. There just should not be any quid pro quo. The NFL could actually benefit from a study that shows a link to CTE because it provides them with the invaluable opportunity to make necessary policy changes that will improve their public image, instead of damage it like this story has done. However, the NFL needs to know that the NIH is not Congress and that meddling in an impartial process is impermissible. This is important because it not only harms the image of the NFL, a company that has done a lot of good for a lot of people and owns a day of the week, but also harms what may well be the last frontier of trusted and accountable governance in our country.