By Roy Poses, MD, Clinical Associate Professor of Medicine at Brown University, and the President of FIRM – the Foundation for Integrity and Responsibility in Medicine. Originally posted at Health Care Renewal website
Probably because it involved the favorite American sport, the controversy about the risk of concussions to professional National Football League (NFL) players, and how the NFL has handled the issue is very well known. A recent article in Stat, however, suggested that one less well known aspect of the story overlaps some issues to concern to Health Care Renewal.
Allegations that a Prominent Physician and NFL Official Tried to Influence the NIH Grant Review Process
The article began,
Dr. Elizabeth Nabel, president of Boston’s Brigham and Women’s Hospital [BWH] and one of the nation’s most prominent medical executives, was part of a National Football League effort to ‘steer funding’ for a landmark concussion study away from a group of respected brain researchers, according to a congressional committee report that was sharply critical of the league.
The report found that the NFL ‘inappropriately attempted to influence’ the National Institutes of Health’s [NIH] grant selection process.
Dr Nabel, in fact, not only runs the BWH, a renowned teaching hospital and major component of Partners Healthcare, but also serves as the “chief health and medical advisor” to the NFL. Anyone who has followed even a bit of the media coverage about the NFL and concussions affecting football players knows that the NFL could be negatively affected by any more research that associates playing professional football, concussions, and the adverse effects of concussions.
The Stat article chronicled the intricate communications between Dr Nabel and the NIH as documented by a report from the Democratic staff of the House Committee on Energy and Commerce.
It cited a series of communications between NFL representatives, including Nabel, and officials of the NIH, and a foundation that accepts gifts from private donors to support NIH research. The discussions began after the NIH decided last year to award a $16 million grant to a research team led by Dr. Robert Stern of Boston University — but before the award was publicly announced.
The money for the grant was to come from a donation pledged by the NFL to the Foundation for the National Institutes of Health, and league officials say they were concerned about aspects of Stern’s group and the proposed study.
Research by Stern’s team and BU colleagues has helped establish a link between football and chronic traumatic encephalopathy, long-term brain damage that’s been observed in a growing number of athletes, including former NFL players, who suffered repeated head injuries.
The implication seems to be that this research group might be counted on to fearlessly pursue research even if the outcomes suggested that playing football might lead to adverse medical effects, which might not be so good for the NFL’s interests. So,
Nabel, who knows the NIH well from her 10 years working as a high-level manager in the agency, sent two emails to Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke [NINDS], according to the report. That’s the NIH branch that was awarding the grant.
In one email on June 23, 2015, she wrote, ‘I am taking a neutral stance here,’ while noting a concern about a potential conflict of interest: members of the NIH grant review panel had coauthored papers with two researchers that she had heard might be receiving the grant — Dr. Ann McKee and Dr. Robert Cantu of BU.
Later that day, she wrote Koroshetz that ‘a Dr. Stern, who may also be with this group, has filed independent testimony in the NFL/Players Association settlement.’
Indeed, Stern was critical of how the settlement would be administered, pointing out flaws with the neuropsychological tests that the league proposed using to determine how to compensate injured players.
Notwithstanding that Dr Nabel had an obvious conflict of interest herself: she worked for the NFL. In any case,
‘I hope this group is able to approach their research in an unbiased manner,’ Nabel’s email continued, the report says.
Nabel sent Stern’s testimony to Koroshetz, according to the report.
‘My sole objective,’ Nabel said in her statement, was to ask her former NIH colleagues to ‘ensure there were no conflicts of interest among grant applicants.’
The NIH found no conflicts involving the grant review panel and stuck with its decision to award the grant to the Stern group. It ended up using internal funds, not the NFL money, to pay for the grant.
The NIH told STAT it agrees with the ‘characterization of events in the report.’
An Affront to the Sanctity of the Grant Review Process?
Although Dr Nabel and the NFL asserted that they acted appropriately at all times, neither the committee staff nor one very prominent ethicist agreed,
The committee report said that Koroshetz disagreed …, and said he was aware of no other instance where a donor raised objections to a grantee prior to the issuance of a notice of grant award.’
‘The NFL’s characterization of the appropriateness of its actions suggests a lack of understanding of the importance of the NIH’s independent peer review process,’ the committee report states.
Nabel’s spokeswoman said Koroshetz never told Nabel her actions were inappropriate. ‘In fact, all of their interactions were very collegial and cordial,’ she said.
I will interject that the question was not whether Dr Nabel was hostile or bullying, but was whether she tried to inappropriately influence the grant review process. So also,
Arthur Caplan, a professor of bioethics at New York University, said Nabel’s actions, as described in the report, risk harming Nabel’s reputation and that of the Brigham. ‘When she did anything to try to shape the selection of investigators or challenge the objectivity’ of the grant selection process, he said, ‘she had to know that that was 100 percent inappropriate, 100 percent unacceptable.’
Having served on numerous NIH and Agency for Healthcare Research and Quality (AHRQ) review committees (known as “study sections”), let me add some context at this point. Study section members must meet rigorous standards for freedom from conflicts of interest. They also fiercely guard their independence. The grant reviews they construct are supposed to be entirely about the scientific, clinical and public health merit of the proposals, and the scores they give proposals are the most important determinants of whether it gets funding. Funding decisions are actually made by agency staff and advisory boards, but are supposed to depend only on the reviews and the general priority of the proposals’ topics. Nobody – I repeat, nobody – outside of this process is supposed to influence the funding decisions.
So the notion that big wigs from big outside organizations with vested interests in how a particular research project might turn out were communicating with top NIH officials about grant proposals, and that the officials allowed them to continue to communicate, and allowed even the chance they would be influenced by their communication strikes this old reviewer, to quote Dr Caplan, as “100 inappropriate, 100 percent unacceptable.”
Did the Revolving Door Enable the Attempt to Influence NIH Grant Review?
Not directly discussed in the Stat article, however, was why Dr Koroshetz, director of NINDS, was willing to accept, if not agree with Dr Nabel’s communications. The article did note that Dr Nabel was a former “high-level manager” at the NIH. In fact, according to her official Brigham and Womens’ Hospital biography, Dr Nabel was director of the US National Heart, Lung and Blood Institute from 2005-2009. She became CEO of the BWH in 2010. Thus, she was a former top NIH leader who once held a rank commensurate with that held by Dr Koroshetz.
But wait, there is more. Also according to her official BWH biography, Dr Nabel’s husband is one Gary Nabel, now the chief scientific officer at Sanofi. Dr Gary Nabel, in turn, was Director of the Vaccine Research Center at the National Institute for Allergy and Infectious Diseases (NIAID), another NIH institute, through 2012, but then according to Science, became chief scientific officer at Sanofi. So Dr Nabel’s husband was also a high-ranking NIH leader, although apparently not as high-ranking as his spouse and the NINDS director with whom she communicated.
Thus it appears that maybe Dr Nabel had outsized influence at the NIH and on the NINDS director because she was a former NHLBI director, and the spouse of a former high-ranking NIAID leader. Her attempts to influence the NIH grant application process therefore appear to be a possible manifestation, albeit delayed, and partially at one spousal remove, of the revolving door pheonomenon.
We have noted that the revolving door is a species of conflict of interest. Worse, some experts have suggested that the revolving door is in fact corruption. As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,
The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.
This case suggests how the revolving door may enable certain of those with private vested interests to have excess influence, way beyond that of ordinary citizens, on how the government works.
Worse, this case also suggests how it seems that the country is increasingly run by a cozy group of insiders with ties to both government and industry. In fact, just a little more digging reveals that a key player in this case has even more ties to big private health care organizations. According to ProPublica, in the last three months of 2014, Dr Elizabeth Nabel received $26,070 from Medtronic, mainly for food, travel and lodging, but which included $8572 for “promotional speaking/ other.” In 2015, she was appointed to the board of directors of Medtronic, despite not having previously owned any Medtronic stock, according to the company’s 2015 proxy statement. Also in 2015, she was appointed to the board of directors of Moderna Therapeutics. Her husband, as noted above, now works as chief scientific officer for Sanofi.
So, as we have said before…. The continuing egregiousness of the revolving door in health care shows how health care leadership can play mutually beneficial games, regardless of the their effects on patients’ and the public’s health. Once again, true health care reform would cut the ties between government and corporate leaders and their cronies that have lead to government of, for and by corporate executives rather than the people at large.
Video addendum: the beginning of “League of Denial” from PBS Frontline
Doctors get a lot of business from football. Injuries, steroid shots, human growth hormone shots, pain killer shots. Football is a thing which should right about now fade into obscurity. The thing that ruined it was steroids and HGH and all that stuff which turns men into monsters. When I played football in high school long ago it was already a little dangerous but on the plus side it taught teamwork to the youth and built strong bodies. Now it’s ridiculous. If you have a 350 lb. dude with sprinter’s speed colliding with you of course there will be many injuries. I’m an ex-player, and it’s not too strong a word to say I hate it. I will leave the area if there is a game on TV. I don’t want to know who is in the super bowl. This is a repeat of the Christians and lions fiddling while Rome burned. Sorry for the mixed metaphor. The only sport I sometimes watch now is pocket billiards—nobody gets hurt. And I admit sometimes I watch women’s tennis.
Women’s tennis? What about Maria Sharapova and meldonium? She’s been doping for years.
As for high school football, I played one season 40 years ago. I can still hear the sound of the leg of the big booster’s son snapping, when they let the little guy practice as back-up quarterback and his blockers fell on him…
I’m an ex-player, and it’s not too strong a word to say I hate it. I will leave the area if there is a game on TV. I don’t want to know who is in the super bowl.
I was recruited in HS and refused to play. In fact a college chum and I were offered a Chi Bears training camp walk on, back when that was done, by the late Geo Hallas in the lobby of his condo, (Edgewater Beach apts) in 1980. Ironically my chum was previously concussed out of the Miami Hurricanes
It was a destructive sport then and I knew it, now it is much worse… As you imply, F=MA
The NFL is a progressively sophisticated scheme that sucks in intellectually immature kids served up by their parents!…
The infinitesimally small % of Players that ascend, to the man cripple themselves, and do so for not enough money and brief fame.
The spectators that finance it vicariously identify w/ a “tribe” they could never actually be part of are paying to maim/kill their preferred gladiators. To me a monumental moral disconnect.
My contemporary that is now a physical and neurological cripple.. in the end for no good reason:
tell me this guy isn’t self medicating a damaged brain:
Robert Hayden Avellini (born August 28, 1953) was a quarterback in the NFL. For most of his career, he played for the Chicago Bears
In October 2013, a DuPage County grand jury indicted former Avellini on felony drunken driving charges a week after his sixth DUI-related arrest since 2002.
In May 2009, Avellini was arrested for driving under the influence and acquitted for the third time. He had been convicted of the offense in 2002. On November 19, 2014, Avellini was sentenced to 18 months in prison for his 3rd DUI. Avellini declared bankruptcy on February 27, 2012 listing debts of more than $2.2 million and assets of $1.3 million.
On November 20, 2014, Avellini was sentenced to 18 months in prison for aggravated DUI.
Then there’s Dave Duerson
Duerson owned three McDonald’s restaurants in Louisville, Kentucky for six months, from late 1994 to April 1995. He purchased the majority interest in Fair Oaks Farms (formerly Brooks Sausage Company) in 1995. Duerson grew the company from $24M revenue to over $63.5M in six years. He sold his stake in the company in 2002 and started Duerson Foods, but that company was forced into receivership in 2006 and most of its assets were auctioned off.
Duerson was found dead at his Sunny Isles Beach, Florida home on February 17, 2011. The Miami-Dade County medical examiner reported that Duerson died of a self-inflicted gunshot wound to the chest. He sent a text message to his family saying he wanted his brain to be used for research at the Boston University School of Medicine, which is conducting research into chronic traumatic encephalopathy (CTE), a neurodegenerative disease, which can be caused by playing professional football. He left behind three sons and a daughter from his marriage to ex-wife Alicia Duerson.
On May 2, 2011, neurologists at Boston University confirmed that he suffered from CTE, which is linked to concussions.
..and Erik Kramer
In 1994, he signed as a free agent with the Chicago Bears, and spent the next five years with the club. In his two full seasons as a starter (1995 and 1997), he was highly productive and passed for over 3,000 yards.
Kramer survived a self-inflicted gunshot wound with life threatening injuries in an apparent suicide attempt on August 19, 2015. According to Kramer’s ex-wife, her husband has a “beautiful soul” but is not the same man she once married due to head injuries suffered during his time as an NFL quarterback.
And this is just a brief span of time w/ one team!
Women’s badminton. Speed, grace, strategy, guile…
Most school sports is a form of child abuse. It is not about building strong bodies, but winning at all costs because…genuflect….competition for the entertainment of school alumni and the inflation of athletic dept wages. Coaches often make the highest salaries in a school. I worked for an insurance company for over 30 years, the amount of sports injuries is amazing. Youth have delicate developing bones and muscles, throwing children into a constant maelstrom of competitive sports sets them up for injuries that will effect them the rest of their lives. My dad was a national champion swimmer from Lane Tech. He had no sports injuries. He had a heart attack in older age and the doctor told him he would have died except for the fact that all the smaller vessels going to the heart were so expanded from his years of swimming that they compensated for the blocked arteries (he smoked). We need sports that improve and not damage the bodies of our children.
I’d say that is an over-generalization. First problem, sports at what age? Second, which sports? Third, at which schools?
I played sports as a kid. None of the year-round-the-same-sport-travelling-team-at-age-nine crap, but a different sport according to the season. I never played football, except the flag or tag versions in gym or for fun. I was never going to be a star at any of them, or get a scholarship, but I think it was good for me over all. Teamwork, cooperation, being active, etc.
Of course an injury can happen with any activity; I knew kids who got bad ones. But there’s risk in letting kids be sedentary, too. And yes, towns get stupid over sports, as in Steubenville… but that was a problem with the whole culture that made boys who were good at football into gods and then punished the girl whom they victimized. Inherent to football as the head injuries? Dunno. Enabled by adults with no sense of priorities? Hell yeah.
I think sports are even better for girls than for boys — remember that Nike ad from way back? Little girls saying, “If you let me play sports… ” followed by positive effects in later life. Including, “I will be more likely to leave a man who beats me.” (I’m not shilling for Nike, but the ad stuck with me.)
Girls who might otherwise be socialized to be physically demure all the time, or to believe that women must be catty with one another, learn to cooperate, to fail and to try again, to get sweaty and grubby and have fun doing it. Possibly outside, depending on the sport. They learn that they can be tough, can cooperate with other girls, and also compete.
Oh, and they develop spacial acuity, which helps with math skills. (As does music, of course.)
Anyway, it sure beats ballet, or competitive gymnastics.
Now, the NCAA? Making millions off of disproportionately minority male stars while skimping on their education? That’s a whole ‘nother issue.
Well, there has to be a balance. Yes, if the child has an intellectual household where people just play musical instruments and read all the time he may not need organized sports. But many youths have a lot of energy which they will burn one way or another. Sports keeps a lot of kids out of trouble. But football is not a good choice, in my opinion. BTW, I should have added nobody gets hurt at pocket billiards—-unless you play for money. Even if you win the money you might end up like Fast Eddie Felsen in “The Hustler” with your hands smashed.
/s: Big Pharma has found a solution for all the natural energy that children have. Call them hyperactive and drug them until they can be used in contact sports.
Volleyball… Doesn’t require much space.
Not perfect but no one is intentionally trying to run into someone else with the intention of hurting them
Football is mostly about big business now. That and acting as a motivational device/pass time for the inner city underclasses, for most of whom sports serve as the only perceived realistic way out (followed closely by the military for the rest) of a mostly hopeless situation.
As an older person (in my 60’s) whose father was a doctor and was against highschool football because of head injury risks, and who also remembers when pro football was not all/only about collision (and boxing was on national TV weekly), and who has read Dr. Omalu’s reports, and seen the Frontline docus, and other sports med articles relating to this syndrome, —and knows more than a few people living with brain injury— I can say that
1) this should not be news to anyone in the medical community,
2) the NHL has been screwing with results and researchers and funding around this issue for quite some time, so of course they’d have tried to mess with the NIH,
3) the revolving door is clearly a corruption problem seeded throughout the US regulatory system, and
4) while closed head injury that results in brain damage isn’t going to be prevented with better helmets, or fancy assessment regimens or teaching how to recognize concussion, football *could* go back to the more running game that it was in the ’60’s & even ’70’s, and be less catastrophic to its players…
.. but it probably won’t. The billions of dollars the NFL makes, and its shareholders bottom lines, assuree they will do anything it takes to keep the money flowing, and they built today’s game on crushing violence, and a culture of promoting the players as warriors, and positioning the game as a way out of poverty when in fact the # of high school players who hit the big leagues is minuscule.
It should be, IMO, shunned and relegated to the barbaric past, the way boxing largely is today. When the public got to see the shattered remains of the once glorious Ali, they took a step back from accepting what boxing does; that will I hope happen sooner than later with football.
American football says as much about this country as any single endeavor. It yields captivating TV, it offers the illusion of fairness and competition but really revolves around money, it chews up and then spits out damaged young men who are nevertheless glorified role models for the next generation, it “proves” that the USA is the best because an American team is “world champion” every year… I feel like I could literally go on forever.
I think the powers that run American football are shared sh1tless that CTE is going to kill the golden goose (which would be intolerable, unlike CTE killing the players after they retire, which is entirely tolerable). I’m not surprised at the degree of underhandedness with which they operate in this sphere.
You forgot “After football, many of them go into finance.” Concussions and all.
Lenny “Nails” Dykstra tried all kinds of business ventures, including stocks, and was sentenced to 3 years in prison, serving six months. The Mitchell Report observed he used anabolic steroids while playing baseball.
Why does the subject of steroid abuse never come up?
When you mix steroids, insulin and growth hormone – all common doping agents – with head injury, you get hyperphosporylated tau. All four of these prompt misfolding in tau. Diabetes is already a common side effect of doping and a risk factor for Alzheimer’s – which, like other neurodegenerative diseases, also features tangled tau.
There are consequences to cheating and, apparently, one of them is CTE. Not one single article has ever covered these basic facts that you can look up on PubMed.
Why should we have sympathy for guys who cheated to get their jobs over other, honest competitors who didn’t dope?
If you want to dope with a concussion, try progesterone.
Don’t get me started on what happens when you douse this situation with opiates to get injured players back out on the field without proper rehabilitation…
Football isn’t safe and no helmet can make it safe.
Anyone that says otherwise is taking money from the NFL.