Thursday, May 26, 2016

Are You Ready for Some (Political) Football? - the NFL, Concussion Research, the NIH, and the Revolving Door

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

ADDENDUM (29 May, 2016) - This post was republished on the Naked Capitalism blog.

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