Concussion Inc. (11 page)

Nowinski (a former WWE wrestler who had to retire from the ring due to his own cumulative brain trauma) proved Maroon dead wrong: Omalu found in Long's records a letter, written by Maroon, recommending that Long be given two weeks off following a concussion incident. (Thanks to Dustin Fink of the invaluable TheConcussionBlog.com for this catch.)

20 January 2011..........

Eric Adelson of the ThePostGame.com is reporting that the National Football League ordered new Oakland Raiders head coach Hue Jackson to sever his ties with a supplement company called Sports with Alternatives to Steroids (SWATS), whose product IGF-1 contains a banned substance.
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“We have a long-standing policy that prohibits coaches from any relationship with a supplement company,” said Brian McCarthy, the NFL's director of corporate communications.

Curiously, no such policy applies to team or league physicians, such as Dr. Joseph Maroon, a long-time neurologist for the Pittsburgh Steelers and member of the NFL concussion policy committee. I have been reporting that Maroon endorses a supplement called Vindure, which is based on the red-grape abstract resveratrol, and is an owner of the company that licensed Harvard Medical School research to Vindure's producer, Vinomis Labs.

So far as I know, Vindure contains no substances banned by the league. But Vinomis Labs is a supplement company.

In addition — and as I am reporting here for the first time — Dr. Maroon endorses another supplement called Sports Brain Guard, described as a “daily tri-delivery bioactive protection program” for concussed athletes, from Irvine, California–based Newport Nutritionals.
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Maroon also is medical director of WWE. Dr. Bryan Donohue, WWE's consulting cardiologist, is an owner of Vinomis Labs. Both Maroon and Donohue are at the University of Pittsburgh Medical Center, whose officials refuse to comment on whether Vinomis Labs and other outside business interests are covered by a recently revised and much-publicized ethics policy.

When I asked NFL spokesman Greg Aiello if the league had a parallel ethics policy for team physicians, he said they were bound only by the codes of their professional medical societies. I will forward this post to Aiello and invite comment on why the NFL bans its coaches but not its doctors from relationships with supplement companies.

WWE has not commented on whether it has an NFL-modeled or any other conflict-of-interest policy for its consulting doctors.

This is all of particular relevance because the Federal Trade Commission, on the request of Senator Tom Udall, just opened an investigation of the promotional claims of the NFL's official helmet supplier, Riddell. Those claims are based on NFL Charities–funded research conducted by Maroon.

Greg Aiello, the NFL's conscientious media liaison, got back to me quickly in response to my post earlier today. Aiello said, “The league's supplement endorsement policy applies only to league and club employees. If any club or person affiliated with a club engages in or promotes conduct that violates our policy on performance-enhancing substances, all involved would be held accountable.”

The language here recalls that of Commissioner Roger Goodell at the October 2009 hearings of the House Judiciary Committee. Pressed about questionable denials of chronic traumatic encephalopathy research issued by the NFL concussion policy committee, Goodell insisted that the committee doctor-members — Maroon among them — are not league employees. But they are certainly league
consultants
who draw fees and ancillary commercial benefits.

I'm not saying that the supplements endorsed by Dr. Maroon contain substances listed as performance-enhancing. But the principle that came through at the Judiciary Committee hearings applies: he is a walking infomercial, not someone whose word on player safety and on the NFL's vigilance on its behalf earns the benefit of the doubt.

23 January 2011..........

The
New York Times
story today on the federal football helmet ­investigation
5
fails to make the important connection to its own recent big story: the Federal Trade Commission investigation of safety claims by Riddell, the official helmet supplier of the National Football League, for its Revolution model.

Reporter Alan Schwarz leads today's account of action by the National Operating Committee on Standards for Athletic Equipment by stating that it was spurred by the Consumer Product Safety Commission. Yet the piece doesn't mention at all the FTC probe of Riddell initiated earlier this month by Senator Tom Udall.

The concussion story is more than the sum of the blocking and tackling by dueling experts. It is also the story of a process: the ecosystem of clinical research, an interdependent web of leading doctors, research journals, and commercial interests.

Today ground zero is an article in the February 2006 issue of
Neurosurgery
, “Examining Concussion Rates and Return to Play in High School Football Players Wearing Newer Helmet Technology: A Three-Year Prospective Cohort Study.” One of the co-authors was Dr. Joseph Maroon. Two of Maroon's three co-authors were University of Pittsburgh Medical Center colleagues Micky Collins and Mark Lovell; they are also partners in the concussion management software company ImPACT Applications, Inc. The article's other co-author, Thad Ide, is chief engineer at Riddell. The Pittsburgh research was underwritten by NFL Charities.

As news of the FTC investigation broke, Maroon threw Riddell under the bus, claiming that the company's promotion of the Revolution helmet emphasized the blue-sky findings of the
Neurosurgery
article while ignoring its disclaimers. But is that explanation good enough?

Here is the full text of the abstract of the article:

OBJECTIVE: The purpose of this study was to compare concussion rates and recovery times for athletes wearing newer helmet technology compared to traditional helmet design.

METHODS: This was a three-year, prospective, naturalistic, cohort study. Participants were 2,141 high school athletes from Western Pennsylvania. Approximately half of the sample wore the Revolution helmet manufactured by Riddell, Inc. (n = 1,173) and the remainder of the sample used standard helmets (n = 968). Athletes underwent computerized neurocognitive testing through the use of ImPACT at the beginning of the study. Following a concussion, players were reevaluated at various time intervals until recovery was complete.

RESULTS: In the total sample, the concussion rate in athletes wearing the Revolution was 5.3% and in athletes wearing standard helmets was 7.6% [[chi]2 (1, 2, 141) = 4.96, P < 0.027]. The relative risk estimate was 0.69 (95% confidence interval = 0.499–0.958). Wearing the Revolution helmet was associated with approximately a 31% decreased relative risk and 2.3% decreased absolute risk for sustaining a concussion in this cohort study. The athletes wearing the Revolution did not differ from athletes wearing standard helmets on the mechanism of injury (e.g., head-to-head strike), on-field concussion markers (e.g., amnesia or loss of consciousness), or on-field presentation of symptoms (e.g., headaches, dizziness, or balance problems).

CONCLUSION: Recent sophisticated laboratory research has better elucidated injury biomechanics associated with concussion in professional football players. This data has led to changes in helmet design and new helmet technology, which appears to have beneficial effects in reducing the incidence of cerebral concussion in high school football players.

2 February 2011..........

I don't think Dr. Joe Maroon gets off the hook in the Federal Trade Commission investigation of Riddell helmets just by asserting that the company inflated the claims of the assessment of the helmets' safety in
Neurosurgery
. After all, Maroon co-authored the piece for the journal of the Congress of Neurological Surgeons.

Nor do I think
Neurosurgery
itself gets off the hook for publishing a decade's worth of research, much of it funded by the NFL, that arguably retarded rather than accelerated professional and public awareness of the magnitude of CTE and related issues.

Here are unanswered questions I've submitted to Dr. Nelson Oyesiku of Emory University, the current editor-in-chief of
Neurosurgery
:

1. There is currently a Federal Trade Commission investigation of promotional claims by the Riddell football helmet manufacturer that were based on data in a 2006 article in
   Neurosurgery
   .
         Does the journal have a comment on this controversy?
         Are there historical examples of allegations of exaggerated claims from
   Neurosurgery
   -published research by another marketer of a consumer product? I exclude here the categories of professional debates over the efficacy of particular pharmaceuticals, surgical techniques, therapies, and the like; I am referring only to products sold in general ­consumer markets. If the answer is yes, could you provide some parallel examples?
   
2. Questions have arisen concerning the relationships of authors of articles published in
   Neurosurgery
   with the National Football League.
   Particular controversy surrounded work by Dr. Elliot Pellman, then chair of the NFL's concussion policy committee, with a series of articles, beginning in 2003, in
   Neurosurgery
   , which at the time was edited by Dr. Mike Apuzzo, a consultant for the New York Giants. Dr. Robert Cantu, then a senior editor of the journal, suggested that the sample size of the data would not have warranted publication of a similar article about a subject other than football head injuries. And according to reports, Dr. Pellman revised one of the articles post–peer review and prior to publication, and without consulting co-authors. Did the Congress of Neurological Surgeons publish any subsequent correction or clarification? Was any other action taken?
         Was this scenario covered by the Congress's existing code of ethics? If so, in what particular passages? If not, were changes contemplated in the wake of the Pellman episode?
   
3. Dr. Kevin Guskiewicz, director of the Sports Research Laboratory at the University of North Carolina, was quoted by ESPN as saying, “The data that hasn't shown up makes [the NFL doctors' work] questionable industry-funded research.” What is your response to that allegation?
   

25 March 2011..........

As long ago as a 2007 article in
ESPN The Magazine
, Peter Keating has written extensively about the start-up company ImPACT Applications, whose concussion management software was by then being used by 30 of the 32 National Football League teams.

Two of ImPACT's co-founders, Drs. Joseph Maroon and Mark Lovell of the University of Pittsburgh Medical Center, were members of the NFL's Committee on Mild Traumatic Brain Injury.

Christopher Randolph, professor of neurology at Loyola University Medical Center in Chicago, and former team neuropsychologist for the Chicago Bears, told Keating, “It is a major conflict of interest, scientifically irresponsible.”

Other key points:

• Lovell and a third Pittsburgh Medical Center colleague and ImPACT stakeholder, Michael Collins, were co-­authors of all 19 of the publications listed in the “Reliability and Validity” section of the ImPACT website.
  
• In 2005, Loyola's Randolph published a study in ­
  Journal of Athletic Training
  , which found that only one peer-­reviewed article involving a prospective controlled study with ­ImPACT had been published.
  
• Another then unpublished study by Stephen Broglio, professor of kinesiology at the University of Illinois at ­Urbana-Champaign, concluded that ImPACT and two other tested computerized systems were “less than optimal.”
  
• Without disclosing their financial interests, Maroon and Collins published laudatory comments on a 2006
  Neurosurgery
  article about ImPACT that was co-authored by Lovell and three other members of the NFL concussion committee.
  
• Lovell declined to be interviewed for ESPN's investigative series
  Outside the Lines
  .
  

23 April 2011..........

Author-journalist Matt Chaney's piece today, “Critics, Evidence Debunk ‘Concussion Testing' in Football,” suggests that I have been far too kind in my criticisms of the ImPACT system.
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Some highlights:

• A peer-reviewed article in
  Current Sports Medicine Reports
  by Loyola University's Dr. Christopher Randolph details ImPACT's “glaring faults,” with unacceptable rates of false positives and false negatives.
  
• Chaney writes, “An overwhelming majority of journalists, politicians, educators, and football experts ignore the accumulating evidence rebuking concussion testing as invalid and unreliable, choosing instead to endorse the quick-fix notion and push it for mandate by law.”
  
• Generally speaking, the neuropsych tests on the market “are unsuitable for clinical work with concussions,” according to Dr. Lester Mayers of Pace University.
  
• Dr. Bennet Omalu, who discovered chronic traumatic encephalopathy in athletes in contact sports, says, “ImPACT testing is not a diagnosis tool … Using [computerized] testing in the acute phase of injury can actually make the symptoms
  worse
  .”
  

11 June 2011..........

The NFL's new PR website, NFLHealthandSafety.com, has a video demonstrating how Dr. Joseph Maroon, team neurosurgeon for the Pittsburgh Steelers, might examine a player who has been concussed. The clip, which Maroon describes as a kind of “two-minute drill” showing how a trained professional can check out a player “efficiently and expeditiously,” is unintentionally comical.
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The obvious flaw here is that the person Maroon is examining passes all his markers perfectly. Is the NFL representing this as a typical outcome?

A companion piece might be a skit with the cast of
Saturday Night Live
reenacting the anecdote about the player who, the coach is told, doesn't know his name. “Well, tell him his name and get him back out there!” the coach says.