Thursday, May 26, 2016

Ellenbogen/NFL vs. US Congress: A Case of Research Misconduct?

Earlier this week the Democratic staff of the US Senate Energy and Commerce Committee released a report of its investigation (here in PDF) into the alleged role of the NFL in trying to influence research funding decisions of the National Institutes of Health. In response, one of the academic scientists who has worked with the NFL for years, Prof. Richard Ellenbogen of the University of Washington, wrote a letter in response to the Senate Committee, criticizing the report.

Here I arbitrate this dispute, which falls right into my wheelhouse - the intersection of science policy and sports governance. I conclude that the Senate Committee is spot on and Ellenbogen's objections are substantively vacuous. In fact, the Senate Committee should have been much stronger in its critique of academics who were clearly dancing around the line of research misconduct.

The allegations levied against Ellenbogen are troubling, to say the least. Here is what the Senate report says:
Dr. Ellenbogen is a primary example of the conflicts of interest between his role as a researcher and his role as an NFL advisor. He had been part of a group that applied for the $16 million grant. After his group was not selected, Dr. Ellenbogen became one of the NFL’s primary advocates in expressing concerns surrounding the process with the BU grant selection. He not only participated on a conference call with NIH and FNIH on behalf of the NFL; he also reached out to Dr. Koroshetz separately to share that he would be unable to recommend to the NFL owners that they fund the Boston University (BU) study. This series of events raises significant questions about Dr. Ellenbogen’s own bias. It is clear that he should not have been communicating directly with Dr. Koroshetz or any other NIH staff about the grant selection process.
In his defense presented in his letter, Ellenbogen cites three objections to the report.

First, he was not interviewed by the committee:
Yesterday a report from the minority staff of your committee was released to the media alleging that I and others participated in an effort to influence an NIH grant selection process. Nothing could be further from the truth. Unfortunately, I was not afforded the simple opportunity to make this plain to your staff members, despite the fact that my contact information was provided to them and my willingness to engage with them on any question was made clear to them. I find this basic lack of fairness, combined with the disregard for the opinions and reputations of the medical professionals named in this report, to be unworthy of the important committee that you lead. At a minimum, I hope you can understand my profound objection to this maligning without so much as the courtesy of a direct question to me by your staff.
As a matter of procedure, Ellenbogen is correct. The Committee should have interviewed him, simply as a matter of comprehensiveness. However, Ellenbogen does not use the letter to explain where the Committee report is factually incorrect in any way that might have been corrected by such an interview.

Ellenbogen's second objection appears to be the focus of his defense, and he states that he is not paid by the NFL:
To be clear, I am not and never have been paid by the NFL nor have I ever received funding through the research grant dollars in question. 
This is either flat out untrue or deeply misleading, and this is easily shown. It is remarkable that Ellenbogen would make such a claim, given how ridiculous it is - his financial conflicts of interest here are many.

For instance The Seattle Times explains in an article from August, 2015:
A $2.5 million donation from the National Football League (NFL) will kick off the newly formed University of Washington Medicine Sports Health and Safety Institute aimed at advancing research, education and advocacy to prevent sports-related concussions. . . The UW institute will be led by [Dr. Stanley] Herring and Dr. Richard Ellenbogen, chairman of UW Medicine’s Department of Neurological Surgery.
And that is not all, from 2013:
University of Washington neurosurgeon Rich Ellenbogen was on the sidelines at a Seahawks game last year when he got word that “the boss” wanted to see him. That would be the top boss, team owner and Microsoft co-founder Paul Allen. “I’d never met him before,” recalled Ellenbogen, who volunteers as a neurological specialist for the Seahawks and the NFL. . . During the two-year, $2.4 million study, scientists at the UW and the Allen Institute for Brain Science in Seattle will examine the brains at the structural, cellular and molecular levels, looking for changes related to traumatic-brain injury.
Want more? Ellenbogen is listed on the NFL website as being among the recipients of $40 million in research funding from the League. He was also a co-PI on a grant proposal to the NFL-sponsored competition that is at the Center of this controversy.

The cherry on top is that as a member of the NFL's Head, Neck and Spine Committee Ellenbogen receives Super Bowl tickets and travel (Source: E&C Report), which depending on where he sits, each might be worth anywhere from $5,000 to $80,000. Coincidentally, the minimum threshold for a financial conflict of interest under NIH policies is $5,000.

Any of the examples above would on their own qualify as a financial conflict of interest under NIH policies. Such a conflict would prohibit Ellenbogen from serving as a reviewer on any funding application to NIH under a research partnership with the NFL.  It is not even close. Why he chose to take a stand on his lack of conflict is puzzling.

Ellenbogen's third objection has to do with the substance of the proposed research at Boston University that he intervened to try to stop being funded:
Medical professionals can and always will discuss priorities and debate protocols; that is healthy and appropriate. I believe strongly that there is a vital need for a longitudinal study that tracks the impact concussions have over many years. 
This objection is irrelevant. Sure, we academics can complain out in public about our objections to federal agency funding decisions. We can write blogs, op-eds and sing from the mountain tops. And we do it all the time.

What we cannot do is insert ourselves into the federal agency peer review process and try to alter it in our own preferred direction.

The Senate Committee concluded:
Although he did not violate any specific NIH rule we are aware of, Dr. Ellenbogen’s participation in these discussions 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.
I don't think that this goes nearly far enough. Much of the attention here has been, appropriately, focused on the NFL. More needs to be paid to academics behaving badly.

Monday, May 23, 2016

How Independent is WADA's Sochi Investigation?

Last week WADA published the Terms of Reference (ToR) for its investigation into allegations published in the New York Times of systematic, state-sponsored doping at the Sochi 2014 Winter Olympics.  The investigation is on a fast track, with a report due in less than 2 months, presumably so that the report can inform decisions about Russia's status in the Rio 2016 Olympics.

Here I focus on the structure of the investigation, and specifically the notion of independence and conflict of interest, two topics that I've written about often. Sports organizations have had a difficult time with the notion of "independent advice" and WADA is no different. Because the Sochi investigation is to play a critical role in any decision to exclude or include Russian athletes in Rio this summer, it is critical that WADA has all of its ducks in a row, regardless which way that decision goes.

The Sochi ToR explains that "an Independent Person (IP) has been appointed" -- this is Richard McLaren, who also recently served with Dick Pound on the WADA Independent Commission that looked into the last batch of allegations of systemic doping in Russian athletics (that effort had some issues with "independence" as well). McLaren is a long-time WADA collaborator, CAS arbitrator and has a stellar resume in the world of sports governance. His impressive credentials are not at issue here -- but his advertised "independence" is.

The notion of "independence" has come up as an important issue in the structure of the Sochi investigation. WADA explains:
Sir Craig Reedie acted swiftly to name Richard McLaren further to requests received by the former director of Moscow’s anti-doping laboratory, Dr. Grigory Rodchenkov; and, whistleblower, Vitaly Stepanov.  Dr. Rodchenkov and Mr. Stepanov – that are the informants for this investigation -- both expressed concerns regarding ‘independence’.  These are sentiments that were echoed by Beckie Scott, the Chair of WADA’s Athlete Committee.  Dr. Rodchenkov and Mr. Stepanov indicated that, in light of a perceived conflict of interest -- given that the allegations relate to the Sochi Olympics and that WADA is funded by the International Olympic Committee (IOC) – they would only provide evidence in their possession to an independent person.
But what is an "independent person" in this context? If you dig a bit deeper, behind the words, you'll find that that WADA's Sochi investigation is in no way "independent" and instead should be considered an internal investigation.

There is nothing wrong in organizing an internal investigation - organizations do this all the time. However, it is misleading to label such an internal activity as "independent." Let's dive into some of the details.

The ToR for the McLaren investigation do not define what it means to be an "Independent Person." The ToR states:
The IP will be bound by the Conflict of Interest policy adopted by the WADA Executive Committee in May 2011, and in this light, are required to complete and sign a Statement of Independence and Interest in accordance with such policy.
It turns out that the WADA Conflict of Interest Policy is not publicly available. I emailed WADA last week requesting a copy and they responded quickly with a copy of the Conflict of Interest Policy dated December 2015 (and not May 2011, as stated in the ToR) that was last modified 20 May 2016. I am happy to make that document available here in PDF.

Interestingly, the WADA COI Policy does not define "conflict of interest" as is standard practice in such policies - here are some examples I rounded up last fall. Here is what WADA states about COI:
Every person who is subject to the Policy shall, in the exercise of his or her functions on behalf of WADA, be free of undue influence or other factors which may give rise to a conflict between his or her own interest or the interest of any other person and that of WADA.
What does this mean?  It is not at all clear. The WADA COI Policy is so imprecise and circular that it does not mean much at all. Contrast this with the COI policies of IOC (PDF) or IAAF (link).

I have emailed WADA with the following questions:
1. Can you tell me the budget for McLaren's investigation, including his remuneration?
2. Can you share McLaren's "Statement of Independence and Interest"?
In addition, McLaren is operating under some restrictive communication policies. For instance, under the ToR McLaren is "required to sign a confidentiality agreement upon appointment" and also "must read and agree to comply with WADA’s Media Relations policy." The WADA Media Relations Policy is also not a public document, but I have requested it as well from WADA. McLaren's efforts are to be staffed by WADA officials and people from WADA labs.

To summarize:

  • McLaren is being paid by WADA;
  • WADA determines what McLaren can say and to whom;
  • WADA is staffing and overseeing the investigation.
The bottom line here is that the investigation does not look very "independent" at all. It is an internal WADA effort, being led by a long-time WADA collaborator. This may all be just fine, however, WADA has made a big deal about the "independence" of its investigation to address concerns raised by whistle blowers and athletes.  WADA has not addressed their concerns in any meaningful way.

The lack of independence of it Sochi investigation has set WADA up for problems when a decision is ultimately made on Russian participation in Rio 2016, no matter how that decision is made. 

There are a few loose ends to the above, and I will follow up as they are addressed.

Tuesday, May 17, 2016

Revisiting a Doping Cover-Up: A Guest Post by Jon Nissen-Meyer, University of Oslo

NOTE: This is a guest post by John Nissen-Meyer of the University of Oslo

In June 2013, the New York Times reported on an alleged cover-up by anti-doping officials. The paper reported that prior to the 2012 London Olympics, Italian track and field officials and the IAAF had evidence that race walker Alex Schwazer, who won gold at the 2008 Olympic Games in Beijing, used performance-enhancing drugs but that these organizations made no effort to prevent him from competing in the London games.

Schwazer was, however, ultimately  caught by WADA shortly before the 2012 London Olympics. The NYT reported, “neither the Italian federation nor the IAAF moved to stop Schwazer from competing in the Olympics.” An Italian prosecutor explained, “this circumstance can only be explained by the desire to ‘preserve’ a national track and field star for the 2012 London Olympic Games, in the expectation that he would perform well for Italy both in the 20 and the 50 km walk race.”

Now back from his doping suspension, Schwazer is in the news again after winning gold in the 50 km race-walking championships in Rome earlier this month.

On May 8, the German TV channel  ZDF had a report about Schwazer that adds further details to the possibility of a cover-up by sports officials. After about 4 minutes into the ZDF report they reveal a table showing Schwazer's blood values for the time period 2010-2012 (a screen grab is shown below). His blood values from May 21st are remarkable; they are in fact extreme and need an explanation, since they clearly suggest some type of blood manipulation or EPO doping.
His values from the spring of 2012 are also a bit suspicious, but completely "innocent" compared to the values from May 21, 2010.

Nevertheless, it seems that the values from 2012 were the ones that triggered WADA’s doping investigation against Schwazer (he was caught the last part of July 2012) and which motivated the charges against Italian and IAAF officials that they were aware that that Schwazer used EPO, but did not report it.

Schwazer states that he started using EPO winter/spring 2012 and that he informed at least one Italian doctor about it. But Schwazer claims that he never used blood doping before that, and based on this testimony, he obtained a reduced punishment, which ultimately led to his return to eligibility to race this spring.

The evidence from ZDF suggests however that Schwazer may have been doping as early as April-May 2010, which calls into question both his testimony and raises important questions for Italian and IAAF officials about the scope of a possible longer-term cover up.

In Rome earlier this month, Schwazer completely outclassed all his competitors in the 50 km World Cup in Rome and is now a favorite to win the 50 km in Rio this summer. Some of his (presumably) clean competitors are bitter about this and suspect that the whole story has not been told -- and they may be right.

There is no evidence to suggest that he is doping now, but based on the data provided by ZDF there are reasons to suspect that he may have done so before 2012.

Are anti-doping officials interested in knowing what happened? Or are they so overwhelmed by recent allegations that another possible cover-up is best left unexplored?

Thursday, May 5, 2016

A New Meldonium Literature Review

Today, Dr. David J. Greenblatt of the Tufts University School of Medicine sent me proofs of a forthcoming literature review of Meldonium, Here is the citation:

H. K. Greenblatt and D.J. Greenblatt, 2016 (in press). Meldonium (Mildronate): A Performance-Enhancing Drug? Clinical Pharmacology in Drug Development.

Here is the article's conclusion:
In sum, there is minimal evidence from North America and Western Europe regarding meldonium’s role in the treatment of disease, or whether it can produce meaningful performance enhancement in highly trained athletes. Extrapolations and recommendations based in in vivo or animal data should be weighed critically. There is also insufficient evidence to establish the temporal sensitivity of currently-used analytic screening procedures to detect meldonium use in the context of athletic competition.17 As such, the athletes’ claims described above cannot be refuted. Further study is necessary to determine meldonium’s clinical effects, if any, upon trained athletes, as well as to determine what conclusions may be drawn from positive screening results. Given that meldonium is not used clinically, experimentally, or recreationally in Western countries, satisfactory evidence seems unlikely to emerge in the near future.
The state of the science is such that Meldonium will continue to present challenges for evidence-based anti-doping.  WADA reports that 288 athletes have now tested positive for the drug. Here is my recent perspective in Newsweek on the challenges posed for anti-doping by letting regulation get out ahead of evidence.

Thursday, April 28, 2016

First Hints at Sharapova's Meldonium Concentration