EXCLUSIVE: Did ImPACT Concussion Software Developer Mark Lovell Disclose Conflicts of Interest in Federal Grant Applications?

Mark Lovell – consultant for the National Football League and World Wrestling Entertainment, director of the University of Pittsburgh Medical Center Concussion Program, and co-owner of ImPACT Applications, Inc., the Pittsburgh-based company that markets concussion management software – may not have disclosed financial conflicts of interest in grant applications to the National Institutes of Health over the last decade.

The substance of the applications themselves is accessible online, but the module relating to conflicts is blocked under old NIH rules. Those rules were recently revised to make conflict disclosures publicly viewable on grants moving forward.

Lovell has not responded to an email last Friday requesting clarification of his conflict disclosures. Susan Manko, the UPMC media relations specialist on sports concussions, has not responded to the same message, or to a fax or phone messages this morning.

Examination of NIH’s online database shows that between 2002 and 2005 Lovell was listed as the project leader on at least four grants from the federal agency for research on sports concussions and fMRI (functional magnetic resonance imaging). These grants totaled more than $2 million:

– $538,499 in 2002

– $554,652 in 2003

– $571,292 in 2004

– $588,429 in 2005

In 2007, Peter Keating of ESPN The Magazine revealed that Lovell – a Ph.D. neuropsychologist (not a medical doctor), who was the NFL’s director of neuropsychological testing – “is also the chairman of a company that sells testing software to NFL teams, a dual role which raises questions about conflicts of interest.” This new development raises the additional issue of whether undisclosed financial conflicts supported Lovell in securing public funding to underwrite the for-profit ImPACT Applications company’s research and development. (ImPACT stands for Immediate Post-Concussion Assessment and Cognitive Testing.)

Lovell joined UPMC in 2000. The medical center’s announcement of the formation of its new sports concussion program noted that he would be coordinating the efforts of other “nationally known sports concussion experts at UPMC — Joseph Maroon, MD, professor and a vice chairman of neurosurgery at the University of Pittsburgh School of Medicine, and team neurosurgeon for the Pittsburgh Steelers; and Charles Burke, MD, assistant professor of orthopaedic surgery at Pitt, team physician for the Pittsburgh Penguins, founder and director of the National Hockey League Concussion Program and current president of the NHL Team Physician Society. Also joining the UPMC concussion program staff is Michael Collins, PhD, who recently completed a neuropsychology fellowship at the Henry Ford Health System in Detroit, during which time he conducted two major multi-site studies involving concussion effects and return-to-play evaluation methods. The studies were published in the Sept. 8 and the Dec. 22, 1999 Journal of the American Medical Association.”

Asked about NIH conflict-of-interest disclosure policies, the NIH Office of Extramural Research issued this statement:

Investigators are expected to disclose their significant financial interests to their institution (http://grants.nih.gov/grants/policy/coi/coi_faqs.htm#3184). The institution then determines if the significant financial interest constitutes a financial conflict of interest with the investigator’s NIH-funded research. The institution is required to report any identified FCOI [financial conflict of interest] to the NIH (http://grants.nih.gov/grants/policy/coi/coi_faqs.htm#3208) through the eRA Commons FCOI Module. With regard to public accessibility of financial conflicts of interest information, this is a new requirement of the revised regulations, and it is the responsibility of the institution to make the information available. Here is some additional information regarding the public accessibility requirement related to identified FCOIs: http://grants.nih.gov/grants/policy/coi/coi_faqs.htm#3205.

Note that we are currently in a window during which institutions are implementing the recent revisions to the regulations. Until institutions implement the changes required by the revised regulation, they will continue to operate using the 1995 regulations.

Though the 2002-2005 applications for grants on which Lovell was the project leader do not have publicly viewable online conflict-disclosure modules, the hard copies of those documents clearly seem to be public records. In addition to the NIH statement that “it is the responsibility of the institution to make the information available,” the University of Pittsburgh’s own online guidelines to faculty and staff regarding information requests states: “[W]hen you have successfully applied for a federal grant, your grant application is subject to release by the funding agency under FOIA [Freedom of Information Act].”

I am forwarding this post to Robert Hill, vice chancellor for public affairs at the University of Pittsburgh, with a request for release of the conflict-of-interest disclosures in Mark Lovell’s National Institutes of Health grant applications.

I also am forwarding this post to the NIH Office of Extramural Research with a request for release of the complete 2002-2005 Lovell grant applications under FOIA.

Finally, I am forwarding this post to all members of the Senate Commerce Committee, and soliciting comment from them. The committee last week held a hearing on corrupt marketing of anti-concussion products.

Irv Muchnick

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