Recent claims that a kind of chocolate milk could aid in concussion recovery have come under fresh scrutiny by the university where the work was carried out.
On Friday, a University of Maryland committee released a report that raised “serious concerns” about the principal investigator of the as yet unpublished study involving a chocolate milk drink, Fifth Quarter Fresh, produced by the company Fluid Motion LLC.
The committee declared that the faculty member, Jae Shim, was in violation of university regulations regarding conflict of interest. Multiple times, Shim failed to disclose that Allied Milk Producers, an organization of which Fluid Motion was a member, contributed $200,000 to his lab.
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“The committee has found a concerning lack of understanding of the basic principles of conflict of interest (COI) in research at all levels of the process among those we interviewed,” the report reads.
This is the latest chapter in a months-long saga that began in January, when HealthNewsReview questioned the validity of a press release touting the benefits of the milk for athletes who experienced concussions. The press release was based on preliminary data that had not been peer-reviewed or published.
The new report indicates these concerns stretched back to the study’s early days. Technical reviews of Shim’s research proposal, solicited in 2013 by the Maryland Industrial Partnerships (MIPS) program, which was funding the project, raised questions about Shim’s qualifications to conduct the study and the scientific merit of the project.
“The PI does not have any experience in nutritional/supplementation research,” one reviewer pointed out. And the project was “missing numerous elements that would make this effective in concluding anything useful to the company or to the state of the literature.”
According to the report, Shim never received these concerns. Other reviewers provided positive comments, and the overall review was positive.
The project was funded and conducted over subsequent years.
One phase of the study involved high school students and purported to show that Fifth Quarter Fresh was effective at mitigating concussion symptoms. These students were not required to give informed consent to participate in the study, the report found, becuase Shim received a waiver from the university’s institutional review board. According to the report, Shim also recommended an additional test be conducted on the high schoolers.
Committee chair Ann Wylie, a professor in UMD’s geology department, said that the high school players were drinking the milk anyway and taking tests as part of high school protocol, which she thinks is the reason the IRB may not have required informed consent.
But some schools knew they were part of a study. Keshia Williams, athletic trainer at North Hagerstown High School, said that her school was in the “control group” and others were in the “study group.”
This raises the question of the exact nature of the relationship between the schools and the university throughout the course of the study.
Wylie said there was no formal agreement between the university and the school districts.
Wylie said that her committee asked the IRB to review the entire process by which it approved the study.
The university has returned all of the funding provided by Allied Milk Producers. They also returned funding provided by Fifth Quarter Fresh in accordance with university policy, as well as funds equivalent to the value of chocolate milk provided by the company for free to the university.
Wylie said that the committee found no wrongdoing on the part of Fluid Motion.
In a statement late Friday, Fluid Motion said it was “disappointed” to learn that the research was “mishandled.” The statement added that Shim and his partners “represented that they would provide reliable and unbiased work that would be acceptable to the research community.”
Patrick O’Shea, vice president at UMD, said he could not comment on whether Shim or others would be subject to any disciplinary action.
Brian Ullmann, assistant vice president of marketing and communications for the university, said that there is no plan to do any more work on these research studies.
As for the press releases, the report noted that they were circulated internally before publication, but it was “poorly defined” who had ultimate authority for approving them. The committee recommended that press releases never include data or conclusions not yet accepted for publication in a peer-reviewed journal or book.
Allied Milk and Fluid Motion could not be reached for comment.