Public institutions in Maryland still ducking basic questions about chocolate milk and concussions study

• High schools mum about rights, safety of student study participants
• Product endorsement by public schools chief, no response to questions
• Request for public records gets only a timeline and fee schedule from UMD
• Flawed news release, masquerading as news, repeated by yet another site

In December, the University of Maryland put out a news release claiming a certain chocolate milk product “helped high school football players improve their cognitive and motor function” and even improved concussion recovery scores. But when we asked to see the study report in order to review the release, the university clammed up. As questions mounted, the university announced an internal review of the matter, which apparently is still underway. University communications veteran Earle Holland has called Maryland’s tight-lipped responses “a classic example of errors” and poor communications management. Holland is now pursuing a formal public records request. Meanwhile, Andrew Holtz has repeatedly asked officials from Washington County Public Schools, whose high school students participated in the study, to answer a few basic questions about the children’s involvement. Holtz and Holland provide an update on their efforts to get answers from these public institutions below.

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Parents may not have given permission for children to be in study

The University of Maryland is not the only public body keeping mum in this affair. The Washington County Public Schools (WCPS) in Hagerstown, Maryland, which is responsible for the high school students who were assigned to the chocolate milk and concussions study, is not answering questions about the rights and health of the children in their charge.

Baltimore Business Journal reporter Sarah Gantz wrote that the leader of the study, University of Maryland public health professor Jae Kun Shim, said he did not “did not require waivers from players or permission from their parents”. I was astonished. Not only is informed consent a fundamental right of trial participants, but when our kids were in school, I remember having to sign permission slips for everything from field trips to watching a movie.

The University of Maryland communications handlers said Prof. Shim would not talk to me about these and other questions. So I turned to the schools that offered up their students for study. In early January, I asked to speak with WCPS Superintendent Clayton Wilcox. He did not respond. I was referred to school district attorney Anthony Trotta. After almost a week of leaving messages, I was finally contacted by school district communications officer Richard Wilcox. At his request, I submitted written questions on February 3^rd. Despite numerous follow-up telephone messages and emails, I have received no response.

Here is where the silence of those responsible for the high school students leaves us:

• The Washington County (Maryland) Public School District has not provided any information to indicate the study was reviewed by appropriate authorities within the district or whether there was an evaluation of the study’s design, methods, conduct, scientific merit or participant protections.

• The district has not provided any information to indicate that parents gave permission for their children to participate in this study, which would be a violation of ethical and perhaps legal standards.

• Shim was given access to concussion evaluation test results, even though the student athlete participation packet (see page 28 regarding concussion testing) says that the results would not be shared with anyone other than “School athletic trainer, consulting neuropsychologist, Director of Athletics and Activities, and any physician designated by parent/guardian.”

• The study involved giving students chocolate milk after each football practice. Some of these students may have diabetes or lactose intolerance, which might mean that the high-sugar milk product could be harmful to them. The student athlete participation packet includes forms which ask about these and other possibly relevant medical conditions. The district has not indicated whether anyone checked to see if the study might present any special risks to certain students.

Then there is the matter of a public school official endorsing a commercial product. As our review of the University of Maryland news release noted, the superintendent raved about the Fifth Quarter Fresh product.

“There is nothing more important than protecting our student-athletes,” said Clayton Wilcox, superintendent of Washington County Public Schools. “Now that we understand the findings of this study, we are determined to provide Fifth Quarter Fresh to all of our athletes.”

Do school district policies permit top officials to endorse commercial products? Was this endorsement approved by the district? Was Dr. Wilcox aware of details of the study, including flaws that undermine its conclusions? Neither Dr. Wilcox nor the district has responded to these questions.

Science cannot function and the rights of study participants cannot be protected in darkness. We are waiting for answers.

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University chooses bureaucracy over transparency

As allowed under Maryland’s Public Information Act, we made a request for a few specific documents, all public records, that should provide answers to questions the University so far has refused to answer.

We wanted to see the final Institutional Review Board (IRB) protocol, or plan, that approved using children in this research, possibly without parental consent.  We also wanted to see the main researcher’s Conflict Of Interest (COI) form the institution requires all researchers to fill out annually.  And lastly, we wanted to see a copy of any research agreement between the University and the local school system – both public entities – authorizing the research.

The institution has announced and is conducting a “review” of the study in question and how a press release was issued touting the work.  It has said it will answer questions once the review is done, but has offered no estimate of when that will be.

But some answers are available now, or at least should be if the University is conducting its research according to its own policies.  Major research universities have switched to computerized systems for managing both their IRB reviews and their COI compliance, meaning records are just a few keystrokes away.  And any agreement between the schools and University should be a part of this project’s file, readily obtainable for staffers managing that research.

In answer to our public records request, Maryland’s associate general counsel Laura Anderson Wright responded, informing us that “that the review process will take thirty (30) days from the date your request was filed.” She also provided an estimated cost for providing records that, after all, are public:  “We expect that fulfillment of your request will generate a fee between $100 and $150,” pointing out that they do not charge for the first two hours of work to process our request.

So, to be clear, to get copies of records the public has a right to see, the University will charge a requestor a considerable amount of money for staff time related to the request, plus a per-page charge for the paper.  The IRB form will be less than a dozen pages and the COI form should even be shorter.  The research agreement between the school and the University shouldn’t be much longer either.  Ours was not a major public records request.

The Maryland Public Information Act allows institutions to waive any fees if the information requested serves the public good by its release.  In countless cases throughout the country, small public records requests by the news media – working on behalf of the public – to government entities are often fulfilled at no cost, ostensibly as part of the public agency’s obligation to be transparent.  HealthNewsReview.org is clearly a part of the news media.

The concern over this questionable Maryland research is fundamentally linked to the University’s refusal to speak openly about the project.  Administrators and researchers have refused to offer more than cursory comments at best. Documents that should be readily available are produced slowly, after considerable prodding, and at considerable cost to the requester. Meanwhile, the public is left in the dark, wondering if this case is indicative of others.

Public records laws are on the books specifically to insure that the public knows its officials are working in their interests.  This isn’t about the money — it’s about the people’s right to know.

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Other notes on this chocolate milk headache…

• The flawed news release about chocolate milk and concussions continues to echo around the Internet. Just a few days ago, despite numerous news reports about the issues we first raised, yet another web site posted a lightly-revised version as if it were an independent report. Notably, this “story” does not even include the disclaimer about the preliminary nature of the study that the University of Maryland added to the news release after HealthNewsReview.org raised questions. So much for good ideas driving out bad ones in the marketplace of ideas. In the Internet Age, bad information bounces blithely along.
• Last October, Fifth Quarter Fresh announced a three-year deal with Bucknell University. It said the company’s chocolate milk would be “the primary workout and sports recovery drink for its athletes.” Chad Mason, associate director of athletics for operations and events at Bucknell, told me that the university has given athletes chocolate milk for several years based on the advice of its own nutrition experts. He said the decision to purchase the Fifth Quarter Fresh product was based on the product’s ingredients, not the University of Maryland study of concussions or an earlier one that, according to a news release, compared the milk to other recovery drinks (though here again the study itself has been withheld). Our gratitude to Mr. Mason for answering a few basic questions, something that should be routine, but in this case is anything but.