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The Waisman Center
What if a simple blood test could determine if your child — as young as 18 months — has the developmental issues associated with autism spectrum disorder? That outcome could both speed up the diagnosis and treatment of an often-devastating childhood disease.
Creating that blood test has been the longtime goal of Elizabeth Donley, chief executive officer of Madison-based Stemina Biomarker Discovery. It is also an explosive case in point of UW-Madison's problems in doing business-sponsored research.
On Nov. 1, Stemina’s NeuroPointDX division announced that its blood test was now available to the public if ordered by a doctor.
This came on the heels of Stemina publishing its first findings of an $8 million study of 1,100 children at eight clinical sites, including the University of California-Davis, the Children's Hospital of Philadelphia and Vanderbilt University in Nashville.
UW-Madison's Waisman Center, internationally known for its studies of developmental disabilities and neurodegenerative diseases, chose not to participate in 2017. This infuriated Donley, who has close ties to the University of Wisconsin.
“This is such a missed opportunity for everyone,” she wrote in a July 2017 email to campus leaders, including Chancellor Rebecca Blank. “We have families from Wisconsin who call us and want to enroll their children in the study, and we have to tell them the closest site is Children’s Hospital of Cincinnati. They are disappointed that our own Waisman Center cannot enroll them.”
Donley continues: “We spend a lot of time telling the Legislature how UW is a resource for companies for research, and how UW is creating jobs in Wisconsin through its start-up companies, and yet when the rubber meets the road, that is really not the case.”
Donley, who has a law degree and Master of Science in bacteriology from UW-Madison and a master's in business administration from UW-Whitewater, knows firsthand about the Madison campus’ mixed record on business outreach. (The campus ranks sixth in the nation for overall research funding, but an undistinguished 48th for corporate-sponsored research.) Before co-founding her biotech startup, Donley spent nine years working for the Wisconsin Alumni Research Foundation — UW's independent patenting and licensing arm — as a patent attorney, general counsel and director of business development.
“It just isn't easy doing collaboration with the university,” she says flatly.
Waisman researcher Albee Messing, who's now emeritus, was the interim Waisman director when Donley proposed that Waisman enroll patients in Stemina's study and support a grant application.
“It was a very short timeline,” he says. “She presented sort of an outline of an idea for this grant. When we started asking questions, she became very defensive, very argumentative and basically stood up and walked out of the room yelling along the way. She was very upset because she felt we had no right to ask these questions.”
He adds: “We couldn’t really participate in the way she asked. That basically was the end of it.”
Donley says Messing "mischaracterizes" what happened. In her email to campus leaders she suggested a more self-interested motive for Waisman's rejection: Its leadership was concerned “that Waisman doesn't make any money doing these studies and that it taps into Waisman's patient base so that families will be reluctant to participate in future studies that are designed by Waisman's [principal investigators].”
The Stemina study — known as CAMP, for Children's Autism Metabolome Project — was largely funded by the National Institute of Mental Health and the Nancy Lurie Marks Family Foundation. The first research paper emerging from the data appeared in a peer-reviewed journal called Biological Psychiatry. It found that about 17 percent of the metabolic subtypes detected irregular proportions of amino acids in children with autism spectrum disorder.
These imbalances, as well as others validated in CAMP but not yet published, were detected in about 30 percent of children with ASD, according to a press release. This means at least some expressions of autism spectrum disorder could be identified by a relatively simple blood test, as opposed to waiting for a diagnosis based on a doctor's observation of a child’s behavior.
This holds the promise of earlier diagnoses and treatment geared to a child's biology, Donley says. She told the tech website Xconomy Wisconsin that Stemina's business division will begin shipping the test to “early adopter” laboratories before the end of the year.
Donley is bullish. “The CAMP study is going to change the way kids are diagnosed. It's a big deal,” she told me.
Messing is not impressed. When I contacted him in August, he sent me a statement that he said represented his thinking as well as the judgment of the Waisman Center and UW Health: “We share the goal of developing diagnostic methods that allow early identification of individuals at risk for these disorders. However, the approach advocated by Stemina Biomarker, Inc., a for-profit company that necessarily combines scientific and commercial interests, is not one that the scientists at the Waisman Center believe to be valid.”
Donley was furious.
She emailed Messing, copying the chancellor and others: “You know nothing about our approach because you never looked at it. You know nothing about our CAMP study because you never participated in it. You know nothing about the results or what we’ve accomplished because you’ve never seen them.”
She was angry at what she said was Messing insinuating she was motivated by Stemina's “commercial interests.” (Donley has a son who has autism spectrum disorder, which she says is a source of inspiration for her work.)
“What is wrong with you?” she asked Messing. “Do you care nothing about the kids who will benefit from our work? Do you care nothing about great science and advancing research in autism? Do you care nothing about the Wisconsin Idea? Do you care nothing about anything but your own agenda?”
She also fired off an email to UW geneticist Qiang Chang, who is the new Waisman Center director, asking if Messing had been authorized to speak on behalf of the center. (Once again Blank and others were copied.) Donley said the statement Messing had sent me was "actionable." That it was "completely false" and damaging to her business.
The next day, from out of the blue, I received a terse email from Lisa Brunette, UW Health director of media relations, who copied UW messaging chief John Lucas. She advised me that Messing's statement “was his own and not a communication on behalf of UW and/or UW Health.”
I should add that Messing says that he's worked with business in his own research. Chang, in an email (he declined to be interviewed), says Waisman “has always had cutting-edge industry-sponsored research.”
An open records request seeking five years of data on Waisman’s contracts and agreements with industry revealed only two business-sponsored clinical trials. They accounted for about $200,000 of Waisman’s $1.4 million in business-related revenue in the five fiscal years of 2014-18. The lion’s share came from Waisman’s side business of doing lab work for other researchers. This contract work, while producing revenue for the Waisman Center and supporting research at other universities, produces no intellectual property for UW-Madison.
This is part of a series of stories on UW-Madison’s role in bringing new technology and research discoveries to the public. All the stories in this series on UW-Madison research can be found at isthmus.com/topics/uws-challenge/
Editor's Note: This article originally referred to John Lucas as Lisa Brunette's "boss," which was incorrect.
