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UA profits from fired prof's work

Though she was accused of manipulating data, labs are investing in her Alzheimer's test.

Eric Weslander

Citizen Staff Writer

Jan. 7, 2002

     The University of Arizona is earning thousands of dollars from an Alzheimer's disease blood test invented by a professor fired from the school partly on an allegation that research behind the test was a fraud.

     Dr. Marguerite Kay, a physician and researcher who once held the prestigious title of Regents' professor of microbiology and immunology, lost her tenured position ...

     The University of Arizona is earning thousands of dollars from an Alzheimer's disease blood test invented by a professor fired from the school partly on an allegation that research behind the test was a fraud.

     Dr. Marguerite Kay, a physician and researcher who once held the prestigious title of Regents' professor of microbiology and immunology, lost her tenured position in 1998 after a faculty investigation found her guilty of "scientific misconduct."

     One of several allegations against Kay was that the basis for her Alzheimer's blood test - that certain antibodies could identify Alzheimer's in human brain tissue - was a lie that Kay propped up by manipulating data in a 1997 article.

     Nonetheless, UA owns the rights to Kay's patent-pending Diagnostic Assay for Alzheimer's Disease and has earned about $7,000 in licensing fees from a British biotechnology company working to develop and commercialize the test.

     UA, which has rung up more than $1.3 million in legal fees to justify Kay's controversial firing, released the licensing revenue after the Tucson Citizen filed a public records request.

     A UA administrator said the money from the test doesn't contradict Kay's firing. A scientist "could lie and falsify data, but in the end their idea could be right," said Richard Powell, vice president for research.

     UA President Peter Likins, who fired Kay based on a faculty panel's finding that she violated safety rules, mismanaged her laboratory and manipulated data in three research papers, declined to comment. Likins has said he can't discuss details of Kay's case for legal reasons.

     Carol Bernstein, president of the Arizona conference of the American Association of University Professors, said UA is being hypocritical. She said the revenue shows how little the professors who investigated Kay - none of whom was a member of the microbiology and immunology department - knew about her science.

     "The research that led to the invention and the research criticized during the investigation are one and the same," said Bernstein, a research associate professor in Kay's former department.

     The commercial scientists developing Kay's test are aware of her firing. They even researched her work by reading some of the same material UA criticized as a sham.

     Kay, who now lives in Texas and could not be reached for comment, has claimed all along that her research is viable and strong. When she came to UA in the early 1990s from Texas A&M, she was paid six figures and was the first woman to earn the distinction of Regents' professor.

     Two of her former lab workers sparked UA's investigation in early 1997 by claiming that Kay was violating safety rules, but she says the university fired her in retaliation for questioning how it handled grant money for research.

     For example, Kay alleged that UA had billed a Veterans Administration grant for work that she didn't do, a mistake later attributed to poor accounting and a lack of oversight.

     Where the university found a "false" claim and a "serious deviation" from accepted practices in Kay's Alzheimer's research, biotechnology companies saw an opportunity.

     Hypoguard Limited, a British company specializing in medical tests, licensed the Alzheimer's technology around the time Kay was fired, and Drew Scientific Group paid Hypoguard about $2 million for a sublicense to the test in April 2000.

     Hypoguard's licensing fees trickle down to UA via Tucson-based Research Corporation Technologies, which has a contract with UA to market Kay's work and pay the patent costs for her inventions in exchange for a share of any revenue.

     Through August, $20,116 has been distributed to UA from the licensing of the Alzheimer's test, UA records show. The school has given Kay $13,058 of that in accordance with a distribution formula.      At least $2,823 has gone to UA's "intellectual property account," which is used to pay legal bills for patents.

A scientist 'could lie and falsify data, but in the end their idea could be right.' - Richard Powell, UA vice president for research, on whether the revenue the school makes from Marguerite Kay's research in some way contradicts Kay's firing

     The rest of the money, $4,235, was earmarked for Kay's discretionary use in her lab, but she no longer has a UA lab. Frank Hartdegen, director of UA's office of technology transfer, said that in general, when inventors leave the university, money going into their discretionary lab account usually is split among the intellectual property account, the department's account and the college dean's account.

     In the 1997 article in the journal Gerontology, Kay argued that the same changes in brain cells during the onset of Alzheimer's disease- specifically, deterioration of a type of protein known as "band 3" -occur in red blood cells throughout the body. The types of antibodies Kay had developed to recognize changes to band 3 in brains could also be used to test blood cells, she said.

     Two graphs in the paper showed that Kay's antibodies reacted strongly with Alzheimer's brain tissue, but the panel that investigated Kay said the idea was bogus because the graph showed results from tests on only one Alzheimer's brain and one normal brain.

     "A major claim of this paper, that antibodies raised by Dr. Kay reliably distinguish between (Alzheimer's disease) and normal brain tissue, is false," the investigation panel alleged.

     Andrew Kenney, research and development director for Drew Scientific, declined to comment directly on the university's investigation. He did say he's read Kay's papers.

     "Indeed, our decision to participate in the project was only taken after we had evaluated the published work," Kenney wrote in an e-mail interview with the Citizen. "Our judgment, based on the published literature, was that enough had been done to make it an intriguing and potentially valuable possibility."

     Kay maintained throughout the investigation that it was acceptable to use a small sample in the two graphs because her emphasis was on testing different antibodies, not different human tissue samples.

     Kay's supporters argued that the graphs were intended to show the qualities of some of her strongest antibodies, which later would be tested against a large number of human tissue samples to see whether the trends held.

     Also, Kay has argued that her claim regarding brain cells was well-established and was a secondary point of the paper, which focused more on the potential for a blood test.

     Powell, UA's vice president for research, said the university may be earning money from Kay's inventions but is not turning a profit. The university has put time, effort and money into helping license and patent Kay's work, he said.

     Powell argued that even though the panel took issue with the way Kay presented the graphs in the Gerontology article, it never claimed there was false information in the documents Kay used to apply for patents and describe the invention in detail.

     "I think what they looked at was how she performed the experiments and reported the results," said Powell, who began his current job six months after Kay's firing and cautioned that his knowledge of the case is limited. "I don't think they ever took a stand on saying the invention declaration claims were flawed. I think you really have to differentiate between the two."

     Bernstein said that's hairsplitting.

     Hypoguard and Drew Scientific have been unable to make Kay's antibodies work so far, but her supporters say that even if the test is a flop, it doesn't mean she's guilty of misconduct.

     "This is not a finished experiment. This is a report of ongoing research which might hold up or not," said David Soll, a University of Iowa microbiologist who testified in Kay's defense.

     Other companies are working on different methods of Alzheimer's tests, and the company that develops the most efficient one first will corner a growing market, said Thomas Goodman, director of commercialization for Research Corporation.

     Today, 4 million Americans have Alzheimer's, and that number is expected to more than triple in the next 50 years, according to the Alzheimer's Association.

     "It would be a terrific irony if this turned out to be an extremely valuable assay for Alzheimer's disease, but that hasn't been shown yet," Goodman said. "All we can say now is that these companies are very interested, and they're testing it. For the sake of the people who have this disease, I hope the irony comes out."