Quest for Way to Spot Mad-Cow Disease Stirs a Scientific Squabble in USDA Lab

April 30, 2001 Wall Street Journal by Steve Stecklow

One of the scariest things about mad-cow disease is that there's no test for it before symptoms appear, either for cattle or people. You can't tell, for instance, if blood used for transfusions is infected. Scientists all over the world are trying to develop a test.

Eighteen months ago, the U.S. Department of Agriculture announced that one of its researchers in Ames, Iowa, had made a breakthrough that might lead to one. Studying a related sheep disease called scrapie, researcher Mary Jo Schmerr developed a potential way to test blood for rogue proteins known as prions, which are believed to cause both scrapie and mad cow. The USDA put out a glowing news release hailing her achievement. Since then, her technique has won a U.S. patent.

British government scientists are planning large-scale tests with sheep blood. German government scientists plan to try it with human blood to diagnose Creutzfeldt-Jakob Disease, a brain-wasting malady similar to mad cow. A veterinary unit of American Home Products Corp. is negotiating licensing rights for a range of animal applications.

It might seem that Dr. Schmerr, a feisty 55-year-old biochemist and ex-nun, would be well along the path to prizes. Instead, she says, she is under attack. A researcher with whom she shared information publicly challenged her claims at a recent scientific conference. Rumors circulate in Europe that her process doesn't work. Perhaps most surprisingly, Dr. Schmerr accuses superiors within her own organization of obstructing her research by restricting her travel and collaboration with other scientists, and even belittling her.

The USDA says it is investigating this as an employment dispute and can say little more. In Dr. Schmerr's view, "The issue is: I've developed a test that's gotten a lot of attention, and it's generated a lot of jealousy." 'Holy Grail' It has certainly generated controversy. "I've seen her present in scientific meetings absolutely ground-breaking data on the detection of prions in blood, which is the Holy Grail of the whole industry. But because she's not in the [medical establishment's] prion crowd, she was basically dismissed out-of-hand," says Clarissa Desjardins, an executive of Caprion Pharmaceuticals Inc. Caprion, a private firm in Montreal, wanted to work with Dr. Schmerr, but her superiors wouldn't allow it.

But Paul Brown, a researcher at the National Institutes of Health, says the key issue is that so far, no one has been able to reproduce Dr. Schmerr's results, partly because she wouldn't give out complete details. "It's the worst test that I have ever seen in 40 years of working in the laboratory from the point of view of reproducibility and standardization," he says. "If you can't reproduce an experiment, the experiment cannot be considered science."

It would be a run-of-the-mill spat if the stakes weren't so high. Mad cow has caused a panic in Europe, where governments are slaughtering cattle by the tens of thousands to try to stop it. Ninety-four people, nearly all in Britain, are believed to have died from the human form, called new-variant Creutzfeldt-Jakob Disease. Health officials fear the fatal disease might be transmissible through blood transfusions, though this remains unproved.

The U.S. bars blood donations by anyone who lived in Britain for at least six months between 1980 and 1996. Mad cow's ability to lie latent in the body for years or possibly decades before causing symptoms makes finding a blood-screening test an urgent task. Big Market Researchers who work with abnormal prions, which are aberrant proteins, are racing to develop a blood test.

"I don't know of anybody who's not involved in this," says Bob Rohwer, a prion-disease specialist at a federal laboratory in Baltimore. "We'd all love to have a blood-based assay." Such a test could be lucrative. The market would include not only blood banks and farmers but also drug and food companies wanting to be sure their animal-based products were untainted.

Dr. Schmerr, a soft-spoken woman who lives on a 40-acre farm and loves to make quilts and garden, seems an unlikely lightning rod. But she is a passionate defender of her scientific work and doesn't hesitate to blast anyone she thinks has attacked it unfairly. "I don't want to fight with anybody. But when people start going after your heart and soul, then it's difficult not to fight," she says. "If you close the doors, I'll open the windows."

Dr. Schmerr is an expert on scrapie, the related sheep disease that some theorize led to mad cow in the 1980s after ground-up sheep parts were added to the feed of British cattle. She has worked at the USDA's National Animal Disease Center in Ames for 26 years. She began there while a student at Iowa State University, where she earned a doctorate in biochemistry after spending seven years in a Catholic religious community.

Dr. Schmerr set out to find a way to test for scrapie, which, unlike mad cow, has been found in the U.S. She teamed up with Andrew Alpert, a biochemist who does protein analysis at his private company in Columbia, Md., called PolyLC Inc. The two devised a complex two-step process that involves extracting abnormal prion protein from blood or tissue samples and measuring its effect on a fluorescent dye.

"It wasn't a brainstorm," Dr. Schmerr says. "Each obstacle would be overcome with some idea I'd get in the middle of the night." The two say the procedure can detect evidence of scrapie in a two-month-old lamb, while symptoms don't usually show up until a sheep is at least two years old. The patent application says the test method has been used successfully on the blood of sheep and also of mule deer and elk, which can get a prion malady called chronic wasting disease. It's not yet clear whether it will detect mad-cow disease in cattle or humans. The U.S. granted a patent in November.

Dr. Schmerr had already been making the rounds of scientific meetings devoted to prion research. She published two articles in peer-reviewed technical journals. They "electrified the whole blood diagnostics field," says the NIH's Dr. Brown. Although scientists theorize that abnormal prions are in the blood of infected animals and people, no one before Dr. Schmerr claimed to be able to detect them.

Dr. Rohwer in Baltimore says that "the sensitivity required to detect this protein in blood is extremely high, and actually pushes the limits of what is possible ... " What frustrated some scientists was that Dr. Schmerr didn't give full details of her technique because of the pending patent. "There was just no possibility for anybody to verify Mary Jo's results because they wouldn't let go the details of the key step," says Dr. Brown at the NIH. "It didn't used to be that every scientist who discovered something immediately contacted his patent lawyer and commercial companies," he complains.

Dr. Schmerr says she actually wasn't a strong proponent of seeking a patent. The USDA applied at the urging of an American Home Products veterinary unit in Overland Park, Kan., called Fort Dodge Animal Health. It has helped fund the research in exchange for certain licensing rights to any tests that resulted. Dr. Alpert, as co-inventor, also has licensing rights.

Even though Dr. Schmerr now stands to earn part of any licensing income, she says that "if I could have opened up that process, we would have been a lot further along." A number of scientists, including Drs. Brown and Rohwer in the U.S. and researchers in Britain and Germany, asked Dr. Schmerr for her aid in verifying the test. She agreed.

Dr. Rohwer, who has a five-year, $10 million NIH contract to develop diagnostic tests for prion diseases, says he offered Dr. Schmerr, who is a subcontractor, a chance "to clear up the controversy surrounding" her technique by setting up blind tests. Some of her findings weren't consistent with results he was getting with infected hamsters, he says. Dr. Rohwer acknowledges he is a competitor as well as a collaborator, because he is likely to be "a significant player" in a company being formed to develop a different test.

Last June, he arranged for Dr. Schmerr to test a batch of coded blood samples from 15 sheep. She tested six samples of each one's blood. Dr. Schmerr says that with five sheep, her test correctly read all six blood samples. With five more sheep, the test got five of the six samples right. With the others, results "were all over the place."

Dr. Rohwer arranged for a second batch of samples. This time her test couldn't read any of them. She and Dr. Alpert say the reason turned out to be impurities in the test cartridges, which they solved with prewashing. Dr. Rohwer has since set up a third round of testing, which Dr. Schmerr is now working on.

Word Gets Out

The blind tests' results were supposed to be confidential until completion, but word reached other researchers that she was having problems. She blames Dr. Rohwer. "He blabbed it all over Europe," she says. Dr. Rohwer says he has made no "public comments" about the results at conferences in Europe or anywhere else. But he admits he relayed the impression in private conversations that things weren't going smoothly and expressed his skepticism. He says he told at least one British researcher that Dr. Schmerr had to do the tests three times and that the second round failed for technical reasons.

Roy Jackman, a prion researcher at a British government laboratory, says word of Dr. Rohwer's negative comments reached him. Mr. Jackson's Veterinary Laboratories Agency in Weybridge, England, is helping fund Dr. Schmerr's research, and doing its own large-scale study to see if her test can detect scrapie.

Mr. Jackman says that "personally, I thought it was totally out of order" for Dr. Rohwer to talk about his continuing blind test with Dr. Schmerr. Mr. Jackman says that the test's problems have been fixed, that his lab has made other improvements, and that "we're now at a stage where the technology works extremely well."

At the American Home Products unit helping fund Dr. Schmerr's work, research director Steve Chu says she did "very good-quality work," and he is "optimistic that the technology does have merit." All agree it still needs refinement. Says Dr. Schmerr: "This is a test in development. It needs to be improved. It will not be 100% accurate."

But her credibility was challenged at a prion-disease conference last October in Alexandria, Va. She gave a presentation on her sheep work and finished by saying there had been promising results with samples of cerebral spinal fluid from human Creutzfeldt-Jakob Disease patients, provided by a German researcher.

The next speaker was Larisa Cervenakova, an American Red Cross researcher who had collaborated with Dr. Schmerr and also had worked with Dr. Brown, the NIH scientist who is critical of the test. Dr. Cervenakova said she had tried to apply the test on blood from humans and chimpanzees, but it couldn't differentiate between diseased and healthy blood.

Responding to a question from the audience, she displayed more results from samples she and Dr. Brown sent to Dr. Schmerr, saying the results were no better. Dr. Schmerr, in the audience, became visibly upset. Some other scientists were aghast. "It's distressing to see a controversy like this to be aired in public," says Neil Cashman, a Canadian researcher who says he is a friend of both women.

Dr. Schmerr says Dr. Cervenakova's tests didn't exactly duplicate hers because, among other reasons, the chemicals weren't identical. Dr. Cervenakova acknowledges that. In any case, Dr. Schmerr says, it wasn't fair to attack her work publicly when it's still under development. She says she always describes it as preliminary. Dr.

Cervenakova replies that if Dr. Schmerr is going to discuss her results publicly at all, it's fair to try to verify them. "My motive is to find the truth -- if it works or not. I personally don't feel anything against her." She and Dr. Brown have included in a medical-journal article a mention of their inability to replicate Dr. Schmerr's results. Dr. Cervenakova says she has resumed trying since she learned the test had some modifications she wasn't aware of.

Alongside this spat on the global scientific stage is one in a much smaller world, the USDA's National Animal Disease Center in Ames. Late last year, Dr. Schmerr formally complained to the USDA of sexual discrimination. She alleged she had been denied promotion, accused of "fraudulence and deception" about her research, and even once was told that women weren't suited to be scientists.

She said that after coming to the defense of a woman scientist who was harassed, she was restricted in her travel to scientific conferences and kept from collaborating with the Canadian company.

The USDA Is Still 'Excited'

A USDA spokeswoman says the agency remains "excited about Mary Jo's work" and calls her complaint a classic interemployee dispute. "When you have an organization with 8,000 people, you're not going to have everybody get along with everybody at all times," says the spokeswoman, Sandy Miller Hays. She says it would be an invasion of Dr. Schmerr's privacy to respond publicly to the specific allegations, and the USDA won't make available the Ames animal-disease center's chief, Keith Murray.

Dr. Murray recently required Dr. Schmerr to do a blind test of the procedure on about 200 sheep-blood samples. Dr. Schmerr says this wasn't appropriate because the technique is a work in progress. The blind test produced numerous "false positives," she says, which she later realized had happened because too much of the blood was processed.

She has explained what went wrong but worries that her superior will judge her work on the initial readings. She also says he waited more than a month to tell her the results. "He's trying to torture me. That's just a mind game he's playing," she claims.

The USDA's Ms. Hays says the tests were needed to determine whether the agency should provide additional funding. "We don't spend money playing mind games," the spokeswoman says. "If she wants to talk about this, fine. Keith Murray's not going to."

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