'Mad Cow' Fears Create a Market; Firms Rush to Develop Better Tests for Disease

'Mad Cow' Fears Create a Market;
Firms Rush to Develop Better Tests for Disease

May 29, 2001 The Washington Post by Terence Chea

If you studied in France for a semester or spent a summer touring Britain as far back as 1980, soon you won't be allowed to give blood at the American Red Cross.

The agency badly needs more donors, but last week it said it will stop accepting blood from anyone who has spent as little as three months in the United Kingdom or six months in Europe during the past two decades.

Such restrictions on blood donors stem from growing fears over the human form of "mad cow" disease. There's no proof that the brain-wasting ailment can be transmitted by human blood, but Red Cross officials don't want to take any chances with a disease that has decimated the British beef industry and claimed more than 100 human lives. The agency is resorting to such extreme precautions because there's still no test to detect the disease in blood.

"Without a test, we can't tell how big or how small the problem is," said Jacquelyn Fredrick, the Red Cross's senior vice president of biomedical services. "We have no test to determine if it's in the blood, how long it stays in the blood or how infectious it is."

The need for tests to detect the deadly disease -- which eats away at the brain tissue of its victims -- is generating a flurry of scientific investigation and entrepreneurial activity. Around the world, more than 20 companies, including two Maryland firms, are racing to develop better tests to identify the infectious particles believed responsible for mad cow disease, formally known as bovine spongiform encephalopathy (BSE), and its human form, the new variant Creutzfeldt-Jakob disease.

The demand for new tests is being fueled by the lack of medical and scientific knowledge about how the disease is contracted and spread, and exacerbated by the extended period of time it takes for symptoms to appear. Without hard evidence to the contrary, the possibility that the disease may be spreading among humans through blood transfusions, the food supply and the numerous consumer products derived from cow parts has created a mushrooming market for diagnostic products practically overnight.

In Europe, where the epidemic started, government officials have ordered that all cattle older than 30 months be tested before they can enter the food supply, creating a market for tests projected at $ 186 million this year. That market could grow if other countries follow Europe's lead. In the United States alone, human blood is donated more than 12 million times a year.

Existing tests to detect the disease in cattle require lab analysis of brain tissue after an animal has been slaughtered. A rush of new competitors believe they can design tests that not only are faster, cheaper and more reliable than those currently available but, more important, can detect the disease in living animals or humans.

Many companies, such as Prion Developmental Laboratories Inc., are trying to develop such a blood test. The Baltimore firm has enlisted the expertise of famed AIDS researcher Robert Gallo, whose co-discovery of the human immunodeficiency virus in 1984 led to the first blood test to detect the condition.

"There's an urgent need to get a blood test to find out how many Americans carry it, if any, and protect the blood supply," said Gallo, PDL's principal investigator, who also directs the University of Maryland's Institute of Human Virology in Baltimore. "Tests right now are too complex and tooinsensitive."

But jumping into the market for mad cow diagnostics is not without risks. So far, only Europe requires widespread cattle testing, and regulations could change if current measures halt the spread of the disease. And the disease has not appeared among cows or humans in the United States, so the market for testing here is still relatively speculative. Plus, the sheer number of companies that are now developing mad cow diagnostics raises the odds, as the market becomes crowded with competition.

Since it was first discovered in cattle in 1984, mad cow disease has devastated the European cattle industry and killed more than 100 people, mostly in Britain. The disease has been detected in about 200,000 cattle, but because of the lack of better diagnostic tests, more than 4.5 million animals have been slaughtered on suspicion they had the disease, at an estimated cost of $ 2.5 billion.

Mad cow disease and its human variant are believed to be caused by abnormal proteins called prions that cause normal proteins to fold into abnormal shapes. The misshapen proteins slowly accumulate in the victims' brain tissue, causing it to become spongy and full of holes. The disease's long latency period means many years, or even decades, can pass before an infected animal or human begins to show symptoms: dementia, loss of neurological control and finally death.

Most scientists believe that the humans who became infected did so after eating infected beef. Studies in laboratory animals have shown that mad cow disease can be transmitted in blood, but scientists are divided over whether it is transmissible in human blood.

Current tests can detect the disease only in its later stages, once a victim begins to show symptoms. That worries health officials because it means infected cattle may have entered the food chain, or been used in other consumer products, without detection. It could also mean infected humans may have donated blood not knowing they carried the disease.

In the absence of scientific certainty about the disease's transmission, proponents of testing see the ability to certify beef as disease-free as a competitive advantage in the global marketplace.

"Who do you want to buy from, a country that's tested or a country that hasn't tested?" asked Thomas Pringle, an authority on the disease who runs the Sperling Biomedical Foundation in Eugene, Ore. "You're talking about gigantic industries that have lots to lose, and a public that has a lot to lose, too."

Sensing a consumer revolt against beef and other cattle products, some major corporations are taking measures to preemptively stem a backlash against their products. In March, British grocery chain Sainsbury's announced it would start testing all beef supplied to its supermarkets.

"Everybody's scrambling to offer tangible evidence in the form of a negative test that their product isn't infected," Pringle said.

The competition to design a better test includes major diagnostic firms such as Bayer Diagnostics of Tarrytown, N.J.; Germany's Boehringer Ingelheim GmbH; and smaller biotechnology firms such as Caprion Pharmaceuticals Inc. of Montreal and Paradigm Genetics Inc. of Research Triangle Park, N.C.

In Gaithersburg, Igen International Inc. has announced plans to develop its own test, based on its Origen detection technology, which uses light-emitting compounds to indicate the presence of biological substances. The company has teamed up with a London start-up headed by British researcher John Collinge, who was among the first to link mad cow disease to its human version. The company hopes to have a test on the market by year's end.

In Baltimore, Prion Developmental Laboratories Inc. was launched in November to design "rapid, sensitive and inexpensive" tests to screen for mad cow and other prion diseases. Funded by New York investment firm Genesis Bioventures Inc., the firm is working with prion-disease researchers at universities in Ohio, New York and Maryland.

Current tests used in Europe, which include kits made by Prionics AG of Switzerland, Bio-Rad Laboratories Inc. of Hercules, Calif., and Enfer Scientific Ltd. of Ireland, require samples of brain tissue to be removed at the slaughterhouse and shipped to a laboratory for testing. None of the tests can detect the disease in live animals.

"Nobody's really satisfied with the old test," said Robert Petersen, PDL's chief scientific adviser and a pathologist at Case Western Reserve University in Cleveland. "It would be nice if someone had a simple blood test so you can test before you actually cut open the animal."

Unlike foot-and-mouth disease, another epidemic that has ravaged Europe's livestock industry, mad cow disease is not caused by a virus or bacteria, which are easier to detect in blood because the body creates antibodies to fight them.

To detect mad cow disease early, researchers must design a test that can distinguish between normal prion proteins and their rogue cousins, a major challenge for researchers. "You're looking for a gray straw in the middle of a large mass of yellow straw," Gallo said.

The Red Cross is starting to evaluate various tests to protect its blood supply, though it may be several years before one is ready, Fredrick said. Until then, the agency, which collects about half of the nation's blood donations, will have to rely on measures that screen donors based on risk factors, such as whether they've lived in Britain in the past 20 years. The agency is drawing up a policy now so restrictions can be put in place in September.

"The test is really the defining step in dealing with any public health issue and the public fear surrounding a disease," Fredrick said. "Obviously, what we really want is the information to find a cure for the disease."

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