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'Mad cow' tainted blood a risk
Expert: 'Might be 21st century's AIDS epidemic'

September 22, 2002 Connecticut Post by Marian Gail Brown mgbrown@ctpost.com
All those pleas that blood banks make when supplies dwindle spurred Doug McEwen to roll up his sleeves not once, not twice but more than a dozen times to donate blood.

McEwen, a rugged guy who enjoyed hunting deer and eating game, had a good job in Salt Lake City and a solid future. He was 29 years old with a wife, two young children and a new house the couple's first under construction. He felt blessed with a good life. And partly because of his Mormon upbringing, he tried to help others by donating blood.

He's dead now. And his generosity haunts his surviving relatives. That's because they fear that through a transfusion someone else might contract what killed McEwen

Creutzfeldt-Jakob disease, an always-fatal condition caused by mutated prions. It's the same protein linked with "mad cow" disease and its human form in Great Britain, a new variant of Creutzfeldt-Jakob disease.

"This might be the 21st century's own AIDS epidemic," says John Stauber, co-author of Mad Cow USA. "That's how massive an epidemic we face."

It seems that "more could have been done" says Kay McEwen, his mother, from her home in Salt Lake City. "I don't think they knew what they were doing with him," she says of the neurologists and disease detectives who have studied slivers of her son's brain since his death in 1999. Part of their aim was to determine whether McEwen consumed venison infected with chronic wasting disease, a neurologic prion disorder in deer and elk, similar to mad cow, that has spread in some parts of Colorado, Wyoming, Michigan and Wisconsin.

"Now I think they are trying to ignore it," as if it didn't exist and isn't any problem, McEwen says, her voice cracking. "I'm sorry but it's gotten so I can't talk about it."

Voluntary recall

Eventually all those pints of McEwen's blood were pooled with donations from as many as 60,000 other people. Then it was divvied up into countless plasma products that Bayer corporation, with facilities in West Haven, Conn., and Raleigh, N.C., shipped before the U.S. Food & Drug Administration suggested a "voluntary recall" of McEwen's plasma.

"We treated it as if all the plasma we had [on hand], all the inventory and products could be implicated. Everything was put on hold," says Stephen R. Petteway Jr., vice president of research and pathogen safety at Bayer's biological products division. "We stopped everything that we were doing with it."

Bayer began a rigorous self-examination of its plasma purification process convincing both itself and the FDA that its processing and in-house testing were capable of filtering out prions, lowering the chances of infection by 100,000-fold or more than 99.99 percent.

Chances remote

But what of those other products the pharmaceutical company generated from McEwen's blood that already were distributed? Are prions quietly circulating in somebody else's blood undetected?

Michael Hansen, a scientist with Consumers Union, says Bayer informed McEwen's family that his blood potentially was already in 120 separate plasma products by the time McEwen became aware of his condition.

Pathologists, hematologists and policy experts all say the chances of blood tainted with prions can pass from one person to another are remote.

"There is simply no evidence that the disease can be transmitted through blood transfusion," says Dr. Ritchard Cable, medical director of the American Red Cross Blood Services-Connecticut. Nevertheless, Cable acknowledges that it is possible for prion-laced blood to be circulating through blood banks because there is no diagnostic test to detect its presence in blood.

The safeguard against prion-laced blood getting into the nation's blood supply is a checklist about a donor's travel patterns to the United Kingdom and other parts of Europe, where outbreaks of prion disease have occurred. Depending on how much time they've spent in those places, they could be banned from donating blood for life.

"There is a concern that it might be transmitted through blood. [But] that's based on theoretical risk because it's a new disease and the agent [that causes it] has been found outside the brain, in the appendix, the spleen and the tonsils," says Dr. Ermias Belay, a medical epidemiologist with the federal Centers for Disease Control and Prevention.

Yet, if the risk of transmission through blood is really only "theoretical," why ban blood donations from travelers who have spent lengthy periods in the United Kingdom and Europe between the 1980s and 1990s during its mad cow epidemic? Belay, who oversees the CDC investigation into suspected cases of human prion diseases, believes science and public policy support the FDA's ban on blood from those potential donors.

Long incubation

"If you wait until you have evidence of the transmission [of prion disease], you will be way behind the curve on this," Belay says. "And with the long incubation period, it means a lot of [human] exposure." Rather than waiting for that, he says, "the FDA wanted to be proactive."

The incubation period for Creutzfeldt-Jakob disease runs anywhere from a decade or so, in the British new variant form diagnosed in young people, to up to 30 years for the classic or genetic variety that often doesn't materialize until someone reaches their 60s or 70s. For the sporadic version, the kind McEwen was diagnosed with, the incubation period is believed to be somewhere in between.

Scientists are looking for any evidence of chronic wasting disease in hunters with CJD who handled or consumed contaminated deer or elk meat, Belay says. "And whatever limited data we have, we don't have evidence of transmission to humans. It doesn't mean it has never, ever happened."

Meanwhile, the British government is considering banning anyone who has ever had a transfusion from donating blood after new research in the UK indicates that mad cow disease can pass through the blood of one animal to another. The Institute of Animal Health in London found that one in six animals that received blood from sheep infected with scrapie, a sheep-version of mad cow or bovine spongiform encephalitis, developed the disease. The institute will publish its research in November in the Journal of General Virology.

"In the 1980s, AIDS was something that could have been controlled, but wasn't," says Stauber, the co-author of the book "Mad Cow USA."

"If chronic wasting disease moves into people and I think it already has what if CJD is transmissible through bodily fluids as it is in deer? It's like another version of AIDS. And what if it spreads like a cold or the flu through the air," Stauber says. "Again we don't know that, but is it better that we sit on our hands or dive in and commit resources to investigate this disease?"

"If blood comes from a donor who has a TSE disease, there is definitely a possibility" they could transmit it, Stauber says. "That's why Great Britain no longer uses its own blood plasma."

The federal "government's policy is show us the dead bodies. But we're not gonna look too hard," Stauber says. "At this late stage of the game, the federal government's inability to address TSE risks in the United States is terrifying."

Altogether, the U.S. has spent more than $27.6 million since 1999 probing prion disease, marshaling the forces of the CDC, the National Institutes of Health, the FDA, the U.S. Department of Agriculture and the recently established National Prion Disease Pathology Center at Case Western Reserve University in Ohio.

Nevertheless, the FDA already has evidence in its files of patients contracting Creutzfeldt-Jakob through tissue transplants. That's because the equipment hospitals use to sterilize surgical instruments can't reach temperatures high enough to break down or destroy prions.

In many ways, prions are more deadly than cancer cells or viruses. Because they are not alive, even though they can replicate, radiation and chemotherapy do nothing to halt their spread.

Creutzfeldt-Jakob occurs naturally in about one in a million people. Some people are born with it, but it lies dormant until they reach old age.

Rarity probed

A Yale University research project, however, casts some doubt on the rarity of Creutzfeldt-Jakob. In the early 1990s, Yale University neuropathologists studying Alzheimer's disease autopsied 46 patients to learn more about that devastating brain-wasting disease. The researchers expected the autopsies to confirm the Alzheimer diagnosis.

Yale discovered that 13 percent of those "Alzheimer" patients actually had Creutzfeldt- Jakob disease.

"We were surprised actually that they turned out to have CJD. We didn't expect that," says Dr. Laura Manuelidis, a neuropathologist at Yale University who heads its research into neurodegenerative diseases. In the 1970s, Manuelidis and her team were the first researchers in the country to transfer CJD from humans into guinea pigs. It took 550 days for the first generation of rodents to become sick. And with each new generation the disease became more virulent, killing the guinea pigs in as few as 180 days.

Findings such as Yale's give experts like Dr. Norman L. Foster, associate director of the Michigan Alzheimer Disease Research Center, cause to fear that Creutzfeldt-Jakob and other transmissible spongiform encephalopathies are vastly underreported.

Foster, a professor of neurology at the University of Michigan at Ann Arbor, believes epidemiologists should reexamine all reported cases of viral meningitis and encephalitis cases as possible TSE cases.

"There must be far many more young people with TSEs than previously thought. We reported two cases at the University of Michigan in people under 30 and both had prion diseases that suggest that this may be more frequent than usually suspected," Foster says. "Without a [brain] biopsy, these cases could easily be ascribed to some other disease such as encephalitis or a meningitis."

For now, the only completely reliable way of determining whether a patient has Creutzfeldt-Jakob disease is through an autopsy. Although physicians are encouraged to report unusual diseases, many states do not require them to document cases of CJD with state health departments. Moreover, many states, such as Connecticut make CJD reportable only for patients under 55 years old. That's because it's assumed that anyone older than that is one of the one-in-a million people born with the disease, as opposed to acquiring it from the environment.

"The real problem is, we do not have an effective system in the United States for surveillance of these kinds of diseases," Foster says. "Too often these cases are not fully investigated."

FDA blasted

And because mutated prions appear to be concentrated in the brain until the end stages of the disease some experts believe the chances of acquiring the prion disease through a blood transfusion are slim. But are those odds really that small?

In 1997, the General Accounting Office analyzed the Food & Drug Administration's oversight of the nation's blood supply and found it anemic. The GAO discovered that the FDA did not require unlicensed blood collection facilities centers that do exchange blood across state lines to report errors and accidents in how blood is handled. These facilities account for two-thirds of the nation's blood collection facilities and contribute about 10 percent of the nation's blood-products inventory.

"Moreover, the FDA's inspection for both licensed and unlicensed blood facilities appear to be inconsistent in focus, scope and documentation," the GAO inspectors told Congress. "In addition, these inspections are often not conducted within time periods set by the FDA's own guidelines. Furthermore, the FDA does not maintain a central repository for its inspection reports."

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