라이오듀라(Lyodura)

- 뇌 경막 이식수술에 사용한 제품으로 CJD를 감염시킨 것으로 보임.
- 독일에 본사를 둔  B. Braun Melsungen AG의 제품으로 1969년부터 출시.
- 사체의 뇌 경막조직을 동결건조시켜 장기간 보관을 가능하게 했으며, 물에 몇 분만 적시면
간편하게 사용할 수 있음.
- 인간 사체를 부검한 후 뇌 경막을 수거.
- CJD와 연관성 확인된 후 불법적인 방법으로 뇌 경막 조직을 수거한 사례 조사.
- 제조사 측에서는 고열 소독 과정을 거친 후 조직을 냉동건조시키기 때문에 CJD감염 조직과 다른 조직의 교차오염의 가능성이 없다고 주장하고 있음.
- 일본에서는 2009년 이후 뇌경막 수술에 의한 CJD 감염이 138건 보고됨.(시술환자 20만 이상인 것으로 알려짐)
- 캐나다에서는 현재 사용이 금지됨.
- 일본에서는 1997년 이후 사용이 금지됨. 2000년 조사결과 일본에서 뇌경막 수술을 받은 사람이 20만명에 이르는 것으로 밝혀짐. 유럽에서 사용금지된 재고품이 아시아지역에서 판매되어 사용되었을 것으로 추정됨.
- 식약청 발표로는 한국에서는 1987년 이후 라이오듀라 제품이 사용된 바 없다고 함. 일본에서 1997년 사용금지 조치가 실시되었는데… 한국에서는 언제 사용금지 조치를 내렸는지 규명해야 함. 재고품의 사용여부도 확인해야 함.
- 현재 국내에서 사용되고 있는 제품은 라이오플란트(Lyoplant) : 라이오듀라를 제조한 회사에서 출시한 새로운 상품으로 소의 심막을 원료로 만든 것임. 이 원료가 광우병에 감염되었을 경우 인간광우병에 감염될 우려가 있음. 식약청에서는 수입 통관 시 마다 전염성해면상뇌증 미감염증명서 제출을 의무화하고 있다고 밝히고 있음.
(바이오플란트 제품 소개 : http://www.bbraun.com/cps/rde/xchg/bbraun-com/hs.xsl/products.html?prid=PRID00000805 )
- 라이오듀라 이식수술을 받은 환자 실태조사 및 역학조사, 라이오듀라 이식수술 환자 중 헌혈 사례 조사 및 이로부터 헌혈을 받은 사람들에 대한 역학조사, 라이오듀라 이식수술 환자가 수술 받은 병원에서 비슷한 시기 같은 수술도구로 수술을 받은 환자들에 대한 역사조사 등등

- 관련 문학작품 : 아름다운 13월의 미오카 
이시다 이라 지음, 최선임 옮김 / 작품 / 2009년 4월



라이오듀라(Lyodura)

Lyodura was a medical product used in neurosurgery that has been shown to transmit Creutzfeldt-Jakob disease, a degenerative neurological disorder that is presently incurable, from affected donor cadavers to surgical recipients. Lyodura was introduced in 1969 as a product of B. Braun Melsungen AG, a leading hospital supply company based in Germany.

The product was used as a quick and effective patch material for surgery on the brain. It was a section of freeze-dried tissue which could be stored for extended periods on hospital shelves and could be made ready for use simply by soaking it in water for a few minutes.

What was not known by the consumer was the origin of the source material, the efficacy of its processing methods, and the danger of its use.

The raw material for Lyodura was the dura mater of a human cadaver. The tissue would usually be harvested during an autopsy and then sold to the manufacturer. After neurological diseases were linked to use of Lyodura, an investigation determined that the manufacturer had obtained the donor tissue by black market methods. Autopsy staff would remove the tissue from cadavers, regardless of whether the deceased’s family had agreed to an autopsy or not, and sell it in quantity to representatives of the manufacturer. Due to this illegal method of collection, no record of patient history accompanied the tissue to production.

Large quantities of the harvested tissue would be mass sterilized in a heated vat. The tissue would then be freeze dried and packaged for purchase. The manufacturer believed that its sterilization procedure was sufficiently powerful to render any tissue harmless and was therefore unconcerned about cross-contamination from CJD-containing tissue to other tissue in the same sterilization vat. It is now believed that almost all Lyodura product was tainted with Creutzfeldt-Jakob disease through this process.

An award-winning documentary was produced on the subject. CBC’s The Fifth Estate segment, Deadly Harvest, dealt with the product’s history, sale in Canada, and health effects worldwide. According to the documentary, there have been more than 70 CJD-related deaths in Japan since Lyodura’s distribution. The product has since been banned for use in Canada.

FDA urged to ban feeding of chicken feces to cattle

Food and consumer groups say the practice increases the risk of cattle becoming infected with mad cow disease. A beef industry trade group say a ban isn’t needed.

By Jerry Hirsch
 
출처 : LA타임즈 October 31, 2009
http://www.latimes.com/business/la-fi-feed31-2009oct31,0,1227725.story?track=rss

A fight is brewing over the practice of feeding chicken feces and other poultry farm waste to cattle.

A coalition of food and consumer groups that includes Consumers Union and the Center for Science in the Public Interest has asked the Food and Drug Administration to ban the practice. McDonald’s Corp., the nation’s largest restaurant user of beef, also wants the FDA to prohibit the feeding of so-called poultry litter to cattle.

Members of the coalition are threatening to file a lawsuit or to push for federal legislation establishing such a ban if the FDA doesn’t act to do so in the coming months.

Farmers feed 1 million to 2 million tons of poultry litter to their cattle annually, according to FDA estimates.

Using the litter — which includes feces, spilled chicken feed, feathers and poultry farm detritus — increases the risk of cows becoming infected with bovine spongiform encephalopathy, or mad cow disease, said Michael Hansen, a senior scientist at Consumers Union.

That’s because the spilled chicken feed and the feces contain tissue from ruminants — cows and sheep, among other mammals. The disease is transmitted through feeding ruminant remains to cattle.

“It takes a very small quantity of ruminant protein, even just 1 milligram, to cause an infection,” said Steve Roach, public health program director with Food Animal Concerns Trust, a Chicago-based animal welfare group that is part of the coalition.

Although it is rare, people can contract a fatal form of the disease by eating meat from cows with BSE.

The National Cattlemen’s Beef Assn., the beef industry’s main trade group, said the ban was not needed and that several FDA reviews had determined that the chance of cattle becoming infected with mad cow disease from eating poultry litter was remote.

“Science does not justify the ban, and the FDA has looked at this now many times,” said Elizabeth Parker, chief veterinarian for the trade group.

Parker noted that the FDA this year banned the use of certain types of tissue from any form of animal feed, even that eaten by chickens. Those tissues include brain, spinal cord material and other high-risk tissues where the pathogens believed to cause mad cow disease typically are found. The tissue ban greatly reduces chances that prions, implicated in mad cow, can find their way into the food chain, Parker said. She also said the disease was not a threat to public health.

“We have tested 800,000 cattle in recent years and have not found any evidence of BSE circulating in the herd,” Parker said.

But others remain concerned.

“I still think you need to totally restrict using any ruminant protein in feed that gets back to ruminants,” said Linda Detwiler, a food safety consultant and former U.S. Department of Agriculture veterinarian.

Prohibiting high-risk tissues as a feed source makes the chances of transmitting mad cow disease through poultry litter low but does not remove all risk, Detwiler said.

The practice also makes McDonald’s, one of the nation’s biggest beef purchasers, nervous. “We do not condone the feeding of poultry litter to cattle,” it said in a statement.

The issue has kicked around since the first U.S. case of mad cow disease was discovered almost six years ago in an animal imported from Canada. There have been two known indigenous cases of mad cow infections in domestic cattle since then, but both were in animals born before the enactment of stricter regulation of feed.

Generally, the FDA has left the decision on whether to feed cattle poultry litter up to state regulators. California allows the practice with one exception: Poultry litter is banned in feed for lactating dairy cows.

In 2004, the FDA announced its intention to prohibit the use of poultry litter in cattle feed, but after reviewing the proposed ban decided against it. The agency said its rules prohibiting the use of high-risk tissues in all animal feed were sufficient to keep mad cow pathogens from reaching poultry feed. The FDA also said there was little risk to human or cattle health from the other components of poultry litter.

“With respect to pathogenic microorganisms, drug residues and contaminants in poultry litter, FDA is not aware of any data showing that the use of poultry litter in cattle feed is posing human or animal health risks that warrant restrictions on its use,” the agency said.

But Hansen, the Consumers Union scientist, said that besides the mad cow risk, the feed can contain disease-causing bacteria, antibiotics and even foreign objects such as dead rodents, rocks, nails and glass.

Such hazards are not eliminated by any processing of the feed that might occur, he said.

Feeding farm animals feces may sound gross, but it goes back to the dawn of animal agriculture, said Dean Cliver, professor emeritus of food safety at UC Davis.

“In the old days when people had mixed farms, what came out the back end of the cows was eaten by pigs, and what came out the end of pigs was eaten by chickens. That was the natural way of farming,” he said. “Anything that hit the ground was fair game.”

jerry.hirsch@latimes.com

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