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From: TSS ()
Subject: Japan vCJD case poses blood-donor concerns
Date: June 23, 2005 at 5:14 pm PST

Japan vCJD case poses blood-donor concerns


WASHINGTON, DC, United States (UPI) -- The case of a Japanese man who contracted the human form of mad cow disease might have widespread implications for the safety of the U.S. blood supply.
The man, who was in his 50s when he died last December, is thought to have contracted the fatal disease, known as variant Creutzfeldt Jakob disease, or vCJD, in 1990 during a stay of less than one month in the United Kingdom.

His stay coincided with the height of an outbreak of mad cow disease. Humans can contract vCJD from eating beef products contaminated with the mad cow pathogen.

This case could impact the U.S. blood supply because the man`s stay in England was much shorter than current restrictions on blood donations specify. The deferral period, established by the Food and Drug Administration, prohibits anyone from donating who spent three months or more in the United Kingdom between 1980 and 1996.

Consumer groups think the FDA should order one of its advisory committees to review the Japanese case and how it might impact the U.S. donor policy, but so far the agency has not moved in that direction.

"We review our policies on a periodic basis," FDA spokeswoman Lenore Gelb told United Press International. "In terms of any deferral decisions, it`s based on looking at how much risk reduction you`re going to get and how it will impact supply."

Gelb said the Japanese case has not been placed on the agenda of upcoming meetings of the two advisory committees that would handle it -- the Blood Products Advisory Committee, which meets next month, or the Transmissible Spongiform Encephalopathies Advisory Committee.

Mad cow is one of several diseases classified as transmissible spongiform encephalopathies, or TSEs.

More than 160 people worldwide have contracted vCJD, with most cases occurring in England. Health officials long have been concerned the deadly disease could be transmitted through blood transfusions. Their fears have been borne out in the last two years because two people who contracted vCJD through transfusions were detected in England.

The Japanese government previously had banned blood donations from people who had been in England for one month or longer. After the December case came to light, the government subsequently reduced the deferral period, banning donations from anybody who visited England for a day or more between 1980 and 1996. Now, there are concerns this could cause a blood-supply shortage in Japan, because it may have limited the pool of available donors too much.

The AABB, formerly known as the American Association of Blood Banks, whose members collect nearly all of the blood in the United States, said it was following the FDA`s lead, and so far the Japanese vCJD case has not caused it to consider changing its blood donation policies.

"Exposure (to mad cow) could be from the one time you ate the wrong piece of meat, so it`s always been recognized the policy is trying to maximize safety while not badly affecting availability," Dr. Steven Kleinman, senior medical adviser to AABB and affiliated with the University of British Columbia, told UPI.

It is possible "somebody who had been over there (the United Kingdom) in 1990 who is now in the United States could have (the vCJD pathogen) in their blood," Kleinman said, "but that`s the reason we have the deferral in place."

Michael Hansen, a biologist and senior research associate with the watchdog group Consumers Union, told UPI he thought the FDA should review its blood-donor ban. He added, however, that any new restrictions on blood donations would have to be balanced against the impact they would have on supply.

The Japanese case "is something that desperately needs to be looked at and debated, but we all have to realize there is a significant tradeoff that is important for people," Hansen said. Some patient groups, such as hemophiliacs, require blood products on a routine basis and may be willing to accept a small risk of acquiring vCJD vs. not getting therapies that are essential to them, he said.

Dave Cavenaugh, of the Committee for Ten Thousand, a U.S. hemophilia advocacy group, told UPI the concern over the deferral period may be moot, because he thinks vCJD already may have contaminated the U.S. blood supply.

"I think it`s here already in the blood supply -- not much, but some," Cavenaugh said.

Instead of focusing on the FDA, his group is trying to educate members of Congress about the risk.

"You can`t really apply pressure on FDA, but you can apply pressure on congressmen and senators that have oversight over FDA," Cavenaugh said.

Hansen said one option that would not reduce supply would be to label blood products that come from donors who spent time in England or other countries with mad-cow outbreaks.

"Having a label would be perfectly fine so people can decide for themselves," he said.

E-mail: sciencemail@upi.com

Copyright 2005 by United Press International



WASHINGTON, DC, United States (UPI) -- The case of a Japanese man who contracted the human form of mad cow disease might have widespread implications for the safety of the U.S. blood supply.

The man, who was in his 50s when he died last December, is thought to have contracted the fatal disease, known as variant Creutzfeldt Jakob disease, or vCJD, in 1990 during a stay of less than one month in the United Kingdom.

His stay coincided with the height of an outbreak of mad cow disease. Humans can contract vCJD from eating beef products contaminated with the mad cow pathogen.

This case could impact the U.S. blood supply because the man`s stay in England was much shorter than current restrictions on blood donations specify. The deferral period, established by the Food and Drug Administration, prohibits anyone from donating who spent three months or more in the United Kingdom between 1980 and 1996.

Consumer groups think the FDA should order one of its advisory committees to review the Japanese case and how it might impact the U.S. donor policy, but so far the agency has not moved in that direction.

"We review our policies on a periodic basis," FDA spokeswoman Lenore Gelb told United Press International. "In terms of any deferral decisions, it`s based on looking at how much risk reduction you`re going to get and how it will impact supply."

Gelb said the Japanese case has not been placed on the agenda of upcoming meetings of the two advisory committees that would handle it -- the Blood Products Advisory Committee, which meets next month, or the Transmissible Spongiform Encephalopathies Advisory Committee.

Mad cow is one of several diseases classified as transmissible spongiform encephalopathies, or TSEs.

More than 160 people worldwide have contracted vCJD, with most cases occurring in England. Health officials long have been concerned the deadly disease could be transmitted through blood transfusions. Their fears have been borne out in the last two years because two people who contracted vCJD through transfusions were detected in England.

The Japanese government previously had banned blood donations from people who had been in England for one month or longer. After the December case came to light, the government subsequently reduced the deferral period, banning donations from anybody who visited England for a day or more between 1980 and 1996. Now, there are concerns this could cause a blood-supply shortage in Japan, because it may have limited the pool of available donors too much.

The AABB, formerly known as the American Association of Blood Banks, whose members collect nearly all of the blood in the United States, said it was following the FDA`s lead, and so far the Japanese vCJD case has not caused it to consider changing its blood donation policies.

"Exposure (to mad cow) could be from the one time you ate the wrong piece of meat, so it`s always been recognized the policy is trying to maximize safety while not badly affecting availability," Dr. Steven Kleinman, senior medical adviser to AABB and affiliated with the University of British Columbia, told UPI.

It is possible "somebody who had been over there (the United Kingdom) in 1990 who is now in the United States could have (the vCJD pathogen) in their blood," Kleinman said, "but that`s the reason we have the deferral in place."

Michael Hansen, a biologist and senior research associate with the watchdog group Consumers Union, told UPI he thought the FDA should review its blood-donor ban. He added, however, that any new restrictions on blood donations would have to be balanced against the impact they would have on supply.

The Japanese case "is something that desperately needs to be looked at and debated, but we all have to realize there is a significant tradeoff that is important for people," Hansen said. Some patient groups, such as hemophiliacs, require blood products on a routine basis and may be willing to accept a small risk of acquiring vCJD vs. not getting therapies that are essential to them, he said.

Dave Cavenaugh, of the Committee for Ten Thousand, a U.S. hemophilia advocacy group, told UPI the concern over the deferral period may be moot, because he thinks vCJD already may have contaminated the U.S. blood supply.

"I think it`s here already in the blood supply -- not much, but some," Cavenaugh said.

Instead of focusing on the FDA, his group is trying to educate members of Congress about the risk.

"You can`t really apply pressure on FDA, but you can apply pressure on congressmen and senators that have oversight over FDA," Cavenaugh said.

Hansen said one option that would not reduce supply would be to label blood products that come from donors who spent time in England or other countries with mad-cow outbreaks.

"Having a label would be perfectly fine so people can decide for themselves," he said.

E-mail: sciencemail@upi.com

Copyright 2005 by United Press International

TSS




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