>FDA Restricts Blood Donations
Canada bans 6 month blood, UK residents
Blood banks fret over shortages
FDA: revised blood guidlines dated 16 Aug 99
Prions stick to stainless steel surgical instruments
US Senators push for warning labels on French wine
Religious groups push for FDA labels on Frankenstein foods
Saudi Arabia rejects South African beef citing BSE
Future costs of BSE epidemic staggering
British ranchers see long road back
Reluctant Australia considers British blood ban
Japan may join ban on British blood donors; Germany hasn't
Feed scare: EU may extend dioxin testing on Belgian exports
18 Aug 99 press accountsComment (webmaster):
With this many millions of Americans and Canadians exposed and possibly incubating disease for 15 years already, it is only a matter of time before nvCJD manifests itself in NortH America in a person who has already given blood. Note that residents of England would have a much higher cumulative exposure over the years than the average tourist.
The real issue here is whether FDA or the committee really got the straight dope from Britain. Obviously, since they started the tonsil studies 18 months ago, they have an excellent idea of the extent of the epidemic by now. And since MJ Schmerr went to Europe this spring, giving her talk on direct detection of rogue prion in blood which she has been testing in humans for the last 18 months; direct data is probably available, again with nothing released to the public. So FDA actually has an excellent idea about prions in the blood supply by now.
The blood banks and others will aggressively oppose early publication because once they know or should have known, the liability kicks in, given that they will continue to sell product. Which brings us to the constant drumbeat of stories of greater harm coming from public panic, deferred liposuction, and the like:
Yesterday we saw speculation about how the greater harm on vaccine was going to come to kids affected by these historic diseases because they didn't get their shots, not to the tens of millions of kids injected with fetal BSE calf serum in vaccines.
Sir John Pattison, the chairman of the government's scientific advisory body on the disease, said it would take a decade to know the full impact of the crisis. ``We, as a population, are in deep trouble,'' he said. ``That is why the range of possible numbers of variant CJD still goes from something not very different from the numbers we have at the moment to six- or seven-figure numbers.''
His remarks led another panel member, David Pepper, to warn that the chance of such comments causing ``alarm and despondency and maybe even worse are quite high.''
The Peppers of this world are in control of the data at this point -- people up to their ears in guilt are determining the public interest. Most conveniently, the hypothetical panic scenario protects, or delays accountability, for those who took beef exports as the one and only goal of public policy. After thousands of scare headlines in British tabloids over the last 15 years, who could panic at this point?
18 Aug 99 The Associated Press By LAURAN NEERGAARDWASHINGTON - Some Americans who visited Britain frequently at the height of that country's mad-cow-disease scare will be banned from donating blood back home, the government decided today.
Britain is one of American tourists' top destinations, and today's decision by the Food and Drug Administration will affect only a small portion of those travelers: Americans who have spent a total of six months in Britain since 1980. The average tourist who spent just a few weeks in Britain can still donate blood, the FDA said. Blood experts say that in the U.S., the ban will affect as many as 285,000 people, or 2.2% of the nation's donors. Another 25,000 will be affected in Canada.
Canada is issuing similar restrictions today, said the FDA, which worked with that country as well as top U.S. blood experts in developing the policy.
There is no evidence that any mad-cow-type illness has been spread through blood transfusions. But because mad-cow disease has been linked to a human brain destroyer in Britain, federal health officials decided the blood donor ban was an appropriate precaution.
The decision, which blood banks have expected all summer, was controversial because the United States is poised for blood shortages. Blood donations already have been falling, and the American Red Cross says the new policy will cut the U.S. blood supply by 2.2 percent.
At issue is an infection that kills by literally eating holes in brain tissue. In cows, it's called mad-cow disease, and from the late 1980s through 1996, British cows suffered an epidemic.
About one in 1 million people around the world gets a similar brain disease called Creutzfeldt-Jakob disease, or CJD. Although CJD sometimes is hereditary, usually its cause is not known.
The worry about blood stems from Britain's discovery in the mid-1990s that some people caught a new variety of CJD apparently by eating beef infected with mad-cow disease. Named ``new variant CJD,'' it has killed 41 Britons. There is no known mad-cow disease in U.S. cattle, the United States has not allowed importation of British beef for over a decade and no American has caught new variant CJD.
But because these brain diseases can incubate for years without causing symptoms, some scientists say the possibility exists that years from now they will discover a link between blood transfusions and infection.
U.S. blood banks will have six months to phase in the ban on donations by Americans who spent a total of six months in Britain between Jan. 1, 1980, and Dec. 31, 1996 - when Britain began destroying mad-cow-infected herds. The ban covers travelers to England, Scotland, Wales, Northern Ireland, the Isle of Man and the Channel Islands.
Reuters North America Tue, Aug 17, 199 By Lisa Richwine9ROCKVILLE, Md. The U.S. government Tuesday ordered U.S. blood banks to ban donations from people who visited Britain frequently during the mad cow disease outbreak. The Food and Drug Administration said it was taking the step to prevent the possibility that donors who ate tainted British beef could pass along the human version of mad cow, a fatal degenerative brain disorder, through blood transfusions.
The FDA, based in Rockville, Maryland, issued a statement calling the move "a precautionary measure." No case of mad cow disease or its human equivalent has ever been documented in the United States, and scientists do not even know if the disease can be transmitted through the blood. "No evidence exists that the disease has been transmitted by blood transfusion, but current studies cannot exclude this possibility," the FDA said.
But because of the possibility, the FDA ordered U.S. blood banks to turn away potential donors who spent six months or more in Britain between 1980 and 1996. The blood banks are expected to adopt the recommendation within six months, the FDA said.
The American Red Cross estimated that 10.7 percent, or 1 million units, of the current blood supply would be lost if people who had lived or traveled in Britain could not make donations. The FDA said Canada's health ministry was expected to make a similar recommendation Tuesday.
Mad cow disease, or bovine spongiform encephalopathy, peaked in Britain in 1992, and officials there have taken steps to make the blood supply safer. The disease's human equivalent is called new variant Creutzfeldt-Jakob disease. Mad cow disease swept through British herds in the mid-1980s. Its spread was helped by the practice of giving healthy animals feed made partly from the remains of animals that had carried the disease. The use of dead animals in feed has since been banned.
Health and agriculture officials believed the disease was harmless to humans until cases of new variant Creutzfeld-Jakob disease started to be found. The incurable and fatal disease is caused by a misshapen protein known as a prion, which has been found in a range of tissue, including the brain, lymph nodes and spleen, and has also been traced to the blood.
The issue of whether to ban donations of blood from people who may have eaten tainted beef has been under consideration for some time. In December 1998 an FDA advisory panel recommended the government consider barring blood donations from people who lived in or visited Britain during the epidemic.
British beef returned to European markets this month, ending an export ban imposed in March 1996. 14:13:20 EDT Subject: Travelers' Blood Donations Limited MIME-Version: 1.0 Content-Type: text/plain; charset="us-ascii" Content-Transfer-Encoding: 7bit X-Mailer: Unknown (No Version) To: undisclosed-recipients:;
Tue, 17 Aug 1999 The Associated Press By LAURAN NEERGAARDWASHINGTON ( - Some Americans who traveled frequently to Britain during that country's mad cow disease crisis are being banned from donating blood back home - a restriction that will cut the U.S. blood supply during a critical time of shortage but one the government deems a necessary precaution. The Food and Drug Administration on Tuesday imposed the ban on blood donations by anyone who has traveled to, or lived in, Britain for a total of six months since 1980. The average tourist who spent just a few weeks in Britain can still donate blood - but people who went to Britain repeatedly between 1980 and 1997, the crisis years, will have to add up their trips to see if they're under the six-month limit. Canada issued a similar restriction Tuesday.
The donor ban is strictly a precaution - there is no evidence that any mad cow-type illness has been spread through blood transfusions. But the mad cow disease that swept through Britain's cattle has been linked to a human brain-destroying illness, and both illnesses are so mysterious that scientists simply can't rule out the possibility they could infect blood.
Still, the FDA's donor ban is controversial. It is sure to frighten Americans whose blood is refused.
Worse, the American Red Cross estimates the ban will cut U.S. blood donations by 2.2 percent at a critical time. Even before Tuesday's action, experts were predicting severe, nationwide blood shortages to hit as early as next year because blood donations already were falling. As many as 200,000 to 250,000 blood donors could be turned away by the new ban, said James MacPherson of America's Blood Centers, which represents blood banks that provide half the nation's supply. Because people in the Northeast and large cities travel more than people from other parts of the country, areas such as New York could be hard hit.
``We certainly do not intend by this to scare people,'' said Mary Elizabeth Jacobs, the FDA scientist who coordinated the policy's development.
The FDA plans to work with blood banks to find ways to ease the donor loss, but MacPherson said the government also needs to help blood banks explain the issue to the confused or frightened donors they turn away. ``It's going to be an extremely difficult issue for people to understand,'' he said.
At issue is an infection that kills by literally eating holes in brain tissue. In cattle, it's called mad cow disease, and it swept through British herds starting in the late 1980s. About one in 1 million people around the world gets a similar brain disease called Creutzfeldt-Jakob disease, or CJD. Although CJD sometimes is hereditary, usually its cause is not known.
The worry about blood stems from Britain's discovery in the mid-1990s that some people apparently caught a new strain of CJD by eating beef infected with mad cow disease. Named ``new variant CJD,'' it has killed 41 Britons. There is no known mad cow disease in U.S. cattle. The United States has not allowed importation of British beef for over a decade and no American is known to have caught new variant CJD. But because these brain diseases can incubate for years without causing symptoms, some scientists say the possibility exists that they'll one day discover a link between blood transfusions and infection.
Much is not known about the new human disease, including exactly how Britons were sickened. Theoretically, even a brief visit to Britain could have exposed someone to new variant CJD. But the FDA settled on the six-month limit to reduce the possible risk without slashing the U.S. blood supply; banning donors who spent less time in Britain would have had a far greater impact. The ban covers travel to or residence in England, Scotland, Wales, Northern Ireland, the Isle of Man and the Channel Islands.
18 Aug 99 press accountsComment (webmaster):
The main tonsil publication is from Collinge's group, which appeared in Lancet 1999 Jan 16;353(9148):183-9," Investigation of nvCJD with tonsil biopsy samples". Results from study were well in hand 8-15 months prior to physical appearance in print (and well known to government).
The fortuitous appendectomy in one nvCJD victim iln September 1995, eight months before displaying signs of nv-CJD [numbness in face and right hand in May 1996] and 33 months before death in June 1998, presented somewhat of an opportunity to determine the scope of the epidemic. Samples from the yearly 44,000 appendectomies and 800,000 tonsillectomies are kept by hospital laboratories; samples go back to 1920 in some cases. Once again we are reminded of AIDS. We do not know how much earlier than eight months rogue prion can be detected, whether it is a reliable predictor of if and when a person will develop nvCJD, or whether it is necessarily indicative of nvCJD as sometimes claimed.
Keep in mind that government and committee insiders have easy access to work in progress. The political furor over whether Collinge could or should even undertake this study or other surveys (such as sheep) goes back earlier (and was settled by grant money available outside the system, from Wellcome Trust, though it was never clear that DoH would release the tonsil samples).
Obviously it is no problem for a small group to look at a 1000 samples per week -- the repetitive work is done by entry level lab techs. It's all a question of how badly you want to know (or if you want to know at all).
But if it is arranged that nobody can know through holding back samples and grants etc., that solves the problem of leaks and coverups. And that has been the backbone of British policy throughout this whole mess.
So far 43 Britons have died of nvCJD, believed to have been caused by eating beef from animals infected with Bovine Spongiform Encephalopathy or mad cow disease. The disease causes progressive wasting of the brain. Officers at Health Canada will announce the donor ban in Ottawa Tuesday, the Ottawa Citizen and the Toronto Star report in Tuesday editions.
Under the plan, the six-month cut-off will be the minimum requirement that Canada's two blood agencies must follow. The Canadian Blood Services, which collects and delivers blood everywhere expect Quebec, will adopt the minimum standard. All potential donors who have cumulatively spent six months or more in Britain from 1980 though 1996 will be banned from giving blood.
The blood agency says the new policy will exclude about three per cent of its 600,000 donors, with the impact being felt hardest in cities like Vancouver and Toronto.
Hema-Quebec is poised to ban donations by anyone who has spent a month or more in Britain. The Quebec agency believes it can withstand the more stringent standard because far fewer of its donors have visited Britain.
Health Canada is giving both agencies until Feb. 1 to implement the policies, although their new programs may be in place as early as this fall, the newspapers report. A similar policy was announced by the U.S. Food and Drug Administration.
For months, there has been pressure on Canadian regulators to move in tandem with the U.S. About half of all plasma contained in blood products used by Canadians - ranging from hemophiliacs to cancer victims - comes from U.S. plasma donors.
Erma Chapman, president of the Canadian Hemophilia Society, said she was pleased with the decision reportedly being taken by Canadian regulators. "We're very supportive of the policy," Chapman said. "It's a step forward in safety for Canadians."
Durhane Wong-Rieger, a former head of the hemophilia society, resigned as a consumer representative on the CBS to protest the lack of resistance by the group to the proposed ban. Wong-Rieger complained the policy was being rushed through although there was only a hypothetical risk that nvCJD may be blood borne. As a result, there will be a major blood shortage and Canadians who rely on the blood supply could lose their lives, she warned.
However, Chapman said the six-month cutoff is a reasonable compromise and she is hopeful that shortages can be averted through a "very aggressive campaign" to recruit new donors to replace those who are lost.
Reuters North America Tue, Aug 17, 1999OTTAWA - No one who lived in Britain for six months or more from 1980 to 1996 will be permitted to give blood in Canada, the Canadian government said Tuesday, as it bids to squelch the threat of mad cow disease. Canada's health department ordered Canadian Blood Services, which collects and delivers blood everywhere in Canada except Quebec, to implement the ban on September 30.
The agency said it supports Health Canada's decision but remains concerned about maintaining a proper supply of blood. It said it will lose 3 percent, or at least 20,000 bags, of its donated blood a year in the bid to curb the risk of infecting Canadians with Creutzfeldt-Jakob Disease. Creutzfeldt-Jakob Disease is believed to be caused by eating beef infected with bovine spongiform encephalopathy or mad cow disease.
Mad cow disease swept through British herds in the mid-1980s. Health and agriculture officials said it was harmless to humans until strange cases of the human version of the disease emerged in 1995. The incurable and fatal disease is caused by a mutated version of a protein known as a prion, which has been found in a range of tissue, including the brain, lymph nodes and spleen, and has also been traced to the blood.
Health experts say that, in theory, blood donors in countries where mad cow disease has been found may be at risk of transmitting the human equivalent. Authorities have not confirmed a human mad cow case in North America, but 43 case have been identified in Britain and one in France.
"We don't feel we can wait until all the evidence is in and make a very clear simple statement, because by then who knows what might have happened," Dr. Harvey Schipper, a Canadian Blood Services board member said at a news conference Tuesday. "We must err on the side of caution in this case," he said.
The U.S. Food and Drug Administration also recommended Tuesday a similar restriction on donors who have spent six months or more cumulatively in the United Kingdom from 1980 through 1996. A three-year-old European ban on British beef was lifted last month.
Hema-Quebec, the nation's other blood agency, plans to bar blood from people who have spent only a month in Britain. The Quebec agency said it can afford a more stringent standard since fewer of its donors visit Britain.
"We are relying on the generosity and dedication of Canadians now, more than ever," said Lynda Cranston, chief executive of Canadian Blood Services. "We don't know absolutely for sure what the effect will be," Cranston said when asked whether a loss of blood supply would immediately affect surgeries. She added that a contingency plan to support a flood of lost blood is in the works, but its cost was unknown.
The Canadian agency said only 5 percent of Canadians donate blood. In an attempt to recruit fresh donors, it has launched television and radio advertisement aimed at youth. "Nobody knew about this disease a few years ago," Schipper said. "So we're all going to have to live with some uncertainty."
BW HealthWire Aug. 17, 1999BRAINTREE, Mass. Today, the Food and Drug Administration as well as Health Canada issued guidance to each nation's blood collection agencies which prohibits them from collecting blood from anyone who has visited the United Kingdom for an extended period of time since 1980.
This guidance may reduce by as much as 2.2%, or 286,000 units, the amount of blood donated in the U.S. each year. Additionally in May, the National Blood Data Resource Center ("NBDRC"), predicted that the United States' need for blood would exceed its supply by 249,000 units next year.
In effect, there is a potential blood shortage of more than 500,000 units which may pose a problem as great as any other we face in the year 2000. This is particularly alarming given statistics shown by a 1998 Nationwide Blood Collection and Utilization Survey conducted by NBDRC which showed that as early as 1997, because of blood shortages, 9% of hospitals had to cancel surgical procedures and 25% were unable to meet their non-surgical blood needs on one or more days.
The FDA has approved technology from Haemonetics that allows blood centers to safely collect twice as many red blood cells from one donor as they can collect with traditional manual techniques. By using this technique, known as apheresis, blood banks will be better able to meet blood supply needs, even if the donor population continues to shrink every year because of tighter FDA guidelines.
Apheresis is not new. It was pioneered by Haemonetics in the 1970s for collecting platelets and then plasma. What is new is the ability to use apheresis to collect red blood cells, the most frequently needed blood component. More than 40 million red cell units are transfused annually worldwide.
Dr. Harvey Klein, Chief of Transfusion Medicine at the National Institutes of Health, said, "This FDA directive has the purpose of reducing the risk of transmitting new variant Creutzfeldt-Jakob Disease ("nvCJD"). The donor deferral is being recommended even though there is no scientific proof that CJD is transmitted by blood because to await definitive proof might expose US patients to avoidable risks."
"Mandates such as these are intended to assure a safe blood supply, but they often reduce blood availability which creates different patient risks. Haemonetics' two-unit red cell apheresis technology is becoming more important to increase the availability of life-saving blood. In fact, by using apheresis technology for the collection of red cells, blood centers could significantly increase the number of red cell units collected from their existing donor base," he added.
The FDA guidance specifically states that blood centers must defer blood donations from any person who has visited or resided in the United Kingdom for a cumulative period of six months or more since 1980. The guidance was given as a result of a recommendation by the Transmissable Spongiform Encephalopathies Advisory Committee, whose intention was to reduce the theoretical risk of transmitting new variant Creutzeldt-Jakob disease (a derivative of mad cow disease) through blood transfusion.
Apheresis is an automated blood collection technique using a closed circuit disposable collection system. Donated blood is centrifuged immediately into its component parts (platelets, plasma, and red cells) allowing one or more transfusable doses of the desired component(s) to be separated into blood collection bags. The unused portion of the blood is then returned to the donor. Unlike traditional manual collection processes, the blood collected through apheresis requires no further processing before transfusion to a patient, making apheresis an efficient and cost-effective procedure for blood centers....
Mark Kennedy The Ottawa Citizen 17 Aug 99HALIFAX -- Canadians who have spent six months or more in Britain since 1980 must be banned from donating blood, according to a safety measure to be announced today by the federal government.
The donor deferral policy is a precaution to screen out people who have unknowingly contracted new variant Creutzfeldt-Jakob disease -- a fatal brain disorder associated with mad cow disease.
Officials at Health Canada will announce the regulatory requirements in Ottawa this morning. Under the plan, the six-month cutoff will be a minimum requirement that Canada's two blood agencies must follow.
The Canadian Blood Services, which collects and distributes blood everywhere except Quebec, will adopt the minimum standard. All donors who have cumulatively spent six months or more in Britain from 1980 through 1996 will be banned.
The blood agency's own survey has found the ban will cause a loss of at least three per cent of its 600,000 active donors, with the impact being felt hardest at blood banks in large cities such as Toronto and Vancouver.
Hema-Quebec is poised to go beyond the minimum regulatory standard. Because far fewer of its donors have visited Britain, the agency believes it can withstand a move in which donors who have spent one month or more in Britain are banned.
Health Canada is giving both agencies until Feb. 1, 2000, to implement the donor deferral policies, although it's expected they might have new programs in place as early as this fall.
Erma Chapman, president of the Canadian Hemophilia Society, said last night she was pleased with the decision by Canadian regulators. "We're very supportive of the policy. It's a step forward in safety for Canadians." Ms. Chapman said now the blood agencies must implement a "very aggressive campaign" to recruit new donors to replace those who are lost.
There are no known cases of new variant Creutzfeldt-Jakob disease being transmitted through blood, but experts say there is a theoretical risk this can happen, especially since the strain is much more virulent than other forms of the disease. Mad cow disease first appeared in British beef in 1980. In 1996, the human form, nvCJD, began appearing in Britons who had apparently eaten the beef.
Victims of the neurological disorder suffer memory loss, restlessness, seizures, loss of speech, dementia and usually within a year, death.
A foremost expert on the disease, Dr. Neil Cashman of the University of Toronto, wrote in a report to the federal government this year that: "CJD is a nightmare disease: clinically devastating, rapid, fatal and utterly untreatable."
Ms. Cashman added that nvCJD poses a significantly higher risk than the more common version, known as classical CJD. The newer version is more virulent, hits victims at a younger age and spreads through the body instead of being concentrated in the brain.
As well, because nvCJD only surfaced in 1996 in Britain and infected people are still incubating the disease without showing symptoms, the risk of it being blood borne remains unknown.
Times of London 8/18/99 BY BEN MACINTYREAMERICANS and Canadians who have visited Britain frequently since 1980 have been barred from donating blood in their countries to prevent the possible spread of "mad cow" disease in its human form. There is no scientific evidence that bovine spongiform encephalopathy (BSE) or its fatal human version known as "new variant" Creutzfeldt-Jakob disease can be spread by normal blood transfusions, but the US Food and Drug Administration (FDA) said the ban was sensible for safety.
"As a precaution, FDA recommends that donors who have spent six months or more in the UK from 1980 through 1996 be indefinitely deferred," the agency told blood banks.
The Canadian Government announced the same restriction, and the health service ordered that the ban should go into effect on September 30. "We don't feel we can wait until all the evidence is in . . . because by then who knows what might have happened," Dr Harvey Schipper, a member of the board of Canadian Blood Services, said.
The authorities in Quebec imposed an even more stringent standard, barring blood from anyone who has spent more than a month in Britain between 1980 and 1996.
The incurable brain-wasting disease cannot be detected by blood tests, and US scientists fear that tourists who may have absorbed the BSE agent by eating infected meat in Britain, where BSE and new variant CJD have been most prevalent, could potentially infect many others. New variant CJD caused by eating BSE-infected beef has resulted in at least 35 deaths in Britain, but there is no recorded case of BSE or its human equivalent in the US.
The new policy has been criticised by some blood banks, who say it will further diminish a dwindling blood supply. The American Red Cross found that 23 per cent of recent blood donors had travelled to Britain at least once between 1980 and 1996. No case of CJD has ever been traced to blood or blood products, but laboratory tests found that the agent, or prion, could be passed from one mouse to another by the direct injection of blood into the brain. Some scientists argue that a link may be established in the future since brain diseases can incubate for years.
The restriction will be phased in over the next six months, and will not affect Americans who visited Britain after January 1, 1997, when the slaughter of cattle infected with BSE began. [Note the subclinical epidemic is still substantial in August 1999 -- webmaster]
By Jeremy Manier Tribune Staff Writer August 18, 1999A directive issued Tuesday by the U.S. Food and Drug Administration that bars many people who have lived in the United Kingdom from donating blood will put additional strain on the nation's dangerously dwindling blood supply, experts say. Fallout from Tuesday's announcement might be felt most in large metropolitan centers such as the Chicago area, where international business travelers make up a small yet important group of blood donors.
The FDA recommended that blood banks exclude donors who lived in the UK for a total of six or more months from 1980 to 1996--a time when doctors say those who ate beef had a small chance of contracting a human variant of mad cow disease. Even without the new guidelines, the American Association of Blood Banks has projected that demand for blood products will outstrip supply for the first time next year. Loss of the UK travelers is expected to cut blood donations nationwide by nearly 300,000, or 2.2 percent of the yearly total--on top of a 5.5 percent drop between 1994 and 1997.
"We're already looking at a loss of donors," said Amy Gardner-Nummer, a spokeswoman for Lifesource Blood Services, Chicago's main blood bank. "With a lot of international companies and one of the biggest international airports here, (the FDA recommendation) certainly affects us." The national donor shortfall has been driven by declining ranks of volunteers in the post-World War II generations, experts say, and rising demand from accidents and surgical procedures.
Most national blood banks oppose the new measure, fearing confusion might even discourage donations from people who had traveled to Britain but are still eligible. "These questions are often quite complex and difficult to convey to prospective donors," said Dr. Richard Davey, chief medical officer of the American Red Cross in Arlington, Va. "This will make our job increasingly harder."
People infected with HIV, hepatitis and some other diseases already are barred from donating blood. The exclusion announced Tuesday is unusual because it targets a variant of mad cow disease never recorded in the U.S. and a means of blood transmission that remains purely theoretical. Mad cow disease and its closest human equivalent, Creutzfeldt-Jakob disease (CJD), kill their victims by eating holes in brain tissue and are thought to be caused by mysterious infectious proteins called prions.
Although CJD has long been known as a rare disease in humans, scientists isolated a new variant called nvCJD in Britain in 1996 and linked it to an outbreak of mad cow disease in that country that peaked in 1992. Epidemiologists in Britain have traced 43 confirmed or suspected deaths to nvCJD. They believe the disease was transmitted from cows through meat products. Laboratory studies on mice suggest the prions responsible for nvCJD might be transmitted through blood. Yet studies on humans have found no such link, with no sign of blood transmission even in hemophiliacs, who receive large amounts of blood products and normally are at increased risk of blood-borne diseases. Aside from one death in France and Ireland, no cases of nvCJD have been found outside Britain.
Mary Elizabeth Jacobs, who coordinated development of the new FDA guidelines, said the scarce data available give reason for caution but not alarm. "This is a message to people who receive transfusions that we want to minimize the potential of risk--rather than a message to people who've been in the UK and have eaten beef," Jacobs said.
Surgeon General David Satcher has directed the FDA to review the scientific basis for the exemption every six months, Jacobs said.
Satcher also has asked public health agencies to monitor any blood shortage from the new policy and to look into new ways of recruiting donors. One increasingly popular approach is the use of donor incentives, such as providing cholesterol tests or free T-shirts or coffee mugs. A Red Cross study found that donors getting such compensation increased from 26 percent of the pool in 1995 to 62 percent in 1998.
Most blood banks say they cannot make the incentives too enticing or provide cash outright. Donors who give blood solely for the reward may conceal risk factors that would disqualify them, said Davey of the Red Cross. "We need to think creatively about how to attract new donors and yet maintain the safety of the blood supply," Davey said.
Blood donors who are uncertain whether they fall under the new exemption can call Lifesource at 800-486-0680.
18 Aug 99 Associated PressAt least 2.7 million Americans carry the hepatitis C virus, making it the most common blood-borne infection in the United States, a study found. The study from the Centers for Disease Control and Prevention represents the first look at the prevalence of hepatitis C in the U.S. The estimate was published in Thursday's New England Journal of Medicine.
"This is what we consider a conservative estimate," said Dr. Harold S. Margolis of the CDC. "This is everyday Mr. and Mrs. American who live in a household. This doesn't include the homeless and the prison population. The number could be higher." For reasons that aren't entirely clear, an estimated 1.2 million other people who were once infected no longer have any signs of the virus, Margolis said.
"We and others have said that once infected, not everyone remains infected. Unfortunately, it's still a pretty high percentage that stay infected, 75 percent," he said. Scientists discovered the virus in 1989.
People who inject illegal drugs or engage in unprotected sex account for most people who carry hepatitis C, but people who had blood transfusions before mid-1992 also are at risk. The disease and alcohol abuse rank as the leading causes of liver disease. The infection can lead to cirrhosis and liver cancer and results in about 1,000 liver transplants annually in the United States.
The standard treatment is the drug interferon or a combination of interferon and ribavirin. In some patients, drugs can make all signs of the virus disappear, but it's unclear how long the effect lasts.
18 Aug 99 MedlineComment (webmaster):
Mol Med 1999 Apr;5(4):240-3 Zobeley E, Flechsig E, Cozzio A, Enari M, Weissmann CThe transmissible agent of Creutzfeldt-Jakob disease (CJD) is not readily destroyed by conventional sterilization and transmissions by surgical instruments have been reported. Decontamination studies have been carried out thus far on solutions or suspensions of the agent and may not reflect the behavior of surface-bound infectivity.
As a model for contaminated surgical instruments, thin stainless-steel wire segments were exposed to scrapie agent, washed exhaustively with or without treatment with 10% formaldehyde, and implanted into the brains of indicator mice. Infectivity was estimated from the time elapsing to terminal disease.
Stainless steel wire (0.15 x 5 mm) exposed to scrapie-infected mouse brain homogenate and washed extensively with PBS retained the equivalent of about 10(5) LD50 units per segment. Treatment with 10% formaldehyde for 1 hr reduced this value by only about 30-fold.
The model system we have devised confirms the anecdotal reports that steel instruments can retain CJD infectivity even after formaldehyde treatment. It lends itself to a systematic study of the conditions required to effectively inactivate CJD, bovine spongiform encephalopathy, and scrapie agent adsorbed to stainless steel surfaces such as those of surgical instruments.
Lancet 1999 Feb 27;353(9154):693-7 Collins S, Law MG, Fletcher A, Boyd A, Kaldor J, Masters CL s.collins@pathology.unimelb.edu.auApart from the small number of iatrogenic and familial cases, the cause of most cases of Creutzfeldt-Jakob disease (CJD) is not known. We aimed to identify risk factors for sporadic CJD. In a case-control study, we compared the medical history and selected demographic characteristics of 241 definite (neuropathologically confirmed) and probable (clinically likely) patients with CJD, ascertained from the Australian National Creutzfeldt-Jakob Disease Registry between Jan 1, 1970, and October 31, 1997, and of 784 controls, recruited from the community by random telephone interview in August, 1997. Standard logistic regression was used for the comparisons.
Surgical procedures were significantly associated with the development of sporadic CJD. This risk progressively increased with the number of surgical treatments to a maximum for three procedures (odds ratio 2.13 [95% Cl 1.34-3.41], p=0.002). There was also a significant association between risk of CJD and residence or employment on a farm (p<0.001) or market garden (p=0.002) for longer than 10 years. We found no significant risk associated with a history of blood transfusion, organ transplantation, major dental work, or occupation.
Our findings accord with the hypothesis that a range of surgical treatments may serve as unrecognised contamination events and account for a proportion of cases of sporadic CJD. Possible biases in different methods and times for the acquisition of data on cases and controls suggest our findings need to be replicated in independent studies with community controls.
August 9, 1999 ReutersComment (webmaster):
WASHINGTON, DC, -- Three US senators are advocating that French wines carry labels warning of possible contamination with animal blood infected with bovine spongiform encephalopathy (BSE, or 'mad cow' disease). BSE has been linked to Creutzfeldt-Jakob disease, a fatal degenerative brain disorder in humans.
The senators' proposed legislation would amend the US Federal Food, Drug and Cosmetic Act to require French wines to carry a warning label saying "dried animal blood is occasionally used as a clarifying agent in French wines." However, French officials say the practice was stopped in 1997, and that all wine containing animal blood has been seized and made unavailable for export.
Both Creutzfeldt-Jakob disease and BSE are thought to be caused by prions, rogue proteins that cause a gradual deterioration of brain tissue. Creutzfeldt-Jakob disease begins with personality changes and difficulties with movement, and progresses to irreversible dementia. The disease is invariably fatal within about one year.
Some experts believe that cases of a new variant Creutzfeldt-Jakob disease in Europe may have been linked to consumption of beef from animals infected with BSE. That suspected association led to a temporary ban on exports of British beef.
US Senators Pat Roberts (R-KS) joined two Democrats, Bob Kerrey of Nebraska and Max Baucus of Montana, in offering the legislation after news that China had halted sales of French wine because of concerns that vintners had used dried cattle blood as a clarifying agent.
"It is ironic that the French, who have long banned the import of US beef products based on unproved health concerns, now face a growing scandal in regard to their prized wine product," Roberts said.
"They have argued their consumers need to be warned of all the 'possible' risks of foreign-produced food products. While the vast majority of French wine is probably perfectly safe, US consumers are entitled to the same disclosure of information regarding French products," he said.
Before the European Union banned the practice in 1997, some European vintners used albumins (proteins) from animal blood to filter out impurities and sediments. Last month French authorities identified a handful of wineries still using cow's blood, a French trade official said.
"All of that wine has been seized," the French official said. "It's not possible for any of it to be exported." [Yes, but what about all the other red wine that has been exported to the US over the last 15 years? -- webmaster]
Mon, 16 Aug 1999 ReutersSouth Africa on Tuesday rejected reported Saudi Arabian claims that its beef products could be infected with mad cow disease.
"We don't have mad cow disease in South Africa - we never have," said Gideon Bruckner, director of food safety and veterinary public health in the Department of Agriculture. A foreign news agency reported earlier in the day that Saudi Arabia had banned beef imports from South Africa because of concerns over the disease. Bruckner said South Africa had not had any official confirmation of the reported ban.
The South African Minister of Agriclture, Thoko Didiza, says he's received no official notification of a ban and was investigating the sources of what he described as irresponsible and unfounded allegations. Mr Didiza stressed that South Africa certainly had no record of mad cow disease, which can cause the fatal human brain ailment, Creutzfeldt-Jacob Disease CJD.
Comment (webmaster): This item is mysterious. There have been no reports of TSE anywhere in Africa. It is possible that South Africa imported meal and bone meal from England and may have been exposed as did Portugal and France. Or there could be some confusion with another disease such as rinderpest or rabies.
Reuters World Report Wed, Aug 18, 1999The British taxpayer may have to foot a growing bill for years to come in the wake of the mad cow crisis even though a worldwide ban on British beef has been lifted, a cross-party group of politicians said on Thursday. Parliament's Public Accounts Committee said the cost of measures aimed at protecting public health and getting the beef ban lifted was expected to total 4.2 billion pounds ($6.74 billion) by March next year.
The committee conceded the government had been forced to act fast when it came clean about BSE in 1996, setting up a scheme to destroy cattle over 30 months old, but it should have acted faster and negotiated with abattoirs harder to contain costs.
Now, it must look to persuade the world it was safe to phase out the scheme in the years ahead. "We recognise that this will be possible only if scientific advice and European Union requirements permit," the committee's report said. "But a further 15 years of the scheme, the slaughter of another four million animals and the continuing cost to the taxpayer are daunting prospects."
...The committee said EU money towards the cost of destroying millions of cows was paid only upon the destruction of each animal. Because of insufficient incineration capacity, thousands of carcasses are in storage awaiting destruction. By September 1997, there were 260,000 tonnes in storage a figure likely to increase by 65,000 tonnes per year, it said. [That works out to 2,800,000,000 quarter-pounders -- webmaster]
"The cost to the taxpayer from the BSE crisis is already high," it said. "There will be additional burdens...and further delay in reimbursement from the EU unless the negotiations and the terms of contracts for incineration capacity lead both to the timely disposal of meat and bone meal and best value for money."
Proving that BSE scares refuse to go away, the government was forced on Wednesday to quell concerns after the United States and Canada banned blood donations from people who had lived in or visited Britain during the crisis. "The British government's view is that there is no evidence that new variant CJD has ever been transmitted through blood transfusions or blood products," a health spokesman told Reuters. But he did admit there was a theoretical risk.
The U.S. Food and Drug Administration (FDA) described the ban as a precautionary measure. "No evidence exists that the disease has been transmitted by blood transfusion, but current studies cannot exclude this possibility," it said.
8 Aug 99 The Associated Press By BRUCE STANLEYSTANFORD LE HOPE, England - For farmer Ian Frood, the global ban on British beef exports due to fears of ``mad cow'' disease meant more than a plunge in profits and the forced slaughter of his herd of 100 cattle. The 3-year embargo, which ended this month, brought an additional hardship - record-keeping rules that force Frood to spend two hours each evening in front of a personal computer, updating data on the weight, diet, health, movements and reproductive habits of each animal in his new herd.
``If I didn't have them,'' he says of his three PCs, ``I'd just go out and shoot myself. I couldn't cope with the paperwork.'' Frood's bookkeeping chores multiplied after fears of bovine spongiform encephalopathy, the medical name for ``mad cow'' disease, led the European Commission to ban exports of British beef in March 1996. The commission, which enforces rules for the European Union, acted after medical researchers linked the cattle disease to a new strain of the fatal human brain ailment, Creutzfeldt-Jacob disease.
The ban may be over, but cattle farmers and other members of the British beef industry have little reason to celebrate. They say exports will take years to recover to their pre-embargo level of 246,000 metric tons per year. Some argue that the additional steps they now must take to monitor their cattle make it too expensive for them to even bother trying to claw back overseas sales.
Each cow, bull and calf in Britain must now have a ``passport,'' a barcode and two identification tags - one attached to each ear. Farmers can't sell cattle more than 30 months old, yet smaller animals are more expensive to process. Meatpackers can no longer sell organs and fat for use in animal feeds for domestic use, and slaughterhouses must get a special permit to prepare beef for export. At present, only one slaughterhouse has such a permit, and last week it processed the first carcass of British beef destined for overseas markets since the export ban ended. Yet relief at the official lifting of the ban turned to fury when the German government said it would not allow imports of British beef before the end of September, pending further assurances that the meat is safe to eat. ``It's outrageous,'' Frood said, a military-style mustache quivering on his ruddy face. Germany's stance is just the latest humiliating setback for an industry that long prided itself on a tradition of quality. Frood, 51, is the third generation of his family to farm. He's an official in the National Farmers Union, holds a PhD in agriculture and worked for several years as a nutrition consultant. He took up cattle farming in 1978 at a farm called Old Hall, an 800-acre spread with a 200-year old farmhouse near Stanford le Hope, 30 miles east of London. Today his wife Moira, daughter Helen and son Andrew all pitch in. Frood used to sell many of his animals for export to Italy. The ban cut him off from this market, slashing his revenues by a third, or $48,000. It also created a glut of beef on the domestic market, depressing prices by about 30 percent and causing further strain for beef producers. Frood's herd of black and white cattle had to be killed and incinerated, and he has had to rely ever since on sales of wheat, barley and peas for the bulk of his income. He also bales hay for other farmers and raises sheep. And Frood receives about $160,000 in annual government subsidies, half of that a grant for protecting sensitive wetlands on the farm. ``We 'duck and dive' to make a go of it,'' he said. ``We're not a traditional farm.'' Frood has survived - so far - but the export ban has squeezed untold numbers of farmers, cattle markets and slaughterhouses out of business. Tim Brassington, a livestock auctioneer, lost his last job when the cattle market that employed him closed due to low beef prices and the lack of exports. He found work in May at the Colchester Cattle Market, an hour's drive northeast of Frood's farm. ``I'm moving to Canada, I think, if this one goes,'' he said of his current job. Slaughterhouse owner Joseph Cheale said the export ban cost him 40 percent of his sales overnight. Cheale Meats Ltd. in Brentwood, 25 miles east of London, responded by processing only pork. ``Beef export will never be as it used to,'' Cheale said.
After the beef ban took effect, Frood bought 90 new breeder cows and three stud bulls to provide calves for local sale. But he plans to focus on the domestic market and sees only bleak prospects for exports. ``A lot of my colleagues are more optimistic,'' he said, ``but that's often from a position of ignorance.''
Mon 16 Aug 99 FDA guidance letterComment (webmaster):
They reversed course again on sporadic CJD though the passage is confusing. Now that McEwen's blood is used up, it is a good idea again to defer sporadic CJD.
They're going to provide counseling for everyone that ever had brain surgery and tries to donate blood.
These deferrals cover an immense number of people when vaccines are considered: "FDA recommends that blood donors who have received bovine insulin or other injectable products made from cattle in BSE endemic countries such as the United Kingdom, be indefinitely deferred."
Question: Since 1980, have you knowingly obtained and been injected with a non-U.S. licensed drug product made from cattle, such as bovine (beef) insulin?
People rejected here are not eligible for counseling. There is a contradiction implicit here: if they are not at risk of nvCJD, why are they being deferred?
Guidance for Industry
Revised Precautionary Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease (CJD) and New Variant
Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products
Comments and suggestions regarding this document should be submitted
within 60 days of publication in the Federal Register of the notice
announcing the availability of the guidance. Submit comments to
Dockets Management Branch (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments
should be identified with the docket number listed in the notice of
availability that publishes in the Federal Register.
Additional copies of this guidance document are available from the
Office of Communication, Training and Manufacturers Assistance
(HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1448, or by
calling 1-800-835-4709 or 301-827-1800, or from the Internet. For questions regarding this document, contact the Director,
Division of Hematology, at 301-496-4396.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research (CBER)
August 1999
This guidance document represents the agency's current thinking on
precautionary measures to reduce the possible risk of transmission
of Creutzfeldt-Jakob Disease (CJD) and new variant CJD (nvCJD) by
blood and blood products and to assure that blood and blood products
are not adulterated or misbranded, within the meaning of the Federal
Food Drug and Cosmetic Act, and are safe, pure and potent within the
meaning of the Public Health Service Act. It does not create or
confer any rights for or on any person and does not operate to bind
FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute,
regulations or both.
GUIDANCE FOR INDUSTRY
Revised Precautionary Measures To Reduce The Possible Risk of
Transmission of Creutzfeldt-Jakob Disease (CJD) and New Variant
Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products
I. INTRODUCTION
This guidance is released for immediate implementation. Justification
for implementation prior to comment is as follows: 1) the guidance
presents a less burdensome policy that is consistent with the public
health for the management of blood components and plasma derivatives
in cases where the donor has classic CJD or CJD risk factors, and
2) there are public health reasons for immediate implementation of
the recommendations regarding additional safeguards with respect to
new variant CJD.
This guidance supersedes the FDA memorandum of December 11, 1996,
entitled "Revised Precautionary Measures to Reduce the Possible Risk
of Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood and Blood
Products." It summarizes the reasons for changes to the December 11,
1996 memorandum and provides comprehensive current recommendations,
including new recommendations concerning nvCJD.
FDA recognizes that the scientific technology for determining
individuals at risk for CJD and nvCJD, and detecting the infectious
agents in tissues and in products, is continuing to advance, and that
there may be a need for future updating of the relevant guidance.
II. BACKGROUND
CJD is a rare but invariably fatal degenerative disease associated
with a poorly understood transmissible agent (1, 2). CJD cases occur
at low frequency by an unknown mechanism (sporadic CJD). It may also
be acquired by exogenous (usually iatrogenic) exposure to infectious
material; or may be familial, caused by a genetic mutation of the
prion protein gene. Clinical latency for iatrogenic CJD may exceed
30 years.
In 1996, a previously unrecognized variant of CJD was described
almost exclusively in the United Kingdom (3), and is referred to as
new variant CJD (nvCJD). Although to date only forty patients have
died of nvCJD, the extent and occurrence of a nvCJD epidemic in the
United Kingdom cannot yet be determined. No cases of nvCJD have been
identified in the United States. Laboratory and epidemiologic
studies have linked nvCJD to an outbreak of bovine spongiform
encephalopathy (BSE) in the United Kingdom (4, 5). BSE infection in
cattle appeared in 1980, peaked in 1992, and fell to low levels by
1996.
On December 11, 1996, the Food and Drug Administration (FDA) issued a
Memorandum to all registered blood and plasma establishments and all
establishments engaged in manufacturing plasma derivatives entitled
"Revised Precautionary Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood and Blood
Products." The memorandum recommended as a precaution, to quarantine
and destroy in-date Source Plasma and plasma derivatives, and in-date
transfusion products prepared from donors who were at increased risk
for developing CJD or who were subsequently diagnosed with CJD. The
memorandum recommended permanent deferral of donors with CJD or CJD
risks, unless, for cases of genetic risk, the donor underwent genetic
testing which did not reveal a familial-CJD associated abnormality of
the prion protein gene. This document did not make recommendations
specific to nvCJD. New FDA recommendations announced on September 8,
1998, specified 1) reversal of the recommendation to withdraw plasma
derivatives from donors with classic CJD or CJD risk factors, and
2) recommendation to withdraw all material from nvCJD donors.
A. CJD: Rationale for Not Withdrawing Plasma Derivatives from
Donors with CJD or CJD Risk
Accumulating epidemiologic information and laboratory studies
have indicated that transmission of the CJD infectious agent by
blood products is highly unlikely. Five published case-control
studies analyzed over 600 CJD cases. None of these studies
showed that blood transfusion increased the risk for CJD (6-8).
Investigations of recipients of blood components from known CJD
donors have not revealed transmission of the CJD agent (9, 10),
although these cohort studies are limited by the small numbers
of such recipients, especially with long-term follow-up, and
thus would only be likely to reveal a high transmission rate.
National mortality surveillance performed by the Centers for
Disease Control and Prevention (CDC) indicates that patient
populations with increased exposure to blood or blood products
are not at increased risk for CJD (11). During a 18-year
period (1979-96), 4,468 cases of CJD were reported to CDC.
When death records were searched, none of these cases were
reported to have had hemophilia, thalassemia, or sickle cell
disease. More directed evaluation of persons with hemophilia
have not shown a link to CJD. In one study, brain tissue from
24 hemophiliacs who died with neurologic disease was examined;
none had evidence of CJD (12). In a second study, brain tissue
from 33 hemophiliacs in the United Kingdom, who died of various
causes was examined, and none had evidence for CJD (13).
Additional surveillance of cryoprecipitate recipients is
underway in Seattle, WA. Through 1997, no CJD cases have been
reported among 101 patients who, together, received over
238,000 units of cryoprecipitate between 1979-85; 76 of these
subjects are alive from 12.5 to 18.5 years later (14). Three
of these recipients were known to have received at least one
unit of cryoprecipitate from donors known to have developed CJD.
While epidemiological studies have not revealed transmission of
CJD in humans by blood and blood products, and laboratory
experiments have demonstrated that manufacturing significantly
lowers the amount of the CJD infectious agent in plasma
derivatives, some laboratory experiments have shown that blood
and plasma fractions from experimentally infected animals
transmit CJD to recipient animals when directly injected into
the brain (15-17). In a single case, transfusion of blood
directly from an infected hamster transmitted disease to the
recipient (Transmissible Spongiform Encephalopathy (TSE)
Advisory Committee transcript, December 1998) (27).
In contrast, other laboratory studies have not supported the
transmission of CJD through transfusion of blood. Transfusion
of blood units from 3 CJD patients failed to transmit CJD to
chimpanzees (15), and the validity of reported positive
transmissions to animals using blood from patients with CJD
has been questioned (17).
Plasma derivatives are unlikely to transmit disease in humans
because: 1) a CJD-implicated plasma unit would be diluted into
a large plasma pool, leading to a low number of infectious
units in a dose of the final product, 2) intravenous and
intramuscular inoculation alone is less efficient than cerebral
inoculation for CJD transmission, and 3) further processing of
plasma pools by Cohn fractionation and manufacturing processes
such as column chromatography, precipitation, and filtration,
have been shown to diminish titers of CJD-like agents, in
spiking experiments using scaled-down manufacturing procedures
(16) (TSE Advisory Committee transcript, December 1998) (27).
B. NvCJD: Current Case Definitions, and Rationale for
Withdrawing Plasma Derivatives From Donors with NvCJD
NvCJD is distinguished from CJD by differences in clinical
presentation and neuropathologic changes (3, 18-20).
Clinically, nvCJD patients have an earlier age of onset, with
median age at death of 29 years, compared to CJD patients,
whose mean age at death is 67 years. NvCJD presents with
predominantly psychiatric and sensory symptoms, and absence of
diagnostic EEG changes frequently seen in CJD. NvCJD patients
have a more prolonged duration of illness (median survival 14
months) than patients with CJD (median survival 4 months) (21).
Neuropathologic features of nvCJD include florid prion protein
plaques surrounded by spongiform changes, which are rarely
found in CJD. In addition, prion protein can be detected
immunohistochemically in the lymphoid tissues of nvCJD, but
not CJD patients (22). This observation led to concerns that
transmission of nvCJD by blood might be possible.
Neuropathologic examination of brain tissue is required to
confirm a diagnosis of nvCJD. A confirmed or definite case of
nvCJD is currently defined by the following neuropathologic
findings: 1) numerous widespread kuru-type amyloid plaques,
surrounded by vacuoles, in both cerebellum and cerebrum
("florid plaques"); 2) spongiform change most evident in the
basal ganglia and thalamus, with sparse distribution in the
cerebral cortex; and 3) high density accumulation of prion
protein, particularly in the cerebrum and cerebellum as shown
by immunohistochemistry.
In cases where adequate neuropathology specimens are not
available, a clinical diagnosis of "suspected" nvCJD could be
made based upon certain atypical clinical features. Although
recommended diagnostic evaluations and criteria for nvCJD are
evolving, at present the CDC would classify cases in the United
States with all of the following features as "suspected" nvCJD:
1. Current age (if alive) or age at death <55.
2. Persistent painful sensory symptoms and/or psychiatric
symptoms at clinical presentation.
3. Dementia, and delayed development (> or = 4 months after
illness onset) of ataxia, plus at least one of the
following three neurologic signs: myoclonus, chorea, or
dystonia.
4. A normal or abnormal EEG, but not the diagnostic EEG
changes often seen in classic CJD.
5. Duration of illness greater than 6 months.
6. Routine investigations do not suggest an alternative,
non-CJD diagnosis.
7. A history of possible exposure to bovine spongiform
encephalopathy (BSE), e.g., having been a resident or
traveler to a BSE-affected country from 1980 through
1996.
8. No history of iatrogenic exposure to CJD, such as
receipt of a dura mater graft, or human
pituitary-derived hormones.
9. The patient does not have a prion protein gene mutation,
or, if this has not been determined, there is no history
of CJD in a first degree relative.
The transmissibility of nvCJD by blood or blood products is
unknown, although laboratory and epidemiologic studies are
underway to evaluate this risk. NvCJD appears to be distinct
from classic variants of CJD both clinically and biologically
and therefore transmissibility cannot confidently be predicted
from studies of CJD. Until more is known about the possibility
of nvCJD transmission by blood components or plasma derivatives,
a precautionary policy of withdrawal for all of these products
is recommended for material from donors with nvCJD.
C. Current CJD and NvCJD Recommendations
On January 29, 1998, the Public Health Service (PHS) Advisory
Committee on Blood Safety and Availability reviewed laboratory
and epidemiologic information concerning CJD transmissibility by
blood, as well as the impact of CJD-related withdrawals upon the
supply of medically necessary plasma derivatives. Based upon
this review, the committee recommended that FDA consider
revising its December 11, 1996 guidance to the extent necessary
to relieve shortages of medically necessary plasma derivatives.
Subsequently, epidemiological and laboratory studies were
evaluated by the Department of Health and Human Services Blood
Safety Committee, which determined at its July 23, 1998 meeting,
that the current CJD guidance on quarantine and withdrawal of
blood products should be revised. A policy position to modify
the withdrawal recommendations for plasma derivatives was
announced by Surgeon General David Satcher, M.D. on August 27,
1998, at a public meeting of the PHS Advisory Committee on
Blood Safety and Availability. It was recommended that plasma
derivatives be withdrawn and intermediates quarantined only if
a blood donor develops nvCJD and that previously recommended
withdrawals and quarantines be discontinued for classical CJD
and CJD risk factors. A consistent recommendation was made
available on the Internet by the FDA on September 8, 1998.
United Kingdom residents have an increased risk of developing
nvCJD. The number of people incubating nvCJD in the United
Kingdom cannot yet be predicted. The FDA received additional
advice from the TSE Advisory Committee (27) on December 18,
1998, concerning deferral of donors who have traveled to or
resided in the United Kingdom for a certain period of time,
and therefore could have been exposed to the nvCJD agent. The
TSE Advisory Committee recommended deferring such donors, but
requested additional information concerning the impact of
deferrals on the blood supply in order to provide more specific
advice about time of residence in the United Kingdom. On
June 2, 1999, the TSE Advisory Committee reaffirmed its
recommendation to defer donors who have traveled to or resided
in the United Kingdom, until more is known about the potential
risk of nvCJD incubation in such donors and about the ability
of blood to transmit nvCJD (28).
Comprehensive revised recommendations based upon the above
discussions and PHS and FDA internal deliberations are
contained in this guidance document. Recommendations for donor
deferral, product disposition, and recipient notification have
been developed based upon consideration of risk in the donor,
risk in the product, and the effect of withdrawals on the
supply of life- and health-sustaining blood components and
plasma derivatives. In particular, nvCJD is distinguished from
CJD and CJD risk factors, based on lack of sufficient
historical and epidemiological experience, and lack of available
scientific studies relevant to the likelihood of transmission of
nvCJD via blood components or derivatives.
III. RECOMMENDATIONS FOR DONOR DEFERRAL
A. Recommended Donor Deferral Criteria
1. FDA recommends that donors who have been diagnosed with
nvCJD or CJD be permanently deferred.
2. FDA recommends that donors at increased risk for CJD (as
identified by questions in section III.B.) be
indefinitely deferred and appropriately counseled.
Donors are considered to have an increased risk for CJD
if they have received a dura mater transplant, human
pituitary-derived hormones, or have one or more blood
relatives with CJD.
3. FDA believes that donors who have resided in the United
Kingdom (as identified by questions in section III.D.)
may be at risk for exposure to nvCJD. As a precaution,
FDA recommends that donors who have spent six months or
more cumulatively in the United Kingdom from 1980
through 1996 (i.e., from January 1, 1980 through
December 31, 1996) be indefinitely deferred.
4. FDA recommends that donors who received injectable
products made from cattle in BSE endemic countries (as
identified by questions in section III.D.) be
indefinitely deferred. FDA has previously recommended
that material from cattle in BSE countries not be used
in the manufacture of FDA regulated products (59 FR
44591, August 29, 1994).
B. Recommended Questions for Identifying Donors at an Increased
Risk for CJD
FDA recommends that Source Plasma donors be questioned at the
first donation and at each annual physical examination
thereafter, and that Whole Blood donors be questioned at the
time of each donation. If the donor is not familiar with the
term "Creutzfeldt-Jakob Disease," it may be taken as a negative
response. These questions are similar to those in the December
11, 1996 guidance, except that receipt of human pituitary
gonadotropins has been added as a risk factor, based upon
reports of CJD transmission by these preparations (23, 24).
Question 1) "Have you or any of your blood relatives had
Creutzfeldt-Jakob Disease or have you ever been
told that your family is at an increased risk
for Creutzfeldt-Jakob Disease?"
NOTE: This may be asked as one or two questions
in order to elicit complete information
regarding a family history of CJD.
Question 2) "Have you ever received human pituitary-derived
hormones, such as growth hormone or
gonadotropins?"
NOTE: If the donor is uncertain about his or
her treatment, the following question
describing human pituitary-derived growth
hormone injections may be asked: "Was the
hormone treatment given by injection?"
Question 3) "Have you ever had brain surgery?" and if so,
"Have you received a dura mater (or brain
covering) graft?"
FDA considers that donors who answer "Yes" to any of the above
questions are at an increased risk for developing CJD.
C. Recommendations Regarding Donor Reentry After Donor Deferral
for Risk of Familial CJD
If a donor is deferred because of family history (one or more
family members with CJD), that donor may be reentered if:
1) The diagnosis of CJD in the family member(s) is
confidently excluded, or CJD in the family member(s) is
iatrogenic, or the family member(s) is(are) not a blood
relative(s); or
2) Laboratory testing (gene sequencing) shows that the
donor does not have mutations associated with familial
CJD.
D. Recommended Questions for Identifying Donors at Risk for
Exposure to BSE
Note that the United Kingdom is defined as England, Scotland,
Wales, Northern Ireland, Isle of Man, and Channel Islands.
Residence in the Republic of Ireland is not counted as
contributing to risk of nvCJD exposure.
1. Donors who have resided or traveled to the United
Kingdom
Question 1) Have you visited or lived in the
United Kingdom (England, Northern
Ireland, Scotland, Wales, the Isle of
Man, or the Channel Islands) from 1980
through 1996?
Question 2) If so, have you spent a total time of
6 months or more in the United Kingdom
from 1980 through 1996?
FDA recommends that donors who answer "Yes" to both of
the above questions be indefinitely deferred.
2. Donors who have been exposed to bovine-derived
injectable products made in BSE endemic countries
No cases of transmission of nvCJD have been reported in
recipients of bovine insulin or other injectable
products manufactured in BSE-affected countries.
However, as a precaution, FDA has recommended that
material from cattle in BSE countries not be used in the
manufacture of FDA regulated products (59 FR 44591,
August 29, 1994). Consistent with these recommendations,
as a precaution, FDA recommends that blood donors who
have received bovine insulin or other injectable
products made from cattle in BSE endemic countries such
as the United Kingdom, be indefinitely deferred.
The following question or a similar question is recommended
to be asked of potential donors:
Question: Since 1980, have you knowingly obtained
and been injected with a non-U.S.
licensed drug product made from cattle,
such as bovine (beef) insulin?
FDA recommends that donors who received injectable products
from cattle in BSE endemic countries be indefinitely
deferred. A current report of BSE surveillance in Europe
can be obtained on the Internet (29).
IV. RECOMMENDATIONS FOR DISPOSITION OF IMPLICATED PRODUCTS
A. Blood Components
The recommended disposition of blood components is the same for
all of the following: donors with CJD, donors with CJD risk
factors, donors with nvCJD, and donors with potential exposure
to nvCJD (travel or residence in the United Kingdom for 6
months or more, cumulatively from 1980 through 1996, or
recipients of bovine-derived injectable products from BSE
endemic countries since 1980).
1. FDA recommends that all in-date blood components under
the control of the Establishment (Whole Blood, blood
components, Source Leukocytes, Pooled Platelets,
unpooled Source Plasma) that were collected from the
donor and intended for use in transfusion or for further
manufacturing into injectable products be immediately
retrieved and quarantined for subsequent destruction.
FDA is not recommending the withdrawal and quarantine
of classical CJD materials intended for further
manufacturing into non-injectable products; however FDA
recommends that such products be labeled appropriately
(see section VI.A. for labeling recommendations). FDA
recommends that material from nvCJD donors be
immediately retrieved and quarantined, but may be saved
for use in research on nvCJD by laboratories qualified
to use this material (see section VI.A for labeling
recommendations). Furthermore, FDA recommends that
Establishments immediately notify the CJD Surveillance
Unit of the Division of Viral and Rickettsial Diseases
of the Centers for Disease Control and Prevention (CDC)
at (404) 639-3091, and the FDA, Director, Division of
Hematology at (301) 496-4396, if they receive a report
of a donor with nvCJD.
FDA also recommends immediate notification of CDC and
FDA in case of a post donation report of a donor with
a physician's clinical or pathological diagnosis of CJD
and age less than 55 years. Donors under 55 years of
age who are diagnosed with CJD will be investigated and
reviewed by FDA in collaboration with CDC. The purpose
of such investigations will be to assess the likelihood
of nvCJD, in order to identify any case which occurs in
the United States.
2. FDA recommends that all consignees should be notified
within one week after receipt of post donation
information, to immediately retrieve and quarantine any
implicated in-date blood components intended for use in
transfusion or for further manufacturing into injectable
products, for subsequent destruction. NvCJD-implicated
material may be saved for use in research on nvCJD by
qualified laboratories (see section VI.A. for labeling
recommendations).
B. Plasma Derivatives
1. Plasma derivatives from donors with CJD or CJD risk
factors, or potential exposure to nvCJD (as defined in
section III.A.)
a. FDA recommends that pooled plasma, intermediates,
and derivatives should not be withdrawn.
b. FDA recommends consignee notification for all plasma
intended for further manufacture into derivatives.
Consignee notification is recommended in order to
effect withdrawal of plasma that has not already
been pooled for manufacture. FDA recommends that
single, unpooled units of plasma be retrieved and
quarantined for subsequent destruction. FDA does
not recommend retrieval and quarantine of plasma
that has been pooled prior to consignee notification.
2. Plasma derivatives from donors diagnosed with nvCJD
FDA recommends that Establishments immediately notify
the CJD Surveillance Unit of the Division of Viral and
Rickettsial Diseases of the Centers for Disease Control
and Prevention (CDC) at (404) 639-3091, and the FDA,
Director, Division of Hematology at (301) 496-4396, if
they receive a report of a donor with nvCJD.
a. FDA recommends that if an Establishment receives
a post donation report of nvCJD diagnosis, the
Establishment immediately retrieve and
quarantine for subsequent destruction pooled
plasma, intermediates, and derivatives, and any
other materials containing plasma from the
nvCJD donor. Alternatively, material from nvCJD
donors may be saved for use in research on nvCJD
by qualified laboratories (see section VI.A. for
labeling recommendations). FDA recommends
against the use of such material for
non-injectable products.
b. FDA recommends that, within one week of
receiving a post donation report of nvCJD
diagnosis, the Establishment notify all
consignees to immediately retrieve and
quarantine for subsequent destruction pooled
plasma, intermediates, and derivatives, and any
other materials containing plasma from the
nvCJD donor. Alternatively, this material may
be saved for use in research on nvCJD (see
section VI.A. for labeling recommendations).
3. Plasma derivatives from donors with a physician's
clinical or pathological diagnosis of CJD and age less
than 55 years
FDA recommends that Blood or Plasma Establishments
immediately notify the CJD Surveillance Unit of the
Division of Viral and Rickettsial Diseases of the Centers
for Disease Control and Prevention (CDC) at (404) 639-3091,
and the FDA, Director, Division of Hematology at
(301) 496-4396, if they receive a report of a donor with
a physician's clinical or pathological diagnosis of CJD
and age less than 55 years.
Donors under 55 years of age who are diagnosed with CJD will
be investigated and reviewed by FDA in collaboration with
CDC. The purpose of such investigations will be to assess
the likelihood of nvCJD, in order to consider precautionary
withdrawal of plasma derivatives.
a. Recommendations to quarantine and withdraw
plasma derivatives from such donors will be made
by FDA on a case-by-case basis, depending upon
results of the investigation. Precautionary
quarantine and withdrawal may be advised if
available information is ambiguous, and does
not clearly indicate the presence of a classic
form of CJD.
b. FDA recommends that quarantined and withdrawn
material from such donors should be treated in
the same manner as for nvCJD (see section
IV.B.2.).
C. Disposal of Retrieved and Quarantined Products
The transmissible agent of CJD is quite resistant to most
disinfecting regimens. There is no current consensus of
specific details of decontamination requirements for blood
products. However, the preferred methods of destruction of
CJD-implicated material are steam autoclaving at 132 degrees C
for 1-4 hours, incineration, or treatment with 1 N NaOH or
concentrated sodium hypochlorite for at least 1 hour at room
temperature (25, 26 and 30). These treatments are known to
diminish, but may not completely eliminate, infectivity.
FDA believes that blood components and plasma derivatives from
donors with nvCJD, or which have been withdrawn because the
donor might have nvCJD, may be saved for use in research on
nvCJD by qualified laboratories (see section VI.A. for labeling
recommendations).
V. CONSIGNEE NOTIFICATION AND COUNSELING: ADDITIONAL
RECOMMENDATIONS
FDA recommends if a donor is found to have CJD, nvCJD, risk factors
for CJD, or if withdrawal is recommended in cases under investigation
for nvCJD, that Establishments inform all consignees of previously
distributed blood components from that particular donor. FDA
recommends that the search of records to identify prior collections
from that donor extend back indefinitely to the extent that electronic
or other readily retrievable records are available. Consignee
notification will enable the consignee to inform the physician or
other qualified personnel responsible for the care of the recipient
so that recipient tracing and medically appropriate notification and
counseling may be performed at the discretion of care providers.
In cases of donors diagnosed with nvCJD or donors under investigation
for nvCJD, FDA recommends that Establishments inform consignees of
affected plasma derivatives as well as blood components.
NOTE: If a donor is found to have risk factors for nvCJD (due to six
months domicile in the United Kingdom from 1980 through 1996, or due
to injection of a bovine-derived product made in a BSE endemic
country), FDA recommends consignee notification for the purpose of
quarantine and disposition of in-date blood components (see section
IV.A.). However, FDA does not recommend additional consignee
notification for the purpose of tracing and notifying prior recipients.
VI. LABELING RECOMMENDATIONS
A. Labeling of Implicated Products for Research or Intended for
Further Manufacture into Non-Injectable Products
FDA recommends that blood components from donors with CJD or who
are at increased risk for CJD or exposure to nvCJD, intended to
be used in research or manufacture into non-injectable products,
be appropriately labeled with the following statements:
1. "Biohazard";
2. "Collected from a donor determined to be at risk for
CJD"; or "Collected from a donor diagnosed with
CJD"; or "Collected from a donor with potential risk
of exposure to new variant CJD"; and
3. "For laboratory research use only"; or "Caution: for
use in manufacturing non-injectable products only."
FDA believes that blood components from donors with nvCJD should
not be used for further manufacture into non-injectable
products. However blood components and plasma derivatives from
donors with nvCJD or which have been withdrawn on a case-by-case
basis for suspicion of nvCJD, may be used in laboratory
research on nvCJD by qualified laboratories. FDA recommends
that these products be labeled with the following statements:
1. "Biohazard";
2. "Collected from a donor with new variant CJD"; and
3. "Only for laboratory research on new variant CJD".
B. Labeling of Non-Implicated Products
No transmission of CJD or nvCJD by human blood components or
plasma derivatives has been documented to date. However, as a
precaution, FDA recommends that all blood components and
plasma-derived products include labeling to address the
theoretical risk. Because albumin has never been known to
transmit viral diseases, and because model laboratory
experiments suggest that albumin is less likely to contain
CJD-like agents than other plasma fractions, FDA believes
that a more specific statement may be provided in the package
insert for albumin and products containing albumin.
1. For Whole Blood and blood components, FDA recommends
the Circular of Information be revised to include
under "Side Effects and Hazards," the following statement:
"Because this product is made from human
blood, it may carry a risk of transmitting
infectious agents, e.g., viruses, and
theoretically, the Creutzfeldt-Jakob disease
(CJD) agent."
Until the circular is revised, this statement may be
inserted or attached to the current circular.
2. For plasma-derived products other than albumin, FDA
recommends the package insert warning section be
revised to include the following statement:
"Because this product is made from human
blood, it may carry a risk of transmitting
infectious agents, e.g., viruses, and
theoretically, the Creutzfeldt-Jakob disease
(CJD) agent."
3. For plasma-derived albumin, FDA recommends the
package insert warning section be revised to include
the following statement:
"Albumin is a derivative of human blood.
Based on effective donor screening and product
manufacturing processes, it carries an
extremely remote risk for transmission of
viral diseases. A theoretical risk for
transmission of Creutzfeldt-Jakob disease
(CJD) also is considered extremely remote. No
cases oftransmission of viral diseases or CJD
have ever been identified for albumin."
4. For products containing plasma-derived albumin, FDA
recommends the package insert warning section be
revised to include the following statement:
"This product contains albumin, a derivative
of human blood. Based on effective donor
screening and product manufacturing processes,
it carries an extremely remote risk for
transmission of viral diseases. A theoretical
risk for transmission of Creutzfeldt-Jakob
disease (CJD) also is considered extremely
remote. No cases of transmission of viral
diseases or CJD have ever been identified for
albumin."
VII. IMPLEMENTATION OF RECOMMENDATIONS
The recommendations contained in this guidance may be implemented
without prior approval from the agency. FDA recommends that
Establishments implement this guidance as soon as feasible, but not
later than six months from the date of publication of this guidance.
Licensed Establishments implementing these recommendations should
submit in their annual reports (21 CFR 601.12(d)) a statement
indicating the date that revised standard operating procedures (SOPs)
consistent with the recommendations have been established and
implemented. If Establishments elect to use an insert to incorporate
the language recommended in this guidance (until the Circular of
Information is revised), the annual report may also reference the
date of use of the insert. In the event that a Blood Establishment
elects to use other wording, FDA requests the Establishment to submit
the labeling in accordance with 21 CFR 601.12(f)(2). FDA further
requests manufacturers of plasma-derived products to submit labeling
changes in accordance with 21 CFR 601.12(f)(2).
If a manufacturer of blood components or plasma-derived products
believes that an alternative approach to the recommendations
contained in this guidance document would provide equivalent
protection, the manufacturer is invited to discuss the approach with
FDA.
VIII. REFERENCES
1. Am. J. Pathol. 1995 146:785-811.
2. Ann Neurol. 1979 5:177-88.
3. Lancet 1996, 347:91-5.
4. Nature 1996 383: 685-690
5. Nature 1997 389: 498-501
6. Neurol. 1996 46:1287-91.
7. Lancet 1993 341:205-7.
8. Lancet 1998 351:1081-5.
9. Lancet 1994 343:298-9.
10. Transfusion 1997 37(suppl.):2S.
11. Emerging Inf. Diseases 1997 2(4):333-36.
12. Transfusion 1998 38:817-20.
13. Thromb. Haemost. 1998 80:909-11.
14. A. Thompson, unpublished.
15. Ann Neurol. 1994 35: 513-29.
16. Transfusion 1998 38:810-16.
17. Brown, P. Curr. Op. Hematol. 1995 2:472-77
18. Lancet 1997 350: 903-7.
19. Lancet 1997 350: 908-10.
20. FEMS Immunol. Med. Microbiol 1998 21:91-5.
21. Br. Med. J. 1996 315:389-95.
22. Lancet 1999 353:183-9.
23. Aust. N Z Med. 1990 20:592-3.
24. Lancet 1993 307:507-8.
25. Biologics 1992 20: 155-58.
26. Arch. Virol. 1994 139:313-26.
27. http://www.fda.gov/ohrms/dockets/ac/cber98t.htm.
28. http://www.fda.gov/ohrms/dockets/ac/99mtbc.htm.
29. http://www.oie.int/status/A_BSE.htm
30. http://www.ehs.ucsf.edu/manuals/BSM/appendix%20L.html
Wed, Aug 18, 1999 By Philippe Naughton Reuters North AmericaSYDNEY- Australia is considering following a North American lead and banning blood donations from people who may have been infected with mad cow disease by eating tainted beef in Britain. But a senior Red Cross official said on Wednesday Australia's close ties with Britain -- its former colonial master -- meant such a decision could have a serious impact on blood supplies.
"The effects it would have on blood supplies would be considerably greater than in Canada or the USA, so we need to consider this action very carefully," Dr Tony Keller, chairman of the Donor and Product Safety Committee of the Australian Red Cross Blood Service. U.S. and Canadian blood banks were ordered on Tuesday to stop collecting donations from people who lived in or frequently visited Britain during the mad cow disease outbreak, which lasted from 1980 to 1996. The U.S. Food and Drug Administration said the move was "a precautionary measure" to remove the theoretical possibility that donors might pass on the human version of mad cow disease through blood transfusions. "No evidence exists that this disease has been transmitted by blood transfusion, but current studies cannot exclude this possibility," the FDA said.
Keller told Reuters that whereas the decision would have very little impact on North American blood supplies, 29 percent of Australian residents had visited Britain during the mad cow years.
"If we were to introduce a similar policy to that introduced in Canada and the USA, the exclusion of donors who had lived in Britain for more than six months, we would exclude an average of 5.3 percent of donations," Keller said.
The Australian Red Cross has set up an independent expert committee headed by Professor Colin Masters, Australia's foremost expert on CJD and other transmissible spongiform encephalopathies. The committee, which would balance the dangers of disrupting Australian blood supplies with the medical risk of transmission, was expected to report back within a month with its advice.
Australian Associated Press Fri, Aug 20, 1999 By Rada Rouse, National Medical CorrespondentBRISBANE -- Australians who lived in Britain during the past 20 years may be prevented from donating blood because of fears of spreading mad cow disease. Such a ban would reduce blood donations by more than five per cent, creating a crisis in supply, Australian Red Cross product safety committee chairman Dr Tony Keller said today.
But because of the risk of transmitting the human form of mad cow disease through transfusions, the blood bank has asked an independent committee to investigate new variant Creuzfeldt Jakob Disease (NV-CJD). The committee would be headed by Australia's CJD expert, Professor Colin Masters from the University of Melbourne and would report in September.
Dr Keller said the move followed a decision in the US and Canada to "defer" donations from anyone who had spent more than six months in Britain between 1980 and 1996, when there was an outbreak of mad cow disease or bovine spongiform encephalopathy. Cases of NV-CJD, presumably from eating beef, have claimed 43 lives in Britain, one in Ireland and one in France.
Two weeks ago at the International Congress of Virology in Sydney, Professor Jeffrey Almond, who chaired the British Mad Cow Expert Committee, said any beef-eating Australian who had lived in the UK through the peak period of the outbreak would be at risk. Dr Keller said any decision to reduce prospective donors would not be taken lightly in Australia.
"Even today we face marginal supply situations in some areas and we couldn't afford to implement a ban unless there were contingency plans that meant Australians would donate blood in droves," he told AAP. In Canada the policy will result in a loss of 2.5 per cent of donors, in the US some 2.2 per cent but in Australia the impact would be greater, with a loss of 5.3 per cent of donors.
"We are a country of travellers and we know that 30 per cent of our donors have travelled to the UK since 1980," he said. Dr Keller said the risk may be reduced with less of an impact if the ban only applied, for example, to people who had lived in Britain for a year or more in the peak exposure period.
Meanwhile, the blood bank wants to ensure that people don't "self-defer", or decide to exclude themselves just because they've lived in the UK for a stint. "I urge all currently eligible donors to continue to support this vital community service on which potentially everyone in the community depends," he said.
Tue, Aug 17, 1999 By Robert S. Greenberger Staff Reporter of The Wall Street JournalWASHINGTON -- What do three rabbis, a Roman Catholic priest, a Seventh-day Adventist minister, an Eastern Orthodox cleric and a Buddhist who converted from Judaism have in common? The answer: They all are part of a lawsuit in federal court here against the Food and Drug Administration.
The suit charges that the lack of labeling of genetically engineered foods makes it impossible for religious people to observe dietary laws and customs. The religious plaintiffs are demanding mandatory safety testing and labeling. The lawsuit, filed in May 1998, adds a new and unusual twist to the debate over biofoods. Almost since such products started appearing on supermarket shelves a half-dozen years ago, critics worried that such experiments as splicing flounder genes into beets to make them resistant to cold could produce unpredictable results.
In Europe, too, memories of mad-cow disease, along with old-fashioned protectionism, have stoked antipathy toward U.S. biofoods. But the lawsuit filed by the religious officials charges, among other things, that genetically altered foods are sinful, unethical - and maybe not kosher.
"The religious groups add a vital aspect," says Andrew Kimbrell, who heads the Center for Food Safety, a nonprofit group that is litigating the action. "It brings in a lot of the ethical questions that allow the public to better understand this."
The religious group was assembled by Steven Druker, a peripatetic lawyer, Transcendental Meditator, Torah student and founding faculty member of Maharishi International University in Iowa. To Mr. Druker, 52 years old, the issue is very clear. In the Bible, Leviticus 19:19 forbids mating one species of animal with another, as well as sowing a field with two types of seeds. Companies and scientists who disobey this law, he declares, have "cosmic chutzpah."
The FDA doesn't see it that way. It treats the new gene combinations in biofoods just like the variations produced by more traditional breeding techniques; in neither case does the regulatory agency require mandatory screening or rules. "Do we see [genetically engineered foods] as being so different as to be put in a special class, and be treated differently and regulated differently? I say no," says Eric Flamm, senior policy adviser in the FDA's office of policy planning and legislation.
But if Mr. Druker prevails, and strict labeling is required, the consequences for the biofood industry could be huge. "The large concern [about labeling] in the back of everybody's mind is a boycott of products," worries Alan Goldhammer, executive director for technical affairs at the Biotechnology Industry Organization, a trade group. "That could have a serious economic impact." Mr. Goldhammer says biofoods have nutritional qualities that benefit consumers and agronomic qualities that aid farmers.
He adds that the religious plaintiffs aren't making a "cogent argument," because "a gene is a gene." He explains that when a cow gene is put in a tomato, "it's no longer a cow gene," because it has been chemically synthesized in a test tube.
Mr. Druker began to focus on forcing biofood companies to use labels in 1996. He had grown up in a not-very-observant Jewish household in Des Moines, Iowa. But about a decade ago, divorced and practicing law in Los Angeles, he joined a Torah study group. "I became more involved with Judaism and studying Judaism and believing that we do have a duty to uphold the integrity of God's creation," he says. Several years later, Mr. Druker began research for a planned book on the integration of religion, science and ethics. The more he researched, the more concerned he became about genetic engineering. He decided that the only answer to his concerns would be a lawsuit forcing food makers to at least label the ingredients of biofoods.
Mr. Druker says that one morning in August 1996, while praying in his apartment in tiny Fairfield, Iowa, he received guidance. "I don't want to come across as Joan of Arc," he says, "but I felt on an inner level a very strong inner feeling to go ahead and leave the book off for a while and go ahead" with the legal action. And so he began crisscrossing the country, gathering his Noah's Ark of plaintiffs, many of whom share his mystical spirituality and distrust of authority. In December 1996, on his first recruiting trip to the East Coast, he was put in touch with Jossi Serebryanski, a Brooklynite and Hasidic rabbi.
Rabbi Serebryanski is part of Judaism's cabalistic tradition, which focuses on the mystical dimension of the Torah and other Jewish law. He told Mr. Druker that he believes there is a spiritual energy in food, an energy he feels when he eats kosher foods. Indeed, he says, he has channeled that energy to help heal people. He claims it has taken him three to five minutes to heal carpal tunnel syndrome. Mixing different species in food results in "destroying the natural boundaries of nature," says Rabbi Serebryanski.
"No one is big enough to know all the damage that causes, and no one is big enough to repair it," he says. He signed on as a plaintiff. Mr. Druker signed up four others after he spoke at the July 1998 "Summerfest of the North American Vegetarian Society" near Pittsburgh. One listener linked him up with Father Samuel Kedala, a priest at her church, the Holy Spirit Orthodox church in Wantage, N.J. In his written declaration in the lawsuit, Father Kedala sounds an apocalyptical warning against biogenetic engineering.
It is the biofood industry's worst labeling nightmare: "Viewed from the Eastern Orthodox theological perspective, this process appears to be utilizing the infectious, destructive forces of nature in the creation of new life forms, which seems like a gross affront to the Creator's original design."
Mr. Druker's speech also caught the attention of the Rev. DeWitt Williams, director of health ministries for the Seventh-day Adventist church in North America. About half the church's 10 million members world-wide are vegetarians, he says. "The reason I'm concerned about genetic foods is that many are made from soybeans," about one-third to one-half of which have been genetically engineered, he says.
Ron Epstein, a child of the radical 1960s, was concerned about other living things, including insects. "The basis for all Buddhist teachings is respect for life," says Mr. Epstein, who converted to Buddhism from Judaism. He worries that the damage from biofoods, which sometimes contain insect genes, could be permanent. "If General Motors puts out a car, and it's got a problem, you can recall it; genetic changes are out there forever."
After three years of recruiting plaintiffs, Mr. Druker also even succeeded in finding common ground between observant Jews and Muslims. Both religions eschew pork products. Joseph Regenstein, a Cornell University professor who has written about biofoods, says the biofoods issue "is not a problem" for even strict kosher certification organizations. And Mr. Druker says he doesn't think there are any biofoods on the market that contain pigs' genes. But without mandatory labeling, he says, there's no way to know what is in biofood.
Insects, says Mr. Druker, aren't kosher, citing the Torah's proscription against eating "swarming, crawling creatures." The lawsuit is also crawling along, as Mr. Druker collects more religious supporters. According to one court document, the list recently consisted of: 113 Christians, 37 Jews, 12 Buddhists and 122 people who checked a box saying "my faith is not easily categorized."
Wed, Aug 18, 1999 ReutersTOKYO - Japan is considering joining Canada and the United States in banning the collection of blood donations from people who lived in or frequently visited Britain during the outbreak of mad cow disease. A Japanese Health Ministry official said on Wednesday that a committee has been discussing the issue for several months but has yet to reach a decision.
"This would be a strictly preventive measure, as there is no scientific proof the disease is spread through blood," the official added.
Blood banks in the United States and Canada were ordered on Tuesday to stop collecting blood from people who may have been exposed to contaminated beef in Britain. Officials said the move was to stop donors who had eaten tainted beef from passing on the human version of mad cow disease, a fatal brain disorder.
Japan was hit by a major scandal involving HIV-tainted blood supplies in the mid-1990s. The Health Ministry did not ban unheated blood products until December 1985, resulting in the infection of around 8,000 haemophiliacs with the virus that causes AIDS. [Japan has also had a bad experience with dura mater imported from Europe in iatrogenic CJD. -- webmaster]
Wed, Aug 18, 1999 Reuters World ReportBERLIN - Germany currently has no plans to join North America in barring blood donations from people from Britain to prevent the possible spread of the human equivalent of mad cow disease, a top medical official said on Wednesday.
"There are no plans in Germany to carry out such a measure. We have been discussing this issue for some time and the decision by the United States and Canada will add impetus to the debate," said Johannes Loewer of the Paul Ehrlich Institute. "But this is not a specifically German problem and would need to be discussed at European level."
Blood banks in the United States and Canada were ordered on Tuesday to stop collecting donations from people who spent more than six months in Britain during the mad cow outbreak. The Paul Ehrlich Institute, together with the Federal Chamber of Doctors, sets the German guidelines that govern blood donations.
Mad cow disease, or bovine spongiform encephalopathy, first broke out in British herds in 1986 and peaked in 1992. Scientists in 1996 identified a human equivalent, called new variant Creutzfeldt-Jakob Disease (nvCJD), which causes degenerative brain disease.
Loewer said the decision by the U.S. Food and Drug Aministration to bar blood donations from people who spent more than six months in Britain was "not particularly scientific" and noted that no case of the disease being transmitted by blood had yet been found.
COMTEX Newswire Thu, Aug 19, 1999EU may extend dioxin testing -The European Union may prolong for two weeks the period in which Belgian beef, pork and poultry must be tested for carcinogenic dioxin before export, an EU source said today.
The export testing of products containing more than 2% animal fat was ordered through Aug 31 by the European Commission after dioxin entered the Belgian farm food chain through contaminated feed shipments. Dairy products are exempt.
An extension through Sep 15 could be ordered by the Commission's Standing Veterinary Committee when it meets in Brussels Aug 24 and 25. The Flemish language daily De Morgen today said the currently used tests for the dioxin markers, called PCBs, are not considered reliable.
The paper quoted sources as saying a summer shortage of qualified civil servants has forced the EC to accept samples for testing taken by employees of the same companies whose products are being tested, a practice considered prone to fraud. The tests are being done at tens of thousands of meat export facilities.
Meanwhile, there is a virtual suspension of Belgian animal product exports. It was reported from Bulgaria that 3.5 tonnes of meat imported from Belgium had been incinerated in the furnaces of metallurgical plants because of fear of dioxin contamination.