BSE Tests Ignored -- Untested British Beef Exported
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BSE tests are ignored -- untested British beef exported
China suspends French wine imports, US wants labels
Germany refuses to lift ban on British beef
Additional nvCJD reported
Beef ban lifting celebrated
CDC investigates Seattle cluster
US to filter blood supply?
Risky reuse of medical equipment is on rise
Belgium In Desperate Bid To End Dioxin Scare
Growth hormone gene put in `Frankenfish'
Prion survives 15 years at 600 degrees?

BSE tests are ignored by the beef industry British beef not tested for BSE is exported

THE INDEPENDENT, August 2, 1999 By Charles Arthur Technology Editor
Comment (webmaster):
This is a timely article by Charles Arthur. The webmaster would like a published source for "an analysis in 1996 showed that for every BSE case reported, there were about 40 sub-clinical cases" but that figure seems reasonable. Annualizing 1040 1990 cases to 1560, which x 40 gives 63,800 BSE cases for calendar year 1999, a lot. Coupled with Schmerr's observation that PrPsc can peak in blood during the preclinical phase and decline by clincial onset, this is not a good situation. I think they were too hasty in resuming exports and should have established eradication first.

Tests which could identify cattle infected with bovine spongiform encephalopathy after slaughter are being ignored, The Independent can reveal.

As the Agriculture minister, Elliot Morley, tucked into a steak yesterday during a barbecue to mark the lifting of the European Union's worldwide export ban on British beef, experts and relatives of victims of new variant Creutzfeldt-Jakob disease (nv-CJD) expressed concern that the simple and readily available tests were not being used.

Although the number of BSE cases reported in Britain is more than 20 times higher than anywhere in the world, with 3,161 cases in 1998 and more than 1,040 so far this year, the EU has not required that beef for export to Europe be tested with any of three clinical tests validated by the European Commission (EC).

The father of one victim of v-CJD, caused by BSE, said that the lack of testing left him "speechless". Roger Tomkins, whose daughter, Clare, died in1998, said: "If there is such a test, it's in everybody's interest to identify the animals incubating the disease and get them out of the way as soon as possible."

The tests would be used to identify cattle in slaughterhouses which have BSE but no symptoms. An analysis in 1996 showed that for every BSE case reported, there were about 40 sub-clinical cases which would go undetected into food.

The Meat and Livestock Commission (MLC), which lobbies on behalf of the meat industry, said the use of a test would help revive the export market, which was worth £500m annually before the Government announced a link between BSE and v-CJD in 1996. "Once we have a test that is as foolproof as possible, we would press for its wider use," said John Pratt, veterinary adviser to the MLC.

But a number of tests have been put through trials. The EC carried out an experiment last year in which four companies with tests were sent unidentified samples, some from animals showing BSE and others from New Zealand-born animals free of BSE. The results, published last month, showed that three of the companies - Enfer of Ireland, Prionics of Switzerland and CEA of France - scored 100 per cent in identifying both groups. Further tests with diluted solutions from the two groups were also carried out, with similar results: the Enfer test, which uses a system developed by Proteus International of Macclesfield and can be carried out in four hours, scored perfect marks with a solution diluted by a factor of 30.

Arthur Rushton, chief operating officer of Proteus International, said: "The question is, why aren't people taking this up? From the scientific point of view it's hard to say what more is needed. These tests work." A spokesman for the Ministry of Agriculture, Fisheries and Food said: "We are looking at possible diagnostic tests, but we need to look at them carefully before deciding how to use them. The test results are important, but are only one step."

Mr Pratt said: "The question is which tissues you should test for sub-clinical BSE - its eems to migrate from the gut to the nerves, to the spinal column and then to the brain."

BSE Inquiry prepares to hear from final witnesses

PA News Mon, Aug 2, 1999  By Eileen Murphy, Consumer Affairs Correspondent, PA News
The public inquiry investigating the BSE crisis today held its closing session before preparing to hear evidence from its final witnesses. The inquiry has now been running almost two years and has so far heard evidence from more than 300 witnesses and published more than 500 written statements.

The London-based inquiry was set up in the wake of the Government's announcement of a possible link between "mad cow disease" and a new variant of Creutzfeldt-Jakob disease in humans in 1996. Chairman of the inquiry, Lord Phillips, said today that there was still a lot of work to be done and evidence to be considered before the final report could be written.

He said: "There is an immense amount of work to be done before we resume oral hearings. I have instructed the inquiry team to set about the task of analysing and synthesising the huge volume of background documentary material upon which we will wish to base a number of volumes of the report."

Lord Phillips said he anticipated that the inquiry still had to take oral evidence from about 40 witnesses and said hearings would resume on October 14 and continue into the new millennium. The BSE inquiry is set to report back in March next year.

The Department of Health today confirmed that up to June 30 this year there had been 43 definite and probable cases of new variant Creutzfeldt Jakob Disease (nvCJD) in the UK. The BSE inquiry has already taken evidence from relatives of those who have died from the degenerative brain disease which was linked to eating BSE-infected beef.

EU won't buckle to sanctions threat

7/21/99 "Appeal Democrat" 
BRUSSELS, Belgium - European Union officials were not swayed Tuesday by the threat of heavy U.S. tariffs and said they remain wary of American beef because -it is treated with growth hormones. They said they hope Washington will accept compensation from Europe rather than retaliate against the EU's ban on American beef with tariffs.

"We are ready to pay the price," said Henrik Dam Kristensen, Denmark's minister for foodstuffs. "We want to examine the consequences for consumers of hormone meat." EU officials also said they recognize the legality of U.S. threat to impose l00 per-cent tariffs worth an estimated $116.8 million.

China Suspends French Wine Imports

 Fri, Aug 6, 1999 AP
BEIJING -- China has blocked imports of French wine after reports that some used a banned blood product that could spread "mad cow" disease, a French official said today. Nine French vineyards were charged in July with using cow albumen to clarify wine despite a 1997 European Union ban, the official said.

China suspended imports on July 21 while it confirmed that the affected wine wasn't exported, the official said. He said French police seized the wine and plan to destroy it. France expects the suspension to be lifted as soon as it explains the case, but the Chinese official in charge has been on vacation and unavailable, said the official, who spoke on condition of anonymity.

The European Union restricted the use of cattle products after tens of thousands of British cattle were struck by bovine spongiform encephalopathy, commonly known as "mad cow" disease. The disease was linked to a new strain of a fatal human brain ailment, Creutzfeldt-Jacob disease.

Cow albumen had traditionally been used to remove particles that can make wine appear cloudy. Chinese trade and quarantine officials would not immediately comment. But state media have reported the suspension and say health authorities are testing French wines on sale in Chinese markets. France exports 2 million gallons of wine a year to China.

US senators propose warning labels on French wine

Thu, Aug 5, 1999 Reuters North America
WASHINGTON - A trio of farm state senators are proposing that the U.S. government put warning labels on French wine because of possible contamination from animal blood infected with mad cow disease. Sen. Pat Roberts, a Kansas Republican, joined two Democrats, Bob Kerrey of Nebraska and Max Baucus of Montana, in offering the legislation after news China had halted sales of French wine because of contamination concerns.

Despite the Chinese action, the senators' real motivation seemed to be to goad the French, who have staunchly opposed lifting a decade-old European Union ban on U.S. and Canadian beef from cattle raised with artificial growth hormones. "It is ironic that the French, who have long banned the import of U.S. beef products based on unproven 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, U.S. consumers are entitled to the same disclosure of information regarding French products," Roberts said. Before the EU banned the practice in 1997, some European vintners used a by-product of blood known as albumims to filter out impurities and sediments.

Last month French authorities caught 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."

A Chinese television report said state quarantine officials were worried about exposure to bovine spongiform encephalopathy, or mad cow disease. However, the report did not mention if any wine had been found to be contaminated. The senator's proposed legislation would amend the U.S. 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."

Additional nvCJD reported

DoH web site 2 Aug 99 and webmaster opinion
The Department of Health released statistics up to June 30 showing 43 definite and probable cases of new variant Creutzfeldt Jakob Disease (nvCJD) in the UK. This statistics page is back online after a one month hiatus in July. One additional nvCJD case is reported in the month, with death in July 1999 (showing rapid analysis of caseload).

The UK total is 43; the worldwide total is now 45, counting the French and Irish cases. The French bodybuilder injected bovine pituitary products and is atypical -- the question here is what has happened with other bodybuilders using this product.

The number of referrals to the CJD Unit is still running somewhat lower than they had predicted. Sporadic CJD remains puzzlingly low given that a 5-6 month course of disease would not allow earlier intensified surveillance to take away from this year's tally. No results are being released from the tonsil study which must be far advanced by now.

If this unknown and possibly non-existant methodological change is estimated by annualizing sporadic CJD for 1999 (22 cases) and bringing it up to the average for the last 3 years (51), and that multiplier (2.3) used on annualized nvCJD (6), an adjusted total of 14 cases of nvCJD would occur in 1999, similar to 1998.

Or the initial blip of early onset cases could have peaked with further peaks possibly to come over the next 50 years. These first cases cannot be explained by unusual or early exposure or by codon 129 alone (many millions of met/met in UK with occupational risk or more serious dietary exposure).

In the webmaster's opinion there is a purely genetic explanation for why these 43 individuals and not others because the met/met statistics are so dramatic. Met/met could be a red herring with it simply being tightly linked to a recessive real cause. The English still have not sequenced promoter or polyA regions as far as I know, despite striking results in sheep and in other amyloid diseases.

However, it need not be in the prion gene. No one has looked at microsatellite markers on the 43 cases. See Am J Hum Genet. 1999 Apr;64(4):1063-1070:

"...To study ancestral origins of the 200K mutation-associated chromosomes, we selected microsatellite markers flanking the PRNP gene on chromosome 20p12-pter and an intragenic single-nucleotide polymorphism at the PRNP codon 129. Haplotypes were constructed for 62 CJD families originating from 11 world populations. The results show that Libyan, Tunisian, Italian, Chilean, and Spanish families share a major haplotype, suggesting that the 200K mutation may have originated from a single mutational event, perhaps in Spain, and spread to all these populations with Sephardic migrants..."

CDC investigates Seattle cluster

KING5 TV King County Washington 1 August 99 and correspondence
Two victims within 10 miles of each other is odd, and CDC flew people in to investigate what they had in common, at the urging of the sister-in-law of the older victim. The age is obviously young but not unheard of for sporadic CJD, one age 40 and the other age 42. Both victims were "tall, thin, athletic and outgoing, and suffered similar symptoms" as described by the families. Common risk factors are unknown.

Officials at the Centers for Disease Control in Atlanta have requested medical records of William Lapp of Carnation and Matthew Look of Issaquah, Washington. Officials want to determine whether the men could have had a new variant of the disease related to the epidemic that killed people in England several years ago. The disease is not easily transmitted between people [this is unclear -- webmaster] . The fatal disease is called Creutzfeldt-Jakob disease, also called CJD, and it strikes without warning.

Two families in Western Washington are coping with the loss of their loved ones and they fear others in this area could be infected. Shelley Look was not sure what was happening to her husband. 42-year-old Matthew Look was a responsible business owner, husband and father of two, when suddenly he began acting strangely, but doctors could not identify the problem. Shelley Look now believes her husband died of Creutzfeldt-Jakob disease.

George Yapp¼s 40-year-old brother William was diagnosed in 1997 with the disease and died less than a year later. Both families said the men had similar symptoms, including a change in personality, memory loss and loss of their motor skills. Federal and state health officials are investigating both deaths. Doctors say CJD is extremely rare and they do not know what caused it.

The forty two year old reportedly has on his death certificate "presenile dementia" and while some early indictions spotted at the U of WA could indicate CJD, pathologists have yet to come to any concludions. The family has not received the final results from the biopsy. Dr. Kiet Ly, a state Health Department epidemiologist, has been asked to review the cases.

George Lapp, brother of the 40 year old who died April 11, 1998 has been in contact for the last 8 months with the Look family. One lab test for Mathew Look is back and positive for CJD. Two more results are not back and not yet confirmed for CJD, and the family is still awaiting the results. It does appear to the family at the least, it will be yet another case of CJD. Thus it is too soon to speak of a confirmed cluster. [Please do not attempt to contact family members with quack cures and questions. -- webmaster]

Deaths of two eastside men studied for 'mad cow disease' link

Aug. 2 /99 Seattle Post-Intelligencer AP
BELLEVUE -- Officials at the Centers for Disease Control and Prevention in Atlanta are , according to this story, investigating whether CJD, linked to "mad cow disease" caused the deaths of two Eastside men, and have requested the medical records of William Lapp, 40, of Carnation, who was diagnosed with Creutzfeldt-Jakob disease and died in April 1998, and Matthew Look, 42, of Issaquah, who died in May of unknown causes that researchers believe could be attributed to the same rare disease.

Creutzfeldt-Jakob, a fatal degenerative brain disorder, strikes about one person in Washington state each year. What raised the interest of CDC researchers was the relatively young age of the two Eastside victims: 90 percent of the people who die from the disease are over 55.

Dr. Marcia Goldoft, an epidemiologist with the state Department of Health, was quoted as saying, "Until the cases are reviewed, we will not be able to make a statement on whether the public should be concerned. If there are 10 cases, then that definitely is too many, but with two or even three cases, that could be a coincidence. But it's also prudent to find out what's happening because people are concerned, and they want to know."

Some of the most concerned people are, of course, the families of Lapp and Look. After watching their loved ones die of the rare, little-understood disease that mimics the signs of dementia, they are seeking answers. Amy Blakeney, who watched Look, her brother-in-law, quickly deteriorate before his death was quoted as saying, "It's a disease that, because of the way people die, you never forget it."

Beef ban lifting celebrated

AP Financial Sun, Aug 1, 1999 
LONDON -- With open-invitation barbecues, British farmers celebrated on Sunday the lifting of a three-year ban on British beef exports imposed by European regulators after an outbreak of mad cow disease. A supermarket chain offered free beef sandwiches to travelers arriving by train from France at London's Waterloo station, and government officials joined in some very public beef-eating before TV cameras at the barbecues.

But there is a long way to go to regain markets and try to re-establish confidence that British beef is safe, particularly in other European countries. The embargo crippled Britain's beef industry, which lost an estimated $2.4 billion in sales. "It won't happen tomorrow or the day after," said Tony Pexton, deputy president of the National Farmers' Union, who hosted a barbecue at his farm near Lancing, in West Sussex, southern England. "But let's start fighting for our markets back again."

The Brussels-based European Commission, which enforces rules for the 15-member European Union, imposed the ban after a 1996 outbreak in Britain of bovine spongiform encephalopathy. Medical researchers say the disease, commonly known as mad cow disease, is linked to a fatal human brain ailment, Creutzfeldt-Jacob disease, which has killed 43 Britons.

EU veterinarians approved the end of the ban, but British beef still will be subject to strict precautions. Meat must be de-boned and come from cattle born after Aug. 1, 1996, when a ban came into force on the feeding to animals of meat and bone-meal. Meat from cattle more than 30 months old will not be exported.

The first consignment of British livestock to be exported for the first time in three years is due at a slaughterhouse in Cornwall, southwest England, on Monday. The meat will be sent to France mid-August as the centerpiece of a marketing drive to persuade the French to buy British beef again.

Elliot Morley, a deputy Agriculture Minister in the Labor Party government, said the ban on sales of beef on the bone would continue until independent experts were convinced such meat was safe. "We are not going to take risks with people's health," said Morley. [When did this policy start? -- webmaster]

ministers And Farmers Upbeat As Beef Ban Lifted

PA News Sun, Aug 1, 1999By Michael Clarke and Eileen Murphy
Farmers were celebrating today's lifting of the European Union ban on British beef exports. The first consignment of British livestock to be exported for three years is due at a Cornwall slaughterhouse tomorrow. After being killed the meat will be left to mature for a fortnight before being sent to France where it will form the centrepiece of a new marketing drive to persuade continental shoppers British beef is safe. In 1995, about 277,000 tonnes of beef and veal, worth over 520 million pounds, were exported.

But British diners are still barred from eating beef on the bone, and junior agriculture minister Elliot Morley confirmed the ban would stay until independent experts were convinced it was safe. "We are not going to take risks with people's health," he said. He said the Government's chief medical officer, Dr Liam Donaldson, would produce a report on the subject at the end of August which would probably not be published until the autumn. And ministers would not lift the controversial ban until both Dr Donaldson and a separate advisory committee on human "mad cow disease" had reported.

Mr Morley said 43 people had died from new variant Creutzfeld-Jakob Disease (nvCJD) and the stakes were too high to risk lifting the ban. He said it was only tough action in the past that had persuaded the EU to lift the general ban on beef exports, imposed out of a fear that cows fed with animal remains had passed on CJD to humans. Meanwhile ministers were upbeat about today's lifting of the export ban.

Agriculture Minister Nick Brown said: "It is nearly three and a half years since the ban on British beef exports was introduced. These years have been a bleak time for the British beef industry. "The lifting of that ban today is an important breakthrough for the industry and marks a new opportunity to regain markets that have been lost over that period."

Mr Brown said that it had not been easy to convince some EU countries that they could have confidence in British beef but the Government had succeeded in arguing the industry's case. He added: "The job is not finished but the foundations for a better future are in place. I am sure that working together with the industry we can begin to rebuild confidence in British beef both at home and abroad."

Farmers around the country are gearing up to celebrate the lifting of the ban after declaring August 1 National British Beef Day. The National Farmers' Union said the day would be marked with a series of events. Barbecues, fun days and beef roasts will take place today at farms up and down the country with an open invitation to members of the public to join farmers in marking the occasion. Mr Morley was expected to visit Church Farm, Coombes, Lancing, West Sussex, to tuck into a roast beef joint with NFU deputy president Tony Pexton.

NFU president Ben Gill said: "This will be a chance for farmers and members of the public to celebrate together the excellent quality of British beef. "And we hope people up and down the country enjoying their traditional Sunday roasts will also choose beef. Our product is second to none and August 1 is a chance to demonstrate this."

Supermarket chain Asda is joining in the celebrations with a cheeky event offering European visitors to the UK a British beef sandwich as they disembark from the Eurostar train service at London's Waterloo station. A special bus, loaded with beef rolls, will park outside the station today and offer the free food to thousands of passengers.

More than 400 beef rolls were handed out, said a spokeswoman for Asda supermarket who organised the event. She said: "There seemed to be no suspicion at all about British beef and they liked the taste. They seemed to appreciate that, when an industry has been under the microscope as the British beef industry has been, then there must be a lot of safety measures in place."

... Chairman of the Scottish Quality Beef and Lamb Association, John Ross, told BBC Radio Scotland it could be Autumn before exports restarted. He said: "The commercial decisions that abattoir owners in Scotland have taken have to be based on whether or not it is likely to be profitable."

British Beef Export Finally Gets OK

2 Aug 99 The Associated Press
PROBUS, England - A government minister on Monday slapped an official approval stamp on the first British beef carcass destined for foreign consumers since exports were banned three years ago. European regulators on Sunday lifted the ban imposed after an outbreak of mad cow disease.

Elliot Morley, a deputy Agriculture Minister in the Labor Party government, stamped the 880-pound carcass brought into a slaughterhouse in Probus, Cornwall. The steer was one of 12 sent to the slaughterhouse. After being hung and deboned, the meat will be sent to France in mid-August as the centerpiece of a marketing drive to persuade the French to buy British beef again.

The European Commission in Brussels, Belgium, which enforces rules for the 15-member European Union, imposed the ban after a 1996 British outbreak of bovine spongiform encephalopathy. Medical researchers say the disease, commonly known as mad cow disease, may be linked to a new strain of the human equivalent, Creutzfeldt-Jacob disease, which has killed 43 Britons.

Beef exporters acknowledge they face a tough task in trying to restore consumer confidence. ``It is going to take time, there is no doubt about that, and we are not complacent about the task that faces us,'' Morley said.

New export conditions require a complete pedigree of each animal, date of birth and identity of their mothers, all movements recorded, and the animals must be aged between 6 and 30 months old when slaughtered.

More mad cow disease reported in France

1 Aug 99 The Associated Press
PARIS - A new case of mad cow disease has been reported in France, officials said Friday, bringing to 16 the number of cases detected this year. A milk cow in the central region of Puy-de-Dome was found to be infected with the disease, also known as bovine spongiform encephalopathy. The farm's herd of 40 cattle will be slaughtered this weekend, authorities said.

Since 1990, 65 cases of bovine spongiform encephalopathy have been reported in France. The disease causes holes in the brain, making cattle stagger and drool. There is no known cure. Scientists believe mad cow disease could be linked to an equally fatal human brain ailment, Creutzfeldt-Jakob disease.

Benefits of Filtering Blood Supply

ABCNEWS:  Thursday, July 29, 1999  World News Tonight (This is an unedited, uncorrected transcript.)
PETER JENNINGS The Centers for Disease Control reported today that the average lifespan of Americans has increased by almost 30 years since 1900 from 47 to 76. The century has seen such extraordinary advances in medicine, and so many infectious diseases have been wiped out. Simple math would tell us that if it goes on like this, the average lifespan will be well over 100 by the year 3000. Every year, four million people in the United States get a blood transfusion, and very often it saves their life. To make it clear at the outset, the American Red Cross says that the blood supply in the country is safer now than it ever has been. But they also acknowledge that with some more money, it could be even safer. In this report, every time you hear the word leukocytes, think white blood cells. Heres ABCs Deborah Amos.

DEBORAH AMOS, ABCNEWS (VO) Every year, blood donors give 12 million pints of blood for patients who need it to get well. However, white cells in the blood called leukocytes can make us sick, causing fevers, infections and weakening the immune system.

DR RONALD SACHER, GEORGETOWN UNIVERSITY MEDICAL SCHOOL Can the blood supply be made safer by leukocyte reduction? I believe it can be.

DEBORAH AMOS (VO) Normally, leukocytes are good. In our blood, white blood cells help fight off bacteria and viruses. But after donation, leukocytes die, then break down, spewing out chemicals that can be harmful. So if the blood supply could be safer by filtering out leukocytes, why dont most hospitals do it?

DR RONALD SACHER Its significantly expensive to leukocyte reduce all of the blood supply.

DEBORAH AMOS (VO) In Birmingham, Alabama, last year, the Red Cross began filtering out leukocytes.

CINDY WILLIAMS, CARAWAY METHODIST HOSPITAL ADMINISTRATOR The primary interest truly was patient care, the initial interest.

DEBORAH AMOS (VO) At Caraway Methodist Hospital, filtering drove up the costs per unit of blood by about 30 percent, enough to worry most hospitals and their accountants.

DR JAMES NEWSOME, CARAWAY METHODIST HOSPITAL So they come knocking on the door and say, What are you doing? Your expenses have gone up 30 percent.

DEBORAH AMOS (VO) But by using filtered blood, the hospital showed remarkable savings.

CINDY WILLIAMS We estimate, probably on an annual basis, we can save well over $1 million with just cardiovascular surgery patients. Their length of stay has dropped by over three days.

DEBORAH AMOS (VO) Last year, the FDAs blood advisory panel recommended all US hospitals eliminate leukocytes from the blood supply. But so far, progress has been slow. The Red Cross, which controls almost half of the nations blood supply, wants to go to 100 percent leukocyte filtered blood by the end of the year 2000. But hospitals still must be convinced that the extra costs will bring savings as well as safety. Deborah Amos, ABCNEWS, Birmingham, Alabama.

PETER JENNINGS To be very specific, the Red Cross says that in the United States, it currently filters out 100 percent of leukocytes, white blood cells, in four of its 37 regions.

Paying to Attract Blood Donors

ABCNEWS: Good Morning America Friday, July 9, 1999  (This is an unedited, uncorrected transcript.) 
MORTON DEAN, ABCNEWS The nation's blood supply is drying up. Fewer and fewer donors are volunteering to give blood. And to reverse the trend, ABC's Andrea McCarren reports blood banks are trying new ways to attract blood donors.

ANDREA McCARREN, ABCNEWS (VO) At this multiplex movie theater in Virginia, the crowd isn't here to buy tickets, it's here to give blood. Free movie passes are just one of the latest gimmicks to lure desperately needed blood donors.

AARON NAAS, Blood Donor If somebody gave me a car for giving blood, I'd be going every day. So, you know, a movie ticket's about the best alternative, really.

ANDREA McCARREN (VO) Although no one can explain why, donations nationwide are down more than 5 percent, while transfusions are up nearly 4 percent.

KAREN SHOOS LIPTON, American Association of Blood Banks Sometime within the next year, we're predicting that there's going to be a very serious supply and demand problem.

LINDA WILSON, Inova Blood Donor Services There's no substitute for the blood that's given by human beings for human beings. So we have to depend on people who will willingly come out and volunteer and give blood.

ANDREA McCARREN Even if it takes a movie pass.

LINDA WILSON Even if it takes a movie pass.

ANDREA McCARREN (VO) In San Diego, Chargers fans give blood just for the chance to meet players. (on camera) And one blood bank even teamed up with American Airlines to offer frequent flyer miles for plasma and platelet donations. (VO) In the past, a thank you was enough to motivate blood donors. Now, giving the gift of life seems to require a greater incentive. Andrea McCarren, ABCNEWS, Washington.

MORTON DEAN The American Red Cross has a new president. Dr. Bernadine Healey will replace Elizabeth Dole, who resigned earlier this year to campaign for president. Healey, a former head of the National Institutes of Health, will be the first physician to head the Red Cross.

Belgium In Desperate Bid To End Dioxin Scare

Reuters Online Service Thu, Jul 29, 1999 By Gillian Handyside
BRUSSELS, Belgium - In a desperate bid to convince its European partners it had contained the crisis over dioxin-contaminated food, Belgium said Thursday it had quarantined 175 more farms and would destroy all stocks of suspect food. But the measures, described as "drastic" by Prime Minister Guy Verhofstadt, failed to convince Denmark, which confirmed it would go ahead and ban all imports of Belgian meat from Friday.

In the latest move to end Europe's worst health scare since mad cow disease, Verhofstadt announced the destruction of all 115,000 tons of potentially dioxin-contaminated beef, pork, poultry and derived products held in Belgium and abroad. "All meat in stock -- pork, beef and poultry -- will be destroyed," Verhofstadt told a news conference, adding that the move would cost at least $158.8 million.

Belgium said earlier this week it would destroy suspect pork and processed pork products containing more than 20 percent fat, which have been impounded since early June. But it stopped short of ordering the destruction of suspect beef and poultry stocks. The EU has insisted all possibly risky products with a fat content of more than 2 percent must be destroyed, meaning foodstuffs now on the market would also have to be recalled.

Verhofstadt said the government had also added another 175 pig and poultry farms to its blacklist after new tests, more rigorous than those carried out by the previous government, revealed the presence in animal feed of polychlorinated biphenyls (PCBs) -- toxic chemicals which can indicate the presence of cancer-causing dioxins.

The tainted feed was supplied by the firm Versele, which used animal fat from Verkest, one of two fats processors identified as the source of the original dioxin crisis. The crisis, officially estimated to have cost over $1.5 billion in lost revenue, first erupted in late May. It triggered worldwide bans on sales of Belgian meat, eggs, dairy products and processed foods, and helped oust the former government in June elections.

Verhofstadt said PCB levels at the newly blacklisted farms were much lower than the danger limit set by the World Health Organization but above the stricter limit Belgian set itself. "We have set very strict norms and are showing extreme prudence.... This is a drastic policy.... It is the only way to solve the dioxin crisis," Verhofstadt said. "We agreed with the European Union that when we detected anything suspect we would quarantine farms and only lift the ban when tests showed they were contamination free. We are doing strictly what the EU demanded," he said.

Produce from these farms would be traced and checked to ensure everything on the market was safe, he said, adding that a few more farms might be blacklisted once the final results of the PCB tests were known. "There could be others, but not on this scale, he said. The prime minister, who took office less than three weeks ago, said senior EU veterinary officials and the 15 EU governments had been informed of the measures urgently Wednesday night.

Verhofstadt said he had replied to Denmark's concerns Wednesday over the safety of Belgian food exports. But Denmark continued to insist it had not received satisfactory information from Belgium. Verhofstadt said the cabinet proposed to set up by the end of the year an independent agency, answerable to the health minister and similar to the U.S. Food and Drug Administration, to control food safety from farm to table.

Spain Seizes Belgian Pigs

AP Online Thu, Jul 29, 1999
MADRID, Spain -- Spain's Agriculture and Health Ministries have ordered seized some 2,500 pigs and 3 tons of pork products imported from Belgium in a precautionary measure triggered by fear of dioxin contamination, authorities said Thursday.

Spain and the other European Union countries are waiting for the results of Thursday's EU Veterinary Committee meeting before they decide what to do with the pigs, according to a ministry spokeswoman who declined to be identified.

The pigs -- 1,500 of them from a farm in the northeastern province of Lerida -- are mainly piglets being fattened and were not yet due to enter the consumer market, the state-owned news agency Efe reported. This measure follows dioxin scares earlier this year with poultry and animal feed products imported from Belgium.

The Spanish government has criticized Belgium for slowness and lack of transparency in disseminating information on animals or products that may be contaminated by cancer-causing dioxins, the spokeswoman said.

Risky Reuse of Medical Equipment Is on Rise

Monday, August 2, 1999 Los Angeles Times By SYLVIA PAGAN WESTPHAL
Comment (webmaster):
This practise raises special concerns in regards to transmission of CJD as hospital sterilization procedures would have little effect on infectious agent.

U.S. officials say the largely unregulated practice has resulted in catheter tips breaking off in hearts, caused infections and created other problems. FDA action is imminent. Millions of medical devices that come in contact with blood or other body fluids and are supposed to be discarded after one use are instead being reprocessed and reused, putting other patients at risk without their knowledge, some experts fear.

The U.S. Food and Drug Administration is poised to crack down on the largely unregulated practice, which is escalating because managed care reimbursements are not sufficient to cover the costs of new devices. About 1 million disposable devices are reprocessed every year in the United States. Reports stored in government files document malfunctions related to reprocessed disposable devices, such as cases of cardiac catheters with tips that have broken off inside a patient's heart. Other incidents include infections caused by presumably non-sterile devices, as well as adverse patient reactions to bacterial toxins left after devices are cleaned.

The situation is most critical at hospitals, which often lack guidelines on how to reprocess a device. About one-third of all hospitals use reprocessed disposable devices, according to a recent survey. "It's a pretty grim scene, as far as I'm concerned, with what's going on in the hospitals," said Anne Cofiell at a recent meeting co-sponsored by the FDA and the Assn. for the Advancement of Medical Instrumentation. Cofiell represents workers at hospital sterilization facilities.

"I can tell you, just in general, there's lots of reuse going on with no protocols, no standards, no nothing," added Patty Stein of Advanced Sterilization Products. The FDA historically has not considered reprocessing illegal, openly exercising regulatory discretion with those who reprocess single-use medical devices. That includes hospital in-house reprocessing facilities, as well as a rapidly growing group of "third-party" reprocessors.

At present, the agency does not require reprocessors to demonstrate that a device is safe after it has been reprocessed. But that might not last long. In a recent letter to the Assn. of Medical Device Reprocessors, the FDA stated that "third-party reprocessing of devices labeled for single use is unlawful" unless reprocessors provide documentation that a device is safe.

Manufacturers also are urging the agency to take a stand on the issue of reprocessing. In May, the Medical Device Manufacturers Assn. requested a ban on use of reprocessed single-use devices. And recently Sen. Richard Durbin (D-Ill.), who is proposing legislation to force stricter regulations on reprocessors, asked the U.S. General Accounting Office to investigate the practice of reprocessing.

Caught in the middle of the controversy is the patient. Doctors are not required to inform patients that a reprocessed single-use device will be used on them. Also, the patient is usually billed the same amount, regardless of whether a device was new or reused.

"It is only a matter of time until the public becomes aware in large measure of the reuse situation," said Lynn Sehulster of the U.S. Centers for Disease Control and Prevention at the conference in May. "Will they tolerate this practice? This remains to be seen, but for now, reuse is largely unadvertised." The situation sets manufacturers, who want to sell as many new devices as possible, against the rapidly growing industry of third-party reprocessors, who cater to hospitals striving to save health care dollars.

According to the manufacturers, reusable devices are made of durable materials, shaped so they are easy to clean, and tested for multiple use. In contrast, says the association, single-use devices are engineered for only one use. "These devices are intricate, they have sharp points or tightly coiled wires, and they're often made of materials not used to withstanding mechanical or biochemical aspects of reprocessing," said Philip Grossman, a Miami gastroenterologist who is a consultant for manufacturers.

Widely reprocessed devices include electrophysiology catheters--long wires guided through a blood vessel into the heart that are used for measuring the organ's electrical activity. Also on the list are angioplasty balloons--thin inflatable devices that unclog arteries--and biopsy needles, used to take small tissue samples. İİİİİ

Rising Costs Drive the Practice

Even as the controversy unfolds, economic pressures are forcing hospitals to consider reuse of disposable devices more than ever. For example, the cost of two new cardiac catheters during a typical electrophysiology procedure can amount to about $2,000, said Mark Salomon of Vanguard Corp., one of the biggest third-party reprocessors. This is about 60% to 80% of the reimbursement for the entire procedure, including personnel and surgical costs.

Third-party reprocessors can save the hospital from 30% to 50% of the cost of the devices. If reprocessing were to be restricted, health care costs for hospitals would escalate, many argue. According to the American Hospital Assn., restrictions on reprocessing could "seriously affect both the quantity and the quality of health care we offer our patients." Roger Richter, a spokesman for the California Healthcare Assn., said he doubts that a ban on reprocessing will lead to higher reimbursements for procedures.

Reprocessors agree that not all single-use devices are reusable. In fact, Salomon said that out of the thousands of single-use devices, his company reprocesses only 15 types. Salomon said Vanguard will reprocess only those devices that can be successfully cleaned and sterilized. Reprocessing, when done well, does not pose a threat to patients' health, reprocessors say. But FDA files on adverse outcomes from reused disposable devices in the last few years would seem to argue the contrary. Some involve malfunctioning devices, such as three cases of electrophysiology catheters that broke during surgery.

In one case, the tip of the catheter remains lodged in the patient's atrium. In another, the 4-inch-long tip traveled from the patient's heart to his stomach, leading to additional surgery in which doctors opened the man's stomach in an attempt to remove the tip. The device's manufacturers say they are unaware of any cases in which such a catheter broke during its first use.

Also, cardiac catheters became contaminated with high levels of bacterial toxins in a Colorado hospital. "One death occurred from this particular outbreak, and these were definitely reprocessed catheters," said Trish Perl, an infection control practitioner at Baltimore's Johns Hopkins Hospital. But as emotionally charged as those incidents are, FDA officials stress that they are isolated, considering that tens of millions of devices have been reprocessed over the years. And even then, they say, it is hard to prove that a device malfunctioned or spread an infection because it had been reprocessed.

In fact, the FDA has many reports of new devices failing during their first use. And a number of tuberculosis and hepatitis C outbreaks have been linked to devices that were approved to be reused. "The problem all along, and the reason why we have not exercised any regulatory discretion, is because we have not had really good data with which to project that a certain amount of harm was occurring to the public," said Larry Spears, director of the division of enforcement at the FDA's center for devices and radiological health. The lack of adverse reports is not hard to envision in a system where tracking of reprocessed devices is poor, manufacturers say. Product failures are often registered as a problem with the device itself, without mentioning that the device was reprocessed.

Health professionals know that using a reprocessed single-use device can bring liability, a clear disincentive to report an adverse outcome. And there is no proper follow-up on patients on whom reprocessed devices have been used. Many participants at the recent conference agreed there is no good tracking, by either hospitals or doctors, of which patients have been operated on with reused devices. "So we don't really know what's happening to all of these patients. Sometimes complications that can occur look like the complications [that] occur from other things," Grossman said at the conference.

Few Safety Studies Have Been Undertaken

Independent, peer-reviewed studies of reused disposable devices are scarce. The few studies that have been done, experts agree, are not substantial enough to conclude that reprocessing disposable devices is either safe or unsafe. Other analyses abound that tend to incriminate or absolve the practice of reprocessing--but these are mostly sponsored by manufacturers or reprocessors, and the results tend to support the sponsor's point of view.

İManufacturers say all they ask of the FDA is a level playing field. Health care in the United States is based on the premise that devices and drugs need to be proven safe before they even go to the market. If it is not known whether reprocessing is safe, manufacturers argue, those devices should not be allowed near patients until their safety is proven beyond doubt. Right now, if a manufacturer wants to change the label of a device from "single use" to "reusable," the FDA requires it to submit documentation, called pre-market notification, showing that the change in use is safe.

But the FDA does not require third-party reprocessors to submit similar documentation, even though reprocessing essentially changes the classification of a device from single-use to reusable. In fact, manufacturers argue that many third-party reprocessors are not even registered with the FDA. Of an estimated 23 such companies, only seven are registered with the agency.

The FDA is considering several options. One is to force reprocessors to submit documentation that reprocessed devices are safe. The agency also could request manufacturers to prove that labeling a device as "single use" really means that it can't withstand reprocessing. "Absolutely, some simpler-looking devices labeled as single-use can maybe be reused. But the burden will be on the person [who wants to find out]," said Josephine Torrente, president of the Assn. of Disposable Device Manufacturers. In fact, some of the instruments being reprocessed, Vanguard's Salomon said, used to be marketed by manufacturers as reusable before the labels were changed to "single-use."

Others claim that in the past, manufacturers knew that hospitals were reprocessing their single-use devices, and it did not seem to be causing much concern. "So it appears to many of us that as long as it was just hospitals reprocessing any device, that was not a problem. But as soon as the reprocessors stepped on the playing field and took too much of the piece of the pie, then there was cause for a concerted alarm," said Kay Watson, who manages sterilization for the Texas Heart Institute. FDA officials said the agency hopes to have an official position on reprocessing of single-use devices by October.

Growth hormone gene put in `Frankenfish'

PA News Thu, Jul 29, 1999
Britain's sole Green parliamentarian today warned of an "environmental nightmare" after details of secret research into so-called "Frankenfish" were revealed. Robin Harper, a Green Member of the Scottish Parliament, demanded a full list of all experiments involving genetic modification being carried out by the government.

He said he was "horrified" at learning genetically modified salmon - which grew at four times the normal rate - were reared in Scotland. Dr John Reid, Secretary of State for Scotland, revealed details of the secret experiments in a reply to London MP Joan Ruddock. She had tabled a private member's question asking the Government to answer "persistent rumours" about the research.

Dr Reid said the work was carried out three years ago at Otter Ferry Salmon near Loch Fyne in Argyll. The fish were all destroyed after the experiment. He said: "Copies of a growth hormone gene from taken from Chinook Salmon were introduced into 10,000 Atlantic Salmon eggs. "The fish were grown in a land-based containment facility for up to one year. Approximately 50 of the fish grew at four times the normal rate, with no sign of abnormalities."

The fish farming industry is known to be looking at improving yields in salmon. The "transgenic" salmon grown in the secret tests proved that fish can grow to market size in 12 to 18 months rather than three years. That could double the turnover of salmon raised in tanks -- and potentially double the profit.

Ms Ruddock told PA News: "I have now got to the bottom of the persistent rumours that there have been experiments on fish in Scotland. "The results were obviously what they were looking for. If you can cut the costs of production and get the fish to market faster, you can maximise profits." Mr Harper said:" We have only just got details of this experiment, who knows what other experiments are going on at the moment?

"I will be tabling a question to the Scottish Executive demanding a full list of all GM experiments being carried out. "I know these fish were destroyed, but it could be done again and if huge monsters like this, with huge appetites, escaped into the sea they could devastate our already threatened fish stocks and do untold damage to the environment. Its a nightmare."

Later Mr Harper said there should be a ban on any future GM experiments. "Unlike the experiments going on right now with genetically modified crops which have already been let loose in the countryside, at least the dangers of GM salmon were realised and these fish were contained in tanks," the MSP said. "However, we should be extremely concerned about genetically modified fish because of the danger that they could escape into the wild.

"It's a similar, if not even more dangerous threat, to that we are facing with GM plants. If a GM fish escaped or was released accidentally in to the wild it could never be recaptured. This fish could breed with wild populations and devastate the existing natural balance with its modified behaviour.

"There can be no doubt as to the huge threat GM fish would be to fish stocks wherever they were released in the World's oceans. This fish if it escaped into the North Atlantic could do untold damage to the ecology both of the north Atlantic and Scottish salmon rivers. "A big problem now is the knowledge that this technology is available and is in the public domain. Someone else may be tempted to use this technology indiscriminately.

"Experiments on genetically modifying fish should never have taken place and should not be allowed in future. There must be a world-wide agreement that this particular line of inquiry should be declared a dead-end. "Scottish producers could lead the world in quality not quantity, the way forward for Scotland is organic salmon not GM salmon."

Prion survives 15 years at 600 degrees?

July 27, 1999 By Anita Manning, USA TODAY
"Deadly organism seems indestructible One of the world's leading experts on CJD, Paul Brown of the National Institutes of Health,calls it "probably the single most resistant organism on the face of the Earth. You can boilit, you can put it in formaldehyde, you can autoclave it for a little while, you can treat i with the usual disinfectants, you can hit it with ionizing irradiation - and it's like you didn't do anything," he says. "You can even bury it for two years. This is not to say that someof the agent under these conditions isn't destroyed. But the remarkable thing is that some of it survives. In experiments I haven't even published yet, I can tell you that some of it survives after 15 minutes' exposure at 600 degrees centigrade [original quote of 15 years was corrected on 7 Aug 99; the meeting tape was poor quality. The reporter thinks what Brown meant to say was that he had buried it for 15 years and then exposed it to 600 degrees centigrade.] Now that's a hell of an organism, and it's actually incompatible with biological life as we know it."

Comment (webmaster): That's the quote as it appeared in the newspaper. However, review of the mumbling on the tapes now indicates 15 minutes, not 15 years, was said. The questions that comes up are what sort of apparatus was used to maintain these temperatures, how was actual sample temperature measured, was sample dried, kept at atmospheric pressure exposed to air oxygen or hypobaric pressure in aqueous solution, how many logs of infectivity were lost? The main processes would be oxidation (which seldom reaches equilibrium), hydrolysis of bonds, and pyrolysis of various unstable amino acids and side chains. This account should be treated with great caution until a publication is available.

Germany refuses to lift ban on British beef

Tue, Aug 3, 1999 PA News By Eileen Murphy, Consumer Affairs Correspondent
Reuters World Report Tue, Aug 3, 1999 
BERLIN - Germany will continue to ban sales of British beef because of fears of mad cow disease despite the European Union's decision to lift an EU-wide embargo, German Health Minister Andrea Fischer said on Tuesday.

"We are agreed that the lifting of the import ban is too early," Fischer, a member of the ecologist Greens party, said after meeting health ministers from Germany's 16 federal states. Fischer said Germany would press the EU's executive Commission to introduce more stringent safety measures on imported British beef, which was banned in 1996. "The aim is to remove our concerns," Fischer said, adding that talks with the Commission were likely in October.

Germany, along with the other 14 EU members, is obliged to pass the EU ruling into national law. Fischer said preparations to do so were under way and so Germany was not technically breaking EU regulations by maintaining its own ban. The German parliament had been due to vote on the lifting of the import ban in September. Fischer said this would now be put back, however.

British beef was allowed back on to the shelves in most EU countries on Sunday. But Germany has been particularly loud in voicing its concerns about the safety of the meat. A global blockade of British beef was imposed in March 1996 after BSE, also known as mad cow disease, hit Britain's cattle herds and the government admitted a possible link with a new form of the human brain disorder Creutzfeld-Jakob Disease (CJD).

Germans, particularly sensitive to health and ecological issues, have been disturbed by the idea that British beef would once again be on sale across the country. Concern has even been voiced about accepting blood from British donors because of the risk they might be carrying CJD.

Germany said today it would continue its ban on British beef, imposed in the wake of the BSE crisis, because it feared European regulations allowing meat exports back on sale were not strict enough. German health minister Andrea Fischer, a member of the Green Party, said the domestic ban would be left in place until her government reconvened after the summer recess, and further discussions with the European Commission had taken place.

But the British Government said it believed the current regulations ensured British beef was now the safest in the world. A Ministry of Agriculture spokesman said: "We are aware that the Germans have requested further talks with the European Commission (EC) so that they can move forward to lift the ban while continuing to protect the health and interests of German consumers. "We welcome their willingness to talk about it. We never expected any of our European partners to overturn the bans in their countries in August.

"We also knew that some would take longer than others and that the Germans had concerns. They did vote against the lifting of the ban and we've never made an issue of that." The spokesman said Germany was not a "significant market" for British beef, but added: "We have convinced the Commission that British beef is safe and we are sure that the stringent conditions applied mean it is among the safest in the world."

After meeting health ministers from Germany's 16 federal states today, Ms Fischer told reporters that they had agreed it was too early to lift import restrictions. However, Germany - along with the other 14 EU members - is obliged to eventually lift the ban under European law.

The Meat and Livestock Commission, who are charged with promoting British beef exports abroad, said they believed German opinion would eventually come round. Terry Lee, head of export marketing, said: "We would be surprised if the Commission asked us to do any more. We suspect that when other countries start buying British beef, so will the Germans." Shadow home secretary Ann Widdecombe protested: "This is quite outrageous. "If these reports are proved to be true, the Germans are clearly acting in direct conflict with an EU-wide decision to lift the export ban on British beef. "If the European Union is to operate properly, all countries within it must equally observe its directives and decisions."

Agriculture minister of state Joyce Quin said the fact that the EU had lifted the ban on British beef was a "clear indication" that it believed the meat to be safe. In a statement, she said: "It is now up to all EU governments to abide by the Commission's decision and lift their own bans. "The conditions the Commission required the UK to meet before lifting the ban were extremely stringent. "The UK has met these conditions. British beef is now probably the safest in the world. "The German government is treaty-bound to lift the ban. We are sure they will do so."

A spokeswoman for the National Farmers Union said: "UK farmers have worked hard and taken every conceivable step to meet all the criteria under the date-based export scheme to assure the EU authorities and consumers that British beef is among the safest in the world. "This hard work has been fully recognised by the European Commission. "The NFU has always recognised that the restoration of lost beef markets was not going to happen overnight and that the number of exports was initially going to be limited. "However, it will be a great shame if certain member states tried to stop their consumers from enjoying a product which is now among the safest in the world."

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