Inquiry blasts ministers and civil service
New admission: 30,000 exposed to UK plasma
BSE blood went to 660,000,000 pounds of cattle feed
Compensation for nvCJD ... or just for cows?
BSE risk to US vaccines: FDA committee indifferent
FDA: a culture of corruption
Eyeopening web site on vaccine risks
US geneticist slaughters Yanomamos in vaccine experiment
Crohn's disease: another bovine disease cover-up
Fifth Queniborough death linked to nvCJD
Water buffalo claimed Canadian risk
Sat, 30 Sep 2000Opinion (webmaster): Like cockroaches in the midnight kitchen, responsible parties in England are scurrying to avoid the light shed by the Inquiry. Over and over, we hear the explanation "it was not my remit" (not in my job description), even from physicians (indeed a whole Dept of Health) actively participating in what may be the worst public health debacles in a century.
In the end, BSE and nvCJD were in no one's remit. And while said an "institutional failure", here too every institution did what was in its remit. So you see in the end no one was responsible. One is reminded more of an ant colony than a nation -- the anthill is collapsing but it is not in the remit of ants in the forager caste (or any other) to fix it.
The monthly statistics just released show an average increment of 4, though at least two confirmed cases were held back while the official count showed 84. In one cases, parents of a confirmed case not on the list inconveniently came forward with their daughter's story. There are 9 known cases still alive, not the 7 in the official statistics.
There is nearly a case a week of nvCJD now -- up from a case a month last year (+343%). This is said by authorities (and duly repeated by the press) to represent a 25% increase. Hello?
October 1 2000 Sunday Times Jonathan Leake and John ElliottFORMER Tory ministers are to be accused of complacency over the BSE crisis in an official report that will also criticise civil servants for knowingly misleading the public over risks from the disease.
Drafts of the report, seen by The Sunday Times, will also say government scientists concealed or delayed scientific findings that would have helped to explain the cause of BSE.
If ministers and officials had acted differently, the spread of BSE could have been contained earlier, says the report, which is based on a two-year inquiry headed by Lord Phillips, a high court judge and the new master of the rolls. Tens of thousands of people's lives were put at risk - and an estimated £4 billion has been spent trying to contain the disease.
A draft of the report adds that government policy at the height of the BSE crisis was not based on scientific evidence but "on a fundamental lack of it".
John Major's cabinet is criticised for rejecting plans put forward by Douglas Hogg, then agriculture minister, on March 19, 1996, that would have largely halted the sale of infected beef.
It was the day before Stephen Dorrell, then health secretary, was to announce that 10 young people had died from variant CJD, the human form of the disease - but Major and his cabinet decided the measure would do disproportionate harm to the beef industry.
The report refers to a phrase used by Hogg in the inquiry, in which he described Major's cabinet as a "disorganised rabble" over the issue. Hogg's proposals were implemented a month later after a public outcry.
Phillips will hand the finished report to Nick Brown, the agriculture minister, tomorrow. It will coincide with figures showing that the disease is still accelerating with the number of confirmed cases rising from 69 to 73, with another 11 "probable" victims.
The revelations will cast a shadow over the Conservative party conference which opens in Bournemouth today. Senior Tories fear speculation about the report's contents could dominate the news agenda.
The report says that John MacGregor, agriculture minister from 1987 to 1989, took a crucial decision to "slap down" advice from officials that farmers should be given compensation when BSE cows were slaughtered. The decision in February 1988 was not reversed until that August, but even then farmers were offered only half the value of an infected cow. It was not until 1990 that they were given full compensation, by which time, says the report, hundreds of thousands of infected animals had entered the human food chain. In total nearly 1 million such cattle were eaten.
Gummer is also criticised for his decision to feed a beefburger to Cordelia, his four-year-old daughter, in an effort to prove that the meat was safe. This has become one of the enduring images of the BSE crisis.
The report says Gummer's reassurances that beef products were safe, although made in good faith, flew in the face of scientific evidence such as the 1990 discovery of BSE in a cat - clear evidence that the disease could jump species. It contrasts such public reassurances with meetings Gummer was holding with officials to discuss the possible slaughter of the entire national herd.
The report singles out several officials, including Keith Meldrum - chief veterinary officer from 1988 to 1997 - who admitted having made no contingency plans to protect the public if BSE was found in humans.
This weekend few senior Conservatives would comment but it is understood that a senior frontbencher - possibly Tim Yeo, the agriculture spokesman - may address the issue. The option of including an implicit apology to the families of victims was under discussion.
Hogg said he was furious that the handover procedure gave the government three weeks to read the report and leak its contents before those criticised had a chance to see it. Of his former cabinet colleagues, he said: "They did not fully understand the gravity of what was about to burst upon them."
March 26 2000 Sheep flocks to be tagged and tested for BSE Government scientists have become so concerned about the threat of BSE appearing in sheep that they are setting up a national programme to test thousands of flocks. It coincides with a decision by ministers to order civil servants to draw up a scheme to tag all the nation's 40m sheep.
July 16 2000 US sheep may be infected with BSE from British feed Vets have found the first evidence that sheep could have become infected with BSE. Three flocks in America were this weekend being taken to laboratories for slaughter and examination after tests showed signs of the disease.
July 23 2000 Top scientist says BSE is in sheep flocks A Nobel prize-winning scientist has warned that there is increasing evidence that BSE, so-called "mad cow" disease, is endemic in British sheep.
September 3 2000 BSE inquiry will censure Tory ministers The official report into the BSE crisis will criticise former Tory ministers, including John Gummer, for being "too adamant" in their assurances that British beef was safe.
September 24 2000 New BSE outbreak linked to blood in feed Up to eight cows have contracted BSE in an outbreak that scientists believe could be linked to the continued use of bovine blood in cattle feed.
August 8 1999 Risk of BSE in vaccines revealed Four of Britain's most senior scientists downplayed the potential risk of the transmission of BSE to humans through vaccines to prevent a serious health scare.
November 14 1999 Comment - Two sides of beef Britain suffers from two self-imposed handicaps in its handling to the Anglo-French beef dispute.
November 21 1999 Beef war turns more Britons against euro The prospects of Britain joining the euro in the next parliament are fading fast because of a hardening of public opinion against European monetary union (Emu) and the heightened risk that the euro will slump below parity with the dollar, according to City analysts.
November 28 1999 Brown will lift beef on bone ban in two weeks The ban on beef on the bone will be lifted within the next two weeks, according to government sources, writes Eben Black.
June 1 1997 BSE is worst in imported beef Senior scientific advisers to the government are to warn ministers that beef imported from Europe poses a greater risk to the public than home-bred cattle, which are subject to stricter rules to control "mad cow" disease.
June 8 1997 Chickens in BSE scare Government scientists are investigating whether "mad cow" disease could have spread to chickens, writes Edward Welsh.
September 28 1997 'Mad cow' link to CJD proved Scientists have proved that "mad cow" disease has caused Creutzfeldt-Jakob disease (CJD) in humans. The final confirmation comes after years of uncertainty and will bolster calls for a full judicial inquiry and compensation for victims' families.
November 16 1997 Secret dumping of BSE-risk beef angers villagers A government agency is secretly dumping cattle carcasses with a high risk of BSE contamination at a landfill site.
June 7 1998 Modified gene will make cows immune to BSE Scientists are creating a genetically engineered cow that is immune to BSE in an attempt to ensure that the infection is permanently eradicated from beef.
March 24 1996 Scientists fear ban must now spread to lamb The safety of British lamb so far untainted by the BSE crisis is in doubt as fears emerge that "mad cow" disease (BSE) may have been passed on to some sheep.
Bogus health forms threaten BSE controls An illicit trade in bogus health certificates for cattle threatens to undermine government attempts to control "mad cow" disease (BSE), investigators fear. Their warning comes after a government vet was filmed apparently handing over blank certificates and cattle tags in exchange for money.
BSE: a scandal of dither and delay The disclosure that mad cow disease may endanger human health after all contradicts years of misleading assurances. Steve Connor and Michael Prescott report
True cost of cheap food A A Gill says that we have chosen to ignore the way low food prices have been achieved
March 31 1996 Entire herds face threat of mad cow cull Scientists advising the government are pressing for the slaughter of entire herds under emergency plans that will target beef and dairy farms worst hit by "mad cow" disease.
Beef eaters grab mad cow cover Beef eaters across Britain are rushing out to buy a new insurance policy called Human Mad Cow Insurance Protection, the first to cover the human equivalent of BSE
The culling fields Will the mass slaughter of cattle purge worldwide panic over BSE? Or will thousands of livelihoods still be in jeopardy? By Walter Ellis, Paul Nuki and Steve Connor
May 12 1996 British threat of EU walk-out over beef ban The cabinet is to consider disrupting the workings of the European Union unless it lifts the worldwide ban on exports of British beef.
May 26 1996 Tourists fight shy of mad beefeaters Who's afraid of BSE? French tour parties, German language students and Hungarian au pairs are shunning Britain this summer because they fear they will catch "mad cow" disease from Sunday roasts and steak and kidney pies.
June 2 1996 Revealed: Major went to war on beef to save Hogg's head The real reason for the timing of John Major's declaration of a "beef war" with Europe was revealed last night: he did it to save Douglas Hogg, his friend and agriculture minister, whose cabinet resignation would otherwise have been demanded by Tory backbenchers.
July 7 1996 French sell BSE cows to Britain French cattle with BSE have been exported to Britain, according to official information that has been withheld by the British government because of fears that it might offend a European partner.
July 14 1996 EU 'loses' vital mad cow papers Vital documents that could shed light on an alleged plot by Brussels bureaucrats to cover up "mad cow disease" are missing from the European commission's files, it emerged this weekend. July 21 1996
Cereal farmers to pay BSE bill Grain farmers are likely to have their huge European Union subsidies cut to help meet the cost of the BSE beef crisis
September 15 1996 Hogg puts beef exports at risk by reducing cull The cabinet will abandon plans to slaughter up to 147,000 cattle this week in a move which means the export ban on British beef will continue for years.
September 22 1996 Germans stand firm on beef ban Germany ruled out any compromise with the government over the BSE crisis last night by warning that its ban on imports of British beef would not be lifted until the disease was "completely eliminated" in Britain.
November 10 1996 Government to donate unsold beef to homeless As Marie Antoinette might have said: let them eat steak. Thousands of tons of unwanted beef are to be given to Britain's homeless, writes Paul Nuki
September 27 2000 London Times VALERIE ELLIOTTTONY BLAIR will decide whether compensation should be paid to the families of victims of nvCJD, the human form of "mad cow" disease. The issue is seen as particularly sensitive in government. A senior Whitehall source said yesterday: "The matter has gone to the highest level."
The conclusions of an inquiry into the illness by Lord Phillips of Worth Matravers will be given to the Cabinet next week. Ministers have accepted that they must take action if Lord Phillips makes a statement on liability. If he does not, the normal course would be for the liability to be determined in the courts.
Ministers believe that the victims' families have acted with dignity and tolerance during the three-year investigation, which has cost £40 million. The Government is also aware that it would be politically disastrous to pursue a lengthy court case in which it was perceived to be "haggling" over compensation. Ministers, however, still have no idea of the scale of the outbreak. "It is clear this is not a case where we will have to write out a blank cheque," a source said. "It is more like a standing order for we do not know the final number of victims."
Mr Blair has instructed ministers to be "particularly guarded" about the findings of the report. He wants them to refrain from making political capital from the illness which has already claimed 74 lives. There are another nine probable cases and the possibility of thousands more deaths. The Prime Minister is concerned that some ministers may use the report to criticise former Tory ministers and damage the Conservative Party conference next week.
A leaked Cabinet Office memo circulated to officials earlier this month said that there would be no compensation payments to victims or families of nvCJD, "without proof of legal liability". Some ministers insist that this is a holding position by the Government which is yet to recognise the political implications of the issue. Downing Street said yesterday that the memo did not represent government policy. Ministers will discuss the fallout of nvCJD next week.
There is anger among former ministers, civil servants and scientists that they are not to be told of any criticisms of them or their departments in the report until its planned publication date on October 26. They believe that once it is passed around Whitehall, it will be leaked and there will be attempts to spin the story.
An inquiry spokesman said that the panel would not show the report to witnesses who might be subject to criticism and that the findings were reserved for the Cabinet. Individuals criticised by the Scott Inquiry into illicit arms sales to Iraq were informed of the findings in advance. Some witnesses in the BSE inquiry are so concerned about the secrecy that they have complained to ministers.
Nick Brown, the Agriculture Minister, and Alan Milburn, the Health Secretary, are to seek guidance from the Speaker's Office. In theory, because the report is for Parliament, the Speaker must give permission for it to be shown to interested parties before MPs. There is no easy solution, however, because a successor to Betty Boothroyd, the former Speaker, is yet to be appointed and the post will not be awarded until MPs return to the Commons at the end of the month.
A government source said that individuals may be allowed to see extracts of the report that relate to them a few hours before it is published.
Tue, Sep 26, 2000 By Andrew Woodcock and Danny Kemp, PA News,Victims of the human form of mad cow disease today vowed to continue their fight for compensation, despite a leaked Whitehall memo suggesting that the Government will try to block any claims.
A report today claimed that ministers have been briefed to avoid admitting any Government blame for the BSE crisis, in order not to open the floodgates to compensation claims potentially running into billions of pounds.
Solicitor David Body, who is acting for 75 of the 83 known and suspected victims of "variant" CJD, told PA News that the instruction was not unexpected and would not stop the fight for compensation. And Roger Tomkins, whose daughter Clare died of nvCJD at the age of 24, said: "I feel very strongly that those who are to blame should be accountable. A debt is owed."
All claims for compensation by victims and their families are presently on hold, awaiting the publication on October 26 of Lord Phillips' report into BSE, drawn up after the largest public inquiry in British history.
According to the Daily Express, the leaked memo advises ministers to steer clear of blaming the previous Conservative government for the disaster, even if Lord Phillips points the finger at Tory mistakes or negligence.
The paper quoted the memo as saying: "There will be considerable pressure on the Government to accept the inquiry findings and apportion blame. "But to do so would be to risk incurring unforeseeably large expenditure, depending on the scale of the human disease, for which there would otherwise be no legal grounds."
Legal advice obtained by Whitehall suggests that victims and their families would have little hope of persuading a court that their sufferings are the Government's fault unless a minister admits liability, the paper said.
Mr Body, of Sheffield solicitors Irwin Mitchell, told PA News that he was hoping to reach an agreement on compensation without having to resort to litigation. But he added: "For the Government to completely rule out compensation at this stage -- as this document apparently does -- is premature, because they don't have the substantive findings of the inquiry in front of them. "We are open to this matter being resolved out of court as part of the broad resolution of the problems emerging from the BSE epidemic. But I have many clients who are determined enough to take this to court if necessary.
"There is a precedent in the litigation over people who contracted CJD >from human growth hormone. "In that case, we offered the Government a scheme to provide for compensation. The Government turned it down flat, went to court and lost."
Mr Body said it was impossible to predict the final compensation bill for victims of CJD, as scientists believe the disease's incubation period may last decades, creating new victims throughout the first half of this century.
But he added: "Compensation was offered for cows which were culled without any thought that it would eventually cost more than 4 billion. "I don't see why the same principle should not apply to people. Otherwise we are making a distinction in favour of compensating for cows rather than for people."
Mr Tomkins, from Norfolk, whose daughter contracted nvCJD despite being a vegetarian, said he would be "extremely disappointed" if the Government tried to resist paying compensation. He said: "I would be extremely disappointed if they have taken that view, bearing in mind what we families have suffered and will continue to suffer.
"I have made no secret of the fact that my daughter's death could have been avoided. Had the appropriate decisions been made at the outset of the BSE crisis, then I have no doubt Clare would still be here today. "To me, the people in authority who took the decisions to risk people's lives are responsible and should be held responsible for my daughter's death. Therefore I feel very strongly that those who are to blame should be accountable. A debt is owed."
Clare, a pet shop supervisor, gave up eating meat in 1985, but started showing symptoms of nvCJD 11 years later and died after lengthy and distressing illness in 1998.
Mr Tomkins said: "It is devastating for my family and for many other families. Now every time I walk past a cow on a farm, a butchers' shop, a hamburger restaurant, they all come back to me as a potential cause for the death of my daughter. It's something I am going to have to live with for the rest of my life."
Reuters World Report Mon, Sep 25, 2000Britain's ruling Labour Party will resist paying compensation to the human victims of "mad cow" disease, the Daily Express newspaper reported on Tuesday. Around 70 people have died in Britain from new variant Creutzfeldt-Jakob Disease (vCJD), the human form of bovine spongiform encephalopathy (BSE) which first broke out in British herds in 1986 and peaked in 1992. Four years later scientists identified nvCJD, which destroys the brain. The Express quoted a "confidential" Cabinet paper as saying: "The Department of Health's general policy is that there will be no payment (to people) of compensation without proof of legal liability." It quoted David Body, a solicitor acting for dozens of CJD victims, as criticising the government for compensating for the cost to farmers of culling affected herds of cattle while ignoring the plight of human sufferers. "Otherwise, we are making a distinction in favour of compensating for cows rather than for people," Body is quoted as saying. The Express said the report is expected to be published on October 26 after parliament returns from its summer break. In an editorial, the Express added: "(Prime Minister Tony) Blair and his colleagues must do more than try to hide from the BSE fallout. They must pay out to those who suffer."
Mon, 24 Sep 2000 Jonathan Leake London Sunday TimesOpinion (webmaster): This is rather a fuller length version of the earlier bovine blood story and differs in significant details: There is this continuing confusing over the number of BSE cases for 2000, the MAFF web page clearly showing 1326 confirmed cases to date, this story saying 850, and a Maff press release today saying 30 a week. The other bizarre numbers have to due with nvCJD, reported in Maff press releases today to be 70 whereas the Dept of Health posted on the official tally web page "to 4 September 2000. Total number of definite and probable cases of nvCJD = 82" which does not count 2 French and one Irish case. Gelatin used in cattle feed is worse than we imagined: " For gelatin there were even bigger question marks. The material includes the crushed vertebrae of slaughtered cows - a process that can easily incorporate remnants of the spine, where huge concentrations of prions can build up in infected animals. " Mysterious new cases of BSE are emerging. Some experts believe dangerous loopholes remain in government measures to make the food chain safe. reports The call to the ministry came early in the morning. A Devon farmer, concerned at the stumbling gait and aggression of one of his cows, had rung in to report another case of BSE - mad cow disease.
Vets working for the Ministry of Agriculture, Fisheries and Food (Maff) normally take two or three days to visit a suspect animal, but this case, in May, was different.
The sick cow, said the farmer, had been born more recently than any other he had seen with the disease; in fact, it had been born after a ban on infected animal feed that was supposed to stop the BSE epidemic. By Maff's calculations, there was no way the cow could have caught BSE.
Vets hurried to the farm and the animal was killed within the hour, beheaded, and the carcass sent for incineration. Soon afterwards a brain examination confirmed the worst - the cow had been suffering from BSE.
For Maff it was devastating news. In 1996 it announced it was putting an end to the farm practices that had turned cows into cannibals, eating the minced-up remains of other cows. Sweeping rules banned the feeding of all mammalian meat and bone meal - which was seen as the cause of BSE - to farmed livestock.
So how could this cow have caught the disease? Maternal transmission was considered, but its mother had been fit and healthy and had never been exposed to infected feed. In the four months since the case, an intensive investigation has still not determined how the cow was infected. Worse, the casualty list appears to be growing.
More than 850 cows have been diagnosed with BSE this year - but they were all born before the feed ban in 1996. This week the Sunday Times has learnt that eight more animals born after the ban in August 1996 have also been diagnosed as likely BSE casualties.
Some experts have warned Maff for years that the disease might spread through new and unexpected routes.
Professor John Collinge alerted agriculture ministry officials to the danger in the early 1990s. He was later drafted onto the Spongiform Encephalopathy Advisory Committee (Seac), which advises the government on how to handle the disease in animals and humans.
In 1996 he and Professor Peter Smith, now acting chairman of Seac, were also invited to meet Tony Blair, then leader of the opposition, and Harriet Harman, shadow health secretary. Collinge told the future prime minister that the only way to stop the epidemic was to impose strict controls on animal feed manufacturers to prevent any cannibalism.
That message, repeated to government ministers by Collinge and other scientists, had some impact. Soon afterwards Maff introduced its ban on mammalian meat and bone meal - but it left three loopholes. Maff decided that animal blood, gelatin and tallow could still be fed to cows. At the time all three were considered safe from infection.
With hindsight, the reasoning behind this looks highly suspect. Blood was excluded because prions - the agents that cause BSE - had never been found in it. Yet tests are fallible and prions occur in the blood of most other species affected by BSE.
For gelatin there were even bigger question marks. The material includes the crushed vertebrae of slaughtered cows - a process that can easily incorporate remnants of the spine, where huge concentrations of prions can build up in infected animals. In January 1996 Seac discussed this risk - and dismissed it because the chemicals used to process gelatin were, they decided, likely to render the prions harmless.
The minutes of Seac show, however, that there was little scientific evidence for this. In fact, having decided to allow gelatin they then decided to ask the manufacturers what evidence they had for its safety.
They received predictable reassurances - but it is only now that independent work is being done to establish the facts by scientists at the Institute of Animal Health. Professor Chris Bostock, director of the institute, confirmed: "As far as gelatin is concerned, the jury is still out."
For many people even the slightest hint of risk in retaining such cannibalistic practices would be enough to ban them - but not so for this or the last government.
In a statement this year Baroness Hayman, minister of state for agriculture, said: "Gelatin and blood products are exempt from the feed ban in both EC and UK legislation. Such materials are not widely used in animal feed in the UK."
According to the agriculture ministry, about 22,000 tonnes of feed containing the products are given to livestock, predominantly cattle, each year. [This works out to 660,000,000 pounds of material over the course of the epidemic -- webmaster]
"John Collinge has always been against [that practice]," said Harriet Kimbell, a lawyer expert in civil litigation who serves on Seac. "But we were assured that there is no infectivity in blood and so we allowed renderers to continue to use it in feedstuffs.
"If Bostock's work shows blood can transmit the infection, we will have to reverse that decision immediately." Bostock recently announced research showing that the blood of sheep incubating BSE can infect other animals when transfused into them.
However, Bostock remains cautious about applying his findings to cattle because prions are known to behave very differently in sheep and cattle. He points out that prions have never been detected in the blood of cows with BSE.
Bostock is, like Collinge, a member of Seac and has sat through several meetings that have discussed the safety of blood, gelatin and tallow in cattle, humans and sheep. His argument - and that of other members of the committee - has been that unless such materials could be shown to be infectious they should not be banned.
Such an approach is dismissed by Collinge, who said: "Just because there is no evidence that infection is happening does not mean it isn't. After our experiences with BSE, we should be taking a much more cautious approach."
It is an old scientific adage that absence of evidence is not evidence of absence: bovine blood could contain prions in concentrations too low for current tests to detect.
For those who have lost loved ones to variant CJD, the academic arguments are infuriating. Most believe that the government should simply insist on every precautionary measure available - including banning any remaining form of cannibalism.
The Callaghans are one such family. Five years ago Maurice Callaghan died an agonising death from the disease. He had married two years before and Clare, his wife, had borne him one child and was pregnant with his second. She gave birth 10 days after his death and has spent the years since worrying that her children may also be infected - although there is no evidence of paternal transmission.
The family is, however, aghast that other people may still be put at risk because the government refuses to implement a full ban on feeding the remains of cattle to cows, which are herbivores.
The risks may be small, but Collinge's concerns about whether BSE can be transmitted in blood raise terrible questions about variant CJD. If BSE can be transmitted by blood, are humans still at risk of contracting variant CJD? Is there a possibility that the disease could have been passed on by victims who gave blood before they were diagnosed?
More than 86 people have died from or been diagnosed with variant CJD and that number is expected to increase next week with the release of the latest figures.
On the same day the report of the BSE inquiry will be handed to ministers. But experts are still divided on the issue of blood. Some believe the dangers are too small to measure - and anyway, the trade in feed using blood is declining.
Others, like Collinge, believe the record of the past two governments on BSE is one of doing too little, too late, and that there must now be a full ban on feeding animal parts to cows.
Opinion (webmaster): The appallingly arrogant and ill-informed FDA meeting to decide BSE risk to US vaccines is reprinted below. The meeting basically degenerated into a discussion of how to avoid accurate labelling.
FDA has now allowed bovine-to-human blood transfusion, as reported in wire service stories Mon, 25 Sep 2000. It seems that some company has a bovine red blood cell in saline product that the FDA allowed in human transfusions. While the bovine blood was described as "highly purified" and the use was touted for Seventh Day Adventists, were all cell surface antigens really removed (beyond the most flagrant blood groups), leaving the bovine prion for example anchored on the cell surface. How was it determined that the source herd was TSE-free?
TSE Advisory Committee 7/27/2000 pdf "...I feel the need to say something. It's theoretical. I agree with your sense of how often it's going to occur totally. What could we do? What could they do? DR. SNIDER: This is Dixie Snider. Yeah, we can hear from him, but you made a criticism of my comment, and I just want -- I thought it might be useful to have something to go along with their U.S. Today story that they were reading. That's all. Something that's authoritative from the FDA. CHAIRMANBROWN: I'm glad I'm the Chairman of this committee, not this committee. DR. RATZAN: If I could try to answer that, there is a scientific nature to how do you look at communication. You don't overreact to infinitesimal risks, and at the same time you don't under-react when there is a real risk that's involved, because that does undermine the public trust. What I heard today were some of the steps that were being taken by some of the manufacturers, the two that presented, that they are trying to embody the public trust in terms of their processes. I think more of the open nature, even meetings like this of being able to have advisory meetings, meetings also that might have the professional associations where you have opinion leaders who might be able to defuse the information appropriately. A blanket communication -- We often say Marshall McCluhan, a Canadian scholar in media, said, if you try to reach everybody, you reach nobody. By doing that, it's really key in thinking about communicating with the people that need to know. Ninety million Americans are either marginally or low literate, meaning they can't understand a bus map or can't understand a bus schedule or locate their intersection on a map. We can't communicate with the same message to them that we might communicate to people who are making vaccine decisions at the state or county or other levels. So I'm answering in a circuitous way, because I think we've heard some of the right steps being taken today, the open hearing, some of the voluntary efforts that are being done in good faith by the manufacturers, and some of the other ways that continue to monitor the open disclosure. I think the surveillance systems that we've put in place not only here in the United States but now abroad in looking at BSE and looking at the CJD that we heard from CDC and others where the numbers are. So I would say, by all means, keep the surveillance. Keep the voluntary efforts. Continue to focus upon the science, and communicate that appropriately on, whether it's a quarterly basis, or use the different channels, the Institute of Medicine channels that are out there. I think there's a variety of different expert committees as well. So, thank you. CHAIRMAN BROWN: Thank you very much. Yes? MS. FISHER: You may not want to communicate this theoretical risk to the public, but that doesn't mean it's the right thing to do. I think that part of what the National Childhood Injury Act of 1986 was all about, the safety provisions, was communicating risk to parents before they get their children vaccinated. I think that, you know, the FDA's charge is to ensure the purity and potency of vaccines. It seems to me that the least that we can do at this juncture when we know something is to let the people know we know, rather than keeping it from them. CHAIRMAN BROWN: Hold on, Dave. Shirley? MS. WALKER: There's an old German proverb, "Don't point the devil on the wall; otherwise, he will jump off." I think the devil has already jumped off. The inserts in the packets for pharmaceuticals are great. Notification to the doctor is great. But I represent something like 79,000 mothers who have children in Dallas County who we actively promote to get vaccinated. So Monday morning when I go back to work, I'm going to have to tell someone, a percentage of these young mothers, that, hey, your child is at risk for whatever that minute amount is for CJD. So what do we do at this particular point? Do we remain mute and say nothing or do we promote and give some type of information? So I am saying to FDA that we do need some kind of general information that we can impart to our constituents. CHAIRMAN BROWN: Thank you. I'm going to ask for just a couple of more comments in this discussion, and then in the event that a number of people on the committee may have to leave, there are two or three very specific questions that the FDA would like some discussion-on, and I want to move to them. We've touched on some of them already, but if there's anything more to say on this -- Yes, go ahead. 263 DR. STEPHENS: I guess I'm really concerned that this discussion is kind of spinning out of control in terms of the risk. I must agree with the consumer advocate who spoke a minute ago -- CHAIRMAN BROWN: Dr. Ratzan. DR. STEPHENS: -- that, you know, this is -- We are at some -- We have a duty, in my view, to protect the vaccine system in this country. I think that this discussion has gotten to the point of at least suggesting that we believe that this is a significant problem. The data suggests that the risk is in the billions, that there have not -- there's not been a single case of new variant CJD in this country, despite the use of vaccines manufactured in this way for years. So I think the issue is we need public disclosure. That's not the question. I think we all are in agreement on this committee, but I think to emphasize this point where you're concerned about going back to your group of mothers and saying there's a risk -- I think that's something we don't want to send. That's a message we do not want to send. CHAIRMAN BROWN: I opened this whole seminar with the notion that we're starting from a very, very small amount of infectivity, if there is any, and that there is a tradeoff between, as several people have said, a theoretical risk and a real risk, which would be discrediting in some way vaccines or causing vaccine shortages or difficulties or refusal to get vaccines. In other words, this is the tradeoff. Right at the outset, this was the scene that I hoped to set. But you're right. All of our committee discussion meetings tend to spin out of control at about this time of the afternoon, and sometimes it's in one direction, and sometimes it's in another direction. I think the word risk has enlarged as the afternoon has progressed, and maybe we should shrink it down a little bit and get a little better perspective or a little different perspective. So I tend to agree with you. Let me -- DR. BOLTON: Paul, can I get in my comment? CHAIRMAN BROWN: I'm sorry? Go ahead. BOLTON: I agree that it would be important to communicate known risks or even good estimates of risk to the public, but I'm not sure what that estimate would be at this point. I don't think that we really have enough information to communicate to the public and have it be meaningful and not simply scare people away. I can't imagine the negative impact on the program in this country if parents started thinking that, if I vaccinate my child, he or she may come down with new variant CJD. To me, the other way that we communicate is by action. It seems to me that there are actions that can be taken in terms of looking at the process of vaccine manufacture and where the real -- the greatest of the theoretical risks are. It seems to me that the viral/bacterial master seeds are really at the very lowest end, as are the master cell banks, and also trying to change those creates the biggest problem. >From that point on, from the working seeds on down through production, I think that the manufacturers have issues that they can address in terms of removing the use of at-risk bovine materials from that point on. I guess my question to anybody at the FDA is: Are at-risk bovine materials currently in use at the -- certainly from the production step on, and even at the production of the working seeds and working cell lines, are they in use now, and how long before they will be phased out? CHAIRMANBROWN: I guess what you're -- to add to that, are the sources of anything currently coming from BSE designated countries? DR. STEPHENS: When I say at risk, I really mean those bovine materials are coming from Europe or at-risk countries. CHAIRMAN BROWN: Right. Does the FDA -- You might be better off -- DR. EGAN: As I mentioned in my opening talk, for some bacterial vaccines there was bovine derived fermentation media where that skeletal muscle and pancreas derived from several European countries. I think it was Germany, Denmark, Poland, the Netherlands. CHAIRMAN BROWN: Right. So they are currently in use in this country. DR. EGAN: They have all agreed to -- That will be changed, but as I mentioned, by the time -- You know, they've gotten new sources, but that comes into new vaccines -- What? DR. BOLTON: Is that the only material that's now sourced from at-risk countries? DR. EGAN: That's used in the production. I think I also mentioned hemin. I think that was it, but I'd have to go back to it. DR. BOLTON: So I guess my recommendation would be that the FDA work with the manufacturers to set a definite timeline to phase out all those materials. In terms of the master virus seeds and the bacterial stocks and the master cell lines, I think that the risk is so small as to be really counterproductive to try to change those, because the risk of changing the product by changing those is much, much greater than any risk that there would be from proceeding. CHAIRMAN BROWN: One of the questions that the FDA specifically wanted some judgment on was: Is it necessary to re-derive bacterial master seeds? I mean, I'm getting the sense -- Every time I get the sense of something, the sense changes. You know, we had a consensus about informed consent, and now we have a consensus about not smother it, but be awfully, awfully, awfully careful. Now I thought we had pretty much decided that, at least for current products, that it will not be necessary to re-derive bacterial master seeds. That was my sense. Dr. Huang? DR. HUANG: I completely agree. I think that the derivation of new master seed stocks would be more dangerous than this perceived danger that we are facing now. CHAIRMAN BROWN: Does anybody -- As I asked before, does anybody differ from that opinion? All right. We have answered one definitive question that the FDA wanted to asked. They also want an answer to a question I think should be very easy to answer. That is: Is 1980, form all that you have heard, an appropriate cutoff date before which one need not worry about anything in terms of sourcing of the products we are talking about? We always worry about something, but 1980 -- is that an appropriate date before which not to be concerned? That's a pretty focused question. Is there anybody that feels that one should be concerned about products produced before 1980 from anywhere? Yes? DR. ROOS: I think 1980 sounds like a good year, Paul, and with respect to our blood donation pool in the United States,'we were concerned about BSE and started with 1980. CHAIRMAN BROWN: It has the merit of consistency as well. All right. That's two questions. The third question they were concerned about was: Do we think that the small amount of fetal calf serum from the U.K. around 1985 used in the production of master cell banks constitutes a negligible or -- well, the phrase was "a negligible or a significant risk"? Again, a question about fetal calf serum, sourced from the U.K. in the middle of the 1980s, use in the production of master cell banks constitutes any kind of significant risk? Yes? DR. CLIVER: May I start by saying negligible. We'll see if anybody disagrees. CHAIRMAN BROWN: Do I hear significant? Negligible? DR. BOLTON: I agree that it's negligible. CHAIRMAN BROWN: Okay. Any differing opinion that fetal calf serum used for the production -- just for this specific purpose, used in the production of master cell banks? Well, that answers the three questions that you most wanted some judgment on Dr. Ewenstein? Dr. EWENSTEIN: There was also the products that are still under investigation. I think, you know, we should address that. I think one of the comments before was, I think, right on the point. That is that it's different if you have a licensed drug or product that has, therefore, documented benefit versus recruited volunteers. I think we should think about what we should answer for number 3. I think that it's appropriate to include again, with the correct caveat, about theoretical and negligibly small risk in a consent form. but I certainly wouldn't like to see all clinical trials stopped of such vaccines. CHAIRMAN BROWN: Yes. This is the idea about an investigational drugs. We haven't touched on that, and we might just continue that discussion a bit. Peter? DR. LURIE: Yes. I think Dr. Ewenstein is right, if I understood him correctly. I think that it is indeed a different situation. For one thing, not only is the benefit of the vaccine unknown, but for another, one actually does know the name of the patients, and one is personal contact with those patients on a semi-regular basis. I think that the ethical responsibility toward those people is quite different than is owed to the population at large......"Opinion (webmaster): The composition of this committee raises many questions as to who here repreesents the public interest. For example, committe member Scott Ratzan has no meaningful background in BSE, vaccines, or biomedical research True, he is Editor in Chief of the 'Journal of Health Communication' but this is a vanity journal he founded in in 1996 that contains all 17 of his publications.
Who would put this person on an FDA BSE vaccine safety committee and with what would be their agenda in doing so:
By Scott C. Ratzan The Wall Street Journal (May 11, 1997)
"It has all been much ado about nothing. Based on available scientific evidence, we can be virtually certain that mad cow disease poses no threat to humans. ...the CJD-mad cow hypothesis turned out to be wrong. We still don't know how humans contract CJD. But what is clear is that people don't get it by eating meat from cows or lamb.... Yet the scare continues, fed by the press...."
"Mad cow disease now joins the Dalkon Shield, electromagnetic fields, Alar, breast implants and other spurious health hazards. In each episode, the principal victims were the related industries and the public, which is scared for no good reason..."
September 25, 2000 By Dennis Cauchon, USA TODAYOpinion (webmaster): We can see from this that the BSE vaccine safety committee was all too typical of an FDA proceeding, in that there was little or no interest in vaccine safety, only in marketing the vaccines better through non-disclosure of risks. More than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions, a USA TODAY study found.
These experts are hired to advise the Food and Drug Administration on which medicines should be approved for sale, what the warning labels should say and how studies of drugs should be designed.
The experts are supposed to be independent, but USA TODAY found that 54% of the time, they have a direct financial interest in the drug or topic they are asked to evaluate. These conflicts include helping a pharmaceutical company develop a medicine, then serving on an FDA advisory committee that judges the drug.
The conflicts typically include stock ownership, consulting fees or research grants. Federal law generally prohibits the FDA from using experts with financial conflicts of interest, but the FDA has waived the restriction more than 800 times since 1998.
These pharmaceutical experts, about 300 on 18 advisory committees, make decisions that affect the health of millions of Americans and billions of dollars in drugs sales. With few exceptions, the FDA follows the committees' advice.
The FDA reveals when financial conflicts exist, but it has kept details secret since 1992, so it is not possible to determine the amount of money or the drug company involved.A USA TODAY analysis of financial conflicts at 159 FDA advisory committee meetings from Jan. 1, 1998, through last June 30 found:
At 92% of the meetings, at least one member had a financial conflict of interest. At 55% of meetings, half or more of the FDA advisers had conflicts of interest. Conflicts were most frequent at the 57 meetings when broader issues were discussed: 92% of members had conflicts. At the 102 meetings dealing with the fate of a specific drug, 33% of the experts had a financial conflict. "The best experts for the FDA are often the best experts to consult with industry," says FDA senior associate commissioner Linda Suydam, who is in charge of waiving conflict-of-interest restrictions. But Larry Sasich of Public Citizen , an advocacy group, says, "The industry has more influence on the process than people realize."
USA TODAY analyzed financial conflicts of interest on the 18 expert advisory committees established by the Food and Drug Administration's Center for Drug Evaluation and Research. These committees vote on whether new drugs should be approved and what regulations should govern the drug approval process. The newspaper created a database of financial conflicts disclosed at all 159 advisory committee meetings from Jan. 1, 1998, through June 30, 2000. About 250 members appeared 1,620 times during those meetings.As required by law, FDA advisory committees disclose when members have a financial interest in the subject of the meeting. Financial interest is defined in FDA regulations "as the potential for gain or loss as a result of government action on a particular matter."
By Dennis Cauchon, USA TODAY
In October, pharmaceutical giant Johnson & Johnson sent a team of executives to a Holiday Inn ballroom in Silver Spring, Md. Their job: persuade the Food and Drug Administration's panel of independent experts that an expensive antibiotic, Levaquin, should be the first drug approved to treat penicillin-resistant pneumonia.
For Johnson & Johnson executives, the FDA's Anti-Infective Drug Advisory Committee included some familiar faces. At least two of the experts were paid consultants to the drug company and had worked on the very same medicine that they were being asked to evaluate for approval in an important new market.
The expert panel's "consumer representative," whose assignment is to defend consumers' interests, had the most extensive financial relationship with Johnson & Johnson. Keith Rodvold, a pharmacy professor at the University of Illinois-Chicago, serves on a company anti-infective drug advisory board, according to Johnson & Johnson spokesman Marc Monseau. Rodvold advised the company on how to design and analyze the clinical trials that got the drug approved. In 1999, he designed a study to measure how Levaquin is absorbed in the lungs. The company also uses him regularly as an consultant on a variety of issues, Monseau says.
Rodvold declined to discuss his relationship with Johnson & Johnson and his work on Levaquin. The company declined to say how much Rodvold had been paid during the five years he has consulted for it.
The case of Levaquin reveals how deeply pharmaceutical industry money and influence penetrates the drug approval process. FDA advisory committees consist almost entirely of pharmaceutical industry consultants and researchers. Even consumers' and patients' representatives on the committees often receive drug company money.
At least one committee member had a financial stake in the topic under review at 146 of 159 FDA advisory committee meetings, according to a USA TODAY study of advisory committee meetings held from Jan. 1, 1998, through June 30, 2000. At 88 of those meetings, at least half the advisory committee members had financial interests in the topic being evaluated.
Eighteen FDA advisory committees play a crucial role in nearly every major decision on drug regulation. They help decide what drugs should be approved and how the pharmaceutical industry should be regulated. In recent years, the FDA has followed every advisory committee recommendation to approve or reject a medicine - except once, FDA spokeswoman Susan Cruzan says. (The FDA approved the flu drug Relenza in July 1999 despite an advisory committee voting 13-4 against approval.)
Investors follow advisory committees closely. A committee vote can add or subtract hundreds of millions of dollars from a drug company's stock market value.
The FDA is required by law to screen all committee members for financial conflicts. The law says members have conflicts when committee action could have the "direct and predictable effect" of causing the member a financial gain or loss. The federal agency is forbidden from using experts with financial conflicts unless a waiver is granted, usually on the grounds that the experts' value outweighs the seriousness of the conflict. The FDA grants these waivers routinely.
In the period analyzed by USA TODAY, the FDA granted 803 conflict-of-interest waivers. Seventy-one other times, members had financial conflicts that were voluntarily disclosed but did not require a waiver. In the 746 other member appearances on the committees, there was no conflict of interest.
The FDA says granting waivers lets it tap the nation's leading researchers, most of whom do work for the pharmaceutical industry. "The system is designed to bring together the best scientific experts we can find," says FDA associate commissioner Linda Suydam, who approves waivers.
She says conflict-of-interest waivers go through as many as eight levels of review before they are granted. But Larry Sasich, a pharmacist who works for the Ralph Nader-founded Public Citizen's Health Research Group, says, "It is outrageous that the pharmaceutical industry's influence is so great that even some consumer representatives are on drug companies' payrolls."
Sasich says it might sometimes make sense to let experts with financial conflicts participate, but "it should be rare and that person should not be allowed to vote."
Financial conflicts were most common when committees considered broader issues, such as warnings labels for pregnant women or how cancer studies should be designed. At the 57 meetings on regulatory policy, committee members had conflicts 91% of the time.
At the 102 meetings involving specific drugs, 33% of committee members had a direct financial stake in the outcome.
It is impossible to determine how advisory committee decisions might have been influenced by the financial relationships its members have. The FDA stopped making details of financial conflicts public in 1992, after controversies about whether the financial interests of committee members had biased decisions on breast implants, Prozac and a drug to treat Alzheimer's disease. The FDA says it stopped releasing details on conflicts because of concerns about violating the privacy rights of committee members, not because of the controversies.
Financial conflicts include stock ownership, consulting fees, research grants, a spouse's employment and payments for speeches and travel. The conflict could be a tie to the company whose drug is under consideration or to a company that sells a competing drug.
Many financial conflicts are considered too small to require disclosure or a waiver and were not counted in USA TODAY's study. For example, a committee member can be paid up to $50,000 a year by a drug company without any financial conflict being disclosed if the work was on a topic other than what the committee is evaluating, according to FDA guidelines. Committee members also can own up to $5,000 in stock in the company appearing before the committee.
Advisory committees include many of the nation's leading researchers. The pay is not high considering the stature of many members: about $400 a day for meetings, plus travel expenses, and nothing for work done outside a meeting. However, the assignments are prestigious, and committee members, whose terms last four years, are in heavy demand as industry consultants.
Conflicts are most common on the committees that consider heart drugs. Forty-eight percent of experts had financial conflicts when considering the worthiness of specific heart medicines. "The greater degree of expertise, the greater the potential for conflicts," says Milton Packer, chairman of the Cardiovascular and Renal Drugs Advisory Committee.
Packer is a good example. He is a leading figure in cardiovascular research and has helped pioneer the development of drugs to treat congestive heart failure. Last year, he led an effort by 150 leading cardiac researchers to establish consensus guidelines on how to treat congestive heart failure, which is suffered by 5 million Americans.
But his work with pharmaceutical companies creates many financial conflicts. The FDA granted him a waiver that allowed him to participate in a meeting May 2 on the drug Refludan, which treats clotting. (Packer says he doesn't recall what the conflict was.) And Packer did not participate in a meeting May 1 on the heart drug Altace because of a financial conflict. (He declines to say what the conflict was.)
Packer says consolidation in the pharmaceutical industry has increased the potential for conflicts because there are fewer companies and nearly all have heart drugs.
Financial conflicts are so common that eight of 10 members who evaluated the drug Aggrastat, made by Merck, had conflicts of interest. Packer says he doesn't believe that financial conflicts distort the recommendations of advisory committees: "There are so many checks and balances, it would be almost impossible for a single individual to steer the committee."
At the meeting on October 20, 1999, on Levaquin, the chairman of the committee and one other member stepped aside because of financial conflicts. Of the 10 members remaining, four had received conflict-of-interest waivers from the FDA.
In addition to Rodvold, New Jersey physician Carl Norden had consulted for Johnson & Johnson in 1997 on the design of Levaquin studies for illnesses other than the treatment of penicillin-resistant pneumonia, the company said. Johnson & Johnson says having its consultants on the advisory committee didn't create bias.
"We don't believe (advisory panel members) would let a consulting arrangement compromise their reputation and stature in the medical community," says Monseau, the Johnson & Johnson spokesman.
The advisory committee voted unanimously to recommend that Levaquin, an $8-per-pill antibiotic, be approved for treatment of penicillin-resistant pneumonia. The FDA ratified the decision in February. Levaquin has been on the market since 1997, but the FDA's action allows Johnson & Johnson to market the medicine as the first antibiotic approved for the more than 25% of pneumonia cases that are resistant to penicillin.
Industry influence on advisory committees will increase later this year. As required by a law approved in 1997, the FDA will add official industry representatives to the committees. The industry officials will participate in deliberations, but they will not be allowed to vote.
Thu, 28 Sep 2000 VaccinesOpinion (webmaster): The cumulative effect of looking at a compilation of vaccine incidents and risk:benefits is disturbing, to say the least. It dovetails with the slop reported above for US FDA vaccine committees and the girsly measles vaccine experiment on the Yanomamo Indians. This new site, by its wide coverage, helps provide perspective on childhood vaccines sourced from UK BSE herds, which does not seem to be an isolated incident at all in the world of vaccines.
TSEs have been proven twice in the past to have contaminated vaccines, both time with vaccines made in sheep brain. Full text of the British 1946 scrapie-contaminated louping ill vaccine and the 1998 Italian mycoplasma vaccine [Lancet 1999 Feb 13;353(9152):560-1] are online. For humans, the Semples sheep brain rabies vaccine used so widely in India is a serious cause for concern.
Documentation of variable quality at Vaccines website
AIDS Allergies Alzheimer's Anaphylaxis Aplasticanemia Arthritis Asthma Autoimmune Autism Bell's Palsy BrainS welling Blood Reactions Bullous pemphigoid BSE risk Cancer Cardiac complications Cerebral Palsy CFIDS/ME CIC (Klinkers) CJD risk Cot-Death--SIDS--Crib-Death Convulsions Chronic inflammatory Demylenating Polyneuropathy (CIDP). Crohn's Disease Deafness Demyelination Development disability Diabetes Death Dermatomyositis Down's syndrome Dyslexia
Ear Encephalitis Encephalomyelitis Eczema Epilepsy Erythemamultiforme Eye damage Fanconi's anemia Foetal damage Foot and mouth disease Gait disturbances Gangrene Gastroenteritis Glomerulonephritis. Guillain-Barre syndrome Gulf War Syndrome Hair loss Headache Hemolyticanemia Henoch-Schoenlein Purpura Heart Hepatitis B Hyperkinetic syndrome Immune Suppression Kidney disorders Leukemia & lymphoma Lennox-gastaut syndrome Lichen planus Liver disorders Lupus
Lyell's syndrome Lyme disease Meningitis Meningoencephalitis Mumps MS Myocarditis Neurological Optic Neuritis Pancreatitis Pericarditis Panniculitis Postvaccinal parkinsonism Polio Respiratory Seizures Shaken Baby Syndrome Skin disorders Spanish Flu SSPE Stevens-Johnson syndrome Syphilis TB Tetanus Thrombocytopenia purpura Tourette's Syndrome Transverse myelitis Vaccinia Vasculitis Violent Behaviour Feline sarcomas
References [1.1] Non-Paralytic Polio and PPS Marcia Falconer, Ph.D. cell biology and Eddie Bollenbach, M.A. biology Lincolnshire Post-Polio Library Publication, January 1999 http://www.ott.zynet.co.uk/polio/lincolnshire/library/falconer/nonparalytic.html [1.2] Late functional loss in nonparalytic polio. Falconer M, Bollenbach E BioSoma Technologies Incorporated, Nepean, Ontario, Canada. Am J Phys Med Rehabil 2000 Jan-Feb;79(1):19-23 PMID: 10678598, UI: 20142066 [1.3] Nonparalytic polio and postpolio syndrome. Halstead LS, Silver JK National Rehabilitation Hospital, Washington, DC 20010, USA. Am J Phys Med Rehabil 2000 Jan-Feb;79(1):13-8 PMID: 10678597, UI: 20142065  Polio Biology VI - The Polio War and Vaccine Strategy Eddie Bollenbach A Lincolnshire Post-Polio Library Publication 6th August 1999
Guardian ... Wednesday 27 September 2000 James MeikleThe government is considering more stringent controls on blood plasma used
Between 20,000 and 30,000 people a year are still thought to receive plasma
from British donors despite other measures to reduce the threat from
accidental transfer of variant Creutzfeldt-Jakob disease via blood.
The national blood service said yesterday that new anti-viral treatments of
plasma and artificial alternatives were among the options following recent
evidence that a sheep could transfer a BSE-like disease to another animal
through blood transfusion long before displaying outward signs of the
The admission comes less than two weeks after the service and the
Department of Health attempted to allay concerns sparked by research by
scientists at the Institute of Animal Health. They then pointed to the
precautionary measures introduced over the last two years - the filtering
out of white cells, thought most likely to carry the nvCJD agent, from blood
and the use of plasma in blood products imported from countries without
These would minimise the risk of future cases through transfusion. Seven
known nvCJD victims among the 74 dead and eight probable cases are thought
to have been blood donors and there is as yet no test that could screen
donations for the presence of the nvCJD agent.
But some British plasma is still used to help clot the blood of victims of
trauma or patients in long operations needing large transfusions. The blood
service said this was a blood component from a single donor and not a
factory- made product made from plasma pooled from many donors. [How can
such a large transfusion come from a single donor -- he would just be
trading places with the injured party]
"There is a subtle difference", said Tim Wallington, the service's medical
spokesman. "I don't think we have been misleading the public . What we have
done is what was considered practical at the time. The truth is the sheep
stuff has made everybody think again . We are doing everything we possibly
can about this threat."
The health department said plasma was in short supply and alternative
commercial sources were collected from European countries, which though
vCJD-free, were not BSE-free. Plasma for other medical products was
imported from the US . The plasma used from UK sources was filtered in the
same way as other blood donations.
A drugs company, Octopharma, claimed it could offer less risky alternatives
to the fresh plasma used in emergency cases, even though it conceded that
no known treatments could remove the deformed prion protein thought
responsible for spreading nvCJD. It sourced plasma from countries where the
reported cases of BSE were from imported animals and there were no reported
cases of nvCJD.
Brian Stack, Octopharma's acting UK general manager, said: "The evidence
about nvCJD is mounting. Why are they sitting on the fence and putting at
risk the British population? " The company has complained to the European
commission, alleging unfair charging policies by the national blood service
which makes British plasma less
than half the price of its own.
The row over blood coincides with a leaked cabinet memo which confirms the
government's determination not to offer compensation to nvCJD victims
without fighting them through the courts first. The families have already
formally started legal action.
Wed, 27 Sep 2000 UK GuardianThe American Anthropology Assoc. the U. S. Atomic Energy Commission, and the geneticist, James Neel, are about to be exposed in an investigative book, "Darkness in El Dorado," a case study of "the dangers in science of the uncontrolled ego, of lack of respect for life, and of greed and self-indulgence."
American scientists in collaboration with the government deliberately unleashed a virulent measles epidemic that killed hundreds/thousands of Venezuelan Indians in the mid 1960s--because scientists were anxious to discover what might happen to communities when large numbers were wiped out by nuclear war.
Once the epidemic was under way, according to the book, the research team "refused to provide any medical assistance to the sick and dying Yanomami, on explicit order from Neel. He insisted to his colleagues that they were only there to observe and record the epidemic, and that they must stick strictly to their roles as scientists, not provide medical help".
Lest anyone think that this cannot happen today, think again. The "anything goes" mentality among certain genetic and pharmaceutical backed researchers has led us to the brink. This powerful special-interest group--assisted by FDA officials--are about to dismantle an ethical inconvenience--The Declaration of Helsinki.
If adopted at the Oct 3-5 meeting of the World Medical Association, the proposed revisions of this universally adopted medical ethics code will legitimize high risk, no benefit experimentation on individuals--if they (the research industry) decide that the research is important for society or if they postulate that the GROUP--not the individual--may benefit in the future.
Paul Brown, Environment correspondent Saturday September 23, 2000 The GuardianThousands of South American indians were infected with measles, killing
The astonishing story of genetic research on humans, which took 10 years
to uncover, is likely to shake the world of anthropology to its core,
according to Professor Terry Turner of Cornell University, who has read
"In its scale, ramifications, and sheer criminality and corruption it is
unparalleled in the history of anthropology," Prof Turner says in a
warning letter to Louise Lamphere, the president of the American
Anthropology Association (AAA).
The book accuses James Neel, the geneticist who headed a long-term project
to study the Yanomami people of Venezuela in the mid-60s, of using a
virulent measles vaccine to spark off an epidemic which killed hundreds
and probably thousands.
Once the epidemic was under way, according to the book, the research team
"refused to provide any medical assistance to the sick and dying Yanomami,
on explicit order from Neel. He insisted to his colleagues that they were
only there to observe and record the epidemic, and that they must stick
strictly to their roles as scientists, not provide medical help".
The book, Darkness in El Dorado by the investigative journalist Patrick
Tierney, is due to be published on October 1. Prof Turner, whose letter
was co-signed by fellow anthropologist Leslie Sponsel of the University of
Hawaii, was trying to warn the AAA of the impending scandal so the
profession could defend itself.
Although Neel died last February, many of his associates, some of them
authors of classic anthropology texts, are still alive.
The accusations will be the main focus of the AAA's AGM in November, when
the surviving scientists have been invited to defend their work. None
have commented publicly, but they are asking colleagues to come to their
One of the most controversial aspects of the research which allegedly
culminated in the epidemic is that it was funded by the US atomic energy
commission, which was anxious to discover what might happen to communities
when large numbers were wiped out by nuclear war.
While there is no "smoking gun" in the form of texts or recorded speeches
by Neel explaining his conduct, Prof Turner believes the only explanation
is that he was trying to test controversial eugenic theories like the Nazi
scientist Josef Mengele.
He quotes another anthropologist who read the manuscript as saying: "Mr.
Tierney's analysis is a case study of the dangers in science of the
uncontrolled ego, of lack of respect for life, and of greed and
self-indulgence. It is a further extraordinary revelation of malicious
and perverted work conducted under the aegis of the atomic energy
Prof Turner says Neel and his group used a virulent vaccine called
Edmonson B on the Yanomani, which was known to produce symptoms virtually
indistinguishable from cases of measles.
"Medical experts, when informed that Neel and his group used the vaccine
in question on the Yanomami, typically refuse to believe it at first, then
say that it is incredible that they could have done it, and are at a loss
to explain why they would have chosen such an inappropriate and dangerous
vaccine," he writes.
"There is no record that Neel sought any medical advice before applying
the vaccine. He never informed the appropriate organs of the Venezuelan
government that his group was planning to carry out a vaccination
campaign, as he was legally required to do.
"Neither he nor any other member of the expedition has ever explained why
that vaccine was used, despite the evidence that it actually caused or, at
a minimum, greatly exacerbated the fatal epidemic."
Prof Turner says that Neel held the view that "natural" human society, as
seen before the advent of large-scale agriculture, consists of small,
genetically isolated groups in which dominant genes - specifically a gene
he believed existed for "leadership" or "innate ability" - have a
In such an environment, male carriers of this gene would gain access to a
disproportionate number of females, reproducing their genes more
frequently than less "innately able" males. The result would supposedly be
a continual upgrading of the human genetic stock.
He says Neel believed that in modern societies "superior leadership genes
would be swamped by mass genetic mediocrity".
"The political implication of this fascistic eugenics is clearly that
society should be reorganised into small breeding isolates in which
genetically superior males could emerge into dominance, eliminating or
subordinating the male losers in the competition for leadership and women,
and amassing harems of brood females." Prof Turner adds.
In the memo he says: "One of Tierney's more startling revelations is that
the whole Yanomami project was an outgrowth and continuation of the atomic
energy commission's secret programme of experiments on human subjects.
"Neel, the originator of the project, was part of the medical and genetic
research team attached to the atomic energy commission since the days of
the Manhattan Project."
James Neel was well-known for his research into the effects of radiation
on human subjects and personally headed the team that investigated the
effects of the Hiroshima and Nagasaki bombs on survivors and their
According to Prof Turner, the same group also secretly carried out
experiments on human subjects in the US. These included injecting people
with radioactive plutonium without their knowledge or permission.
"This nightmarish story - a real anthropological heart of darkness beyond
the imagining of even a Joseph Conrad (though not, perhaps, a Josef
Mengele) - will be seen (rightly in our view) by the public, as well as
most anthropologists, as putting the whole discipline on trial," he says.
"This book should... cause the field to understand how the corrupt and
depraved protagonists could have spread their poison for so long while
they were accorded great respect throughout the western world... This
should never be allowed to happen again."
Yesterday Professor Turner told the Guardian it was unfortunate that the
confidential memo had been leaked, but it had accomplished its original
purpose in getting a full response from the AAA.
A public forum would be held at its AGM in November to discuss the book
its revelations and courses of action.
In a statement yesterday the association said "The AAA is extremely
concerned about these allegations. If proven true they would constitute a
serious violation of Yanomami human rights and our code of ethics. Until
there is a full and impartial review and discussion of the issues raised
in the book, it would be unfair to express a judgment about the specific
allegations against individuals that are contained in it.
"The association is anticipating conducting an open forum during our
annual meeting to provide an opportunity for our members to review and
discuss the issues and allegations raised in the book."
Tue, 19 Sep 2000 By THOMAS H. MAUGH II, LA Times Medical WriterOpinion (webmaster): There are some uncanny parallels here to language used by agencies in the early days of BSE. It is disturbing to find an ' expert' on FDA "milk safety team" who can't even read a petri plate. The "milk safety team" itself is no doubt be largely comprised of dairy industry lobbyists.
An as-yet-unpublished study by the Ministry of Agriculture in Britain found that researchers could grow MAP from at least 3% of samples of commercial pasteurized milk, Hermon-Taylor said. "It confirms, as sure as God made little green apples, that retail milk in Britain is a definite source of human exposure to these bugs," he added. MAP is extremely difficult to kill, and commercial pasteurization--which involves heating milk to 161 degrees Fahrenheit for 15 seconds--is not sufficient, according to studies by Grant. Heating to higher temperatures--up to 194 degrees for the same period of time--is also not effective, she said, but increasing the pasteurization time to 25 seconds, even at 161 degrees, is. Last year, several large milk distributors in Britain told their suppliers to increase pasteurization time, and that has been accomplished. Activists want to see the same steps taken here. "There comes a point in time where consumer health takes precedence over commerical concerns," says Karen Meyer, president of the Paratuberculosis Awareness and Research Assn. "If a human pathogen is entering the food chain, that is a major concern. We need to ensure the protection of the public health."
Sat, Sep 30, 2000 By Alistair Keely, PA NewsComment (webmaster): The Dept of Health says he "died peacefully at his home" -- most unlikely, a cheap shot that belittles this death. This may be the bottom case below, still unnamed. Note that the Dutch story gives the age contradictorily as 30. This case or cases would presomably already have been included in the statistics as confirmed, still living.
Queeniburough so far:
-- Glen Day, age 35, died late Oct 1998, resident -- Stacey Robinson, mother of one, age 19, died early Oct 1998, former resident, moved to Thurmaston -- Pamela Beyless, aged 24, onset August 1996, died August 1998, frequent visitor from nearby Glenfield -- Martyn Wormleighton, age 19, died May 2000 in Leicester hospital, Wigston four miles from Queniborough -- unnamed man, age 24, diagnosed by May 2000 in Leicestershire, doing poorly, village 2 miles away from Queniborough.
A fifth person is believed to have died from new variant CJD - the human equivalent of BSE - in the area where the Government is investigating into a cluster of cases. The victim died on Thursday evening at his home in Leicestershire, close to the village of Queniborough, the Department of Health said. Four other people who had connections with the village have died from the disease, their deaths prompting the Government to investigate possible links. A spokesman for the Department of Health said a post-mortem examination was due to be carried out on the latest victim. He said: "I can confirm that a man died peacefully at his home on Thursday evening. New variant CJD is suspected, but that will depend on the results of the post-mortem. "I can confirm he came from the same areas as the others," he added. An investigation is under way involving experts from the CJD Surveillance Unit in Edinburgh, the London School of Hygiene and Tropical Medicine, and the public health laboratory service as well as the local health authority and officials from the Ministry of Agriculture and Department of Health. On Monday the Department of Health will publish new national figures for the number of people who have died from nvCJD.
ANP Sun, Oct 1, 2000Een 30-jarige man uit Leicestershire in midden-Engeland is donderdag aan de gevolgen van de ziekte van Creutzfeld-Jacob gestorven. Dat heeft het Britse ministerie van Gezondheidszorg zondag bevestigd. Creutzfeld-Jacob of hersenverweking is de menselijke variant van de gekkekoeienziekte BSE. De officiele doodsoorzaak kan pas na autopsie worden gegeven.
Het slachtoffer komt uit het 2300 zielen tellende dorp Queniborough waar sinds 1998 vijf mensen aan de ziekte gestorven. Wegens het grote aantal ziektegevallen in het dorp zijn de autoriteiten daar een onderzoek begonnen, aldus de BBC.
Maandag komt het ministerie van Gezondheidszorg in Londen met de nieuwste cijfers over het aantal slachtoffers van de ziekte van Creutzfeld-Jacob. Tot nu toe is bekend dat er in Groot-Brittannie zeventig mensen aan bezweken. Now they report another Queniburough death, wrongly called the 4th case (see listing below). The age and village fit for the 5th case, leaving the age 30 case a mystery. The second story gives another case, age 21; a total of 9 cases are said to be still alive, with this case reportedly kept out of the Oct 2 statistics even though the diagnosis confirmation date by the Surveillance Unit was early to mid September. Onset was March 2000. Recalling data from last month, this would make a monthly increment of 3 including Donna (assuming the count was not thrown off by the timing coincidence of the Inquiry report) and the last 6 month increments 3 3 5 4 2 1 = 18, a rate for the last 4 months annualizing to 45. Hopefully we can get the age and date of onset list refreshed soon at the House of Lords (15 new data points is a significant addition). It is really not the monthly increments that are of interest to modelling, but the month and year they are assigned as onsets. Here is a new first BSE cow from Dec 84 that I wasn't familiar with; MAFF clings to Nov 86; the Inquiry had April 85. The chief medical officer was not told until 40 months later, March 1988. How the death of Cow 133 started a tragic chain of events Staff Reporter Observer ... Sunday 1 October 2000 December 1984 A farmer in Surrey reported that a Friesian cow had contracted a strange disease. Within two months it had died. This cow is now known as Cow 133 - the first animal with BSE.... Farm worker is fourth victim in CJD 'death valley' By Andrew Buncombe Independent ... Sunday 1 October 2000 A young farm worker has become the fourth person with close links to the same Leicestershire village to die from new variant CJD - the human form of mad cow disease. It was revealed yesterday that Christopher Reeve, 24, died last Thursday after suffering from nvCJD for at least a year. He is the fourth victim from the village of Queniborough , in the Wreake Valley, where the Government has launched an investigation. The news comes as the independent inquiry set up to examine BSE and CJD will today pass its report to ministers. The £16m inquiry - which has taken two-and-a-half years to complete - has looked at the causes of the disease and the adequacy or otherwise of the official response. Mr Reeve, the youngest of six children, lived in the neighbouring village of Rearsby but worked in Queniborough. His parents, Tony and Linda, placed a notice in a local newspaper which said: "Christopher has passed away peacefully after as much pain as anybody could cope with. "We watched over him for months and watched him suffer but in all the times he never complained. He would laugh and joke and smiled at us right to the end. "We keep asking 'Why him?' He was gentle, kind and never hurt anyone. We held him in our arms and we wished we could make him better but it wasn't to be." A Queniborough resident, who asked not to be named, said: "This area is being called 'death valley' and fear is hanging over everyone . "You just wonder who is going to be next ...."
Stuart Millar Observer ... Sunday 1 October 2000Donna McIntyre is just 21 . She is dying in hospital from the human form of BSE - mad cow Disease. Her family feels she has been betrayed by civil servants, farmers, and government . A long-awaited report on the BSE crisis goes to Ministers tomorrow. But it will not come in time to save Donna.
Billy McIntyre steeled himself as best he could. As he reached the entrance to the hospital ward he paused, took a deep breath and somehow managed to drag a smile on to his lined, pale face - as he had done every night for weeks before visiting his daughter.
Donna was in her usual position, curled up awkwardly in the worn, green leather reclining chair beside her bed at the end of the ward. The visit last Monday started well enough: father hugging and tickling daughter, while keeping up the smile and a steady stream of upbeat chatter. But the 21 year old's mood changed, and she became agitated and distressed. Then, in a momentary flicker of lucidity that crushed all her dad's mental preparations, she looked straight at him and asked: 'Am I dying? '
The straightforward answer is: yes . Donna is far too ill to comprehend her rapidly-deteriorating condition, let alone deal with its inevitable conclusion, so her father laughed off the question. But three weeks ago she was diagnosed as one of the latest cases of new variant Creutzfeldt-Jakob disease (vCJD), the fatal brain disorder which is the human form of BSE, or mad cow disease. She is unlikely to survive much beyond next spring .
McIntyre, an electrician from Aberdeen, has now taken the unusual decision to speak publicly about his daughter's plight while she is still alive. While the bereaved relatives of some victims have provided a glimpse of nvCJD's impact, Donna's story provides a sobering insight into the daily ordeal being endured by the McIntyres and at least eight other families across the UK - a plight caused by the scandal of farmers feeding cattle with the brains and vertebrae of other animals, and the repeated disgrace of Ministers and civil servants' failure to stop it.
'I still don't believe this is happening to us,' McIntyre told The Observer. 'This is something that affects people on television and in the newspapers, not my daughter. Every day, I try to imagine how I would feel if it was me, to imagine how it must be for her, but it tears me apart just to think about it.'
His intervention comes as the mad cow disease scandal returns to centre stage. This week Lord Phillips, chairman of the public inquiry into BSE, will hand his long-awaited final report to Ministers. After two-and-a-half years and more than £16 million, the 16- volume report will be the definitive judgment on the causes of the BSE/CJD affair and the adequacy of Ministers' response.
Although Phillips had already made clear that the findings would not decide the thorny issue of liability , the victims' families had hoped the report would pave the way for the Government to set up a compensation scheme. But last week a leaked Whitehall memo revealed that Ministers have decided not to take any blame for the crisis .
About £4bn has been spent on a no-fault scheme to compensate farmers for culled cattle, but Ministers, says the memo, baulked at the prospect of a multi-billion pound compensation bill from human victims.
When the inquiry began in March 1998, the disease had claimed 24 lives. The toll is now 74 . A further eight victims are still alive, according to official figures which do not yet include Donna . For the McIntyres, news of the memo was devastating. Less than a month after they were told that Donna had contracted a disease which should never have been allowed to emerge, they found they also may face a long, painful legal battle for damages .
'It is sickening what the politicians have tried to do ,' said her father. 'They knew about the problems in the food chain, about spinal cords and other bits of animals getting mixed into cattle feed, but they did nothing . Now they won't take responsibility. Money is the last thing on our minds now, but I hope Tony Blair chokes on his breakfast when he reads about my daughter.'
Donna's life was just coming together when early signs of the disease emerged. She was working as a receptionist in Aberdeen and living in a rented flat there. She was shy, but at weekends she went dancing with friends. Nothing trendy; Donna remains a loyal fan of Take That. Like any young woman, she was meticulous about her appearance.
Last Easter, she stayed at her father's small terraced council house. It was the first time they had spent together for three years, and they both loved it. Donna even talked of giving up her flat and moving back in. She spent the week there. Then she disappeared. For two months the family heard nothing. Telephone calls and letters went unanswered. Her flat was deserted. In July, she should have celebrated her twenty-first birthday. McIntyre and his partner, Bernadette Prescott, sent a card and tried to find her. Nothing.
This is classic nvCJD behaviour. In the initial stages, victims are unable to comprehend what is happening to their bodies . They merely know that something is going wrong. They become depressed and paranoid , withdrawing into themselves. Some have nightmares . But the McIntyre family could not have known.
When Donna eventually resurfaced, the news was not good. She had been sleeping rough and had a serious skin condition and a bizarre twitching in her limbs. Donna began believing that other people were present in the room. She would talk to them. Sometimes she would demand that someone stand up and offer their chair to her brother, Thomas, who died in a fire in 1996. Like many other relatives of nvCJD victims, Donna's family started suspecting mental problems. After several visits to her GP, she was referred to psychiatrist. But he was unable to help.
By mid-August, Donna's condition was still worse. There were violent mood swings, her speech was slow and badly slurred, and her short-term memory had faded. She was losing the use of her arms and legs, her balance had gone and she needed support to walk. On 28 August, she went into Aberdeen Royal Infirmary for tests.
'We had no idea what it could be, although it was obviously serious,' said McIntyre. 'They tested her for multiple sclerosis and diseases like that, but they kept coming up with nothing. We didn't even think about it being nvCJD. Donna was always a meat-eater; she liked her burgers and her pies, but it never crossed our mind that her illness could have had anything to do with that.'
A week after Donna was admitted, her father was called to the hospital by his daughter's consultant. The doctor told him the tests had found no alternative, treatable explanation - she was 50 per cent certain Donna had nvCJD. Cases cannot be confirmed without analysis of the brain after death but, under rules introduced this year, living probable cases can be diagnosed by the National CJD Surveillance Unit in Edinburgh. Its specialists tested Donna and confirmed the diagnosis .
Sitting in his living room surrounded by photographs of Donna and her six brothers and sisters, McIntyre struggled with tears to describe the impact of that: 'My whole body just went numb. I couldn't take it in. I tried to ask questions but I couldn't form any words. Then I broke down. I'm not ashamed of it - I cried like a baby.'
Donna's body is now failing fast. She behaves most of the time like a very young child, sitting in her green chair, smiling to herself but unable to follow events around her, or to understand simple questions. As dementia slowly took hold, her short-term memory all but disappeared. Sometimes, she has failed even to recognise her father. Occasionally, some lucidity returns and she becomes more animated and engaged.
The physical effects of the disease are obvious, too. Pale and thin, her legs can no longer support her weight, and she is frequently incontinent. Last Friday night, The Observer arrived at the hospital as a guest of her family to find Donna lying, extremely distressed, on the floor beneath her chair. She had realised she needed to use the toilet but her legs had given way and she had fallen over, soiling her pyjamas in her distress. Her brain is so damaged, she is almost certainly unable to tell that her body is deteriorating.
Unlike her family. 'Sometimes I have to drag myself up to see her because I am so scared to see what condition she is in,' said her father. 'Then I feel a huge guilt - what we're going through is nothing compared to how she is suffering.'
He knows worse is to come. Before long, Donna will lose the power of speech completely. Her eyesight will fade, and she will be unable to swallow. Eventually, she will have to be fed by a tube. Even then, however, death could be months, rather than weeks, away.
But McIntyre is determined to see her through to the end with dignity. Against medical advice, he plans to take her home to care for her himself. 'It will be hard, but there will soon be a time when she is no longer there and I don't need to care for her any more. Any time we have is precious.'
AP WorldStream) Fri, Sep 29, 2000LILLE, France. A French beef merchant who tried to sell a cow suffering from mad cow disease to a slaughterhouse has been placed under investigation for fraud, a French prosecutor said Friday. Prosecutor Pascal Marconville said the merchant from the Nord region in northeastern France was being investigated for fraud, related to a consumer product, which could have had a serious impact on human health.
Veterinary officials in the Nord region said at a press conference Friday that the sick cow was taken to a private slaughterhouse in Noeux-les-Mines in the Pas-de-Calais region, northeastern France, on Sept. 4.
Catherine Nicolet, a veterinary inspector at the slaughterhouse, said that the cow was suffering from bovine spongiform encephalopathy, or mad cow disease, and was in "a terminal stage."
"This animal should not have been at the slaughterhouse," said Emile Perez, director of the veterinary services in the Nord region, citing a government decree which dates from June and which forbids the transport and access to slaughterhouses of sick animals.
The farmer who owned the cow has not been placed under investigation. His herd of 20 cows was slaughtered last Sunday.
More than 40 cases of mad cow disease have been identified in France since the beginning of the year, compared with 31 cases in 1999. Officials have been checking more animals this year as part of a broadened plan to help root out the disease.
Tue, 26 Sep 2000 South China Morning PostOpinion (webmaster): This is more show-trial hypocrisy for the benefit of cattle industry exporters, with eery parallels to the Vermont sheep. There is no evidence whatsoever that these water buffalo had any exposure to TSE -- they were in quarintine back in Denmark. Meanwhile, Canada itself has had just as many BSE cases as Denmark (namely, one) and continues, like the US, to import mammoth amounts of BSE-contaminated feed direct from the UK.
Why doesn't Canada cull all its cows that were exposed to blood-gelatin-tallow from England as well? you're in charge again! i am off to Steens for a week.
By Neville Judd 1 Oct 00 Env News Agency
|DUNCAN, British Columbia, Canada, September 28, 2000 (ENS) - A Vancouver Island farming
family is fighting an order by government food inspectors to destroy its 27 water buffalo because of
fears the herd has bovine spongiform encephalopathy (BSE), otherwise known as mad cow disease.
Compared with other domestic livestock, the water buffalo is known to be less vulnerable to bovine diseases. (Photo by Christine Budke)
BSE is a progressive, fatal disease of the nervous system of cattle. When it occurs in humans it is known as Creutzfelt-Jakob disease. The disease occurs worldwide, but how it is spread from person to person is still unknown. It has a high media profile because United Kingdom scientists suggest that a new form of Creutzfelt-Jakob disease may be caused by human exposure to BSE.
Scientists believe that the United Kingdom's BSE epidemic was caused by feeding cattle meat and bone meal supplements that had inadvertently become contaminated with the disease agent. This occurred in the late 1970s and early 1980s, and established the infection in cattle. It was then magnified by the practice of feeding of rendered material from slaughtered cattle back to other cattle.
Despite no recorded cases of the disease in water buffalo, and only one Canadian case in a cow imported from the UK 13 years ago, the Canadian Food Inspection Agency (CFIA) ordered Anthea and Darrel Archer to remove their herd from Canada by September 15, a deadline later extended to October 13. If the herd cannot be removed they must be destroyed at the Archers' expense, said the agency.
The order follows a dairy cow becoming infected with BSE in February in Denmark, where the Archers had purchased their water buffalo a month before. This was enough to trigger the Canadian government's zero risk policy on BSE.
Despite clearing risk assessments in Denmark and being given a clean bill of health by Canadian government veterinarians, the water buffalo were imported in contravention of Canada's Health of Animals Act, according to the agency.
Fairburn Farm dates back to the mid-1880s and has been in Darrel Archer's family since 1955. The Archers stand to lose their farm unless CFIA changes its mind. (Photo courtesy Fairburn Farm)
The Archers have applied for judicial review of the order but the federal court in Vancouver is unlikely to hear the case until late October, after the October 13 deadline.
"We've sought judicial review to try and get to the bottom of this because the Canadian Food Inspection Agency isn't telling us anything," Anthea Archer told ENS. "It's not as though, we're suing them, we just want some answers."
The family has asked the agency to delay the deadline so the judicial review can take place but has not heard back. The agency was tight lipped when asked about the case by ENS.
"Christ, we can't talk about that," said agency spokesman Dr. Don Olson, citing orders from CFIA lawyers. "Sorry, I can't say anything while it's before the courts."
The Archers spent months negotiating Canadian and European red tape before being given a permit to import 19 water buffalo to their historic Fairburn Farm, near Duncan, just north of B.C.'s provincial capital Victoria. The animals are originally from Bulgaria and were shipped in quarantine to Denmark in 1997 where they were inspected by veterinarians and approved for export by the CFIA.
"We run a bed and breakfast but we wanted to be self sufficient and planned to start producing milk and mozzarella cheese from the buffalo," said Anthea Archer. "We mortgaged the farm to pay for them and have invested about $200,000 so far. This is our life and it's being destroyed for no good reason."
There has never been a documented case of water buffalo contracting BSE, according to the Institute of Zoology in Monterotundo, Italy, the Office International des Epizooties, Paris, and the Food and Animal Organization in Rome, Italy. (Photo by Christine Budke)
The Archers have enlisted the support of farming organizations like the Island Farmers Alliance, which has sent letters to government ministers on the issue. They are also investigating the possibility of flying the herd back to Denmark before October 13, which would spark a new battery of tests by CFIA to show the animals are free of North American disease such as Blue Tongue.
"There's no guarantee Denmark would taken them back, but it would be at our expense," said Archer.
Oblivious to the fuss, the water buffalo continue to graze happily on the Archers' farm where instead of closing the bed and breakfast this winter, the family will continue to take guests in order to pay off their mounting bills.
Two Canadian farmers have been ordered to get rid of a herd of water buffalo because authorities say the animals could be carrying mad cow disease (BSE, bovine spongiform encephalopathy).
[The farmers] imported the animals from Denmark in January as part of a long-term plan to start producing milk and mozzarella cheese from the buffalo, the first herd of its kind in Canada.
But soon afterwards, the first reported case of BSE in Denmark prompted some countries to ban Danish dairy products and meat. Canada has a strict policy of forbidding the importation of animals in which BSE has been detected.
Even though there have been no documented cases of water buffalo contracting the disease, the Canadian Food Inspection Agency has told the [farmers] their 27 animals must be removed from Canada or destroyed by next month.
The order has devastated the family, which had mortgaged their farm on Vancouver Island to purchase the herd and develop an associated dairy business. They are now asking a court to save their herd. "These animals haven't been contaminated," [one of them] said. "They should be grazing in the fields right now."
Before the detection of BSE in Denmark, the [farmers] had received federal approval to import the animals.
While they await an uncertain future, the 27 buffalo are being quarantined at the farm outside Victoria. Eight of the 27 were born in Canada, while 9 of the original 19 were shipped from Bulgaria to Denmark, where the 10 others were born.
Federal food-inspection scientists said the destruction order was a precautionary measure designed to protect Canadian cattle and the export trade.
"Any case of BSE in Canada would be devastating to the cattle industry," said agency official Dr Debbie Barr. There has been 1 recorded case of BSE in Canadian cattle.