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BSE Inquiry: Meldrum indicted on 35 counts, thirty officials criticized
Youngest nvCJD case slipping: onset age 11
Hundreds more exposed to nvCJD appendectomy scalpels and dental tools
France: mad cow meat sold to shops
nvCJD toll accelerating: 42 predicted for next 12 months
Massive compensation package for nvCJD families?
Polio vaccine recalled over BSE fears
CWD draft federal regs: input wanted
FDA knew of Medeva vaccine horror, still okayed for US.

BSE Inquiry: Meldrum indicted on 35 counts

Mon, 23 Oct 2000  press accounts, primarily Sunday London Times
Opinion (webmaster):

There is quite the media event shaping up for this Thursday and no doubt favorable spins will be put on it by MAFF, as journalists will hardly have time to read the 16 volume report before their deadlines. To give everyone a jump-start on this information overload, the main Inquiry report conclusions are given below.

The best parts of the 16 volume report (issued as a CD-ROM) are hammering the department heads at MAFF who interfered with TSE scientilfic investigations, recommendations to reorganize and strip away any residual authority the ministry (and its new pro-industry clone, Food Standards Agency) have, and getting rid of industry-slanted advisory committees in favor of the precautionary principle. This will have a strong effect on non-BSE issues such as genetically modified food trials where the validation experiments themselves are seen as too risky.

The UK will announce a victim compensation scheme on Thursday to soften the impact of report. This could be a bit of black hole if the per victim payment is at all sizeable because it would have to be continued for decades until the epidemic is over.

The MAFF, which has had access to the report for 24 days, will make a Parliamentary Statement about the report at 12.30pm London time Thursday 26th October 00. Here is how they are handling the press arrangements:

Venue: Queen Elizabeth II Conference Centre, Broad Sanctuary, London Tel:
020 7798 4426
Registration: 9.30am
Embargoed advance media access 10.00am
Registration for Press Conference        12.00pm
Parliamentary Statement 12.30pm; Press Conferences 1.45pm
"Because of the length and complexity of the BSE Inquiry report, they are making arrangements for members of the press to have advance access to the report on the day of publication under controlled conditions. Access will be available from 10.00 am. Journalists can arrive at any time but will then be required to stay in the building and not to contact anyone until the report is presented to the House at 12.30pm. Those attending will be kindly requested to hand in mobile phones at the door. Cameras will not be permitted for this part of the event.

Hard copies of the first volume of the report, which comprises findings and conclusions of the BSE Inquiry including an executive summary, will be available to journalists. The full report (16 volumes) will be available on CD ROM (PC and Mac format) at the back of the first volume."

Reportedly over 30 government officials and former Conservative ministers are criticized in the Inquiry report for a catalogue of failures that allowed mad cow disease to devastate British agriculture and infect humans. The report is scathing about the quality and competence of many of those in charge of the Ministry of Agriculture, Fisheries and Food from the mid 1980s to 1996. Whitehall insiders describe it as the most powerful indictment of a ministry they have ever seen.

MAFF honchos are accused of creating a "culture of secrecy" and a "bunker mentality" . The report's release coincides with official predictions that the number of people to contract variant CJD, the human form of BSE, will reach 100 early next year.There are 74 dead of nvCJD and 11 diagnosed living, with numbers growing faster each month.

Among the most serious findings is that between 1985 and 1988 when BSE was first appearing, officials and senior governemnt vets ordered junior scientists to change the titles of scientific papers and rewrite their contents to exclude any suggestion that BSE was related to scrapie.

Those findings, implying that scrapie could jump species - and so reach humans - was seen as too damaging to the beef industry. The report says the real priority - human health - was ignored. It adds that such decisions actually caused the destruction of the beef industry - and also demolished the credibility and integrity of Maff's own scientists.

A "bunker mentality" developed in Maff at the time the first known cow with come down with BSE was seen in the mid-1980s to the 1996 announcement by Stephen Dorrell, then health secretary, that the disease had spread into humans.

The findings could lead to a further reorganisation of Maff, which has already been stripped of its food safety function, and to further upheavals at the Department of Health.

Many of the ministers who ran those departments come in for expected criticism. The heaviest condemnation is, however, reserved for officials and scientific advisors, who served far longer in their posts during the 1990s than any individual agriculture or health minister.

Keith Meldrum, Maff's chief veterinary officer from 1988 to 1997, is said to face 35 separate criticisms. They include failing to ensure that abbatoirs kept banned materials such as bovine brains, spines and offal out of the human food chain.

His predecessor, Howard Rees, in office from 1980-88 is said to have been largely responsible for delaying his staff in making public the possible link between BSE and scrapie.

The Department of Health also comes in for criticism. Donald Aitchison, chief medical officer from 1983-91, is also criticised as is Kenneth Calman, Scottish medical officer from 1989-91.

Most of the officials who oversaw the BSE crisis have moved into different jobs but the report makes it clear that the bureaucracy that perpetuated their mistakes remains.

The government response is almost certain to include a partial restructuring of both ministries. It has already stripped Maff of all responsibility for food safety by setting up the Food Standards Agency.

Former ministers such as John Gummer, agriculture secretary >from 1989 to 1993, and John MacGregor, who held the post from 1987 to 1989 are bracing themselves for the report's publication, due on Thursday. Gummer notoriously posed for photographers while attempting to fee his daughter a beefburger to demonstrate the supposed safety of the meat. An inquiry team insider says the report finds that Gummer's judgment "proved quite simply to be wrong".

MacGregor is also strongly criticised - one reason being his 1988 decision to give farmers only half the market value in compensation for any cow hit by BSE. The report says that his decision meant tens of thousands of infected cows entered the human food chain.

They and other former ministers face particular criticism for their inability to respond to the the crisis quickly even when the science clearly showed the dangers. These include Angela Browning, now a Tory shadow cabinet member, David Maclean and Gillian Shepherd. Some health ministers and Ken Clarke, the former chancellor, are criticised, but not John Major, prime minister from 1990-97.

One example cited in the report was Gummer's slow response to the discovery that a cat had died from FSE. Rather than order any response, he and his officials waited another 3 months, while pigs' brains were injected with BSE to see whether they would catch the disease. It was only when the pigs became infected that Maff took action to stop bovine material entering farm food chains.

"The report dismisses any suggestion that there is a conspiracy theory to explain what happened," one of those involved in producing the report said last night. "It shows a group of ministers, scientists and civil servants who took it on faith that BSE could not jump the species barrier, simply because scrapie (the sheep equivalent of BSE) had never spread beyond sheep.

"They allowed this to colour all their subsequent judgments. As a result, they are repeatedly criticised for delay in taking the necessary action - whether on offering full compensation for the slaughtering of sick cattle, or accepting that the 1990 death of a cat from the disease should have prompted more immediate action."

The report calls for a major change in future public policy toward potential health risks. It says that the way Whitehall consistently responds to scientific problems, by setting up advisory committees of scientists, is fundamentally flawed.

Instead, it says, minister must in future operate on "the precautionary principle" - that of being prepared to spend money or issue public warnings even before scientists have given a definitive judgment on risk. "In a nutshell, it's better to be safe than to be sorry," as one source put it last night.

Such a change would have huge implicatons for other scientific controversies such as the introduction of genetically modified food where the approach to date has been to experiment with trial crops and then measure their impact on health and the environment. A switch to the so-called "precautionary principle" suggested by the report would mean most such experiments would be automatically regarded as far too risky.

The 16 volume report contains hundreds of recommendations, on everything from the presentation of scientific evidence by civil servants to cabinet ministers, to animal husbandry.

Douglas Hogg, junior agriculture minister at the time of the 1996 announcement that CJD had spread to humans, is rare among the former minister in winning praise as well as earning criticism. He attempted to introduce much tougher rules to prevent infected cattle entering the human food chain - but was blocked by his Cabinet colleagues who said he was going too far.

Last week Baroness Hayman, the agriculture minister, acknowledged the impact the report would have. At a private luncheon organised by the meat industry she said: "Lord Phillips' report is not the end of a process, it is the beginning. It is a magnum opus and it is going to change everything."

Next Thursday the government will also announce a compensation scheme for the families of CJD victims. The decision was made at a cabinet committee meeting last Thursday, where - according to one minister - "Nick and Alan Milburn, health secretary fought like tigers" against the Treasury to secure the payments.

"We have had to agree to pay." said a Whitehall source. "There is no way this government can oversee continuing compensation payments for sick cows without authorising compensation payments for dead people. Nobody believes the state can get away with having spent £300m on the bse inquiry, more than one billion pounds on compensation for mad cows - and then refuse any money for the people affected."

nvCJD child slipping

 Sun, 22 Oct 2000 Sunday Times of London
Comment (webmaster):

Another family has come forward with their story. The Zoe Jeffries case is significant because it is the youngest onset and also the latest date of birth (Dec 85) so far, raising questions about the route of exposure given the nominal beef ban.

Note that official data provided this week to the House of Lords apparently fails to list Zoe's case, which had onset in Nov 1997. The nearest listed case in age has onset of July 98 in a 12 year old still alive. The Surveillance Unit may have fudged the numbers a little to soften the horror of such an early onset.

According to an interview initiated by the family :

Britain's youngest victim of variant CJD - the human version of mad cow disease - was this weekend said to be critically ill. The girl, identified for the first time as Zoe Jeffries, now 14, who showed the first signs of the disease when she was 11, is suffering serious respiratory and other difficulties. She lost the power of speech and any sign of self-awareness many months ago and has to be fed by a tube into her stomach because she cannot swallow.

Zoe's case has huge scientific significance. She was born in late 1985 -- when the BSE crisis was in full swing. Just a few months after her birth the government imposed a ban on the human consumption of the brains and other nervous tissue from cattle - declaring this move sufficient to prevent the infection passing to humans. Her illness effectively proves that all those assurances were wrong.

Her family, from Wigan, have decided to make her final weeks public to highlight the way they say nvCJD victims are being ignored by the government. Recent weeks have seen a series of Whitehall leaks suggesting that victims should get little in the way of extra care or compensation.

Helen Jeffries, who has cared for her daughter at home throughout the illness said: "When Zoe became ill we were given no care and treated horribly. Now I am watching Zoe die - while civil servants are advising ministers on how to avoid paying compensation. I don't want money but I am furious at the attitude of the government."

Zoe showed the first signs of illness in 1997 when she was 11. Before then she had won awards in dancing and athletics and was a keen gymnast. She also attended drama school where she hoped to learn how to become an actress.

Within months she was suffering acute pains in her back and legs, hallucinating that she was being attacked by monsters and had a phobia of water. A series of visits to hospitals saw her diagnosed with depression.

It was not until April 1999 - more than 28 months after the first signs that nvCJD was diagnosed. ~The family subsquently had to fight a series of battles with the local health authority to get help to care for Zoe. The family now gets round the clock support.

Despite that her condition has deteriorated. Zoe has been bedridden for more than a year and has to be fed via a tube into her stomach because she can no longer swallow. She used to suffer hallucinations and screaming fits but as the disease destroyed more and more of her brain these have stopped and she spends most of her time asleep.

Her mother Helen Jeffries further said she was deeply concerned that cannibalistic recycling of bovine material such as blood gelatine and tallow was still allowed. Government regulations permit cows to be fed on such material -- even though blood has been shown to carry infectivity in laboratory species.

Jeffries said: "The doctors have told me she is going to die but I still cannot accept it. She is still my baby.

When CJD strikes: A father's story

Saturday, 21 October, 2000 BBC
John Williams watched his lively daughter Alison as her life was wrecked, then ended by vCJD. He tells BBC News Online his story.

Many CJD victims have mood changes that precede their actual physical decline - and John Williams noticed how his young daughter Alison's character gradually changed. When she left her college course abruptly, and began to become more introverted, he put it down to worry for her mother, who was seriously ill at the time.

"She was in a top stream at college and she just packed it in for no reason at all."

He did not think there could be a physical problem - after all, she still enjoyed activities like sailing, golf and hiking in the mountains near her home in Caernarfon in north Wales. "She was like a mountain goat, she'd run up Snowdon" he said.

However, her psychological problems continued to worsen. John said: "She progressively got worse - she didn't want to meet people except close friends."

Alison's mother's heart condition became terminal, and she died in 1994. The apparent psychological problems were joined by physical symptoms.

"If she walked she'd walk with a goosestep - we noticed she couldn't walk in a straight line, she was veering off all the time."

Alison secured a job but collapsed at work only a month later - doctors diagnosed acute depression, and a few weeks were spent in hospital.

Now the behaviour became stranger - Alison was running baths but never getting in, and sleeping inside her quilt instead of under it.

She was also beginning to lose weight, but instead of diagnosing anorexia, a psychiatrist said that the problem wasn't mental, and called in a neurologist, who called in a genetics expert.

Finally, the diagnosis was made. John said: "He said he was 90% certain that Alison had CJD but this couldn't be confirmed until she died.

"I was broken hearted, of course. I was shattered from that point of view. I realised what the implications were."

Alison became more seriously ill, and in November 1995 went into hospital. She never came out. "She had to be fed, watered and everything. She became progressively worse." After Christmas that year she suddenly went blind; in February she died at the age of 30.

John, living on his own, was in despair: "I'm quite a strong willed indivual - if I was not, I'm pretty certain I could have committed suicide."

Instead, he channelled his energies into learning more about vCJD and its causes, and helping other families whose relatives had just been diagnosed with the illness.

He does not believe that his family's diet at home was the source of Alison's nvCJD.

"We didn't eat that much meat because my wife wasn't very partial to it. We ate more lamb than beef."

He thinks that a brief sojourn at college led to a diet of cheap cuts of meat in fast food, and was probably the source.

Five years on, he is hoping that the BSE inquiry report will be acted on to ensure that such an event never happens again. "There's a massive coverup somewhere and ultimately I blame the government of the day.

"I felt sorry for the farmers in many ways - but there are rogue farmers like there are rogue car dealers. "The scientists simply don't know how many more deaths there will be - but one death is too many."

Hundreds more exposed to tainted scalpels

22 Oct 00 press preports including Sunday London Times
Comment (webmaster):

This case is of special interest in view of calibration of the ongoing tonsil and appendix survey to determine the magnitude of the nvCJD epidemic. This case, #79 in the official tally, had onset in November 1999. Her appendix was removed some 40 months earlier in 1996 and recovered from storage and reinvestigated for prion contamination only last month.

The positive result means that biopsy of lymphatic tissue may give up to 40 months lead time to onset of symptoms. Similar results were obtained in a coastguard man, but another appendix removed 11 years earlier in a third case proved negative, suggesting there are limits to early warning. Dental surgery has come up before, with apparently uncommon transmission to successive patients even in sporadic CJD.

Two hospitals who unwittingly operated on a patient incubating new variant CJD have warned that hundreds of other patients may have been infected during subsequent operations with the same surgical instruments. The infective agent thought to transmit nvCJD have been shown to be unscathed by the conventional sterilisation techniques used by both hospitals.

Bassetlaw district general hospital in Worksop, Nottinghamshire, and the Northern General Hospital in Sheffield, have ordered immediate inquiries and will examine records to see if those exposed can be traced. At the time of the operations, in 1996, the woman showed no outward signs of nvCJD. She died earlier this year at the age of 24.

Recently, however, doctors got the results of an analysis of her appendix - removed at Bassetlaw in 1996 - which showed high concentrations of prions. The cuts made to remove it would have exposed the instruments used to the infective particles which are remarkably adherent to surgical steel.

It has also emerged that Bassetlaw sent the instruments used on her to a hospital in Rotherham for sterilising. The instruments would then have been distributed to several other hospitals in the same region that use the same sterilising facilities. It means hundreds of additional people could have been exposed to infectious prions.

The revelations follow last week's polio vaccine scare where thousands of doses were recalled because they were grown using banned bovine material that could have been infected with BSE.

The risk from surgical instruments is considered by many to be far greater. There have already been several cases in which related forms of CJD have been transmitted by surgical instruments - even after repeated high-temperature sterilisation.

Judith Andrews, head of nursing at Bassetlaw, said the hospital would start an immediate investigation. "This is a very serious issue. At the time we followed all the guidelines on sterilisation but now we know that this disease can withstand such procedures. "

A spokesman for the Northern General - where the infected woman had two dental operations in 1996 - said it too would hold an inquiry.

Professor John Collinge, the medical research council's professor of prion research, has repeatedly warned that the disease could be transmitted by surgical instruments.

Writing in The Lancet he warned: "A further possible route of transmission of variant CJD is via contaminated surgical instruments. Transmission of CJD via neurosurgical instruments has been reported and normal hospital sterilisation procedures are not likely to completely inactivate prions. There is evidence that CJD may also be transmitted by other surgical procedures."

The Department of Health has already responded to such fears with new guidelines for the cleansing of instruments used in brain and spine operations and is still considering the use of disposable surgical instruments throughout the NHS.

A member of the dead woman's family said: "We have only just heard that her appendix was infected with prions and we have told the hospitals immediately. It was terrible to see her die of this disease - and even worse to think others may get it too.

The latest scare follows the revelation last month that nine people incubating nvCJD had given blood - and that their plasma had gone into a pool that could have been used on hundreds of subsequent patients.

Prion proteins are present in all mammals and normally play a role in brain chemistry. In CJD - and related diseases such as BSE -the prion protein becomes deformed with the misshapen molecules acting as a template that converts others from the normal to the dangerous form. Once concentrations build up they clump together, disrupting the workings of the brain and killing cells. hat has shocked scientists is the tenacity of prions.

Unlike bacteria and viruses they are not destroyed by high temperature or most disinfectants. In one experiment a scientist took some brain extract fom a BSE cow, heated it to 600C, and then injected it into another animal - which still developed the disease.

In Australia doctors examining a patient with neurological disease used a special probe to examine their brain. The patient turned out to be suffering from a slightly different form of CJD which occurs naturally but which is also transmissible.

When subsequent patients also died of the same form of CJD doctors found they too had been examined using the same probe. It had transmitted the disease from the first patient to others despite repeated sterilisations. When the probe was tested on primates - many months later - they too got the disease.

France: mad cow meat sold to shops

 Sat, 21 Oct 2000 Reuters Online Service
Comment (webmaster):

France is hardly the only foreign country to be affected by British BSE in various feed products but it has been the most forthright and proactive (along with Switzerland). nvCJD may also become a significant worldwide problem, though so far the only reported cases abroad have been one in Ireland and three in France (one in a muscle-builder who injected bovine hormones).

Declining to resume British beef imports until the epidemic is controlled, France became the target of a retaliatory publics relations campaign that dramatises every new case of BSE found in their intensive surveillance program, even as Britain has 22 times the current BSE caseload.

France reportedly has a further nvCJD bombshell to unload on the British, the timing of its release would likely coincide with Thursday's Inquiry report. A great deal of Britain's exports of blood-gelatine-tallow, which continued to everyone's surprise at 22,000 ton a year into this year, ended up in France and Belgium (a major relabel/trans-shipment center). These products were not deemed fit for UK domestic use but somehow were suitable for export to an ancient adversary.

France's Agriculture Ministry said Saturday about a ton of beef from a herd in which a case of mad cow disease had been discovered had been sold to supermarket chain Carrefour.

The ministry said it had immediately told Carrefour to withdraw the suspect meat, which went on sale from October 9 in 39 supermarkets in northern France and the Paris region. The supermarket confirmed it had done so.

Two more tons of meat from animals in the same herd had been intercepted at the abbattoir and a legal investigation had been launched against the trader who sold the animals, the ministry said in a statement.

"The abattoir's veterinary inspection service detected abnormal behavior in a cow sent for slaughter on October 10. The animal was put down... A prion test was confirmed positive... on October 20, the statement said.

"Eleven cows from the same herd were sent to that abattoir on October 4... The animals came from a rearing firm which was going out of business and had sold them to a trader," it added. French media said the trader, his wife, son and a farm worker had been arrested. The ministry said the remaining animals in the herd would shortly be put down.

Agriculture Minister Jean Glavany told French LCI television the risk of human infection from the meat was extremely small. "Nothing indicates at this stage that the meat in question was contaminated," the minister said. "Even if the animals in question were infected, the job of cutting (the meat at the abattoir) is designed to eliminate risk tissue," he added. Glavany said the ministry had traced most of the meat and hoped to retrieve the rest within the next few hours.

France this week reported nine new cases of the fatal mad cow disease or bovine spongiform encephalopathy (BSE), bringing the total number reported in the country this year to 71, compared to 30 in 1999. Scientists believe BSE-infected meat products could cause a new form of Creutzfeldt-Jakob disease, a brain-wasting illness that has affected 85 people in Britain and two in France.

France remains locked in a legal battle with the European Commission over its refusal to end a ban on imports of British beef because of fears it is not entirely free from BSE.

Britain has reported more than 176,800 cases of BSE since 1986, making the French outbreak small by comparison. But while the number of cases in Britain is falling, it is increasing in France, despite measures introduced almost a decade ago to combat the spread of BSE through contaminated animal feed.

BSE beef reaches stores in France

Sat, 21 Oct 2000 Reuters
France's Agriculture Ministry said on Saturday about a tonne of beef from a herd in which a case of mad cow disease had been discovered had been sold to supermarket chain Carrefour .

The ministry said it had immediately told Carrefour to withdraw the suspect meat, which went on sale from October 9 in 39 supermarkets in northern France and the Paris region. The supermarket confirmed it had done so.

Two more tonnes of meat from animals in the same herd had been intercepted at the abattoir and a legal investigation had been launched against the trader who sold the animals, the ministry said in a statement.

"The abattoir's veterinary inspection service detected abnormal behaviour in a cow sent for slaughter on October 10. The animal was put down... A (mad cow) prion test was confirmed positive... on October 20, the statement said.

"Eleven cows from the same herd were sent to that abattoir on October 4... The animals came from a rearing firm which was going out of business and had sold them to a trader," it added.

French media said the trader, his wife, son and a farm worker had been arrested. The ministry said the remaining animals in the herd would shortly be put down.

Agriculture Minister Jean Glavany told French LCI television the risk of human infection from the meat was extremely small."Nothing indicates at this stage that the meat in question was contaminated," the minister said. "Even if the animals in question were infected, the job of cutting (the meat at the abattoir) is designed to eliminate risk tissue," he added.

Glavany said the ministry had traced most of the meat and hoped to retrieve the rest within the next few hours.

nvCJD toll accelerating: lastest predictions 42 in next 12 months

21 Oct 00 data release by Dept of Health to House of Lords 
Statistical analysis by webmaster
Efforts to predict the total scope of the nvCJD epidemic in humans have not yielded meaningful results to date. Less ambitiously, it is feasible to best-fit a curve to the 73 months of accumulated data and predict the toll for the next year or so. The caseload is clearly seen to be accelerating but not dramatically so. Nonetheless, the 42 cases predicted over the next 12 months would represent half again the accumulated total to date (84 cases in 6 years).

There is an issue in promptly testing onset predictions because these only saturate some months after the nominal date. In some ways, it would be better to directly predict the "observable" which here is the monthly utterances of the Dept of Health. These are dates of diagnosis (= dates of onset + some skewed distribution centered on 8 months). Since DoH switched systems in Mar 00, there is only a limited data set to work with.

The prediction here for the coming year is that these numbers will go from the current 3 a month (2-4 range) to 4 a month (3-5 range), not quite a case a week.

These levels, while accelerating and most assuredly a tragedy for individual families, still allow some breathing room for the masses in terms of rational therapy development. If we see a marked departure, say 5-7 onsets a month, then little time will remain for animal tests of intervention efficacy, and above that therapy options for many would amount to wildcat experimental approaches with no real experience with efficacy or side effects, hardly better than medicines promoted on the internet.

This is, in a nutshell, why 15 years of wait-and-see was too risky a policy choice with regard to largely forseeable costs (probalistic sense). The cost of developing a therapy starting in 1986 would have been miniscule compared to observed industry compensations.

total year
8 94 onsets
10 95 onsets
11 96 onsets
14 97 onsets
16 98 onsets
23 99 onsets
2 00 onsets

Curve-fitting details:
cases (t) = 1 + 0.0782t + 0.0156t2, where t = months elapsed since 1 Jan 94
for parameter Q=6 coming cases not yet assigned to onset bin
month   Q=0     Q=6     Q=12
73       84.0    90.0    96.0 the most recent onset is Jan 00, month 73
74       86.1    92.4    98.7
75       88.2    94.8   101.4
76       90.3    97.2   104.1
77       92.5    99.7   106.9
78       94.7   102.2   109.7
79       96.9   104.7   112.6
80       99.1   107.3   115.4
81      101.4   109.9   118.4
82      103.7   112.5   121.3
83      106.0   115.2   124.3
84      108.3   117.9   127.4
85      110.7   120.6   130.4 one year from now, Oct 01
Official onset data to 15 Oct 00: import to spreadsheet to analyze

case no.,year onset,month onset,month decimal,age onset,agedeath,date death,yrs since jan 94,old years elapsed,smoothed,cumulative,elapsed time mo

Polio vaccine recalled over BSE fears

Fri, Oct 20, 2000  By Maxine Frith and Sam Greenhill, PA News 
Comment (webmaster): This is an extremely bizarre development. The need for sourcing from BSE-free sources was discussed and implemented 15 years ago even by pet food companies. Surely a vaccine company does not need a government regulation to know that it should not be distributing potentially tainted products to millions of children. Who is responsible in a company bought and sold 3 times within 9 months? The cost of importing fetal calf serum from New Zealand is a miniscule aspect of vaccine production costs.

Britain's vaccine program has been nothing short of barbaric. Earlier, it emerged that injected children vaccines (measles, mumps, rubella, diphtheria, tetanus and whooping cough) sourced in UK herds continued to be used from 1991 until potentially tainted stocks were exhausted in 1995. Thatcherism lead to deregulation -- an honor system with voluntary compliance from pharmaceuticals, with government licenses freely issued with no real knowledge of the manufacturing process or sourcing. Manufacturers then abused this system as needed to cut costs. Over and over in the Inquiry, we see plaintive letters from the Health Dept begging manufacturers from some hint of what they are doing, but often the letter was ignored or extraneous information provided.

Because of the long incubation period of CJD, it is imperative not to expose children to even the tiniest amounts of infectious agent. TSEs have been involved in two previous veterinary vaccine accidents involving vaccines sourced in scrapie sheep brain. A high proportion of vaccine recipients developed proven clinical disease within two years in both incidents, showing sourcing risks are hardly theoretical.

Extensive background material on the history of the vaccine debacle are provided below and for the polio incident separately. Note in particular that 88% of all polio cases in the US and Britain are caused by the attenuated live vaccine itself (19 of the 28 British cases and 124 of the 133 American cases).

A polio vaccine used to inoculate millions of children in the UK was today recalled amid fears over mad cow disease.

The Government's Medicines Control Agency ordered the recall after it discovered that the oral vaccine was produced using foetal calf serum from the UK. Guidelines designed to prevent the spread of BSE and its human form, nvCJD, ban the use of bovine material from countries known to be affected by mad cow disease.

Chief Medical Officer Professor Liam Donaldson has written to all GPs today informing them about the recall and warning them not to use the vaccine. The Department of Health said the risk of people being infected with nvCJD was "incalculably small". [Until infectivity assays are begun, the risk cannot be quantified; the same was said for the risk of BSE meat transmitting to human. -- webmaster]

Professor Donaldson said: "I know that this recall will worry parents, but it is important to remember that polio is a potentially lethal disease which we have virtually eliminated from this country.

"I am advised that the risk of a person contracting nvCJD from this oral polio vaccine is incalculably small. However, public confidence in medicines safety is paramount. We have to approach this from a precautionary principle, knowing that these important guidelines have been breached. Worried parents and patients are being told to contact their GP or the helpline NHS Direct.

Production of the vaccine ceased in September, but supplies were still being sent out to GPs until today. The Department of Health said it had repeatedly "sought and received" assurances from the Medeva, the company which made the vaccine, that UK bovine material was not being used in the production.

Medeva and Wellcome produced about 11.5 million doses of oral polio vaccine since 1989, according to the Department of Health. It was produced in seven batches, six of which are confirmed free from BSE herds, but it is unclear whether the batches were mixed before being split into individual doses. If the batches were mixed, all 11.5 million doses could be affected. If not, the figure is more likely to be between one and two million doses.

But suspicions were raised in June that the guidelines were being breached and further investigations revealed that UK-sourced foetal calf serum was being used as a growth agent in the vaccine. The vaccine has been used in the UK since the early 1980s and until September accounted for a third of inoculations given to children, travellers and other patients in this country.

Since guidelines were introduced last year banning UK-sourced bovine material in oral vaccines "hundreds of thousands" of doses have been given, the Department of Health said. [It is incomprehensible with only a handful of licensed vaccines that in 15 years the government would not have validated sourcing on all of them -- webmaster.]

Andrew Kemp, chief executive of the British Polio Fellowship, which supports polio victims, said: "As the Department of Health has said, the risk is incalculably small and the infected vaccine was in the process of being withdrawn anyway.

"What we would hope is that this does not deter anyone from being vaccinated. The vaccine has been extremely successful in combating polio. Only a few years ago in Holland, for example, a religious community decided against vaccinations and they later came into contact with someone with polio. There was a polio epidemic. So the risk is real."

Mr Kemp called for greater safeguards in the light of today's recall. He said: "The assurances the Government were given were clearly not adequate. It suggests there is a need for a more stringent monitoring process."

Medeva said it was preparing a statement on the recall of the vaccine. [What is there to say? That vaccine companies don't consider sourcing risks which have been under discussion for 15 years, but went ahead anyway to save a few pounds in manufacturing costs? -- webmaster]

Guidelines banning the use of bovine material from BSE-affected countries in injectable medicines were introduced by the Committee on Safety of Medicines (CSM) in 1989. Although not technically covering oral medicines, manufacturers were asked in 1996 and 1999 to ensure bovine material from BSE-affected countries was not being used.

Last year the ban was extended to oral medicines like the Medeva vaccine, and the MCA wrote to manufacturers seeking assurances that the guidelines were being adhered to. The Department of Health said they "sought and received", assurances from Medeva regarding the ban.

But in June of this year the CSM decided to tighten up procedures and the MCA again wrote to manufacturers. The MCA became suspicious that Medeva had not switched from UK-sourced material to non-BSE countries of origin and further investigations were made. A DoH spokesman said: "We discovered that the assurances given were inaccurate."

The MCA immediately ordered the recall of the vaccine and Professor Donaldson used the emergency Epinet system to inform GPs of events. Production of the vaccine ceased in September of this year but supplies were still being sent out to doctors up to today.

Because the guidelines do not have any legal force until next year when a European directive is enacted, no action can be taken against Medeva [No action is possible for lying to a government licensing agency on a major regulatory matter??? -- webmaster]

Anti-vaccine campaigners said the recall was another example of the hidden dangers of inoculations. Ann Coote, a spokeswoman for JABS, a self-help group for people worried about vaccines, said:

"This will scare parents. They will want to know: Why weren't we told before? What really is the risk?' The Government always says the risks are `minimal', but we won't know, will we, until and unless someone gets the human form of BSE from it. It always takes much longer for these things to come out. Parents will be very concerned at this."

The Government said supplies of polio vaccines would not be adversely affected. Smith Kline Beecham, which already accounts for two thirds of the market, confirmed it has sufficient supplies to meet demand.

Jackie Fletcher of JABS - a self-help group for people worried about vaccines - said: "It is not good enough just having regulations. They have got to be enforced. In this case, they have been - but not soon enough. What I can't understand is why this product was given a licence in the first place. That's where we need to tighten procedures up. It's a question of money coming before safety. There needs to be transparency and there needs to be less trust and greater checking of drug companies."

Pharmaceutical company PowderJect bought Medeva's vaccines business on October 1, it said today. A statement said: "The last shipment of oral polio vaccine from Medeva was on July 12, prior to PowderJect's acquisition of Medeva's vaccines business. PowderJect did not, and does not intend to manufacture, market or sell the Medeva polio vaccine."

Medeva said later that records relating to the batch of vaccines in question did not "fully clarify" the BSE-free status of the UK herd used to produce it. The company said it shared the Medical Control Agency's view that any risk was "incalculably small". [Why? over 35,084 herds ultimately proved infected, 37.5% of the total. In a controlled veterinary, herd feed records are kept. -- webmaster]

In a statement, Celltech, the pharmaceuticals giant that owned Medeva earlier this year, said: "Celltech has reviewed the extent to which any oral polio vaccine was produced by the former Medeva vaccines manufacturing operation during the period in which Celltech owned it from January 26, 2000, to September 30, 2000.

"Polio vaccine is produced by blending three previously manufactured poliovirus vaccine strains. Two of these strains had been manufactured by Medeva before 1996 [Perhaps guidlines came in then, but the BSE epidemic became a critical issue for sourcing vaccines a decade earlier. -- webmaster]. The third strain was in stock when the business was purchased from Wellcome in 1991.

"It is this third strain which has occasioned the concerns of the Medicines Control Agency. It has been established that six batches of this strain were manufactured by Wellcome using foetal bovine serum sourced from BSE-free herds in New Zealand.

"Records relating to the seventh batch do not fully clarify the BSE-free status of this veterinary-controlled UK herd, although there is no evidence to suggest that the herd was infected. The last time that Medeva blended and packaged the vaccine into finished product was on an intermittent basis during the 12-month period to August 1999.

"This was then stored and, under the Department of Health contract, Farillon -- its distributor of vaccines -- drew down shipments. The last of these occurred on July 12, 2000.

"We share the Medical Control Agency's view that any risk from this orally-administered vaccine is `incalculably small'. In addition, it does not arise from a vaccine component primarily manufactured either by Celltech or by the former Medeva."

Dr Peter Fellner, chief executive of Celltech, the company which owned Medeva until the beginning of this month, said today he felt they were being "unfairly put in the frame" over the vaccine recall. He said: "We are absolutely astonished and amazed by the statement from the Department of Health. We feel that we have been unfairly put in the frame for a situation which has nothing to do with the actions of people during the period in which we owned the company."

Dr Fellner said that batches of the polio vaccine produced by Wellcome, which had sold the business to Celltech, had been shipped out by Celltech until July of this year. Wellcome had assured Celltech that there were "no question marks" over the vaccine, Dr Fellner said.

When the Department of Health launched an inquiry into the safety of all vaccines earlier this year, Celltech asked to look at Wellcome's archives and discovered that one batch of the vaccine had been produced in 1986 using calf serum from a UK herd.

Dr Fellner said: "We wrote to the DoH on August 17 informing them of this and correspondence continued up until last week. "We informed the Department of Health ourselves about this. We had had assurances from Wellcome that there were no issues over the vaccine and had passed on these assurances to the Department. "What Wellcome told us was found not to be accurate."

Shadow health secretary Liam Fox said: "The immunisation programme is one of the most important parts of public health policy. "It is an area in which we have experienced shortages of vaccine for tuberculosis and influenza and a lack of openness about the safety of meningitis C and it has not been well-handled by current ministers. "It is therefore essential that all information is fully disclosed by the Government to help retain the confidence of an understandably sceptical public."

Liberal Democrat health spokesman Nick Harvey said: "It is crucial that children continue to be vaccinated. Polio is a far more serious threat to c

hildren's health than the small risk of BSE. "But the Government's vaccine programme is in confusion and disarray. This latest scare raises serious questions about the lack of transparency and accountability in the vaccine programme. The Government must now prove that vaccines are safe."

Experts knew of suspect polio jabs

October 22 2000  Lois Rogers and Jonathan Leake Sunday London Times
GOVERNMENT advisers have known for months that "old" polio vaccine was still in use, despite the fact it contravened safety guidelines, it emerged last night.

One of the three strains of polio vaccine used to immunise children until last week has been in deep-frozen storage since the mid-1980s.

It was produced from bacteria grown on serum from British cattle, which is forbidden by European guidelines for use in vaccine manufacture despite the fact that serum has never been shown to pass on BSE, or mad cow disease.

The committee on safety of medicines was alerted to this breach of the rules in August. A spokesman for the health department said the government's medicines control agency shortly afterwards launched an investigation, which was only completed earlier this month. A health department vaccines expert said the safety of the polio vaccine could be virtually guaranteed.

Warning over BSE link made in 1989

October 21 2000 London "Times   NIGEL HAWKES
SENIOR government advisers said as early as 1989 that vaccines could provide a route by which BSE could be transferred to human beings.

Their fears were brushed under the carpet because the Department of Health was worried that any adverse publicity about vaccines could cause a panic, with parents refusing to have their children vaccinated. The true feelings of those involved have emerged through evidence given to the BSE inquiry under Lord Phillips of Worth Matrvaers, which is due to publish its report next week.

Sir Richard Southwood, who led the first inquiry into BSE in 1988, soon identified that the greatest risk of human transmission lay in the injection of contaminated material in vaccines, and identified this as a priority area for action. In a meeting in May 1988, the Government's chief medical adviser, Donald Acheson, called for "urgent advice".

Sir Richard wrote a letter circulated to officials in which he said "the possibility of human infection is moderately high". He also wrote to the Committee on the Safety of Medicines three times asking for action. But his report played down the threat by saying that the risks "appeared remote". He told the Phillips inquiry that the committee used reassuring language because it did not want to cause a flight from vaccines and have the deaths of children on their consciences.

They were also told privately by the Health Department that steps would be taken to reduce the risks. But in writing to the vaccine manufactures, the department merely reiterated that the risks of infection through medical products was remote.

In January 1989, the CSM ruled that future vaccines would be taken only from herds certified to be free of BSE [it first became possible to reliably test carcasses ten years later -- webmaster] , but took no action to remove stock from the shelves made before this change was introduced. The vaccines continued to be used until 1993, and included MMR (measles, mumps and rubella) and vacccines against diphtheria, tetanus and whooping cough. Norman Baker, the Liberal Democrat MP who has campaigned on the issue, says this was "potentially criminally negligent".

The Health Department says that if vaccinations had been stopped there would have been a risk of epidemics, and deaths, among children. This risk was real, while that of transmission of BSE was "remote and theoretical".

Health ministers have given evidence that they were never properly briefed. Kenneth Clarke, a former Secretary of State for Health, has said that had he been told he would have ordered the vaccines to be withdrawn. So far, no evidence has emerged which implicates the vaccines in new variant CJD, the human form of BSE, which has claimed 75 lives. Most scientists still believe that eating contaminated beef is a more likely source, although the young age of many nvCJD victims has led others to suspect a role for vaccines.

The latest alarms over the oral polio vaccine do not change the picture. Even if it was contaminated, eating the infective agent for BSE is less dangerous than being injected with it. Celltech, which now owns Medeva, the company responsible for the vaccine, and the Health Department believe the risks from the vaccine are "incalculably small". Credibility of government assurances in this area is not very high.

Vaccines are often made from weakened versions of the agent responsible for disease. Such so-called live viruses can stimulate the immune system to fight the disease but are not strong enough to cause it. As living organisms, they have to be grown in cultures. Foetal bovine serum is widely used for growing vaccines but if it comes from BSE-infected cows, it has the potential to produce a vaccine which might carry the infective agent.

Bacgrounder on vaccine scandal (research and development by Terry S. Singeltary Sr.):

-- Vaccines and CJD -- FDA says Mothers to stupid to understand... 7/27/2000 US TSE Advisory Committee
-- CJD/Vaccines/children 'Confidential'-- could the "V" in vCJD mean vaccine???
-- Louping-ill vaccine accident
-- Vaccine Documents Commission Of The European Communities 111/3385/92-EN Final Jan 1993
Committee For Veterinary Medicinal Products Working Party On Immunological Medicinal Products
--Biological Products
Advisory Committee Joint Meeting of the Transmissible Spongiform Encephalopathies Advisory Committee
Vaccines and Related  - Preliminary Summary
-- MINUTES OF NPU - CVL MEETING - 27 APRIL 1993 BSE/TSE Transmission Testings
-- VACCINES/MEDICAL BIOL. ANNEX 8, 9, 12, 13 AND 15 1988/1989
-- Commercial In Confidence/BSE/surgical Implants/blood Contact Devices (1989)
-- Commercial In Confidence
Medicines Act - Veterinary Products Committee
Minutes of the Biologicals Committee meeting held on Tuesday 5 July 1988
-- ANNEX 5 COMMERCIAL IN CONFIDENCE MEDICINES ACT - VETERINARY PRODUCTS COMMITTEE Minutes of the Biologicals Committee meeting held on Tuesday 7 June 1988
-- VACCINES ANNEX 1 (VACCINES) MAFF Research and Services CVL and VIC 86/00.00/1.1

CWD draft federal regs: input wanted

Fri, 20 Oct 2000 
 Lynn Creekmore
Staff Veterinarian, Wildlife Disease Liaison
USDA, APHIS, VS, National Animal Health Programs Staff
4101 Laporte Avenue
Fort Collins, CO  80521
Comment (webmaster):

The government is looking for substantive comment on their CWD program for captive elk in the next week or so. Comments can be sent to Dr. Creekmore Generally a federal program makes more sense than idiosynctratic state-by-state programs run by mickey mouse ag and wildlife agencies.

The federal government will need to come down on Colorado, which seems incapable of doing a simple thing like shutting down the hunting season in an area with 15% pathologically confirmed CWD incidence in wild deer.

Who would eat meat from a herd of cows with 15% BSE or a flock of sheep with 15% scrapie? The risk is similar according to the best available science.

Chronic Wasting Disease: A Proposed Program For Captive Elk

The following proposal describes a Federal-State-Private Sector program designed to eradicate chronic wasting disease (CWD) from captive elk herds in the United States. Chronic wasting disease is a type of transmissible spongiform encephalopathy (TSE). As of August 2000, it has been found in free-ranging cervids, including mule deer, elk, and white-tailed deer in Colorado and Wyoming and in captive elk herds in Colorado, Montana, Nebraska, Oklahoma, and South Dakota as well as the Canadian province of Saskatchewan.

This proposal is based upon an initial program design put forward by the North American Elk Breeders Association and others. It was recommended to the United States Animal Health Association (USAHA) in 1998 and supported by a resolution of that organization in 1999. This version is the result of a series of discussions held with representatives of Veterinary Services of USDAís Animal and Plant Health Inspection Service (APHIS), State Departments of Agriculture and State Departments of Wildlife, Federal and State university diagnostic laboratories and research agencies, and producer associations. These associations include the North American Elk Breeders Association, the Exotic Wildlife Association, the American Sheep Institute, and the North American Deer Farmers Association.

Through these discussions, there has been broad agreement that Federal and State agencies and private organizations must work together to solve the problems posed by CWD in cervids. There is also agreement that the presence of CWD in captive elk is only part of a much larger and complex issue. As in any effort of this nature, however, the devil is in the details. There are aspects of the present proposal which some regard as an onerous burden upon captive elk owners. There are aspects which others regard as not being aggressive enough in eliminating the disease in positive herds.

Taken as a whole, the proposal represents an attempt to apply the best available and current scientific and diagnostic information to the management practices and economics of elk production units. The science of chronic wasting disease, like that of other TSEs, is rapidly evolving. As new information becomes available, the program will change. The current proposal is designed to have the necessary flexibility to respond to new developments.

The proposal is presented in two parts. The first is a series of questions and answers concerning the context, intent and substance of the program. The second is the set of the proposed regulations which would formally and legally define the program.

In addition to this program description, additional guidelines are available or will be developed as part of program implementation. These guidelines will cover: definitions, diagnostics, animal ID, carcass disposal, sample collection, and decontamination of premises. In addition a template for herd plans and examples of herd plans based on case studies will be produced.

1. What is the goal of the program?

The goal of the program is the eradication of CWD from captive elk herds in the United States. Captive elk herds refers to those elk which are privately or publicly owned and held for economic or other purposes within a perimeter fence or confined space. While the program may be used as a model for other captive cervids in the future, it is intended at this point only for captive elk. Measures for dealing with CWD in free-ranging cervids is a major concern with this disease, but it is not the focus of this more limited program.

2. How and when would a national program be implemented?

States would design and implement CWD certification programs for their own captive elk producers. State programs would meet minimum USDA/APHIS criteria and guidelines to ensure that programs were equivalent to one another (see part 2 of this proposal). States could make program standards that were more stringent than those minimum criteria and could make the program mandatory if they chose. USDA/APHIS would collaborate on the implementation of this program with American Indian tribal authorities.

Existing State CWD programs and participating producers would be grandfathered into Federal program if they meet the minimal requirements. USDA/APHIS would assist producers in those States which were unable to establish certification programs.

The Federal government, USDA/APHIS, would allow interstate movement of captive elk only from herds participating in certification programs. Producers would have to participate only if they wished to move their elk to another State or if the program were mandatory in their State.

The Federal Government would provide indemnity for depopulation. This could be supplemented by payments from States and industry. In the event of a positive diagnosis, the herd would be dropped from the certification program.

Implementation of the national CWD certification program would begin in Fiscal Year 2002 or as Federal funding becomes available.

3. What is the rationale for some of the technical elements in Herd Certification?

(I.A.) Fencing is designed to reduce the risk of transmission from free- ranging cervids to captive elk and from captive elk to free-ranging cervids. Double fencing is strongly recommended in areas where CWD is endemic in free-ranging populations and it may be required when a positive captive herd has been identified.

(I.B) CWD has been diagnosed in elk as young as six months. Early diagnosis moves the industry more rapidly to the goal of eradication, but practical limitations at this time make 16 months a more reasonable age to begin surveillance.

(I.C.) Federal, State or accredited veterinarians may collect samples for submission. Sample collection guidelines must be carefully followed. Herd status can be jeopardized by improper or poor sample collection.

(I.D.) Herd inventory is central to surveillance. Software applications have been developed by several States to facilitate the maintenance and cross checking of herd inventories. Herd inventories must include information on separately managed subunits if subunits are to be utilized in herd plans. Annual verification may be integrated with TB program requirements.

(I.F.) Guidelines for animal identification will be developed as a part of program implementation.

(I.J.) Diagnostic work will be conducted by laboratories certified for CWD testing by the National Veterinary Services Laboratory in Ames, Iowa. It is expected that a minimum of four laboratories will be so certified. A standard protocol for CWD diagnosis has been developed. Stringent quality control standards will be followed.

4. What is a herd plan and what does it contain?

A herd plan is a document written in conjunction with State/Federal officials in conjunction with the producer. It outlines steps to be taken as a response to a positive or trace herd. Plans may contain a range of actions from whole herd depopulation with no repopulation to selective depopulation with additional surveillance and management actions.

5. Why is herd depopulation the preferred option in the event of a positive diagnosis?

(II.A.) Given CWD's long incubation period, absence of a live animal, pre-clinical test and current state of knowledge on transmission, whole herd depopulation with no restocking on contaminated premises presents the least risk of further spread of the disease once a positive diagnosis has been made. However, whole herd depopulation may not be possible for a variety of reasons. These include limitations on indemnity funding, the current knowledge of CWD epidemiology in captive elk and the desire to encourage initial participation and reporting on the part of producers.

6. What are key elements in herd plans?

(II.A-D.) Herd plans must analyze the risk of continued disease transmission by subclinical animals and/or by environmental contamination. Herd plans set out specific actions to be followed during the quarantine period to reduce the risk of continued disease incidence within the remaining animals. Common factors in herd plans include:

Whole herd or selective depopulation
Identification of high risk vs. low risk animals based upon preexisting
management patterns
Continued surveillance
Cleaning and decontamination
Other relevant factors
(II.A-D.). Given current state of knowledge, repopulation on the same premises may result in reinfection of a new herd through environmental contamination. Research is just beginning on steps to ensure decontamination.

7. How would control of interstate movement work?

(III.A-C) Interstate movement would be controlled through the use of health certificates and Federal enforcement of their use. Nebraska has opted for the control of intrastate movement of captive elk through the use of similar certificates.

Proposed Program Regulations

I. Herd Certification Program

A. States should have perimeter fencing requirements adequate to prevent ingress or egress of cervids.

B. Surveillance based on testing of all deaths over 16 months of age is required. The state veterinarian can approve exemptions.

C. Good quality sampling is essential for surveillance. State veterinarians have the authority to adjust surveillance levels and herd status if poor quality samples are routinely submitted from a premise.

D. Herd inventory with annual verification by an accredited veterinarian or state or federal personnel is required. Inventory is to include a cross check of all animal identifications with the herd inventory and specific information on the disposition of all animals not present. Inventory should include information on management subunits that might be useful in assessing risk should a positive animal be diagnosed.

E. Mandatory death reporting and documentation of all interstate movement of animals is required.

F. Each animal should have a minimum of two State and Federally approved unique identifiers.

G. Premise locations must be specifically identified by GPS or detailed description during the first herd inventory. A detailed description of the physical facilities also is required.

H. Herd status will be based on number of years under surveillance with no evidence of disease: Level A is one year, level B is two and three years, level C is four and five years and level D is six years and above.

I. Herd additions are allowed from herds of equal or greater status. If herd additions are acquired from a herd of lower status, the receiving herd reverts to the same status as the herd from which animals were acquired. If a herd participating in the certification program acquires animals from a nonparticipating herd, the receiving herd must start over in the certification process.

J. A positive diagnosis is based on post-mortem brain testing at a CWD certified laboratory. A positive diagnosis at one laboratory must be confirmed by the National Veterinary Services Laboratories (NVSL) or a second CWD certified laboratory prior to producer or State notification.

K. Once a positive animal is identified in the herd, the State will impose an immediate quarantine. This herd can no longer participate in the herd certification program until all herd plan measures have been carried out.

II. Disposition of Positive and Trace Herds

Herd plans will be developed for any positive or trace herd. These plans will be developed by State and Federal officials in conjunction with the producer and will be subject to approval by the State Veterinarian. Such plans contain the following options for positive or trace herds.

Positive Herds

A. Whole herd depopulation with/without repopulation.

Depopulation of the whole herd with payment of indemnity is the preferred option for this program. Animals that are depopulated must be disposed of according to USDA guidelines for Transmissible Spongiform Encephalopathy (TSE) carcass disposal.

Animals to be depopulated may be sent to slaughter and testing. Payments received from an abattoir would be deducted from indemnity payments. CWD positive carcasses are not allowed to enter the human or animal food chains. CWD positive carcasses must be disposed of according to USDAís TSE disposal guidelines. CWD negative carcasses have no restrictions. Repopulation of cervids on the same premises after depopulation requires stringent guidelines. These would include: premise cleaning, disinfection, changes in stocking patterns on the land and 36 months of surveillance before interstate animal movement is allowed.

B. Quarantine with/without selective depopulation of high risk animals

Selective depopulation would be feasible where documented management practices (see inventory) indicate differential levels of risk exist within a herd. Such a herd plan requires a risk assessment on the part of the State and Federal officials to establish possible risk levels. It would also require: Herd inspection by State or Federal officials with removal and CWD testing of any clinical suspects and high risk animals; disposal of these animals must follow steps outlined in A.2-3; Herd inventory with individual animal identification and annual verification of inventory changes by accredited, State or Federal veterinarian; Perimeter fencing adequate to prevent fence line contact with captive and free-ranging cervids; Quarantine of herd for five years from the last case; Herd surveillance (mandatory death reporting and CWD testing of all age animals) will be conducted during the quarantine and will continue for 5 years from the last case.

2. When differential levels of risk cannot be established, the herd plan would consist of the above elements (II.B.1.a-e.) with no selective depopulation.

Trace Herds

A trace-forward herd is any herd that has received animals from an affected herd within 36 months prior to the death of the affected animal. A trace-back herd is any herd where an affected animal has resided up to 36 months prior to death.

C. Herd Plans for trace-forward herds:

Removal and testing of the trace animal with indemnity

a.  If animal is positive, herd is considered to be positive and an
appropriate herd plan is to be developed (see II.A-B.)
b.      If animal is negative, herd plan would contain:
i.      Herd inspection by State or Federal personnel with removal and CWD
testing of any clinical suspects; disposal of animals must follow steps
outlined in II.A.2-3.
ii.   Herd inventory with individual animal identification and annual
verification by accredited, State or Federal veterinarian;
iii.  Herd surveillance (mandatory death reporting and CWD testing of all
age animals) for five years from removal of the trace animal from the herd.
If trace-forward animal is not removed, steps  II.C.1.b.i-ii. would be
followed and
a.  Herd surveillance (mandatory death reporting and CWD testing of all age
animals) for five years.
b.  Quarantine of herd for five years from time of arrival of the
trace-forward animal.  However, if the herd has been participating in
surveillance as part of the herd certification program, surveillance done
after arrival of the trace animal may count as time in quarantine at
discretion of State Veterinarian.
D. Herd Plans for Trace-back Herds:

Herd inspection by State or Federal personnel with removal and CWD testing of any clinical or high risk suspects; disposal of these animals must follow steps II.A.2-3. Herd inventory with individual animal ID and annual verification by an accredited, State or Federal veterinarian. Quarantine of herd for five years from the last case traced back to the herd. Length of quarantine may be altered by the State Veterinarian if epidemiology suggests herd is not herd of origin of disease for trace-back animal. Animals may be sent to slaughter and testing as in step II.A.3. Herd surveillance (mandatory death reporting and CWD testing of all age animals) will be conducted during the quarantine and will continue for 5 years from the last case.

III. Minimum Requirements for Interstate Movement of Captive Elk

A. State of origin must require all suspected or confirmed cases of CWD be reported to the State Veterinarian.

B. State of origin must have the authority to quarantine source herds and herds affected with or exposed to CWD.

C. Animals will be accepted for movement only if they are from herds participating in the herd certification program and the above response measures for positive and trace herds are being followed in the State of origin.

There are technical difficulties of implementing the proposed program for captive elk being held under simulated open range conditions for aesthetic or hunting purposes. At this point, however, it is not feasible to develop separate programs for different management regimes.

In August 2000, it was not certain what the amount nor structure of indemnity payments would be. 2002 is the first fiscal year for which Federal funding with a distinct line item has been requested. Implementation also assumes States, USDA/APHIS, and elk producers and others have reached agreement on the outlines of this or a modified program.

Guidelines for sampling procedures have been developed and will be distributed in conjunction with program implementation. Herds are defined as captive elk on a legally permitted premises. Subunits of that herd are elk which have been managed separately and have no or minimal contact with other subunits. Such subunits may be used to establish differential risk levels in herd plans.

Proposed CWD Program Plan ...

FDA knew of Medeva vaccine horror, still okayed for US.

Guardian ... Sunday 22 October 2000 ... Martin Bright and Antony Barnett
Revealed: full scale of vaccine blunders. US authorities horrified by conditions at factory in BSE-tainted polio drug scare

The drug factory at the centre of the polio vaccine scandal has a history of contamination and production blunders, leading to fears that its vaccines against other diseases are unsafe.

The lives of thousands of old people and children have been put at risk by drug shortages caused by a catalogue of problems that have plagued the Medeva vaccines plant on Merseyside. One serious incident led to British soldiers being sent abroad without protection against Yellow Fever.

Last year, investigators from the US Food and Drug Administration (FDA) were horrified by the conditions they found at the plant in Speke, near Liverpool, which also makes vaccines against flu, tuberculosis, tetanus and Hepatitis B.

On Friday, the Department of Health was forced to recall Medeva's oral polio vaccine after it was discovered that the firm had potentially been using BSE-infected material. This weekend, an investigation by The Observer can reveal that the problems surrounding the polio vaccine may prove to be the tip of the iceberg . A week-long inspection by the FDA last summer into the production of the flu vaccine Fluvirin at the plant found Medeva had failed to :

- 'clean, maintain and sanitise equipment at appropriate intervals to prevent malfunction or contamination ';

- maintain systems to prevent unacceptable levels of toxins and bacteria contaminating the production process;

- ensure batches of vaccines 'conformed with all established standards, specifications and characteristics' ; and

- prove that vaccines on doctors' shelves would be free from 'bacteria and fungi' .

Last October the FDA's director of compliance, Steven Masiello, fired off an official warning letter to Medeva's head of primary production, John O'Brian, telling him to sort out the problems or have its product banned from entering the US. Fluvirin is used by some 20 million Americans and more than a million British people, many of them elderly.

Although the extent of the excess levels of toxins and bacteria at the Speke factory is not known, in extreme cases, contaminated vaccines can lead to severe adverse reactions, including toxic shock and fever. In the old and fragile, the impact could be lethal.

The FDA letter, seen by The Observer , contains the disclosure that instead of dealing with the problems, managers at the plant wanted to raise the level of contamination deemed to be acceptable. Sources familiar with the company's operations claim that there were serious production problems running through the factory and abuses were routinely ignored.

Although it is not known what other contamination problems the factory had, it is known that production difficulties were not confined solely to the manufacture of the flu vaccine.

The Observer has learned that the company was forced to stop making its Yellow Fever vaccine Arilvax, leading to a widespread shortage throughout the country. The Ministry of Defence last night confirmed that the situation became so serious that earlier this year it sent British soldiers on overseas missions without protection against Yellow Fever. Many travellers were also unable to get vaccinated against the horrifying tropical disease, which attacks the stomach and kidneys. The company has still not restarted production.

This March, The Observer revealed that production problems at the Medeva factory had led to warnings of a tuberculosis epidemic after the company failed to supply sufficient quantities of vaccine to health authorities. Three months after the FDA inspection the shortage of TB vaccines led to the suspension of routine school vaccinations .

Liberal Democrat consumer affairs spokesman Norman Baker is now calling for an immediate investigation into events at the Speke factory and a full explanation from the Department of Health. He also said that the Medicines Control Agency (MCA), the body which regulates drug companies, had serious questions to answer about why it had failed to take any action.

Baker said: 'The Department of Health and the MCA have completely failed to act in the interests of public health. In their desperate attempts not to undermine the vaccination programme, they have tried to sweep all problems under the carpet. As a result, public confidence has been shattered. When will they learn that the answer is not to cover up, but to identify problems and deal with them immediately?'

The Medicines Control Agency refused to answer any questions posed by The Observer about Medeva's vaccines and production at the Merseyside factory. A spokeswoman for the Department of Health said: "The MCA would not have allowed vaccines to be produced at this factory unless it was sure it was safe."

The troubled Speke plant has changed hands twice over the past year. When the problems were first identified by the FDA, it was owned by Medeva Pharma, which was bought by Celltech in January. Just last month, the vaccine business was sold on to Oxford-based Powderject and is now called Evans Vaccines.

A spokesman for Powderject said the company had first looked at buying the business last year, but pulled out after reading the FDA report . After receiving reassurances that the problems had been resolved it went ahead with the purchase: £56 million has been spent on improvements and the management team has been changed, although a number of senior personnel remain with the firm. The FDA confirmed that it had not reinspected the plant since its October warning letter, but was satisfied that problems were now being dealt with. It has authorised the import of the flu vaccine this year. A spokeswoman said: "The FDA would not allow this vaccine to enter the country if it was not safe."


Massive compensation package for nvCJD families?

 Sat, Oct 21, 2000 By John Deane and Andrew Woodcock, PA News Political Staff
Sufferers from the human form of "mad cow disease" are to benefit from a Government-funded multi-million pound compensation package, it was reported tonight. The deal is set to be announced on Thursday along with the publication of Lord Phillips' long-awaited report on his inquiry into the BSE disaster.

The Observer newspaper quoted senior Whitehall sources as saying that although there were practical and legal difficulties to be ironed out, the Cabinet committee set up to deal with the Phillips report had agreed a no-fault scheme that will see victim's families paid hundreds of thousands of pounds. [Each or in total? -- webmaster]

A Department of Health spokeswoman said only: "In advance of publication of the BSE report, we cannot confirm or deny the report in The Observer about a compensation package." Since 1985, 85 people in the UK are known to have contracted so-called new variant CJD (Creutzfeldt Jakob Disease), the human version of BSE, which is believed to be caused by eating infected meat....

Lord Phillips' 16-volume report is not expected to make specific recommendations for Government action, nor findings of legal liability. But if they feel it necessary, it is expected that victims and their families will be able to use its findings as the basis for legal action in pursuit of compensation.

Lord Phillips and his team sat for 138 days between March 1998 and December 1999, taking oral evidence from 333 witnesses, including senior politicians, scientists, doctors and relatives of those who have died.

The inquiry gathered more than 3,000 files from Government departments, received 12,000 letters and considered written evidence from 630 witnesses. The total cost of the investigation, one of the biggest public inquiries in British history, has reached 27 million.

CJD victims welcome payout reports

Sunday, 22 October, 2000 BBC
Relatives of people who have died from the human form of mad cow disease are welcoming reports that the government has approved a compensation package costing millions.

Details are due to be announced on Thursday after the long awaited publication of the report from the BSE inquiry headed by Lord Phillips.

More than 74 people have died so far from new variant CJD and their families were expected to launch legal action for compensation this week

But ministers have decided it would be "morally impossible" not to set up a 'no-fault' compensation package, according to the Observer newspaper. The Department of Health will not confirm or deny the claim.

Deputy Prime Minister John Prescott told BBC1's Breakfast with Frost programme that BSE/CJD was "a terrible problem that we inherited". He declined to comment specifically on the reported compensation package, and said a government statement would be made on Thursday. "We must wait until then," he added.

David Body, a solicitor representing variant CJD victims, said even with the extent of infection in the population unknown ministers would not be making a liability for themselves by approving a compensation package.

"I don't think it creates a difficult precedent for them," he said. "It does have the problem that it doesn't know how many cases there will eventually be. "But I think what it does recognise is that those cases will be over the next 15, 20 years so the government isn't creating an enormous liability for itself this minute."

David Body told BBC News 24 that he gave news of a compensation package "a cautious welcome". He said: "I want to see what the deal is in black and white."

He said there had been inconsistencies across the UK in care for CJD victims and that centralising such care would eliminate such problems being repeated.

Mr Body said he welcomed an opportunity to discuss a compensation package with the government. He added that any financial deal would have to be large enough "for us to rely on it, not just for this year or next but for the next 10 or 15 years."

The BBC's Daniel Sandford says it is not yet clear whether ministers will respond to another key demand of the families.

Terry Bishop, whose wife Jane died of variant CJD, is hoping to be compensated but is also calling for a central body to co-ordinate the health and social care of any future victims of the disease.

"It's ridiculous to think that we are still five, six years down the line batting in the dark. "Somebody or a collective body of people must get together now and formulate a team that can go round and help the families immediately."

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