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Pig, chicken feedback loop closed
BSE-type agents could be carried in blood
Recalls, quarantine create gamma globulin shortage
Watchdog 'didn't tell' health dept about mad cow blood
Fear of CJD justifies lawsuit
Farmer Martin Hayes has died from CJD
Butchers defy beef ban amid wider backlash
British government says beef ban has teeth
Drop that steak or we shoot
10,000 badgers to be culled in trial to save cattle
Nationwide shortage of antibody medicine

BSE-type agents could be carried in blood

Reuters World Report Thu, Dec 18, 1997
LONDON, Dec 18 (Reuters) - Swiss researchers said on Thursday they had discovered that B-cells in the blood play a crucial role in the development of scrapie, the form of madcow disease that affects sheep. Their findings suggest that B-cells may be the physical carriers of the agents that can carry Bovine Spongiform Encephalopathy (BSE, or madcow disease) and related disease in the body.

It is thought to be the first firm evidence that these agents could be carried in blood -- a vital link, researchers believe, that could help reduce the risk of the diseases spreading. The researchers from the University of Zurich found that mice bred to lack B-lymphocites, a type of white blood cell, failed to contract scrapie despite being injected with the agent that causes it.

Although some of the specially bred mice were found to be carrying the infection, they did not develop the disease. The absence of B-lymphocites completely blocked the scrapie agent from invading nerve cells, they wrote in the science journal Nature. The researchers hope the discovery could lead to treatments for people exposed to BSE, which has been linked to a new variant of its human form, Creutzfeldt-Jakob Disease (CJD).

"If you know that you have been exposed to infection, it might be possible to do some kind of therapy," one of the researchers, Michael Klein, told Reuters
. One possible treatment would be to suppress the immune system, reducing B-cells, as a form of post-exposure protection against developing the disease. The research was carried out entirely on mice using mouse prions rather than specifically those for either BSE or CJD. Nevertheless, the researchers believe their findings may help reduce the risk of the diseases spreading.

Britain recently withdrew two batches of blood-clotting factor from blood banks after finding that their donors had developed CJD. It said at the time, however, that there was no evidence that anybody had been infected with CJD by receiving donated blood. The World Health Organisation has also urged a ban on people at risk of CJD from donating blood.

"The involvement of B-lymphocites in neuroinvasiveness adds another reason to consider a step that will deplete white blood cells during the commercial processing of blood, to reduce the possibility of transmitting CJD through blood products," Paul Brown of the National Institute of Neurological Disorders and Stroke in Maryland, wrote in a Nature commentary on the findings.
B lymphocytes and neuroinvasion
Nature 390, 662-663 (1997)
Paul Brown
A crucial role for B cells in neuroinvasive scrapie. Although prion proteins are most efficiently propagated through intracerebral inoculation, peripheral administration has caused the diseases kuru, iatrogenic Creutzfeldt--Jakob disease (CJD), bovine spongiform encephalopathy (BSE) and new-variant CJD. The development of neurological disease after peripheral inoculation depends on prion expansion within cells of the lymphoreticular system.

Here the authors investigate the identity of these cells by using a panel of immune-deficient mice inoculated with prions intraperitoneally: they found that defects affecting only T lymphocytes had no apparent effect, but that all mutations that disrupted the differentiation and response of B lymphocytes prevented the development of clinical scrapie. As an absence of B cells and of antibodies correlates with severe defects in follicular dendritic cells, a lack of any of these three components may prevent the development of clinical scrapie.

However, they found that scrapie developed after peripheral inoculation in mice expressing immunoglobulins that were exclusively of the M subclass and without detectable specificity for the normal form of the prion PrPc, and in mice which had differentiated B cells but no functional follicular dendritic cells. They conclude that differentiated B cells are crucial for neuroinvasion by scrapie, regardless of the specificity of their receptors.

 A crucial role for B cells in neuroinvasive scrapie
Nature 390, 687 (1997)
M A Klein, R Frigg, ...  M Suter, R M Zinkernagel & A Aguzzi

Farmer Martin Hayes, 51, has died from CJD

Scottish Daily Record  December 15, 1997, Monday
A farmer has died from CJD - the human form of mad cow disease. But the only livestock Martin Hayes had on his Suffolk farm were ostriches and emus. Doctors are probing the theory he caught the killer bug from infected beef products fed to the birds. Medics have also told his family the disease could have been genetic.

Martin, 51, started to feel ill and unsteady on his legs in August. Experts from a specialist CJD team in Edinburgh travelled south to carry out a series of tests before he died. Then a post mortem confirmed he had the disease. His devastated brother Keith said: "The end came very quickly. " He and the rest of his family are now being tested for any signs of the illness.

The Mirror December 15, 1997, Monday Peter Kane And Harry Arnold

A farmer who kept emus and ostriches has died of CJD - the human form of mad cow disease. Bachelor Martin Hayes, 51, was taken ill at his remote small-holding. One theory is that the bird feed he used was contaminated with BSE from the remains of slaughtered cows banned from the human food chain. Doctors believe Mr Hayes could have contracted the killer brain bug by inhaling it or by getting a minute speck of infected dust in an eye. An amount 1billion times smaller than a pin-head may cause CJD, say US scientists.

The mobile home where Mr Hayes lived has been removed and some belongings burnt.

The birds - now being fed by his brother Keith - are behind 10ft-high wire fences in the Suffolk village of Bramfield. Notices warn people to stay away. Keith said:

"Martin was perfectly healthy until the end of August when he began to suffer loss of balance. "The end came very quickly and his death is still a mystery. "Martin always insisted on eating good quality food. He would never buy a cheap hamburger. But he did love his beef. "Martin always believed he had either cancer or CJD. And he has been proved right. "The possibility of a link between the birds and their feed is very worrying for me because I'm feeding them until they can be sold. "
Keith said doctors told him Martin's CJD may be genetic but no relatives knew of any other cases in the family. Mr Hayes was admitted to hospital in Norwich and later transferred to St Mary's in Paddington, London.

Experts researching CJD and BSE travelled from Edinburgh to carry out tests. But his condition worsened and he died. Tests are being carried out on his brain at the specialist Maudsley Hospital, south east London. Keith, of Bury St Edmunds, Suffolk, and brother Roy will have blood tests to see if they are carrying the CJD virus.

Keith said: "I'll be asking the doctors a lot of questions. How can the illness have been genetic when there is no record of anyone else in the family ever having CJD? "What made Martin ill so quickly? And why did it happen so soon after he began farming emus and ostrichs? "

Watchdog 'didn't tell' health dept about mad cow blood

 December 16, 1997, Tuesday The Mirror Richie Taylor
Health minister Brian Cowen last night expressed shock over the way the "mad cow " blood scare was kept a secret from his officials. The watchdog Irish Medicines Board failed to notify civil servants that 268 hospital patients had been given transfusions of blood tainted with CJD, the human equivalent of BSE.

The IMB was told on November 18 that a batch of English blood plasma included supplies from a donor who had subsequently died of new variant CJD. It advised distributors to begin withdrawing contaminated supplies immediately. But it was a further NINE days before news of the crisis leaked to health officials and an explanation was demanded.

The watchdog body said it had followed standard procedures and assessed the risk involved before contacting the Department. But Fine Gael health spokesman Alan Shatter said yesterday that he was not satisfied that the matter had been given priority treatment. He is to raise the matter in the Dail.

Yesterday Mr Cowen stepped in to defuse the crisis. He said new procedures would ensure that he and his department were informed immediately of any scares. He said:

"I'd have thought the IMB would have let us know sooner. I've told them it's important we have information as soon as possible. "
He defended his own staff who delayed passing on the news to him for several days.
"It was an ethical problem, " he explained. "There is a doctor- patient relationship to be respected and there's also the possibility of psychological distress. "But, unlike Britain, we've decided to inform people. "I'm happy my staff began to take steps immediately. But in future I'll be the first person to be told. "
He denied there had been any attempt to cover up the scandal and said he had planned to make the information public as soon as all the patients affected had been informed.
"We had actually arranged a meeting for today to put in process the mechanism to inform patients, " he said. "But now we have to deal with it in the public glare. " Patients who received the tainted product, Amerscam Pulmonate II Agent, have heart and lung conditions. They will all be individually contacted, he said, in a way that is "prudent, sensible and sympathetic. " He moved swiftly to allay their fears. "The level risk is extremely low, in fact, infinitesimal, " he said. "Unfortunately there is no test available at present. "But we've identified everybody who received the product and advice and counselling will be put in place for them. "
He said that, so far, the Department had received only one phone call from a distressed patient. He warned against panic and said: "People should go to their GPs if they are worried. We sought expert advice and set everything in motion. " So far no deaths from CJD have been reported in the Republic. But 22 peole have died in the UK from the disease which can incubate for up to 15 years. Two of them were reported to be blood donors.

Moves to bring in new feed curbs

PA News  Wed, Dec 17, 1997 By Amelia Gentleman
The Government is set to ban the practice of feeding pigs and poultry with recycled pork and chicken products, Agriculture Minister Dr Jack Cunningham announced today. Following a review into dangers of feeding animal products to animals of the same species, Dr Cunningham said some current feeding practices would have to end.
"The current practices of processing certain types of waste containing porcine material and feeding it as swill to pigs and using poultry and feather meal as high protein rations for poultry will have to end," he said.
The Spongiform Encephalopathy Advisory Committee concluded after their review that there was no immediate risk from intraspecies feeding, but said that the practice of recycling waste as feed within a species posed dangers nevertheless. Dr Cunningham said:
"The committee describes the risk as small, but considered that it could not be discounted completely. It recommended that the Government develops a strategy to remove this risk."
Before any legislation is passed to ban the practice, the Government is to conduct a review into the disposal of animal waste nationwide in the New Year.

An order aimed at banning the feeding of pig waste and unprocessed pet food to pigs as swill is due to go out for consultation early next year. The Government will discuss with the European Union a possible ban on the use of poultry and feather waste as poultry feed and it will also look at methods to prevent pig and poultry material in catering waste being fed to pigs and poultry.

"This action to avoid any possibility of a risk which the committee described as `small' and `potential' means that consumers will continue to enjoy the highest possible protection against the risks from transmissible spongiform encephalopathy and give the assurance that pig and poultry products remain TSE free," Dr Cunningham said.

Moves to bring in new feed curbs

18 Dec 97 PA News/Reuters
U.K. Agriculture Minister Dr Jack Cunningham was cited as saying today that the Government is set to ban the practice of feeding pigs and poultry with recycled pork and chicken products, following a review into dangers of feeding animal products to animals of the same species, adding,
"The current practices of processing certain types of waste containing porcine material and feeding it as swill to pigs and using poultry and feather meal as high protein rations for poultry will have to end." he said.
The stories say that the Spongiform Encephalopathy Advisory Committee concluded after their review that there was no immediate risk from intraspecies feeding, but said that the practice of recycling waste as feed within a species posed dangers nevertheless.

Before any legislation is passed to ban the practice, the Government is to conduct a review into the disposal of animal waste nationwide in the New Year. An order aimed at banning the feeding of pig waste and unprocessed pet food to pigs as swill is due to go out for consultation early next year.

Butchers defy beef ban amid wider backlash

December 17 1997 Times BY PHILIP WEBSTER, ADRIAN LEE AND CHARLES BREMNER 
THE Government dismissed predictions of mass civil disobedience by meat traders yesterday after it faced a backlash at home and on the Continent over its ban on the sale of beef on the bone and on European imports that do not match British standards.

After warnings that the bone ban was "unenforceable" hours after it came into effect, senior officials said that butchers were law-abiding citizens and would comply with the new regulations, which would soon "settle down".

But throughout Britain yesterday they continued to sell beef on the bone. Butchers were given warning that they faced prosecution and possible jail sentences. An enforcement officer said: "If they lay down the gauntlet it is just a question of time before someone is brought before the courts."

The row took an angry turn when Jack Cunningham, the Agriculture Minister, accused William Hague of "breathtaking hypocrisy" for backtracking on his earlier support for the measure. The Tory leader backed opponents of the ban during a dawn tour of Smithfield, London's meat market. He accused the Government of "insufferable arrogance" by introducing the ban and failing to maintain support for the farming industry, which is still suffering from the BSE crisis and the effects of the strong pound on exports.

Dr Cunningham said that Mr Hague had expressed support for the ban on the basis of advice from scientists, but was now prepared to play "fast and loose" with public health to score political points.

Sources close to the minister have insisted that he had no choice but to impose the ban because he was acting on scientific advice about the risk of humans contracting new variant Creutzfeldt-Jakob disease.

Kenneth Calman, the Government's Chief Medical Officer, is understood to have told Dr Cunningham both before and after the advice from the Government's scientific committee that there should be no question of allowing meat infected with "mad cow" disease to enter the human food chain. "No responsible minister could have done anything else," informed government sources said.

In the Isle of Man and Jersey, which have their own parliaments, the sale of T-bone steak, oxtail, and rib will be allowed.

Last night Dr Cunningham rejected criticisms of the regulations. In a statement issued after his return from Brussels, he insisted it would be obvious to inspectors and customers if meat was being sold on the bone.

"Environmental health officers visit butchers as part of their day-to-day enforcement duties," he said. The new rules had been introduced "to protect the public and it is in the public interest that they be applied".
In Brussels, where European Union farm ministers met, Franz Fischler, the Farm Commissioner, said that the legality of the import restrictions was still being investigated. However, despite calls from MEPs for immediate legal action, Britain could be saved from prosecution because it will be difficult to squeeze a case through the European Court of Justice before the measures take effect across the European Union in three months' time.

The deadline for the implementation of the new rules was delayed from January 1 to April 1 in a vote by the 14 other EU member states on Monday, the move that was the trigger for Dr Cunningham's decision.

EU farm ministers told Dr Cunningham that they were unhappy with Britain's move to require the removal of bone and offal from the meat, according to Fernand Boden, the Luxembourg minister who chaired the Brussels session. "You shouldn't go it alone when it comes to matters of public health. A unilateral decision is not something that will restore consumer confidence," he said.

The strongest criticism came from Germany, which claims it has no native "mad cow" disease and is resisting EU moves to impose the new hygiene rules on all member states. Jochen Borchert, its minister, said the British move was "legally unjustifiable". The EU rules that allowed states to take unilateral action did not apply in this case because they could only be invoked over a sudden emergency and there was none in this case, he said.

The British minister played down differences with the EU yesterday, saying: "The atmosphere was good. We had a long amicable discussion . . . no one is falling out."

Confused Germans in no mood to fight

GERMAN officialdom stamped its foot and cried "foul" yesterday at the British threat to ban European beef imports. Most Germans, however, were a little confused. "I thought the whole point was that we have tougher rules than the British," said Elke Walbroel in a Bonn supermarket. The pensioner pointed to a headline in Bild: "Blood from sick Briton sold all over the world."

The feeling on the front line - the butcher's shop - seems to be: "Let's get back to eating beef providing it is not from Britain." Richard von WeizsÓcker, the former President and one of Germany's most trusted figures, is appearing in pro-beef advertisements, declaring it to be an essential part of the German menu.

There is, in short, no stomach for a new beef war. The hysteria has faded. Germans have been told, day after day for two years, that their herds are free of BSE. The handful of reported cases have all been traced back to a British import. This has done little to restore domestic beef consumption, which has dwindled to its lowest levels since the war. It has, however, convinced farmers that they must export or die.

Badgers to be culled in trial to save cattle

December 17 1997 Times BY MICHAEL HORNSBY
AT LEAST 10,000 badgers are expected to be culled in an attempt to find the best way of halting the increase in tuberculosis among dairy cattle. The culls, in areas with the highest levels of bovine TB, will last for five years to allow comparison of different culling methods with a policy of no culling at all.

Jeff Rooker, the Food Safety Minister, announced the experiment yesterday on the advice of an independent review group of scientists headed by John Krebs, Royal Society Research Professor in the zoology department of Oxford University.

"Next to BSE, bovine TB is the most serious animal disease that the Ministry of Agriculture has to deal with," Mr Rooker said. "The report by the group gives us an updated and authoritative basis on which to proceed."
The report, commissioned by the previous Government and released yesterday, concludes that "evidence strongly supports the view that, in Britain, badgers are a significant source of [TB] infection in cattle".

Professor Krebs said that policies in the 1970s and 1980s of killing all badgers in TB-infected areas had suggested that the culls could reduce the incidence of the disease in cattle. But culling policies had never been subjected to scientific analysis. Farmers' groups yesterday welcomed the report's acknowledgement of the probable link between badgers and bovine TB, but voiced dismay that all badgers in infected areas would not be slaughtered immediately. Farmers are also worried that the limited culling now carried out by the ministry will be suspended outside the trial areas.

The National Farmers' Union called the report a watershed that vindicated what farmers had been saying for a long time, but said that, during the trials, many farm businesses would be left unprotected. Sir David Naish, its president, said that while evidence was being collected, "many farming families will be facing ruin".

Ministry of Agriculture officials admit that the current policy has failed to slow the rise in the number of herds with TB outbreaks, up from 125 in 1991 to 471 last year. Badgers are culled only if they are found on a TB-affected farm, and lactating sows with young are excluded. Under the most drastic of the options to be tested, all badgers, including lactating sows, will be killed.

The culling will be done by trapping and shooting. Animal welfare groups said they remained to be convinced that culling was necessary. "Current control strategies have not worked," Colin Booty, of the RSPCA, said. "We fear that the inclusion of lactating sows in the culls could leave young cubs to starve."

Although the number of herds infected with TB is only about 1 per cent, the incidence of the disease has been increasing and has spread from southwest England to areas with no recent history of infection. A recent study put the badger population at more than 400,000, a 77 per cent increase on previous estimates.

Recalls, quarantine create drug shortage

 Times Union (Albany, NY)  December 14, 1997
MONTEREY, Calif. -- Thousands of patients will be without their ''immune system in a bottle'' because of fears the plasma supply has been infected with a malady closely related to so-called mad cow disease.

Beginning last January, the U.S. Food and Drug Administration issued a series of recalls of gamma globulin -- a medicine of concentrated antibodies derived from human plasma -- fearing the blood product was infected with Creutzfeldt-Jakob disease. Though the drug is best known as an antidote for hepatitis A, it is also used to treat diseases ranging from AIDS and pediatric HIV to Alzheimer's and leukemia.

Creutzfeldt-Jakob disease, a neurological disease that causes loss of muscle control and eventually death, is closely related to what has been called mad cow disease, which caused beef to be pulled off shelves in European markets in the past year.

Since October, there has been a chronic shortage of gamma globulin. Doctors and hospitals say they are unable to get the drug. Patients are beginning to fall ill. Because the disease can be transmitted through blood, the blood product industry has been asked to take extra precautions with their donor pools.

But more than half of all companies that make plasma products are not in compliance with good manufacturing practices, said Anne Marie Finley, an investigator for a congressional committee with jurisdiction over the FDA, the Center for Disease Control and the National Institutes for Health.

In a telephone interview from her Washington, D.C., office, Finley said there is no upper limit on the number of donors in a plasma pool, and the number can reach almost 500,000.

''If you make these huge pools, you vastly increase the chances of infection, but it's economically efficient (for the manufacturers) to make the pools as large as possible,'' she said, adding that in the past donors have returned to tell companies that they have been exposed to Creutzfeldt-Jakob disease.
There have been 24 FDA withdrawals of globulin-related products since the beginning of 1997, and the FDA requested an industry-wide quarantine on the drug until tests for Creutzfeldt- Jakob disease can be perfected, with exceptions for patients who have hepatitis A. Patients with low white-blood cell counts and low platelet levels can take gamma globulin intravenously to restore their immune systems.

Drop that steak or we shoot

The Economist  December 13, 1997 
EVEN by the standards of the hypochondriac Economist, the past week or so has been a nervous time. Staff luncheons regularly include beef, some of it attached to bits of bone. Though the meat's ostensible purpose was to nourish, the real aim, it now appears, was to assassinate. For there is probably a very, very small chance--correction, a very, very, very small chance--that bony-beef eaters will contract a new variant of Creutzfeldt-Jakob Disease, deriving from bovine spongiform encephalopathy ( "mad-cow disease ") and transmitted, maybe, in beef bones.

Though hard knowledge of the risks is scant to nonexistent, guesses by the government's mad-cow experts suggest that the average Briton is 60 times more likely to die by lightning, 750 times more likely to drown in the bathtub, 24,000 times more likely to die playing soccer. But since all risk is terrifying, and even one preventable death is too many, there are not many intact fingernails left around this place.

Luckily the British government is getting tough, as the phrase goes, on the sellers of the perilous stuff. Now, some people might argue for warning the public and letting consumers choose for themselves how much risk to take, as they do every time they step into a car or go for a swim; others might go a bit further, and require warning labels on ribs of beef. But is not the death of even one innocent child too many? "Saving one more young life would be far more valuable than the loss of a Sunday roast, " says Jack Cunningham, Britain's agriculture minister. And so in Britain it will soon be illegal to sell or buy a T-bone steak.

If the matter is merely to save lives, surely it is odd to forbid ribs while allowing tobacco. Fortunately, the Americans are squarely on that case. They are busy campaigning against smoking in general, and smoking by teenagers ( "children ") in particular; and to that end some of the states are busy testing young people for traces of nicotine and, if the drug is found, revoking the malefactors' driving licences, ejecting them from sports teams and fining them as much as $ 1,000. In Idaho, underage smokers get up to six months' imprisonment. That will teach them to disrespect their bodies. As if seconding the motion, the city of Roanoke, Virginia, has, as the New York Times recently put it, begun "getting tough " with drunks: if a court finds that you are a "habitual drunkard ", you can be sent to jail for up to a year if you are caught "drinking so much as a sip of wine, or even possessing a beer. "

The health inspector calls

Death, modern science has discovered, is the leading cause of mortality, followed closely by folly and freedom. It is thus reassuring to see that governments are cracking down on all three. They could do more to get tough with risk-takers and health malefactors, however.

Food, it turns out, is full of substances. Broccoli contains small amounts of carcinogens. Mushrooms can give you botulism, peanuts aflatoxin, ground beef E. coli. America's Food and Drug Administration has recently approved the irradiation of red meat to kill nasty bugs--a technique already allowed for poultry, fruits and vegetables.

Date: Thu, 18 Dec 97 15:26:50 -0500 From: "Michael Hansen" To: , , , , , Subject: CJD FEAR PATIENTS ALLOWED TO SUE MIME-Version: 1.0 Headline:

CJD fear patients allowed to sue

PA News Thu, Dec 18, 1997  By Stephen Howard, PA News
Physically healthy patients treated with human growth hormone which killed others after they contracted a form of mad cow disease were today allowed to seek compensation from the Government. Mr Justice Morland accepted in the High Court today that they may have suffered psychiatric illness brought on by fear of contracting the incurable fatal disease.

The Creutzfeldt Jakob Disease litigation was begun last year by parents of children who died after being given the growth hormone extracted from corpses to combat dwarfism. Mr Justice Morland ruled in July 1996 that the Department of Health was negligent in not heeding the warning of Dr Alan Dickinson, who in 1977 told the Medical Research Council about the risk of contracting CJD from the hormone treatment.

His later judgment that parents of children whose treatment "straddled" the compensation cut-off point of July 1, 1977, were not eligible was overruled by the Court of Appeal last month. And today the same judge allowed those who were treated after the cut-off point to sue for damages even though they have not contracted the disease. He said it was a "matter of law" that those injected with the human growth hormone after 1977 can sue the Department of Health who were in breach of their duty of care. Any psychiatric illness was "substantially caused" by becoming aware of the risk of developing CJD, he said.

 "The risk of CJD was not merely the risk of lethal disease but of a disease
which would cause the victim ghastly suffering not capable of treatment or
amelioration."
He said those who received the injections were all children at the time. "They themselves did not choose to receive the treatment. They were selected for the treatment by clinicians at Growth Centres."

The Department of Health could have concluded after the 1977 warning that the risk of CJD becoming a reality could occur within "a huge time span" - up to many decades after injection.

"It was reasonably foreseeable that a patient might receive the shocking news towards the end of adolescence, in early adulthood or middle age." Mr Justice Morland added: "In my judgment the evidence shows that the defendants not only should have reasonably foreseen the risk of psychiatric injury but did in fact do so."
He said all those who received the treatment and were of "normal fortitude" or having a vulnerable personality who can prove that his psychiatric illness was caused by his becoming aware of the risk of CJD and suffered a psychiatric illness can recover compensation. All eligible cases will return to the High Court later for a decision on the amount of compensation.

Nationwide shortage of antibody medicine

December 19, 1997 By LINDA A. JOHNSON, Associated Press Writer 
TRENTON, N.J. -- Tens of thousands of people who need blood-based immune globulin because of conditions such as deficient immune systems are facing a severe, nationwide shortage at the worst time -- the peak of cold and flu season.

The sudden shortage of the life-saving medicine is blamed on increased demand, production problems and product recalls.

"In the last couple weeks, it has gone from short supply to not available at all," said Jason Bablak, spokesman for the International Plasma Products Industry Association.

Without their monthly intravenous dose, tens of thousands of patients, many of them children born without working immune systems, risk debilitating illness and death from common ailments.

"I've lost two boys with hemophilia to AIDS already, and I'm terrified of losing Teddy," said Elaine DePrince of Cherry Hill, whose three hemophiliac sons all contracted AIDS from tainted blood-clotting products.

Teddy, 17, needs a monthly intravenous dose of immune globulin because his body cannot make antibodies. DePrince said Thursday the home care company providing the medication has none for Teddy this month and is unsure when it can get any.

"I was utterly horrified," DePrince said.

Teddy got a dose in December because another young hemophiliac died of AIDS and the family gave her his medicine. But next month, he may have to stay home from school and choir rehearsals.

The Food and Drug Administration, which inspects every lot of the medicine before it is sold, is "working closely with manufacturers to expedite distribution of all available product without compromising safety," FDA blood chief Dr. Jay Epstein said Thursday.

No one knows when the shortage will end, though Alpha Therapeutic of Los Angeles, Bayer Pharmaceutical of West Haven, Conn. and Baxter Healthcare of Deerfield, Ill., are awaiting approval of new facilities so they can expand production.

"I suspect (it) will be in short supply for the foreseeable future," said industry consultant Donald Tankersley, who previously directed the FDA's plasma derivatives laboratory.

Immune globulin is made by separating antibodies from blood plasma, most of it collected from paid, repeat plasma donors, then treated to kill viruses. The American Red Cross pays Baxter to make its immune globulin brand from plasma separated from whole blood the Red Cross collects.

The other manufacturers are Novartis of East Hanover and Centeon of King of Prussia, Pa.

Interviews with the manufacturers and other experts indicate the biggest problem is steadily increasing demand for immune globulin as more physicians prescribe it for additional uses, many of which are not life-threatening. Those include chronic fatigue syndrome; diabetes and autoimmune diseases; rheumatoid arthritis and lupus.

"Physicians need to be mindful to direct the product to the patients that need it the most critically," Epstein urged.

Besides pediatric AIDS, immune globulin is approved by FDA for patients getting bone marrow transplants and for those with primary immune deficiency (PID), a group of about 50 inherited immune system disorders.

British government says beef ban has teeth

December 20, 1997  Agence France-Presse 
LONDON (11:48 a.m. EST http://www.nando.net) - The British ministry of agriculture, fisheries and food warned Saturday that butchers who don't respect the government ban on beef on the bone risk heavy penalties and even prison.
"If butchers choose not to follow the ban then there are penalties under the Food Safety Act which can mean anything up to a 1,000-pound ($1,600) fine and or six months in prison, depending on each case," a ministry spokesman said. "We have told all the trade bodies about the penalties and it is up to local environmental health and trading standards officers to keep a check and police the ban."
The warning came amid allegations in a daily newspaper of widespread violations of the ban imposed to counter the latest fears of "mad cow" disease spreading to humans. Citing a nationwide survey, the Daily Mail newspaper said one out of four butchers were still selling beef on the bone four days after the ban went into effect.

The government imposed the ban, which took effect at midnight Monday, because of new fears that bovine spongiform encephalopathy (BSE) can be transmitted through the bone and marrow of cattle. Until then it was believed the main vector for spreading the disease were organs like the spinal chord and brain. The new ban is the government's latest attempt to end mad-cow fears and pave the way for a lifting of a worldwide British beef export ban imposed by the European Union in March 1996.

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