Stressed-out from knowledge of exposure
Oprah to take on Texas cattlemen again
Hong Kong recalls Baxter plasma linked to mad cow scare
Experts urge more aid for CJD victims
FDA panel says spinal-cord gelatin is free of mad cow risk
No mad cows on organic farms?
Progress made on diagnosing scrapie
Another Belgian herd
Beef-on-bone ban stays despite Scottish ruling
PA News Wed, Apr 22, 1998 By Cathy Gordon, PA NewsSix people who live in fear of developing the human form of "mad cow disease" launched a High Court test case today to claim damages for psychiatric injury.
The court was told they were all "negligently" treated with human growth hormone and say they have developed a psychiatric illness as a result of being told that they may be incubating the CJD (Creutzfeld Jakob Disease) agent. The six plaintiffs are representative cases for a group of people who were treated with the human growth hormone after July 1, 1977, and who fear they will contract the incurable fatal illness.
Paul Nicholas Andrews, Neil Scanlon, David Lockhart, brother and sister Philip and Claire Johnson and Justin Parkes, have been selected from what is referred to as Group B in the CJD litigation to indicate a range of severity of psychiatric injury according to three broad categories - severe, moderate and mild.
Their counsel Stephen Irwin QC told Mr Justice Morland in London that there were another 29 cases in that group beyond the six now before the court.
He said that in the cases of Paul Andrews, Neil Scanlon, David Lockhart and Philip Johnson it was accepted by the defendant, the Secretary of State for Health, that psychiatric illness had been caused by learning of the risk of developing CJD. "In those cases the dispute between the parties is as to the nature and severity of the illness and the extent of damages which may be recoverable."
In the so-called "mild" cases of Claire Johnson and Justin Parkes, the defendant considered that no psychiatric illness has been sustained, said Mr Irwin. The CJD litigation was started in 1996 by parents of children who died after being given growth hormone extracted from corpses to combat dwarfism.
From 1959-85 nearly 2,000 children in the UK whose growth was stunted because of a deficiency in the secretion of growth hormone in their pituitaries were treated with doses of human growth hormone extracted from corpses. The programme was ended in May 1985 after several children who had been treated in the US died of CJD.
In July 1996 Mr Justice Morland, who is hearing today's cases, ruled that the Department of Health was negligent in not heeding the warning of Dr Alan Dickinson. In 1977 he had told the Medical Research Council about the risk of contracting CJD from the hormone treatment.
Last year people who were given the hormone treatment and claim they have suffered a psychiatric illness brought on by fear of contracting the disease were given the go-ahead by the same judge to seek compensation.
He ruled then that 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 to him and that he has suffered a genuine psychiatric illness can recover compensation".
Mr Irwin told the court today that psychological symptoms displayed by the many of the Group B plaintiffs included sleep disruption, anxiety about marriage, sex and reproduction and the transmissibility of the CJD agent. There was also the fear that physical signs, such as faintness or lethargy, were the early signs of CJD development.
He told the judge there was also a difficulty in being able to obtain any lasting resolution of anxieties about CJD: "The last point means that for many plaintiffs counselling is of little or no use since the threat of CJD cannot be removed." At the close of a CJD hearing in May 1996, he said, 16 recipients of the growth hormone had died or who were dying of CJD.
"Less than two years on, the total number of those who have died or who are dying has risen to 27. "If the number of casualties increases substantially there may well be cases where a plaintiff manifests a serious deterioration in their mental condition," said Mr Irwin.
PA News Wed, Apr 22, 1998 By Natalie Martin, PA NewsA family are demanding an inquest into the death of the son they say was "poisoned" by BSE-infected beef.
Keen sportsman Chris Warne, 36, from Ripley, Derbyshire, died in October last year from new variant CJD - nvCJD - the human form of mad cow disease. This was confirmed at a post mortem examination by doctors at the CJD surveillance unit in Edinburgh. A conference at Warwick University last week was told of mounting evidence that nvCJD was linked to contaminated beef.
But Derby Coroner Peter Ashworth's office has said he will not be holding an inquest into computer analyst Mr Warne's death. Inquests are usually held when a death is deemed to be violent or unnatural.
Mr Warne's parents Terry and Shirley - who are still coming to terms with what has happened - question the assumption that his death was from natural causes.
"We feel Chris was poisoned and it should not have happened ... that somebody killed him," said Mr Warne. The couple say they have agonised over whether to pursue the inquest, but feel it is the right thing to do and have contacted their solicitor for advice.
"We feel very strongly about it - we want to know that we have done everything we can to find out what happened ... to prevent other people suffering in the same way we have. We saw our son go from a young man as fit as a fiddle to comatose," said Mr Warne.
"I want to know why what happened - and what the (inquest) verdict would be. It is definitely not natural causes - it was the most horrific experience - to see your son go down so quickly."
Inquests into two other cases of new variant CJD elsewhere in the country have recorded verdicts of misadventure. The Warne family are puzzled why inquests are held in some cases but not in others. Clive Evers, of the CJD Support Network, said: "If there is not an adequate standard of decision making around the country it does seem to merit investigation.
"Coroners have a great deal of autonomy. Whatever guidelines they work to they need revision ... another look in relation to cases of CJD because of this variation around the country." He said an inquest was often a part of the whole grieving process for families.
Birmingham Coroner Dr Richard Whittington, former president of the Coroners' Society, said according to Section eight of the Coroner's Act 1988, an inquest must be opened if the Coroner had reasonable cause to suspect there had been a violent or unnatural death.
"It is question of whether, in the Coroner's judgement, CJD is an unnatural cause of death," said Dr Whittington. "For instance, people may see it as an infection. It is a question of interpretation. "CJD was first described in the early part of this century by Dr Creutzfeld and Dr Jakob separately, long before BSE had been described. There does appear to be a new variant that is arguably not natural, that is believed to be caused from eating contaminated meat," he said.
Any decision not to hold an inquest can be challenged through the courts by asking for a judicial review. There have been 24 reported cases of nvCJD so far - and scientists still do not know how many may occur in the future.
The family of the first victim of the new strain, 19-year-old Stephen Churchill from Devizes, Wiltshire - who died in May 1995 - campaigned successfully for an inquest into his death. Their local coroner referred to the Home Office for guidance, which directed that an inquest - yet to be held - should take place.
Father David Churchill - who runs the Human BSE Foundation for victims and their families and also lobbied for an inquiry into BSE - said those families who wanted an inquest should have the opportunity.
A coroner could open and adjourn a hearing until the outcome of Lord Justice Phillips' inquiry into BSE, now due to report in June 1999, he said.
Reuters Financial Report Fri, Apr 17, 1998AMARILLO, Texas - Talk show queen Oprah Winfrey, who won an earlier legal showdown with Texas cattlemen, will have to strap on her guns again after another lawsuit was filed on Thursday charging her 1996 show on mad cow disease drove down beef prices.
The suit seeks $1 million in damages for cattlemen who say they lost money when Winfrey vowed never to eat another hamburger after a show guest said cattle feeding practices could lead to a mad cow disease epidemic in the United States. The plaintiffs include Cactus Feeders Inc., whose chief executive Paul Engler filed the first unsuccessful suit against Winfrey, and 137 other cattlemen who kept their livestock in Engler's feed lot.
Like the first suit, in which a federal jury found in February that Winfrey had done nothing wrong, the new one was filed under Texas' "veggie libel" law which forbids the false disparagement of agricultural products. In the first trial, U.S. District Judge Mary Lou Robinson threw out most of the case before it went to the jury. Opponents say veggie libel laws violate constitutional rights to free speech.
The latest suit was filed in Dumas, Texas, 40 miles (64 km) north of Amarillo, in state district court. In state courts, judges are elected every four years, not appointed for life like federal judges. Plaintiffs attorney Kevin Isern said the cattlemen expected more favorable treatment from State District Judge Ron Enns, in whose court the case will be heard. "I think the state court will not let it go to the jury," Isern said.
The defendants include Winfrey, her Harpo Productions, and the controversial guest Howard Lyman, a vegetarian activist. None could be reached for comment.
In the April 16, 1996 show, Lyman said the now-banned practice of feeding ground-up animal parts to cattle was a common practice that could spread mad cow disease, or bovine spongiform encephalopathy, to humans in the United States.
Winfrey responded: "It has just stopped me cold from eating another burger." [The reporter makes a serious misrepresentation here -- the transcript and video unequivocally show Oprah's statement later in the show was in response to feed material, not mad cow disease -- webmaster]
The plaintiffs in the first suit said the comments were misleading and cost them $10 million when cattle prices fell after the show. They appealed the federal verdict last week.
The practice of feeding animal parts to cattle has been blamed for the spread of mad cow disease in Britain where at least 20 people are thought to have died from eating infected beef. British authorities ordered the slaughter of 1.5 million cattle to stop the epidemic. U.S. officials say mad cow disease does not exist in the United States.
AP Financial Fri, Apr 17, 1998DUMAS, Texas -- Texas cattlemen aren't finished with Oprah Winfrey. Ms. Winfrey, who in February won an $11 million federal libel lawsuit filed by cattlemen, was sued for $1 million in state court by some of the same people who still have a beef. The lawsuit was filed in Dumas, 45 miles north of Amarillo, on Thursday, the second anniversary of the show that cattlemen claim cost them millions of dollars.
On that episode, vegetarian activist Howard Lyman said that including processed cattle in cattle feed -- a practice banned last summer -- could spread mad cow disease to people in the United States. The brain-destroying disease has never been found in cattle in the United States, but is suspected of killing 23 people in Britain. Ms. Winfrey at one point said the information "just stopped me cold from eating another burger!" [Note the subtle change but the same misrepresentation -- the transcript and video clearly show Oprah's statement was in response to feed material, not mad cow disease -- webmaster]
When cattle prices fell to 10-year lows in the days after the show aired, the plaintiffs termed it the "Oprah crash." They sued under the state's "veggie libel" law, which protects agricultural products from false and disparaging remarks.
The case was expected to the nation's biggest test of such laws, which exist in 12 other states. However, U.S. District Judge Mary Lou Robinson ruled that the case could not proceed under that law but would instead be tried as a simple business disparagement case. That meant the cattlemen had to prove that Ms. Winfrey deliberately sought to harm the beef industry.
The federal court jury said they failed to prove Winfrey knowingly gave misleading information. The verdict is being appealed. Like the earlier suit, the new case says Lyman, Ms. Winfrey and her production company knowingly disseminated false and disparaging remarks about beef and violated the "veggie libel" law.
The plaintiffs in the first case were three cattle-feeding operations and four ranches. This lawsuit involves 130 cattle owners, many of whom were customers at the Cactus Feeding Club Inc. when the show aired. Cactus Feeding is owned by Paul Engler, a plaintiff in the first suit.
The latest filing surprised Ms. Winfrey's attorney, Charles Babcock. "I am stunned that they're continuing to pursue this after they've lost," he said.
The earlier case began in state court but was bumped to federal court because alleged damages exceeded $75,000 and the plaintiffs and defendants came from different parts of the country. Lyman's attorney, Barry Peterson, said he believes the new lawsuit will be thrown out of state court because both conditions apparently still exist.
UPI US & World Sat, Apr 11, 1998AMARILLO, Texas -- The beef defamation dispute pitting Oprah Winfrey and her show against Texas cattlemen has deepened after the Texas Beef Group and other cattle companies joined an appeal against a jury decision acquitting Winfrey and her show.
Cattleman Paul Engler filed an appeal March 27 after an Amarillo jury acquitted Winfrey, her show and a guest of allegations that their comments defamed beef and cost the beef producers millions of dollars. The civil trial ended in February.
Court documents show that Texas Beef Group, Perryton Feeders Inc., Maltese Cross Cattle Co., Bravo Cattle Co., Alpha 3 Cattle Co. and Dripping Springs Cattle Co. joined the appeal Friday in Fifth Circuit Court of Appeals in New Orleans.
In June 1996, Engler sued in U.S. District Court, two months after Winfrey and a guest discussed the health threat from beef consumption. The April l6, l996, show was broadcast during an international scare over so-called "mad cow" disease, which devastated cattle herds in the United Kingdom.
The disease, which can affect the brain, poses a threat to humans who consume infected beef. After a trial that turned hundreds of Panhandle residents into stargazers out to catch a glimpse of Winfrey and her Hollywood guests, jurors acquitted Winfrey and the other defendants.
Reuters World Report Fri, Apr 17, 1998. HONG KONG - The Hong Kong government advised doctors not to use any remaining stock of a plasma batch collected from a donor who later died of Creutzfeldt-Jakob Disease (CJD), the human form of mad cow disease.
A Department of Health spokesman said on Friday that Baxter Healthcare Corporation, the company which manufactured the plasma, was withdrawing all remaining plasma-based products and intermediate fractions derived from the unit collected from the donor who died of CJD.
"The recall is a precautionary measure undertaken by Baxter," the spokesman said.
The importer of the product had been notified and asked to inform all institutions and doctors that could have received the affected vials. The importer was to arrange for the immediate recall of the product, the government said.
Hong Kong health authorities said earlier this year that the test reagent, used in the diagnosis of heart and lung ailments, might have infected 108 hospital patients with CJD. [No illness has been found at this point -- webmaster] Ten of the Hong Kong patients since died, although doctors in Hong Kong have stressed it was unclear whether CJD had caused the deaths. "There is at present no evidence that CJD is transmitted by blood or blood products," the Department of Health said.
Dow Jones Fri, Apr 17, 1998The product being recalled is albumin, a plasma-based product. The recalled product will be destroyed.
The Baxter spokeswoman said the recall would have no material impact. The company has previously initiated other product withdrawals, in "scattered jurisdictions" around the globe, all precautionary in nature. The spokeswoman could not immediately say where the previous recalls occurred. The AP reported that the Hong Kong Department of Health said 450 vials of the affected product were imported in to Hong Kong in 1994, and were distributed to private medical institutions and private doctors.
The Department of Health also said the recall was a precautionary measure and that there is no evidence that Creutzfeldt-Jakob Disease is transmitted by blood or blood products. Creutzfeldt-Jakob Disease is the human form of bovine spongiform encephalopathy, which afflicts cattle and is known as mad cow disease. It has killed at least 20 people in the United Kingdom.
Earlier this year, the Hong Kong government disclosed that more than 100 patients in Hong Kong were given a fluid made by Nycomed Amersham PLC (NYE) suspected to have been contaminated with Creutzfeldt-Jakob, The AP reported.
The fluid, Amerscan Pulmonate II, is injected into patients requiring a lung scan and enables doctors using special equipment to get a picture of the lungs. Nycomed Amersham said at the time that it had recalled batches of the product last year after a blood donor in Britain who died was diagnosed as having Creutzfeldt-Jakob Disease.
The recall affects less than 1 percent of the company's annual production of the product, said Mary Thomas, a spokeswoman at the company's Deerfield, Ill., headquarters. The affected plasma product, called albumin, was distributed in the United States and Hong Kong in 1994, and distributed to private medical institutions and doctors.
``We initiated the voluntary withdrawal as a precautionary measure,'' Ms. Thomas said. ``CJD is not known to be transmitted through blood or blood products.'' [However, this is likely possible, given results in mice -- webmaster]
Thu, Apr 16, 1998 By Natalie Martin, PA NewsA conference on the human form of mad cow disease today heard repeated calls for more to be done to help sufferers and their families. Experts said doctors and nurses often did not know how to approach the degenerative illness which leaves patients trapped inside their own bodies. Delays in diagnosis can add to the trauma and even after Creutzfeld Jakob Disease is suspected many families struggle to get help from cash-strapped social services departments, the specialists told the conference.
About 100 people attended the one-day event at Warwick University organised by the CJD Support Network. It has been working with social services chiefs to prepare national guidelines to ensure help is available. "At the moment it is extremely variable and depends on where you live," said conference organiser Clive Evers.
Support worker Gill Turner, who has helped many families, said the care available was fragmented. "When families have to struggle it means they spend their energy doing that - rather than caring for their loved one," she said.
The network is also hoping to introduce guidelines for GPs later this year.
"There is a difficulty in diagnosis and this disease has got to be treated immediately," said Gill. [There is no treatment -- webmaster] "Assessment procedures can take three to six months and some of our patients are dead in that time. "Professionals are learning on their feet and it takes carers a long time to battle for the services they need."
Mr John Williams, from Caernarvon, whose daughter Alison died from new variant CJD in February 1996, said many health authorities did not know how to deal with CJD victims. "We want those national guidelines issued to all health authorities. At the moment one authority offers one thing and in the next county it is different," he said.
There have now been 24 cases of new variant CJD - which scientists believe is linked to BSE in cattle - reported across the country. And last year there were 32 cases of classical CJD - which usually occurs in older people - and a small number of other forms of the disease.
Neurology Registrar Dr Martin Zeidler said part of the problem was CJD was still rare - with a GP statistically seeing one case every 500 years. But Dr Zeidler, who used to work at the Edinburgh CJD Surveillance Unit, said he was confident cases were not being missed by the experts. "We cannot be 100% but I am confident the detection rate is high," he said.
PA News Wed, Apr 15, 1998 By Rachael CroftsFamilies and health workers caring for patients suffering with CJD - the human form of mad cow disease - will today exchange experiences and knowledge of the illness at a national conference. The CJD Support Network will host its second annual conference on prioritising the need for care and support for families affected by all strains of the disease.
Network co-ordinator Gillian Turner said: "While the BSE Inquiry continues its work, we should not forget that many people have to cope with the day to day consequences of a loved one contracting some form of CJD. "It is the support and services they require which this conference will address."
She added that a recent audit of services for people with CJD found that social services and healthcare responses to the disease were inconsistent, with services ranging from excellent to poor in different parts of the country. Speakers at the conference at Warwick University include Dr Martin Zeidler from the World Health Organisation and Dr Richard Knight from the National CJD Surveillance Unit.
Liz Armstrong 17 April 98
"I wanted to let each of you in on something that has had a profound effect on me over the past few days. I had forwarded information about the contact I made with the Red Cross regarding Dad's donations and their "lack" of response to an individual doing an article on CJD & Blood Products.
This person was advised by the Red Cross that Dad was not in the donor database. This is absolutely absurd!! Dad was a faithful donor!! I was told this morning that even if he was in the database that we would have to get a court order to get to the information!
I have contacted individuals that were directly involved with the blood drives and should be receiving documentation to substantiate his donations. Those of you concerned about the blood products manufactured from donations made by your loved ones should attempt to obtain any and all documents to prove they did in fact donate blood BEFORE you attempt to notify the Red Cross of the CJD. It seems it is easier for them to delete the donor from the database than to worry about recalls."
Thu, 16 Apr 1998 By Otesa Middleton Dow JonesWASHINGTON --A Food and Drug Administration advisory committee will vote Thursday morning on whether the agency should relax rules on tallow and its derivatives related to the threat of mad cow disease. The panel will also determine if more rules are needed regarding gelatin and the human brain covering, dura mater, which is sometimes transplanted during surgery.
At its meeting Wednesday, the FDA's transmissible spongiform encephalopathies advisory committee heard from industry representatives who insisted tallow products are safe. The committee explored tallow's uses and manufacturing processes as it discussed the threat of bovine spongiform encephalopathies, commonly called mad cow disease, in light of European outbreaks of the disease.
Tallow is made from cooked animal remains including bones, hides and muscles taken from places like slaughterhouses, restaurants and butchers. The remains are cooked and the resulting oily substance is used in thousands of products. The FDA panel is only concerned with its use in foods, cosmetics and pharmaceuticals. Tallow and its derivatives can be found in contact lenses, lipstick, lotion, soap, cooking oil, capsules and tablets.
Dr. John Bailey, director of the FDA's office of cosmetics and colors, asked the panel to "assess the safety of imported and domestic tallow and tallow derivatives." Dr. David Taylor, a representative from Scotland's Institute for Animal Health, said there have been 167,336 confirmed cases of mad cow disease in Great Britain. According to industry representatives, edible tallow doesn't contain heads, eyes or spinal cords, which are considered infectious materials.
Mitch Kilanowski, of Darling International Inc. (DAR), an Irving, Texas, recycler of food processing by-products, spoke to the committee about the market for tallow. He said 1.45 billion pounds of edible tallow are produced each year in the U.S. Almost 6.5 billion pounds of inedible tallow are produced. "Tallow to us is the building block used to make many products," said Dr. Charles R. Green, a director in the Soap and Detergent Association.
Dr. Philip Merrell of Mallinckrodt Chemical said virtually every solid drug used contains magnesium stearate, a tallow derivative. Mallinckrodt Chemical, a unit of Mallinckrodt Inc. (MKG), is the largest supplier of magnesium stearate. "In pharmaceuticals, 1.5 million to 2 million pounds of magnesium stearate are used annually," Merrell said.
Stan P. Gorak, of ICI Americas, spoke about the manufacturing process for polysorbates, another tallow derivative. Although polysorbates can be made from vegetable sources, tallow is widely used because it is less expensive and more readily available, Gorak said. Dennis Walker, of Proctor & Gamble Co., said 'in our estimation tallow contains no discernable risk of (mad cow) infectivity.'
Reuters North America Thu, Apr 16, 1998BETHESDA, Maryland - The U.S. Food and Drug Administration (FDA) should continue to bar imports of tallow from countries that have had outbreaks of mad cow disease, experts who advise the FDA said on Thursday.
They said there was a small risk that people could be infected by products made from cows that had bovine spongiform encephalopathy (BSE or mad cow disease). "It doesn't seem things are broke, so I'm not sure why we need to fix it," said Peter Lurie of the University of Michigan, a member of the FDA advisory panel. He said the current lack of imported tallow has not made products unavailable to consumers.
U.S. manufacturers say they do not need foreign tallow, and only an estimated one-half of one percent of U.S. tallow is imported. The United States supplies nearly three quarters of the world's tallow, said Don Franco of the National Renderer's Association.
Currently the United States only imports tallow from Canada, which is designated BSE-free [despite a confirmed case -- webmaster]. Other members of the panel said that despite sterilization and limited tallow importation, Americans might still be exposed to BSE through tallow products. Tallow is used in foods and food additives.
But five panelists thought the FDA should allow some tallow products into the U.S. "I think that the ban ignores science and ignores the opportunity we have to manage risk," said committee member William Hueston of the University of Maryland. [It would seem that continuing the ban is already a painless opportunity to manage risk on the tiny 1/2 % of imports. The media reported Hueston testified against Oprah for a reported $25,000 fee, then broke down and cried as conflicts were elicited during cross-examination --webmaster]
The panel said the FDA should relax its policy on tallow derivatives, which members saw as posing less risk. Derivatives are used in pharmaceuticals, soap, cosmetics and food additives.
The U.S. Department of Agriculture has final say over the importation of agricultural products but takes advice from the FDA, the agency that regulates which ingredients can go into certain food products, cosmetics and pharmaceuticals. There is a worldwide ban on beef products from Britain, which has had an epidemic of BSE since the mid-1980s. There is growing evidence that people can get a human version of the fatal brain disease, Creutzfeldt-Jakob disease (CJD), from eating infected beef products.
Countries that are designated as "BSE countries" because the disease has been recorded in herds there include Britain, France, Netherlands, Belgium, Switzerland, Portugal, Luxembourg and Ireland. The European Union has proposed banning all trade in tallow and other byproducts, which the United States estimates could jeopardize $4.5 billion of dollars in American pharmaceutical and cosmetics exports to Europe.
April 16/98 ReutersBETHESDA, Md - A panel of scientists was cited as telling the U.S. Food and Drug Administration today that gelatin made from cattle bones and hides in countries with mad cow disease is safe if certain precautions are taken. The FDA usually follows the recommendations of its advisory panels.
Committee chairman Paul Brown of the National Institute of Neurological Disorders and Stroke said the advisers want to review gelatin safety again in a year, when more industry studies are completed.
The FDA restriction has caused a supply shortage because U.S. manufacturers rely heavily on Europe for raw material, and spinal columns are not routinely removed in those countries, said William Stringer of the Coalition of Gelatin Capsule Manufacturers.
Stringer said the panel's decision would help ease the shortage, but added that "there is no evidence that gelatin or gelatin products serve as a vector for BSE (bovine spongiform encephalopathy, or mad cow disease)."
Field tests by the British government found no evidence of BSE in skins or hides, although there was some hint that it might be in the bone marrow of animals more than 30 months old, said Raymond Bradley of the U.K. agriculture ministry.
Earlier on Thursday, the panel separately recommended that the FDA continue to bar imports of tallow from countries with outbreaks of mad cow disease. They said there was a small risk that people could be infected by products made from cows with the disease.
Dow Jones Tue, Apr 14, 1998 By Otesa MiddletonWASHINGTON --Oprah isn't the only one concerned about mad cow disease. A U.S. Food and Drug Administration panel will meet Wednesday and Thursday to discuss the safety of certain products made from animal remains: tallow, gelatin and dura mater products.
Tallow, which is made from uneaten animal remains including bones and hydes, is found in cosmetics, soaps, pharmaceuticals and other products. Gelatin is also derived from boiling animal remains. Dura mater, the thin covering that protects the brain and spinal cord, is sometimes transplanted during brain surgery.
Experts and industry representatives will discuss with the FDA's advisory committee on transmissible spongiform encephalopathies what safety measures are taken and whether there needs to be more in light of European cases of bovine spongiform encephalopathy, commonly called mad cow disease. The discussion of gelatin and dura mater are a follow-up to the committee's meetings last April and October.
Last April, the committee discussed the safety of importing gelatin from countries where there had been outbreaks of the disease. There is no test or treatment for the disease, which incubates for years in cattle and humans and results in neurological disorders and death. Representatives of the National Renderers Association will present information on their industry at the meetings.
"We will discuss the source of tallow, how it's processed and the dynamics of the marketplace," said Tom Cook, executive director of the association. Yearly, the rendering industry boils more than 40 billion tons of non-edible raw animal products. "In the U.S., rendering is a $2.5 billion to $3 billion industry annually," Cook said.
Tallow is found in numerous products, including tires and lipstick, because it is easy and cheap to produce. "With the (bovine spongiform encephalopathies) outbreak in Europe, people are concerned about the perception," Cook said. "We don't have BSE in this country. We have had a surveillance program in the U.S. since the late 1980s." "The FDA (committee) will be looking at safeguards and gathering information," Cook said.
Sun, 19 Apr 1998 By MICHAEL HORNSBY / The Times of LondonLondon - A hill farmer treated for 10 years as a tiresome crank has been told by the Ministry of Agriculture that his theory about pesticides causing "mad cow" disease merits research after all. Mark Purdey, an organic dairy farmer near Elworthy, Somerset, received a letter from the ministry after he gave evidence earlier this month to the BSE inquiry.
"We do now feel that this is an area where more scientific work could usefully be done," said the letter.
The ministry had previously refused to give any credence to Mr Purdey's claims. The change was prompted by experiments at the Institute of Psychiatry in London suggesting that Phosmet, an organophosphate pesticide used to kill parasites, could have made cattle far more susceptible to BSE. These findings coincided with doubts about the official hypothesis that BSE was caused by scrapie being passed to cattle in feed containing rendered sheep remains.
Attempts to find a strain of scrapie that looks like BSE have failed, and many scientists now suspect that the disease may always have been present in cattle at a very low level. Phosmet could have been the trigger that caused what had been a rare endemic condition to explode to epidemic proportions.
Purdey and a small group of other organic farmers raised money from private donors to fund the work by the Institute of Psychiatry.
The ministry first crossed swords with Purdey in 1982 when it ordered farmers to treat their cattle with Phosmet twice a year to kill warble fly, a parasite that harms the animals health and reduces the commercial value of their hides. After a legal battle Purdey was exempted from using the pesticide and allowed to treat his herd of 70 Jerseys with a non-organophosphate alternative.
"When the first cases of BSE were reported, I was sceptical that infected feed could be the explanation," he said. "There has never been a case of BSE in any animal born and bred on an organic farm. Yet I, and most other organic farmers, had all given our cattle the supposedly infected feed."
Sat, 11 Apr 1998 Associated Press By CURT ANDERSONWASHINGTON (AP) - Mad cow disease grabs the headlines, but a similar brain disease called scrapie has been a scourge for sheep and goats around the world for at least 250 years.
In fact, some scientists believe that mad cow disease - bovine spongiform encephalopathy - arose because cattle in Britain were fed ground-up parts of scrapie-infected sheep. That epidemic, which reached 1,000 cattle cases per week in 1993 but has largely subsided, is blamed for the deaths of 23 people who ate infected beef.
Although mad cow disease has never been reported [the reporter means confirmed, non-experimental bovine TSE] in the United States , scrapie has been diagnosed in more than 900 flocks since the first sheep was found with the malady in Michigan in 1947. Eight goats have been diagnosed with it. The fatal disease is called scrapie because infected animals often rub against objects as if suffering from an itch.
It has been around for centuries, but scientists still don't understand how it is transmitted or why it can lie dormant for up to eight years before symptoms appear. So far, there is no evidence that humans can contract the disease from sheep.
The Agriculture Department is moving on two new fronts in an effort eventually to eliminate scrapie from U.S. sheep flocks. There are more than 7 million sheep and lambs in this country, sources of lamb chops and mutton and about 28 million pounds of wool last year.
This week, Agriculture Secretary Dan Glickman announced development of a new inexpensive test for scrapie. And the department is preparing to impose new regulations on movement of flocks to prevent the disease from spreading across states.
The test consists of snipping a sample of a sheep's third eyelid, which harbors proteins called prions that many researchers believe cause both scrapie in sheep and mad cow disease in cattle. Similar disease affect deer, elk, mink, cats, even humans.
``Until now, scrapie could only be confirmed by examining the brains of dead animals,'' Glickman said. ``This test will allow producers and veterinarians, for the first time, to easily detect scrapie in sheep before the animals show signs of the disease.''
The test is a breakthrough in part because it costs only about $25, compared to $500 for biopsies on internal sheep organs. Without early detection, regulations aimed at controlling scrapie often fail because the sheep can transmit the disease within flocks long before signs appear.
``In the past, there was really no good way to tell for certain if a flock, county or region did or didn't have scrapie in its sheep population,'' said Paul Rodgers, American Sheep Industry Association animal health director.
As the test becomes more widely available, the Agriculture Department is contemplating an update to rules controlling the movement of sheep and goats infected with scrapie. Current regulations do not restrict movement of animals within a state.
``There is a risk that scrapie infection that originated in an infected or source flock could spread interstate,'' the department said in a notice about the rules. ``The risk is higher in states that do not quarantine scrapie- infected and source flocks.'' [Scrapie has been reported from 39 states already -- webmaster]
Possible new regulations could include further restrictions on states that don't impose such quarantines and on flocks considered to be at high risk. In addition, officials are examining whether to impose a better identification system to keep track of sheep and goats and enable infections to be traced to the source.
``These changes would help protect all American livestock,'' said Joan Arnoldi, deputy administrator for veterinary services at the USDA's Animal Health and Plant Inspection Service.
Right now, the Agriculture Department is in the fact-gathering stage, with proposed rules the next step and a final resolution unlikely for at least a year.
The American Sheep Industry Association is welcoming the regulations, even if they might restrict movement of flocks. The promise of eliminating scrapie, producers say, is worth the trouble. [No such promise has been made by researchers involved; eliminating carrier sheep is very difficult; some sheep genotypes are intrinsically hazardous; and many eradication programs failed in the past -- webmaster]
``We need to continue to take the lead in this,'' said Steve Raftopoulos, past president of the association. ``We have to focus on the ultimate benefits, not the short-term hardships of taking an aggressive stance on disease control.''
Apr. 20/98 ReutersBRUSSELS -- The Belgian agriculture ministry was cited as saying in a statement today that a four-year-old cow from a farm in Tielt, in the province of West Flanders, was diagnosed with mad cow disease or BSE (bovine spongiform encephalopathy) earlier on Monday and that an entire herd of 82 cattle would be destroyed. This was the country's fourth case of mad cow disease. The story said that the ministry was trying to establish the cause of the contamination but noted that the animal was born on the farm.
Tue, Apr 21, 1998 By Samantha Poling and Jo Butler, Consumer Affairs Correspondent, PA NewsThe Government's controversial ban on beef-on-the-bone was thrown into confusion today after a court dismissed the first prosecution brought for serving banned meat.
A Scottish sheriff threw out the test case against hotelier Jim Sutherland, describing the regulations as "defective" and "manifestly absurd". In his ruling, heard at Selkirk Sheriff Court in the Scottish Borders, Sheriff James Paterson also accused Parliament of destroying safety regulations which cover the distribution of beef and undermining the protection of consumers from eating bad meat.
As farmers' groups across the country hailed the judgement "a victory for common sense" and leading politicians called for the ban to be scrapped, Agriculture Minister Dr Jack Cunningham said he would studying the implications of the case. But he maintained the regulations were essential for public safety - and insisted the ban remained in place.
Meanwhile Milton Keynes Council announced it was pressing ahead with plans to prosecute two butchers for selling beef on the bone in what could become the first case in England and the first to target meat traders.
Today's case was brought after Mr Sutherland, 44, held a high-profile farmers' Prohibition Dinner where he served roasted beef ribs to 180 people at The Lodge, Carfraemill, near Lauder, Berwickshire, on December 22 last year - five days after the ban was imposed.
Throughout a four-day hearing, lawyers acting for the hotelier argued that the Beef Bones Regulations 1997, under which their client was charged, were unlawful because they were introduced under delegated legislation. Michael Upton QC also argued there had been a severe lack of consultation between the Government and the hotel, restaurant and catering trade before the ban was imposed.
Sheriff James Paterson agreed and in a short but blunt ruling, which he read out to the court, he said it was the wording of part of the regulations which had forced him to dismiss the case. Regulation 3(2), said the sheriff, states that no person shall use any bone in beef in the preparation of any food or ingredient for sale direct to the ultimate consumer. But the word "preparation", he said, meant simply subjecting a carcass of beef to cold temperatures.
"The word is so imprecise it could mean anything. Every caterer will, by merely chilling part of a carcass of beef, be guilty of the offence of which the present accused in charged. "That will make illegal the present distribution of beef from slaughter houses to caterers and butchers," said Sheriff Paterson, adding that meat is normally stored in a chilled room. "Thus, in one short sentence, in a piece of subordinate legislation, Parliament has destroyed the present system of meat distribution and undermined one of the main purposes of the Food Safety Act, namely the protection of consumers from eating bad meat."
Sheriff Paterson also noted that the regulations were not made public in full until January 20 of this year - one month after the hotelier held his highly-publicised dinner. Hugging his family and friends outside the court, Mr Sutherland said he was delighted the sheriff had been so outspoken in his ruling.
"We have a sheriff who saw what the problem was and he was prepared to stand there in court and tell the Government that they have got it seriously wrong on this occasion. "If you read his judgment, the wording of the regulations is absolutely crazy. I decided to take a stand and, although it has been stressful at times, the outcome has been the right one."
Defending the regulations, Agriculture Minister Dr Jack Cunningham said the case had "turned on a legal technicality" and was not a judgement on the food safety issues behind the ban. He said the ruling was not legally binding on any other UK court, including other Scottish courts and said the Crown was considering an appeal.
"The Government has already made clear that the Beef Bones Regulations 1997 remain in force," he said in a statement issued this evening. "The prohibitions on the use of bone-in beef remain valid, unless overturned by a decision of a Higher Court. "The requirements of these regulations are essential for the protection of public health and the Government expects them to continue to be observed and enforced."
The minister also hit out at political opponents who seized on the judgement to criticise the ban. Dr Cunningham accused both the Tories and Liberal-Democrats of being complacent about public health and said the Conservatives had learned nothing from their mistakes in the handling of the mad-cow crisis now being revealed in the BSE inquiry.
Shadow agriculture minister Michael Jack, said the court's decision threw the Government's beef-on-the-bone policy into "a state of chaos". "We told the Government before Christmas that these regulations were unenforceable and unnecessary. Today's decision vindicates our judgment."
SNP's parliamentary agriculture spokesman John Swinney called on the Crown not to appeal the case and said it was important action was taken immediately "to bring this shambles to an end". The president of the National Farmers' Union in Scotland, George Lyon, called on the Government to reverse its ban in the wake of today's finding.
"We believe it is wholly disproportionate to the perceived risk involved. Today's judgment strengthens our view that the ban was brought in a hasty and ill-considered manner by the Government."
The NFU in England and Wales said the judgement was a "victory for common sense", but insisted it was the ban rather than the wording of the regulations which had been a mistake.
Despite the ruling, Milton Keynes Council said it was set to go ahead with action against two butchers in the town of Bletchley for selling pre-wrapped foreribs of beef on the bone. The cases, which rely on a different part of the regulations covering the sale rather than the preparation of beef, are due to be heard on May 8 at Milton Keynes Magistrates.
The Council's chief environmental health officer Phil Winsor said: "We will be studying the Scottish court case decision but at the moment it looks as though we will still go ahead with our cases." Rother District Council, which is planning to prosecute a Sussex pub landlord for allegedly serving banned meat, said they too would be studying the judgement. Alan Coomber, 52, has been summoned to appear in court on May 18.