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Ottawa scientists censored
UK drug company's nvCJD infected drug causes chaos in Spain
Health supplement industry seeks cure for sagging sales
Drug encapsulation industry working to address gelatin fears
BSE: Still searching for answers
Denmark confirms 4th mad cow case
Mad cow risk in US tiny but real
Vermonters plan protest over 'mad cow' sheep seizure

Ottawa scientists censored

Wednesday, February 21, 2001 Globe and Mail By MARK MacKINNON 
A Health Canada scientist who questioned the federal government's decision to ban Brazilian beef has been suspended for two weeks without pay for "disregard of her duty of loyalty."

Margaret Haydon and another Health Canada scientist who had asked not to be named caused an international storm when they told The Globe and Mail earlier this month that they thought Canada's decision to ban Brazilian beef imports may have been motivated by political, rather than health, concerns.

The two scientists said there was no consultation about the ban with those who study the beef before Health Canada gave its approval. Both said they thought the ban was tied to a trade dispute with Brazil over aerospace subsidies.

Within days, Dr. Haydon was called in by her acting manager, Diane Kirkpatrick, and sharply reminded that only the department's public relations officers are authorized to speak with the media. Tuesday, she was called into Dr. Kirkpatrick's office again and told of her suspension, which begins Wednesday and runs 10 working days.

The formal reason given for Dr. Haydon's suspension was "disregard of her duty of loyalty." It was noted that her statements in The Globe had implications to Canada's relationship with Brazil. Dr. Haydon wouldn't comment Tuesday. One of her colleagues called the suspension "intimidation" and said the scientists' union would likely grieve the matter and fight it in court, if necessary.

The suspension comes less than five months after a federal court judge ruled it was "unreasonable" for Health Canada to ask its scientists not to speak out on public-health matters.

Dr. Haydon was involved in that case too, which came about after she and a colleague spoke out about pressure in the department to approve a controversial bovine-growth hormone about which they had safety concerns. On Friday, the Council of Canadians recognized Dr. Haydon for speaking out about the growth hormone, giving her a "whistle-blower award."

The ban on Brazilian beef is expected to be lifted soon, government sources said Tuesday, though likely not before Friday. A team of Canadian Food Inspection Agency officials who travelled to Brazil last week is in the process of consulting with the U.S. and Mexican scientists who accompanied them before advising Agriculture Minister Lyle Vanclief of their decision.

In the interim, Canada, which has permission from the World Trade Organization to impose $344-million a year in sanctions on Brazil as compensation for losses in the aerospace dispute, is holding back on taking those measures until the beef dispute simmers down. Government sources say the beef ban, which has sparked anti-Canada street demonstrations in the South American country, has escalated tensions to the point that a full-blown trade war would be likely if Canada were to take fresh measures.

Opinion (webmaster): Canada has taken another step backwards that will alieniate scientists worldwide. Loyalty oaths smack of McCarthyism (1, 2, 3, 4); few scientists think that public relations "officers" are qualified to speak on complex diseases especially when economic agendas clearly trump public health considerations. Doctors have recognized for millenia a clear duty to speak out on health matters.

Most damning, Canadian authorities were unable to respond on the merits to specific issues raised by the two scientists. It does now appear that Canada trashed the Brazilian national herd solely because of airplane trade tariffs. No substantive BSE issues have ever been raised in conjunction with Brazil. Indeed, it seems that Canada might first get its own house in order:

Mad cow infection could be in Canadian beef but not detected: scientists

5 Feb 2001 CP
Canadians may be at risk of contracting the human form of mad cow disease from domestic beef because current testing is inadequate, scientists say. Neither the United States nor Canada do large-scale testing which is needed to detect diseases like mad cow, said Michael Hansen, a biologist with the U.S. Consumers Union.

"I would predict that if they tested enough animals here they'll find a positive," Hansen said in an interview Wednesday. He said the government should be using a new test which is quicker, cheaper and would allow large-scale assessment.

Canada tests about 900 animals a year and that is not enough to detect disease if it is present, agreed David Westaway of the Centre for Research on Neurodegenerative Diseases at the University of Toronto. "It means you can't make a definitive statement you don't have it (mad cow disease) here," he said. "They should do more testing. They should come more into line with Europe."

Westaway said 20,000 animals are being tested weekly in France, while Canada generally tests only those that are visibly sick. He said the disease has a five-year incubation period, and animals could easily be infected without showing symptoms.

Hansen said Canada and the United States should be using the new Swiss-developed Prionics test. Markus Moser, a spokesman for Zurich-based Prionics, said Canada cannot be sure it is free of bovine spongiform encephelopathy (mad cow disease) with its current testing levels. "With 800 or 900 tests a year, the situation would have to be an absolutely catastrophic one in order to see something," said Moser. Switzerland tested 20,000 cattle last year and found five BSE cases. This year the country is testing all animals over a certain age.

Claude Lavigne, a spokesman for the Canadian Food Inspection Agency, said large-scale testing is not needed because mad cow has not been detected in North America. [Circular reasoning here -- if testing is not done, unsurprisingly nothing is reported. And how could Lavigne be unaware the confirmed Canadian BSE case of 1993? -- webmaster]

But Moser noted that other countries, such as Germany, once confidently declared themselves BSE free. Only when private meat-producers began their own testing were the German cases discovered. "It wouldn't be the first time that a country claims it's impossible that we have a problem and then when it starts to test, finds there is a problem," said Moser.

Much of the concern about mad cow disease has focused on imports of cattle feed manufactured from animal parts from Europe, especially from the United Kingdom. A Statistics Canada official said Wednesday the agency has traced U.K. feed materials imported in 1990, and has determined they were not fed to cattle.

David Dodds would not name the importer, nor would he say what the materials were used for. He said the agency has not attempted to trace animal parts and bone meal imported from Germany and Denmark.

Hansen said risk is not only from European animal feed, which has been imported by both Canada and the United States, but also from spontaneous mutations in domestic animals. Two U.S. studies suggest a significant percentage of presumed Alzheimer's patients actually have variant Creutzfeldt-Jakob Disease (nvCJD), the human form of mad cow, he said. In a Yale University study, autopsies were done on 46 patients who died with possible Alzheimer's, and six turned up to be cases of nvCJD, he said. In another study at the University of Pittsburgh, autopsies revealed three undiagnosed cases of nvCJD among 55 patients who had died with symptoms of dementia.

USDA lifts temporary suspension on Brazilian beef imports

Feb. 23, 2001USDA press release No. 0032.01
The U.S. Department of Agriculture today announced that it is lifting the temporary hold on imports of processed beef and associated products from Brazil. This decision was made following a site visit to Brazil by animal health officials, who were able to review and analyze requested data to complete a bovine spongiform encephalopathy risk assessment.

Upon reviewing this data, USDA was assured that Brazil has taken sound measures to prevent BSE and that the suspension on imports should be lifted. There are three conditions that imports of Brazilian beef products must meet to enter the United States to ensure the safety of U.S. livestock:

1) Shipments must be certified as containing beef products from cattle that were born and raised in Brazil and not from any imported sources of beef;

2) The beef must come from cattle born after Brazil enacted its 1996 ruminant-to-ruminant feed ban; and

3) Shipments must have a statement accompanying them that certify that the cattle used in the products were exclusively grass-fed and not fed any animal proteins.

USDA, along with appropriate federal health agencies, has determined that there is no risk of BSE introduction associated with the import of Brazilian beef and beef products under the above conditions. There is no evidence of BSE in Brazil. Imports are to resume immediately.

In announcing the decision, Secretary Ann M. Veneman said, "USDA pledged to work expeditiously to resolve this issue. The Brazilian government has been very cooperative in this effort and we are pleased to announce this decision today."

Canada, U.S., Mexico lift Brazil beef ban

Saturday 24 February 2001 By Tom Cohen, Associated Press Writer
Facing a deadline for a possible trade war, Canada announced it was lifting a three-week ban on Brazilian beef products that had forced the United States and Mexico to follow suit. The announcement Friday by the Canadian Food Inspection Agency came after the U.S. Agriculture Department confirmed it was lifting the U.S. ban, which Canada had initially imposed because Brazil failed to provide information that would prove its beef was free of Mad Cow disease.

No cases of Mad Cow disease have ever occurred in Brazil, and the Brazilian government accused Canada of imposing the ban on Feb. 2 to punish Brazil over a trade dispute involving government subsidies to Embraer, an aircraft manufacturer that competes with Bombardier of Canada. Under the North American Free Trade Agreement, the United States and Mexico were required to join the Canadian ban. In Brazil, the ban sparked public protests against Canada, with people refusing to sell Canadian goods and dockhands leaving cargo from Canada unloaded.

A team of experts from Canada, the United States and Mexico went to Brazil last week to assess the situation. Canadian officials said Friday they were satisfied that Brazil had taken sufficient measures to prevent BSE, or Bovine Spongiform Encephalopathy, commonly known as Mad Cow disease.

The Canadian statement was similar to a U.S. Department of Agriculture statement issued earlier Friday that said Brazil "has taken sound measures" to prevent Mad Cow disease. Brazilian Agriculture Minister Marcus Pratini de Moraes thanked Veneman. Wearing a tie depicting smiling, dancing cows that has become his trademark through the dispute, Pratini de Moraes said Mexico would also lift the ban Monday, albeit as a formality, because it imports no Brazilian beef anyway.

"We are sure Brazil has no BSE and we can certify this for products we export around the whole world," he told reporters.

A Canadian foreign affairs spokesman said there was no message in the timing of the announcements by Washington and Ottawa. The U.S. government generally gets its announcements out more quickly than the Canadian government, said the spokesman, Andre Lemay.

"Are we following the U.S. lead on this? No. It's the time it takes," he said.

In imposing the ban on Brazilian corned beef and beef extract, Canada claimed Brazil had failed to provide sufficient paperwork on several thousand animals imported from Europe. Canada imports about dlrs 6 million a year worth of corned beef from Brazil and about dlrs 667,000 worth of extract, used as a flavoring by the food industry. It has never imported fresh or frozen beef or cattle from Brazil.

The United States imported dlrs 82 million in Brazilian beef products last year, and Brazilian officials said the ban automatically cost the country 10 percent of its beef export markets. The Brazilian government gave Canada three weeks to lift the ban or face a major trade war. The deadline was Friday.

The Canadian ban came as the trade dispute with Brazil over export subsidies for the aerospace industry remained unresolved. Canada has permission from the World Trade Organization to impose trade sanctions on Brazilian products, but has yet to implement them.

UK drug company's nvCJD infected drug causes chaos in Spain

24 February 2001 LANCET Volume 357 by Xavier Bosch
Spain's health ministry and the health departments of the country's autonomous governments received dozens of calls from worried former patients of hospitals that had allegedly used variant Creutzfeldt-Jakob disease (nvCJD) contaminated plasma in a diagnostic procedure.

As concern over the transmission of bovine spongiform encephalopathy (BSE) is increasing amoung Spaniards--7 new cases were announced on Feb 14--a Spanish newspaper revealed that patients who had a lung scintigraphy in 1996 and 1997 had been given a drug that was manufactured with albumin from a UK donor who died from nvCJD in November, 1997.

In June, 1996, the contaminated blood was sent to the UK National Blood Authority's laboratory, where it was used for various products. The donor's plasma was mixed with 49 000 other donors to make 8,174 bottles of albumin.

One bottle was sent to Nycomed Amersham, a UK drug company, which used the albumin in 14 000 vials of Amerscan Pulmonate II Technetium Lung Agent. This intravenously injected drug is used to assess lung perfusion by scintigraphy and is especially used to diagnose lung embolisms.

In November, 1997, as a precaution, the UK Medicines Control Agency, ordered the removal of two "tainted" batches of the agent that were sold to 20 Spanish hospitals and also informed the Spanish health ministry.

Nycomed and the health ministry then warned each hospital about the infected drug. However by then at least 757 patients had received the drug. The ministry recommended that each regional government take on the responsibility to inform the infected patients and suggested that patients should be notified in a personal letter from their doctor.

Only the Galicia regional community told their patients and, as a result, 35 patients promptly filed lawsuits.

On Feb 9, Eduard Rius, head of the Catalonian health department, said that 181 patients had received the drug in Catalonia. But his department did not inform patients after two expert committees advised him that first, there is no scientific evidence of nvCJD being transmitted by blood products and second, the notification would have caused unnecessary anxiety to patients.

His department adopted the "biomedical ethical principle of not doing damage", he said. This was also the recommended course of action by the UK government. Rius pointed out that these patients have been actively followed up and none of the patients has developed nvCJD. In fact, 30% of them have died from causes other than nvCJD infection.

Juan Luis Encina, director of Nycomed Amersham in Spain, said the issue was settled 3 years ago when the tainted batches were removed from circulation. In November, 1997, Nycomed said that it had recalled batches of the product, which had been sold to several countries.

In Denmark, more than 400 patients were examined with the drug in 1997 and the Danish parliament decided to inform all patients, which was done by the hospitals. Australia also had a similar problem and decided to inform its patients.

The UK's health department has advised doctors that patients who have received blood products donated by nvCJD patients should not be told because the risk of developing the disease is so slight that there is no reason to cause alarm. Isidre Ferrer, neuropathologist at the Hospital de Bellvitge, Barcelona, agrees and says that the risk is "negligible or null" as has been demonstrated in experimental studies on mice. [Nothing of the sort has been demonstrated, on the contrary. Why should the product be recalled if proof existed that it was safe?-- webmaster]

Brain-devouring disease in blood supply

Sunday,February 18,2001 By MARIA ALVAREZ NY Post
Nancy Kaner feels like a walking time bomb. It's been nearly five years since she learned the blood injected into her body to treat an immune-system deficiency was tainted with CJD - a fatal brain-eating disease that sufferers like Kaner believe is the human version of the dreaded mad cow disease.

She said she had been using the blood for a year before being notified that it came from a donor who died of CJD, or Creutzfeld-Jakob Disease. And blood banks across the country have recalled batches of plasma donated by victims of CJD during the 1980s and mid-1990s, even though there is no evidence the killer disease is transmitted through blood.

There is no test to find out if a person has CJD, leaving recipients of contaminated blood wondering if they are incubating the illness. CJD eats away at the nervous system and leaves the brain looking like a sponge - the same deadly result when humans are struck down with mad cow disease. Thousands have died from CJD nationwide.

While researchers say it's related to mad cow, they insist it's not the same thing. CJD is a fast-moving, debilitating disease that causes memory loss and seizures that paralyze the limbs. It can develop spontaneously, genetically or through surgery to the cornea and ultimately cripples victims before they become vegetables.

The FDA refused to immediately reveal how many people were affected by the recalls, claiming the information could only be obtained through a Freedom of Information request. But according to a March 1995 FDA notice, there were CJD blood recalls in October 1995, when the American Red Cross identified a donor who gave blood 96 times over the past 20 years.

But families of victims, who have banded together on the Internet, believe cases are escalating and that CJD is more closely related to mad cow than anyone has admitted. "No, they are very, very different, but they belong to the same family," said Dr. Pierluigi Gambetti, neuropathologist at Case Western Reserve University in Cleveland.

Brain-devouring disease in blood supply

Sunday,February 18,2001 By MARIA ALVAREZ NY Post 
Nancy Kaner feels like a walking time bomb. It's been nearly five years since she learned the blood injected into her body to treat an immune-system deficiency was tainted with CJD - a fatal brain-eating disease that sufferers like Kaner believe is the human version of the dreaded mad cow disease.

She said she had been using the blood for a year before being notified that it came from a donor who died of CJD, or Creutzfeld-Jakob Disease. And blood banks across the country have recalled batches of plasma donated by victims of CJD during the 1980s and mid-1990s, even though there is no evidence the killer disease is transmitted through blood.

There is no test to find out if a person has CJD, leaving recipients of contaminated blood wondering if they are incubating the illness. CJD eats away at the nervous system and leaves the brain looking like a sponge - the same deadly result when humans are struck down with mad cow disease. Thousands have died from CJD nationwide.

While researchers say it's related to mad cow, they insist it's not the same thing. CJD is a fast-moving, debilitating disease that causes memory loss and seizures that paralyze the limbs. It can develop spontaneously, genetically or through surgery to the cornea and ultimately cripples victims before they become vegetables.

The FDA refused to immediately reveal how many people were affected by the recalls, claiming the information could only be obtained through a Freedom of Information request. But according to a March 1995 FDA notice, there were CJD blood recalls in October 1995, when the American Red Cross identified a donor who gave blood 96 times over the past 20 years.

But families of victims, who have banded together on the Internet, believe cases are escalating and that CJD is more closely related to mad cow than anyone has admitted. "No, they are very, very different, but they belong to the same family," said Dr. Pierluigi Gambetti, neuropathologist at Case Western Reserve University in Cleveland.

Health supplement industry seeks cure for sagging sales

Feb. 24, 2001 Los Angeles Times By DENISE GELLENE
The health supplement industry, which made the exotic echinacea plant a modern alternative to chicken soup, is scrambling to find a cure for its sales malaise. Americans last year reduced purchases of vitamins, herbs and other health supplements for the first time since 1994, a sign that consumers have become skeptical of natural remedies marketed for maladies ranging from sniffles to depression.

The slowdown comes despite continued high prices for prescription drugs and dissatisfaction with managed medical care -- factors that drove the self-care market during the last decade. But developments in science and the marketplace, along with recurrent questions about safety, have taken a toll on wellness products.

Research on top-selling remedies has raised questions about whether they work. In two separate studies published last year, for example, scientists drew opposite conclusions about echinacea's purported cold-fighting ability. Sales of the strong-selling remedy dropped from 1999. That causes nutritional-industry consultant Robert G. Donovan to ask: If experts can't agree, whom should consumers trust?

Quality-control issues won't go away. Watchdog groups and, most recently, online testing service, have found that ingredient levels in supplements frequently fall short of amounts stated on product labels. Of 13 SAM-e products tested last year, for instance, five didn't contain the amount of S-adenosyl-methionine stated on the label. SAM-e is promoted as an antidepressant.

Health-conscious consumers have more choices. Vitamin-fortified cereals and drinks, herbal teas and such anti-cholesterol butter substitutes as Benecol offer Americans ever-widening alternatives to pill-popping. "Consumers may be looking to foods first," said Phillip W. Harvey, an official with the Newport Beach, Calif.-based National Nutritional Foods Association, which represents mostly retail stores.

Beyond these issues is "mad-cow" disease, a concern up and down the nation's food chain. The Food and Drug Administration asked supplement makers on Jan. 29 to identify the source of bovine-derived products, including glandular extracts, collagen, glucosamine and chondroitin, which aren't covered by regulations that protect Americans from infected beef.

Trade groups representing the industry said they haven't been able to trace the source of every product and might not be able to do so. Supplement makers aren't required to maintain records on ingredient sourcing or meet federal manufacturing standards, as drug companies are. "It is a multinational business," Harvey said. "It is very difficult to track."

Mad-cow disease, formally known as bovine spongiform encephalopathy, or BSE, and its human form, new-variant Creutzfeldt-Jakob disease, haven't been linked to dietary supplements. Industry officials consider the possibility of contracting the disease through supplements remote. But they worry that the faintest mention of the fatal brain-wasting illness -- detected in cattle in nine European countries -- might cause consumers to swear off supplements.

"My paramount concern, if consumers freak out and overreact, is that we won't be able to manage that problem," said Loren D. Israelsen, executive director of the Utah Natural Products Alliance, whose members mostly market herbal products.

Questions about safety have plagued the supplement business. The FDA has received about 2,900 so-called adverse-event reports about herbal remedies, including ginkgo, ginseng, St. John's wort and ephedra, a stimulant that also has been linked to 70 deaths. Earlier this month, a jury awarded $13.3 million to an Alaska woman who suffered a stroke after taking a weight-loss product containing ephedra, which is the subject of a lengthy FDA investigation.

The industry consistently has maintained that ephedra, also known as ma huang, and other herbals are generally safe. It argues that the number of people who experience adverse reactions is small compared with the estimated 20 percent of American adults who regularly use them. Loyal users of nutritional aids haven't been scared off. Rose Albano, a Los Angeles secretary, has been taking dietary supplements for close to 30 years and believes she is healthier for it. "I'm a big proponent of supplements because they get to the problem, unlike drugs that mask the problem," said Albano, 48.

But reports of serious side effects help explain why overall confidence in nutritional supplements is relatively low for substances intended to improve healthfulness. Prevention magazine reports that 14 percent of consumers consider herbal remedies "very safe." Only 30 percent of shoppers think herbal products' claims are "extremely credible," according to Natural Marketing Institute, a Philadelphia-based consulting company.

And the industry's image hasn't been helped by online sellers of "body-building" products containing GHB, a depressant that can result in coma and death, or the industrial solvent BD, formally known as 1,4 butanediol. Congress passed a law in April prohibiting sale of the substances as supplements.

A broader problem for supplement makers is product quality, which officials acknowledge is inconsistent. The industry regularly has been embarrassed by results posted by, a testing service founded by a physician and former FDA chemist. The Internet company has found labeling errors in random tests of ginseng, saw palmetto and ginkgo biloba, among other supplement products.

But so far, the industry -- represented by five divergent trade organizations, including the American Herbal Products Association and the Council for Responsible Nutrition, which represents manufacturers and multilevel marketers, including Herbalife International -- has been unable to adopt its own quality standards.

Instead, supplement makers have been lobbying the FDA to promulgate so-called good manufacturing practices, which would, among other things, regulate cleanliness of supplement factories and the potency and stability of ingredients. The FDA has called adoption of such standards a priority, one that is likely to draw heightened attention because of mad-cow concerns. In a videotaped address to a Consumer Health Products Association convention in Anaheim, Calif., on Jan. 31, Joseph A. Levitt, director of the FDA unit that regulates supplements, said he is "very concerned there are no regulations at FDA on BSE. The industry needs regulations," he said. The FDA planned to move the issue "quickly to the front burner."

By some estimates, the supplements industry continues to mushroom. Nutrition Business Journal reports sales rose to about $16 billion in 2000 from $15.4 billion in 1999, figures that include a broad range of products, including weight-loss formulations, sleep aids and sports supplements. The General Accounting Office, an arm of Congress, estimates that in 1999 consumers spent $31 billion on supplements and related products, such as herbal teas, snacks and other so-called functional foods.

But Donovan, the industry consultant, and others see signs of weakness below the surface. Mass-market sales of herbals fell 14 percent in 2000, as each of the top five herbs -- echinacea, garlic, ginkgo biloba, ginseng and St. John's wort -- posted double-digit sales declines. The slide is troubling because herbals had been the industry's star performers.

Besides quality issues, herbals have other challenges. Piecemeal research into their effects has led to product warnings and recommendations, sometimes within a matter of months. Take the case of St. John's wort. Last February, the FDA issued a public health alert about taking it with other medications. That came on top of evidence that it can cause temporary nerve damage when users are exposed to bright sunlight.

But a study in the September issue of the British Medical Journal found the herb was as effective as and had fewer side effects than the commonly prescribed antidepressant imipramine, and concluded St. John's wort was a better choice for treatment of mild depression. Still, mass-market sales of St. John's wort skidded 45 percent last year.

Claims of other herbal products haven't held up. Various studies have found little evidence to support ginseng's purported benefits as a performance enhancer, an anti-cancer agent or an aphrodisiac. There are bright spots. Sales of glucosamine and chondroitin, touted for relief of arthritis pain, grew 25 percent from 1999. A study published in the medical journal Lancet last month found glucosamine might help stop progression of osteoarthritis, an inflammatory disease that attacks the joints.

Sports performance supplements also are strong sellers, although the FDA recently told the industry of its concerns about androstenedione, an alternative to anabolic steroids once used by home-run slugger Mark McGwire. A 1999 study on the effects of "andro" found that it increased levels of the female hormone estrogen rather than boosting testosterone and strength as promised.

An economic downturn could hurt products that are doing well. A 20-day supply of glucosamine and chondroitin can cost as much as $40, more than three times the price of a similar supply of ibuprofen. Supplements aren't immune to economics. Unit sales fell 6.6 percent last year, a sign that some mass-market shoppersweren't willing to pay higher prices.

Said the National Nutritional Foods Association's Harvey: "We're kind of going through growing pains. Maybe we'll see a resurgence. Or maybe we won't."

Drug encapsulation industry working to address mad cow disease fears

2001-02-20 Reuters Health By William Langbein 
The drug encapsulation industry appears ready to respond to the public's fears about bovine spongiform encephalopathy (BSE), or "mad cow disease," particularly if two small companies can ramp up production of their alternatives to bovine-derived gelatin.

For 65 years, gelatin--the wonder substance of Jell-O and gummy bears--has also been a key material in drug encapsulation. Gelatin is typically produced by boiling the skin and bones of cattle or pigs and is used either as a bonding agent in coated tablets or as the primary element in soft-gel capsules. It also is often a component of vaccines, infusion solutions and medical implants.

Gelatin producers and end-users have tested a number of natural and synthetic substitutes for animal gelatin, but have had limited success--and, until recently, little motivation to change the status quo, as the material historically has been produced with reasonable reliability and without health risks.

The drug-encapsulating machines developed in the 1930s have resisted nearly all non-gelatin alternatives, and substituting a new ingredient could require a lengthy regulatory review. With few compelling reasons to institute the complicated changes, manufacturers mostly opted to forgo them.

But as awareness of mad cow disease has increased, drug firms have found that public perception of the risk associated with bovine materials has became an issue--despite the fact that most experts agree patients are unlikely to contract Creutzfeldt-Jakob disease, the human form of mad cow disease, by taking a drug made with gelatin. [The risk question would be whether "bones" includes spinal cord sourced from cattle from known or at-risk BSE countries. -- webmaster]

"Like most closed industries, there has not been much motivation to innovate," concedes Greg Bowers, president of BioProgress Technology International, and a 20-year veteran of the drug manufacturing industry. "It wasn't until the last 5 years that companies began to seek out improvements."

The research and development arm of Atlanta-based BioProgress is in England, where mad cow disease has struck the hardest. The company makes a cellophane-like film as an alternative to gelatin for encapsulation, but it had initially planned to focus on consumer goods rather than on pharmaceuticals.

"I first saw the [BioProgress] film at a trade show and they were using polyvinylalcohol to make a flushable diaper," Bowers told Reuters Health. "Another company then asked BioProgress if the film could encapsulate bath oils. They discovered they could. I joined shortly after that and we started to develop the machinery that could process the film and refine an ingestible product."

BioProgress calls the product XGel FS, for XGel Film System. The company believes the ingestible material holds potential in drug encapsulation, but it has not yet been approved for that purpose in the US. BioProgress uses a patented process to form, fill, seal and cut soft capsules without animal ingredients. The technology for non-ingestible soft capsules is already in use, while the ingestible form is in the final stages of development. The two products are created using similar machinery, but different raw materials: for the ingestible form, only natural and sustainable materials are used, BioProgress said.

The company claims that the advantages of its product go beyond calming consumers' fears about mad cow disease The film takes only 2 days to produce, compared with the 8 days needed for gelatin-based products, and is also less expensive, according to the firm

The non-gelatin product does not need to be heated and mixed before delivery to the encapsulation machine or dried before packing, BioProgress said. In addition, the use of several low-water content materials reduces the number of batch rejections. And because gelatin does not dissolve in cold water, XGel FS can be used in some medical applications in which gelatin cannot, the firm claims.

Although the US Food and Drug Administration (FDA) has not yet moved to prevent the use of gelatin, many pharmaceutical firms are hedging their bets by looking into alternatives.

"In June of last year, I received calls from 8 or 9 major drug companies in a week and they all said the same thing," BioProgress Chairman Barry Muncaster told Reuters Health. "Their concern was they would be spending millions of dollars to develop a new drug and the FDA would then delist gelatin. The drug companies know it's difficult to change substances in manufacturing and they want an alternative as soon as possible."

Bowers believes the tablet and softgel drug encapsulation market totals about $3 billion worldwide. However, it is not clear how much incentive there will be for manufacturers to move away from gelatin, how rapidly large volumes of synthetic alternatives can be produced, or how long the clinical testing required for US approval will take.

The FDA's current regulations prohibit the use of the brains and spinal cords of cows from countries where cases of BSE have been identified. Scientists consider those pieces of cattle infectious, as they are the most likely to carry prion, the misfolded protein believed to cause BSE and Creutzfeldt-Jakob disease.

But the FDA has not banned the use of gelatin made from bovine hides or bones because there is no evidence that BSE can be transmitted to humans through the product. Still, in 1997, an FDA advisory committee said that the agency should be allowed to regulate gelatin if necessary. The FDA may examine the issue later this year, according to Bowers.

"It's not that the use of gelatin is necessarily harmful, but market forces are pushing drug manufacturers toward alternatives," said BioProgress' Muncaster. "Using animal byproducts is just becoming too costly of a risk."

"There's a lot of emotion behind BSE and the FDA can't say there is zero risk with gelatin," agreed Dr. Kerry Bottom, who is president and COO of the High Point, North Carolina-based drug delivery firm Pharmacore and a BioProgress shareholder. "The FDA has to balance the whole issue: the products involved, the available alternatives, the health risk [and] the cost to manufacturers who believe they have been producing safe products for years."

In July of last year, BioProgress licensed XGel FS to Peter Black Healthcare Limited, a UK supplier of private label vitamin, mineral and herbal supplements. The license grants Peter Black exclusive use of the system for dietary supplements and non-prescription medicines in the UK and the Republic of Ireland. BioProgress also has agreements with Nestle and The Boots Company, the UK's leading health and beauty retailer, to develop a range of new consumer products using the encapsulation technology.

Bowers explained that future partnerships will be similar to the Peter Black agreement, in which the company purchased the necessary manufacturing machines from BioProgress and gained access to the technology for 10 years at an annually declining fee. Peter Black will received the prototype machine in April The firm will purchase the XGel film from BioProgress according to demand. In January, BioProgress shipped film to two unnamed drug companies, and the firm said it expects that more orders from pharmaceutical manufacturers will be forthcoming.

South San Francisco, California-based FibroGen, a producer of recombinant collagen that may hold potential as an alternative to gelatin, is working with 28 drug companies to conduct feasibility studies of new delivery methods All of the partnerships were formed in the last 18 months, according to the firm. FibroGen's genomics-based technology allows the production of the gelatin precursor collagen through recombinant expression systems, such as recombinant yeast fermentation and transgenic plant expression. The recombinant collagen product is currently available to researchers for use as a reagent.

Company spokeswoman Nina Ferrari said that the product, which can be modified for the drug and target, could potentially enhance delivery and potency. But FibroGen could be hampered by the difficulties inherent in producing large volumes of recombinant collagen, she acknowledged.

Last month, FibroGen entered an agreement with Aventis Pasteur under which the French firm will use the material to improve the stabilization and activity attenuation for certain vaccines. Through the partnership, FibroGen will receive upfront payments, program funding, milestone fees, supply revenues and royalty rights on end product sales.

Western Producer

BSE: Still searching for answers

4 Jan 01 Barbara Duckworth Western Producer
Shotgun shells roll across the dashboard of Simon Banfield's Land Rover. Earlier that day, he had to shoot three dairy heifer calves. He lined them up at the edge of a trench and, one by one, shot each week-old calf in the head. Then he and his herdsman covered up the trench and returned to their chores.

"A Charolais steer was at Yeoville yesterday," the herdsman says. "They only offered 90 quid for it so the auction rang up the farmer and told him to come take it away."
"That's terrible," replies Banfield.
"That cow had her calf earlier today."
"What was it?" asks Banfield.
"A bull."

By being born male and sired by an Angus bull, that calf can be finished on grass and sold as Aberdeen Angus beef to the Waitrose supermarket chain for a premium price. Female calves are set aside for a week when Banfield shoots another batch of heifers. He has no choice.

In the aftermath of the bovine spongiform encephalopathy crisis in Britain, heifers have no value as veal or beef in the British market. The alternative is to pay £40 (note: at time of publication, £1 = $2.25 Canadian) a head to ship them to a dedicated abattoir for slaughter and incineration.

It is believed the disease can be passed from dam to calf. Unless heifer calves go into the breeding herd, they have no value. They can't be sold as beef.

"It's just bloody awful. I'm miserable for the rest of the day," Banfield said in an interview on his farm near Dorchester. "It's the most disgusting, dishonorable thing I have ever had to do."

Banfield grows cereals and forage on 1,000 acres for his 140-cow dairy. Prices for all farm commodities have plummeted in England and he is still recovering from having the worst case of bovine spongiform encephalopathy in Dorset County. The farm has been free of BSE for seven years but Banfield feels bitter and betrayed by agricultural experts, feed companies and government. He saw his first case of BSE in late 1987 in a four-year-old cow. As he watched his most productive cows die, he did not know what was wrong or why it was happening. Banfield eventually lost 118 cows.

The first cows to go down were checked by his vet for brain tumors, toxins or other illnesses. The diagnosis was BSE, a reportable disease ravaging dairy herds across England since 1985. By 1987, British scientists had linked the cause to protein supplements made from BSE-infected cattle and fed back to other cattle.

At Banfield's farm, the deadly pattern repeated itself almost daily. A seemingly normal cow would enter the milking parlor in the morning. By evening, the same cow refused to enter. The cows' peripheral vision was affected and they became easily agitated. They were spooked by sudden noises such as a dog barking or a tractor starting. Unsteady on their feet, they spread their legs outward in an attempt to regain their balance. On a number of occasions, Banfield called the vet to examine one cow. By the time the vet arrived, three other cows were licking their nostrils and stumbling about the yard.

At first, the government paid full market value for the stricken animals. But as the epidemic spread across England, the compensation was cut in half. "The government was very quick to realize that this was potentially a serious situation but not linked to human health," Banfield said. "It was a large number of cases on a very small number of dairy farms to start with."

About 30 percent of dairy herds were widely affected while another third never had a single case of the disease. Banfield grew 99 percent of his own feed ration, to which he added a commercial product that contained 42 percent protein.

The brand name was Sea Mill so he assumed it was fish meal. In fact, it contained bovine meat and bone meal but there were no labeling requirements at that time so he did not know. Pinpointing the source of infection was difficult because the farm bought protein from several different suppliers. Banfield was told there was no threat to human health so he did not have to dump the milk. In hindsight, he should have insisted on knowing the ingredients in the supplements.

"I admit we were naive in many ways."

Banfield suspects that feed companies looking for cheaper products gradually decreased fish meal and substituted meat and bonemeal from cattle. The companies then guarded the ingredients of their products as proprietary information. An investigation has laid some of the blame on a deregulation policy that began during former prime minister Margaret Thatcher's tenure. Regulations at all levels of agriculture and food processing were to be administered with a light touch.

Today, Banfield is forced to use more costly soy meal imported from the United States and he must guarantee customers that the milk from his dairy contains no genetically modified material. He has been battered financially, lost genetic potential in his herd and given away a piece of his heart in this post-BSE age. The losses continue to reverberate. Because no British beef or live animals are exported, Banfield's veal calf trade with France has disappeared.

He used to receive £160 per calf . Now, he has to pay to have them destroyed or shoot them himself to save the expense.

He joined a farm quality assurance program covering his beef, dairy and cereals. His farm is subject to regular inspections and he must maintain farm records for seven years.

To further guarantee safety, all bovines require passports that record every movement to and from the farm. While he dislikes the paperwork, Banfield supports complete traceability and farm assurance schemes that are designed to restore consumer confidence.

His farm office wall is lined with farm assurance record books for every product he produces. His safe is full of cattle passports and his filing boxes are filled with farm records. In addition to the records, he must abide by each commodity's code of practice.

He figures dairy inspections cost £100 and beef inspections cost £80 per animal. "We all realize it is going to be necessary forever more," said Banfield.

Denmark confirms 4th mad cow case

23 Feb 2001 (AP)
Danish health authorities on Friday confirmed the Scandinavian country's fourth case of mad cow disease. The latest case was detected last week when a farmer contacted a veterinarian because of the unusual behavior of a cow on a farm near the city of Soenderborg, 240 kilometers (150 miles) southwest of Copenhagen.

Initial tests were positive and final confirmation came Friday. The whole herd, which has been in quarantine the past week, will be destroyed on Sunday, authorities said.

The Danish Veterinary and Food Administration has said it expects the figure of confirmed cases of mad cow disease to reach 10 by yearend.

Health authorities also said they suspect another cow that was found dead on a different farm has bovine spongiform encephalopathy, or BSE, as mad cow disease formally is known. But the cadaver was so decomposed that confirmation tests will take two to four weeks to complete.

Danish farmers' unions have criticized officials for announcing suspected mad cow cases before they are confirmed, because some prove to be false alarms but cause panic anyway.

In line with a European Union directive, Denmark checks all cattle over the age of 30 months that are slaughtered. That's about 250,000 cattle.

Fears of mad cow disease and its deadly human form, the brain-wasting variant Creutzfeldt-Jakob disease, have spread in Europe since cases were discovered on the continent late last year. Some 94 people have died of the disease since the mid-1990s, mostly in Britain.

Sweden says may have found first case of BSE

Feb. 23 2001 Reuters/ Agence France Presse English/AP
The Swedish Agriculture Ministry was cited as saying on Friday it had found a suspected case of mad cow disease in Sweden, until now thought to have been free of the brain-wasting illness.

It said in a statement that a routine preliminary test for bovine spongiform encephalopathy (BSE) in a young milk cow came up positive, but believed the probability it was a real case of BSE was small.

Dutch authorities on Friday were cited as confirming they had found a new case of mad cow disease, bringing to 13 the number of affected animals discovered in the Netherlands since 1997. The five-year-old animal was taken for slaughter last week and confirmed to be carrying the brain-wasting disease after a series of tests.

Three new cases of mad cow disease were confirmed Friday in Germany, bringing to 39 the number of infected German-born cattle found since the end of November, regional authorities announced.

Swedish mad cow report unfounded

February 26, 2001 Radio Sweden News
What was feared to be Sweden's first case of Mad Cow Disease, or BSE, has turned out to be a false alarm. A preliminary positive test has been followed by several negative test results, while a more conclusive test carried out in Britain will take several weeks. Despite the negative test, the authorities say for psychological reasons they are removing beef from the market in the area involved.

Swedish Prime Minister Göran Persson says it was necessary to take precautions -- even though there is little chance of the disease existing here -- just to avoid a crisis in confidence. Both the Swedish government and the Farmers' Association have argued that for Sweden's exemption from BSE testing as this country banned fodder containing animal protein several years ago.

Fifth case of mad cow supposed in Italy

24 Feb  2001  AP
A fifth bovine suspected of mad cow disease of was discovered in Italy, in the area of Pouilles in the south of the country, announced Saturday by the Minister for Health Umberto Veronesi. It is the first suspect case discovered in the south of Italy. The bovine one is seven years old. The first test was positive and complementary analyses were being done to confirm the diagnosis, declared Mr. Veronesi at Italian agency ANSA.

According to the ANSA, the stockbreeder concerned declared himself amazed explaining that he had tried not to nourish its animals with animal flours, accused in the crisis of mad cows. Until now three cases of bovine spongiform encephalopathy (ESB) were confirmed in Italy. Analyses are in hand to confirm a fourth case.

BSE in milk substitute

26 Jan 2001 El Mundo
Herbert Wohn, the president of the German Veterinary College has reported at a Congress in Fulda that the Institute of Viral Diseases of Tubingen (Germany) has detected prions in milk substitutes of maternal milk used to feed calves.

This product contained animal fat, bone meal, vegetarian meal, and vitamins, and is used to feed newborn calves instead of maternal milk. This works out [to be] cheaper than using maternal milk and allows the cow to be milked for human consumption.

Dr. Whon has stated until 1997 the animal fat used in these products was only heated up to 80 degrees [centigrade ?], an insufficient temperature to neutralize the prion agent and new cases infected through this source could therefore be possible until 2003. Spain only changed the industrial process in 1988.

This scientific finding sheds new light on the case of the cow confirmed BSE-positive 3 Jan 2001 in Zamora (Spain) belonging to one of the best farms in the region. The farmer stressed to the press he only gave milk substitutes and concentrates to his cows until the age of 4 to 5 months and then mixed his own food from brought-in corn, soy, lucerne [alfalfa], beet root and mineral supplementation.

Scientific Steering Committee publishes risk assessment if BSE were to be found in sheep

14 February 2001 Brussels press release 
The Scientific Steering Committee (SSC) advising the European Commission inter alia on BSE related issues has today published a pre-emptive assessment of the risk to human health in case the presence of BSE were to be found in sheep under domestic conditions.

The scientists consider that at the current stage there is insufficient information to draw definite conclusions on the potential risk to the human population. They therefore develop three scenario's about the potential risk and how to deal with it. The scientists state there currently is no evidence to confirm that BSE is present in sheep and goats, but add that the knowledge in this area is very limited and that the adequate testing methods and monitoring to confirm a diagnosis are not available. It is therefore necessary to start collecting the information required for assessing the likely prevalence of TSE in sheep.

BSE has up to date not been found in sheep under field conditions. Laboratory experiments have however demonstrated that BSE can be transmitted to certain genotypes of sheep and goats.

In addition, it is likely that some specific groups of sheep and goats may have been fed meat-and-bone meal that was possibly BSE-contaminated, in particular before the EU-wide ruminant MBM feed ban of 1994 was effectively implemented by national authorities.

Therefore the SSC reiterates its 1998 opinion that under the current situation it has to be assumed that BSE could have been introduced into parts of the EU sheep and goat population. The SSC underlines that there is a need to start collecting the information that is required to properly assess the possible prevalence of BSE in sheep in a country or region. The scientists notably point to the need for better and more intensive surveillance of sheep flocks, for developing rapid tests which can distinguish BSE in sheep from scrapie, for introducing a system of individual identification of sheep and for certifying the TSE-status of small ruminant flocks.

Feeding practices of sheep vary considerably by flock, country or region, farming system (intensive or extensive) and farming purpose (meat, milk, wool). The only testing method currently available to confirm the presence of BSE in sheep, using bio-assays in mice, takes up to two years before results are obtained.

Very few of such tests undertaken have been completed to date. Clinical signs of BSE might be difficult to distinguish from scrapie, a disease posing no threat to humans. Scrapie is endemic in the sheep population of most EU countries. Research to develop better testing methods is ongoing.

The SSC also examined the latest evidence on the distribution of (experimentally introduced) BSE infectivity in the body of sheep and goat. As opposed to cattle, where the infectivity remains mainly concentrated in specific body tissues such as the brain and the spinal cord, the evidence points to a more general distribution of BSE infectivity in sheep tissues, possibly similar to the distribution pattern of scrapie. This would imply that a more comprehensive list of tissues would have to be eliminated from the food chain in sheep than in cattle, should it be concluded that BSE in sheep is likely.

As a precautionary measure, Community legislation already imposes the removal of specific risk materials(1) of sheep and goat from the food and feed chain in the whole of the EU since October 2000. In case BSE would be confirmed in sheep or goats, strict eradication measures would have to be applied with the entry into force of the new EP and Council Regulation on the eradication, prevention and control of Transmissable Spongiform Encephalopathies expected to come into effect on July 1, 2001:

The skull including brains and eyes, the tonsils and the spinal cord of sheep and goat over 12 months, the spleen of sheep and goats of all ages are to be excluded.

Mad cow risk in US tiny but real

February 20, 2001 Los Angeles Times by Melinda Fulmer
Experts Say Gaps in food quality rules are raising questions: gaps in U.S. food safety regulations and enforcement and the dearth of information about how "mad cow" disease spreads have raised questions over whether American consumers really are insulated from the disease that has caused the deaths of 94 people across Europe.

While country after country in Europe has fallen prey to Britain's mad cow epidemic, U.S. regulators have stood firm on their assurances that Americans are safe, citing import bans, animal testing, curbs on blood donations and feed restrictions. Although no cases of bovine spongiform encephalopathy have yet been reported in the United States, and experts claim it is "highly unlikely" that BSE will become a problem here, the same experts concede that it is impossible to rule it out.

"I don't think that any country can say they are 100% sure that they are free of BSE," says Ralph Blanchfield of the independent Institute of Food Science and Technology based in Britain.

"I think it's reasonable that people are worried," says Stephen DeArmond, a UC San Francisco neuropathologist who collaborated on the 1997 Nobel Prize-winning research on the agent that causes BSE.

Many food safety advocates are wary of government assurances in the wake of the recent StarLink fiasco, in which a genetically modified animal feed corn not approved for human consumption wound up in everything from taco shells to corn chips. Though the risks of a mad cow outbreak in the U.S. may be slim, there are concerns about gaps in these areas:

* Feed mills. If BSE does exist undiagnosed somewhere in the nation's cattle or dairy herds, there's a chance that it could be spread by mix-ups at feed mills, some of which have been lax in following regulations aimed at stopping BSE. The disease was spread in Europe through contaminated animal feed.

* Imports. American companies imported feed from Britain made of rendered animals for three years after BSE was diagnosed there in 1986. Moreover, over the past decade, 32 cows were shipped in from Britain that U.S. Department of Agriculture officials can't account for.

* Inadequate testing. Although 12,000 so-called downer cattle, or cattle that could not walk on their own when they were brought in for slaughter, were destroyed in the U.S. this decade and their brains tested for BSE, some industry observers believe that is not enough to guarantee that U.S. herds are free of the disease. There is no test that can detect the disease in live animals.

* Related diseases. Sheep, deer, elk and mink in this country have contracted diseases in the same family as BSE known as transmissible spongiform encephalopathies, or TSEs, which are not fully understood and carry some of the same neurological symptoms. BSE affects the central nervous system of cattle and is known to cause a human version called new variant Creutzfeldt-Jakob disease, which bores holes into the brain, causing bodily dysfunction, dementia, hallucinations and death.

Worldwide there have been about 178,000 cows identified with the disease since it was diagnosed in Britain 15 years ago. The disease has spread from Britain to native-born cattle in other European countries, such as France, Italy, Switzerland, Germany, Portugal, Ireland and Spain, through contaminated feed and been exported to areas such as the Falkland Islands and Canada....

If BSE does exist undetected in this country's herds, the biggest threat to the food chain would come from lax practices at feed mills. U.S. regulators have barred mills from selling cattle feed made from meat and bone meal from BSE-susceptible animals since 1997. However, rendered dairy cows, sheep and goats are still used in feed for pigs, a point that concerns some scientists, who fear that the disease could spread to other species. They say the practice leaves the door wide open for mix-ups such as the one at Purina Mills in Gonzalez, Texas.

There, the company acknowledged selling cattle ranchers feed made from rendered cows, prompting a quarantine of 1,222 cattle. The animals, which were bought and taken out of the food chain by Purina, are not believed to have been infected with BSE. However, the incident highlighted how easily a contamination could start and raised questions about the Food and Drug Administration's ability to effectively police the food chain. It was cross-contamination like this that played a part in how the genetically modified and potentially allergenic feed corn called StarLink made its way into the food supply last year.

To ensure that it was operating at "zero-risk," Purina vowed to stop mixing meat and bone meal into all of its animal feeds. However, some of the nation's largest feed companies, such as Land O'Lakes Farmland Feed and Cargill, still use meat and bone meal in feeds for animals other than cows.

And not all of them are using it responsibly, according to a report issued last month by the FDA. In its inspections of more than 1,000 U.S. feed mills, the FDA found that 20% did not have the proper precautionary statements on their labels. And 9% did not have a system in place to prevent commingling of cattle feed with feed meant for other animals. The report did not identify the violators.

Five recalls have been issued for improperly labeled feed since the 1997 ban, the FDA said. There are probably many more companies not in compliance. The FDA has not yet finished its first inspection of all of the nation's feed mills and renderers. It has no system in place for regular inspections or sampling, says Stephen Sundlof, director of the FDA's Center for Veterinary Medicine.

Critics say the agency will also need to take a tougher stance on enforcement to keep companies honest. Currently, offenders of the ban are given an oral warning and a letter asking for a recall before any product is subject to seizure.

"It doesn't do any good to have regulations if you have no enforcement," says Mark Ritchie, director of the Minnesota-based agricultural think tank Institute for Agriculture and Trade Policy. "These companies should be [temporarily] shut down if they are violating the rules."

Some food safety experts insist that because USDA officials acted early to restrict imports and close in on potential problems, current regulations should be sufficient to protect consumers and prevent the spread of the disease. The U.S. has had a ban on live animals imported from Britain since 1989 and on animals, meat, bone meal and other products from affected European countries since 1997.

However, because some animal products were shipped over after animals were diagnosed in Britain, the risk of BSE existing here cannot be ruled out, Blanchfield says. "The U.S. imported just under [44,000 pounds of British feed] in 1989, when the epidemic started to get going but was not at its peak."

In addition to feed, the USDA keeps tabs on more than two dozen cattle that were shipped in from Europe during the past decade and still live on farms in Texas, Minnesota, Illinois and Vermont, says the USDA's head veterinarian and mad cow expert, Linda Detwiler. So far, none has exhibited symptoms of BSE, and they are believed to be too old to harbor the disease. [This is a misunderstanding on the part of the reporter. A low initial exposure could lead to late onset. Kuru still occurs in New Guinea today. -- webmaster]

However, some observers worry about the 32 cows shipped in from Britain during the past decade that USDA officials still can't account for. Academics say the risk to this nation's 98 million head of cattle from fewer than three dozen animals is too low to even calculate. "The risks of having a U.K.-like [situation] are infinitesimally small" because of the feed ban, says George Gray, researcher at the Harvard Center for Risk Analysis, which has studied the subject for two years.

It was the continued sale of feed made from the meat and bone meal of contaminated animals that was responsible for BSE's rapid spread across Europe, and that practice was promptly stopped in the United States.

Still, skepticism is understandable, scientists say, given how much is not yet known about the disease. "We don't have the tests yet to verify that there is no problem [in our herds]," says DeArmond of UC San Francisco. A number of companies are rushing to come out with a blood test that will detect the disease in live animals. Currently, the disease is diagnosed only by studying brain tissue after an animal dies or is killed. During the past decade, the brains of 12,000 so-called downer cattle have been tested, and all tests have been negative, Detwiler says.

Contributing to the confusion and fear is the host of similar diseases affecting other animals in this country, such as deer, elk, sheep and mink. Although these diseases have not been shown to jump species, scientists can't say they haven't. And the experts can't fully explain how the animals developed the cell abnormality to begin with.

Two hunters in this country who ate deer and elk, and one non-hunter who ate venison, have died from Creutzfeldt-Jakob disease, Detwiler says. There was no direct link established, however, because it is not known whether they ate animals infected with TSE.

Ritchie, the think tank director, argues that there hasn't been enough education for hunters and additional precautions taken to protect consumers. "Why government hasn't acted on what it's known is a very big question," he says. "This is a direct threat, and it's not being dealt with."

So far, cases of so-called mad deer disease have been identified in wild animals in Colorado, Wyoming and Nebraska, and on 13 elk farms in those states plus Montana, South Dakota, Oklahoma and Saskatchewan, Canada....

"I probably wouldn't worry too much about eating beef in the U.K.," says Dean Cliver, a food safety professor at UC Davis. "And I certainly wouldn't worry about it here."

Vermonters plan protest over 'mad cow' sheep seizure

Feb 15 2001 Reuters
The Department of Agriculture is expected to seize and slaughter two flocks of Vermont sheep the federal agency says may be infected with mad cow disease, local shepherds said.

Some local residents may risk arrest for taking part in protests planned when the federal agents arrive at the East Warren farm of shepherds Linda and Larry Faillace.

Barry Simpson, an elected town official, says the Faillaces enjoy widespread support in the community for their contention that their 150 imported dairy sheep are not infected with the fatal brain disease, which can be transmitted to humans.

Simpson estimates that as many as 200 demonstrators may turn out next Wednesday morning when the USDA is tentatively set to round up the Faillaces' sheep and ship them to a special slaughterhouse near Newburgh, N.Y.

The USDA is expected to go the following day to the Greensboro farm owned by philanthropist Houghton Freeman, where a flock 200 sheep also imported five years ago from Belgium is also suspected of harboring mad cow disease.

However, a USDA spokesman in Washington, D.C., said the agency had no immediate plans to seize the animals.

According to the USDA, four sheep culled from Freeman's flock tested positive last year for a category of illnesses that includes mad cow disease. The category also includes scrapie, a brain disorder affecting sheep and goats. Scrapie is fatal to the animals but poses no threat to humans.

Mad cow disease, or bovine spongiform encephalopathy (BSE), has been linked to the deaths of nearly 94 people in Britain and continental Europe.

The owners of both flocks of sheep have been challenging the USDA tests in federal court since July.

Linda Faillace says the test results are based on "bogus science," and she notes that no sheep anywhere in the world has been found to be infected with BSE.

U.S. District Judge Garvan Murtha ruled last week that the planned slaughter of both flocks can go ahead. But yesterday, Murtha ordered USDA not to seize the sheep until the 2nd U.S. Circuit Court in New York can review the case. Murtha set a deadline of Feb. 21.

"We can't stop USDA from taking our sheep," said Linda Faillace. Arrests resulting from at least a symbolic blockade on the part of protesters "won't surprise me," she added.

If the sheep are taken, it will mark the end of an emotionally exhausting battle waged by the Faillace family. "It will mean the end of our farm," said a tearful Linda Faillace. "It will be more than just losing the animals we love."

The two sets of sheep owners were offered a total of $2.4 million in compensation for loss of their animals as part of an appropriation measure ushered through Congress by Vermont's two U.S. senators. But an agreement between the shepherds and USDA could not be reached prior to the mid-November 2000 deadline set for accepting the buyout offer.

Under the law, USDA must still pay the flock owners the "fair market value" for their animals. But according to Linda Faillace, agriculture officials have not indicated the specific amount to be offered.

Update (Linda and Lawrence Faillace):
"Good news-- The US Second Circuit Court of Appeals decided yesterday that they want to review all of the information regarding our stay on March 6. It is not clear whether they will rule on that day or at some later time. What this means is:

**USDA will not be coming to get the sheep this weekend, they must wait until the court decides.

**The court is taking our appeal seriously and really wants to study the information before deciding.

We are definitely looking at this as a small victory. In fact, when you consider Murtha's latest ruling that delayed USDA for a few extra days; that's two in a row for our side, and for the side of getting the truth to the public. In retrospect, that extra time that Murtha gave us was vitally important, and has helped buy us more time."

Supporters flock to Statehouse

February 23, 2001 By Robin Palmer TIMES ARGUS STAFF
MONTPELIER - A noontime rally on the Statehouse lawn Thursday called not only for government support for a flock of Warren sheep but for better protection for all Vermont farmers. Organized by a new group called FACT, Farmers and Citizens for Truth, the rally attracted nearly 70 supporters, each holding signs, and included four mock sheep and plenty of song.

"We are here, we are here, we are here to save our sheep. Ask us why we're here today. We are here to save our sheep," sang Warren resident Roger Hussey, stopping the music has he shouted the last words at the Statehouse. "Doctor Dean, what will you do? The cover-up will tarnish you."

East Warren residents Linda and Larry Faillace first imported East Friesian dairy sheep from Belgium in 1996 with the help of the U.S. Department of Agriculture with a dream of making gourmet cheese. Two years later, however, the USDA ordered the animals quarantined on the Faillaces' Roxbury Mountain Road farm.

Then in July of last year, Secretary of Agriculture Dan Glickman issued an emergency order to have the Warren sheep and two other flocks in the state seized and destroyed for fear they harbored a form of mad cow disease. The USDA reported that four of the animals from a farm in Greensboro had tested positive for mad cow disease. But after years of test results had showed their animals were healthy, the Faillaces and Houghton Freeman, the Greensboro sheep farm owner, called the USDA's science faulty and have repeatedly appealed rulings to have the animals seized.

The latest reprieve for the sheep, which produce 10 times the milk of a domestic sheep, came Wednesday when the 2nd Circuit Court of Appeals ruled the USDA could not take the sheep this weekend as planned, but rather must wait until the Faillaces' latest appeal could be heard, Larry Faillace told the crowd on the Statehouse lawn yesterday.

That appeal is scheduled to be heard on or after March 6 by a panel of three judges, Larry Faillace said. "We really feel this a sign we're heading in the right direction," he said. "It's a miracle that we still have the sheep at this point," said Linda Faillace, thanking supporters for attending the rally despite the cold.

Former Vermont Sheep Breeders Association president Jim McRae, of Pittsford, called the Faillaces "true Vermont heroes." "We have to stand up here not only for Linda and Larry, but for all Vermonters," McRae said. "Let's get behind them and tell the USDA how we feel."

Signs supporters held as they made their way off the Statehouse lawn and down State Street, where they stopped in front of the Federal Building to protest, made it clear how they felt about the USDA. "Why can't our Vermont leaders fight a USDA witch hunt?" asked one sign. "Keep the public ignorant, confused and fearful and you have control," read another. "The sheep are healthy, our government is sick," read a third. And a fourth read: "At least these sheep have brains."

Marshfield vegetable farmer Anne Miller held a sign stating "test don't kill," but said she had a better idea for a banner: "These sheep aren't mad but I am." "I've just been hearing about this," said Miller, baffled over a Vermont Department of Health warning not to eat the Faillaces' sheep cheese. "I haven't heard you can get (the human version of mad cow disease) from eating the cheese. "It doesn't seem like the USDA has done its homework," Miller said.

Sign holder and Plainfield vegetable grower Joe Klein said he was concerned the USDA would be taking away a viable and innovative Vermont business. "I think we really need to be careful about eliminating these sheep," Klein said. "This whole sheep dairy industry has tremendous potential. It just seems like the USDA doesn't have the best interest of Vermont farmers in mind," Klein said.

State Rep. Kinny Connell (D-Warren), who stepped out meetings inside the Statehouse to join sheep supporters in their march, said she thought a resolution from the Legislature supporting the sheep would be forthcoming, but she couldn't say when.

After a few honks of support from passing drivers, the sign holders made their way back up State Street and reorganized beside the state agriculture building. On the walk, Pam McBrayne said she had just moved to Waitsfield from Maine in September but, as a former sheep farmer, had quickly educated herself on the Warren sheep situation. "I never heard of mad cow disease in sheep," McBrayne said.

While in fact, mad cow disease has never been found in sheep, Cornwall beekeeper and organic farmer Ross Conrad, said the rally was more about individuals' rights than sheep. "Something fishy is going on," Conrad said. "It's disturbing, that's why I'm here."

At a quickly assembled podium in a courtyard beside the agriculture building, Warren Selectman Barry Simpson led the crowd in chants and spoke of alleged USDA motives behind attempts to seize the sheep.

"Big beef and big drugs want the sheep snuffed out as a means of distracting an apprehensive public from the impending catastrophe in their own industries," said Simpson, referencing European meat and bone meal that had been fed to American cattle until 1997 and bovine-based medicines, including vaccines.

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