Prion Disease News -- April 1999
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VA study dodges nvCJD blood issue
"Occasional blood donations may contain infectious agent" ... Paul Brown
EU to carry out check for madcow disease in sheep
Europeans don't want Frankenstein foods
U.S. to tighten controls on hormone-free beef
US blasts EU on beef delays
Portugal BSE cases at 216 a year rate
nv CJD to 41 cases
Dietary sSupplements For Alzheimer's Disease debut
First cloned goats to produce blood product

VA study dodges nvCJD blood issue

 U.S. Department of Veterans Affairs 18 Apr 99 press release
Comment (webmaster): This is a dangerous and highly irresponsible bit of political science from the VA. What is the point, in a disease with an incubation period of 40 years or more, of looking at 1994-95 recipients of CJD blood from a single uncharacterized single donor, using the death certificate method? Note the main press release from the VA even fails to state the date of donation. Even Prusiner's group, which rarely comments on public policy issues, felt obliged to point out deficiencies in the study.

This study is like looking at people exposed to chicken pox 4 days after exposure and saying it is not transmissible when the incubation period is 7-21 days. The VA should butt out of prion research if it can't do better than this. If you aren't part of the solution, you're part of the problem.

The hidden agenda here is a very real concern about nvCJD blood donors from military personel stationed in Britain during the height of the mad cow epidemic. nvCJD blood is a completely issue from sporadic CJD in that it was food-borne and thus strongly infected the lympho-reticular system (white blood cells).

Why did the VA study fail to look at tonsils of GIs stationed in Britain who died of other causes to see if they were incubating disease? Are they afraid of what they might find? Is the VA planning to pooh-pooh nvCJD blood risks the way it did Gulf War Syndrome and post-traumatic stress disorder to short-change service personnel? It looks like they are headed that way, to rationalize continued use of blood donated by high risk vets carrying a very different form of the disease and save money on blood recalls and notifications. Not to mention cover up a failure to take decisive steps earlier to reduce risk from overseas donors. America's veterans deserve better.

Meanwhile, Paul Brown of NIH is scheduled to give a talk at the National Blood Safety Council ln May 6 In Vancouver, BC entitled, "New experimental data from a TSE-infected mouse model: why CJD is not transmitted by blood products despite evidence that at least occasional blood donations may contain the infectious agent." No conference web site is available. Dr Penny Chan tel 416-256-2675 or fax 416-256-3944 is listed as conference staff.

SAN FRANCISCO -- Classic or sporadic Creutzfeldt-Jackob Disease (CJD) does not appear to be transmitted through contaminated blood transfusions or blood products, according to new research from the U.S. Department of Affairs (VA). Researchers examined more than 8,000 inpatient episodes and 500 death certificates of veterans who received blood products prepared from plasma of donors subsequently found to have died from CJD.

The researchers report that their data showed none of the patients died from, or had medical conditions consistent with CJD -- a rare and fatal degenerative disorder for which no treatment exists. The VA study is one of the largest to date to look at the potential risk of contracting this infectious disease from CJD-contaminated blood or plasma derivatives. The findings will be presented at the Ninth Annual Scientific Meeting of the Society for Healthcare Epidemiology of America (SHEA), in San Francisco, April 18-20.

...The major focus of VA research at the SHEA meeting will be the CJD paper presented by lead author, Abid Rahman, Ph.D., Epidemiologist, VA AIDS Service, Office of Public Health. This study came about as a result of VA's look-back notification program of patients who potentially received CJD-contaminated blood products. According to medical experts, there is no evidentiary basis showing the illness can be transmitted through blood components. In fact, the Centers for Disease Control and Prevention has described the risk as "small, immeasurable and theoretical."

Notwithstanding the theoretical risk, in 1995 VA voluntarily elected to notify all patients of the exposure to potentially contaminated blood products, when it was discovered that patients might have received blood components from donors who died of the disease. "Our patients had the right to know of the potential problem [of blood contamination], even if the risk was minimal," said Dr. Rahman.

"The next thing to do was to develop a means of tracking and clinically managing these patients, and determining if there was any indication of CJD in this group." Rahman and colleagues examined the morbidity and mortality records of 1,568 patients at 62 VA medical centers, who were administered potentially CJD-infected blood derivatives or plasma products. The patient group examined was 98.6% male, 86% white, with nearly 77% over the age of 60.

The researchers reviewed 8,614 inpatient episodes of care (including 862 episodes of care since the administration of the contaminated products) and 543 death certificates of patients who may have been infected. They found the primary diagnoses for inpatient stays was circulatory system diseases (29%), followed by 15% for digestive system diseases and 11.3% for neoplasms. None of the 862 episodes were consistent with conditions associated with CJD. The death certificate review produced similar results. The immediate causes of death indicated that neoplasms and circulatory system disease were the major causes of death at 30% and 28.2%, respectively. Respiratory, infectious and nervous system diseases, along with mental disorders, accounted for the rest.

"The study has significant public heath care implications," said Rahman. "Based on what the data show, thus far, there is only a small theoretical risk of transmitting CJD from contaminated blood products." Noting the disease's long incubation period, Rahman said VA continues to monitor the clinical history of these veterans.

Creutzfeldt-Jackob Disease is rare degenerative disease of the brain and central nervous system characterized by a rapidly progressive dementia. Other symptoms may include cognitive impairment and muscle spasms. It belongs to the class of diseases known as transmissible spongiform encephalopathies. It is the human equivalent of bovine spongiform encephalopathy, more popularly known as "Mad Cow" disease. The illness reportedly affects one in a million people in the U.S. annually.

1994 CJD donor studied

Mon, 19 Apr 1999 ProMed
No one seems to have caught the deadly, brain-destroying Creutzfeldt-Jakob disease (CJD) from infected blood -- at least not yet, researchers said Sunday. A study of 1,500 patients who were given blood from an infected donor has found that none show any sign of CJD, said Abid Rahman and colleagues at the U.S. Department of Veterans Affairs (VA).

This does not mean the patients were not infected but researchers were hopeful following the study, Rahman told a meeting in Washington, DC of the Federation of American Scientists Experimental Biology (FASEB).

In 1994 the American Red Cross said a blood donor had later died of CJD, which is always fatal and which has no cure. Blood products from the patient had been given to more than 1,500 people at VA medical centers. (The number is so large because blood from many donors is often pooled before being distributed.) No one knew in 1994, if CJD could be passed on in the blood, although CJD is known to be infectious through brain matter.

Rahman's team looked at medical records for every time one of the patients went to the hospital, and got death certificates from 543 of them. None seemed to have any symptoms of the disease, which can only be ultimately diagnosed by examination of the brain after death.

"Thus far, CJD does not appear to have been transmitted from the blood products manufactured from the plasma of the CJD patient," Rahman told the meeting. "However, caution must be exercised because of the long incubation period of transmissible CJD."

It can take decades for CJD to start showing symptoms. It is a rare disease, affecting about one in a million people for no apparent reason. It can also be spread through infected brain matter -- for instance, if an infected person has a brain operation and the instruments are re-used or if infected brain matter is used in a tissue transplant.

There are also signs that it (new variant CJD, nvCJD) can spread to people who eat beef from cattle infected with mad cow disease, also known as bovine spongiform encephalopathy (BSE). BSE swept British herds in the 1980s and doctors believe that about 30 people who died of a new form of CJD (nvCJD) contracted it by eating infected beef.

"Mad cow' study checks blood of vets

April 19, 1999 San Francisco Examiner  Tue, Apr 20, 1999 Ulysses Torassa 
Disease not linked to transfusions: A new study of more than 1,500 veterans who received blood products from people who later died from the human equivalent of "mad cow" disease has found no evidence that any of them came down with the rare ailment. The study, presented Sunday at a conference of epidemiologists in San Francisco, coincides with other inquiries that have yet to find a documented case of Creutzfeldt-Jakob disease, which is transmitted by blood or blood products. However, the disease has been linked to transplants of infected tissues, including corneas and brain material. An outbreak of the disease in Great Britain has been linked to eating beef of infected cows. In Creutzfeldt-Jakob disease, as well as mad cow disease in animals, spongelike holes form in the brain, leading to dementia and death. Strange, misshapen proteins called prions are believed to be responsible. They can be infectious, but scientists believe they can also arise spontaneously from genetic mutations.

Researchers at UC-San Francisco, where prions were discovered, cautioned against drawing firm conclusions from the study. For one thing, proving a negative - that the disease is not passed through blood - requires a very high standard, said Fred E. Cohen, a UCSF scientist researching prions.

The study by researchers at the Department of Veterans Affairs looked at death certificates from patients known to have gotten blood products from people who later came down with the disease. But death certificates are notoriously inaccurate, Cohen said, especially when it comes to diagnosing rare diseases like Creutzfeldt-Jakob, which occurs in one person in a million each year in the United States.

Furthermore, Cohen said past research in animals has shown that prions probably are carried in white blood cells at an early stage of infection. "One just needs to be extremely careful if the conclusion is the blood supply is safe," Cohen said.

The study's author, Abid Rahman, an epidemiologist with the Department of Veterans Affairs Office of Public Health, agreed that the results don't prove that the disease cannot be transmitted via blood. However, he said it appears there is only a "small, theoretical risk" of getting it that way. "It at least gives us some evidentiary basis for no transmission through blood so far," Rahman said.

The FDA banned blood products from people with Creutzfeldt-Jakob disease in 1995. However, the disease can have a very long incubation period, so it may be many years before it is discovered that someone who gave blood had the disease. More recently, the FDA has considered a proposal to ban blood donations from people who have spent time in Britain at the height of the mad cow disease outbreak. A decision has yet to be made, however it is estimated such a ban could cut the blood supply by 10 percent.

EU to carry out check for madcow disease in sheep

Thu, Apr 22, 1999 Reuters Financial Report By Andrew Osborn
The European Commission is drawing up contingency plans to deal with the possibility that sheep might be harbouring mad cow disease, or BSE, an internal paper showed on Thursday. EU Farm Commissioner Franz Fischler has asked for elaborate contingency plans should BSE (Bovine Spongiform Encephalopathy) in sheep be confirmed, the document obtained by Reuters said.

The EU executive also intends to require all European Union farmers to carry out stringent checks on their sheep and goats to ensure they are free of BSE, the paper said. The EU's decision to tighten controls follows a report earlier this month from the British Spongiform Encephalopathy Advisory Committee (SEAC) which suggested the British government adopt new methods to determine whether BSE was present in sheep.

But the Commission's decision to consider how it might act in the event of BSE being found in sheep did not mean it had new evidence that sheep were carrying the deadly disease, a spokesman for the EU executive said on Thursday. "We have no evidence that sheep can get BSE under farming conditions. Sheepmeat is, in general, an extensively produced, grass-based product," Gerry Kiely told Reuters. "Nevertheless sheep can get scrapie and popular science holds that BSE came from scrapie. We have to work on the precautionary basis that it cannot be excluded that sheep can get BSE," he added.

More than 90 percent of sheepmeat produced in the EU comes from lambs under 12 months of age whereas BSE had a tradition of long incubation, he said. In September last year a British government adviser suggested there was a theoretical risk that sheep could be infected with BSE and that it could be passed to humans. "I think there's a distinct possibility that BSE is out there in the sheep population. If we found BSE in sheep, it would be a national emergency," Professor Jeffrey Almond said at the time.

The British National Farmers' Union played down Almond's comments, accusing him of scaremongering. The outbreak of BSE in Britain was originally linked to the use of high-protein cattle feed that included the remains of sheep infected with scrapie, a form of BSE. The EU imposed a worldwide ban on British beef exports in 1996 following an admission by the British government of a possible link between BSE and a new variant of the human brainwasting disorder Creutzfeld-Jakobs Disease (nvCJD). EU farm ministers cleared British beef for export again in November last year and EU officials now expect the ban to be finally lifted in the next few months.

Lifting Beef-on-bone Ban Is First Priority - Welsh Tories

Fri, Apr 23, 1999  By Brendan Berry, PA News
Conservatives today said their first priority in the new Welsh Assembly would be the immediate lifting of the beef-on-the-bone ban in Wales. Rod Richards, the Welsh Conservative leader, called on all parties to support fully his move in support of the agriculture industry.

"As soon as the Assembly convenes on May 12, I shall be tabling a motion calling for the lifting of this ridiculous ban on beef on the bone. This will be the first chance for the National Assembly to prove that it can make a difference", he said. During an Assembly election campaign visit to Denbighshire, where he met local farmers, Mr Richards criticised continuing delays by the Government in ending the ban.

He said consumers were 70 times more likely to win the National Lottery jackpot and 10,000 times more likely to be murdered than to contract CJD from eating beef. The Assembly will take over responsibility for Welsh agriculture and its politicians have already been advised that they would have power to lift the ban in Wales.

U.S. to tighten controls on hormone-free beef

Fri, Apr 23, 1999  Reuters Business Report
BRUSSELS, Belgium - The United States has agreed to tighten up controls on hormone-free beef exports after a European Union study said supposedly hormone-free U.S. beef contained hormone residues, an EU document showed Friday.

The EU's executive Commission on Wednesday threatened to ban imports of U.S. hormone-free beef from June 15 if a solution to the problem could not be found by then. U.S. Trade Representative Charlene Barshefsky initially reacted angrily to the move, saying it was a step in the wrong direction, while acknowledging that any technical issues concerning U.S. beef imports could probably be resolved. But U.S. officials, in talks with their EU counterparts in Washington on Wednesday, took a more conciliatory approach, according to the Commission document obtained by Reuters.

The officials said the United States did not dispute the objectivity of the EU study and was anxious "to correct the problem" of the residues, the paper said. "The U.S. was surprised at the results of the ... study, since they had no advance awareness of problems and believed that the control measures in place were effective," it said. The United States asked the EU for a list of slaughterhouses which supplied the meat analyzed in the study, it added.

U.S. officials assured the EU that they were reviewing controls in abattoirs and would not sign meat export certificates to the EU unless they were satisfied, it said. The Commission on Friday welcomed these comments. "We welcome the United States' constructive approach. We have a mutual interest in resolving the problem as we have no desire to ban U.S. imports provided they are produced without hormones," Commission spokesman Gerry Kiely told Reuters.

Kiely has said previously he expects EU veterinary chiefs on Tuesday to endorse the Commission's view that an import ban is necessary. A formal proposal would probably then be drawn up on Wednesday, he said. The ban, if adopted, would effectively block all U.S. beef imports into the EU which already bars the import of all U.S. beef produced from cattle reared using hormones. The EU imports between 7,000 and 8,000 metric tons of U.S. hormone-free beef a year, worth around $20 million. It is high quality meat sold in restaurants and shops.

EU vets poised to recommend ban on U.S. beef

Reuters Financial Report  Mon, Apr 26, 1999
BRUSSELS - European Union veterinary experts are expected on Tuesday to vote to ban imports of hormone-free beef from the United States after some shipments were found to contain hormones, EU officials said on Monday. The ban, if adopted, would take effect from June 15 unless the U.S. authorities could prove they had solved the problem by then, officials said.

The EU's executive Commission called for a ban last week after scientific tests showed that 12 percent of supposedly hormone-free U.S. beef contained residues of hormones. The EU already bars U.S. beef from cattle reared using growth hormones on the grounds that it might be carcinogenic. A further ban on hormone-free beef would therefore effectively block all U.S. beef imports into the 15-nation EU.

The United States is already threatening punitive 100 percent duties on a range of EU goods if the hormone beef ban is not lifted by May 13. This latest twist is likely to further sour relations. EU vets would probably vote in favour of a ban on U.S. hormone-free beef imports on Tuesday since it was the first item on their agenda, but there was an outside chance the vote might be delayed until Wednesday morning, EU officials told Reuters.

The Commission was then expected to adopt the ban formally at its weekly meeting on Wednesday, they added. An internal Commission document last week said the United States had agreed to tighten up controls on hormone-free beef exports and was anxious "to correct the problem" of residues. The two sides have, nevertheless, so far failed to find a common solution. The EU imports between 7,000 and 8,000 tonnes of U.S. hormone-free beef a year, worth around $20 million. It is high-quality meat sold in restaurants and shops.

Monsanto wins hormone exemption at European Court

Reuters World Report Thu, Apr 22, 1999
LUXEMBOURG - U.S. biotechnology giant Monsanto on Thursday won a European Court of Justice ruling that would exempt the company from having to set maximum residue levels (MRLs) for its Somatech hormone, used on cows.

The court said in a statement the ruling annulled a European Commission decision to reject an MRL exemption for Somatech. However, the judgment will have no immediate impact because of a European Union ban on milk boosting bovine somatotrophin (BST) hormones currently in place until the end of 1999. The Commission has recently conducted further tests on BST and suggested the ban could be extended at the end this year. The court based its decision on a similar case brought by Lilly Industries over its Somidobove hormone, which contains the same active ingredient as Somatech.

U.S. group welcomes tight EU control on gene food

Reuters World Report Fri, Apr 23, 1999
BRUSSELS - Europe has nothing to fear from the United States if it maintains tight regulations over genetically modified foods, a leading U.S. consumer campaigner said on Friday. There is nothing in World Trade Organisation rules to stop the European Union from resisting U.S. pressure to open its market to GM foods, according to Jean Halloran, director of New York-based Consumers Union.

Unlike in the beef hormone case, the EU could easily win a debate in the WTO over gene foods, Halloran tolds Reuters. "There are numerous recommendations from bodies like the World Health Organisation, which would stand up in any WTO challenge. If you couch your rules in terms of basic consumer rights, they're unchallengeable," Halloran said. The U.S. government is increasing the pressure on the EU to speed up its procedure for approving new GM crops, while the two sides remain in conflict over trade in beef.

The WTO has given the EU until May 13 to bring its laws into line with last year's ruling, which said its ban on imports of U.S. beef produced using hormones violated world trade rules. But Halloran said GM foods would fall under a different chapter of the 1994 world trade accord. Washington says U.S. biotechnology companies and farmers are being unfairly kept out of the EU market because of unjustified consumer fears about the safety of new strains of GM crops.

The United States has struggled maize to Europe this year because it cannot guarantee shipments are free of GM varieties which have not been approved in the EU. About 35 percent of the U.S. maize crop and more than half its soybean crop will be made up of GM varieties this year.

Halloran rejected U.S. government claims that U.S. consumers did not share European concerns over the safety of GM foods. "It is absolutely untrue and mildly infuriating to those of us involved in this, when we see those claims," she said. "Public concern is growing rapidly." Halloran said recent polls show that only three percent of U.S. consumers know that GM food is already on the market, while between 80 and 90 percent believe there should be a mandatory labelling scheme to alert consumers to the presence of genetically modified organisms (GMOs) in their food.

"Our government claims that we have this wonderful regulatory system which guarantees the environmental and health safety of GMOs. In our view, these claims are a fraud," she said. Halloran praised the EU for responding to public pressure by initiating labelling legislation and looking for ways to tighten the approvals process, and said the United States had failed to do so because of lobbying from industry. Halloran is in Brussels to attend the so-called Transatlantic Consumer Dialogue, which forms part of efforts by the EU and U.S. to establish regular talks on a range of industrial issues.

Irradiation of hot dogs

AP US & World): Thu, Apr 22, 1999 By JANELLE CARTER AP Farm Writer 
A federal proposal to allow irradiation of uncooked meats should be expanded to include ready-to-eat products like hot dogs and luncheon meats, a quasi-governmental group of food safety experts said Thursday. "There is a clear benefit for irradiation of ready-to-eat meat products," said Dennis Olson, director of the Utilization Center for Agricultural Products at Iowa State University, citing the numerous recalls of contaminated ready-to-eat products.

Olson is part of the Food Safety Consortium, established by Congress in 1988 at the University of Arkansas, Iowa State University and Kansas State University to investigate meat and food safety. Several companies have been forced to recall their luncheon meats and hot dogs in recent months due to possible contamination by Listeria monocytogenes bacteria.

In December, Zeeland, Mich.-based Bil Mar Foods had to recall 15 million pounds of hot dogs and lunch meats after Listeria-contaminated products from the plant were linked to 100 illnesses in 22 states, as well as 15 deaths and six miscarriages or stillbirths. "Irradiating those products may have helped prevent illnesses associated with some of those products," Olson said.

Olson and others representing the consortium said irradiation would provide "an additional layer of safety" for precooked foods. The current Agriculture Department proposal would permit -- but not require -- irradiation only for refrigerated or frozen uncooked meat. During irradiation, low-level doses of gamma rays or electron beam irradiation are administered to kill bacteria. USDA is accepting public comment on the proposal before issuing its final rule.

"We can no longer ignore the food safety benefits irradiation provides," said Dr. Richard Hunter, deputy state health officer for the Florida Department of Health. "The federal government needs to be more active and dedicate more resources to educating the public about the benefits and safety of irradiation." The National Food Processors Association is preparing to petition the federal government to expand the proposed irradiation rule to include precooked meats, said spokesman Tim Willard. "There would obviously be strong consumer benefits to making this technology available," Willard said.

Washington blasts EU threat to ban more U.S. beef

Reuters Business Report Wed, Apr 21, 1999 By Doug Palmer
WASHINGTON - A threat by the European Union to block the little U.S. beef it imports is a step in "the wrong direction" to resolve a larger beef-trade dispute, U.S. Trade Representative Charlene Barshefsky said Wednesday.

"The timing of this announcement is suspect," Barshefsky said in apparent reference to a May 13 U.S. deadline for the EU to drop a long-time ban on imports of beef from cattle fed artificial growth hormones. "The EU seems to be moving in decidedly the wrong direction with respect to U.S. beef of any type," she said.

Earlier, a spokesman for the European Commission said the EU would probably ban imports of "hormone-free" beef from the United States beginning June 15 because residues of growth hormones had been detected in some recent shipments. Each year, the United States ships between 7,000 and 8,000 tons of high-quality, hormone-free beef to the EU for sale in restaurants and stores. The amount represents only a tiny fraction of what U.S. cattlemen estimate the EU market could absorb if the 10-year-old ban on beef hormones were lifted.

Chuck Lambert, a trade specialist for the National Cattlemen's Beef Association, also tied the new EU threat to continuing talks on the hormone issue. With the May 13 deadline approaching, it is not surprising that the EU "would throw some smoke around in the negotiations," Lambert said. Barshefsky said the U.S. Agriculture Department could probably resolve any "technical" issues surrounding hormone-free shipments to the EU's satisfaction.

The United States is threatening to impose punitive duties on hundreds of millions of dollars' worth of EU farm products and other goods if the ban is not lifted by May 13. The World Trade Organization has twice ruled that the EU's decade-long beef hormone ban violates international trading rules.

David Roberts, EU deputy director-general for agriculture, is in Washington this week for talks in the dispute. Whether they will produce a breakthrough depends largely on the EU, Peter Scher, U.S. special negotiator for agriculture, said. "If the EU is prepared to lift the ban and tell us when they'll lift the ban, something will come out of it," Scher told Reuters. "If they're not prepared to lift the ban, I wouldn't expect anything."

Both the United States and the EU have suggested labeling as a way out of the dispute, but there has been no agreement on what labels should say. And at this point in the talks, the main issue is whether the EU will open its market. "The only question right now is, Is the EU willing to respect the WTO ruling and lift the ban?" Scher said. "If they're willing to do that, we can figure out a labeling scheme. We're open to all ideas."

The EU previously offered to provide increased access for hormone-free beef to compensate U.S. producers for being locked out of the larger market. "Maybe they had second thoughts on their offer, and this is a way out," Lambert said.

EU threatens ban on U.S. hormone-free beef imports

 Reuters North America Wed, Apr 21, 1999
BRUSSELS - The European Commission said on Wednesday it intended to ban imports of hormone-free beef from the United States if traces of hormones continued to be found in shipments. Commission spokesman Gerry Kiely said the European Union executive intended the ban to take effect from June 15 if a solution to the problem had not been found by then.

The EU already bans most U.S. beef which is from cattle reared using artificial growth hormones. The existing ban has been fiercely contested by the United States at the World Trade Organisation. The Commission has not yet taken a formal decision on hormone-free imports, but it has indicated that EU Farm Commissioner Franz Fischler will propose the ban to EU veterinary chiefs at a meeting later this month.

"In the absence of a solution, U.S. beef cannot be imported after that date (June 15)," Kiely said. Earlier this week, the Commission released details of scientific tests which showed that 12 percent of supposedly hormone-free beef from the United States contained residues of hormones. Kiely said that in one case there were traces of a hormone which was not even authorised for use in the United States.

Brittan says EU beef labeling must await study

Reuters Business Report  Tue, Apr 20, 1999
WASHINGTON - The earliest that U.S hormone-treated beef could enter the European Union is late this year, despite the looming threat of U.S. sanctions, a top European Union official said Tuesday. EU Trade Commissioner Sir Leon Brittan told reporters that the EU must first finish its study on the safety of eating hormone-treated beef before allowing any imports. Although preliminary results are expected soon, the final report won't be done until near the end of the year, he said.

The World Trade Organization has twice ruled that the EU's ban on hormone-treated beef violates international trading rules and has given the EU until May 13 to comply. The United States is threatening to impose 100-percent punitive duties on hundreds of millions of dollars of EU products -- ranging from tomato paste to small-engine motorcycles -- if the ban isn't lifted by May 13. Brittan, who met Monday with U.S. Agriculture Secretary Dan Glickman and U.S. Trade Representative Charlene Barshefsky, told reporters it would be "useful" for the two sides to start talks on a labeling plan that would let EU consumers decide whether to eat hormone-treated beef.

But even so, the EU could not adopt any label before the health risk study is complete, Brittan said. A labeling plan would also have to go through the EU legislative process, which other officials have said could take 18 months. In the meantime, the EU could provide "temporary" compensation for U.S. cattle producers who have been shut out of the EU market because of the ban, Brittan said.

The United States is open to both labeling and compensation, but wants the EU to set a specific date when it will allow imports of hormone-treated beef. "I'm not in a position to do that," Brittan said Tuesday in a briefing for reporters at the National Press Club.

Despite the delay while the EU completes its study, Brittan said it was possible for the two sides to reach some sort of "contingent agreement" in the meantime. Presumably that would include compensation and some sort of labeling plan, assuming EU scientists give the okay. The United States disputes that the EU has the right to conduct a risk assessment. It also contends the new study is unnecessary since scientific experts have previously determined that artificial growth hormones are safe.

Preliminary results of the EU's risk assessment study could be available by the May 13 deadline, or shortly thereafter, Brittan said. But he said he did not know how detailed those results would be.

U.S., Canada to retaliate if needed on EU beef ban

 Reuters North America Tue, Apr 20, 1999 
OTTAWA - The United States and Canada said Tuesday they would retaliate against the European Union if there is no resolution of a dispute over a EU ban on imports of beef produced with growth-promoting hormones. Both countries have drawn up lists of potential targets for retaliation against the EU if it does not meet a World Trade Organization deadline of May 13 for ending its 10-year ban.

The EU has been working on possible compensation if, as expected, it does not rescind its ban, and has discussed a U.S. interim offer to label U.S. beef. U.S. Agriculture Secretary Dan Glickman and Canadian Agriculture Minister Lyle Vanclief Tuesday made the clearest joint remarks on what would happen if there were no resolution.

"If nothing happens between then and now, my presumption is there will be retaliation," said Glickman, speaking after talks with Vanclief. "If we can't work it out, we will retaliate." "We will not hesitate to retaliate if we don't get what we want," Vanclief said, adding that his first preference was to get the compensation being discussed.

The EU imposed the ban on the grounds that hormone-treated beef was not healthy, but the WTO found that it had not based its conclusion on proper scientific evidence.

EU-US consumer group calls for antibiotic food ban

Reuters Financial Report  Mon, Apr 26, 1999
BRUSSELS - The European Union and the United States should ban the use of antibiotics in animal and human foodstuffs because of the risks they pose to human health, a transatlantic consumer interest group said on Monday. The Transatlantic Consumer Dialogue (TACD), in Brussels last week for one of its regular meetings, said humans were becoming resistant to the medical benefits of antibiotics because they were eating meat which contained growth-promoting antibiotics.

"Because of the potential risks to human and animal health, the TACD calls on the governments of the US and EU to institute a total ban on the non-medical use of antibiotics in animal and food production," the TACD said in a statement. The use of antibiotics to boost animal growth should be outlawed and "a ban on the prophylactic use of antibiotics, except where disease has been identified in an animal or within a group of animals" put in place, it added. The TACD's position is set to worry big multinational pharmaceutical makers of yield-boosting drugs which stand to lose millions of dollars should their products be banned.

Farmers add minute quantities of antibiotics to feedstuffs for pigs and poultry to boost meat yields by keeping animals healthy and free of disease. The EU in December banned four antibiotics from animal feed for the same health-related reasons, prompting an angry response from companies such as Pfizer of the United States and Rhone Poulenc of France, both affected. The companies argued the ban had no scientific justification and would make meat more expensive, damage the environment and distort competition.

EU scientists are now considering banning other antibiotics and are expected to reach an overall opinion on the link between human resistance to antibiotics and their use in animal feed by the end of May, EU officials told Reuters on Monday. The TACD also said it thought the EU and the United States should institute a permanent ban on the use of the hormone bovine somatotrophin (BST) which is injected into cows to boost their milk yields. An EU ban on BST is due to expire at the end of 1999 when it will come up for review.

Portugal BSE cases at 216 a year rate

 Reuters World Report Wed, Apr 21, 1999
Rate of mad cow cases falls in Portugal-minister

LISBON - The rate at which new cases of mad cow disease are appearing in Portugal is starting to fall, Agriculture Minister Luis Capoulas Santos said on Wednesday. The minister said the monthly average had dropped to 11 cases a month (132 per year) over the first two months of 1999 from a monthly average of 18 last year. After Britain, Portugal has one of the highest rates of incidence of bovine spongiform encephalopathy (BSE) in cattle. [Indeed, by far the highest even after massive under-reporting-- webmaster] The European Union banned Portugal's beef and cattle exports last November.

Portugal has implemented a plan to eradicate BSE and hopes to have the bans -- due to last 18 months for cattle and at least nine months for beef -- lifted ahead of time. "The cases still appearing are in cattle that ate contaminated feed five or six years ago, a long time before the plan to eradicate the disease was put in place," Capoulas Santos told journalists.

Britain's CJD Death Toll Rises

Fri, Apr 16, 1999 COMTEX Newswire
LONDON - The number of people in Britain known to have died of new-variant CJD, the human form of "mad cow" disease, has risen to 40, The Times newspaper reported Friday. Since the new-variant Creutzfeldt-Jakob disease (CJD) was identified in 1995, when there were three deaths, the number of cases had risen to ten in 1996 and 1997, and 16 last year.

The latest figures show that one case was notified in the first two months of this year, The Times said. Also on Friday, a group of British scientists reported in the British Medical Journal their more optimistic findings that the incidence of CJD was no higher than to be expected in people who work with animals or carcass. [If they included case #40, in an abattoir worker, 25, conclusions of this ill-timed article would be completely reversed. -- webmaster]

However, in an accompanying commentary published in the same journal, Dr Annick Alperovitch, a French scientist, said the new results by British scientists should be interpreted with caution when using them to predict future death from CJD. The incubation period of CJD is unknown and could be anything from two to more than 30 years, Dr Alperovitch said.

Despite the findings by the researchers from the Imperial College of Medicine in London, this uncertainty re-emphasizes the need to continue epidemiological surveillance of CJD in Europe, she concluded.

Europeans don't want Frankenstein foods

Reuters World Report Apr 19, 1999 By Sharman Esarey
European consumers disdain new gene-modified foods . Fed-up with funny food, Europeans are increasingly turning their noses up at U.S. exports of gene-modified produce in a consumer revolt that could explode into a trans-Atlantic trade war. From London to Lisbon, consumers scarred by a series of food scares are wary of the new grains, whose genetic make-up has been altered to increase resistance to vermin and drought.

Decried as "Frankenstein Foods" and lambasted by Prince Charles, GM foods, critics argue, must undergo thorough, long-term testing to ensure they do not impair health or hurt the environment before widespread use is allowed. In counterpoint, U.S. and European firms are racing to develop the revolutionary new technology that could transform 21st century farming with bigger crop yields, better nutritional content and fewer herbicides and pesticides -- at no known risk.

Last year, the U.S. raised the lion's share of the nearly 30 million hectares (74.13 million acres) of GM seeds sown worldwide, with 40 percent of the soybeans and 20 percent of the maize planted there modified. In Europe, the response has been far more hesitant. While there are scattered trials across the continent, there is no commercial production and some countries like Austria and France have real or de facto bans on specific imports or production.

But most importantly, the European consumer is getting indigestion at the prospect of eating the new foodstuffs. There are calls for better labelling and some supermarkets have joined together to ban genetically modified food. European governments have often been seen as slow to respond, but observers believe the EU might dig in its heels on this issue and trigger yet another trade row with the U.S. which has been unwilling to separate GM from non-GM grain exports.

In early April, the World Trade Organisation decided in favour of the United States and five Latin American countries and against the European Union's banana import policy, resolving a bitter and long trade stand-off. But unlike bananas, the GM food debate is not a pure trade issue. It centres instead on health and safety. And it evokes deep-seated fears of evil big business enriching itself at the expense of the defenceless little guy.

"I think we're headed for a trade war and it's senseless," said a source at a European bio-technology company. Brian Gardner, a leading independent agriculture analyst said GM foods, much like hormone-treated beef exports at the root of another EU-U.S. trade dispute, could spiral into a major battle. The EU banana policy was "a specific obstruction of trade for trade reasons...the others are in the grey area of SPS (sanitary and phytosanitary) issues," Gardner said.

In Britain, the response to genetically modified foods must be seen in the light of the transcendental food scare of BSE, popularly known as mad-cow disease, and the lessons it taught both consumers and the government. After insisting for nearly 10 years that humans could not get the disease from cattle, the British government in March, 1996 climbed down when it said that such exposure was the most likely explanation for a new human disease pattern.

The public outrage at this turnaround explains in part consumer mistrust in the new products, and government reluctance to wade into another food minefield. The environmental group Greenpeace has attempted to set the GM agenda in a bid to rebuild credibility after admitting its campaign against the disposal of the Brent Spar oil loading and storage buoy in the Atlantic was based on faulty data.

"Greenpeace is saying, 'Hold on a wee minute here. Who's controlling this. The government doesn't seem to be controlling this. They are not looking after us,"' said Jacquie Reilly, a researcher at the University of Glasgow who specialises in the media and food scares. "The government, still reeling from BSE, got in the debate late in the day," Reilly said. "The debate has been set by others and it is a wider debate than usual. Greenpeace is basically attempting to set the agenda. It looked around at possible targets and...especially after Brent Spar it had to be careful of the choice."

In February, Prime Minister Tony Blair joined in, saying that as there was no scientific evidence to justify a ban, such a ban would "stop British expertise in farming and science from leading the way (in a) revolutionary science." This was not what critics wanted to hear. "We're happy that supermarkets are taking on board what their customers want and are labelling more than is required but we're not entirely happy that this situation is being led by industry as opposed to being led by government," said the Consumer's Association spokeswoman.

There is also a sense that these products are being "foisted on us from other people," Reilly said. While European companies are competing in the sector, none has been as visible as U.S. based Monsanto Co. Nigel Poole, manager of external and regulatory affairs at Zeneca Plant Science, the division of newly merged Anglo-Swedish AstraZeneca that is developing GM foods, expressed frustration at the emotional tone of the debate.

"Look at this as a marathon race, you don't give up after the first 10 metres. (But) why do we lump everything together when we should be talking about actual products and research programmes?," Poole said. But environmentalists are encouraged by the consumer response. "Our campaign is being successful in Europe and in France," said Arnaud Apoteker, from Greenpeace France. "This is raising hopes that this movement will also reach the main GMO producers like the United States."

Most telling of this success is the small, but spiralling reaction within the European grains markets. In late March in France, maize tendered by the national grain office ONIC fetched a premium of 15-30 francs per tonne over market prices because it was considered GM free as ONIC maize comes from the 1997 harvest and pre-dates GM sowings. In Iberia, importers have been steering clear of genetically modified U.S. maize, and are turning to eastern Europe for supplies although this means daunting logistical problems.

Arpad Nagy, from the grains department of the Hungarian trading company Gabona, said GM hadn't yet played a role with foreign buyers, but he added that the fact that Hungarian grains are not genetically modified "could be an advantage in the future." Demand for organic farming is growing apace, and applications for licensing in Britain were up by 500 percent in February on the level at the same time last year. Still only 0.5 percent of British farmland is organic compared with an EU average of 1.33 percent. Not everyone in the region is as squeamish. Russia, the recipient of EU and U.S. food aid, is in its sixth year and fourth generation of genetically modified pigs.

Dietary Supplements For Alzheimer's Disease Debut

PR Newswire Mon, Apr 26, 1999
No published entries on Medline for PTI-00703 or Rexall exist.  This compound could be of widespread interest for many amyloid disorders or it could simply be part of a stock-kiting marketing scheme.
Dietary Supplements For Alzheimer's Disease Debut At Experimental Biology 99 Meeting

BOCA RATON, Fla. -- Two dietary supplements formulated with PTI-00703(TM), a natural plant derivative that inhibits the formation and growth of brain beta-amyloid deposits, were introduced by Rexall Sundown, Inc. (Nasdaq: RXSD) to the scientific community at Experimental Biology 99 in Washington, DC last week. The proprietary supplements, Neurosharp(TM) and CognoBlend(TM), are marketed under the company's Sundown brand at retail and through its direct selling division, Rexall Showcase International, respectively.

PTI-00703 is a proprietary plant derivative exclusively licensed worldwide to Rexall Sundown in the dietary supplement field of use by ProteoTech, Inc., a Redmond, WA-based biotechnology company. The National Institutes of Health (NIH) recently awarded ProteoTech a substantial grant to further study PTI- 00703 and its role in the prevention and treatment of amyloid protein deposits present in patients with Alzheimer's disease. As the leader in supporting scientific research in the dietary supplement industry, Rexall Sundown also announced plans with ProteoTech to fund and conduct a multi-center human clinical trial testing PTI-00703 in patients with mild-to-moderate Alzheimer's disease.

Comprehensive in vitro testing has shown that PTI-00703 acts as a potent inhibitor of brain beta-amyloid protein fibril formation and growth and disrupts amyloid deposits which are believed to play a role in Alzheimer's disease. Initial animal studies also demonstrate that PTI-00703 inhibits the deposition of beta-amyloid protein deposits associated with Alzheimer's disease.

"For years, scientists have been looking for any substance that acts directly upon the brain amyloid deposits believed to play a central role in Alzheimer's disease," said Debbie DeSantis, Rexall Sundown Vice President of Product Development. "To date, no known preventative or restorative substance has been identified. The discovery that PTI-00703 disrupts amyloid deposits and potentially inhibits their formation is a promising discovery that offers hope to families and enormous potential for the future as the aging population expands exponentially."

Rexall Sundown, Inc. develops, manufactures and distributes vitamins, nutritional supplements and other consumer health products. Visit the Company's website.

This Press Release may contain "forward-looking statements" as such term is defined in the Private Securities Litigation Reform Act of 1995 or by the Securities and Exchange Commission in its rules, regulations and releases, which represents the Company's interpretation or beliefs. These forward- looking statements, by their nature, involve substantial risks and uncertainties, certain of which may be beyond the Company's control and actual results may differ materially depending on a variety of important factors including uncertainties related to acquisitions, government regulation, managing and maintaining growth, the effect of adverse publicity, litigation, reliance on independent distributors of Rexall Showcase International, competition and other factors described in the Company's filings with the Securities and Exchange Commission.

First cloned goats to produce blood product

Reuters Financial Report Mon, Apr 26, 1999 By Maggie Fox, Health and Science Correspondent
Let us hope that these goats do not have preclinical scrapie -- webmaster
WASHINGTON - First sheep, then cattle and mice -- and now goats. Researchers said on Monday they succeeded in genetically engineering goats to produce a human protein used to affect blood clotting, then cloned the goats. The researchers from Framingham, Massachusetts-based Genzyme Transgenics Corp, Tufts University and Louisiana State University said three cloned female goats were born last fall.

It is the first report of a goat being cloned, although goats commonly are genetically engineered to produce human proteins in their milk. More importantly, said Dr. Yann Echelard of Genzyme Transgenics, is that it is the first time that an animal has been both cloned and shown to produce human proteins actively in its milk. "Nobody has reported, to my knowledge, that you can get them to express the protein," Echelard said in a telephone interview.

In this case the three goats have produced in their milk human antithrombin III, a protein naturally found in the blood that helps regulate clotting. The protein is in Phase III clinical trials, the last stage before possible U.S. Food and Drug Administration approval for sale, for use in helping prevent blood clots in patients put on a heart-lung machine during heart surgery.

The goats are not the first animals to be both cloned and genetically engineered. In 1997 researchers at PPL Therapeutics Plc, makers of a sheep named Dolly that was the first mammal cloned from another adult, produced genetically engineered cloned sheep named Polly and Molly. Though Polly and Molly carry the human gene for another human blood factor, one used to treat hemophilia, they have not been reported to produce it in their milk.

Cloning expert Neal First of the the University of Wisconsin in Madison said cloning could be used as a real shortcut to creating genetically engineered animals. Although the science of genetic engineering is improving, it still can be a hit-or-miss proposition. Genetic engineering involves inserting an extra gene or genes into an animal, usually so they will produce an extra protein.

Getting a perfectly transgenic animal -- one that carries the extra gene or genes -- and then cloning it offers a shortcut to creating a herd of animals producing uniform quantities of the desired protein. Many animals, especially goats, are genetically engineered to produce human proteins. Other companies are working to make genetically engineered cloned cattle, but Echelard said goats are attractive because they breed quickly and produce more milk than sheep.

"A cow will give you about 10,000 liters (quarts) of milk per lactation," Echelard said. "A goat will give you maybe a tenth of that at the most, but the advantage of a goat is that it breeds much faster. It has a five-month gestation period and takes seven months to reach maturity, so in 18 months you can have milk, while in a cow it takes three years."

The three cloned goats are genetically identical to one another. The researchers said they used hormones to prompt the goats to produce milk and found that the protein does appear in their milk. "We didn't want to wait to breed these animals (to find out)," Echelard said. But, he added, "These animals will be bred as soon as they are able to be bred, probably in the fall."

Genzyme Transgenics is working to create animals that express 50 different human proteins in their milk, including antibodies, tissue plasminogen activator (tPA), which also affects blood clotting, and human growth hormone.

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