Human mad cow disease presents 'grim outlook' -- Lancet
nvCJD deaths -- why use a lagging indicator?
More nvCJD families to sue
Dairy growth hormone warning given
Kent nvCJD cluster found statistically significant
Arkansas food-disparagement bill
U.S. groups to seek animal antibiotics ban
French press scathing about blood trial verdict
Hepatitis vaccine scare: soldiers exposed to mad cow disease
EU says ``mad cow'' milk should not be drunk
Celsus "BSE Test" for heparin: picomole sensitivity?
Thu, Mar 18, 1999 By John von Radowitz, PA NewsA leading medical journal today forecast a "grim outlook" following reports of an unexpected increase in deaths from the human version of mad cow disease. Since new variant Creutzfeldt-Jakob Disease first emerged in 1996, it has claimed an average of two or three lives every three months. But in the final quarter of last year nine deaths were recorded, setting alarm bells ringing.
The increase, which has already received much publicity, was reported in the Lancet today in a research letter from the CJD Surveillance Unit in Edinburgh. nvCJD is a distinct strain different from other forms of CJD but similar to the related cattle disease Bovine Spongiform Encephalopathy. The disease is thought to have appeared as a result of people eating BSE infected beef in the 1980s. Because of its long incubation period it is not known how many victims might succumb to the disease in the future.
The new figures are the first indication that there might be an epidemic, although only time will tell if this is the case. The figures could be a statistical blip. In an editorial today the Lancet said no one should stop being concerned about new variant CJD. Whether or not there was a serious epidemic the two "take home" messages from the tragedy remained the same, said the journal.
The first was that feeding cattle sheep remains -- thought to be the source of BSE -- is "dangerous folly". The second was that when a threat is posed to public health "precipitant reactions by politicians without any proper attempt either to inform themselves or the public is counter-productive".
The Lancet added: "The outlook, from many aspects, is grim.
"In the UK, the BSE Inquiry will almost certainly publish an anodyne report replete with hand wringing but conclude that no one is to blame. "Worldwide, animal feeding practices will continue to be driven by the prospect of a quick profit and not by considerations of sound animal husbandry. "Clinicians, though, now have at least one good reason to maintain a high index of suspicion concerning unusual presentations of diseases, and to support strict surveillance of these when they occur."
Wed, Mar 17, 1999 By Helen William, PA NewsThere has been an unusually high increase in the number of deaths from the the new variant Creutzfeldt-Jakob Disease, the human form of mad cow disease, it was reported today. Since 1996 there have been an average of two or three deaths every quarter from nvCJD, but nine deaths were recorded in the last three months of 1998, according to the CJD Surveillance Unit.
Scientists remain uncertain about whether the sudden and unexplained increase could snowball into an epidemic within the next few years. The deaths "are a cause for concern", Simon Cousens of the unit told BBC's Six O'Clock News. "They are bad news rather than good news but how bad news they are is difficult to tell. We are going to have to wait another six or nine months to see what numbers of cases occurring over a period are."
Professor John Collinge, a member of the Government-appointed committee which advises on CJD, said: "I think it is concerning that we see more cases of new variant CJD confirmed over the past few months. "It is too early to know what that means. I am personally confirmed that the country may face a serious epidemic of this disease -- it is entirely possible."
In January, the Chief Medical Officer, Professor Liam Donaldson, urged the Government to retain its current beef-on-the-bone ban. Current confirmed cases of nvCJD include three in 1995, 10 in both 1996 and 1997 and 15 in 1998. There has been one confirmed case this year.
Comment (webmaster): The only new factoids to mull over in the research letter:
"However, 41% of the 39 cases were reported and diagnosed within 1 month of death, 79% within 2 months, 97% within 5 months, and all within 6 months. Thus any deaths from variant CJD that have already occurred but that have yet to be reported or confirmed are only likely to affect the numbers of deaths as far back as the third quarter of 1998. "
"Up to March, 2, 1999, 39 deaths from variant CJD had been reported to the National Creutzfeldt-Jakob Disease Surveillance Unit (table)."
A bizarre conclusion can be drawn from these quotes: the UK is not counting as a confirmed case someone with a clinical diagnosis of CJD in conjunction with age under 40 years, a positive tonsil biopsy, and a positive brain biopsy with strain type 4, provided the patient is still alive. But nvCJD can drag on for two or more years. So how many highly probable cases are they holding back?
For physicians unconcerned by these questions, because the prospect of variant CJD affecting themselves or their patients appears remote, or because the number of deaths to date (39) is trivial compared with the toll of more common diseases or of natural disasters, it is worth briefly reviewing the story of variant CJD so far: there are lessons to be learned by physicians and politicians worldwide.
A spongiform encephalopathy affecting cattle (BSE) in the UK was identified in 1986. To the end of January, 1999, 173 718 cases had been recorded in the UK. BSE, which is pathologically similar to a spongiform encephalopathy of sheep (scrapie), was attributed to the feeding of sheep offal to cattle. This distasteful practice was banned in 1988. Notifications of BSE decreased, but in January this year there were still 297 reported new cases. After considerable public disquiet, a BSE inquiry was convened in March, 1998, and was due to report in June, 1999. The inquiry will , predictably, not report on time.
Meanwhile, in March, 1996, a unit set up to monitor spongiform encephalopathies in human beings (the CJD Surveillance Unit, Edinburgh, UK) reported ten cases of CJD (variant CJD) which appeared to be clinically and pathologically distinct from sporadic and other varieties of CJD (Lancet 1996; 347: 921-25). An understandable suspicion that eating BSE-infected beef was to blame for variant CJD provoked mayhem: sale of UK beef was banned throughout the European Union; millions of UK cattle were slaughtered; and the UK public were treated to the unedifying spectacles of a senior politician affirming his belief in the safety of UK beef by feeding hamburgers to his children.
First signs of scientific proof that BSE may be responsible for variant CJD appeared in 1997, with a report that infective prions associated with BSE and with variant CJD appeared identical. Still, the vaunted epidemic in human beings failed to materialise. Notifications to the CJD Surveillance Unit varied (insignificantly) from zero to four per quarter from the first quarter of 1995 to the third quarter of 1998.
Then there was a disquieting change in notification rate, reported in a fast-tracked Research letter in this week's issue (p 979) . In the last quarter of 1998, there were nine deaths from variant CJD notified to the Surveillance Unit. This increase is statistically significant, but it is by no means conclusive evidence that people who were infected by eating beef before sheep offal was banned from the foodchain are now reaching the end of their variant-CJD incubation periods and that worse is to come. Curiously, this information on notifications of variant CJD has been in the public domain for over 2 months without arousing comment. A glance at the graph might lead even the most statistically-naive observer to wonder if something unusual is happening. Perhaps scientists, doctors, and journalists are tired of a topic that since the furore of 1996 seems to have degenerated into political pointscoring.
They should not tire of the topic. Whether there is a drastic epidemic of variant CJD in the offing, or whether there is not, does not alter the take-home warning messages of the tragedy. The first is that to feed cattle--ruminants equipped efficiently to digest only grass and other fodder--neural tissue from a species known to be prone to an endemic brain disease is a dangerous folly. The second, that when a threat is posed to the public health, precipitant reactions by politicians without any proper attempt either to inform themselves or the public is counterproductive.
The outlook, from many aspects, is grim. In the UK, the BSE inquiry will almost certainly publish an anodyne report replete with hand-wringing but conclude that no one is to blame. Worldwide, animal-feeding practices will continue to be driven by the prospect of a quick profit and not by considerations of sound animal husbandry. Clinicians, though, now have at least one good reason to maintain a high index of suspicion concerning unusual presentations of diseases, and to support strict surveillance of these when they occur.
The Lancet 353, Number 9157 20 March 1999 [research letter] R G Will, S N Cousens , C P Farrington, P G Smith, RS G Knight, J W Ironside...The death rate from variant CJD per year has remained approximately constant until recently. We report an unusually high number of deaths from variant CJD in the last quarter of 1998.
Up to March, 2, 1999, 39 deaths from variant CJD had been reported to the National Creutzfeldt-Jakob Disease Surveillance Unit (table). From the beginning of 1996 to the end of the third quarter of 1998, the number of deaths per quarter appears relatively constant, with the largest number of deaths in a single quarter, five, occurring in the first quarter of 1996. In the last quarter of 1998 there were nine deaths.
Given the total number of deaths (35) observed over the 3 years, 1996-1998, the probability of observing nine or more deaths in a quarter, if the death rate from variant CJD was constant over the period, is low (p=0.025). One possible explanation is that the underlying rate of mortality has been increasing over time. If deaths have been occurring at a constant rate from sometime in 1995 onwards, then the plot of cumulative mortality (figure) should be linear (apart from any random variation). However, from the second quarter of 1995 to the end of 1998 there is some evidence of non-linearity (p=0.03), compatible with an increasing mortality rate. Restricting this analysis to the period up to and including the third quarter of 1998 reveals no evidence of increasing mortality.
The unusually high number of deaths from variant CJD occurring in the last quarter of 1998 should be interpreted with caution. The recorded number of deaths could have increased because of improvements in case ascertainment. However, we consider that ascertainment since 1996 is likely to have been almost complete over the age range of observed cases (about 15-55 years). Furthermore, even if there had been under-ascertainment of cases, it seems unlikely that there would have been a sudden improvement towards the end of 1998.
The occurrence of variant CJD cases has been monitored closely since 1996 and this is not the first occasion on which statistical analyses to test for a change in the mortality rate have been done. The p values quoted take no account of sequential hypothesis testing and therefore overstate the real statistical significance of this observation. This analysis takes no account of delays in reporting and confirmation of deaths from variant CJD to the surveillance unit. However, 41% of the 39 cases were reported and diagnosed within 1 month of death, 79% within 2 months, 97% within 5 months, and all within 6 months.
Thus any deaths from variant CJD that have already occurred but that have yet to be reported or confirmed are only likely to affect the numbers of deaths as far back as the third quarter of 1998. The identification of additional deaths in the two or three most recent quarters would tend to strengthen the evidence in favour of increasing mortality.
Although the number of deaths in the last quarter of 1998 was unusual, we do not know if this level of mortality will be sustained. The number of variant CJD deaths during the coming years will provide a clearer indication of whether the apparent increase in deaths towards the end of 1998 was a chance observation or marks a change in the underlying mortality rate.
22 Mar 99 webmaster opinionThe surge in nvCJD at the end of 1998 was both baffling and instructive -- everyone interviewed was talking about deaths from nvCJD, not the confirmed case load.
This means a patient under 35 with a clinical diagnosis of CJD, a positive brain biopsy, anomalous EEG, plus a positive tonsil test is not counted if still living. It is ridiculous to wait for such a patient to die before being counted. The population of England is so small that anyone under 35 with CJD could safely be called nvCJD on age alone, given that there would be 1-2 errors per decade.
The explosive but unwelcome14 Jan 1999 Lancet article from Collinge's group described 9 cases of nvCJD among 20 tonsil tests. Looking once again at table 2, which I recommend strongly to reporters, 5 were still alive, ages at onset average 25.8. Clinical duration in the four that died was 17.9 months (28, 26, 5.5). The five still living averaged 14.6 months, with one greater than 24 months. [ Lancet full text free to non-subscribers who register.]
It seems fair to say that 24 months typical duration of symptoms means looking at nvCJD deaths as of March 1999 [given two month lag in reporting] is roughly looking at multiply confirmed diagnoses of nvCJD as of Jan 1997. The public and press are getting excited over some very stale data. However, no question that there was a deliberate subtext to the news: get ready for really worse news shortly.
Normally no one would use a strongly lagging indicator such as deaths when public policy and research funding decisions need an upper bound leading indicator and the best possible current view of the scope of epidemic. What public benefit is there in downplaying the known incidence?
They could easily go over their referral history and replot their data by date of clinical onset. That would be a far better predictor of the epidemic than this outdated analysis they give us now. Yes, there would be some errors but that is what error bars and statistians are for.
Note Labor/DoH/SEAC are very very careful not to disclose any data on average clinical duration of the 39 deaths. To disclose this simple data point is to disclose the official time-warp. Vicky Rimer is said to have finally have been confirmed to have had nvCJD. That case had a clinical duration of 5-6 years.
Further signs that England is going back to a non-disclosure policy that served them so poorly during the BSE years:
-- Surgically removed organs and highway accident caseshave been tested for CJD but no results released.
--Hospital deaths have been tested for CJD but no results released
-- The CJD monitoring unit has applied for additional funding due to the number of referrals but discloses little about the percent running positive despite immense experience by now.
Going through my files, I came across this commentary in Nature dated 16 Jan 1997 by three of the same authors of the latest Lancet piece. This latest clumsy cover-up reminds me of the Three Stooges tripping over themselves on a bank heist. Don't they realize reporters have access to Nature?
The sole figure in the 1997 paper gives graphically the date of onset, the date of referral, the date of confirmed diagnosis, and the date of death for each of the first 14 cases of nvCJD [sorted by date of onset, not date of confirmation]. Onset is nowhere defined but let us suppose it is clinical signs. Cousens and Smith supply an advanced statistical modelling approach to the future.
Are we to believe that these authors never extended their graph from 14 to 39? Of course they update this figure for their own records -- they just chose not include it in the Lancet article. What a pity they didn't simply revise and update their predictions based on a tripling of the data. Of course they have done that -- they just chose not to release it.
Had they provided the onset data but not the model, some reporter could have run the model ("resulting in a proportional decrease or increase in the numbers of table 2" pg 198). It sounds like the real data must be far worse than scenarios in the 1997 paper which had a worse case of 13,000 deaths. To my best knowledge there has been an absolute crack-down on releasing any more dates of onset since this article appeared.
Times from onset to referral averaged 13.9 months: (26, 24, 21, 12, 17, 13, 10, 14, 8, 15, 7, 14, 6, 7)
...(7 cases had onset in 1994, 6 cases in 1995, 1 in 1996)
Times from referral to death averaged 3.5 months: (6, 2, 4, 2, 5, 4, 2, 3, 4, 1, 4)
Times from onset to death averaged 17.4 months [excluded a confirmed case exceeding 34 months]
Three cases are clearly marked as confirmed prior to death.
Deaths from nvCJD The Lancet 353, Number 9157 20 March 1999 [research letter] R G Will, S N Cousens , C P Farrington, P G Smith, RS G Knight, J W Ironside Predicting the nvCJD epidemic in Humans Nature 385 197-98 1997 [commentary of 16 Jan 1997] Cousens SN, ...., Will RG, Smith PG
The Ottawa Citizen Friday 19 March 1999 Mike Blanchfield See also Blood Recall/Withdrawal - CJD for further CJD and vaccine informationMaj. Dan Drew's seven months in the former Yugoslavia were hell on Earth. He survived the worst battle Canadian soldiers had fought since the Korean War when his battalion took part in a firefight that pitted his fellow soldiers against a Croat army. But now, six years later, Maj. Drew wonders whether the most serious threat to his life occurred before he even set foot on Balkan soil.
He worries that his blood and the blood of thousands of other Canadian soldiers was accidentally contaminated with a fatal brain malady called Creutzfeldt-Jakob disease. And there is no way he will ever know for sure because no detailed military records exist to show which soldiers received the contaminated batch of vaccine.
"We've been exposed to a potential death sentence," Maj. Drew says.
In January 1993, Maj. Drew was one of thousands of soldiers inoculated against Hepatitis A with a batch of gamma globulin immune serum that may have been tainted with CJD, the human form of the so-called "mad cow" disease, the Citizen has learned.
The serum is made from blood products. And the military fears a particular batch given to Canadian troops may have been contaminated by a Red Cross blood donor who had the rare, but fatal disease. The lot in question -- 4,260 vials of it -- was given to Canadian soldiers between January 1992 and June 1994, according to a Dec. 15, 1997, internal military report.
If Maj. Drew was exposed, he realizes it might be decades before he knows for sure. CJD has an incubation period ranging from 18 months to 30 years. No test is available for CJD, which causes dementia and degeneration of body functions.
"There is no way that either the individual or the system could determine who got that lot number," said Capt. Lynne Chaloux, a military spokeswoman. As a result of this incident, Capt. Chaloux said, the Forces tightened the procedures it uses to record the origin of the vaccines its gives to its personnel. Now, each soldiers' personal immunization record contains the lot number of the Hepatitis A vaccine, and the information is now added to a computer data base.
"If this happens today," explained Capt. Chaloux, "we can say 'here you go, here's your lot number.' " In an ironic twist, Capt. Chaloux, the official appointed to comment on this story, will live under the same cloud. "I could have this because I got that vaccine in that time frame," said Capt. Chaloux, who realized this only last night when she was contacted by the Citizen.
This is the latest in a series of health controversies plaguing the Armed Forces. Questions remain about the quality of the anthrax vaccine given in 1998 to peacekeepers in the Persian Gulf. And last fall, it was disclosed that Maj. Drew's colleagues in the Balkans were also unwittingly exposed to radiation and hazardous PCBs.
It has not been proven that CJD can be transmitted to humans through blood or blood products. But that possibility deeply worries health officials. The Canadian blood system was thrown into panic four years ago when it was discovered a carrier of CJD had donated blood. The Red Cross ordered the largest recall of blood products in its history in 1995, after a Vancouver woman told authorities that her father, who suffered from CJD, had donated blood 21 times beginning in 1989.
Again, in September 1997, the Red Cross issued a blood recall because of a donor who was found to have CJD. The agency warned that 50,000 people could be at risk. After that recall, the Canadian Red Cross contacted the Forces to tell them some of their soldiers might have been affected.
Wednesday, March 17, 1999 BBC HealthThe families of people who have contracted the human form of BSE are to sue the government for exposing them to infected beef. Writs were issued on Wednesday for around 10 families of people who have died from new variant CJD.The action was taken before the end of the BSE inquiryto meet the criteria of the three-year statute of limitations.
The cases are linked to the then Health Secretary Stephen Dorrell's March 20 1996 declaration that a set of nvCJD cases had been identified which were probably related to eating BSE-infected meat. More cases are likely to be filed before the end of the year. Thirty-nine people have been confirmed as having nvCJD since 1995.
David Body, the solicitor representing the families, said he will argue that the Department of Health and the Ministry of Agriculture, Fisheries and Food failed in their duty as regulators of the food industry. He will argue the government, which he said took "draconian measures" to stop infection in 1996, should have acted much earlier.
The families, who qualify for legal aid, are looking for "substantial" compensation claims for the suffering of those who died from nvCJD, the cost of caring for them and the economic effect their death has had on their dependents. Mr Body said he would also argue for the provision of "proper care" for people with nvCJD.
News of the action came as the Department of Health moved to play down reports that the number of referrals of nvCJD cases has risen steeply in recent months, prompting fears of an epidemic. A Department of Health spokeswoman said the number of referrals was always much higher than the number of confirmed cases. And a sudden rise in referrals could just represent a cluster rather than an upward trend.
In 1998, 150 cases were referred to the National CJD Surveillance Unit. Sixty of these were confirmed as having CJD, which comes in several forms. Fifteen of them had new variant CJD, thought to be caused by eating infected beef. [This implies 1 in 20 referrals is nvCJD or 20 cases acknowledged in 1999. But recently, a higher percentage has been nv. -- webmaster] Nine of the 15 cases were in the last quarter, possibly signalling an upward trend. The spokeswoman confirmed that there had been a rise in referrals in recent months, but said: "We have no idea what this means. It could be higher awareness. "The unit can have a month with lots of referrals and some with none. [This has never happened -- the monthly reports are on the Internetfor anyone to review-- webmaster.] By the end of the year it all evens out." It takes three to four months for cases to be investigated.
The spokeswoman said the Department of Health would release any information as soon as it was available. Official figures for 1999 show only 16 cases were referred to the surveillance unit by the end of January. [But this is a huge increase that annualizes to 192 -- webmaster] The next figures are due out on 12 April....
Meanwhile, the parents of a man who is thought to have died of nvCJD have spoken of their grief. Twenty-five-year-old Jason Keat died in Bridlington Hospital, Yorkshire, in February after becoming ill last summer. The cause of death has yet to be confirmed at an inquest, but his death certificate lists it as "human variant CJD". Jason's father, Ian, says he thinks his son may have become infected while working at a slaughterhouse in Bridlington, although he said he was "very fond of meat", including burgers.
Mr Keat, from Somerset, said the first sign that there was anything wrong with Jason came when he gave up all his sports and seemed to descend into a depression. He spent hours in a chair sweating heavily and had such dramatic mood swings that he had to be sectioned under the Mental Health Act.
Reuters World Report Tue, Mar 23, 1999BRUSSELS - Milk from cattle with "mad cow disease" should not be used for human consumption, though there is no evidence that it is infectious, the European Union's top scientists said on Tuesday. The Scientific Steering Committee, the EU's top advisory committee on health matters, said there was no evidence that BSE (bovine spongiform encephalopathy) could be passed on through drinking milk.
But it recommended that milk from BSE-infected animals should be destroyed "as a precautionary measure" to stop it entering the human and animal food chain. It may be used to feed the cow's own calf or for research, the committee said.
"We already have a recommendation in force which ensures that the consumer would never get this milk," said European Commission spokesman Pietro Petrucci. "This new data will be considered by the Commission and amendments will be made to the rules if changes are needed," Petrucci added.
European beef consumption slumped in March 1996 after the British government announced a probable link between BSE and Creutzfeldt-Jakob Disease, its human equivalent. Some 39 people have died of the new variant of CJD linked to eating beef from cattle infected with BSE.
The committee said calves from cows with BSE were five to 15 percent more likely to catch the disease themselves, but this was probably not linked to milk, but to other means of "vertical" transmission. Britain, which has had the lion's share of the 175,000 recorded cases of BSE, already bans the sale of milk from infected cows.
Separately, the committee also recommended a ban on using the remains of animals which have died due to unidentified reasons for manufacturing cosmetics and medicines. So-called "fallen animals" include everything from pigs to cats. The committee said they should be "incinerated or burned after rendering and not be recycled for any direct or indirect use," in case they died of BSE or a similar disease.
Thu, Mar 18, 1999 Dow Jones By Daniel Balint-KurtiLONDON -- Milk from cows treated with a synthetic hormone produced by U.S.-based firms Monsanto Corp. (MTC) and Eli-Lily & Co. (LLY) may cause cancer, a key European Union veterinary committee has said.
Use of the hormone in dairy cows could also foster resistance to antibiotics and induce allergic reactions in humans, according to the E.U. Scientific Committee on Veterinary Measures Relating to Public Health. The doubt cast upon the safety of synthetic bovine somatotropin (BST) by the E.U.-appointed scientists could mean the E.U. Commission will not lift the ban on sale of the product later this year.
The ban on synthetic BST was imposed by the E.U. Commission some years ago due to similar health concerns. The E.U. scientists made their statement in a summary of a report obtained by Dow Jones Newswires Thursday. The full report is due to be published within the next few days. The E.U. Commission will debate the report and use it as a basis for its decision on whether to renew the E.U. ban on synthetic BST. The deadline for renewal of the ban is Dec. 31, 1999.
Synthetic BST, which stimulates milk production in dairy cows, is produced by inserting genes from cows into microscopic organisms, which then reproduce the hormone. It is widely used in U.S. dairy herds.
Injection of the synthetic hormone into cows could mean consumers are exposed to "an increased relative risk of breast and prostate cancer" it was stated in the summary report. The E.U. scientists said also that the increased use of antibiotics in cows treated with synthetic BST could lead to those antibiotics finding their way into milk and could foster the development of antibiotic-resistant bacteria.
As the use of synthetic BST increases the risk of cows developing mastitis, a disease which causes the deterioration of cows' udders, cows treated with the hormone are typically given extra doses of antibiotics.
An E.U. Commission agriculture official declined to comment on what impact the report could have on E.U. policy but he did say the summary of the report was 'vague' in its conclusions.
Thu, Mar 18, 1999 Dow JonesNEW YORK --Monsanto Co. (MTC) issued the following statement in response to an earlier report on Dow Jones Newswires that a European Union veterinary committee had stated that the hormone Bovine Somatotropin (BST) may be tied to cancer and other health problems:
'In January 1999, the U.S. Food and Drug Administration reaffirmed that milk, meat and dairy products from BST-supplemented cows are safe for humans. The European Union's Committee on Veterinary Medicinal Products (February 1993), the World Health Organization's Joint Expert Committee on Food Additives (February 1998), Health Canada (January 1999), and regulatory agencies in a number of countries have all concluded that BST is safe for people and animals.
'Concerns raised about carcinogenic effects with this product have also been thoroughly studied and dismissed (over the past decade) by the same regulatory bodies as well as the American Cancer Society and the U.S. National Institutes of Health.
'Additionally, a moratorium on BST use imposed by the E.U. Commission some years ago (as noted in the Dow Jones story) was based on economic and political considerations and not on factors related to animal or human safety.'
By Scott Kilman Mon, Mar 22, 1999 Staff Reporter of The Wall Street JournalThe European Union moratorium on the sale of Monsanto Co.'s synthetic cow hormone is likely to continue because a government-appointed scientific panel is raising human health concerns-albeit ones dismissed by other governments. The EU's five-year-old ban on Monsanto's genetically engineered bovine somatotropin, which is designed to increase a cow's milk output by as much as 15%, was slated to expire on Dec. 31.
The drug, which Monsanto sells under the brand name Posilac, is widely used in the U.S. About 13,000 U.S. dairy farmers inject their herds with it, generating about $200 million in annual sales for the St. Louis biotechnology and pharmaceutical concern.
An EU panel issued a report yesterday that called for more study into whether cows treated with bovine somatotropin also produce an insulin-like growth factor in their milk in such quantities that drinking it increases the risk of cancer in humans. The insulin-like growth factor made by cows is identical to one made by humans and has been a hot subject of study for years. Some scientists are worried because high levels of it are found in people suffering from cancer of the breast and prostate. It is far from clear, however, whether it causes cancer. Cancerous cells may produce it because they've gone haywire, potentially making high levels of the hormone an important indicator for the presence of some cancers.
The EU scientific committee's report won't change the position of the U.S. Food and Drug Administration, which cleared the growth hormone for injection into U.S. dairy cows six years ago. Stephen Sundlof, director of the FDA's center for veterinary medicine, said yesterday that none of the studies conducted since 1993 has shown a credible casual link between insulin-like growth factor in cow's milk and human cancer.
An independent panel of Canadian scientists also concluded recently that there is no evidence that digesting insulin-like growth factor causes cancer. The Canadian government in January nonetheless decided against approving the sale of Monsanto's bovine somatotropin, citing concerns that it's hard on cows.
An EU spokesperson said government officials are unlikely to end the moratorium on the product as long as questions are raised about its safety. A Monsanto spokeswoman said the company will contest the conclusions of the EU committee report. "The science around this product confirms the milk is safe," she said.
Reuters World Report Tue, Mar 23, 1999 By Chris LyddonLONDON, March 23 (Reuters) - Even if the U.S. gets its way and the European Union is obliged to allow sales of hormone treated beef, the impact on the British meat market will be minimal, sector sources said on Tuesday. "We banned hormone treated beef before it was banned by the EU and we certainly wouldn't sell it," said a spokeswoman for the Marks and Spencer retail group.
The crisis caused by the mad-cow disease BSE has raised British consumers' sensitivity to a high level on any issue associated with food safety. "Consumer confidence in British beef is such that sales have just returned to their '96 (pre-crisis) level," said a spokesman for the Meat and Livestock Commission, Britain's meat market promotion agency. "It's vital that we don't undermine that confidence," he said.
A spokeswoman for Iceland answered the question on whether the store would ever sell hormone-treated U.S. beef with a vehement "No." Iceland, which specialises in frozen food, on Tuesday said that its self-imposed ban on genetically modified food had created a big boost in sales.
Tesco Plc was not likely to be selling the beef, a spokesman said. With 97 percent of its supplies coming fron within the UK and the rest from the Irish Republic, extra supplies from the U.S. would not appear on its shelves. "We're committed to supporting British farmers," he said. The National Consumer Council, one of Britain's main consumer organisations, was opposed, a spokeswoman said. "We're applying the precautionary principle. It's something we should be wary of," she said. If the beef were sold, it should be clearly labelled. "Consumers should be informed," she said.
But British farm minister Nick Brown was against the ban, "on the grounds that it is not justified by the science," he said in a statement. The United States targeted more than $900 million of European Union farm goods and other products for possible retaliation on Monday, raising the stakes in a 10-year-old dispute over hormone-treated beef.
The WTO has twice ruled that the EU's ban on imported beef produced from cattle injected with artificial growth hormones violates international trading rules. Last year, the WTO gave the EU 15 months to comply. "We've always supported the ban because of consumer concerns," the MLC spokesman said. "If it (hormone treated beef) has to come, it's vital that consumers know what they're buying."
The U.S. wants Brussels to lift the decade-old ban on imports of beef treated with artificial growth hormones by May 13 -- a deadline set by the WTO for the EU to comply with a dispute panel ruling. The EU has said that scientific studies it has ordered into hormone-treated beef will not be ready in time and is exploring the idea of compensating the United States for lost trade during an interim period while the scientific studies are done or while a labeling option could be worked out.
The U.S. has proposed a mandatory label indicating the meat has been approved by the U.S. Department of Agriculture. The EU wants a label clearly stating that the beef has been treated with hormones and says it will take time to enact any changes to its hormone beef ban.
Reuters World Report Tue, Mar 23, 1999DUBLIN - Ireland's Superquinn said on Tuesday it was the world's first supermarket chain to launch a DNA-based system to track the source of its meat and ensure it came from disease-free cattle.
Superquinn said the "Traceback" system, developed by IdentiGen, a scientific research company based at Trinity College in Dublin, enabled it to trace all fresh meat back to the animal of origin. "This breakthrough in scientific research provides a powerful new tool in beef safety," Superquinn Chief Executive Feargal Quinn said in a statement.
Under the system, every animal selected for Superquinn is entered into a DNA database, which can help identify potential sources of infection among cattle. Irish beef sales have been hit hard by a slump in sales to Russia and Europe, caused partly by the BSE mad cow disease crisis.
Growth hormone is one such substance that is produced by the pituitary gland in the brain, but which is also manufactured for injection. Until now there has been no reliable way to differentiate between the natural and the injected hormone by blood or urine samples, leaving athletes who abuse growth hormone able to escape detection.
However, German and Danish researchers reported in a letter to the Lancet medical journal that they have developed the first test that can differentiate between naturally occurring and manufactured hormones. The test depends on blood being taken within 36 hours of growth hormone injection, which, as the scientists pointed out, means that "out of competition" testing would have to be implemented.
The researchers, led by Dr. Christian Strasburger and colleagues at Innenstadt University Hospital in Munich, Germany, said that the blood test also depends on blood being taken, which is not at present the case for control samples. But the scientists were confident that such administrative obstacle can be overcome by the authorities in politics and sport, in view of the serious side effects of growth hormone misuse.
"From an analytical point of view, the dogma of 'undetectability'of r-HGH (manufactured human growth hormone) misuse no longer holds true," they concluded.
Comment (webmaster): This may cause sports figures to inject pituitary-derived grwoth hormone again with all its attendent dangers of CJD transmission. The sole case of nvCJD outside England occurred in a French body builder.
2 Jan 99 Lancet 353 18-21Comment (webmaster): This 4 page article looked at the geographical distribution of nvCJD. Recall that a rendering plant had been injecting BSE rendering waste into a groundwater well in a region in Kent, England pumping this out for drinking water. There were 26 cases at the time the study was made, 31 Aug 98; it is a bit of a shock to realize the case count has soared 50% in the succeeding 5 months (even using DoH numbers).
The authors simply looked at the distance between residences and rendering plants with census-weighting for population. The problem here is that a small Mom and Pop rendering facility is given the same weight as a giant regional facility. They do not consider the plant's volume of rendering waste nor its method of disposal (well injection, incineration, landfills, surface-applied fertilizer, locally consumed sausage, etc.). Why use the whole human population when only a narrow age band is affected by nvCJD?
There were a mere 54 rendering plants in operation in the year they chose, 1988. These were not contacted even though 9 authors signed onto the paper, a morning's work. No effort was made to locate facilities shut down in the 1980-88 or 1989-98 period, perhaps some of the most primitive. (This information is readily available from industry sources, old phone books, census codes, and tax records.)
Only in the case of Kent did they examine watershed maps showing locations of residences relative to locations of BSE waste injection (2 of 4 Kent victims affected). For incineration, no consideration was given to prevailing winds or dispersion contours (readily available at local airports) which can be very dramatic.
Much to their chagrin, their study methods (which strongly deweighted the Kent scenario a priori) found strong statistical significance being associated with these cases. This motivated them to attack the very statistical methods that they themselves had chosen.
The only sensible part of the article comes when they consider transmission scenarios such as drinking prion-contaminated well-water, inhaling fly ash, or working inside the plant. The problem, as noted many times before, is why are the victims not among the very heaviest exposures, ie, the fellow who chain-saws the spinal cords, lives a half mile downwind of the plant , drinks the well water, and subsists on beef burgers? Surely there is a group here with the appropriate age parameters meeting these conditions and surely the exposure is many orders of magnitude higher than actual victims received. Perhaps exposure and special prion gene control alleles are needed; the high exposure group is too small to have the genetic factor.
The authors should run the current data set. It takes only a few minutes to add new points and have the computer update everything. If any of the 13 lived in Kent or near rendering plant B, it would dramatically strengthen the conclusion that something went wrong here, though no light would be shed on exactly what. One sees the reason the DoH page does not disclose regional information -- somebody might put two plus two together outside their control of the news.
23 Mar 99 listserveMarch 1, 1999 press release from Celsus
Celsus Laboratories announces that all animal-derived raw materials used in the manufacture of its heparin and other glycosaminoglycans are now being tested and certified for absence (<35 x 10-15 moles/mg) of TSE-related prion antigens. Prion antigens have been linked as causative agents of transmissible spongiform encephalopathies (TSE), a collection of fatal neurological diseases sometimes referred to as "Mad Cow Disease". The infectious agent of TSE may be of non-viral etiology; i.e. a transmissible infectious protein that is able to cause and propagate degeneration of brain tissue.
The evidence is that in humans and in other mammals the disease is transmitted through the food chain. In the case of cattle, TSE is transmitted via infected ruminant proteins contained in nutritional supplements. TSE-related diseases have not been observed in swine. It remains to be determined if pigs may act as asymptomatic carriers or reservoirs of TSE-related diseases. However, the common practice of supplementing starter pig diets with ruminant proteins suggests the potential for pig herd contamination. Celsus developed the ultra-sensitive test described above to further assure the integrity of its raw materials.
Morning News (a NW Ark. paper) and >Arkansas Democrat Gazette 10 Mar 99Arkansas Update:
Things are heating up in Arkansas as opposition to the proposed food-disparagement bill continues to mount. For example, today's Morning News also editorialized against the proposed measure (as did the Arkansas Dem. Gazette). Currently, the proposed law is the 20th item on the Committee's list, so it may not get to the matter until Monday.
The Chair of the Senate Ag. Comm. is Senator James Scott. His Committee is scheduled to hear the bill soon. His phone # is (870) 226-3234, fax: (870) 226-3200 and website
By Lisa Richwine 9 Mar 99WASHINGTON - Health, consumer and environmental groups will ask the federal government Tuesday to stop farmers feeding animals antibiotics that are losing their power to treat infections in people. The U.S. consumer group Center for Science in the Public Interest is leading the effort by 37 groups to convince the U.S. Food and Drug Administration it must sharply curtail agricultural use of antibiotics.
Scientists think feeding the drugs to animals destined for dinner plates makes humans vulnerable to so-called superbugs that cannot be treated. Scientists and health-care experts are extremely concerned about strains of salmonella and other potentially deadly bacteria that do not respond to antibiotics. They believe the bacteria outsmart the drugs because of their repeated use in both humans and animals. Farmers routinely add antibiotics to livestock feed to help the animals grow faster. CSPI said any antibiotics needed for humans should be off limits for that purpose.
FDA officials and Congress have been debating how to stifle development of antibiotic-resistant bacteria. In January, an advisory committee recommended the FDA go ahead with plans to make drug companies test for antibiotic resistance before and after they approach the agency for approval.
Dr. Stephen Sundlof, head of the FDA's Center for Veterinary Medicine, said Monday he did not think FDA had the authority to institute the broad ban that CSPI advocates. But under FDA's proposals, individual drugs could be removed from the market if the amount of resistant bacteria they promote exceeds agency limits.
``One way or another we're going to be taking action on this,'' Sundlof said in a telephone interview. Makers of animal drugs said they support efforts already underway to monitor resistant bacteria, but say the FDA's proposals to change the drug approval process, or institute an even broader ban, are unnecessary.
``There is not good scientific data to indicate we need to pull these products,'' said John Keeling, a spokesman for the Animal Health Institute, which represents animal drug makers. The FDA is taking public comments on its proposals for animal drugs until April and will decide whether to implement new rules sometime after that.
March 23 1999 L. Times BY CARL MORTISHED AND VALERIE ELLIOTTTHE United States opened a new flank in its trade war with Europe yesterday by threatening to impose punitive tariffs on $900 million (£542 million) of European agricultural exports in retaliation for a ten-year-old ban on hormone-treated beef imports from the US.
The products t hreatened with hefty duties and likely to hurt British exporters include beef, pork and poultry products, as well as onions, carrots, cut flowers and chocolate. The list will also worry French producers of Roquefort cheese, foie gras and truffles, all of which are threatened with sanctions. Motorcycles and hair dryers are also targeted.
Britain intends to renew pressure on the European Union to lift the ban on the beef; ministers believe that consumers should decide whether they buy and eat the products. Whitehall sources suggested last night that the issue would be raised at the Council of Ministers meeting in Berlin tonight and tomorrow.
The preliminary list of products will be narrowed, probably to between $300 million and $500 million worth of EU exports. They will be subject to crippling tariffs by June 12 if Europe fails to lift its ban on the US beef. Charlene Barshefsky, the US Trade Representative, said: "The EU's ten-year arbitrary and scientifically unjustified ban on US beef has had a substantial negative impact on US beef producers."
Peter Scher, the US special trade negotiator, said that America was prepared to discuss a labelling regime for US beef. However, Mr Scher said that the EU had not been willing to give a commitment that it would both implement a labelling regime and lift the ban.
The European Commission dismissed the US move last night as procedural and said talks about labelling and compensation were continuing. Privately, EU officials say America was prepared to identify its produce only as "US beef" without identifying the presence of hormones.
The World Trade Organisation ruled in August 1997 that the beef ban was illegal and granted Brussels 15 months to conduct scientific assessments.
Wed, Mar 10, 1999 Reuters World ReportPARIS - French newspapers on Wednesday were heavily critical of the acquittal of former Prime Minister Laurent Fabius and one of his ex-ministers in a 1980s AIDS-related blood scandal. A special court on Tuesday did convict one former cabinet minister of manslaughter but, in a near-unprecedented move, waived any sentence against him.
"After the class struggle, now the caste struggle," complained the daily France-Soir, reflecting a popularly held view that France's politicians were a class above the law.
The Court of Justice of the Republic on Tuesday found Fabius, currently speaker of the National Assembly, and former Social Affairs Minister Georgina Dufoix, innocent in the case in which at least 3,600 people were estimated to have been infected with AIDS-infected blood and other blood products. At least 1,000 have died.
Former Health Secretary Edmond Herve was convicted but the court handed down no punishment after deciding he had suffered enough during the five-year inquiry leading up to the trial. France-Soir wrote that "in a special jurisdiction, it is always the most powerful who emerge victorious. There should be the same court for all."
The conservative newspaper Le Figaro said the verdict had opened another trial - "that of unacceptable privileges. "France would be better inspired to copy its neighbours where justice is the same for all. Neither Britain, nor Italy, nor Germany have such procedures for their politicians." The centre-left daily Liberation wrote that the special court "had condemned itself. Its verdict mirrored its make-up and it will not survive."
Victims say the accused were aware of the risks of AIDS-infected blood in 1984-85 but failed to take the necessary steps fast enough to protect the public. "Politicians are like gangsters -- if you don't catch them red-handed, you can't make them pay," said Sylvie Rouy, a wheelchair-bound AIDS victim whose infection through a blood transfusion led to one of Herve's two convictions.
Francois Honorat, a lawyer for some of the victims of tainted blood transfusions, said the verdicts were "nonsense" and the court had manipulated the proceedings to get a favourable result.
March 10, 1999 Reuters Irwin ArieffPARIS -- French farm minister Jean Glavany was cited as dismissing fears of a new wave of mad cow disease at a news conference Wednesday, saying the number of fresh cases was small and should disappear after 2001, adding that the new cases detected so far this year could be traced back to events which took place before late 1996 when tough new controls were slapped on animal feed. It was in the second half of 1996 that the French authorities, hoping to check the spread of the disease, banned using animal nervous tissue, ground bone and certain internal organs in feed intended for pigs and poultry as well as cattle. Before then, such materials were barred from cattle feed but not products destined for pigs and poultry. Glavany said French scientists believed the current mini-wave of new cases was due to the accidental contamination before 1996 of cattle feed with products intended for pigs and poultry. The story notes that France, with a cattle herd of 21 million, has recorded 56 cases of mad cow disease since the authorities began tracking the disease in 1990. In each case, the entire herd of cows is killed off and their bodies burned. In Britain, by contrast, there have been more than 175,000 cases.
Thu, 18 Mar 1999 ListserveThe 7th case of BSE has been diagnosed in the Netherlands from a farm in Markelo. No details yet. All (over 100) herdmates will be culled and diagnosed for TSE by immunohistochemistry.