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Cattle injected with pooled pituitary extracts
BSE contaminated vaccine stocks used on humans through 1996
Sheep brain vaccine in Italy causes outbreak of 'mad goat' disease
Swiss BSE surveillance getting results
Slaughterhouse workers throw meat inspector into offal pit
Pentosan fact sheet
Immunoglobulin short supply blamed on CJD and exports
EU says unlikely to open beef market by deadline
New mad cow case takes French total to 56
French blood case ends with only one conviction

Cattle injected with pooled pituitary extracts

5 Mar 99 Phillips Inquiry and correspondents
Comment (webmaster): It seems there will be further news shortly on pituitary hormones given to UK cattle in the 1960s and 1970s. It seems pooled pituitary extracts from various species were used, including pig and possibly sheep. This is evocative of the connection of pooled hormone products with iatrogenic CJD, especially human growth hormone recipients and the Australian gonadotrophin fertility situation.

Injections, not feed, are used for embryo transplants. For a cow to accept another's embryo, a few dozen cells from a prize animal, the surrogate mother cow must be tweaked with somatotrophin. This may be a very widespread and dangerous practise with international implications. The timing could include the Stetsonville era; note below that improved milk yield was another objective. One school of thought would have the BSE epidemic originate with this, followed by amplification with feed.

Statement 333

Dr Ann Dawson (not scheduled to give oral evidence)
3 March 1988
"12. CVO said the reason for the meeting was to discuss the possible human health implications of BSE. He went on to give a brief account of it pointing out its similarities to scrapie. To date it had affected 490 cattle on 322 farms mainly in the South and South West of England. It had first been identified as a clinical entity in January 1987. However in Dr Watson¼s paper to the Central Zoonoses Group on the 17 February 1988 he mentioned that retrospective studies indicated that the first clinical case probably occurred in April 1985 (YB 88/2.17/1.1-1.3 at 1.3). CVO then discussed possible causes. Veterinary colleagues at MAFF thought that the most likely cause was linked in some way to animal feed.

13. At the time it was known that Creutzfeld Jakob Disease had occurred in some young people with growth hormone deficiency who had been given contaminated human pituitary growth hormone extract. It was also known that cows were currently being given bovine somatotrophin injections to improve their milk yields. Given the similarity between the two diseases, BSE and CJD I asked if injections with contaminated bovine somatotrophin might have played some part in its causation. Mr Rees said that although cows were initially injected with bovine somatotrophin, injections were now produced synthetically. He also went on to explain that epidemiological studies carried out by his team indicated that the probable source was animal feed. He agreed to provide a copy of the epidemiological evidence.

Statement 333

Dr T W A Little (not scheduled to give oral evidence)
5 July 1988 Biologicals Committee Meeting
Detailed discussion of Geoff Wood's draft guidelines (SP3875.2) (Annex 7) (YB 88/07.05/6.1-6.4)Major concern over pituitary gland products and a letter being sent to all licence holders. Amended paper to be presented to NOAH on 11 July and sent to NIBSC and DHSS.

11 July 1988 Meeting with NOAH. (Annex 8) (YB 88/07.11/12.1-12.4)Dr Little briefed the meeting on the emergence of BSE and showed the MAFF Video.Mr Wood presented the proposed guidelines which were discussed. Mr Cook on behalf of NOAH agreed to comment as soon as possible and agreed to obtain information on pharmaceutical products which contained bovine material of UK origin.

6 September 1988 Biologicals Committee of VPC. Some replies from companies using pituitary glands in their products received. Copies of draft guidelines have been sent to NIBSC and DHSS. (Annex 9) (YB 88/09.06/5.1-5.4)"

Swiss BSE surveillance expanded for 1999

 Thu, 25 Feb 1999 Marcus Doherr 
Switzerland, until 31. Dec. 1998, has registered 282 BSE cases that were detected through the mandatory reporting of clinical suspects. Reporting of clinical cases, however, only accounts for part of the BSE cases in the population, and it is possible that BSE-incubating or diseased animals remain undetected and are (a) routinely slaughtered or (b) culled because of other diseases. The Swiss company Prionics AG, Zuerich, has recently developed a Western Blot system (WB) for fast detection of PrP(Sc) in homogenized brain samples. The WB showed high agreement with the immunhistochemistry (IHC) in that it reliably detects BSE-infected cattle in late stages of the incubation period. The WB has the following advantages: It can be performed in 6-8 hours and on a larger number of samples, and it does not depend on the tissue quality and is therefore suitable for use with autolytic material. This test system has been evaluated for use in a BSE surveillance scheme in 1998.

In a 1997 culling program, herdmates of confirmed Swiss BSE cases were identified, slaughtered and destroyed. Brain samples were tested by histology, IHC and, in 1998, with the new WB. Of 1719 cattle tested, 5 were found to be positive for PrP(Sc) without having displayed clinical signs of disease.

In summer and fall of 1998, 3022 cattle, 90% of them cattle older than 2 years of age, were sampled at slaughter and tested for PrP accumulation in the brain. One 4-year old animal was identified in the WB and confirmed by IHC as PrP(Sc) positive.

All animal carcasses, and all specified bovine offals (brain and eyes in the scull, spinal cord and tonsils of cattle), are collected and processed at one Swiss rendering plant, and the resulting meat-and-bone meal is incinerated. Since October of 1998, almost 1000 cattle carcasses (adult animals) that had been delivered to this plant as fallen stock (downer cows, culled animals) were sampled and tested for the presence of PrP(Sc) in the brain tissue. Within this cohort, 4 cattle were found to be WB-positive for PrP(Sc).

The results of the pilot studies are consistent with simulation results of the Swiss BSE epidemic when assuming that approx. 50% of the BSE-affected animals in late incubation or with clinical signs of BSE are detected through the mandatory reporting scheme. A large proportion of the remaining animals in late incubation or with early clinical signs is likely to be culled and therefore will be delivered to the specialized rendering plant. Testing of all culled cattle should detect that segment of the BSE-affected animals. Based on the simulation results, in 1999 between 15 and 20 animals are predicted to appear in this population. Extrapolating the current test results (4/1000) to the annually rendered population (5000 cattle) leads to approx. 20 PrP(Sc)-positive animals to be expected, thereby supporting the modeling results.

Switzerland is now initiating an active surveillance scheme to enhance the detection of BSE cases in all segments of the adult cattle population. In addition to the mandatory reporting of all suspect cases (based on clinical neurological symptoms), all dead cattle showing at least 4 permanent teeth, i.e. being over 24 months of age, that are brought to the rendering plant (approx. 5000 / year) will be sampled. In addition, brain samples will be taken from all adult cattle subject to emergency slaughter (approx. 2000 / year), and from a random sample of cattle showing at least 4 permanent teeth at regular slaughter, bringing the total sample size up to at least 13500 animals. All brain samples will be tested for the presence of PrP(Sc) using the WB, and test-positive samples will be confirmed through the Swiss reference laboratory for animal TSE.

It is expected that in Switzerland using this testing scheme more BSE-affected animals will be detected in 1999 than to be expected through mandatory reporting alone. With the test systems currently available, however, this scheme is considered to be a good approach to further evaluate the status and monitor the development of the BSE epidemic in the national cattle population. Details on the new Swiss surveillance system for BSE will also be announced during a press conference on February 25, 1999.

Dagmar Heim, Swiss Federal Veterinary Office, CH-3003 Bern
Marcus Doherr, Institute of Virology and Immunoprophylaxis, CH-3147 Mittelhaeusern
Marc Vandevelde, Swiss Reference Laboratory for Animal TSE, CH-3012 Bern

British throw meat inspector into offal pit

S Dealler's site 6 Mar 99 news
All Press 28.2.99
  Welsh group that were feeding Prince Charles with meat on the
bone may be taken to court by Government. 

All newspapers and press. 27.2.99
  Prince Charles knowingly eats beef on the bone
at a Welsh meat selling meating. Apparently the whole thing was deliberate and the
press were told that it was to take place. Charles made no statement but it was known that he
was aware of what he was doing. 

Lancashire Evening Telegraph 25.2.99
  Slaughter men kidnap inspector This explains
how individual mean inspectors are being treated progressively badly by the workers in the
abattoirs. This is because they are failing more and more of themeat that is being produced.
The inspectors feel that this action, in which a man was kidnapped and throwninto a vat of
potentially dangerous waste and animal parts, was unacceptable and would go on strike 

Guardian 3.2.99 
  BSE meat inspectors walk out The vote for a strike was concerning the
way that they had been treated by abattoirs. Intimidation from managers due to the inspectors
turning down contaminated meat was the main cause. One inspector had been thrown by
workers into a pit of offal, another had been attatcked with knives. A recent survey showed
that most meat inspectors say they regularly face violence and bullying. 

Guardian 3.2.99
  EU safey measures put beef exports months away. This is due to the
determination by EC that all exported meat must be adequately checked and from the right
animals. Nobody thinks that the exports will return to the 560 million pound level that it was
3 years ago. 

France-Tainted Blood

AP US & World Tue, Mar 9, 1999 By JOCELYN NOVECK
PARIS -- Former Prime Minister Laurent Fabius and another minister were acquitted today in France's tainted blood scandal, but a third official was convicted for his role in two HIV contaminations. In what was clearly a compromise verdict, former Health Minister Edmond Herve was given no penalty despite his conviction.

Judge Christian Le Gunehec said that due to the length of the scandal, Herve had not benefited from the "presumption of innocence to which he is entitled." Herve said the verdict showed that "partisan politics have triumphed over justice and the law." "Once again, the truth was not heard," he said. He said he hadn't decided whether to appeal.

His superior, former Social Affairs Minister Georgina Dufoix, was acquitted along with Fabius in the AIDS deaths of five people and the infection of two others during 1985. Herve was convicted in two of the seven cases.

The ruling by the specially constituted court came in a painful, protracted case infused with both politics and raw emotion. The court was the first since World War II to try ministers for crimes allegedly committed in office.

It was a scandal that shook France's health system to the core: about 4,000 people contracted the AIDS virus from transfusions in the mid-1980s. Hundreds later died. For the defendants, the trial was a chance to finally clear their names. Their accusers saw it as a long-overdue moment of reckoning for ministers who, they say, abused the people's faith.

For Fabius, the verdict appeared to provide the rehabilitation he was looking for. Now parliament speaker, he clearly has further political ambitions. He had been accused of a strategy of favoritism that delayed systematic testing for AIDS, waiting for a French-made test when an American one was available months earlier. But the court said he actually accelerated the decision-making process that led to testing.

Several victims and relatives cried out with anger when the verdict was announced. "It's intolerable. I cannot accept this. It's shameful," Sylvie Rouy, 35, said quietly and tearfully as she was led out of the courthouse in a wheelchair. Rouy, who testified as a witness during the trial, was infected during an August 1985 transfusion while giving birth. "Fabius saved his political career," she said. "It's atrocious for the victims."

She said she was pleased at Herve's conviction, but distraught that he was given no penalty. "I have to live with my penalty every day," she said.

Joelle Bouchet, mother of a hemophiliac who was infected, yelled as Herve left the court: "You have blood on your hands, Mr. Herve!"

During 10 days of debate, the special court of three judges and 12 legislators was asked to untangle a complex file detailing the state of medical knowledge about AIDS in the mid-1980s and what France was doing to fight the disease. The defendants, charged with manslaughter and "attacking the physical integrity of others," faced up to five years in prison and a $90,000 fine.

Herve, the lowest-ranked of the defendants, was accused by an investigating commission of "strangely apathetic behavior," which led to keeping unsterilized blood products in stock after it was known they could be contaminated. He and Ms. Dufoix were also accused of delaying the availability of imported -- and costly -- heated blood products, and of negligence in the screening of blood donors.

State prosecutor Jean-Francois Burgelin had called for all charges to be dropped, saying the affair reflected "an immense breakdown of French medicine" and wasn't the fault of politicians.

Pentosan fact sheet

Dealler site 1 Mar 99  Pentosan polysulphate fact sheet
Pentosan polysulphate is a sulphated chain of xylose sugars that are linked together. Because of this it is a huge molecule that is soluble and has been used as a drug since around 1960. Initially it was used as an anticoagulant (large doses i.v.) then it was used as an anti-inflammatory agent (smaller doses by injection) and then it was used as the major treatment for interstitial cystitis (oral). The drug is made from beechwood shavings and is cheap. It has major properties in preventing the growth of cancers (due to its stopping of the growth of the blood vessels that are needed for the cancer growth), AIDS infection (only been shown to work in test tubes), and in amyloidoses (in test tubes).

Side effects

       1. decrease in blood clotting if the level in the blood is high enough. Not seen when given orally 
       2. decrease in the number of platelets in the blood if the level is high enough. Not seen when given orally. 
       3. allergic responses in the skin (rare). Not currently reported after oral use of the drug. 
       4. bleeding from the gut if the drug is given orally for long periods (over 2 months) 
       5. rare side effects of decrease in platelets levels to dangerous levels. This appears in possible 1 in 30,000 people given the drug i.v.
       (similarly to heparin) but has not been seen in patients given the drug orally yet. The level of the drug in the blood when given orally may
       preclude this. 
In general, as long as the drug is given for relatively short periods (less than 2 months) orally there should be minimal side effects.

Problems with side effect testing

       1. No adequate data in children 
       2. No adequate data in haemophiliacs concerning gut bleeding. 
       3. Gut bleeding must be a direct effect of the drug as it can be used as a reliable method for producing this in experimental rats. 

Research in the past

Shown to be active in preventing the transmission of scrapie from hamsters and mice to another of the same species (i.e. the easiest route). It did not seem to matter whether the drug was given i.v. or intraperitoneally or whether the disease was injected i.v. or intraperitoneally. Multiple doses were much greater than single doses (expt done with dextran sulphate 500). Low doses of disease could be stopped from transmission altogether and the animals actually did not have infection in their body after a single injection of the drug. Work in humans have shown very low levels of toxicity when given orally and why this is so. Pharmacokinetic studies have indicated exactly where the drug goes inside the body and how it gets there. This indicated that the studies in mice and hamsters used doses of the drug that were dramatically too high and that many small doses would be expected to be more effective.

Considered potential use in humans

Blood transfusions, and other conditions by which people may be exposed to inoculations of UK body fluids or tissues. People that carry familial genes associated with CJD, GSS, FFI etc. The possibility of giving the drug to people that might be infected with BSE is still being considered.

Dose

Currently it is expected that it would be given for 2 months to adults at 100mg tds. All on going treatments should be part of a clinical trial. The drug is not currently available in the UK except by named patient prescription from an individual doctor. It is produced by Norton Health Care, Harlow, Essex.

Prophylactic potential of pentosan polysulphate in transmissible spongiform encephalopathies.

Lancet 1999 Jan 9;353(9147):117 
Farquhar C, Dickinson A, Bruce M
Comment (webmaster): This article sees experimental benefits (delayed onset of disease) of interperitoneal injection of pentosan 7 hours after injection of scrapie agent by the same route. However, an oral dose had no effect. The experimental scenario would seem to have no applicability whatsoever to nvCJD or any other TSE, unless it be to individuals accidentally exposed.

Italy hit by outbreak of 'mad goat' disease

Epidemic of transmissible spongiform encephalopathy in sheep and goats in Italy.
Lancet 1999 Feb 13;353(9152):560-1 [no abstract]
Agrimi U, Ru G, Cardone F, Pocchiari M, Caramelli M
The article describes 20 geographically separate outbreaks of TSE in sheep and goats in Italy between Aug 96 and Oct 97, affecting 1,040 animals (based on farmer questionaire; HC, IHC, WB diagnosis). Up to 90% of the animals in some flocks were affected, with a median of 26% in eight all-goat flocks. The 390 goat cases are easily more than the previous cumulative world total.

Contamined BSE feed was ruled out as 8 flocks had never been fed any commecrcial feedstuff.

16 of the flocks had been inoculated subcutaneously with a sheep brain vaccine (against contagious agalactia from Mycoplasma agalactiae). The vaccine originated from a single laboratory using homogenates of sheep brain and mammary gland. The vaccine was "formol-inactivated" which of course is ineffective on scrapie. The incubation period was 23 to 35 months.

Of the remaining 4 flocks, 1 was made up entirely of stolen animals (with unknown vaccination histories) and 3 were sheep flocks without this vaccination. These sheep flocks had very low incidence of disease and may simply represent conventional scrapie with no connection to the vaccine incident.

Missing from the article is the name of the vaccine manufacturer, lot numbers of the pertinent batches, details of vaccine batch size and distribution, and whether vaccines stocks are still being used. Was only a batch large enough to serve 20 flocks contaminated? Were other flocks inoculated but not infected? Was the vaccine distributed to other countries?

This got me wondering how many sheep receive this vaccination worldwide (eg, is mastitis a widespread problem or what) and whether sheep brain is routinely used to produce this vaccine. Not to mention wondering about Mycoplasma bovis and Mycoplasma agalactiae subsp. bovis and whether cows are also vaccinated from sheep brain homogenates.

All in all, this incident is very similar to the 1935 louping ill vaccine, also made in sheep brain and also formalin-inactivated.

And let us not forget human rabies vaccine produced in sheep brain:

Blood donated after vaccination with rabies vaccine derived from sheep brain cells might transmit CJD.
BMJ 1996 Nov 30;313(7069):1405 free full-text
Arya Subhash C, Research Physician, Centre for Logistical Research and Innovation, New Delhi, India. 

Blood donated after vaccination with rabies vaccine derived from sheep brain cells might transmit CJD

BMJ 1996;313:1405 (30ŻNovember) Letters 
Subhash C AryaŻ  
Janet Morgan reports that the National Blood Authority in Britain has decided to tighten the donor screening programme to exclude transmission of Creutzfeldt-Jakob disease or its variant through blood donations. Prospective donors will be prevented from donating blood if they have a history of treatment with human growth hormone or if one of their siblings, parents, or grandparents developed the disease. I would point out that similar care should also be taken when immigrants from Asia and Africa offer to donate blood, in case they received rabies vaccine derived from culture of sheep brain cells when they were living in their country of origin. In many countries in Asia and Africa limited supplies of imported rabies vaccines derived from culture of human cells have been available. Many people continue to be offered indigenously produced sheep brain vaccine after exposure to a rabid animal. Scrapie is known to exist in sheep around many centres where the vaccine is produced. In the mountain sheep of the Kumaon foothills in the Himalayas, for example, scrapie was established more than four decades ago and 1-10% of the flock was reported to have the disease in 1961.2 In the Himalayan foothills the Central Research Institute continues to produce four to five million doses of sheep brain vaccine annually. Transmission of abnormal prion protein, PrPsc, in sheep brain vaccine might have occurred in some of the 30 documented cases of Creutzfeldt-Jakob disease in different regions in India. Because Creutzfeldt-Jakob disease has a latency of about 20 years, many recipients of sheep brain rabies vaccine could emigrate to Britain before becoming ill. Before accepting blood donations from immigrants it would be desirable to ask the potential donors whether they were exposed to a rabid animal and immunised with sheep brain rabies vaccine in their country of origin. Furthermore, indirect assessment should be possible through, for example, assay looking for antibodies specific to rabies."
1.Morgan J. Blood to be screened for CJD. BMJ 1996;313:441. (24 August.)
 
2.Zlotnik I, Katiyar RD. The occurrence of scrapie disease in sheep of the remote Himalayan foothills. Vet Rec 1961;73:543-4. 

Creutzfeldt-Jakob disease in India (1971-1990).

Neuroepidemiology 1991;10(1):27-32
Satishchandra P, Shankar SK
Thirty cases including 20 definite and 10 probable cases of Creutzfeldt-Jakob disease (CJD) seen in India between 1971 and 1990 are reported. Demographic analysis has shown similarities to the previously published reports from other parts of the world. Though 21 (70%) of cases were from two centers--Bombay and Bangalore-, suggesting clustering, this seems to be more apparent than real. One subject worked in the medical field, where possibility of iatrogenic transmission could not be ruled out. None of the cases had positive family history of CJD. There is no epidemiological data of CJD from India so far and hence this report is one such pilot study. Acquisition of spongiform encephalopathies in India through sheep-brain rabies vaccination. Indian J Pediatr 1991 Sep-Oct;58(5):563-5 Arya SC Creutzfeldt-Jakob disease and blood transfusion. BMJ 1991 Aug 31;303(6801):522 Arya SC Spread of 'unconventional viruses' through sheep-brain rabies vaccines. Vaccine 1991 Jan;9(1):70 Arya SC

Italy hit by outbreak of 'mad goat' disease

February 25, 1999 The British Times
A report in The Lancet from the Laboratory of Veterinary Medicine in Rome about a recent increase in transmissible spongiform encephalopathy. TSE is to the goats and sheep of Tuscany, Sicily, Sardinia and Apulia what BSE - "mad cow" disease - has been to the Friesian cows of Norfolk.

Vets studying 20 outbreaks of TSE were cited as suggesting that the timing of the outbreaks (there were 15 in the first six months of 1997) and the high incidence in flocks ( up to 90 per cent) imply that the spread of the disease probably had an accidental cause. It is also unusual for so many goats to be involved, but on this occasion there have been more than 390 cases. It seems, according to this story, unlikely that the sheep and goats were infected by contaminated food, as some of the flocks worst affected were receiving no food that could have been infected by bonemeal or other animal protein.

This story explained that the likely cause is thought to be the contamination of a vaccine prepared with material from the brains and mammary glands of sheep. There are several strains of TSE, with different properties, that may be capable of affecting human beings. There was also an accidental outbreak of scrapie in Scotland in 1935 after the use of contaminated vaccine. It is not known whether there was any increase in Creutzfeldt-Jakob disease as a result.

Vaccine and Not Heard

1 Mar 1999  Private Eye No. 970, p. 26 
THOUGH hearings at the Phillips public inquiry into BSE have broken up for a few weeks, its officials are drawing up what may turn out to be their most controversial document. It is a draft factual account of government policy on vaccines prepared for injection into masses of people, almost all of which contain some material derived from beef.

The first hint that anyone in officialdom was worried about the impact of BSE on these vaccines came at a meeting of senior officials at the department of health on 17 March 1988.

The feeling of the meeting was summed up by ministry of agriculture under secretary; Alistair Cruikshank, as follows: "there is probably no risk in drinking milk or eating flesh from animals affected by BSE, but that the position was much less clear in relation to brains, spleens and other organs. This raised questions about the safety of human vaccines prepared using bovine material."

The chief medical officer Sir Donald Acheson said he suspected there was no risk, but this could take "30 to 40 years to prove". In the meantime, he warned, "ministers would be very exposed, if, as seems inevitable, the press began to devote attention to the subject".

The press showed no interest. But others were worried. A memo from Dr Hilary Pickles at the department of health on 21 June 1988 revealed: "I understand the pharmaceutical industry are also concerned: they had been using bovine not sheep products in various processes because scrapie is endemic in British sheep... the highest risk would be from parenterals [for injection] prepared from brain [Leg rabies vaccine]."

The BSE scare led to the appointment of an expert committee of inquiry under Oxford zoology professor Sir Richard Southwood. On 30 August 1988 Sir Richard wrote to Acheson: "The only outstanding practical matter that we need to address at the present time is the use of serum in pharmacological work. I heard... that Wellcome are now only using serum from New Zealand."

Wellcome's initiative in getting its vaccine beef products from herds in New Zealand, which had not been fed on animal products as in Britain, was not yet insisted on by the government. Three times in 1988, Sir Richard Southwood wrote to the relevant statutory body, the Committee on Safety of Medicines, which is made up of top medical experts, many of whom are linked to the drug companies, asking for more urgent action on vaccines. On 16 December 1988 a meeting of the Southwood committee considered that the response from the safety of medicines committee "was somewhat complacent, particularly in relation to the problem of existing medicinal products". On 26 January 1989, the Committee on Safety of Medicines wrote to Southwood that guidelines for the industry had been agreed. In future, bovine serum should only be taken from "appropriately certified herds".

The committee's letter went on: Many vaccines are stored for up to five years before being released and this will therefore have to be considered."

The Southwood committee report was published the following month, February 1989. "The greatest risk in theory;" it warned, "would be from parenteral injection of material derived from bovine brain or lymphoid tissue. Medicinal products for injection which are prepared from bovine tissues... might also be capable of transmitting infectious agents."

Prompted by the report, the Committee on Safety of Medicines sent 4,000 letters to drug companies asking for information about bovine products. Not all the information from these letters was passed on to the authorities. Sir Donald Acheson, chief medical officer, told the recent Phillips inquiry: "We were told that a number of things that we wanted to discuss were confidential in the commercial sense... and that they could not discuss them with us... They put up with me, but every now and again they would say, 'Sorry, we cannot share that with you'."

Nor was the information always accurate. A memo from the committee ta September 1988 revealed: "The computer list shows 33 product licences extant for preparations of bovine origin." The memo categorically asserted: "There are no licensed products derived from bovine brain." At the recent inquiry Sir Donald Acheson was asked: Q: Would you have been concerned if there were licensed products from bovine brain? A: Surely. Q: I want you to look at an extract from the MCA questionnaire summary... One of the items is under a company number - we have 01234, because it is not right that the company should be identified here. Company name, a large company. The product name is drug X. Animal specification is bovine and the animal ingredients include calf brain. Do you see that? A: I do. Q: If you had known about that at the time, would that have caused you concern? A: It certainly would, unquestionably, which I did not.

After some delay the Committee on Safety of Medicines guidelines ensured that the drug companies got their bovine materials from "healthy herds" in Australia and New Zealand. But what happened to all those vaccines with bovine material from unhealthy British herds, which were stored up sometimes five years in advance? On 31 October 1990, the committee's BSE working group minutes recorded:

"VACCINE STOCKS. Dr David Taylor declared a non.specific non personal interest in (company name deleted) and took part in the discussion. Dr Richard Kimberlin declared a specific personal interest and did not participate in the discussion but remained at the meeting.

"The working group considered that the secretariat should explore with the company the possibility that the unabsorbed vaccines which had limited usage should be replaced with batches using bovine materials which complied with the guidelines, especially where the stock.out date extended beyond 1991. There may be some commercial loss to the licence holder but it is unlikely to be very large." A list of the relevant vaccines was attached.

What happened then? What happened to the stored vaccines which, if injected into people, might carry the danger of infection? No one seems to know. The former Tory ministers who gave evidence to the Phillips inquiry didn't know. Asked about vaccines, they responded as follows. Witliam Waldegrave: "I do not remember that as an issue." John Macgregor I cannot remember frankly..." Tony Newton I do not think I am in a position to help you Edwina Currie: "I have not refreshed my memory.. Had the experts said: 'We feel the vaccines being bulk up are not entirely free of risk, we are therefore going to recommend that they be destroyed and that replacement stocks are acquired, and that this may delay the onset of the (immunisation) campaign for two weeks', we would have said 'fine'." Kenneth Clarke, who was secretary of state for health from 1988 to 1990: "What one clearly got from all this was that they were advising us that we should continue wtth vaccine components and so on and the risk was so remote that [it] would not justify stopping it. I still believe that advice to have been correct."

The Eye asked the BSE inquiry, which has heard 300 witnesses, what information has come to light which reveals what happened to the stocks of vaccines with bovine serum from British cows manufactured before the BSE scare broke. A spokeswoman replied: "We have no information which can answer any of those questions."

The Eye put the same questions to the department of health. "We outsourced the supplies of bovine material for vaccines away from Britain very early," said a spokeswoman. In reply to the question "when were the old stocks replaced?", the department sent a 16 page calendar of events, which reveals: As late as July 1992: "The Group's previous concern about vaccine stocks in relation to a specific company [unnamed] were resolved by the company concerned producing a new batch with New Zealand foetal calf serum of assured quality." Not until November 1996: "All currently licensed vaccines complied with the guidelines and did not contain any UK-sourced bovine material."

Neither item, nor any other in the 16 pages, answered the question.

Life-saving immune globulin in short supply

Health News for March 4, 1999  Reuters Health
SOURCE: Morbidity and Mortality Weekly Report 1999;48:159-162.
NEW YORK -- The US is experiencing a shortage of immune globulin intravenous (IGIV), a life-saving product that protects people with weakened immune systems from infections. A 1998 survey of doctors treating immune-deficient patients revealed that 86% had difficulty obtaining the product.

The Food and Drug Administration (FDA) estimated a 20% shortage of IGIV in 1997 and a 30% shortage in 1998 in the US, according to a report from the Centers for Disease Control and Prevention. In an effort to conserve the drug for those who need it most, doctors should only give the drug to patients with the six ailments for which the drug is FDA-approved, according to the report in the March 5th issue of the Morbidity and Mortality Weekly Report.

Those ailments include primary immunodeficiencies, immune-mediated thrombocytopenia, Kawasaki syndrome, recent bone marrow transplant in adults, chronic B-cell lymphocytic leukemia, and pediatric HIV infection.

"FDA is using several methods to improve IGIV distribution to patients, such as evaluating products manufactured in Europe for possible use in the United States, encouraging manufacturers to set aside emergency supplies of IGIV, continuing to monitor IGIV supplies and distribution, and shortening the lot- release time for IGIV," according to the report.

The pharmaceutical companies that produce IGIV say the shortage is largely due to new safety requirements from the FDA that complicate the manufacture of the blood plasma-derived product. However other issues, including the withdrawal of product lots related to the potential risk of Creutzfeldt-Jakob disease and drug export also contributed to the shortage.

EU says unlikely to open beef market by deadline

Reuters Business Report Tue, Mar 9, 1999
WASHINGTON - The European Union is unlikely to meet a May 13 deadline to open its market to hormone-treated beef, but is prepared to discuss temporary compensation for the United States, an EU aide said Tuesday.

"The deadline of 13 May is going to be difficult, if not impossible for us to meet," EU Ambassador to the United States Hugo Paemen told reporters after a meeting with farm-state senators. "We want to live up to the rules, so we are ready to discuss compensation." EU says unlikely to open beef market

Such compensation would be provided until there is an "end solution, which we think will probably have to be based on labeling," Paemen said. "We think the consumers should be free to make a decision whether they want to eat hormone-treated beef," he said.

The United States has proposed labeling as a way to end the EU's decade-old ban on imports of beef produced from cattle injected with artificial growth hormones. But after talks with the EU last week, U.S. trade officials expressed concern that the EU beef market would not be open by the deadline and hinted that they could soon take steps toward retaliation.

The United States followed a similar course in a dispute over bananas, and last week notified importers that they would have to post bonds to cover pending 100-percent duties on $520 million worth of EU goods targeted for retaliation. In the meantime, talks on the "substance" of the banana dispute have continued with more meetings likely in the next several days, Paemen said.

At issue in the banana dispute are EU banana import rules which the United States says unfairly favor producers from the Caribbean over those from Latin America. A WTO panel will rule on the legality of the EU's newest import regime in April and the EU has said it would comply with the results of that ruling. In the meantime, "it's worthwhile to continue talking" about a negotiated settlement that would address the needs of Caribbean nations, several of which depend on bananas for 60 to 70 percent of the export income, Paemen said.

New mad cow case takes French total to 56

Reuters World Report Mon, Mar 8, 1999 
PARIS - A new case of mad cow disease has been discovered in France, bringing to seven the number of cattle found suffering from bovine spongiform encephalopathy (BSE) this year, the Agriculture Ministry said on Monday.

The case was the 56th to be detected in France -- which has a total cattle herd of 21 million -- since health authorities began tracking the disease in 1990, it said in a statement. The animal in question was born in April 1993 in Sarthe. The 41-strong herd it belonged to was destroyed at the weekend.

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