VACCINE AND NOT HEARD  Paul Foot, Private Eye 19 Feb, 1999

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 [eg 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 in September 1988 revealed: "The computer list show's 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 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 n 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: William 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 built 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 with 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.

Vaccine to be done? (Private Eye, Aug 1999)

The sensitive and unresolved issue of the possible contamination of vaccines by bovine products affected by BSE (see Eye 970) came up again at the Phillips inquiry into BSE on July 21.

Four of the country’s top scientists, the members of the Southwood inquiry into BSE in the late l980s, gave evidence. They were Sir Richard Southwood, Professor of Zoology and Pro Vice Chancellor at Oxford University; Lord Walton, a world-famous clinical neurogist and former president of the General Medical Council; Sir Anthony Epstein, a former head of the department of pathology at Bristol and Dr A.W. Martin, a distinguished vet who had just retired as director of the Moredun research institute in Edinburgh. All four were given a torrid time by the counsel to the inquiry, Paul Walker, on the subject of the vaccines.

He wanted to know whether the Southwood committee report had given a "misleading picture" of the dangers to humans from widely-used vaccines, almost all of which contained bovine material, much of it from cattle infected by BSE. The committee had described such dangers as ‘remote" — exactly the same adjective they had used to describe the dangers of people catching BSEor associated diseases from eating BSE-infected meat. Close questioning of the scientists revealed that all four of them had regarded the dangers of human contamination by BSE-infected vaccines as, er, anything but remote.

Mr Walker asked Sir Richard Southwood: "In your view, at the time, the degree of hazard from medicinal products was greater than the degree of hazard that applied in the case of oral ingestion?"

Sir Richard replied: "Yes". Later, he told the inquiry: "We really thought the medical problem was severe... We were very conscious, all the way through, of the worry about the vaccination programme. And these were very real deaths. One hundred and seventy deaths had been estimated by the Chief Mcdical Officer."

If vaccination with BSE-infected vaccines was much more dangerous than eating BSE-infected meat, why did the Southwood committee describe the risk from both with the same reassuring adjective — "remote"? All four scientists were asked this question and all four wriggled with their replies. Sir Anthony Epstein explained: "The seemingly reassuring — I do not accept that it was — use of the word ‘remote’ was done on purpose because the consequences for the vaccination programme, for the use of medicines, would have been really quite disastrous if the public at large had been alarmed by this... it could have had very serious consequences for public health."

So the committee watered down their published warnings about vaccines. But all four scientists went on to argue with some passion that although their report had appeared to be mild on the subject, they had made every conceivable effort to alert the Department of Health and its relevant agencies to the dangers of BSE in vaccines. All four said they were satisfied that their anxious if private warnings about vaccines would lead to "appropriate action" from the Department of Health.

So what action was taken? The Department issued a statement which emphasised the dangers to the vaccination programme from any public panic about BSE and blandly reiterated the view of the Southwood Committee that the risk of infection from medicinal products was "remote".

Fastening on that magic word "remote", the ministry gave the vaccines the all-clear. There was no need, officials concluded, for pharmaceutical companies to take any steps whatever to insure against the possibility of contaminated vaccines. So the Department of Health and its Committee on Safety of Medicines coolly junked the Southwood committee’s anxious, if unpublished, warnings about the dangers of BSE-infected vaccines.

To this day, no one knows what action was taken to dispose of the five years of stocks of vaccines which had been piled up to initiate the vaccination programme. No one knows whether any of those vaccines compiled before the BSE ban were used on unsuspecting patients, or whether any of the deaths from CJD - a killer disease associated with BSE - can be ascribed to such vaccinations.

 

Risk of BSE in vaccines revealed

Jonathon Carr-Brown
Political Reporter



FOUR of Britain's most senior scientists downplayed the potential risk of the transmission of BSE to humans through vaccines to prevent a serious  health scare.
        They insist that the secret warnings they gave to medical experts to make vaccines from materials that came from non-BSE-infected cattle were not fully implemented.
        New evidence given to Lord Phillips's BSE inquiry reveals that the BSE working group, set up in 1989 by Margaret Thatcher and led by Sir Richard Southwood, believed the risk of transfer through vaccines was "relatively high", not "remote" as its final report claimed. The route by which BSE transfers to humans in the form of new-variant CJD is unknown. There is a possibility that one agent could be the thousands of vaccines used until 1993 that were made out of material likely to have come from infected cattle. The vaccines were used to treat diseases such as measles, rubella and tetanus. In 1989, when knowledge of BSE was negligible, the Southwood re-port proved pivotal in the way other bodies overseeing medical products assessed the risk to the public. In particular, the Committee on Safety of Medicines cited the report when it decided not to destroy thousands of stockpiled vaccines made or cultured using bovine materials.  It calculated that a vaccine health scare could lead to the almost guaranteed death of 170 unvaccinated people, which had to be set against the "remote" risk of anyone contracting CJD through a vaccine. But in a twist to the inquiry, Southwood, professor of zoology at Oxford University, and his former colleagues - Lord Walton, a leading clinical neurologist; Sir Anthony Epstein, a former head of the department of pathology at Bristol University; and Dr William Martin, a distinguished veterinarian - were recalled by Phillips to explain why their report "presented a misleading picture of the working party's views".   Southwood admitted his inquiry did not regard the risk as remote, but "relatively high". Asked if he thought the risk from vaccines was greater than the risk of being infected after eating beef, Southwood replied: "Yes." Yesterday Epstein defended the approach the Southwood inquiry took. "Those authorities were consulted in no uncertain terms," he said. "If they choose to disregard all of the warnings they received and hide behind the word 'remote' what can we do?"

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