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Bovine Material
12.25 pm
Mr. Norman Baker (Lewes): I congratulate you, Mr. Deputy Speaker, on your filibustering for a few moments, which was entirely appropriate.
The title of our debate seems as dull as ditchwater, but we are debating an important issue. I gave the Minister advance copies of my questions, which I hope she found helpful when preparing her response.
People often imagine that the risk of contracting Creutzfeldt-Jakob disease from BSE-infected cows comes from food. I contend that that threat has been overplayed and that the risk from other means of transmission, especially through vaccines, has been significantly and worryingly underplayed. In an answer to a parliamentary question on 8 March this year, the Minister said that the Spongiform Encephalopathy Advisory Committee
- has stated that "BSE and vCJD were caused by a closely similar prion strain, and concluded that vCJD was an acquired prion disease caused by exposure to BSE or BSE like agent."--[Official Report, 9 March 2000; Vol. 345, c. 787W.]
As of 31 January this year, according to information to be published by the House of Commons Library on 3 April, we know that 52 people have either definitely or probably died of variant CJD.
The right hon. Member for Birmingham, Perry Barr (Mr. Rooker), when a Minister at the Ministry of Agriculture, Fisheries and Food, responded to a written question in March 1999, stating:
- There is no scientific proof that BSE can be transmitted to man by beef, but this is seen by SEAC as the most likely explanation, and all our control measures are based on the assumption that it is.--[Official Report, 9 March 1999; Vol. 327, c. 186W.]
I have a lot of time for the right hon. Gentleman, but those words strike me as worrying. It is not the most likely explanation according to the proper hierarchy of risk, so the policy was based on an entirely erroneous assumption.
Eating beef is regarded as posing the least possible risk, yet the current Government and the previous Government adopted a raft of measures to minimise that risk, and no one quarrels about that. The Bovine Spongiform Encephalopathy (No. 2) Order 1988 banned the use of milk from an affected cow for anthing other than feeding its own calf. The Bovine Offals (Prohibition) Regulations 1989 banned the use of specified bovine offals for human consumption. In 1990, the Ministry of Agriculture, Fisheries and Food issued guidance stating that head meat must be recovered from the intact skull before the brain is removed. The Bovine Offal (Prohibition) (Amendment) Order 1992 prohibited the use of head meat after the skull was opened. I could list other measures that Governments have taken to ensure that the human food chain is as safe as it can be. I do not criticise those measures; they were right to play safe.
However, we must contrast that Government action with the measures that were taken on vaccines which, in terms of the Government's hierarchy of risk, are more likely to transmit BSE than oral ingestion. The right hon. Member for Perry Barr was wrong to say that that is the most likely method of transmission. That is not what is stated in the Minister's hierarchy of risk, which appeared in Hansard early this month. It is nothing new: in 1988, an under secretary at the Ministry of Agriculture, Fisheries and Food, Alistair Cruikshank, said:
- There is probably no risk in drinking milk or eating flesh from animals affected by BSE, but the position is much less clear in relation to brains, spleen and other organs. This raised questions about the safety of human vaccines prepared using bovine material.
There has been a question mark about the matter for 12 years.
- The highest risk would be from parenterals prepared from brain.
The Southwood report in February 1989 stated:
The greatest risk in theory would be from parenteral injection of material derived from bovine brain or lymphoid tissue. Medicinal products for injection or surgical implantation which are prepared from bovine tissues. . . . might also be capable of transmitting infectious agents.
That view has not changed; on 21 July 1999, four scientists involved in the production of the Southwood report were interviewed by the BSE inquiry. Sir Richard Southwood was asked if it was his view, at the time, that
the degree of hazard from medicinal products was greater than the degree of hazard that applied in the case of oral ingestion--
a key question, to which he 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.
There is no doubt that the advice from the experts from MAFF and the Department of Health and Sir Richard Southwood himself in 1988-89 was that there was a risk from vaccines using bovine material.
I thank the Minister for her detailed letter dated 14 December 1999, which included statistics. She said:
- The vaccines in use at that time--
between 1989 and 1992--
which used bovine material in the early stages of manufacture and as a medium for cell growth were DTP (diphtheria/tetanus/pertussis), BCG, oral polio and measles vaccines.
The Minister continued helpfully to list the millions of vaccines used during that period when it could not be clear that the vaccines did not include bovine material from cows suffering from BSE. The primary courses of vaccine for diphtheria from 1989 to 1991-92 totalled 2.18 million; they included doses given to 2.11 million children aged 2 or under. The reinforcement doses for diphtheria in the same period were 1.72 million, including 132,000 given to children under the age of 4. Primary courses for tetanus cases for 1989 to 1992 were 2.33 million, of which 2.1 million were given to children aged 2 or under. Then the number goes down. I will not read all the figures but in each case, millions of people, predominantly children, were given vaccines containing bovine material from the United Kingdom herd at a time when the herd included cows suffering from BSE.
- It is not known how many vaccines used UK sourced bovine material during this period in the early stages of manufacture and as a medium for cell growth.
It appears that, at the time, insufficient attention was paid to that and that insufficient steps were taken to monitor what was happening. That is most worrying. It is incumbent on the Minister to give us as much information as possible when she replies to the debate, because parents whose children were vaccinated at that time want answers. I do not want to be thought to be scaremongering. Officials have used the word "remote" and I want my concern to be put in context. Important questions remain unanswered and I hope that the hon. Lady will answer them.
- Bovine material prohibited from use in the human food chain is not prohibited from use in the manufacture of medicinal products, including vaccines--Official Report, 25 March 1999; Vol. 328, c. 378.
It appears that, although guidelines may have been issued, there has been no formal ban. Yet SEAC has stated on the Ministry of Agriculture, Fisheries and Food website:
From 1993, these control ["measures . . . to remove from the human food chain any tissues which might potentially harbour infection"]--have also been applied to animal feed, and from 1997, to cosmetic, pharmaceutical and medical products.
So is a ban in place, or not? Perhaps the Minister will clarify that.
In September 1989, the following products had been identified in order of concern. This information, which I will read to the Committee, comes from the Department of Health's internal BSE inquiry document, so the Minister may recognise it. It states:
- products with bovine brain/lymphoid tissue as ingredients and administered by injection: 111;
products with bovine ingredients (other than brain/lymphoid tissue) and administered by injection: 135;
tissue implants, open wound dressings, surgical materials, dental and ophthalmic products with bovine ingredients: 27;
products with bovine ingredients and administered topically: 5;
products with other animal/insect/bird ingredients: 131,
products with materials produced from animal material by chemical processes (e.g. Stearic acid, gelatin and lanolin: 156.
In March 1989 the Committee on Safety of Medicines used guidelines advising manufacturing companies to switch to non-UK-sourced bovine material. That was confirmed in colums 246-47 of Hansard on 19 October
1999. However, on 23 June 1999 the then Minister for Public Health, the right hon. Member for Dulwich and West Norwood (Ms Jowell), said:
- The precautionary measures introduced in 1989 and subsequent amendments to them did not require manufacturers to prevent the use of existing supplies of medicinal products which had used bovine material in their early stage of manufacture. Neither did the later guidelines issued by the European Commission in 1992.--[Official Report, 23 June 1999; Vol. 333, c. 382W.]
There is either a risk or there is not. If the Department thought that there was a risk, why were the products not recalled? If there was not a risk, why were guidelines issued? The middle path seems somewhat odd. Why did the Department of Health merely issue guidelines for vaccines, when the Ministry of Agriculture, Fisheries and Food had banned potentially contaminated food?
- The exercise to ensure that all manufacturers were complying with the guidelines--
the 1989 guidelines--
was not completed until 1992.
Three years passed. Why did it take three years to confirm that all manufacturers were using non-UK bovine material in their vaccines, when millions of children were vaccinated during that time? Why were stockpiles not cleared straight away and replaced with alternative sources from elsewhere in the world? According to Hansard of 19 October 1999, only by 1999 were all vaccines in use manufactured without UK-sourced bovine material.
We know little about the potential danger. We know that there is a real danger and we also know from the chief medical officer that it could take 30 to 40 years to prove. Therefore, although it may be an historic problem for the Department of Health, it is a future problem for the children who may be vaccinated in this way.
I asked the Secretary of State for Health:
- what estimate he has made of the quantity of vaccines held by manufacturers in whose early stages of manufacture bovine material had been used. [Official Report, 1 July 1999; Vol. 334, c. 280W.]
The one-word answer was "None". I find it extraordinary that the Department of Health could not have made that estimate then, given the problems that occurred. I have concentrated on vaccines, but I could equally have referred to allergen products, dental and surgical material, bovine insulin and indeed cosmetics, which I know fall outside the Minister's brief, but which contain bovine material.
Giving evidence, Sir Anthony Epstein said that no action was taken
- on purpose because the consequences for the vaccination programme, for the use of medicines, would have been quite disastrous.
I suggest that the Department of Health calculated that if it came clean about vaccines, as the Ministry of Agriculture, Fisheries and Food had about beef, there would have been a loss of confidence in the vaccination programme. It therefore decided not to come clean, but to take a risk in order to maintain confidence in the vaccination programme.
12.45 pm
The Minister for Public Health (Yvette Cooper ): I shall try to answer as many as possible of the questions that were asked by the hon. Member for Lewes (Mr. Baker), and I thank him for having made me aware of some of them in advance. He raised some additional points to which I cannot respond now, but I shall follow them up in writing.
I congratulate the hon. Gentleman on initiating a debate on a very important subject. I know that it has been a matter of considerable concern to him, and that over the past few months he has asked several parliamentary questions about it. I welcome this opportunity to respond to some of his worries and to set out clearly the actions that have been taken in respect of the use of bovine material in non-food products since concerns were first raised about the potential for risk to human health from bovine spongiform encephalopathies, or BSE.
As the hon. Gentleman will be aware, the events between 1989 and 1993 to which he has referred took place under previous Governments. Nevertheless, I shall give as much information as I can. I take this opportunity to express the Government's concern about the distress caused to sufferers of the truly appalling illness that we now know as variant CJD, and to the families of its victims.
I understand that the hon. Gentleman's primary concern is the potential risk to public health from the use of bovine material in vaccines and surgical cat gut sutures. I begin by reassuring hon. Members that there is currently no evidence to link the use of any medicinal product with variant CJD. Although bovine material is used in the manufacture of some medicines and, indeed, in the manufacture of some vaccines, it is important to note that the bovine material is not an ingredient of any vaccine, but is merely used in the manufacturing process.
I am advised that general manufacturers of medicinal
products, including vaccines, avoid the use of animal sourced materials wherever possible. In the case of vaccines, bovine materials are used only to promote the growth of cells, viruses or bacteria during manufacture. Subsequent purification is designed to remove all materials that are associated with the manufacture but are not required in the final product. The manufacturers provide validation of those processes to the Medicines Control Agency.Since 1989, bovine materials used in the manufacture of medicines have been subject to extremely rigorous guidelines that govern the geographical source of the material, the type of tissue used and the processes to which such material must be subjected to minimise any risk that it may represent. Those guidelines were first developed in the UK by the Government's independent scientific advisory committee, the Comittee on Safety of Medicines--the CSM--together with the Veterinary Products Committee, because the guidelines apply equally to veterinary medicines.
In 1988, when concerns were first raised about BSE, the CSM established a group of experts to consider the implications for the use of bovine materials in the manufacture of medicines--the BSE working party of the CSM. In March 1989, the CSM published guidelines for the pharmaceutical industry on the sourcing and processing of animal tissues, based on the sub-group's findings. Those guidelines addressed the geographical sourcing of the material to be used and assesssed the potential risk from the use of certain animal tissues; it recommended processing practices to minimise the risk from the use of bovine materials.
When the guidelines were issued to industry, manufacturers of new medicinal products were expected to comply with them immediately, and manufacturers of existing products were asked how they intended to comply with them. I am advised that many manufacturers reported that they had already stopped sourcing material from the United Kingdom because of their concern about reports of illness in UK cattle.
That action was taken as a precautionary measure; the risk to public health from the use of bovine material in medicinal products was assessed by the scientific experts of the Southwood committee to be remote and theoretical. A decision was taken that existing supplies of medicines, including vaccines, should not be withdrawn from the market, because there was concern that withdrawal of such supplies without suitable alternatives being provided would result in a serious risk to public health. In the case of vaccines, there was particular concern that withdrawal could lead to a real risk of deaths caused by epidemics of the diseases that the vaccine programmes were intended to address, such as diphtheria, pertussis and whooping cough.
The Medicines Control Agency, which came into existence in April 1989 and replaced the medicines division of the Department of Health, followed up all manufacturers who had reported the use of animal material in the manufacture of medicines until they were able to report that they complied fully with the CSM guidelines. Priority was given in that exercise to vaccine manufacturers. I am advised that all vaccine manufacturers were contacted in 1989 and that they
decided immediately to source their bovine materials outside the United Kingdom to comply with the guidelines.In 1992, the European committee of independent scientific experts--the committee for proprietary medicinal products--issued its own guidelines to the pharmaceutical industry based almost wholly on those that had been developed some three years previously in the United Kingdom. Those guidelines, with amendments made in the light of new scientific knowledge, are still in force today. The hon. Gentleman asked about bans and I am advised by the MCA that it enforces the guidelines and that it will not license products that do not comply with the guidelines.
The hon. Gentleman expressed specific concern about vaccines that remained on the market after the original guidelines had been issued by the CSM in 1989, and he asked how long they might have remained in use. Many manufacturers of medicinal products were already sourcing bovine materials outside the United Kingdom when the guidelines were issued. I am advised that many of the childhood vaccines used in the United Kingdom were manufactured abroad and did not use bovine material sourced in the United Kingdom. Wellcome, the monopoly manufacturer of DTP childhood vaccines, had used foetal calf serum and meat sourced in the United Kingdom, but by February 1989 it had identified a source of materials in New Zealand, so all vaccines manufactured by Wellcome after 1989 used bovine material from New Zealand.
The manufacture of vaccines is complex and takes many months. Material that was manufactured before 1989 continued to be used so that the vaccination programme would not be compromised. DTP vaccine was issued by Wellcome until June 1991, when stock ran out. Single component diphtheria and tetanus vaccines continued to be supplied until December 1991. I am advised by the MCA that expiry of the DTP vaccine occurred in November 1993, so, although most of it would have been used in 1991, it is possible that small quantities may have remained in doctors' surgeries and been used up to the expiry date.
In 1989, vaccines were issued directly by the manufacturers, not bought centrally by the Department of Health, as happens now. Therefore, there are no figures available on vaccine usage for that period. The MCA has assured me that from April 1989, no bovine material sourced in the United Kingdom was introduced as an element of the manufacturing process for vaccines produced at the time.
One aspect that has not been considered previously is the issue of cell lines, some dating back to the 1960s, from which some viral vaccines are produced. For completeness, I have asked the CSM to examine whether there are any BSE-related issues in this area. To provide the hon. Gentleman with the fullest information about the vaccines, it is important to give him the information I received from the MCA. The expiry date for the diphtheria vaccine produced by Wellcome was November 1992, whereas that for the tetanus vaccine was December 1993. The expiry date for the diphtheria tetanus absorbed vaccine was June 1993, and the DTP vaccine expiry date was November 1993. As I said,
many of the vaccines will have been used before the expiry dates, but those are the last expiry dates that I have been given.
Mr. Baker : Does that mean that no vaccines were recalled after the identification of the risk?
Yvette Cooper : I shall write to the hon. Gentleman on that issue, because one of the vaccines may have been replaced. As I understand it, the vaccines that were manufacturered before 1989 were still in use until the latest date that they could legally be used--the expiry dates that I have given.
I should like to explain in more detail how the risk to human health from medicines, especially vaccines, was assessed, and how and why that was translated into action. I pointed out that Professor Southwood's report identified medicines manufacture as one of a number of uses of bovine material. Although the scientists concluded that the risk to man from bovine materials in medicines was remote and theoretical, they also concluded that parenteral products such as vaccines were, by the nature of their application, likely to present the highest risk. We must also remember that, at that time and until 1996, no action was taken against UK beef and beef products, such as those in the food chain.
When considering what action to take, the CSM addressed the question of whether current supplies of medicines, especially vaccines, should be withdrawn. In the light of the assessment of the risk as remote and theoretical, and the fact that the proposed action was regarded as a precaution rather than a response to an identified risk, I am advised that they conclude on the basis of knowledge at the time that it would not be appropriate to withdraw vaccine supplies. There was concern about the risk of emerging epidemics if the public turned away from vaccination programmes. Because of the minimal risk that it was thought that such vaccines represented, there were no plans to monitor usage of existing stocks, or to contact individuals who have received vaccinations.
Even in 1989, however, there was an understanding that there was likely to be a hierarchy of risk. The guidelines identified those materials thought to pose the greatest potential risk. The hon. Member for Lewes is concerned about people who were vaccinated during the transition period--if it can be described as such--when the change to sourcing materials from outside the UK was taking place. As I pointed out, there was and still is no evidence to link variant CJD with medicines or vaccines.
It is not possible to identify for follow-up purposes those who received vaccine during that time. However, we can examine the vaccine exposure of existing variant CJD cases. That has been done by experts from the BSE unit, the National Institute for Biological Standards and Control and the Department of Health. Their conclusions stated:
- if CJD is the result of exposure to BSE cattle infected material, the vaccines given before the age of 2 appear to have no role in its aetiology to date.
Forty-nine of the 52 cases of variant CJD are in people who were born before 1980 and who would, therefore, have received the vaccines before exposure was possible. The remaining three were born in the 1980s, but, given the long period between starting manufacture from the raw materials and the completion of the finished product, exposure seems unlikely. That analysis will be repeated.
I should like to address the concern about surgical cat gut sutures, although I do not have much time. Like vaccines, surgical sutures are essential products from which the health of millions of people has benefited. Absorbable surgical materials such as cat gut were brought under the controls of the Medicines Act 1971. Given the pressure of time, I shall write to the hon. Gentleman on that subject.
- It being One o'clock, the motion for the Adjournment of the sitting lapsed, without Question put.
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