Plenary, 06 Feb 2003

Meeting date: Thursday, February 6, 2003

Official Report 697KB pdf

---

Vaccines (Thimerosal)

The final item of business is a members' business debate on motion S1M-3765, in the name of Nicola Sturgeon, on the removal from vaccines of thimerosal—no doubt we will hear a range of different pronunciations of that word as the debate proceeds.

Motion debated,

That the Parliament notes with concern that thirteen vaccines currently available in the United Kingdom, including four that are administered to children, contain thimerosal, a compound 50% comprised of ethyl mercury and already banned in the United States of America; further notes the fears of a link between thimerosal and conditions such as autism and Alzheimer's disease, and considers that the Scottish Executive should take steps to eradicate thimerosal from vaccines available in Scotland and, in the meantime, inform the public about the availability of vaccines that do not contain thimerosal.

There are indeed two pronunciations of the word, Presiding Officer. I will stick to "thimerosal", with the stress on the second syllable.

I am grateful for the opportunity to debate the issue, which has received considerable attention in the past few weeks, particularly through some excellent reporting in The Scotsman. If my mailbag is anything to go by, the matter is a cause of concern to many members of the public, particularly parents of young children.

As we all know, vaccines save lives. I make it clear at the outset that the debate is not an anti-vaccine one; it is about what goes into vaccines. I will not try to give conclusive proof that there is a link between thimerosal and conditions such as autism. Many people believe that there is such a link, but I am not a scientist and I do not know whether such a link exists. However, what I have heard and read gives me great cause for concern.

The presence of thimerosal in vaccines, especially child vaccines, is a risk that we do not have to and should not take. Thimerosal is not an essential component in vaccines, but is used as a preservative to kill bacteria and to prolong shelf life. Thimerosal is 50 per cent ethyl mercury. After plutonium, mercury is the most toxic element in the world. We know from studies with animals that ethyl mercury—the substance that thimerosal breaks down into when it is injected into the body—binds with body protein and brain tissue. Once mercury traces are in the body, they are difficult to remove.

According to the United Kingdom medicines information service, the substance is present in 13 vaccines that are available in the UK. The list includes four of the seven available flu vaccines and, most worrying, the DTP vaccine that is given to babies from the age of eight weeks to protect against diphtheria, tetanus and whole-cell pertussis. Every baby receives three doses of the vaccine in the first 16 weeks of life, with each dose containing 25 micrograms of ethyl mercury. Therefore, in the first 16 weeks of a child's life, when the nervous and immune systems are extremely fragile, the child is injected with 75 micrograms of ethyl mercury.

Is that safe? No doubt the minister will cite the views of the Committee on Safety of Medicines, the World Health Organisation, the Joint Committee on Vaccination and Immunisation and others that that level of thimerosal causes no harm. However, I hope that the minister also points out that no major studies have been carried out to demonstrate proper safety limits for exposure to ethyl mercury and that many individuals and organisations express contrary views.

The United States Institute of Medicine stated in a recent report that current scientific evidence neither proves nor disproves a link between thimerosal and neurodevelopmental disorders in children. However, it went on to say that such a link is "biologically plausible" and recommended that thimerosal be removed from vaccines that are administered to infants, children and pregnant women.

The UK medicines information service said that

"The very low thiomersal concentrations present in the pharmacological and biological products are relatively non-toxic in adults",

but

"may be toxic in utero and during the first six months of life."

At question time two weeks ago, the Minister for Health and Community Care said that that statement had been withdrawn from the organisation's website. That is true, but what I—and many parents throughout Scotland—want to know is whether the MIS's statement was true. Parents who are expected to have their children injected with the vaccine have a right to know whether it is toxic. I hope that the deputy minister will answer that question in his comments.

In an internal document that was obtained by The Scotsman, the manufacturer of thimerosal, Eli Lilly, says:

"mercury causes mild to severe mental retardation and motor co-ordination impairment. This chemical contains a property known to the state of California to cause birth defects and other reproductive harm."

Thimerosal has not been used in child vaccines in the US since 1999 and it is no longer used in many other countries. That is a clear indication of the level of concern that exists.

As a result of decisions that are made in London, not in Scotland, the United Kingdom is now the only country in the developed world that has not switched to thimerosal-free vaccines for routine infant immunisations. Unless the minister is willing to state to parents all over the country that thimerosal is safe—and I wait to hear whether the minister will use the word "safe" about the compound—the UK's position must change. There is a chance that thimerosal poses a risk to the health of our children. That is a risk that we should not be taking and, as I said, it is a risk that we do not have to take. Thimerosal does not need to be contained in vaccines.

I am asking the Scottish Executive to do two things. First, it should take steps to inform patients that there is an alternative to the thimerosal-containing DTP vaccine and that they have a right to request it for their children. A mercury-free vaccine called Infanrix is licensed in this country. It costs about £7 more per injection than the thimerosal-containing DTP vaccine, but that is surely a price worth paying to avoid the risk of exposing children to neurological damage.

Malcolm Chisholm said in the chamber two weeks ago that parents have the right to choose. However, what good is that right if most parents do not know that they have it and if most are not aware that an alternative to the routinely used vaccine exists? Information is power; parents should be furnished with the facts to enable them to make informed choices for their children. In the case of the measles, mumps and rubella vaccine—which does not contain thimerosal—we have seen the damage that can be done to public confidence when concerns mount and choice is denied.

Secondly, the Scottish Executive must take steps to eliminate the risk. We should follow the lead of other countries and ensure that all vaccines—especially those that are administered to children—are thimerosal free. Thimerosal is not required in vaccines and it should not be permitted. The Scottish Executive has said that the use of thimerosal in vaccines is being phased out. That, in itself, is an admission—or at least an acknowledgement—of the fact that thimerosal may not be safe. I hope that, tonight, the minister will go further and set out the Scottish Executive's clear intention in a defined time scale to rid all child vaccines that are available in Scotland of thimerosal and mercury, in the interests of child safety.

I associate myself with Nicola Sturgeon's remarks and support entirely what she has said. The accumulation of mercury and heavy metals in our children—both from the environment and from vaccinations—is a problem that is being addressed in nearly every developed country, as Nicola Sturgeon said. However, the problem is not being addressed directly in this country. Using a mercury derivative as a preservative, effectively to extend the shelf life of a product, may well have its benefits for the manufacturer and for central Government, which buys and stocks the vaccination, but that can hardly be cited as justification for using a poisonous substance on children and pregnant mothers.

In the United States, the immunisation safety review committee of the Institute of Medicine concluded that there is inadequate acceptable evidence to establish a causal relationship between thimerosal exposure through child vaccines and the neurodevelopmental disorders of autism. However, in the same paper, the committee made recommendations, which have been acted on, to reduce and effectively remove thimerosal from all child vaccines.

As Nicola Sturgeon said, the debate should not be about whether using mercury as a preservative in vaccines causes specific disorders. The science is straightforward: mercury is a poison in the human body. Mercury in the human body at an early stage, particularly at the foetal stage, can be devastating to the development of the neural pathways, among many other things.

I speak on behalf of the cross-party group on autism and Asperger's and the many parents who have written to me. Those parents are now extremely scared, not of the MMR vaccine, but of the DTP vaccine, especially in light of the evidence that emerged in London in the case of the woman who was tried for, found guilty of and jailed for the death of her two children. We have now discovered that both those children, who had had the DTP vaccine, had high levels of a form of virus that is associated with cot death. One woman in this country has spent nearly two years in jail, gone through a trauma that has destroyed her family and has had to live with the accusation that she caused the death of her two children. Is the Executive prepared for similar cases to come to light, or shall we operate purely on the precautionary principle, as has been requested on many occasions? That approach is simple and has been followed in the United States and the rest of the developed world.

If we want to maintain herd immunity, we must not undermine faith in the vaccination programme by effectively giving people no choice. I urge the minister to tell us that we are moving to a time when choice will be available in all vaccines and that there will be an active campaign for the health service in Scotland to use only those vaccines that do not contain thimerosal for pregnant women and young children.

I thank Nicola Sturgeon for securing the debate and Fraser Nelson of The Scotsman for his thorough investigation of the issue, which has raised awareness and has led to many parliamentary questions and perhaps even to this debate.

As I follow Lloyd Quinan in the debate, I must say that, having been the Health and Community Care Committee's reporter on MMR, I was frightened when I read some of the detailed research on the vaccines containing thimerosal. The comparisons with MMR were not very welcome.

I am joined by my colleague Jamie McGrigor, an expectant father whose child will be born any day now. He sits here looking for advice on vaccinations.

I fully support an immunisation policy that treats parents and patients with respect by giving them the fullest information and choice possible for each vaccine. Thimerosal has been used in vaccines since the 1930s. What major studies have been carried out to demonstrate proper safety limits for exposure to ethyl mercury in small infants, who have received 75 micrograms of ethyl mercury by the 16th week of their lives? As thimerosal was taken out of all child vaccines in the United States and Australia in 1999, its use in the United Kingdom is shocking. We need answers on why it remains in UK vaccines.

Since the topic was first raised, I have asked several questions and have been told in ministerial responses that no research links thimerosal to Alzheimer's, that the regulation and control of vaccines is a reserved matter and that thimerosal is being removed from vaccines as a precautionary measure. Against what is that a precaution? I was told that many vaccines contain thimerosal, that four out of seven flu vaccines contain thimerosal and that the Department of Health states that flu vaccines should not be given during pregnancy, although, in the same reply, I was told that the vaccine does not affect the foetus. If it does not affect the developing foetus, what does it affect?

A reply from the Minister for Health and Community Care said:

"It is anticipated that thiomersal-free vaccines will be considered for provision in the routine childhood immunisation programme after they have been licensed for use in the UK and have demonstrated that they are as effective in protecting children against the real risk presented by vaccine-preventable diseases".—[Official Report, Written Answers, 24 January 2003; p 2844.]

In another answer, the minister said:

"manufacturers are required to ensure that the replacement or elimination of thimerosal does not affect the safety or efficacy of the final product."—[Official Report, Written Answers, 13 November 2002; p 2231.]

That answer also said, "This may take time". That reply was received in November last year, yet I understand that, as Nicola Sturgeon has said, the current DTP vaccine stocks in Scotland include the mercury-free vaccine. In fact, I believe that, out of 110,000 units of the vaccine, 30,000 are a mercury-free vaccine called Infanrix—I hope that I have pronounced that correctly.

Surely that vaccine would not be in stock if it was not fully tested for safety and effectiveness, so why can parents not be given the choice of mercury-free vaccines when they clearly exist? I further understand that one in four Scottish doctors is choosing mercury-free vaccines, so why not give everyone the choice? Parents need information. They need to know what to ask before making that choice. Reports also state that the mercury-free vaccine is 10 times less likely to have side effects, and children are vaccinated at two, three and four months. Surely parents have a right to all that information.

Parents should also be told the efficacy ratio of the mercury and mercury-free DTP vaccines. The current information needs to be updated because, as other members have said, we are almost the last developed country in the world with mercury in the DTP vaccine. Or is it the case that the whole vaccine policy is based on cost? The current mercury vaccine made in France costs £10.17. The mercury-free vaccine made in the UK costs £19. In a devolved health care system in Scotland, surely we can at least tell parents the efficacy ratio of vaccines, which vaccines may trigger side effects, which vaccines contain mercury and what choice is available for mercury-free vaccines. I ask the minister to agree to give patients the information that they need to make an informed choice on the basis of efficacy and potential side effects.

I congratulate Nicola Sturgeon on securing this debate, which is important for many of us with young children, and also for those who, like Jamie McGrigor, have pregnant partners and spouses. It is an issue not just for children but for pregnant women, who can also be adversely affected. In the United States of America, the Institute of Medicine urged that

"full consideration be given to removing thimerosal from any biological product to which infants, children, and pregnant women are exposed."

Pregnant women, it suggested, should be advised to take mercury-free flu jabs, but the only groups advised against the jab in the United Kingdom are people with heart disease or diabetes and people who are allergic to eggshells. Advising women away from mercury would acknowledge the fact that it does pose some kind of medical risk, however remote. That appears to be something that UK ministers—until now, at least—refuse to do.

The Scottish Parliament has the power to ban all mercury from vaccines, and it can do that now, as health is devolved. The vaccines are available and general practitioners have freedom to order what they want. Holyrood should set an example to ensure that we have better practice in this country.

There is a lot of medical evidence on the issue. One study suggests that it is hypersensitivity to thimerosal that triggers autism, and not specifically the mercury poisoning. There will be a study on mercury poisoning later this year, but it will be on Alzheimer's, not autism. Clearly, a lot more research must be done, but why should we take chances? In the United States, all routinely recommended licensed paediatric medicines that are currently manufactured contain no thimerosal or only trace amounts.

There are now two hepatitis B vaccines that are thimerosal free, four haemophilus influenzae type B—HIB—vaccines, and two DTP vaccines. Previously, the maximum cumulative exposure to mercury by routine childhood vaccinations during the first six months of life was 187.5 micrograms of mercury. The newly formulated vaccines allow a maximum cumulative exposure during the first six months of less than 3 micrograms, which is a 98 per cent reduction, and a huge and significant step in the right direction.

The issue has had a much higher profile in the United States than in this country. Indeed, there are now £30 million-worth of lawsuits being launched in the United States because of perceived cover-ups in recent years. The reason for that is that many people who suffer from illnesses such as fibromyalgia, lupus, depression and bipolar disorder directly link their illness to mercury. Clearly, the issue must be given greater focus.

We should err on the side of caution. If several vaccines are available to prevent a range of illnesses, surely we should do what the United States has done since 1999 and ban mercury, except very trace amounts if they are necessary. Of course, the US went even further. The House of Representatives formed a committee specifically to consider the danger of mercury in medicine. The US did that because a study came out of the Faroe Islands based on some 900 children born in 1987 whose mothers had eaten mercury-contaminated whale meat. It was discovered that the children had slow reaction times and diminished attention spans. Mercury is so toxic, as Nicola Sturgeon pointed out, that even if the amount of mercury in the umbilical cord was as low as 1 microgram per kilogram, it will still be enough to trigger a set of neurological conditions commonly associated with autism and other conditions.

I urge the minister to err on the side of caution, and think about the fact that the amount of mercury in a thermometer is enough to pollute an entire loch. For the sake of our children and pregnant women, let us ensure that our vaccines are mercury free.

On pronunciation, I shall take a different view just for the sheer devilment of it. I say thiomersal, and other members say thimerosal.

In this evening's debate, members have raised serious issues that require thoughtful responses. However, I should also place the matter in context by pointing out that certain vaccines are available for children, young children and babies to ensure that we address the difficult problem of whooping cough. In 1951, that disease took the lives of almost 100 young people; however, that number has been reduced to less than one death a year, thankfully. That substantial change has come about largely because of the vaccination programme that was established.

Members have also expressed concerns about the processes that the health department and the Scottish Executive follow in relation to vaccines. I want to explain those processes, because I am concerned that some of the coverage has either skated over, or deliberately misinterpreted the matter. Our advice is taken from the Committee on Safety of Medicines, the Joint Committee on Vaccination and Immunisation and, indeed, the World Health Organisation. I am reasonably content to take their guidance and to follow their judgments on many such issues, because they offer a level of expertise and knowledge that none of us here can aspire to.

Vaccines that contain thiomersal do have an impact; for example, they cause hypersensitivity reactions. Such reactions are a feature of most vaccination programmes, but the scale of the reaction in this case outweighs the vaccine's effectiveness in intervening to prevent whooping cough. It is a matter of record that the World Health Organisation's global advisory committee on vaccine safety has concluded that there is no evidence of toxicity in infants, children or adults who have been exposed to thiomersal in vaccines. I stress that expert advice makes it clear that the actual risks that are posed by vaccine-preventable diseases are significant compared with the theoretical risk from side effects of thiomersal. Some of the coverage has understated that in order to amplify some of the concerns about the impact of mercury in vaccines.

The motion notes that ethyl mercury is

"already banned in the United States of America".

That is not the case. In 1999, concern was expressed in the USA about exposure to mercury following immunisation, based on the realisation that the cumulative amount of mercury—the fact that it is the cumulative amount is important—in the US infant-immunisation schedule potentially exceeded the recommended threshold for methyl mercury. The cumulative amount of mercury that was used in the US infant-immunisation schedule was more than double the Scottish equivalent. That is why steps were taken to reduce the amount of mercury in the US infant-immunisation programme.

Thiomersal-containing vaccines are not banned in the United States. I will quote the most recent statement from the US Food and Drugs Administration's website:

"The FDA believes a recall of thimerosal-containing vaccines is not warranted because data show that these products are safe … The FDA does not believe that thimerosal-containing vaccines ‘present an imminent or substantial hazard to the public health' because available scientific data do not provide adequate evidence that exposure to thimerosal in vaccines can cause neurodevelopmental disorders."

That is an important statement in the context of some of the concerns that have been expressed during the debate and, in particular, in some newspaper coverage.

In discussing possible links with autism, we are dealing with a complex and sensitive area, and individuals suffering from autism and their families want to find explanations for the increase in autism during the past few years. Autism is a complex, debilitating and lifelong set of conditions that manifests itself in a variety of ways. The scientific evidence is clear. The Medical Research Council's review of autism research in December 2001 states:

"no evidence currently exists that proves a link between thiomersal-containing vaccines and autism, attention deficit-hyperactivity disorder, speech or language delays or other neuro-developmental disorders".

In short, no neuro-toxicity has been demonstrated as a result of the low level of thiomersal exposure from routine vaccination.

As a member of the Executive, I am concerned at the suggestion that we are in any way trying to conceal the facts. As recently as 14 January, the deputy chief medical officer issued a letter that included information for all health professionals to help them advise parents and patients on thiomersal in vaccines. It is at the heart of our policy to ensure that parents are given facts about vaccines in a dispassionate and accurate way, in order to enable them to make informed choices. A call has been made for that this evening, which I approve of.

That is related to the fact that the diphtheria, tetanus and whole-cell pertussis—DTwP—vaccine is recommended for babies at two, three and four months old. That recommendation is based on the best possible scientific and medical advice and on the fact that the vaccine provides much better protection than any other does. Cost is not a consideration—our decisions are based entirely on science and on what is best for our children.

As far as researching for the debate was concerned, it was very difficult to develop an awareness of the costs, as they have not featured in our consideration of the availability of vaccines. That reassured me with regard to questions that might have been asked, because it demonstrates that the principal assessment has been based on medical science and judgment, rather than on costs. That it was based on costs was a misconception that I wanted to lay to rest. I do not wish to underestimate the concerns, but it is important that people are informed.

On a Europe-wide strategy, we are—as a precautionary measure—seeking to phase out thiomersal-based vaccines over time. It is important that we remove mercury from vaccines. The Executive, the JCVI and the UK Medicines Control Agency endorse that recommendation, because it is sensible to reduce avoidable exposure to mercury over and above what would be consumed through food substances.

We are looking for a longer-term replacement, but we need to put that in the context of delivering, through research and through the development of medicines, equally effective protection against whooping cough. The primary objective of the vaccination programme is to prevent a return to the dark and deadly days of whooping cough in the late 1950s. That is why vaccine manufacturers are actively developing research programmes to eliminate, substitute or reduce thiomersal in vaccines. When such alternatives are licensed for use in the UK, we will seek the advice of the JCVI on their use in the childhood immunisation programme.

Can the minister confirm whether a mercury-free vaccine is available in Scotland? I previously mentioned Infanrix, which is produced by GlaxoSmithKline.

I reassure the member that Infanrix was already licensed for use at two, three and four months when the JCVI issued its advice in 2000. It was licensed in 1999 first as a booster and then for use at two to four months.

I reiterate that cost was not and is not a consideration in the determination of vaccine policy. If, after discussion with their GPs and other medical professionals, parents decide that it is right and appropriate for them to use alternatives to DTwP, those are available to individuals and their families.

This is an important question. Does the minister believe that GPs should pro-actively advise parents when they take their children for vaccination that a mercury-free alternative to DTwP exists and is available to them if they choose? Is that the basis on which he believes parents should exercise choice?

We ask GPs and health professionals to identify the best course of action in discussion with patients and their families. It is not right and proper for me, as a minister, to determine centrally how they do that. I reiterate that the letter from the deputy chief medical officer set out the process for all health professionals. That letter is available to all GPs. If parents want to explore alternatives to the vaccines that are available, they may do so.

I want to be absolutely clear on this point. In terms of efficacy, is Infanrix an equal substitute to the vaccine that contains mercury? Is it available to all parents in Scotland?

Infanrix has fewer side effects than DTwP. However, data on severity indicates that DTwP protects against whooping cough—that benefit outweighs the risk. The two issues must be balanced. However, the opportunity for parents to choose Infanrix exists. In recent coverage, it has been suggested that Infanrix has been held back on grounds of cost or policy. I assure Parliament that that is not the case. However, judgments are best made by GPs, based on the research that is available.

The minister has slightly misrepresented some of the coverage. No one is suggesting that Infanrix has been held back solely on the ground of cost. More parents do not opt for Infanrix as a mercury-free alternative because they do not know about it. I return to comments that I made in my opening speech: choice can be exercised only if parents have the information that enables them to choose. I am not sure what the minister is saying about the process. Does he think that parents should be given in equal measure information about the vaccine that contains mercury and the mercury-free vaccine, so that they can make genuine informed choices? If people do not know that an alternative exists, they cannot make a choice.

In a written answer dated 24 January, which I quoted earlier, Malcolm Chisholm stated:

"It is anticipated that thiomersal-free vaccines will be considered for provision in the routine childhood immunisation programme after they have been licensed ... and have demonstrated that they are as effective in protecting children against the real risk"—[Official Report, Written Answers, 24 January 2003; p 2844.]

Tonight the minister is saying that the vaccines must be licensed, or they would not be on the shelf. He is also saying that they are as effective as vaccines that contain thiomersal. Within a fortnight, we have the Minister for Health and Community Care saying that thiomersal-free vaccines are not effective and the Deputy Minister for Health and Community Care saying that they are just as effective as vaccines that contain thiomersal. There seems to be a contradiction.

I do not think that I contradicted the Minister for Health and Community Care—perhaps the Official Report will prove me right. I said that we need to have information available. It has been claimed that Infanrix is either being held back on the ground of cost, or is not being made available. I have said that the drug has been licensed for use at two to four months. Infanrix is also offered routinely to children at age four. It is available.

It is important that we have a total picture of vaccination. One of the JCVI's key messages is that it recommends the use of DTwP because, on balance, bearing in mind the scale of risk, it provides the best protection against whooping cough. Because the central purpose of our extensive vaccination programme is to provide such protection, we should take a balanced judgment on the risk once we have assessed it.

However, each family, parent or individual who looks after young children will have to make those choices in consultation with their medical practitioners. It is right and proper that that should be the case. There is no scientific evidence to justify a radical change in present policy. We are heading in a certain direction and taking into account developments. I hope that parents are reassured that cost is not an inhibiting factor in terms of the availability of vaccines.

We must stress the benefits of the vaccination programme while recognising that any vaccination programme has side effects. We must keep our eye on the challenge that has been before us since the late 1950s, which is to ensure that we have an immunisation programme that prevents a recurrence of the whooping cough problem that was a feature in Scotland for too long. That is the real issue at stake in this debate.

I acknowledge the concerns that members have expressed, and we will monitor those areas where appropriate, but I hope that the people of Scotland recognise that we believe that what we are doing at the moment is in their best interests.

Meeting closed at 17:41.