Observer special investigation

Did toxic vaccines ruin lives?

'To think of the drugs giants making millions while children's lives lie in ruins makes me very angry. A chance that someone knew of toxic vaccines makes me even angrier' : The Observer reveals how deaths and brain damage could be linked to the release of thousands of doses of toxic vaccine

Baby deaths may be linked to toxic vaccine

Antony Barnett and Tracy McVeigh
Sunday July 8, 2001
The Observer

Tracy was Bridget and Bill Cowlin's first baby, and for the first year of her life she was beautiful, bright and happy. In October 1969 the little girl went with her mother to the local doctor's surgery in Blandford, Dorset, for her whooping cough booster vaccination.

Within 48 hours the Cowlins' world had been turned upside down as their daughter, aged 16 months, fought for breath between a series of convulsions. 'She was going blue and fighting to get a breath. Then she was screaming, high-pitched screams like we'd never heard. Then came convulsions and fitting. It just went on and on. For three days and nights we just walked around with her constantly trying to comfort this poor little thing. Terrifying,' said Bridget.

Tracy was permanently brain-damaged and now, aged 33, has the mental age of a young child. 'Through the tears I have shed over the years, and there have been many tears, I still want to know why that happened to my healthy baby daughter. I'm never going to stop fighting for that.'

Today The Observer can disclose remarkable new evidence that could offer an explanation to hundreds of parents who saw healthy babies suffer brain damage within hours of being inoculated against whooping cough, in itself potentially fatal to young children.

The Observer has established that around 1968 two batches of vaccine were produced in Wellcome's laboratories in Kent which never passed key toxicity tests. One was 14 times more potent than the British standard dose, the other 16 times. Each batch contained an estimated 60,000 individual doses. A further 14 batches were not tested at all.

The Cowlins have no proof that Tracy was given her vaccination from one of these suspect batches. She could just as easily be one of the unlucky ones who suffered an adverse reaction to a perfectly sound vaccine. Yet it is the very uncertainty over the cause of damage that is deeply troubling for parents like the Cowlins.

But what is known is that around this time Wellcome allowed vaccines from a toxic batch to be distributed to surgeries and clinics across the country where they were injected into thousands of British babies over the following three years.

Some experts now believe these batches could be a reason for a massive rise in reported adverse reactions to whooping cough vaccines between 1968 and 1971, which included a number of deaths.

In1968 Margaret Best took her son Kenneth for his jab in Cork in the Republic of Ireland. Within hours Kenneth was screaming in agony and was later diagnosed as being permanently brain-damaged with severe mental handicap.

In 1982 the Irish government offered the Best family £10,000 compensation, but they refused and took Wellcome to court in 1989. After a bitter court battle the family won £2.7 million. The victory was based on evidence Margaret found while sifting through thousands of Wellcome documents.

She discovered that the vaccine used on her son, batch 3741, had not passed a critical safety test and that it was known to be 14 times more potent than normal doses.

Immunology experts condemned Wellcome in court for what one US scientist described as an 'extraordinary event'. The batch would not have been released in America, he told the court.

Making the award, Justice Liam Hamilton described Wellcome as negligent and he savaged the quality control procedures in its laboratories during that time.

But The Observer has discovered that thousands of doses from batch 3741 and from the second toxic batch, 3732, were also used in Britain. Wellcome documents reveal records of at least one death in the UK from the batch.

Much of this new information has emerged in Ireland where, following pressure from politicians and campaigners, the Irish government has demanded answers from Glaxo Wellcome, now known as GlaxoSmithKline.

Irish Ministers are so concerned that they last week launched a search for the 296 individuals who are known to have received jabs from batch 3741. Trade Minister Denis Naughten told The Observer yesterday: 'There can be nothing more disgraceful than children being left to their suffering amidst a knowing silence from those who have the power to apologise and to compensate.'

It has also been revealed that in the early 1970s Wellcome withheld damaging information about highly reactive batches of the vaccine from the Irish health authorities. In one case a regional health board gave Wellcome details of more than 80 cases of adverse reactions in clinics in Dublin. Yet Wellcome failed to pass this on to the authorities.

It has also been alleged that in the early 1970s batches of cattle vaccines may have been sent to Ireland by mistake and injected into babies. Naughten, who has led the campaign in Ireland, said: 'We now know that something was going very wrong with the quality control process in its [Wellcome's] lab in the later 1960s and early 1970s, but it has taken years for the drug company to give us information. I am sure that all the blunders that have happened in Ireland happened in the UK as well, and I urge British Ministers and politicians to call the company to account.'

Gordon Stewart, emeritus professor of public health at Glasgow University, who was commissioned by Britain's chief scientific officer to report on whooping cough vaccine in 1984, has described the revelations as 'scandalous'. He said: 'It was well known that between 1968 and 1970 there was a big jump in the number of adverse reactions from the vaccine, including numerous deaths. It is possible that a toxic batch could have been the cause.'

Stewart, whose report was never made public by then Health Secretary Kenneth Clarke, said he knew that these potentially 'unsafe' batches had been used on British babies and told the Department of Health at the time. He said: 'When I found out that the same vaccines used on Kenneth Best were used on British children, I was shocked. I immediately informed the Department of Health, but they brushed off my concerns.'

Labour MP Ian Stewart, chair of the all-party Commons committee on vaccine issues, wants the Department of Health to launch an immediate inquiry and to trace British children affected. Some families whose children were the most badly brain-damaged can currently apply for £100,000 in compensation from the Government.

Stewart said: 'If it can be shown that negligence on behalf of Glaxo Wellcome led to a toxic batch of vaccines being given to British babies, and that, as a result, they suffered brain damage, then the question arises whether it should be the state or the company that pays.'

Like many parents at the time, Bridget Cowlin's concerns were swept aside by health officials and many in the medical profession.

A spokesman for Glaxo- SmithKline told The Observer : 'We do not accept that these batches were harmful. Trivax was used in accepted vaccination schemes in Ireland and tens of thousands of children would have received vaccines from these batches. Whooping cough is a very serious disease, which can cause permanent disability, and even brain damage in a small number of cases.

'Trivax was a very effective vaccine which prevented the spread of whooping cough. As is the case with all medicines, no vaccine is completely without adverse effects. However, it is the common belief of the medical authorities and profession that the risks of serious disease from not vaccinating are far greater than the risks of serious reaction to vaccination.'

But for parents still caring for their handicapped children this is not enough. 'You'll never be a grandparent, you'll never enjoy the normal things in life. We are luckier than many in that our daughter is a nice person to be with. She can speak and do some things for herself,' said Bridget Cowlin. 'But when I think of the pharmaceutical giants making millions while all our children's lives lie in ruins, that makes me very angry. That there is a possibility someone knew there were toxic vaccines out there makes me even angrier.'