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DTP or DPT vaccine safety

The Sunday Times

The vanishing victims

To be honest, at the time I never paid attention to this saga's first 23 years. I was either too young, or it was not my story. I have no children. I had never heard of Wilson. And so completely had the world accepted his conclusions that, in April 1988, I casually commented in The Sunday Times that "everybody knows" that the whooping cough vaccine and brain damage were sometimes, albeit rarely, linked.

But then I got a phone call, from a woman in Ireland, that would lead me to think again. And after months of research, particularly of court documents, I came to the conclusion that for the past quarter-century, parents have been tragically and unnecessarily scared.

The caller was Margaret Best, a short, energetic, then 47-year-old Irish housewife, who had successfully sued a drug firm over her brain-damaged son, Kenneth Best. I had also clashed with this firm, the Wellcome Foundation, now swallowed into Glaxo-Wellcome, Britain's biggest company. And possibly on the adage that my enemy's enemy is my friend, in November 1996 she invited me over to stay at her house near the city of Cork.

Although Kenneth's case involved a stronger-than-normal batch of vaccine, at face value it was proof of Wilson's thesis, the clearest case of vaccine damage in the world. After a string of David and Goliath trials in Dublin, which started in April 1989 and finished in July 1995, the Bests won £2.75m, plus costs, in a result which set the company back by nearly £10m. In January 1994, BBC1 broadcast an hour-long celebration of Margaret's victory, entitled Against All Odds.

Margaret was living like a lottery winner in a five-bedroomed house down a maze of country lanes, near the airport. The property had electric gates, a gravel drive, floodlights and barking dogs. Furniture was chunky and fabrics rich. Everything, understandably, looked new. Kenneth was housed in a single-story annexe, with its own kitchen, laundry, bedrooms and lounge.

The story she told me was not new to her. She had been battling over it for decades. It was in 1969 when Kenneth's problems began - the year men landed on the moon. She was just 22 and had been married for 13 months. Her husband was 26, a former fireman. They lived in a cottage on a hill outside Kinsale, then a poor south coast fishing village.

But it was all new to me and I found it a struggle to absorb the essential facts. On Wednesday September 17, 1969, it seemed, Kenneth was 4.5 months old and received his first DTP vaccination. He apparently had a fit, or "turn", six hours later while eating his tea, and, after that, more than 10 times daily. "His face got very red and his eyes turned in to the right, in to the corners," Margaret had told the Dublin judge. "Both his arms came up to his chest and it was as if his whole body was stiff."

She said that she phoned her general practitioner that night, had taken Kenneth to him next morning, and then at least twice a week for months. She claimed, however, that he dismissed her, saying "it was probably a reaction to the vaccine" and "there was nothing to worry about".

There were certain confusions, to which I paid no attention at the time. Despite the GP apparently blaming the vaccine, for instance, Margaret took her baby for two further routine DTP jabs at monthly intervals. And although the doctor's records contained six entries for the family, mentioning trivial ailments such as "nappy rash" and "flu", there was nothing neurological until January 1970.

Eight months later, a paediatrician diagnosed Kenneth as having West's syndrome, a progressively disabling seizure condition which usually starts at between three and eight months of age, and which is often genetic in origin. The records of this doctor, and those of another consultant, also contained oddities. Neither was told about the DTP and both took down dates for the boy's first fits that were many weeks after his jab.

Such discrepancies were serious: experts who believe in the vaccine damage link say that fits must occur with 72 hours to be plausibly linked to it. The contradictions inevitably raised the question of whether Margaret's story was accurate. Yet, in its legal defence, Wellcome's lawyers simply said that she had muddled the dates. "I am not suggesting for a moment Mrs Best is telling lies," its barrister said in court. Counsel for the GP agreed, sympathetically: "I am sure poor Mrs Best believes these things."

It was a fascinating story and, one morning in her kitchen, we did a short interview. We talked about her father, a bookie's clerk, about how she left school at the age of 12, and about her first job as a care assistant. Then we discussed her husband, Ken, and their subsequent separation. And finally the fateful night.

"So, where did you phone the doctor from?" I asked, trying to get a picture in my mind.

Margaret got up, walked across the kitchen and did something or other at the cooker. "Well," she said. "There was a neighbour whose phone I sometimes used."

"Um, so is that what you did?"

She paused. "No," she said, and moved back to the cooker.

I waited until she returned. "So, er, what, you used a phone box?"

"Yes," she said.

It was background colour, of no great consequence. But later I listened to the tape. Why mention the neighbour if she had used a phone box? What was the reason for delaying her reply? Surely, the night which saw her child's life wrecked was indelibly etched on her mind?

*****

The panic over Wilson's paper came and went, as health scares inevitably do. By the end of the 1970s, journalists had run out of angles, while the killer whooping cough epidemic and education campaigns won parents back to vaccination. Any risk to children of being inoculated, it was recognised, was less than of them going without.

But in May 1981 a 184-page government book restored life to the consultant's crusade. It was titled simply Whooping Cough and was issued in a blue cover by Her Majesty's Stationery Office. It contained reports confirming the brain damage link, including two that estimated the risk. They were the hardest evidence produced anywhere. The book joined Wilson's paper as a classic.

The first report was from a panel of six doctors, who studied notes on 229 children. Most were referred by Rosemary Fox, whose association was besieged by handicapped children's parents whenever media stories appeared. She distributed questionnaires, sifted out cases that she considered unlikely to be due to DTP and sent the rest to government doctors. The panel found 125 "suspected" vaccine victims and said that 1 jab in 155,000 led to brain damage, or death.

The second report gave findings from a huge medical survey. Named the National Childhood Encephalopathy Study (NCES), this asked all hospitals to notify investigators of children admitted with certain symptoms. It ran for three years from mid-1976, during which 2m DTPs were given. It concluded that the risk of injury or death was 1 in 310,000 jabs.

Wilson was a member of the six-doctor panel and an advisor to the hospital survey. But the blue book acknowledged two other consultants who by now had assumed prominent roles. Both were epidemiologists and professors of community medicine. One, Gordon Stewart, of Glasgow University, drafted Fox's questionnaire. The other, David Miller, of the Central Middlesex Hospital, London, headed the NCES team.

Government authority and professional prestige oozed from the blue book's pages. The 1-in-310,000 figure was adopted throughout the world (and is still used by health agencies as the official risk estimate). Journalists pounced on the issue again and restarted emotive campaigns. But, as with Wilson's original series of 36, there were grave problems in both reports that have been hidden from parents to this day.

On a strictly scientific basis, the panel's "suspected" cases counted for little. The doctors blamed the vaccine if paperwork - mainly Fox's questionnaires - said that symptoms closely followed a jab. The impact of coincidence was overpowering: more than 2% of infants have fits, for various reasons, and the panel's cases were skimmed from millions of families alerted by media reports. The questionnaires (headed "Adverse Reactions to Vaccines"), moreover, was often filled-in years afterwards by parents seeking compensation.

Such shortcomings were glossed over, but the veneer cracked when a specimen of the cases looked at by the panel came to court. The child in question was Johnnie Kinnear, born in December 1969, and, like Kenneth Best, an apparently obvious vaccine victim. In 1974, his father, a factory worker, had read about Fox's association in The Sun and, with Wilson's and Stewart's support, won £10,000 compensation. He then got legal aid to be the English test case for more than 250 pending actions.

The Kinnear trial began in the spring of 1986 and ran for 29 remarkable days. It was the first time in Britain that any drug company - again it was the Wellcome Foundation - had defended the safety of a product in court. The judge was Mr (later Lord Justice) Stuart-Smith, a 58-year-old father of six.

Johnnie, from west London, had the whooping cough vaccine in February 1971 at the age of 14 months and, according to his mother, had a fit seven hours later. She said she took him to her GP the next morning, but, although severe seizures continued every day for months, the doctor brushed her off. She said he told her that it was "normal for children to have reactions," and there was "nothing to worry about".

But the mother's evidence was so incredible that the Kinnears' barristers informed the judge that they could not carry on. Not only was her tale irrational and contradictory, but it clashed with a Hammersmith Hospital record taken five months after the jab. "Baby boy admitted via casualty," it said. "'Fit' 4 days ago - occurred without warning whilst eating tea." Johnnie was mentally handicapped - possibly owing to breathing problems at birth - but the (blue-booked and compensated) boy, then 16, was not a vaccine victim. His barrister told the judge: "Anybody who was in court and heard the relevant witnesses, and heard them, particularly, cross-examined, and saw the discrepancies between their accounts and the medical records, can be left in no doubt."

Wilson's claimed link between brain damage and whooping cough vaccine was now in trouble. But it was Gordon Stewart, then aged 67, who bore the brunt of the embarrassment. After contacting Fox during the 1970s panic, this white-haired professor had become the victims' champion, backing hundreds of compensation claims and becoming patron of the American campaign. During 80 hours of evidence, he was caught wrongly describing aspects of the NCES and misunderstanding some case studies to such an extent that he was described in court as an "evidential liability". At one point, the company's counsel quoted from an expert report by the professor that apparently summarised a research paper about reactions to the vaccine in children.

"Do you remember anything about the age of the children?" the barrister asked.

"No, not offhand," the professor replied.

"Or the ethnic origin?"

"No, I cannot remember that. It was an American study, I know that."

His interrogator passed him the paper in question. It was a write-up of experiments on rats.

After this farcical hearing, there was a second test case that hinged on the crucial question of whether the vaccine could cause brain damage. Susan Loveday, a 17-year-old suffering from autism, was suing through her mother after receiving a course of jabs from a London GP in 1970. But instead of bolstering the vaccine-brain damage link, her case was even worse than Johnnie's. Fox had weeded-out Susan's questionnaire as implausible. Wilson's compensation system had rejected her mother's claim. Even Stewart thought that she was not a victim. "She was not vaccine-damaged," he said. "She was damaged before."

In spite of this consensus, the trial went ahead on the general principle of the link between the vaccine and brain damage. The judge decided not to hear direct evidence from the mother about fits and timing until after he heard the general issues. And during a mammoth 63-day hearing, Stuart-Smith watched the world's best experts grilled on whether the vaccine could cause serious harm. He probed clinical medicine, animal experiments, biochemistry and epidemiology. He studied scores of individual cases. It was the most exhaustive such inquiry ever held.

For all this effort, the trial turned on one key question: was the National Childhood Encephalopathy Study compelling evidence of a link between the vaccine and brain damage? The NCES was, after all, the only scientifically-controlled study ever to point to such a link. If this study stood up, as at first sight it seemed to, that link was probably real.

In passing, the judge reviewed a number of cases, only to find that they again became vanishing victims. "The parents' account is inconsistent with a previous account given by them," he noted for one child. "Onset of symptoms was in the previous October; it was changed to an onset of less than 24 hours on the basis of the parents' account given many months later," he said for another. "The parents' claim, as recorded in the documents, that the child was normal before vaccination, is plainly incorrect," for a third.

In spite of these oddities, the NCES was compelling, because it appeared to find some clear-cut victims. During the three years for which it ran, hospitals notified Professor Miller of 241 children who he recorded as mentally handicapped after an illness and, of these, seven had apparently received DTP one week or less before the onset. Coincidence was possible, but a statistical comparison with healthy children's histories produced the 1-in-310,000 risk.

But after the judge ordered the patients' notes to be produced from the Central Middlesex Hospital, against Miller's objections on grounds of confidentiality, another crop of victims disappeared. Of the seven children, who the professor had said suffered permanent brain damage, one had Reye's syndrome, which is not caused by vaccination. Three were afflicted by viruses. And the remaining three cases were not brain damaged at all: records showed that the children were normal.

Based on these cases, the vaccine's assumed risk of 1-in-310,000, published in the blue book, collapsed to approximately nil.

There was also something else very odd about the NCES. During the Kinnear and Loveday hearings, two contradictory computer print-outs were discovered which gave scores for children's abilities. And, although they referred to the same examinations of the same patients, the more recent print-out figures were erratically lower, making healthy children appear to be handicapped.

"Do they seem to you to be somewhat curious?" the defendant Wellcome's lawyer asked Miller.

"Yes, on the face of it, they do," the professor, who said he had not compiled either set of figures, replied. "And I cannot offer any explanation."

In March 1988, Stuart-Smith rejected the vaccine-brain damage link, without hearing from Susan Loveday's mother. He said that when he started out on his inquiry he was "impressed by the case reports" and by the "widely-held belief" that rare injuries occurred. "I have now come to the clear conclusion," he said, "that the plaintiff fails to satisfy me on the balance of probability that pertussis vaccine can cause permanent brain damage."

*****

DTP or DPT vaccine safety
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This report is copyright, Brian Deer. No portion of this article on the DTP or DPT vaccine controversy of the 1970s and 1980s may be copied, retransmitted, reposted, duplicated or otherwise used without the express permission of the author. Responses, information and other feedback are appreciated