No one had been able repeat David Miller’s study—remarkable, given its impact.
Miller and his team had worked hard. They had evaluated data from 1,182 children accumulated from July 1, 1976, to June 30, 1979. Further, their study wasn’t limited to London or England; they had also evaluated all children with neurological illnesses in Scotland and Wales. Miller and his team had assessed reactions to more than two million doses of pertussis vaccine; and they’d spent millions of dollars doing it. No study of the vaccine had ever been so thorough or so large. So why weren’t any subsequent investigators able to find what David Miller had found? The answer wouldn’t come from a scientific laboratory, or an academic institution, or an independent research organization. It would come, surprisingly, from a British courtroom.
In the United States, hundreds of lawsuits resulted in many trials. In England, on the other hand, the DTP scare resulted in only three trials. The last would show precisely what had gone wrong with David Miller’s study.
The first trial took place in Edinburgh, Scotland, in 1985, centering on a little boy named Richard Bonthrone.
Bonthrone had received his first dose of DTP vaccine when he was four months old. Three months later, he received his second. Nine days after that, he had the first of many seizures. At the time of the trial, Richard was nine years old with the mental age of a six-month-old. He ate only liquid food and couldn’t do anything for himself. The judge, Lord Jauncey, wrote that Richard’s “only enjoyment of life appears to be in recognition of his mother’s voice and in travel by motor car.” Richard’s parents, John and Iris, sued their doctor, the Department of Health, and a visiting nurse for £145,000.
Two experts testified at Bonthrone’s trial. Dr. John Stephenson, a pediatric neurologist from the Hospital for Sick Children in Glasgow, said that while he accepted that DTP precipitated seizures following fever, he “was unconvinced that permanent brain damage resulted.” Next up was David Miller, who said, “The risk of developing encephalopathy nine days after being vaccinated [is] so small as to be incapable of statistical measurement.” Judge Jauncey ruled in favor of the defense. But the Bonthrone trial hadn’t refuted Miller’s study. Miller had never claimed that DTP caused harm nine days after a dose, only within three days of a dose.
Another trial quickly followed.
Johnnie Kinnear was fourteen months old when he received a dose of pertussis vaccine. According to his mother, Johnnie had a seizure seven hours later. The next morning, she took her son to the doctor who dismissed her concerns, saying it was “normal for children to have reactions” and there was “nothing to worry about.” But the seizures continued, every day for many months. The Kinnears sued the Department of Health, their doctor, the North West Thames Health Authority, and the Wellcome Foundation, which manufactured pertussis vaccine in England. The legal aid board intervened, allowing the suit to proceed only against the health authority and the doctor. The Wellcome Foundation was excused in part because it was one of several manufacturers of pertussis vaccine in England (Glaxo and Lister also made the vaccine); and it was unclear which brand Kinnear had received. But, in an unprecedented move, Wellcome decided to enter the case anyway—in essence, choosing to be sued. Wellcome was tired of the negative press surrounding pertussis vaccine and wanted to settle the issue once and for all. It, too, wanted its day in court. This was the first time that a drug maker in England had defended the safety of one of its products in a full court hearing.
The Kinnear trial began on March 17, 1986, and included many experts in the fields of virology, epidemiology, and statistics; among them were John Wilson, whose paper had ignited fears about the vaccine in England; Gordon Stewart, who had been prominently featured in
Vaccine Roulette
; and David Miller. The judge in the trial was Murray Stuart-Smith. Fifty-seven years old and the father of six, Stuart-Smith had graduated with first-class honors from Cambridge University. He would soon become a celebrated jurist and acquire the title of “Sir.” (Stuart-Smith would later sort out the tragedy that occurred at Hillsborough Stadium on April 15, 1989, when ninety-six Liverpool football fans were killed in a melee.)
The lawyer for the Kinnears was Julian Priest, who began by taking his star witness, Gordon Stewart, through early case reports. Stewart talked about the 1933 Copenhagen report, which described two Danish children who had suddenly died after receiving vaccines. He talked about the study from Harvard Medical School by Byers and Moll, who had reported fifteen children with irreparable damage following pertussis vaccine. He talked about Justus Ström’s paper from Sweden claiming that the vaccine caused permanent damage in one in thirty-six hundred children, far greater than the one in one hundred thousand later claimed by David Miller. Stewart concluded, “No matter how scrupulously the vaccine was prepared, one could not avoid including toxic products.”
The Kinnear case had two large holes. The first problem was a discrepancy between the mother’s testimony and the medical record. Kinnear’s mother testified that her son’s seizures began seven hours after he received DTP. But the medical record showed that Johnnie Kinnear’s first seizure had occurred five months, not seven hours, later. The contradiction was undeniable, causing Judge Stuart-Smith to say, “The mother’s evidence was crucial as to the date of onset of symptoms, which she said occurred very shortly after the vaccination. Unfortunately, she was not telling the truth. And this was apparent to all, including the plaintiff’s advisors.”
The second problem was Gordon Stewart. No one’s reputation would suffer more from the Kinnear trial than his. During the trial, Stewart had repeatedly misquoted details of David Miller’s study. But his greatest embarrassment came during his discussion of another study. Stewart had stated: “Levine and Wenk described a hyperacute allergic encephalomyelitis which occurred in children who appeared to have been sensitized by a previous dose of pertussis vaccine.” Anthony Machin, the Wellcome Foundation’s attorney, asked Stewart, “Do you remember anything about the age of the children?” “No, not offhand,” replied Stewart. Machin pressed on: “Or the ethnic origin?” “No, I cannot remember that,” said Stewart. “It was an American study, I know that.” Machin then handed the study to Stewart, who looked through the paper and then up at Machin, embarrassed. Stewart apologized for his mistake. The study hadn’t been done on children; it had been done on rats. The gaffe marked the end of Gordon Stewart’s role in damning pertussis vaccine. During a subsequent trial, he was labeled “an evidential liability.” Although the Kinnear trial took twenty-nine days, included many witnesses, and cost the government £1 million to litigate, it ended without a verdict.
The litigation, however, didn’t end.
The trial that ended all pertussis vaccine trials in England began on February 1, 1988. Again the judge was Lord Justice Murray Stuart-Smith. The plaintiff was Susan Loveday, a mentally disabled seventeen-year-old who lived in Bradford-upon-Avon in Wilshire. Susan’s story was similar to the others. In 1971, George Renton, Susan’s doctor, administered the first dose of DTP after which Susan “had a high temperature and local inflammation and was sleepy but crying a great deal.” Her mother noticed that she wasn’t as lively and that “one eye seemed odd.” One year later, Renton gave Susan her second dose of DTP. This time she “had a similar reaction and screamed all night.” One month later, she was referred to another pediatrician who noticed that she looked “rather odd and hypotonic [floppy].” Then Renton gave her a third shot of DTP. By the time she had her day in court, Susan Loveday was severely retarded.
Loveday was the lead case in a class-action lawsuit that included two hundred other children with similar stories. Most had been gathered by Rosemary Fox, the head of Britain’s Association of Parents of Vaccine-Damaged Children. Unfortunately, as had happened with Johnnie Kinnear, under closer inspection Susan Loveday’s story started to unravel. It shouldn’t have come as a surprise. In fact, when Rosemary Fox had sent out questionnaires to find vaccine-damaged children, she had weeded out Loveday’s story as improbable. Even Gordon Stewart, an unwavering advocate for the cause, said, “She was not vaccine-damaged. She was damaged before.”
Stuart-Smith had learned his lesson from the first trial. Rather than simply examining the merits of Loveday’s claim to see if it was a true case of vaccine damage, he decided to divide the trial into two parts. The first would be devoted to determining whether pertussis vaccine could cause permanent harm. If the answer was yes, the second part would determine who qualified for compensation. As in the Kinnear trial, the Wellcome Foundation voluntarily joined in. Wellcome wanted to see the data on which David Miller had based his conclusions—to see the stories of the children who were allegedly harmed by pertussis vaccine.
The case of
Loveday v. Renton and Wellcome Foundation Ltd.
took four months, involved nineteen expert witnesses, and cost more than £1 million to conduct. The judgment was more than one hundred thousand words long and included fourteen chapters and six appendices. The verdict was so long that it took Stuart-Smith two full days to read it; and so detailed that it left little room for appeal. Although the Loveday trial considered a great many issues, it was a trial of one study and one study only: David Miller’s. Under the bright lights of Justice Stuart-Smith’s courtroom, Miller’s study fell apart.
Stuart-Smith began the trial by expressing sympathy for parents who believed their children had been damaged by DTP. “For many of [the parents] the answer must seem obvious,” he said. “Their child is vaccinated and within a relatively short time thereafter, perhaps hours or days, [he] becomes seriously ill. [He] may have convulsions, become unconscious, show signs of paralysis; there may be prolonged screaming or vomiting. Later, there are signs of permanent mental handicap; blindness, deafness, paralysis or motor impairment, epilepsy, severe mental retardation. The one event must have caused the other, especially when the time interval between vaccination and onset of symptoms is measured in hours rather than days.” But Stuart-Smith wasn’t going to be swayed by temporal associations. Quoting Samuel Johnson, he said, “It is incident I am afraid, in physicians above all men, to mistake subsequences for consequences.” Then he elaborated. “Where given effects, such as serious neurological disease or permanent brain damage, occur with or without pertussis vaccination, it is only possible to assess whether the vaccine is a cause, or more precisely a risk factor,
when the background incidence of the disease is taken into account
. The question therefore is, does the effect occur more often after pertussis vaccination than could be expected by chance?”
By quoting Samuel Johnson, Stuart-Smith had hit on the central issue in the trial: the power of anecdote. For the parents of Richard Bonthrone, Johnnie Kinnear, and Susan Loveday the issue was clear. Their children had been fine until they’d received the pertussis vaccine. But the mere fact that one event follows another doesn’t necessarily mean that it caused the other. (Unfortunately, it’s hard to fight anecdote with statistical data. An emeritus professor at Duke University School of Medicine tells the story of a friend who took his four-month-old son to get a DTP vaccine. He waited and waited in line, eventually tiring and going home, his child never having received the vaccine. Several hours later the father went to wake the child, only to find that he had died, presumably from Sudden Infant Death Syndrome. One can only imagine what the father would have felt if his son had received DTP several hours earlier. Presumably, no study would have convinced him of anything other than that the vaccine had killed his son.)
Stuart-Smith began by singling out the man who had started it all: John Wilson. After acknowledging that Wilson’s paper had been circumspect and “tentative in its conclusions,” the judge was angry that he had included two children in his report who had never received pertussis vaccine. “Dr. Wilson is entirely convinced that the vaccine on rare occasions causes brain damage,” said Stuart-Smith. “He formed this view at a very early stage and he is completely committed to it. An example of this, small in itself but perhaps revealing, is to be found in the two DT cases in [his paper]. When he gave his evidence Dr. Wilson had forgotten that he had previously known that these were DT and not DTP cases, and so he stated at first that they were DTP. I was not convinced by his explanation that the matter was of no consequence and did not affect the thrust of the article. I think he had forgotten it because it was inconvenient.” Chastened, John Wilson would never again carry high the torch that pertussis vaccine caused brain damage.
Then Stuart-Smith turned his attention to David Miller. Miller was certainly aware of the furor surrounding his study; aware that Rosemary Fox had formed the Association of Parents of Vaccine-Damaged Children; aware that politicians had rallied in support of these children; aware that several doctors, such as Gordon Stewart, had become vocal advocates for the cause; and aware that the press and public knew full well that the national government had funded his study. Miller didn’t want to appear to have whitewashed the issue. So he bent over backward to report any possible problems with the vaccine. Earlier in the trial, one of Miller’s collaborators had stated, “Because it was essential that pertussis vaccine should not appear from this study safer than it actually is, steps were taken at every stage to ensure that the results would overestimate rather than underestimate the risks.” An example of this type of bias appeared in instructions to physicians. “If there is doubt, code the worst picture,” they read. David Miller described what it was like to do a study under the bright lights of the press and public. “We were extremely anxious,” he said. “One has to remember the context in which the study was done, which was that there was a great deal of alarm about the possibility of there being damage associated with the vaccine.... It was extremely important that our results were not subject to criticism by those who might say that we were endeavoring to avoid demonstrating the possibility of a neurological damage associated with a vaccine.... It was very important that we avoided that kind of accusation.” Stuart-Smith was unsympathetic: “I think it can be said that this demonstrates a conscious over-anxiety to appease what I may call the vaccine-damage lobby, which may have led to decisions being biased against the vaccine.”