While Galileo was a rebel, not all rebels are Galileo.
—NORMAN LEVITT
On February 18, 2004—six years after Andrew Wakefield had published his paper in the Lancet—Brian Deer, an investigative reporter for the Sunday Times of London, called Richard Horton, the Lancet’s editor-in-chief. Deer said he had some shocking news about Andrew Wakefield. Horton gathered several other editors into the Lancet’s editorial office and waited; he had no idea what he was about to hear. The meeting lasted five hours. “The allegations made by Deer, as I saw them,” recalled Horton, “were devastating.”
Deer claimed that Wakefield’s Lancet paper contained several errors. For one, Wakefield had written that his “investigations were approved by the Ethical Practices Committee.” But, according to Deer, the committee had never approved Wakefield’s study. Wakefield’s team had put children under general anesthesia, performed spinal taps, threaded fiber-optic scopes into their intestines, taken biopsies, and collected large quantities of blood for testing. These procedures weren’t trivial. Several children had difficulties with the anesthesia, and one five-year-old child was in critical condition after his colon was perforated in several places. If the Ethical Practices Committee hadn’t granted its approval, then Wakefield and his coworkers had circumvented a process designed to protect children from unnecessary and potentially harmful tests—a serious charge.
There were other problems. Wakefield had written that his “study was supported by the Special Trustees of Royal Free Hampstead National Health Service Trust and the Children’s Medical Charity.” But he didn’t mention the study’s largest supporter. Two years before his paper was published, Deer claimed that Wakefield had been given $100,000 by a personal-injury lawyer named Richard Barr. At least five of the eight autistic children in Wakefield’s study were clients of Barr. Deer claimed Wakefield knew that parents of the children in his study had a financial interest in finding a link between MMR and autism; if Wakefield could establish that link, these parents could successfully sue for compensation. Deer also challenged Wakefield’s claim that his interest in MMR stemmed from encountering autistic children during their routine admissions to the hospital. More likely, Deer believed, lawyers had referred patients to Wakefield, who then laundered their stories into a medical publication, grossly misleading the reader. “If this claim were true,” recalled Horton, “it would have meant that the selection of children who took part in the investigation had been badly biased.”
WAKEFIELD’S CONNECTION TO A CLASS-ACTION LAWSUIT AGAINST vaccine makers began in 1996—two years before his Lancet publication—when he met Rosemary Kessick. Kessick was concerned about what had happened to her son after he had received MMR. “He looked strange,” remembered Kessick, a full-time business analyst. “He had a kind of yellow tone. He wasn’t well. Then [he] developed chronic diarrhea.” Fearing MMR had caused her son’s illness, Kessick took him to several doctors, all of whom reassured her that it was probably just a virus. “Most of them were like, ‘Oh, don’t worry your little head about the MMR,’” she recalled. “[But] within weeks of the vaccination, [my son’s] development slowed down, then it stopped and he regressed. Seeing what has happened to him broke our hearts.” Through a parents’ advocacy group, Kessick had learned about Andrew Wakefield who, after examining her son, agreed that MMR had caused his autism. “It means so much to finally be listened to,” said Kessick, “and to find people prepared to stand up and say the safety of these vaccines must be investigated.”
Immediately after leaving Wakefield’s office, Kessick visited the office of Justice, Action, and Basic Support (JABS), an organization that warns parents about the dangers of MMR. (Jabs is the British word for shots.) JABS members believed MMR caused mental retardation, epilepsy, arthritis, and weakened immune systems; Kessick was the first parent to believe it caused autism. In 1994, two years before recruiting Andrew Wakefield to their cause, members of JABS had sued the three pharmaceutical companies that made MMR: Merck, SmithKline Beecham (now GlaxoSmithKline), and Aventis Pasteur (now Sanofi Pasteur). The personal-injury lawyer who represented them was Richard Barr, at the time a partner in the British law firm Dawbarns.
RICHARD BARR HAD CONSIDERABLE EXPERIENCE SUING PHARMACEUTICAL companies, first coming to public attention during his crusade against the anti-arthritis drug Opren. Opren had already been withdrawn from the United States, where it had been linked to more than seventy deaths and 1,000 cases of kidney and liver failure. The drug’s manufacturer, Eli Lilly, eventually settled cases in Britain for $6 million. Unfortunately, because he had filed his claims after an agreed-upon deadline, Barr’s clients received nothing. “My worst day as a lawyer,” recalled Barr “was when the first judgments were handed down in the Opren cases. When [the judges] dismissed all my claims, it was like a firm kick in the solar plexus.” Barr had also crusaded against organophosphate chemicals, claiming that farmers exposed to pesticides and soldiers exposed to nerve gases suffered depression, irritability, difficulty concentrating, and poor sleep (Gulf War Syndrome). Again, Barr failed to obtain compensation for his clients. During the 1990s, Barr moved from one British law firm to another; from Dawbarns in Ipswich he went to Hodge, Jones and Allen in Camden Town and then to Alexander Harris in Manchester, each time taking with him his ever-growing caseload of claims against MMR. After Rosemary Kessick walked into his office—and after the association between MMR and autism first appeared in a British newspaper in November 1996—the number of claims against MMR increased from hundreds to thousands.
To Richard Barr, the case against MMR was clear. “If it can be shown objectively,” he said, “that a child was developing normally prior to being vaccinated; and if there was no other event which could account for the condition, then in all probability the MMR vaccination has played a part in the cause of autism.” According to Brian Deer, Barr had paid Andrew Wakefield more than $100,000 to prove it.
AFTER HEARING DEER’S ALLEGATIONS, RICHARD HORTON ASKED Andrew Wakefield, Simon Murch, Peter Harvey, and John Walker-Smith—four of the thirteen authors on the Lancet paper—to come to his office. Horton told them what Deer had told him, recalling, “Simon Murch and John Walker-Smith [a senior gastroenterologist] were visibly shocked by this revelation.” Deer had asked Horton not to talk to the press until after he had published his story in the Sunday Times. But Horton, reasoning that it was in everyone’s best interest, immediately called the BBC. On February 20, 2004, Horton appeared on BBC Television. “If we knew then what we know now,” he said, “we certainly would not have published the part of the paper that related to MMR.” In the newspaper interviews that followed, Horton said, “There were fatal conflicts of interest in this paper. As the father of a three-year-old who had had MMR, I regret hugely the adverse impact this paper has had.”
Following Horton’s appearance on BBC Television, reporters cornered Wakefield. After denying any wrongdoing, Wakefield admitted that “four, perhaps five” of the children in the Lancet study were clients of Richard Barr. “Was it four or five?” they asked. “Let’s make it five,” he said. “Were they litigants?” “Yes,” replied Wakefield. “Were you being paid to help them build their case?” Again, Wakefield said yes. “Did you tell your colleagues that these children were part of the study?” “I don’t recall,” said Wakefield. “Did you tell the Lancet about these conflicts prior to the publication?” Wakefield said he hadn’t. “Why not?” “I believe that this paper was conducted in good faith,” said Wakefield. “It reported the findings. There was no conflict of interest.” “Do you have any reasons now to change your opinion?” “No,” said Wakefield, “but again it’s a debate. I have no regrets.” Wakefield also disputed the alleged sum of $100,000, claiming that $50,000 was closer and that he had given all of the money to a research assistant. Like Wakefield, Richard Barr pleaded his innocence. “We weren’t trying to get an independent paper published under the carpet,” said Barr. “I remember noting at the time that the funding acknowledgment wasn’t there, but it didn’t seem to be a big deal.”
Simon Murch was furious that Wakefield had never told him about the money from Richard Barr. “It was a very unpleasant surprise,” said Murch. “We never knew anything about the [money]. He had his own separate research fund. We were pretty angry.” Murch called other members of the Royal Free team and explained what had happened. He asked whether they would be interested in lining up behind him to retract the findings of the paper. Ten of the thirteen agreed. On March 6, 2004, three weeks after Brian Deer called Richard Horton, the Royal Free Hospital team’s retraction appeared in the Lancet: “We wish to make it clear that in this paper no causal link was established between MMR vaccine and autism as the data were insufficient. However, the possibility of such a link was raised and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper.” John O’Leary, the Irish pathologist who had found measles virus in the intestines of autistic children, said he was “shocked and disappointed” by Wakefield’s behavior.
The British media also felt cheated. Prior to Deer’s revelations, Wakefield had been a hero, willing to take on powerful, self-serving forces such as public health officials, drug companies, and an entrenched medical establishment. Now some in the British press saw him as a shill for plaintiffs in a massive lawsuit. Headlines in The Guardian and Sunday Times read, “MMR Scare Doctor Got Legal Aid Fortune,” “MMR Scandal Doctor May Face Professional Misconduct Charges,” and “Is This Doctor a Hero or a Health Risk?”
ALTHOUGH THE BRITISH PRESS SAW BRIAN DEER’S ALLEGATIONS as tainting the notion that MMR caused autism, scientific studies had already gone a long way toward refuting Wakefield’s claims. In his original Lancetpaper Wakefield admitted that he had not proven an association between MMR and autism. To determine whether MMR caused autism, researchers would have to perform a series of epidemiological studies, comparing hundreds of thousands of children who did or did not receive the vaccine. Brent Taylor’s study, published in the Lancet and later presented to Dan Burton’s Committee on Government Reform, was the first to clearly show that vaccinated children were not at increased risk. Others followed. Scientists from Helsinki University in Finland examined the records of 2 million children and found no evidence that MMR caused autism. Researchers from Boston University School of Medicine examined the medical records of more than 3 million children; although they found an increase in the rates of autism, that increase wasn’t associated with the children’s getting MMR. Loring Dales and Natalie Smith, from the Department of Health Services in Berkeley, California, also found that increasing rates of autism occurred independent of the use of the MMR vaccine. Brent Taylor extended the study he had presented to Dan Burton by following children for longer periods of time, finding that the MMR vaccine didn’t cause autism up to five years after it was given. Frank DeStefano, from the Centers for Disease Control and Prevention (CDC), performed a study in metropolitan Atlanta showing that children with autism were not more likely to have received MMR. Scientists from Denmark examined the medical records of more than 500,000 children; some had gotten the MMR vaccine and some hadn’t. Again the risk of autism was the same in both groups. The American Academy of Pediatrics (AAP) and the Institute of Medicine (IOM; an independent research group within the National Academy of Sciences) reviewed these and other studies and reached the same conclusion: MMR didn’t cause autism. Finally, public health officials in Japan, who had discontinued MMR following Wakefield’s report, didn’t see any decline in the rates of autism; instead, the number of children with the disorder continued to soar.
More important, Wakefield’s explanation of how MMR caused autism didn’t hold up. Wakefield had claimed the measles vaccine virus in MMR had caused a chronic infection of the intestines, allowing harmful proteins to enter the bloodstream and damage the brain. However, other researchers couldn’t find any evidence that measles vaccine caused a chronic infection in autistic children. Like O’Leary, these investigators used PCR to detect measles virus genes. One of the Canadian researchers, Brian Ward, said, “In our hands, the [data] published by [O’Leary] yielded many PCR ‘positive’ results that turned out to be falsely positive on closer examination. These data are a direct refutation of the reports of persistence of measles virus in the tissues of autistic children. We are hopeful that this paper will simply put a quiet end to the debate surrounding this topic.” Later, independent examiners tested the competence of O’Leary’s laboratory (Unigenetics) by asking it to identify which coded samples contained measles virus. Unigenetics failed the test. One of the examiners said the “record of performance [of O’Leary’s testing laboratory] would not be acceptable for certifying a clinical laboratory.” Stanley Plotkin, an emeritus professor at the University of Pennsylvania School of Medicine and the inventor of the rubella vaccine, concluded, “O’Leary’s data provided Wakefield with the linchpin evidence that was central to his theory. If that falls away, all you have is a hypothesis unsubstantiated by anything. The whole thing falls into the water.” In 2003, John O’Leary admitted his PCR evidence “in no way established any link between the MMR vaccine and autism.”
Wakefield’s contention that MMR caused a leaky gut also suffered several blows. First, Wakefield believed it was the combination of measles, mumps, and rubella vaccine that was causing intestinal disease. He didn’t think giving the vaccines separately would be a problem. But studies later showed that children given MMR were not more likely to develop bowel problems than children given the vaccines separately.
Second, a closer look at Wakefield’s original Lancet study showed that only one in five children had bowel problems before they developed autism. If a leaky gut were the cause, bowel symptoms should have preceded, not followed, the first symptoms of autism.
Third, Wakefield believed harmful proteins were entering a damaged gut. But if the gut were damaged, the leak should go both ways, from the gut to the bloodstream and from the bloodstream to the gut. If autistic children had leaky guts, then their stools should have contained large amounts of proteins normally found in the blood. But this wasn’t the case. Michael Gershon, professor and chairman of the Department of Anatomy and Cell Biology at Columbia University, commented on this paradox: “If the presumed ‘leak’ were large enough to permit [proteins] to enter the body in significant amounts, then body proteins would be expected to move simultaneously in the opposite direction into the [center] of the bowel.”
Fourth, Wakefield believed that the combination of measles, mumps, and rubella vaccines had simply overwhelmed a young child’s developing immune system. But the challenge of these three viruses is minuscule compared with that of vaccines that had been developed and administered in the past. Viruses are made of proteins; larger viruses contain more proteins than smaller viruses. Measles, mumps, and rubella viruses are quite small, containing ten, nine, and five proteins, respectively. Smallpox, on the other hand, is one of humankind’s largest viruses; it contains about 200 proteins. So, although smallpox is only one vaccine and the combination MMR vaccine contains three, the number of immunologic challenges from the smallpox vaccine is much greater than from MMR (200 versus 24). Indeed, children confronted more immunologic challenges by receiving only the smallpox vaccine 100 years ago than they do while receiving 14 different vaccines today (200 versus 153). If immunological overload were the cause of autism, with fewer immunologic challenges in modern vaccines, rates of autism should be decreasing, not increasing.
Finally, the work of Vijendra Singh came under closer scrutiny. Singh had testified in front of Dan Burton’s committee that MMR had induced unusual levels of antibodies against measles virus as well as antibodies against nerve cells. But a closer look at Singh’s science revealed two critical flaws: children with autism didn’t have evidence of nerve cell damage and, according to measles experts, the test that Singh had used to detect measles antibodies didn’t detect them.
ON FEBRUARY 18, 2004, ANDREW WAKEFIELD SAT IN RICHARD Horton’s office after hearing Brian Deer’s allegations against him. During the six years that had passed since he had published his paper in the Lancet, scores of scientific studies had failed to support his contention that MMR caused autism. Horton knew the game was coming to an end; he remembered the moment: “I turned to Wakefield and remarked, more as a way to break the silence than as a comment in need of a reply, ‘It seems like this whole affair is coming to a head.’ It was a baleful understatement, one that failed to match the occasion—the imminent implosion of work that had divided parents from doctors, and doctors from their colleagues. Perfectly aware of these realities, Wakefield looked past me, expressionless.”
For Andrew Wakefield, the news would only get worse.
IN THE UNITED STATES, IF PEOPLE BELIEVE THEY ARE HARMED BY a medical product, personal-injury lawyers represent them. The same is true in England, with one important difference. When lawyers in the United States gather evidence to support a claim, they pay for it themselves. A typical example is described in Jonathan Harr’s A Civil Action. Parents in Woburn, Massachusetts, believed their children got cancer from drinking water contaminated by chemicals from a nearby tanning factory, W. R. Grace. Convinced that Grace had polluted the water supply, they asked a lawyer named Jan Schlichtman to represent them. (Schlictman was played by John Travolta in the movie version.) Schlictman’s law firm spent hundreds of thousands of dollars gathering medical evidence and interviewing toxicologists to support the parents’ claim. In contrast, the United Kingdom has a program called the Legal Services Commission that provides money to lawyers to investigate claims. The commission, which has a fund of more than $1 billion, employs a panel of advisers to determine which claims are worth pursuing. When parents in the United Kingdom believed their children had been harmed by MMR, they sought out Richard Barr, who then applied for and won money from the commission.
In October 2006, more than two years after he had claimed that Andrew Wakefield had received $100,000 from Richard Barr, Brian Deer asked the Legal Services Commission for information under the Freedom of Information Act. He wanted to know how Barr had spent the money. On December 22, 2006, Deer received a report titled “Freedom of Information Act Request: MMR Multi-Party Action.” After he read the report, Deer realized he had grossly underestimated the amount of money that had been spent to support the case against MMR. The commission had provided $30 million: $20 million went to Richard Barr’s law firm; $10 million went to doctors and scientists.
To determine which investigators to support, Barr’s law firm set up a sixteen-person “Science and Medical Investigation Team.” The team’s leader had graduated from college with a Bachelor of Science degree and, according to the pamphlet used to recruit parents for the class-action lawsuit, had “an encyclopedic knowledge of medical matters.” Two members of the team had worked as laboratory technicians, one with Wakefield. Two others were nurses; the rest were lawyers. Not one member of Barr’s team had ever led a scientific investigation or completed graduate-level training in immunology, virology, molecular biology, microbiology, statistics, or epidemiology.
DEER UNEARTHED OTHER CONFLICTS:
Barr’s Science and Medical Investigation Team gave $800,000 to Andrew Wakefield to support his research. When Wakefield had been confronted by journalists two years earlier, following Deer’s claim that he had received $100,000, he argued that the sum was closer to $50,000. Now, with a document from the Legal Services Commission in front of him, Wakefield didn’t deny that the amount was far greater. “This work involved nights, weekends, and much of my holidays,” he explained, “such that I saw little of my family during this time. I believe and still believe in the just cause of the matter under investigation.”
Wakefield had other financial interests. Several months before his press conference announcing the dangers of MMR, he had filed a patent application for a safer measles vaccine. In the application, Wakefield had stated, “I have now discovered a combined vaccine-therapeutic agent which is not only most probably safer to administer to children and others by way of vaccination, but which also can be used to treat [autism] whether as a complete cure or to alleviate symptoms.” The coholder of Wakefield’s patent was the Royal Free Hospital, which had prepared a videotape for the press conference claiming that MMR vaccine was unsafe. Wakefield’s patent contended that measles virus, white blood cells from mice, and pregnant goats could be used to make a safer measles vaccine. Tom MacDonald, a professor at Southampton University and Britain’s foremost gut immunologist, called the concoction “total bollocks.” Wakefield also started two companies, Immunospecifics Limited and Carmel Healthcare (named after his wife), to sell diagnostic kits to parents of autistic children. But his products never progressed beyond the concept stage.
Wakefield wasn’t the only investigator to benefit from Barr’s largesse. Barr’s team had given John O’Leary more than $1 million to perform his studies. But the money hadn’t gone directly to O’Leary. Rather, Barr had given it to Unigenetics Limited, a company that O’Leary had set up on the campus of Coombe Women’s Hospital to test the intestinal samples provided by Wakefield. When the money that Unigenetics had received was made public, O’Leary said, “I cannot confirm the fees paid for this testing, but will consult with our accountants and endeavor to do so. I should also emphasize that I personally have not been paid anything by the Legal Services Commission, although I did receive fees from Unigenetics Limited.” John O’Leary was the director and the major shareholder of Unigenetics.
Kenneth Aitken, the clinical pathologist who had publicly supported Wakefield, had received $400,000. Before receiving the money, Aitken had edited Children with Autism: Diagnosis and Intervention to Meet Their Needs, an important and well-respected textbook in the field. In the book, Aitken had postulated the cause of autism: “It now seems certain that the brains of persons who become autistic in their early childhood already had microscopic faults in their development in early intra-uterine life, probably first expressed among cells of the early embryo, in the first month.” But after receiving money from Barr, Aitken appeared to change his opinion, now believing that autism might be caused by MMR. One month after Wakefield’s publication in the Lancet, Britain’s Medical Research Council appointed Aitken to a thirty-seven-member board to determine whether Wakefield’s science justified a change in vaccination policy. Aitken was the only member of the council to vote that it did (and the only member to have received money from Barr). Following an unrelated scandal, Ken Aitken resigned from his position in Edinburgh.
Walter Spitzer, the Canadian epidemiologist who had testified before Dan Burton’s committee that the odds favored a link between MMR and autism, had received $30,000. Spitzer’s assessment of Wakefield’s claims didn’t go unnoticed by his Canadian colleagues. Angered by his claims, Noni MacDonald, the dean of medicine and professor of pediatrics and medicine at Dalhousie University in Halifax, Nova Scotia, said, “I am embarrassed that he is an emeritus professor at McGill. I think he better go back and look at proper causality assessment before he makes that kind of statement. I would flunk him.”
Arthur Krigsman, the gastroenterologist from the New York University School of Medicine, had declared during Burton’s hearings that his findings were “independent” from Wakefield’s; he had received $30,000.
Marcel Kinsbourne and John Menkes, the California neurologists who had been the first to support Wakefield’s hypothesis in the American press, had received $800,000 and $90,000, respectively. Toward the end of their careers, both men had become expert witnesses for lawyers suing vaccine makers. (Marcel Kinsbourne would be heard from again.)
John March, the veterinarian who had claimed that animal vaccines were tested more extensively than MMR, had received $180,000. As the parent of an autistic child, March had been drawn into the controversy by Wakefield’s claims that MMR hadn’t been adequately tested before licensure. Michael Fitzpatrick, the author of MMR and Autism and father of an autistic child, later talked to John March about his odyssey. “[March] tells an interesting story of how he presented his data, carried out on behalf of the litigation, to a weekend meeting presided over by Richard Barr and Wakefield in a plush country hotel,” recalled Fitzpatrick. “When he told them that there was no difference between the children with autism and controls, he suddenly found that the meeting had moved on to a different subject. It was a Damascene conversion for him. He realized that Wakefield could not hear negative results.” March also talked to Fitzpatrick about the huge sum of money he had received from Richard Barr’s team. “I was interested when it emerged how much he had earned from the litigation,” recalled Fitzpatrick, “because he told me that he had been doing the lab work gratis at first, until he discovered that everybody else was claiming vast expenses and was advised that he should do likewise.” “There was a huge conflict of interest,” said March. “It bothered me quite a bit because I thought, well, if I’m getting paid for doing this, then surely it’s in my interest to keep going as long as possible. The ironic thing is [Barr’s team] was always going on about how, you know, how we’ve hardly got any money compared with the other side who are funded by large pharmaceutical companies. And I’m thinking, judging by the amounts of money you’re paying out, the other side must be living like millionaires.”
Evan Harris, a Liberal-Democrat Member of Parliament, later commented on the money paid by the Legal Services Commission to investigate MMR. “Those figures are astounding,” Harris told Deer. “The lawsuit was an industry, and an industry peddling what turned out to be a myth.”
Richard Barr defended the notion that a team of lawyers could lead a scientific investigation. “We became versed in the key scientific literature, filling yards of shelf space in the offices with prints of relevant papers,” he wrote. “Our office at one stage was full of cardboard urine containers and storage bottles. And we had adventures too.” One of Barr’s adventures involved flying autistic children across the Atlantic Ocean. Because British hospitals often refused to perform spinal taps on autistic children, Barr flew seven autistic children from England to Detroit, where spinal taps were performed in a private clinic. But despite collecting gallons of blood, urine, and spinal fluid from hundreds of autistic children, and despite receiving $10 million, the researchers and clinicians supported by Barr’s team never found the chronic measles infections, leaky guts, or brain-damaging proteins Andrew Wakefield had imagined.
IN SEPTEMBER 2003—AFTER RICHARD BARR ASKED FOR ANOTHER $20 million to pursue his case against vaccine makers—the Legal Services Commission withdrew its support. The commission, convinced that medical research had failed to provide a link between MMR and autism, said it would “not be correct” to spend more money on a trial that “is very unlikely to succeed.” Claire Dodgson, the chief executive of the commission, said, “I appreciate that this decision will come as a great disappointment to the parents involved. I sympathize with their situation. Their children are clearly ill and they genuinely believe the MMR vaccine caused their illness. However, this litigation is very unlikely to prove their suspicions.” Barr was crushed. He appealed the commission’s decision to the Funding Review Committee, but was turned back. On February 27, 2004, he tried one more time, appealing to the federal Judicial Review Committee, again without success. Realizing that further appeals would be unlikely to succeed, Richard Barr dropped his case against pharmaceutical companies, a case that had been expected to go to court in April 2004.
Barr later commented on the decision of the Legal Services Commission to abandon his clients. “I have some idea of what the anonymous sculptor of the Venus de Milo must have felt,” he said. “He had chipped away for years, slowly transforming a piece of the best available marble into a work of unimaginable beauty. Then, just when it was almost ready to be handed over, a well meaning cat rubbed against the base, the whole thing toppled over, and both arms fell off. I don’t know what language the sculptor spoke, but if there was a word equivalent to ‘bugger’ or worse than that I’m sure he uttered it. And [that’s] what I said and thought when the news came through to me on a slow train journey back to Norfolk [England], that the Legal Services Commission had, even after appeal, pulled funding from the MMR cases.” Unlike the 1,300 families he represented, Richard Barr had been compensated for his efforts, his law firm having received more than $20 million.
The case against MMR was the first in England’s history in which the Legal Services Commission financed scientific research. And it will probably be the last. The commission concluded: “In retrospect, it was not effective or appropriate for [us] to fund research. The courts are not the place to prove medical truths.” The commission reasoned that science directed by a team of personal-injury lawyers wasn’t likely to be the best kind of science.
IN DECEMBER 2001, THE ROYAL FREE HOSPITAL ASKED ANDREW Wakefield to resign. “I have been asked to go because my research results are unpopular,” he said. “I did not wish to leave but I have agreed to stand down in the hope that my going will take the political pressure off my colleagues. They have not [fired] me. They cannot. I have not done anything wrong. Losing a London hospital teaching job doesn’t do much for my [resumé] but there are bigger issues at stake. What matters now most is what happens to these children.”
No longer part of a major university or teaching hospital, Andrew Wakefield took his case directly to the press and public, disregarding scientists who disagreed with him. In February 2004, soon after leaving England, he became the director of research at the International Child Development Resource Center in Melbourne, Florida. Two physicians, Jeff Bradstreet and Jerold Kartzinel, direct the center and call it the home of the “Good News Doctor.” In his biography, Kartzinel claims that his youngest son’s autism developed immediately after receiving MMR. One year later, Wakefield moved to Austin, Texas, to work at the Thoughtful House Center for Children, which advertises, “If your child is diagnosed with autism, the next thing to know is that autism is treatable.”
In September 2005, the General Medical Council (GMC) in London, the agency responsible for licensing and monitoring physicians, charged Andrew Wakefield with several counts of professional misconduct. It claimed Wakefield had called for a boycott of MMR without clear evidence that the vaccine caused harm; recruited children to his study through anti-vaccine pressure groups; retained and used human specimens without consent; failed to answer questions from the government’s chief medical officer about the source of his funding; subjected children to “unnecessary and invasive investigations”; and gave five pounds (ten dollars) directly to children attending his son’s birthday party to collect their blood. The consequences of this investigation could be that Andrew Wakefield is permanently barred from practicing medicine in England. Wakefield has contested these charges, denying any wrongdoing.
DURING HIS 60 MINUTES INTERVIEW WITH ED BRADLEY IN NOVEMBER 2000, Wakefield had said, “I would have enormous regrets if [my theories] were wrong and there were complications or fatalities from measles.” Wakefield was right in acknowledg-ing that some parents might soon watch children suffer and die from measles, but he had overestimated his capacity for regret. Although study after study showed MMR didn’t cause autism, Wakefield remains unrepentant, wedded to a belief he considers irrefutable. Seeing himself as a champion of children, he asks: “Should we stop, should we go away, should we stop publishing because it is inconvenient? I’ve lost my job. I will never practice medicine in [England] again. There is no up side to this. But if you come to me and say, ‘This has happened to my child,’ what’s my job? What did I sign up to do when I went into medicine? I’m here to address the concerns of the patient. There’s a high price to pay for that. But I’m prepared to pay it.” Since 2005, when Andrew Wakefield first traveled to Thoughtful House in Austin, he has treated more than 2,000 autistic children, still performing colonoscopies when he believes they are necessary.
Andrew Wakefield, pictured with his wife Carmel, is flanked by supporters on his way to a hearing before Britain’s General Medical Council on charges of misconduct, July 16, 2007 (courtesy of Getty Images).
Michael Fitzpatrick never saw Wakefield as a humble servant of the people. As the father of an autistic son, Fitzpatrick is angry that Wakefield has diverted attention and research away from the real cause or causes of autism, adding his own postscript to the Wakefield saga: “Although Dr. Wakefield’s self-consciously humble posture is a popular departure from the traditional image of the paternalistic doctor, it raises some questions. If it is true that he has learned everything he knows about autism from parents, this suggests that his knowledge is very limited; parents are in no position to acquire the broad scientific understanding of autism required by a medical researcher. If it is not true, which is more likely, it is merely insincere. Furthermore, Dr. Wakefield appears to be highly selective in his listening: while he hears parents who endorse his views, he remains deaf to parents who do not. Nor does he appear to listen to the vast majority of his scientific and medical peers. For all Dr. Wakefield’s talk about humility, his continuing public promotion of the anti-MMR cause in face of the weight of evidence to the contrary does not suggest a surfeit of this virtue.”
FOLLOWING ANDREW WAKEFIELD’S PUBLICATION IN THE LANCET, rates of immunization with MMR declined and measles outbreaks swept across the United Kingdom and Ireland; hundreds of children were hospitalized and four children died from a disease that could easily have been prevented. Further, the campaign against MMR caused, according to Michael Fitzpatrick, “an enormous wave of unnecessary anxiety among parents facing decisions about new immunizations, slowed the introduction of new childhood vaccines in Britain, encouraged the emergence of sleazy clinics selling single-agent vaccines, and added an additional burden of guilt and self blame to parents.” Unfounded fears of the MMR vaccine clearly damaged the public’s health. Who, if anyone, should be held accountable?
Andrew Wakefield, the Royal Free Hospital, the British media, the Legal Services Commission, and the Lancet’s editor-in-chief, Richard Horton, all played a role in the events that followed.
Wakefield published his Lancet paper based on the findings of eight children with autism. He knew that the only way to prove his contention was to show that autism was more common in children who had received MMR. And he knew that he hadn’t done that study. Correctly, Wakefield explained the limits of his study in the discussion section of his paper: “We did not prove an association between measles, mumps, and rubella vaccine and [autism].” It would have been more accurate if he had said he hadn’t provided any evidence that MMR caused autism and had merely reported the convictions of the parents of eight autistic children. But Wakefield came to his press conference with his own public relations firm in tow and, throwing caution to the wind, told the press and the public that he had likely found a cause of autism. When study after study refuted his theory, he remained unrepentant. “I don’t think he’s an innocent in this,” said David Salisbury, the director of immunization for the Department of Health in the United Kingdom. “He knew exactly what he was doing. And throughout he has never shown the slightest contrition for what he has caused. He’s had more than enough opportunities to say to the world, ‘I deeply regret the fact that I, acting out of the best of interests, got this wrong and now realize the consequences of what has happened.’ He’s never done this.”
During Wakefield’s press conference, the Royal Free Hospital showed a videotape warning of the possible dangers of MMR. The hospital was also a coholder on Wakefield’s patent application for a safer measles vaccine. And members of the Royal Free, including John Walker-Smith and Arie Zuckerman, willingly participated. “They could have [and] should have restrained Wakefield at an earlier stage, or at least have stopped the press conference grandstanding,” recalled Michael Fitzpatrick. “But it seems they were all in some way captivated by him, by his offer to end their careers in a blaze of glory. It almost seems that they looked to Wakefield as the savior of the Royal Free, a folly that ended up damaging everybody. Like many aspects of Wakefield’s story, it has elements of a Greek tragedy.”
Following Wakefield’s Lancet publication, the media trumpeted his claims. Journalists like Melanie Phillips of the Daily Mail, Lorraine Fraser of the Sunday Telegraph, and Heather Mills of Private Eye, wrote of unsavory drug company influence and health officials asleep at the switch. They painted Andrew Wakefield as a hero, a man of the people, willing to confront forces bent on crushing him. It was great theater. The deterioration of trust in vaccines could never have happened without them. “The media coverage told parents not only what to think, but also how to think about the MMR vaccine,” wrote Tammy Boyce, author of Health, Risk and News: The MMR Vaccine and the Media. Boyce argued that the media’s ritualistic mantra of balance—equally weighing one man’s speculations with studies that clearly exonerated MMR—created a “charade of objectivity.”
The Legal Services Commission gave $30 million to Richard Barr to investigate the case against MMR. The money spent by Barr’s team funded bad science that was never reproduced by other scientists. When these poorly designed and poorly executed studies were exposed, the commission’s board members questioned whether it was appropriate to allow personal-injury lawyers to direct scientific research. But contrition came far too late, the damage done.
Richard Horton, the editor-in-chief and gatekeeper of the Lancet, was probably in the best position to prevent the harm caused by Andrew Wakefield’s paper. With a database of 8,000 expert reviewers, a circulation of 40,000, and more than 1 million online users, the Lancet is the longest-running general medical journal in the world, and one of the most influential. Launched in 1823 by Thomas Wakley, a doctor, coroner, and Member of Parliament, the Lancetwas the first journal to describe the value of blood transfusions, antiseptics, and penicillin. The Lancet was also known for its muckraking. Wakley, who named the journal for the sharp instrument used to puncture festering boils, used his editorial position to rail against what he saw as corruption, nepotism, and incompetence in the medical establishment. Richard Horton has followed Thomas Wakley’s lead. Journalist Nicole Martin noted that Horton’s “firebrand style and penchant for challenging vested interests in medicine met with admiration and criticism among medical editors.” Another journalist later remarked, “Secretly, I admire him. But I do wonder if he is slipping sideways into journalism rather than scientific editorship.”
Because Wakefield’s paper was inconclusive, Horton simultaneously published an editorial from Robert Chen and Frank DeStefano, vaccine safety experts from the CDC in Atlanta, warning of the study’s limitations. By including Chen and DeStefano’s editorial, Horton believed he had bracketed Wakefield’s paper with the necessary caveats. But doctors, scientists, immunologists, virologists, and public health officials, angry that the journal had published such poor science, immediately flooded the Lancet with letters. Horton defended his decision: “There was no question in my mind that, subject to external peer review and editorial debate, we should publish this work. The description of what seems to be a new syndrome and its relation to possible environmental triggers was original and would certainly interest our readers. Recent history tells us that full disclosure of new data is preferable to well-meaning censorship.” Critics countered that the Lancet published only 5 percent of the 10,000 papers it received every year, wondering whether rejection of the other 95 percent was an act of censorship or editorial judgment. Horton also hadn’t anticipated that Wakefield would hold a press conference warning parents against MMR, even though Wakefield had done exactly that several years earlier when he announced that measles vaccine caused Crohn’s disease, a claim he later retracted in the face of overwhelming evidence to the contrary.
Richard Horton later published two books discussing his role in the controversy, MMR Science and Fiction: Exploring the Vaccine Crisis and Second Opinion: Doctors, Diseases, and Decisions in Modern Medicine. Five years after he had published Wakefield’s paper, Horton was unrepentant. “There [is] an unpleasant whiff of arrogance in this whole debate,” he said. “Can the public not be trusted with a controversial hypothesis? The view that the public cannot interpret uncertainty indicates an old-fashioned paternalism at work. The public is entitled to know as much as possible.” But by ignoring the criticisms of several reviewers, the warnings of an accompanying editorial, Wakefield’s history of holding press conferences, a British press primed for controversy, and a public distrustful of public health officials, Richard Horton allowed parents to question the safety of a vaccine based on flimsy, irreproducible data. The loss of public trust that followed was entirely predictable. “It was a stunning error of judgment,” opined David Salisbury. “It is hard to believe that the paper was properly reviewed. On the link with MMR, it was a complete mess, and had a chance of being correct that was about zero. [Horton] bears a considerable burden of responsibility.”
Learning little from his encounter with Andrew Wakefield, Richard Horton has published papers in the Lancet claiming that genetically modified foods damaged rat intestines, silicone breast implants induced harmful antibodies, and casualties sustained during the U.S.-led invasion of Iraq totaled 655,000 (about ten times the actual number). Like Wakefield’s paper, all of these assertions garnered enormous media attention for his journal, and all have been clearly refuted.
Despite massive educational campaigns by public health officials, measles immunization rates in the United Kingdom never fully recovered. In 2006, more cases of measles were reported than in any single year since 1995. Between June and August 2007, the number of measles cases tripled.
DESPITE THEIR PROFESSED GOOD INTENTIONS, DOUGLAS BIKLEN (facilitated communication), Karoly Horvath (secretin), and Andrew Wakefield (MMR vaccine) had proven to be false prophets in the quest to find a cause and a cure for autism. In the next few years, parents would turn their attention to another vaccine component and yet another group of unlikely heroes.