by Brian Deer
Was this some kind of psychological projection, I wonder? If so, it wasn’t one-off. Back in London, with his sidekick, Scott Montgomery, and Ms. Two, he’d done something similar. They’d been invited by the Medical Research Council to a workshop on autism. But just days before, all three pulled out, saying they’d learned that some participants were being paid to advise drug companies in a lawsuit.
The lawsuit was Barr’s. But the target participants were on the other side. And had Wakefield attended, it might have come out that he’d the same conflict as them. Nevertheless, he wrote to the workshop’s organizers:
While we have no doubt that these individuals have declared their obvious conflict of interest, declaration of such a conflict in an area that is as charged and sensitive to public scrutiny as this one may be interpreted as being merely cosmetic. Such a conflict is irreconcilable and should have precluded them from acting in both roles.
Acting in both roles? A curious reflection. And, even before his conflict regarding the twelve-child paper and his performance in the Atrium to launch a public health crisis, Wakefield’s deal with Barr—to create bespoke evidence—went way beyond acting as an expert.
To be fair to Burton, he couldn’t have known. And he, too, had made up his mind. He couldn’t have run his committee with more partisan glee if the topic was Democratic Party finance. So he posted Wakefield’s letter on the congressional website and likened its author to a titan of medicine.
“I believe other scientists who have differed with the prevailing opinions have suffered similar castigation as you have,” Burton announced when Wakefield finished giving evidence to the committee. “You may rest assured that eventually the truth will out. Louis Pasteur found that out, after seventeen years, when he was knighted. So eventually the truth will come out, and those who criticize, and continue to denigrate what you have done, will be eating a heck of a lot of humble pie.”
Here was a bridge-builder as keen as Schafer. But, back in London with Barr’s class action, the other end of that bridge was on fire.
SEVENTEEN
Unblinded
Were it a few years later, there might have been video. Someone might have pulled out their iPhone or Android and captured the behaviors—reactions, expressions—when, at last, the music stopped. The scene: the unblinding, the moment of truth, when, as far as Richard Barr’s lawsuit was concerned, all would be revealed.
Well, enough.
A year before, the BBC had filmed a precursor. They were present at the scoping of a sixteen-year-old boy whom Wakefield had cited to the congressman, Dan Burton, as a case of vaccine damage. But the green-aproned endoscopist, Simon Murch, gazed at the monitor in the Royal Free’s endoscopy suite and pronounced nothing diagnostic of any condition.
In the BBC video (broadcast on the Panorama investigative program reported by the sister-in-law of the chair of Wakefield’s Visceral entity), the mood was caught in a four-second clip. Here was Wakefield, peering over the endoscopist’s shoulder, with a demeanor resembling the way I think he must have felt as the unblinding ground painfully forward. His right hand rises and covers his eyes, like he’s suffering from migraine, or jet lag. His palm slides to his cheeks, then the back of his neck. His head twists left, with his right elbow rising. He fingers the collar of his shirt.
The unblinding took place over two spring days in 2003: April 27 and 28. The location was a window-walled seminar room, in a low-rise, oddly shaped Venture Centre on the edge of campus at the University of Warwick, in the rolling green midlands of England. The host: Micropathology, a contract diagnostic and research company, which shared a front desk, coffee shop, and bathrooms with maybe twenty small businesses like itself.
Eyewitness reports said that Richard Barr was present, with his scientist and wife, Kirsten Limb, plus a huddle of retained experts and aides. Their purpose: to decode the final laboratory results on both measles virus and opioid peptides.
For the first time ever, the Wakefield hypothesis of viral causation, and the stoned rodent model of childhood autism, would be checked against data from controlled, blinded studies. So the status of the children from whom samples were taken—whether autistic cases or neurotypical controls—wasn’t known to researchers in advance.
Here was the climax to a project unheard of in the annals of forensic medicine. Working under Limb, the agricultural graduate, the lawyers had hired a nurse to travel around Britain, collecting blood and urine from client children and others, then delivering it to Micropathology. In turn, the research company dispatched it to labs, including to the pathologist, John O’Leary, at the Coombe Women’s Hospital, Dublin.
“Our nurse, Sarah Dodd, is working hard to try to collect as many samples in the quickest possible time,” Barr explained to clients in a “strictly confidential” newsletter from his office, where the bottles and boxes were kept. “She has managed to collect blood and urine samples from a total of approximately 100 children so far. This includes ‘control’ children (age- and sex-matched children who have not been affected by the MMR vaccine).”
No question about it, this was a race against time. A decade had elapsed since the case of Richard Lancaster: the Norfolk schoolboy who, after MMR, developed mumps-meningitis, and on whose mother’s house purchase Barr did the paperwork.
Court deadlines loomed: the evidence on autism must be ready for exchange with the drug company defendants no later than the fourth of July.
The once small-town solicitor now ran with the big dogs. By the time Nurse Dodd set off on her rounds, Barr worked for a law firm with a backroom team of dozens. There were week-long meetings with experts from America, conferences with Queen’s Counsel in book-lined chambers, foreign expeditions to keep abreast of the science, and nights at swanky hotels.
“The ironic thing is they were always going on about how ‘you know we’ve hardly got any money compared with the other side,’ ” a veterinary vaccine specialist by the name of John March, who attended the unblinding, tells me. “And I’m thinking, judging by the amount you’re paying out, the other side must be living like millionaires.”
Some surely were. Pretrial court hearings were like parties of middle school geography teachers pitched against the Roman army. Alongside Barr’s team of about eight—to the judge’s right—would be three dozen from the defendants, to his left. The opposition was the same as it was all along: Big Pharma in all its might. Headquartered in Lyon, France, was Aventis Pasteur (later Sanofi Pasteur). From the United States: Merck Inc. of New Jersey. And, from Britain, what was then called SmithKline Beecham (later GlaxoSmithKline, or GSK).
Until now, Barr and Limb had traded on arguments over the ever more elaborate hypothesis-upon-hypothesis that Wakefield had glued together. Born of his inspirational moment in Toronto—speculating on the cause of Crohn’s disease—it had embraced measles virus after he read an encyclopedia. Then he’d picked up the psychobiologist’s opioids conjecture in the post-Newsnight call from Ms. Two.
With minimal forays into other possibilities (such as that measles might damage neural structures directly), they lined up their ducks with the same ol’ same ol’: MMR → persistent measles virus → enterocolitis → leaky gut → opioid excess in blood to the brain → regressive autism.
Bada bing, bada boom.
“I was convinced that one day all of this would come out,” says March, an expert on rinderpest virus, the cattle equivalent and ancestor of measles. “Basically what you had was two legal people running a five or six million pound research program. And that would be unprecedented. If you went to the Medical Research Council and said you were going to have your entire research budget for this year run by a lawyer and a legal assistant, they would just be incredulous. But that really is what happened.”
The pair worked all hours. But whether or not MMR did or didn’t cause autism, their case was in chaos from the outset.
“I cannot overemph
asise the fact that to embark on the litigation in this state would be catastrophic,” wrote a Queen’s Counsel advocate, Jeremy Stuart-Smith (son of the judge, Sir Murray, of the DTP checklist). He’d been hired to work alongside Augustus Ullstein and gave this advice in twenty-two secret pages, two months after the first writ was served.
Despite such warnings, little improved, while fees and costs sprouted like bamboo. So tough was the challenge that, in July 2000, Barr’s team even proposed (the judge called it “daft”) that autism be indefinitely “left to one side” and a trial proceed purely on the claim that MMR caused “autistic enterocolitis.”
And yet, to me incredibly, this alleged new bowel disease was often “subclinical,” they submitted in court, meaning the sufferer didn’t even know they had it. “The fact that the infection may not cause clinical symptoms,” insisted a statement filed from Barr’s team, “is not an indication that it does not exist.”
Even six months before the showdown at Warwick, Queen’s Counsel remained unconvinced. After an intermediate opinion from Stuart-Smith Junior that without better evidence the claims would “fail,” three QCs (Barr hired another, Simeon Maskrey) reported to the Legal Aid Board on the strength of the case over autistic spectrum disorders, or ASD.
We are still not able to say, on the balance of probability, the vaccine has caused ASD.
The balance of probability. Nowhere near scientific proof. And yet, beyond the lawsuit, in both Britain and the United States, fear and guilt over the shot was causing turmoil in families—and outbreaks of disease were crackling. Even the mayor of London, a man named Ken Livingstone, urged parents to shun MMR. “There is no way I would inflict that risk on a child,” he opined on a radio show. “Why whack them all into a child at the same time?”
But behind the veil of Barr’s multiparty suit—which maxed out with compensation claims for sixteen hundred children—his QCs still struggled with the logic. Wakefield’s attempts to satisfy the Stuart-Smith checklist offered little explanation as to why the triple product, over which they were suing, was less safe than single shots. At the heart of the action remained the big idea, shining as brightly as any time in his life.
As one of two judges in the proceedings noted:
The mechanisms all take their point of departure from the demonstrated persistence of measles virus in the body of children with regressive autism.
Wakefield himself couldn’t solve the riddle. He wasn’t a virologist, immunologist, epidemiologist, or any kind of -ologist to render his opinion admissible on such matters in court. And, when interviewed in writing by Britain’s national Science Museum (for an exhibition in London at the time of the unblinding), he admitted that he didn’t know.
SCIENCE MUSEUM: Andrew Wakefield has suggested separating the jabs by one year to be on the safe side, and that’s what most doctors offering single jabs are sticking to. What’s his reasoning?
WAKEFIELD: It’s purely empirical—we have no idea. It’s the public health people’s job to look into that.
And so, back to Warwick: with the coded results from Nurse Dodd’s gatherings of blood and urine. “It was all blinded beforehand,” recalls March, a clean-cut molecular biologist, virologist, and former Harvard Medical School fellow. “And you had one of the people there give results, and say, ‘That was an autistic child, that was a control.’ ”
The action opened like an Oscars-night envelope, and closed like a Las Vegas daybreak. “Once it started being written up on a board,” March says, “it became blindingly obvious that, for every test that was done, there was no difference between autistics and controls—whether that was looking at urines, or looking at measles virus.”
March was a great source. Relieved to talk. And he’d a close relative diagnosed with autism. “I’ve never actually seen this published—I don’t know why—but, bizarrely enough,” he tells me, “there were more of the control kids that apparently had measles virus in them than there were autistic kids.”
I can vouch for such anomalies, using a spreadsheet I obtain of results from the Dublin lab. While Child Two’s blood, for instance, was reported negative for measles, three control subjects—with the family name “Wakefield” and initials I recognize—were tabulated as infected with the virus.
March’s commission was to prove opioid excess—measured by peptide levels in urine. He worked at the Moredun Research Institute, a center for the study of livestock diseases, south of Edinburgh, Scotland. And Barr and Limb hired him to use mass spectrometry—bombarding test samples with electrically charged particles to weigh their molecular components.
In a post-results interlude, March, with a colleague, stepped from the meeting room into a wide, carpeted corridor where, previously blinded to their own test results, they contemplated the implications of the data. To them, “opioid excess” looked dead in the water. Measles: just as bad.
“And I went back in, and they just continued as if nothing had happened,” he remembers. “I kind of said: ‘I’m sorry, I don’t understand. There is no case.’ And they looked at me: ‘What do you mean?’ I said, ‘Well, obviously there’s no case here.’ ”
He says he was asked to sign a confidentiality agreement. The data would never be published. “It was almost like it had become a religion. And if you got a result that you didn’t like, you ignored that result and carried on.”
No surprise there. That was the logic of litigation. The goal wasn’t truth. It was to win—or, at least, maximize billing to legal aid. And, understandably for a lawyer, Barr kept his nerve, even after the unblinding opened eyes. A peptides meeting was promptly convened in Norfolk (flying four academics from the United States to huddle with March), at which “opioid excess” was unsentimentally dumped for a new “opioid suppression hypothesis.”
Defending the big idea was less straightforward. Persistent measles was integral to the argument. So, after doubts were raised over the Dublin lab, Barr had commissioned a backup. Based at Barts and the London Hospital (into which John Walker-Smith’s old workplace was merged), a team with many years of PCR experience was hired to duplicate O’Leary’s tests.
Their machine was the same as his: an ABI Prism 7700. Their “primers” (short strings of engineered nucleotides to seek and bookend gene sequences for amplification) were identical to those at the Coombe. Their “probe” (a different string, meant to bind to the target, so as to trigger a fluorescent signal upon detecting the virus) was, similarly, a perfect match. Everything was set for the Irish pathologist’s findings to get impeccable backup confirmation.
The London work went well. Except for one snag: the English lab couldn’t find the virus. Well, they could find the virus, in positive controls, and a few samples preprocessed in Dublin. But where blood for the tests came directly from Warwick—and never crossed the choppy Irish Sea to the Coombe—they found nothing. Nada. Zilch.
“The lack of positive results in RNA extracted in our laboratory,” wrote Finbarr Cotter, the lab chief and professor of hematology, in a report filed on behalf of Barr’s clients, “leads us to conclude that these samples had no detectable measles virus at the level of detection in our laboratory.”
Reports were now exchanged with the defendants’ advisers (twenty-eight from Barr’s team; thirty-two from the drug companies). Both sides now saw each other’s hands. The companies’ experts—mostly leaders in their fields—were uniformly excoriating of each and every aspect of the MMR-autism allegations. But leading counsel for the children—the three QCs—also bumped rocks close to home.
Wakefield’s report ran to two dense volumes, totaling 198 pages. To my count, the word “consistent” appeared fifty-nine times, and there were five boilerplate statements on causality. “It is my opinion that, on the balance of probability,” he affirmed for Child Two, and four more of eight test cases, “the disease was caused by, or at least contributed to by, MMR.”
That was his conc
lusion. It could hardly be otherwise. But, in volume 1, paragraph 1.1, of his epic analysis, he rushed over an extraordinary admission.
I will not be relying on the data of Kawashima et al. I have been told that according to Dr Kawashima, the data are not available for further scrutiny.
This was the Japanese pediatrician who claimed to find gene sequences “consistent” with vaccine strain measles: the so-called “smoking gun.” But Wakefield’s “coordinating investigator–molecular studies,” Nick Chadwick, had warned him of issues at the time. Kawashima had reported sequences from autistic children’s blood cells that precisely matched tissues from a patient in London with the fatal SSPE brain disease. They’d been sent from Hampstead as positive controls to evaluate the Tokyo doctor’s PCR.
This neatly chimed with Chadwick’s inability to find any measles himself. He was sure the Japanese had reported false positives, and he later made this clear in a statement. “Each of the SSPE positive controls I had been using had quite specific changes in its sequence and so it was easy to determine when a sample had been contaminated from this source,” he wrote. “I mentioned this to Dr Wakefield, but he did not seem to take any particular notice.”
Barr’s three Queen’s Counsel absorbed Kawashima as they pored over reports from both sides. Then, on Friday, August 8, 2003, they put Barr’s lawsuit out of its misery. “Upon the assumption that no further test results would be admitted in evidence by the judge,” they concluded in a secret 218-page opinion, “we consider that the claimants would not prove that the vaccine has caused, or is capable of causing, ASD.”
So that was that. Applicable law kicked in. The legal board stopped the money. And while its decision would be appealed to an independent review panel, to the High Court (twice), and to the Court of Appeal, it would never be overturned. And on Wednesday, October 1, 2003, the board, now renamed the Legal Services Commission, or LSC, issued a statement from its chief executive, with a small-print footnote harking back to the board’s fatal mistake, years before, when it approved Wakefield’s “clinical and scientific study.”