by Brian Deer
Rima, the scientist, had read O’Leary’s Washington speech. So Dada’s team couldn’t say they weren’t warned. The pathologist even identified to Burton’s committee his equipment: an ABI Prism 310 capillary sequencer (94 kg / 210 lbs.). It sifted nucleotides, one by one.
And this technology, with his 7700, wasn’t only the kind of kit that caught serial killers from a smudge of spit or strand of hair. It was what Wakefield had promised to the Legal Aid Board in the summer of 1996. “Strain-specific” sequencing was a key element of the research he was contracted to perform in his vaccine damage test, now more than seven years before.
But O’Leary never delivered. Sequencing wasn’t done—as I later find in papers from the lawsuit. Just as Wakefield had refused to mount a definitive study, when the claims for Barr’s test cases were filed in court the same phrases were deployed, again and again, with regard to the pathologist’s gold standard.
For samples from a thirteen-year-old boy with autism:
It is denied that sequencing is necessary
For those from a second boy, aged fifteen:
Sequencing is unnecessary
And, of course, for those from Child Two, the sentinel case:
It is denied that sequencing is necessary
For these children, the claim was that the vaccine virus in MMR was the ultimate culprit for their autism. But doctors and scientists, supervised by lawyers, able and equipped to fingerprint the suspect—and so maybe save humanity from a repeat offender—had considered this, and chosen not to do it.
TWENTY
The Spoiler
The editor-in-chief of The Lancet, Richard Horton, stared at me like one of us had broken wind, and he feared the finger of suspicion. Seated to the side of a long, polished table, his face was stone, eyes narrowed, lips stretched, as I outlined the first findings of my inquiries. During eight years at the top of the world’s number two general medical journal, his bravest gamble had been the doctor without patients. Yet, here was I, a newspaper reporter, showing him how dumb that was.
“Dapper” is a word I’ve seen used to describe Horton. “Adjective: neat and spruce in dress and bearing; trim.” In his case, “Pleased with themselves.” Still only forty-two at the date of our meeting—which came twelve weeks after my conversation with Ms. Two, and six weeks after Gillian Dada went to Dublin—he’d seized the journal’s chair after two years in New York, seeing off more experienced contenders. I’d heard whispers that he was shrewd to the point of cunning. But he’d still much to learn, as we’d see.
Still unaware of the events at the Coombe, I stood at the table’s head, in the Lancet’s conference room, with my right fist clutching a Magic Marker. Horton sat diagonally to my right, occasionally scribbling, while five of his senior staff, mostly to my left, leaned forward in their chairs, doing the same. At the far end lounged my witness—a member of Parliament named Evan Harris—who I hoped would protect me from any complaints to my editors, of which investigative reporters get a lot.
“And then there’s this,” I say, sketching a row of squares on a flipchart pad mounted on an easel behind me. “Here’s the case series of twelve, extended to thirty kids seen at the Royal Free. So, here it’s got the first twelve from the paper, and then it runs on with another eighteen. Okay? Now look at this.”
In my investigation so far, I’d found a couple of “abstracts” that threw open a window on the pilot study. They were near-identical texts, about three hundred words each, that Wakefield had filed for gastroenterology conferences in the north of England and New Orleans, Louisiana. They were mere snippets of information about the Royal Free research but gave headline data on more of the patients admitted to Malcolm Ward for scoping.
I move along the squares, marking eight of the twelve from the paper’s Table 2: those whose parents had apparently blamed the three-in-one shot for their child’s “developmental regression.”
Eight of twelve. So, two out of three.
“But, according to the abstracts,” I continue, “out of the next eighteen cases, only the parents of three more children—only one in six—named MMR. So why would that be? Why would there be this cluster, right there at the start, and then it fades?”
By then, I knew the answer: the Legal Aid Board contract. What Wakefield couldn’t have expected in 1996, was that a soon-incoming government would introduce a Freedom of Information Act. So I’d made an application, got a briefing from the board—by then renamed the Legal Services Commission—and eventually obtain the two-page document commissioning the “clinical and scientific study,” stating the amount of money involved.
At the time I meet Horton, that deal was still secret. Even Wakefield’s coauthors didn’t know of it. And, although the Scottish professor, Anne Ferguson, nearly rumbled him at the Royal College of Surgeons meeting six years before, he’d even covered his tracks in the lawsuit. “This study received criticism from several quarters,” he noted in his report to the court, citing among that criticism the complaint that the children studied were “a highly selected population.”
Indeed, they were. But he’d an answer for that to make the kids seem like routine patients.
This is a specious argument. Children with gastrointestinal symptoms present to paediatric gastroenterologists. Patients with inflammatory joint pain are referred to a rheumatologist, patients with optic neuritis (inflammation of the optic nerve) come under the care of neurologists. Patients are self-selecting by virtue of their symptoms and disease—this is the nature of medicine.
In fact, the cluster was of children brought by parents intent on complaining about the vaccine. So the paper, and the panic that Wakefield unleashed, had guaranteed public money for the lawsuit (and himself) while, contrary to the rules of biomedical publishing, obscuring the source of his subjects.
There was plenty more at The Lancet. The meeting lasted five hours, with plates of sandwiches brought in for lunch. The next big thing—in some ways the biggest—was the matter of who protected those children from exploitation as they were forced through the hospital, some kicking and screaming, for the battery of sedations, scopings, scans, spinal taps, blood draws, and barium drinks. The paper said the “investigations were approved” by the hospital’s ethics committee. At the table, I tell Horton this is false.
I could see him struggling to suppress a reaction. Not only was he a licensed medical practitioner, but for years he’d virtue-signaled on just such matters. He was the inaugural past president of the World Association of Medical Editors, a coauthor of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, and a founding member of the Committee on Publication Ethics. He was Dr. Squeaky Clean on propriety.
And he wasn’t the only one—in that room or beyond—to be perplexed that day by my findings. This was Wednesday, February 18, 2004—four days before my story (what little I had at the time) was scheduled for page 1 treatment. As I spoke at the Lancet’s offices—two miles south of Hampstead—two miles south of those, at Wakefield’s publicist’s in Mayfair, three of my colleagues were interviewing the man.
By now he was living in Austin, Texas. And after refusing, through his publicist Abel Hadden, to speak to me, he’d flown to London on the condition that I shouldn’t be present when he was questioned for the story. Rather, he saw a chance to work his charisma on journalists who lacked my grasp of the facts.
Our side, however, was led by the paper’s third-in-command: an eerily calm executive, Robert “Whispering Bob” Tyrer, who’d spent years wrangling tricky situations. And with him was Paul Nuki, the “Focus” editor—who, I thought, raised the killer issue in a question that morning that captured the character of our subject.
“I’m saying to you,” Nuki put it, “that the fact that you were an agent, being paid to work for Barr and his clients, was something that should have been disclosed.”
“I don’t agree,” Wakefield r
eplied.
“You don’t agree?”
“I don’t agree.”
And there he was. Rules didn’t apply to him. Not even rules to protect the integrity of potentially life-impacting medical research. The world, he believed, was however he said that it was, just because he said it was so. The kids were referred “solely on clinical need,” he claimed. The investigations were approved by the hospital’s ethics committee. There were no conflicts of interest.
“I acted with due propriety in every case,” he told Tyrer and Nuki. “I have no regrets.”
But the Uniform Requirements were clear on this point. Both third-party funding and expert witness work must be acknowledged as conflicts of interest:
Financial relationships with industry (for example, through employment, consultancies, stock ownership, honoraria, expert testimony), either directly or through immediate family, are usually considered to be the most important conflicts of interest.
In the past, he’d scrupulously adhered to the principles. In his first Lancet study—photographing blood vessels—he stated that he was a Wellcome Research Fellow, and that a coauthor was “supported by a grant from the Crohn’s in Childhood Research Appeal.” In J Med Virol, he again cited Wellcome, plus two foundations. And in his question-marked study, he declared a coauthor as supported by two charities and Merck.
His MMR coauthors and associates were stunned when they learned of what we’d got. John Walker-Smith declared himself “astounded” to hear of the legal board contract. “There was no awareness of any legal involvement when we saw these children,” he tells me, when I phone him at home (referring to the board under its new identity as a “services commission”).
“You must have known that in August 1996, the Legal Services Commission entered into a contract,” I put it to him.
“Absolutely not.”
“For fifty-five thousand pounds.”
“Absolutely not.”
“And that the preliminary report was submitted to the Legal Services Commission in January 1999.”
“Absolutely not.”
The Irish pathologist, John O’Leary, professed himself similarly “shocked.” Simon Murch, the endoscopist, reacted, “We are pretty angry.” And another of the paper’s authors, who asked not to be named, said he was “very, very” angry.
“I would never have put my name to the study if I had known there was this conflict of interest,” he fumed. “And had I not done so, it would never have got published.”
That Wednesday, the two meetings—me at The Lancet, and Tyrer and Nuki in Mayfair—went forward in parallel. Then it was my turn to be stunned. When I finished my presentation, I expected a response. Something like, “We need time to investigate.” But Horton refused to comment and, moments later, told me that Wakefield had entered the building.
On the phone before the meeting, and again before it started, the chief editor had agreed that our discussion would be private. He even offered to sign an undertaking. “You don’t need to worry,” he told me. “We are all, you know, very experienced here in dealing with confidential material.”
But what I didn’t know, because I hadn’t researched him, was that Horton had history with Wakefield. Before joining The Lancet, he’d spent two years at Hampstead, where they’d worked alongside each other. And, just eight months before I stepped into that conference room, the editor revealed himself smitten.
“He is a committed, engaging, and charismatic clinician and scientist,” Horton simpered in a book. “I do not regret publishing the original Wakefield paper. Progress in medicine depends on the free expression of new ideas. In science, it was only this commitment to free expression that shook free the tight grip of religion on the way human beings understood their world.”
Now it seemed that Horton wanted a tight grip himself: over a story that threatened his image. Within hours of the meeting, he put together a team of doctors to investigate and report on my discoveries. He picked Wakefield, Walker-Smith, Murch, and another coauthor, Mike Thompson, who scoped two or three of the kids.
Naturally these four wouldn’t work unsupervised. That wouldn’t do for The Lancet. There would also be a hepatologist named Humphrey Hodgson, who’d taken over from Arie Zuckerman as the Royal Free’s vice-dean. Plus Abel Hadden, Wakefield’s personal publicist, at whose offices Tyrer and Nuki had quizzed him.
“Is it customary,” Horton would be asked later, when a panel of the UK’s General Medical Council was convened to reinvestigate my first findings, “for an investigation of possible serious research misconduct to be carried out by the people who have been so accused of the misconduct?”
“It is customary for the institution to lead an investigation and to gather the data which will inevitably involve those who took part in the investigation,” Horton replied. “It is then the responsibility of the institution to make sure that there is some kind of separation between its interpretation of those findings and those who are involved in the investigation who are being in some sense accused of a set of allegations, and once that interpretation by the institution has taken place and has been conveyed to whoever has brought the allegations to them then we can go forward. So there certainly should be some separation, which is why in the first instance I wanted to get the reaction from Dr Wakefield, Professor Walker-Smith, and Dr Murch, but after that my duty was to go to the head of the institution, the vice-dean, in this case Professor Hodgson.”
They did a great job: exonerating each other on each and every matter they examined. But there was no “separation” and no “independent inquiry”—as the medical school later confirmed. The day after the meeting—Thursday—Horton moved to the hospital, where Walker-Smith, now retired, returned to work with Thompson, rooting through the children’s records. They concluded that all was well, noting they found referral letters, so purportedly disproving my submission of Wednesday that families were marshaled for complaints.
Murch, meanwhile, dug into institutional review files and dismissed any ethical error. He was himself a member of the ethics committee, and even fished out a code number, 172/96, as proof that it authorized the research. “I can confirm that the patients presented in the Lancet study were investigated in accordance with the ethics committee approval,” he ruled on behalf of Horton’s team.
Wakefield wasn’t allowed onto Royal Free premises. But from his family’s house at Taylor Avenue, he supplied the children’s names (which the hospital, medical school, and other authors didn’t have) and drafted a claim that his work for the legal board was for an “entirely separate study.” Whether parents made a link with MMR, he said, had “no bearing whatsoever” on their inclusion.
But a mass of documents told a different story. Starting with the children’s records. None of the twelve lived in London (the nearest’s home was sixty miles away), and files were thick with signs of orchestration, as local doctors rubber-stamped requests from parents (sourced to Jackie Fletcher, Richard Barr, and, in one case, Ms. Two), with Wakefield phoning to ensure cooperation.
Four children were sent to Walker-Smith’s bowel clinic with referral letters not even mentioning bowel symptoms. The Australian proactively solicited two kids. Two more were referred to Wakefield, a laboratory researcher. One boy’s notes contained a legal aid letter. And there were plenty of giveaway phrases.
This 7¾ year autistic child’s parents have been in contact with Dr. Wakefield and have asked me to refer him
[This little girl’s] mother has been to see me and said you need a referral letter from me in order to accept [her] into your investigation programme
Thank you for asking to see this young boy
Simply reading the records would have captured those clues. But Walker-Smith declared nothing amiss. Meanwhile, the claimed approval from the ethics committee concerned a different vaccine, a different number of children, and a different developmental diagnosis. Murc
h would eventually admit (three years later) that his statement for Horton was untrue. And Wakefield, of course, had privately told managers (when Barr’s check came through) that the study was “sponsored” by the board.
But Horton’s investigators confirmed their innocence. So The Lancet rejected nearly all of my findings. It did so, moreover, in a sneaky maneuver to try to pull the sting of my story. In those days, the standard PR advice for slipping out bad news was to release it as a “spoiler,” on a Friday afternoon, inconvenient for newspapers’ schedules. And (while ignoring emails and phone calls from me) that’s what Dr. Squeaky Clean did.
Vice-dean Hodgson knew of this ruse to frustrate me and forewarned his colleagues in an email. “No doubt one—but I believe only one—motive,” he wrote, “is to safeguard the Lancet’s reputation by getting the riposte in first, and ‘spoiling’ the story.”
But if that was the aim, it proved a disaster. Horton’s maneuvers sparked a media firestorm. Given his coauthorship of the Uniform Requirements, one thing he couldn’t deny was Wakefield’s conflict of interest. We even had the figure for the legal board money—not much compared with his personal fees, I’d later learn—for his “clinical and scientific study.” The very word “clinical” was enough to nail it down: from both Latin and Greek for at the bedside.
“This funding source should, we judge, have been disclosed to the editors of the journal,” Horton admitted that Friday afternoon in a three-page public statement. “We believe that our conflict of interest guidelines at the time should have triggered such a disclosure.”