Andrew Wakefield: In it for the money all along?

One of the favorite attacks favored by advocates of pseudoscience, particularly advocates of the sort of pseudoscience favored by proponents of “alternative” medicine, particularly the more militant ones who really, really detest conventional, science-based medicine, is to poison the well with a pre-emptive ad hominem attack that implies that defenders of science-based medicine are somehow interested in nothing but money. The first favored attack is to point out that the pharmaceutical industry is interested in nothing but money. That’s partially true (they are, after all, for profit companies), but it doesn’t change the fact that most pharmaceutical company products are extensively tested and have to be shown to be efficacious and safe before they can merit FDA approval.

Those of us who criticize pseudoscience, particularly that favored by quacks and the anti-vaccine movement, frequently encounter a special variety of ad hominem attack. So common is this tactic that I even coined a term for it–yes, as far as I can tell, I coined it–namely, the pharma shill gambit. Defend vaccines? Well, obviously you must be a minion of big pharma, hopelessly in its thrall, accepting big checks for sitting there in your underwear and doing battle with anti-vaccine trolls. Either that, or your very connection with a medical school, some of whose researchers accept pharma money to perform clinical trials, must also mean that you are hopelessly in the thrall of big pharma. Yes, I personally have been subject to that sort of attack. For the anti-vaccine movement in general, and the anti-vaccine crank blog Age of Autism in particular (particularly a particularly dim young man named Jake Crosby), no connection to the hated pharma is too tenuous or filtered through too many degrees of separation to permanently taint your reputation.

That’s why I can’t help but experience a warm, fuzzy feeling of schadenfreude when I part two of Brian Deer’s report on anti-vaccine guru Andrew Wakefield. I think you’ll quickly get a good idea why just by looking at its title: How the vaccine crisis was meant to make money. What becomes very obvious reading this expose is that to a large extent it was about money from the beginning. When Andrew Wakefield first started his “research” (if it can be called that anymore), it wasn’t just about discovering something new. It was with an eye to make money. Lots and lots of money. Millions of pounds. Millions and millions of pounds. Now, being a capitalist myself for the most part, I don’t begrudge a man a chance to make a buck (or a pound). The problem is that Wakefield is being represented as this selfless, tireless crusader for “vaccine safety” when in the beginning, when it comes to profit motive, he rivaled (and appears to continue to rival) anyone working for big pharma. Worse, the evidence is very strong that he committed scientific fraud to do it, as I discussed last week.

It all began with Wakefield’s relationship with one British solicitor named Richard Barr. This story is relatively well known, but it’s worth reviewing again:

Since February 1996, seven months before child 2’s admission, Wakefield had been engaged by a lawyer named Richard Barr, who hoped to bring a lawsuit against vaccine manufacturers. Barr was a high street solicitor, and an expert in home conveyancing, but also acted for an anti-vaccine group, JABS. And, through this connection, the man nowadays popularly dubbed the “MMR doctor” had found a supply of research patients for Walker-Smith.

“The following are signs to look for,” Barr wrote in a newsletter to his vaccine claim clients, mostly media enlisted parents of children with brain disorders, giving a list of common Crohn’s disease symptoms. “If your child has suffered from all or any of these symptoms could you please contact us, and it may be appropriate to put you in touch with Dr Wakefield.”

These are the sort of children that were being encouraged to contact Dr. Wakefield, who, as we know was ultimately paid £435,643 in fees, plus £3,910 expenses by Barr. But that was chump change compared to the amount of money that Wakefield and his cronies envisioned based on the work they were doing at the Royal Free Hospital. Even while Child 2 was still in the hospital undergoing a grueling workup including an MRI of his brain (which, for children that young usually requires general anesthesia), electroencephalography and evoked potentials, a radioactive Schilling test, blood and urine tests, and a lumbar puncture, all of which had been specified in an agreement with Barr. Then, while the child was still in hospital (as the British say), having just undergone an ileocolonoscopy two days before that 14 years later the British General Medical Council would conclude had not been medically indicated, this happened:

And on Wednesday, with the news that the boy–still on the ward–might have Crohn’s disease, the doctor produced a remarkable document. It was an 11 page draft of a scheme behind the vaccine scare, now revealed for the first time in full.

The document was headed “Inventor/school/investor meeting 1.”15 Based on a patent Wakefield had filed in March 1995 claiming that “Crohn’s disease or ulcerative colitis may be diagnosed by detecting measles virus in bowel tissue, bowel products or body fluids,”16 it proposed starting a company that could reap huge returns from molecular viral diagnostic tests. It predicted a turnover from Britain and America of up to £72.5m a year.

“In view of the unique services offered by the Company and its technology, particularly for the molecular diagnostic,” the document noted, “the assays can command premium prices.”

To help finance the scheme, Wakefield looked to the government’s legal aid fund–meant to give poorer people access to justice. For the previous seven months, child 2 had been enrolled with Barr’s firm,17 which since February 1996– two years before the paper’s publication– had been paying the researcher undisclosed fees of £150 an hour, plus expenses.8

Wow. £72.5 million a year. That’s a lot of cash that Wakefield was planning on trying to make using his patent claiming that detecting measles virus in the gut is diagnostic for Crohn’s disease. Indeed, where other researchers saw suffering children they wanted to try to help, Wakefield apparently saw an amazing profit opportunity. Indeed, he even cranked out the prospectus for this amazing profit opportunity while investigating children referred to him by trial lawyers. This is a massive undisclosed conflict of interest (COI) that beggars imagination. It’s huge compared to most COIs that individual investigators who seek to commercialize their products have, because most such investigators don’t envision making anywhere near as much money as Wakefield apparently thought he could make from developing a diagnostic test. He even wrote that “the ability of the Company to commercialise its candidate products depends upon the extent to which reimbursement for the cost of such products will be available from government health administration authorities, private health providers and, in the context of the molecular diagnostic, the Legal Aid Board.” In other words, Wakefield was already thinking of ways to obtain reimbursement from third party payers for his device, recognizing quite correctly that the success of any such test is utterly dependent upon this.

What was particularly disturbing and depressing about these new revelations was that they reveal just how deeply the Royal Free Hospital was involved in Wakefield’s research, profit-seeking, and outrageous self-promotion. Nowhere is this better demonstrated than in how the hospital helped Andrew Wakefield put together his publicity machine to capitalize on the fraudulent findings that Wakefield published in The Lancet almost exactly 13 years ago. In fairness, at the time the Royal Free Hospital administration didn’t know that Wakefield’s results were fraudulent, but it clearly knew that they were explosive. Remember how I discussed just yesterday how Wakefield produced a video interview around the time his Lancet paper was released, an interview in which he asserted that he doubted the safety of the MMR vaccine and claimed that separating the MMR into its component parts is safer than the MMR? Well, not only did the Royal Free Hospital produce the video, but it was ready for the expected fallout:

Neither school nor hospital stood on the sidelines. They threw their weight behind Wakefield. In the build-up to the press conference, they installed extra phone lines and answering machines to field the expected panic, and distributed to broadcasters a 23 minute video news release showcasing Wakefield’s claims. “There is sufficient anxiety in my own mind for the long term safety of the polyvalent vaccine–that is, the MMR vaccination in combination–that I think it should be suspended in favour of the single vaccines,” he said, in one of four similar formulations on the videotape.28

The press conference and video boosted the commercial plans, which were moving forward behind the scenes. The following week, Wakefield brought two associates to the school for an already scheduled meeting with the finance officer Tarhan. One was the father of child 10 in the paper. The other was a venture capitalist. And two days after the meeting, they submitted a 13 page proposal to launch a joint business with the school. It would be focused on a new company, Immunospecifics Biotechnologies Ltd, aiming not only to produce a diagnostic test, as proposed 18 months earlier, but also “immunotherapeutics and vaccines.”29

From my perspective, if this is true, if the Royal Free Hospital and the UCL were so heavily in bed with Andrew Wakefield and participated so actively in generating publicity for his research in the wake of his Lancet paper, then they were just as guilty as Wakefield in promoting the MMR scare that followed and just as guilty as Wakefield. Not only did they aid and abet Wakefield’s self-promotion, helping him to gain a platform to promote fear mongering about the MMR, but they continued to negotiate with him to partner with him in bringing what can best be described as quackery, up to and including Hugh Fudenberg’s transfer factor quackery, to market as a product. In case you don’t know who Hugh Fudenberg is, we’ve met him before; he’s the source of some of Bill Maher’s anti-vaccine claims. Fudenberg also lost his license to practice medicine years ago. Sadly, by giving Wakefield a platform to promote his execrable science and run a campaign against the MMR and by continuing to try to help him find funding for his dubious “product,” the Royal Free Hospital and UCL both failed miserably in their obligations as science-based institutions of medical academia.

Fortunately, in 1999 a new sheriff arrived in town, so to speak, in the form of a new head of medicine: Mark Pepys. He was a fellow of the Royal Society and a well-respected researcher with expertise in amyloid diseases; in addition, Pepys brought big grants to UCL. He was also appalled at what was going on under Wakefield’s supervision at the Royal Free Hospital. Just as Wakefield’s scheme, which involved Carmel Healthcare Ltd. and another business of which Wakefield would become a director, Unigenetics Ltd. in Dublin, the same business that was later found to have been so incompetent at performing PCR assays for Wakefield looking for measles sequences, was nearing fruition, Pepys brought the hammer down:

Wakefield was summoned from the hospital’s Hampstead campus to the college’s central London headquarters. He was challenged over the scheme, then on the verge of fruition, and was given a two page letter.

“We remain concerned about a possible serious conflict of interest between your academic employment by UCL, and your involvement with Carmel,” it said, in part. “This concern arose originally because the company’s business plan appears to depend on premature, scientifically unjustified publication of results, which do not conform to the rigorous academic and scientific standards that are generally expected.”50

Indeed.

Ultimately, Wakefield was ousted from his job at Royal Free Hospital. Since then, he has claimed on numerous occasions that his firing came about because his research was so”unpopular,” but the Provost’s letter and the paperwork Brian Deer has unearthed for his BMJ articles provide new revelations that directly contradict that claim. In fact, UCL volunteered to support Wakefield’s work. It offered a chance for him to continue on Royal Free’s staff or even to a year’s paid leave in order try to replicate the results reported in his Lancet paper. He was even offered help to carry out a study of 150 children to try to confirm his previous results under more rigorous conditions. From Deer’s report, it appears that UCL and Royal Free Hospital bent over backwards to try to help Wakefield do a study to try to replicate his results. Wakefield, not surprisingly, reacted by turning passive aggressive:

At the time, Wakefield agreed. Then his employer waited. It prompted, waited longer, and prompted again. “Three months have elapsed,” Llewellyn-Smith wrote to him in March 2000, asking for “a progress report on the study proposed” and “not to make any public statements” in the meantime.54

But the study did not happen. The 1998 Lancet research had been a sham.10 Trying to replicate it with greater numbers would have been hopeless.

Wakefield, however, shrugged off his non-compliance as arising from some fault of the school’s. “It is clear that academic freedom is essential, and cannot be traded,” he eventually responded in September 2000. “It is the unanimous decision of my collaborators and co-workers that it is only appropriate that we define our research objectives, we enact the studies as appropriately reviewed and approved, and we decide as and when we deem the work suitable for submission for peer review.”55

This was a step too far, and in October 2001 Wakefield was shown the door.

Even then, Wakefield apparently received two years’ severance pay and a statement clearing him of misconduct. He even got a gag on Royal Free commenting on the whole affair. As Pepys put it, “We paid him to go away.” Would that it were possible to pay to reverse the damage Wakefield did. Meanwhile, Wakefield painted himself as a martyr to the cause of academic freedom.

The truly ironic thing about the Wakefield affair is that, when it all comes down to it, it appears to have been largely about the money right from the very beginning. There might have been some genuine scientific curiosity early on, but it’s obvious that it was rapidly corrupted by Richard Barr and then by the lure of making lots of money selling tests whose results would fuel Barr’s lawsuits against vaccine manufacturers. From very early on, Wakefield showed an entrepreneur’s aggressiveness in pursuing deals to make money off of his fraudulent research, and after he left Royal Free Hospital he rapidly found a nice, cushy spot at Thoughtful House in Texas, a position he occupied at a generous salary until about a year ago, when he was kicked out by the Thoughtful House board of directors in the wake of the GMC’s ruling finding him guilty of research misconduct and ethical breaches, which led to the retraction of his Lancet paper. Meanwhile, his defenders have been deploying and will continue to deploy the pharma shill gambit against those who criticize Wakefield for his fraudulent research and his stoking the fires of an anti-vaccine scare that has done real harm in the U.K. by leading to a massive resurgence in measles cases. To them, it’s all a conspiracy by big pharma and the government to “suppress” Wakefield’s “truth” and protect their profits. That Wakefield was in it for the money doesn’t affect their world view on bit. He’s still their patron saint.

You can see why it’s hard not to feel a bit of schadenfreude here, but it will only be brief. Wakefield has a disturbing tendency to be able to reinvent himself in order to continue to promote his pseudoscience and, above all, himself. Even having his license to practice medicine stripped, his papers retracted, and his position as scientific director of Thoughtful House taken away didn’t keep him from finding a way to keep promoting the scientifically discredited idea that the MMR vaccine causes autism and enterocolitis. I’m under no illusion that he won’t be able to do it again.