In January 2012, David L Lewis, an American retired environmental microbiologist, filed what he represented as a complaint with three UK bodies concerning reports in the BMJ investigating Andrew Wakefield, the disgraced British former doctor and research cheat who claimed that the MMR vaccine caused autism. This is my response.
I first learnt of this man David Lewis in June 2011, when I was told that he’d submitted an abusive attack on me to a small, US-based journal. His article ran to more than 30 pages and was derived from baseless allegations by the discredited former surgeon Andrew Wakefield. Lewis’s general thesis, which he set out in detail later, is that I’m part of a conspiracy with the pharmaceutical industry and government agencies to exact what he calls “retribution” on the purportedly innocent Wakefield. In the article, reference was made to the BMJ.
In the article, Lewis held himself out to be “director” of the “National Whistleblowers Center Research Misconduct Project”, and called himself a “research microbiologist” at the centre. I established that the “NWC” (whistleblowers.org) is a website operated by a firm of Washington employment lawyers, Kohn, Kohn and Colapinto, and shouldn’t be confused with the prestigious Government Accountability Project (whistleblower.org). Although, for all I know, it may do legitimate public interest work, it appears to me that the law firm operates the NWC much as drug companies have been known to operate associated bodies to reach out to potential customers. In this instance, the NWC may attract business, provide speaking, media and publishing credentials for the firm’s partners, and bestows the courageous aura of “whistleblower” upon clients in disputes with their employers. Unlike the GAP, the Kohn entity isn’t listed as a 501(c)(3) not-for-profit, and this renders aspects of its affairs opaque.
The “Research Misconduct Project” is Lewis, and he obtained approval to announce this and designate himself as “director” in December 2010, the month before he took up with Wakefield. Although he’d never contacted me, I found that he’d posted a suite of pages on the NWC website crammed with libellous abuse of me. Some of it was written in an oddly indignant tone. For example:
"We are talking about a reporter with no education or experience in medical practice of any kind… Now, it seems, the whole world is buying into this same ridiculous argument made by a reporter with no competence whatsoever in interpreting medical records of any kind. As a research microbiologist, I must say that this is completely insane."
He falsely claimed not only that Wakefield had been “targeted for retribution”, but that Lewis had also been so targeted in what he suggested were wide-ranging conspiracies of uncanny similarity. He claimed:
“Most scientists have never been targeted for retribution by government, industry or academia. Usually, such treatment is reserved for researchers who gain public attention and directly threaten important government policies or corporate profits. To stop researchers who publish unwanted results, institutions have resorted to using false allegations of research misconduct as a weapon of choice. Scientists who are targeted in this manner suffer lifelong consequences, and the chilling effect it has on other scientists is profound. Few, if any, scientists are willing to step into the firing line of government or big industry and risk being martyred.”
He gives no alleged examples, other than Wakefield and himself.
Upon reading this extraordinary, material, alleging that I was part of such activity, I promptly wrote to Stephen Kohn, who heads both the law firm and the website “center”. Shortly afterwards, most of Lewis’s material was taken down, although he continues to claim on his pages that he’s producing “a non-biased, objective review”.
This claim to objectivity is plainly false. Lewis’s attacks on me ooze with malice, and have been prepared in frank collaboration with Wakefield, who he met in Montego Bay, Jamaica, in January 2011. [See reply to Lewis at nature.com] Both men were invited and funded to attend a small meeting organised by anti-vaccine campaigners at a luxury villa resort. Video of the event suggests that perhaps three dozen people took part. Kohn and Lewis were among a literal handful of individuals present who aren’t well known for anti-vaccine activism, sometimes involving lucrative expert witness work on the US “vaccine court” circuit. Attendees were reimbursed by the “National Vaccine Information Center”, operated by one Barbara Fisher, who has worked with Wakefield since about 1996, and who likens him to Galileo.
Lewis and the EPA
On Lewis’s webpage, a lengthy “director’s story” outlined what I later found to be a misleading account of an extraordinarily arcane dispute between himself and the Environmental Protection Agency. For most of his career, Lewis, now 63, was an environmental microbiologist at the EPA’s lab in Athens, Georgia. In addition to his paid employment, he became active on the side as an expert witness, leading at one point to a complaint to the EPA from a private company that he’d turned his employment with the government agency “into a vehicle to support his private, paid expert witness work”. It may be recalled that one of my revelations about Wakefield was that he’d secretly received huge sums of undisclosed legal money to make a pre-agreed case against MMR, beginning years before his infamous 1998 Lancet paper was published. There was no connection between the pair’s cases, but it’s not hard to see that Lewis, and others whose minds have turned to fantastic conspiracies, might want to exploit one to fuel the other.
Lewis’s principal expertise is in the potential contamination of agricultural land by harmful sewage sludge. It appears that he was being paid by lawyers to make a case against a firm called Synagro [Synagro report and summary on Lewis] – a company I’ve never before heard of, or had any dealings with. Complaints against Lewis included his alleged misuse of EPA credentials to further what was represented to be his private agenda. At some point, Lewis had himself declared a “whistleblower”. Despite its heroic-sounding quality, this is generally a technical legal issue in the US, often invoked in employment disputes. In fact, it appears that his “whistleblowing” was to make complaint against an employee of lower grade in a different section of the EPA, who took a contrary view over Lewis’s sewage sludge claims. Lewis then alleged that EPA had vicarious liability for this other employee’s conduct. Lewis signed a settlement agreement to leave the EPA, but when the date of its maturity arrived, he complained again. Lewis was represented in his dispute by Stephen Kohn, and generated increasingly long documents.
He made countless complaints which, as far as I can tell, were rejected. A relatively straightforward account of some of the matters is contained in a judgment in the US court of appeals dated February 2010, summarised online. This finally rejects his “whistleblower” complaints, after years of apparently futile rancour. Although I’ve not investigated his case, he appears to have made unfounded accusations against both his professional colleagues and his employer. Various investigations and hearings, all the way to the federal appeals court rejected his assertions. At one point, the dispute focussed on his submission of an article to the Lancet, the integrity of which was challenged by the other EPA scientist, who improperly showed it to outsiders. I believe that the paper was rejected. It will, of course, be recalled that the Wakefield issue centres on a paper in the Lancet.
In May and August 2011, while Lewis was hawking his attack on me, he lost two further cases in the federal appeals courts. To say that he has spent a great deal of his life filing complaints and appealing their rejection would appear to understate his activities for more than a decade.
One passage on his webpages, regarding himself, is, I think, particularly revealing:
“So far as UGA [University of Georgia, Athens] is concerned, the allegations remain officially unresolved ─ even though its Science Integrity Officer in charge of ruling on the research misconduct petition called the allegations a ‘witch-hunt’ and testified that she never believed them.”
Lewis’s dispute with the EPA, I believe, casts light on the mindset behind his campaign against me, his abuse of the BMJ and its editor Dr Fiona Godlee, and now his 167 pages of accusations and materials sent to University College London, the UK Research Integrity Office, and the Higher Education Funding Council for England. It appears that he has identified these bodies from reading the BMJ and that he knows, or ought to know, that none have jurisdiction over the journal. But he evidently feels compelled to make complaint and to take it somewhere. So I’m now obliged to generate this lengthy, time-consuming, document.
On 9 January 2012, a website operated on behalf of Wakefield issued an online paid-for press release of Lewis’s complete allegations, dated 8 January, which he had placed online for this purpose. The press release offers a photograph of Lewis and is headed:
“Whistleblower Scientist Accuses British Medical Journal of Institutional Research Misconduct. Actions of BMJ Editor and Reporter ‘More Tabloid News than Science’ According to Dr. David Lewis, and ‘a Genuine Threat to Public Health’.”
This is the second time the two men have arranged for attacks on the BMJ and me to be issued as press releases. The previous occasion, on November 10 2011, was timed to coincide with what they expected to be the publication of Lewis’s allegations in the science journal Nature. That press release was headed:
“Ongoing Investigations by Dr. David Lewis Refute Fraud Findings in Dr. Andrew Wakefield Case. Well-known Whistleblower Calls for Withdrawal of British Medical Journal Article Alleging Fraud.”
Both press releases are confections devised by Wakefield and Lewis, plainly working together. In my view, Lewis’s January submission was intended for publicity purposes. The document, and Lewis’s conduct with it, weren’t any kind of bona fide complaint, or legitimate disclosure of public interest.
The Lewis document wasn’t published on Kohn’s site, but on that of another law firm which has previously published – on an identical format – Lewis’s claims regarding his alleged persecution over his sewage sludge activities. A statement makes clear that Lewis is engaged in a personal campaign:
“The views expressed in this document are my own, and have not been reviewed or approved by the National Whistleblowers Center.”
It appears that Lewis’s many disputes and complaints in the past have wasted much of what ought to have been a productive period in his life. I’ve no knowledge of the rights or wrongs of those conflicts, or whether he acted dishonestly with regard to his research on sewage sludge. It may well be that he has been traumatised by what has happened to him. Nevertheless, he’s responsible for his own conduct. It can’t be right that he seems intent on carrying on with me where he left off with the EPA. I believe that he needs counselling or other support, and in a letter to Kohn of June 2011, I set out my general analysis:
“It seems to me that we are witnessing the bizarre spectacle of Dr Lewis’s psychological transference through which he seeks to punish me as a surrogate for those who he feels have treated him unfairly in the past… Whether such a transference phenomenon goes back only a decade, or whether David Lewis was consumed with bitter grievance long before that, I can only at present guess and try to feel compassion for.”
Lewis’s submission to the BMJ
After an all-out campaign of abuse against me, Lewis changed tactics and sought to exonerate Wakefield with documents provided to him by the disgraced former surgeon. Wakefield was erased from the UK medical register in December 2010 and expelled by the Royal College of Pathologists in January 2011, as a result of proven charges of research dishonesty and the abuse of autistic children. These findings were handed down by a fitness to practise panel of the UK General Medical Council in May 2010.
The documents Lewis obtained from Wakefield were raw data “grading sheets” apparently prepared in 1997 by a consultant histopathologist working with Wakefield at the Royal Free medical school (now a unit of UCL), and also other sheets prepared by a trainee, Dr Andrew Anthony. These sheets recorded observations of bowel biopsies taken from children enrolled in Wakefield’s MMR vaccine research, commissioned by a firm of lawyers and published in the Lancet in February 1998.
The consultant was Dr, now Professor, Amar Dhillon, a co-author of Wakefield’s retracted 1998 Lancet paper. In his approach to the BMJ, Lewis contended that the BMJ and I alleged that Wakefield’s work was fraudulent because of mismatches (identified during the GMC proceedings) between the official reports on bowel biopsies issued by the Royal Free hospital pathology service, and descriptions of “histological findings” tabulated by Wakefield in the subsequent Lancet paper.
As a matter of fact, where the pathology service generally reported healthy biopsy samples from children in Wakefield’s 1998 Lancet research project, the resultant paper reported “non-specific colitis”. The paper, and subsequent statements by Wakefield, claimed the putative discovery of a new inflammatory bowel disease in autistic children. I reported and discussed this mismatch in a BMJ feature of April 2010 titled "Autistic enterocolitis under the microscope”.
These biopsy assessments, however, weren’t the basis upon which, in January 2011, the BMJ concluded that Wakefield’s MMR work was “an elaborate fraud”. The evidence we presented rested firmly on the GMC panel’s findings of research dishonesty, and was overwhelmingly related to Wakefield’s activities with regard to the admission of patients to the study, as well as the purported clinical histories and findings which lay behind a claim by Wakefield of a 14-day temporal link between the administration of MMR and the first “behavioural symptoms” of autism. We say this purported link was fraudulent.
In the 2010 report, I looked specifically at the bowel pathology, and set out what was said to have happened after the hospital pathology service reported largely normal findings from the children’s guts:
“‘It was decided that the senior consultant histopathologist with expertise in intestinal disease (Dr Dhillon) should review all biopsies from autistic children, and that pathology should be graded on a pro forma (or grading sheet) designed by him,’ Wakefield said last March, in a now suspended complaint to the UK Press Complaints Commission about one of my Sunday Times reports.”
I also set out some of the discussion of this matter at the GMC hearing, plus various issues arising from Wakefield’s explanation, and left the matter as a mystery. We didn’t then have the grading sheets, so there was no way of knowing whether, as Wakefield and others said, Dr Dhillon in the medical school found colitis where the hospital pathology service hadn’t. Dhillon declined to speak to me, so we didn’t know what the true position was. However, Wakefield’s claims about Dhillon’s then-undisclosed sheets would need to have been true if the Lancet paper’s “histological findings” (meaning findings under a microscope) were accurate.
But we just didn’t know.
Enter Lewis, who approached Dr Godlee in late August or early September 2011, after his manuscript was rejected by the small journal to which he’d submitted it. Much of the subsequent detail of events is dealt with below in my analysis of his accusations document of January 2012. But at the heart of the matter was Lewis’s presentation to the BMJ of what he and Wakefield said were copies of Dhillon’s grading sheets (supported by others, completed, after the Lancet paper was published, by the trainee, Dr Anthony).
The sheets gave scores for various inflammatory changes, and included a tick-box “non-specific”. Although it later transpired that not all of the sheets were completed by Dr Dhillon, Lewis argued that “non-specific” meant “non-specific colitis”, and that these were ticked in correspondence with the descriptions “non-specific colitis” in the Lancet. He deduced from this that what he characterised as our allegations of fraud against Wakefield were thus proven to be false. He goes on to allege that they were intentionally false.
Among other things, Lewis wrote to the BMJ:
“Dhillon's grading sheets (Attachment 1) included boxes to check, which characterized various conditions that are widely recognized as different forms of colitis, including Crohn's disease, ulcerative colitis ("UC"), and infectious, ischemic, and non-specific colitis. In one case (Child 7), Dhillon left the boxes blank, meaning none of these forms of colitis were present. For the remaining 11 children, he checked "non-specific."”
Dr Godlee sent me the sheets, and within perhaps six minutes it was clear to me that, notwithstanding both Wakefield’s and Lewis’s claims, the sheets overwhelmingly didn’t report colitis. My research in 2010 had given me some lay understanding of such matters, and it was clear to me that the scorings were almost all of observations which pathologists would assume to be physiologic. It also seemed to me that “non-specific” merely meant that findings weren’t specific to anything. As it happens, there’s no accepted entity called “non-specific colitis” and you’d be a long time looking for it in gastroenterology textbooks.
I was surprised that Lewis appeared not to understand relatively elementary fundamentals of GI histopathology when he was representing himself to us as an expert. He evidently couldn’t, or, worse, wouldn’t, read the grading sheets and make sense of them. Within perhaps an hour, I advised Dr Godlee to promptly put the sheets out for expert review. I’m aware of perhaps seven experts who subsequently looked at them. All of them said what I’d said. The sheets largely noted observations of apparently healthy bowel mucosa, and the “non-specific” tick-box wasn’t meant to indicate a finding of colitis.
This was a significant development in the overall MMR story. Here were previously unseen raw data, explicitly invoked by Wakefield as evidence of colitis and of a putative “new inflammatory bowel disease” associated with autism and MMR, which he would later call “autistic enterocolitis”. This was pivotal material which helped to launch the MMR vaccine crisis. And yet the data didn’t show what Wakefield claimed. Nor did they square with what he and others had told the GMC panel, which took evidence under oath. We forthwith began preparing a further report in a BMJ series “Secrets of the MMR scare”, begun in January 2011, when, by coincidence, Lewis was in Montego Bay with Wakefield.
On 9 November, the BMJ published a package of materials. First was an editorial by Dr Godlee, then a news feature by me titled “Pathology reports solve ‘new bowel disease’ riddle”. This was followed by assessments of the grading sheets by two of the experts we consulted. Then came a letter by Lewis, arguing the case that Wakefield didn’t intend to mislead when he reported “non-specific colitis” as “histological findings”. At BMJ Online, the journal published the grading sheets, as supplied by Lewis, but further anonymised to conceal patient hospital numbers, so that readers could see for themselves whether or not what Lewis claimed was true. I also published them at my website, with a tabulation.
Shortly after publication, Professor Dhillon issued a statement in which he confirmed that the “non-specific” tick-box wasn’t meant to indicate colitis, and that a finding of colitis requires both input from clinicians’ and the patient’s history, neither of which were available to him when he completed his sheets.
Our intent in publishing the November package wasn’t to make a fool of Lewis, or really to accomplish much at all with regard to him. Our motive was to bring forward, in the public interest, important new information: raw data from an area of Wakefield’s research where previously we’d none. However, I can understand that Lewis may have felt humiliated to be so publicly exposed as inept – and by a newspaper reporter, to boot. It’s noteworthy that in his 167-page complaint, he now raises no argument about the “non-specific” tick box, even though this was at the foundation of the case he brought to the BMJ and had hawked to other publications.
The Lewis accusations analysed
HEADING “MARKETING DRUGS WITH TABLOID SCIENCE”
DEER: The title is revealingly silly and insulting.
TEXT HEADED “COMMENTARY”
LEWIS: “Editors at the British Medical Journal (BMJ) and Brian Deer, a freelance reporter with no formal training in science or medicine…”
DEER: I’m an experienced investigative reporter with more than 25 years of contentious public interest journalism behind me, much of which has been in the field of medicine. I’ve won two British Press Awards for my investigations, including for my work on the Wakefield affair.
LEWIS: “… alleged that Andrew Wakefield fabricated the diagnosis of colitis in a 1998 Lancet study involving 12 children with autistic spectrum disorder (ASD).”
DEER: At the core of our problems in dealing with Lewis is that nowhere was such an allegation made in the BMJ. He repeatedly identifies my feature “Autistic enterocolitis under the microscope”, published in April 2010, but this simply doesn’t make such an allegation. Plain reading would make this clear.
Not only can I find no foundation for this fundamental of Lewis’s complaint (and I think I’d remember forming any view at that time that the histopathology reporting in the Lancet was fraudulent, as distinct from, say, wrong, misleading or incompetent), we consulted legal counsel, before and after publication, and expert peer-reviewers. We remain unable to identify any text inferring Wakefield’s intent with regard to histology reporting. I’ve similarly asked Nature to identify any such text, and they too have failed.
LEWIS: “In the study, some parents and physicians linked MMR vaccine to the children's gastrointestinal problems and rapid regression into autism.”
DEER: This statement is noted. As a matter of fact, such “links” as were made followed approaches by Wakefield, who, the GMC panel heard, telephoned both parents and doctors to advance his views prior to the children’s evaluation by clinicians.
LEWIS: “In 2010, Deer alleged in the BMJ that Wakefield alone made up the diagnosis by misinterpreting grading sheets from pathologists A.P. Dhillon and A. Anthony, who reviewed the children's colonic biopsy samples.”
DEER: I made no such allegation. My 2010 report couldn’t have offered any inference about grading sheets or their interpretation, as no such sheets were available.
LEWIS: “In the article, Deer wrote that, according to specialists, grading sheets ‘don’t generate clinical diagnoses such as colitis.’”
DEER: My statement is of fact, peer reviewed for the BMJ by gastrointestinal pathologists. Grading sheets (whether in histopathology or other areas of medicine) are research tools, not clinical instruments for patient diagnosis. The consultant pathologist, Dr Amar Dhillon, who completed sheets I reviewed with experts in November 2011 (“Pathology reports solve ‘new bowel disease’ riddle”) confirmed in a statement to the BMJ that grading sheets don’t generate clinical diagnoses. That’s what I’d said, and I was right.
I must assume that Lewis doesn’t understand the meaning of “clinical”.
LEWIS: “Grading sheets I recovered from Wakefield's files, however, show that Anthony wrote "colitis" in marginal notes on a number of his grading sheets.”
DEER: Andrew Anthony was an unaccredited trainee pathologist, and, oddly, was still a trainee eight years later. He was neither qualified nor authorised to set aside the diagnoses of consultant pathologists of the hospital pathology service, particularly since such diagnoses had been agreed with clinicians at weekly clinicopathological meetings.
The “number” Lewis alludes to, but doesn’t state, appears to be 5 of 56 sheets – of which 2 are plainly wrong because the sample reported isn’t from the colon. It appears possible that, in addition to his difficulty with “clinical”, Lewis doesn’t know or is unwilling to acknowledge the meaning of the word “colitis”. For example, on page 80 of his complaint, he notes what he represents as a finding by Anthony of “colitis” in small bowel (ileal) samples:
“There are actually two children in which he wrote some form of "chronic colitis" on his grading sheets. This includes the ileal biopsy for Child 5 (Slide 96-13543) where he wrote "mild chronic colitis." For Child 6 (Slide 96-11992), he wrote "active chronic enteritis + colitis" for the ileal biopsy.”
Colitis, by definition, is inflammation of the colon (the large bowel), and can’t be reported in the ileum, where inflammation is enteritis, or, more specifically, ileitis. It’s hard to believe that both Anthony and Lewis could be so careless as not to spot this. Lewis also failed to take account of this when he wrongly deduced that Dr Dhillon’s “non-specific” tick-box on sheets reporting small bowel biopsies meant “non-specific colitis”.
Anthony’s (dated) evaluations were all performed after the paper was published, and hence can’t be the basis of what was reported in that paper. According to the Legal Services Commission, Anthony was paid £57,499 to support Wakefield’s claims in litigation, including by carrying out evaluations of biopsies. It appears that Anthony’s instructing solicitors may have not realised, or not cared, that he was a junior doctor and would be unable to give expert testimony in high court litigation.
LEWIS: “And, Dhillon included boxes to check for various diagnoses, such as Crohn's disease and "UC" for ulcerative colitis.”
DEER: Dr Dhillon didn’t check any of these boxes.
LEWIS: “Consistent with the Lancet article, both pathologists found that only one child showed no evidence of inflammation.”
DEER: As reported in my heavily-referenced November 2011 report, and an accompanying expert commentary by a professor of gastrointestinal pathology, the normal, healthy, state of the colon is one of “controlled inflammation”. This is inextricably tied up with how it works. The question for pathologists is whether the inflammation is physiologic or pathological. Experts in this field, who the BMJ and I consulted, said that the grading sheets overwhelmingly show physiologic inflammation.
In fact, the all-normal grading sheets for the child referred to was completed by the trainee, not the consultant.
LEWIS: “Last September, BMJ's chief editor, Fiona Godlee, rejected a commentary I wrote about Wakefield's documents. In its place, she invited me to submit a Rapid Response, which I did.”
LEWIS: “But, instead of admitting she had falsely accused Wakefield of making up the diagnosis of colitis…”
DEER: I believe that Dr Godlee made no such admission because she’d never made any such false accusation.
LEWIS: “… she and Deer simply cherry-picked the evidence to come up with a new theory involving "institutional research misconduct."
DEER: Neither Dr Godlee or I came up with any “new theory”. Dr Godlee set out her general view of the institutional issues in a commentary dated 19 January 2011 titled, appropriately, “Institutional and editorial misconduct in the MMR scare”.
LEWIS: “The alleged fraudsters now include University College London (UCL) administrators, the Royal Free Hospital, and all 13 authors of the Lancet study.”
DEER: No such allegations were published in the BMJ.
LEWIS: “Their objective, according to an editorial and feature article Godlee and Deer published with my Rapid Response, was to create the MMR scare so that UCL could sell its own safer measles vaccine, diagnostic kits and ‘autism products.’”
DEER: Neither the editorial nor the feature article made any statement with regard to the objective alleged by Lewis.
The feature made no mention of any safer measles vaccine, diagnostic kits or autism products’.
LEWIS: In her editorial, Godlee acknowledged "the BMJ Group receives funding from the two manufacturers of MMR vaccine, Merck and GSK."
DEER: Among a great many sources of revenue, I believe this is correct.
LEWIS: “To support their new fraud theory, Godlee rewrote my Rapid Response, removing any evidence that undermined their allegations against Wakefield and others.”
DEER: Lewis’s rapid response was extensively re-written because it was false and defamatory. Legal advice was taken. Two peer reviewers rejected the submitted text. No changes had any effect in supporting any “fraud theory”, whether new or otherwise. Lewis approved the published text.
LEWIS: “Then, to prevent me from publishing this evidence on my NWC website, Deer filed a flurry of false allegations of ethical misconduct against me with the NWC.”
DEER: I wrote to the NWC because Lewis had published on its website false and defamatory allegations against me, accusing me of being party to a conspiracy to pursue “retribution” against Wakefield. He did so without ever putting his allegations to me, or of doing anything at all but agreeing his attack with Wakefield.
LEWIS: “Godlee ignored my protests over Deer's behaviour; and some of his false and misleading characterizations of my professional credentials and current work appeared in her editorial and Deer's feature article.”
DEER: Dr Godlee is responsible for what appears in the BMJ, and has no authority over any efforts I must make to defend my professional integrity. The alleged “misleading characterizations” are not particularised.
LEWIS: “When testifying before Parliament in 2011, Godlee agreed that peer-reviewed journals have become "the marketing arm of the pharmaceutical industry."
DEER: That’s not quite what she said, but I’m sure we all get her point. Medical journals carry a great deal of pharmaceutical advertising and are a prime means by which industry communicates with prescribers. They carry a great deal of industry-sponsored research.
LEWIS: “Therefore, it shouldn't surprise anyone if her fraud allegations turn out to be nothing more than a scheme to protect the BMJ's financial interests in companies marketing MMR vaccines.”
DEER: I think it would surprise a great many people. However, the infantile quality of this assertion rather showcases Lewis and his complaint.
LEWIS: “What's so frightening about all of this, however, is that such a scheme requires that one of Great Britain's leading medical journals utterly destroy the reputation of one of the world's most prestigious academic institutions.”
DEER: I doubt whether the BMJ intends to “utterly destroy the reputation” of UCL, whether any “scheme” requires this, or whether the BMJ would be capable of such a feat should it harbour the aspiration.
TEXT HEADED “SUMMARY”
LEWIS: “In November 2011, Fiona Godlee, chief editor of the British Medical Journal (BMJ), and a reporter, Brian Deer, used newly discovered documents I obtained from Andrew Wakefield's personal files to allege that University College London (UCL) may have committed ‘institutional research misconduct.’”
DEER: As indicated above, the “institutional misconduct” charge was made by Dr Godlee in January 2011 – 10 months previously, and before we’d ever heard of Lewis. The documents supplied by Wakefield to Lewis, and by Lewis to us, was in part an occasion for the BMJ to re-rehearse issues arising from the Wakefield affair with the addition of the fresh information. The core of the issues which the BMJ and I believe constitute institutional misconduct have nothing to do with histopathology. And, indeed, they are nothing to do with Lewis.
LEWIS: “The term, which I coined at the National Whistleblowers Center (NWC) in Washington, DC, refers to instances in which institutions, such as government agencies and universities, commit or support acts of research misconduct to protect government policies and industry practices.”
DEER: Lewis can use the expression as he wishes, and presumably so can Dr Godlee.
LEWIS: “According to Godlee, the misconduct may have involved UCL administrators, 13 scientists, and the Royal Free Hospital in London.”
DEER: Apart from 13 “scientists”, a number I don’t recognise regarding scientists in this context, this may be correct.
LEWIS: “It was all part of an elaborate scheme in which the Lancet study was intended to generate an MMR vaccine scare which, in turn, damaged vaccine sales by Merck and GlaxoSmithKline (GSK), which, in turn, opened up the market for UCL to sell safer vaccines, diagnostic kits and ‘autism products.’”
DEER: Lewis is in difficulty again over his understanding of intent. I’ve never expressed concern, or known of anyone else to express concern over the vaccine sales of Merck or GSK. I couldn’t care less. In any event, percentage fluctuations in MMR vaccine sales over the years would be irrelevant to the named companies, aren’t consequential to their profits, and there has never been the slightest evidence of market sensitivity to the Wakefield scandal. If Lewis has evidence of such a motive being alleged, then I’m surprised he doesn’t identify the words complained of, or produce evidence.
The various products were meant to be sold by private companies of Wakefield’s, in which the Royal Free’s trading subsidiary was in negotiation to take a stake. This institutional conflict of interest was revealed in my second “Secrets of the MMR scare” report “How the vaccine crisis was meant to make money” in January 2011.
LEWIS: Godlee wrote that this scheme caused "enormous harm" to public health, and could reflect "the prevailing culture of Britain’s academic institutions." In her editorial and other comments published in the BMJ, she called upon various oversight bodies to investigate, including Parliament, UK's Research Integrity Office (UKRIO), the Higher Education Funding Council for England (HEFCE), and UCL's Office of Provost.
DEER: I believe she did.
LEWIS: “In a previous version of their fraud scheme published in January 2011, and earlier in 2010, Godlee and Deer alleged that Wakefield alone faked the diagnosis of colitis to profit from a patent UCL filed on a ‘transfer factor’ he developed.”
DEER: As previously intimated, no article appeared in the BMJ in 2010 alleging that Wakefield “faked the diagnosis of colitis”, whether to “profit from a patent” or for any other purpose. I know of no connection between colitis and transfer factor. No such article appeared in 2011.
LEWIS: “Transfer factors are used to treat infections in immunocompromised patients who cannot be vaccinated with live vaccines, such as MMR vaccine.”
DEER: I’m unaware of any immunocompromised patient being treated with transfer factor on grounds that they cannot be vaccinated with live vaccines. Immunocompromised patients are generally protected by herd immunity, and this is an aim of vaccination policy.
LEWIS: “These were the first in a series of articles published by the BMJ in which Deer allegedly exposed ‘the frauds behind Wakefield’s research.’”
LEWIS: “Copies of the pathologist grading sheets and other data from the 1998 study, which I obtained from Wakefield's personal files, however, appear to show that the diagnosis was not fabricated.”
DEER: The documents Wakefield gave Lewis show nothing of the sort. They evidence that the claim in Table 1 of the Lancet paper of “histological findings” of colitis for 11 of 12 patients is false. Two consultant histopathologists are named in the paper. Both have separately denied making histological findings of colitis, and pathology reports or grading sheets confirm their statements.
LEWIS: “After rejecting a commentary I submitted to BMJ, which included evidence that the BMJ had wrongly accused Dr. Wakefield, Dr. Godlee invited me to resubmit the documents as a ‘Rapid Response.’”
DEER: As indicated, the rejections followed legal and peer-review advice.
LEWIS: “My report, which I have submitted to UCL, UKRIO and HEFCE, includes 72 emails exchanged between me and the BMJ's editors.”
DEER: I offer the recipients at UCL, UKRIO and HEFCE my sympathy.
LEWIS: “In my opinion, they clearly show that Dr. Godlee and others at the BMJ cherry- picked the evidence and rewrote my Rapid Response to support their new, wider fraud theory. Experts disagree on the clinical significance of the data. But, as a whole, the documents I provided clearly show that the diagnosis of colitis reported in the 1998 Lancet article was not fabricated. In addition, my report includes emails Brian Deer sent the NWC in which he demanded that evidence exonerating Dr. Wakefield, which the BMJ edited out of my Rapid Response, be removed from the NWC website.”
DEER: This paragraph is a pastiche of previous arguments.