How the case against the MMR vaccine was fixedBMJ 2011; 342 doi: https://doi.org/10.1136/bmj.c5347 (Published 06 January 2011) Cite this as: BMJ 2011;342:c5347
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Institutional review boards (IRBs) are delegated only to assess and approve a clinical trial protocol for participant safety and methodological validity, with no remit to monitor a researcher’s adherence to safety standards during the conduct of the study. Although selective outcome reporting leading to biased treatment and adverse effect estimates can be discerned by independent re-evaluation of full outcome data that are made publicly available after publication of a clinical trial, this process does not protect a patient from harm and coercion for the duration they are enrolled in a clinical trial.
I have previously advocated for the important role of data monitoring and safety committees (DMSCs) in conferring protection to participants whilst the trial is in progress. With their in depth understanding of the study objectives and protocol, as well as access to fully disclosed results as they accumulate, these committees are well placed to gauge breaches in safety mechanisms, coercive or fraudulent recruitment as well as compliance with the collection and use of data for all prespecified outcomes from the start of a trial to its completion. Data monitoring committees are independent and widely perceived to be extremely competent. Using these committees to review and approve the completeness of outcomes reported before publication would also enhance the credibility of all studies and make them less likely to be biased. The DAMOCLES Study Group recommends that data monitoring committees “ensure that trial results are published in an unbiased, correct and timely manner” and that the committee discusses final data and their interpretation with study investigators. The ability to monitor for selective data collection and use while the study is being conducted improves the validity and credibility of submitted manuscripts, eliminates the need for resource intensive post-publication re-evaluation, and averts disseminating biased estimates to journal audiences in the first place. Importantly, DMSCs are a trial participant’s ally and guardian angel.
Competing interests: No competing interests
Fiona Godlee fails to cite relevant letters to the BMJ from Andrew Wakefield's co-authors, Susan E Davies  and Amar P Dhillon , the latter notably in response to recent allegations made by herself, by Brian Deer, and Profs Geboes  and Bjarnason . Geboes and Bjarnason have also never responded to Dhillon's letter, which took respectful issue with their claims.
Further confusion relates to remarks made Godlee, Deer and Bjarnason in a Nature report, following David Lewis's accusations in November .
'But he [Bjarnason] says that the forms don't clearly support charges that Wakefield deliberately misinterpreted the records. "The data are subjective. It's different to say it's deliberate falsification," he says...Deer notes that he never accused Wakefield of fraud over his interpretation of pathology records...Fiona Godlee, the editor of the BMJ, says that the journal's conclusion of fraud was not based on the pathology but on a number of discrepancies between the children's records and the claims in the Lancet paper...'
But above all it is impossible to see how Wakefield could be singly guilty of fraud when his co-authors apparently stand by the published findings.
 Geboes K. Commentary. I see no convincing evidence of "enterocolitis," "colitis," or a "unique disease process." BMJ 2011;343:d6985.
 Bjarnason I. Commentary. We came to an overwhelming and uniform opinion that these reports do not show colitis. BMJ 2011;343:d6979.
 Eugenie Samuel Reich, Fresh dispute about MMR 'fraud', http://www.nature.com/news/2011/111109/full/479157a.html
Competing interests: I have an autistic son
Last year the BMJ received an email from Dr David Lewis, a retired environmental microbiologist in the United States. In an attached document he argued that Andrew Wakefield had not committed fraud in relation to the now retracted Lancet paper on MMR and autism. The document contained inaccuracies and misleading statements based on hearsay. But the related information was of interest, including as it did what appeared to be copies of pathology grading sheets completed by one of the Lancet authors Amar Dhillon.
On closer examination these grading sheets did nothing to absolve Andrew Wakefield. They showed that the majority of bowel samples taken from the 12 Lancet children were normal or as near normal as makes no difference. The BMJ eventually published the grading sheets along with expert commentaries and an explanatory article by Brian Deer.(1) (2) (3) We invited David Lewis to prepare a shortened version of his allegations, which we published as a rapid response.(4)
As explained at the time, our aim throughout was to present this new information accurately within its correct context and in the public interest. A great deal of care was taken to achieve this outcome.
David Lewis has made no complaint to the BMJ. However I understand that he has complained to various bodies in the UK, and that he accuses me and the BMJ of fraud. I am grateful to Brian Deer for taking the trouble to provide a point by point response to this complaint, which can be found at http://briandeer.com/solved/david-lewis-1.htm.
The BMJ remains committed to improving the integrity of the scientific record in order to ensure the highest possible quality of evidence on which patients, doctors, and policy makers can base their decisions. Sadly research misconduct continues to cause harm to patients and the public, and the misguided and ill informed actions of people like David Lewis only make matters worse.
1. Geboes K. Commentary. I see no convincing evidence of "enterocolitis," "colitis," or a "unique disease process." BMJ 2011;343:d6985.
2. Bjarnason I. Commentary. We came to an overwhelming and uniform opinion that these reports do not show colitis. BMJ 2011;343:d6979.
3. Deer B. Pathology reports solve "new bowel disease" riddle. BMJ 2011;343:d6985.
4. Lewis D. Letter to the BMJ from David Lewis. Rapid response. http://www.bmj.com/rapid-response/2011/11/09/re-how-case-against-mmr-vac...
Competing interests: I am the editor of the BMJ and responsible for all it contains. The BMJ is part of the BMJ Group, which receives sponsorship and advertising revenue from pharmaceutical companies, including from Merck and GSK, manufacturers of the MMR vaccine. The BMJ and I personally are currently being sued by Andrew Wakefield in relation to articles published in the BMJ in January 2011.
The comments so far has shown how the term “anti vaccine” derails a discussion. The term is ill defined, leading to much time spent debating whether one is or is not “anti vaccine”. For example, Prof. Shaw and Lucija Tomljenovic in their comments focused on this point in his defense of the conference they helped organize.
I would have appreciated if Mr. Shaw would have discussed the conference organization and focus, given his experience as an organizer and attendee. Specifically, the intentions of those who provided the principle financial support (the Dwoskin Family Foundation) and the primary sponsor (the National Vaccine Information Center) . These organizers hold positions on vaccines which are clearly out of the mainstream. Claire Dwoskin has stated from her position as a board member of the National Vaccine Information Center that “Vaccines are a holocaust of poison on our children’s brains and immune systems.” Ms. Fisher, president of the NVIC and conference speaker, has posed the vaccine discussion as being between two camps: “The fact that manmade vaccines cannot replicate the body's natural experience with the disease is one of the key points of contention between those who insist that mankind cannot live without mass use of multiple vaccines and those who believe that mankind's biological integrity will be severely compromised by their continued use.”
Whether these positions are “anti vaccine” or not, they are clearly not pro vaccine, or really supported by science.
Lucija Tomljenovic made a case that the conference was “not an anti-vaccine campaign” by focusing on one speaker at the conference who has expressed pro-vaccine views. Again, rather than debate such an ill-defined term as “anti-vaccine”, it might be worth considering whether the conference is pushing the enveleope or outside the envelope. Other talks at the conference  included Lucija Tomljenovic’s own “Gardasil: prophylaxis or medical misconduct?” In addition, Shiv Chopra spoke on “Vaccination programs: prevention or corruption?” Another example of a speaker perhaps outside the envelope would be Lawrence Palevsky, who spoke on “Rethinking the germ theory”. His website promotes disease over vaccination with statements such as: “children need to be allowed to experience symptoms of acute illness in order for their bodies to appropriately cleanse the wastes and toxins from their systems, and so they can go forward in their lives toward greater optimal health and wellness”. In an interview where he purportedly exposes “vaccine myths” he makes a statement directly on point of vaccine safety:“…I cannot understand how a vaccine with a virus can be safe.” 
The conference had as a primary goal networking not only the researchers themselves, but connecting the researchers with private donors to support research which is not being funded through regular channels. Further, Prof. Shaw has put himself in the position of defending not only the conference he helped organize, but the viewpoints of a present and possibly future source of funding, as he is supported by the Dwoskin Family Foundation.
Just as the attendees of the Jamaica conference have the right to offer criticism of a vaccine program which they may see as a “holocaust of poison”, those of us who rely upon a safe and effective vaccine program should be free to offer criticisms of views of the conference organizers and attendees. Was the conference organized by “anti-vaccine campaigners”? I’ll let each decide that based on their own definition of “anti-vaccine”. Was it a “vaccine safety” conference as it purports to be? Not by my definition.
Competing interests: Father of an autistic child
The case against MMR fixed?
In the debate about the role of MMR in autism we have to deal with(and respond to) a lot of absurdity. Another absurdity, besides the lack of knowledge how conferences are organised and of the basic science in MMR cases is an elementary lack of knowledge of what the relevant drug companies producing MMR and all the other vaccines actually admit.
I think that it is of great interest that Product Insert for Priorix GlaxoSmithKline Australia Pty Ltd MMR vaccine lists inter alia colitis among the gastrointestinal adverse reactions (MIMS Annual 2009: 10-1359).
Sanofi Pasteur Tripeda PI lists autism as one of the serious post marketing reactions to their vaccine.
The vicious personal attacks against Dr Wakefield and some others, and the whole “debate” about colitis, what sort of colitis and how prevalent it is in autistic children, is not just comparable with medieval salem witchhunts but also with much more recent infamous political interference in science and medicine: the lysenkoism during the stalinistic soviet era.
Relevantly, certain people always forget that what they say and do says more about them than about those they target.
Competing interests: No competing interests
The notion put forward by Mr. Deer that the Jamaica vaccine safety conference was somehow served by vested "anti vaccine" interests because Drs. Wakefield and Lewis' trip and accommodations were paid for, is simply absurd. If Mr. Deer had checked with any working scientists, he would realize that conference organizers (and I was one for the Jamaica meeting) typically provide economy transportation, accommodation, and food costs for invited speakers from the conference operating budget. The Jamaica conference, like many others of various sorts that I have attended, was no different in this regard. The fact that the meeting was held in a warm climate (versus, one presumes, a really cold unpleasant venue) is also not a damning indictment as most of the readers of BMJ will know. If Mr. Deer is so blatantly unaware of how most scientific meetings are organized, can we be terribly surprised at his apparent lack of knowledge of the basic science in the MMR case?
Competing interests: No competing interests
For anyone in doubt about Dr Lewis's competence and integrity I am posting some notes relating to his CV (apologies for their somewhat unedited state):
Dr. David Lewis is a former senior-level research microbiologist for the U.S. Environmental Protection Agency (EPA).
Dr Lewis was the only EPA scientist to ever publish first-authored research articles in Lancet and Nature. His research published in Lancet and Nature Medicine on the inadequacy of CDC guidelines to prevent transmission of HIV in dentistry prompted the current heat-sterilization standard for dentistry in the mid-1990s. His environmental research published in Nature received the Science Achievement Award by the EPA Administrator in 2000. Editors at Annals of Internal Medicine rated him in the top 10% of reviewers in 2010. His accomplishments in medical and environmental research have been widely covered professional, scientific and popular publications and broadcasts including Nature, Science, Lancet, JAMA, National Geographic, Reader's Digest, Voice of America, Paul Harvey News, Time, Newsweek, U.S. News & World Report, Forbes, NY Times, Washington Post, London Times, NPR’s All Things Considered, PBS Healthweek, PBS Technopolitics, CBS Evening News, ABC's Primetime Live, and BBC Panorama.
Numerous US Federal and State courts have accepted Dr Lewis as a qualified expert witness in medical malpractice cases including the interpretation of patients' medical records and laboratory results involving the collection of biopsies during colonoscopies. Dr Lewis has been recognised as an expert witness on colonic biopsy procedures. The United States District Court for the Southern District of Georgia agreed Dr Lewis is the only scientist to have researched HPV infections associated with colonic biopsy procedures.
Dr Lewis' environmental research at the U.S. Environmental Protection Agency's (EPA) Office of Research & Development, which was published in Nature and other leading science journals, received EPA's highest award for research science presented by Administrator Carol Browner in 2000.8 He is equally experienced in medical and scientific fields relevant to the collection and examination of biopsies during colonoscopies such at those Wakefield and his coauthors published in The Lancet.
He began his research related to the collection and examination of colonic biopsies as a member of the Graduate Faculty at the University of Georgia (UGA) in the mid 1990s, and continued this work under various adjunct and visiting scientist positions at UGA during the rest of his tenure at EPA. In 1998, EPA made research on colonoscopy part of his official EPA duties under an agreement with UGA; and Dr Lewis served as Principal Investigator for a prospective epidemiological study of hepatitis C associated with colonoscopy from 1999-2007.9
His research on the survival of HIV and other viruses in blood and tissues associated with colonic biopsies and dental procedures published in Lancet, Nature Medicine and other medical journals changed government infection-control guidelines worldwide.10,11 Hippocrates magazine won a national award for its 1998 cover story on this research.12 In 2008, Nature published a news article and editorial applauding his research in which a multi-university study in Ohio confirmed his findings linking gastrointestinal disorders to exposures to biosolids.13,14 He is frequently called upon to review medical research papers; editors at Annals of Internal Medicine rated me in the top 10% of its reviewers in 2010.15
Numerous federal and state courts have accepted Dr Lewis as an expert witness in medical malpractice cases in which he is required to interpret patients' medical records and laboratory results involving the collection of biopsies during colonoscopies. In 2003, for example, the State of New York accepted him as an expert on colonic biopsy procedures at a hearing in which the State revoked a physician's medical license.16 Last month, the United States District Court for the Southern District of Georgia agreed that he is the only scientist who has ever researched HPV infections associated with colonic biopsy procedures.17
8. U.S. EPA Science Achievement Award (2000), presented for Lewis DL, et al. Influence of environmental changes on degradation of chiral pollutants in soils. Nature 1999;401:898-901.
9. Mikhail N, Lewis DL, Omar N, et al. Prospective study of cross-infection from upper-GI endoscopy in a hepatitis C–prevalent population. Gastrointest Endosc 2007;65:584-588.
10. Lewis DL and Arens M. Resistance of microorganisms to disinfection in dental and medical devices. Nature Medicine 1995;1:956-8.
11. Lewis, DL, Arens M, Appleton S, et al. Cross-contamination potential with dental equipment. Lancet 1992;340:1252-4.
12. Finch S. Unclean instruments. Hippocrates. February 1998.
13. [Editorial] Stuck in the mud—The Environmental Protection Agency must gather data on the toxicity of spreading sewage sludge Nature 2008;453:258.
14. Tollefson, J. Raking through sludge exposes a stink. Nature 2008;453:262-3.
15. [Letter] Laine C, Editor, Annals of Internal Medicine to Lewis D. 15 May 2010.
16. State of New York v. Dr. Brian Goldweber. NYC Department of Health Hearing, 23 December 2008.
17. RA McElmurray, JR v. Olympus Optical Co., LTD et.al. Order dated 1 August 2011. United States District Court for the Southern District of Georgia, Augusta Division. Case No. CV 110-058.
Competing interests: Autistic son
As a co-organizer of the vaccine conference in Jamaica I will dare to say that it was not an anti-vaccine campaign. Neither did Andrew Wakefield “headlined the cabaret” as Mr Deer puts it. Wakefield was merely one of the speakers.
There are many scientists on the pro-vaccine side who do not hold on to common dogmatic preconceptions about vaccines. Vaccines are no different to other pharmaceutical drugs which mean they carry risks of side effects, INCLUDING serious side effects. This is a fact and whether one likes it or not is irrelevant. The only thing that remains debatable is how common such serious side effects are. The reason for the Jamaican conference was to open up a discussion on this topic. Such discussion does not make one anti-vaccine. When Toyota found that several of its models had a faulty crankshaft pulley which could have lead to loss of power steering, they discussed the problem and pulled the cars of the market . Does that make Toyota’s management anti-car?
You will also note that one of the speakers of the conference was Dr Yehuda Shoenfeld , one of the world’s leading experts in autoimmune diseases. Shoenfeld is VERY much pro-vaccine (but he is not ignorant of the fact that vaccines can cause problems), as his Nat Rev Rheumatol paper CLEARLY illustrates :
“Vaccines have been used for over 200 years and are the most effective way of preventing the morbidity and mortality associated with infections. Like other drugs, vaccines can cause adverse events, but unlike conventional medicines, which are prescribed to people who are ill, vaccines are administered to healthy individuals, thus increasing the concern over adverse reactions. Most side effects attributed to vaccines are mild, acute and transient; however, rare reactions such as hypersensitivity, induction of infection, and autoimmunity do occur and can be severe and even fatal.”
“Vaccines are clearly essential and safe for most individuals. Nevertheless, our responsibility includes continuing to rigorously assess vaccine safety and attempting to identify possible risk cofactors and at risk individuals so as to minimize vaccine associated serious adverse events and improve vaccination compliance.”
3. Agmon-Levin, N., Paz, Z., Israeli, E. & Shoenfeld, Y. Vaccines and autoimmunity. Nat Rev Rheumatol 5, 648-652.
Competing interests: No competing interests
For many years, David Lewis has been locked in dispute over his sewage sludge research with the US Environmental Protection Agency, from which he was terminated. He has been represented by the Washington employment lawyers Kohn Kohn & Colapinto, which operates what it calls the “National Whistleblowers Center”, whistleblowers.org, a domain registered to one Stephen Kohn. It should not be confused with whistleblower.org, the influential not-for-profit Government Accountability Project.
In January, Lewis and Kohn were guests of anti-vaccine campaigners at the 2,000 acre Tryall Club villa resort in Montego Bay, Jamaica, where struck-off former surgeon Andrew Wakefield headlined the cabaret. An autism website reports that travel costs and hospitality at the five star holidayspot were paid for by the promoters.
You couldn’t make this stuff up, but pursuant to his high season Caribbean trip, Lewis concluded that Wakefield in addition to himself had been “targeted for retribution” by sinister commercial and/or government interests. In a bid to evidence this fascinating proposition, and perhaps find consolation en passant over his sludge research grievance, Lewis got from Wakefield some gut histology proformas.
My BMJ reports of January 2011  made little of sewage or histology, but it may be recalled that in 1998 Wakefield alleged that (a) MMR apparently precipitated autism in 8 of 12 children within days of vaccination; and (b) 11 of the 12 had “colitis”. He announced “a unique disease process”, and fostered lucrative legal claims that a “new variant IBD” made the gut wall leaky, causing autism. 
The forms  were devised by a pathologist, who doesn’t mention “colitis” – much less anything “unique”, “new variant” or “leaky”. He sees almost entirely unremarkable, likely protective, non-specific changes in what has been called the “state of controlled inflammation” in healthy gut mucosa.
God only knows how this helps Wakefield. Previously (a), and now (b), above have been exposed as false. As for “whistleblower”, please watch the most disgusting performance I’ve ever seen by a doctor.
But I’m grateful for the forms, which further illuminate how the appearance of a link between MMR and autism was manufactured in an elaborate fraud.
 Lewis D. A summary of court records in civil actions filed by David L Lewis Ph.D, RA McElmurray III and G William Boyce. Land application of processed sewage sludge (biosolids) 1997-2011. Hallman & Wingate attorneys, 28 September 2011. www.hallmanwingate.com/the-gatekeepers
 Sullivan. The 2011 “Vaccine safety conference” in Jamaica. Leftbrain/Rightbrain. October 6 2011.
 Lewis D. Research misconduct project. Text archived, June 2 2011.
 Deer B. Secrets of the MMR scare. BMJ 2011; 342:c5347, 342:c5258, 342:c7001.
 Deer B. Pathology reports solve “new bowel disease” riddle. BMJ 2011; 343:d6823.
 Deer B. Tabulation of pathology proformas behind “new inflammatory bowel disease” claims. http://briandeer.com/solved/dhillon/tabulation.pdf
 Fiocchi C. The normal intestinal mucosa: a state of ‘controlled inflammation’. In Targan SR, Shanahan F, Karp LC (eds). Inflammatory Bowel Disease: From Bench to Bedside (2nd ed), Kluwer Academic Publishers, 2003.
 Deer B. MMR whistleblower threatened and betrayed. http://briandeer.com/solved/whistleblower-betrayed.htm
 Godlee F, Smith J, Marcovitch H. Wakefield’s article linking MMR vaccine and autism was fraudulent. (editorial) BMJ 2011; 342:c7452
 The New York Times. Autism Fraud. (editorial). 13 January 2011.
Competing interests: My investigation led to the GMC proceedings involving Andrew Wakefield
In January this year, National Whistleblowers Center director, Stephen Kohn, spoke at a vaccine safety conference in Jamaica, where Andrew Wakefield discussed his research.(1) I was invited as an observer. My responsibilities include investigating “institutional research misconduct” in which government, industry, and academic institutions use false allegations of research misconduct to suppress research (www.researchmisconduct.org).
During the conference, the news broke of Brian Deer’s BMJ article on the MMR controversy(2) and the BMJ’s conclusion that Wakefield was guilty of research fraud.(3) Wakefield allowed me to review his personal files concerning the Lancet article. Among them were copies of histopathological grading sheets, which Wakefield told me had been created and filled in by two of his coauthors, pathologists Amar Dhillon and Andrew Anthony (see bmj.com). Wakefield said that the grading sheets related to all but one of the 12 children. Wakefield told me that the General Medical Council had passed the grading sheets on to him along with other documents collated for its investigation. The twelfth child, as a US citizen, was not subject to the GMC’s investigations.
Dhillon’s grading sheets comprised check boxes for the pathologist to indicate the presence and severity of Crohn’s disease or ulcerative colitis, plus a list of other headings: “infection,” “ischaemia,” “non-specific,” and “normal.” In one case Dhillon left the boxes blank. For the remaining 10 children, he checked either “non-specific” or “normal,” with “non-specific” being checked for at least one of each child’s biopsies. Using a slightly different form, Anthony noted mild or active chronic colitis in six children. However, his forms are dated either September 1998 or October 2001 so were completed after the Lancet paper was published.
Wakefield’s files also included a report by Professor Ian Booth, the GMC’s expert paediatric gastroenterologist.(4) Booth had compared routine pathology reports from the Royal Free Hospital with table 1 of the Lancet article and found that on-duty pathologists had indicated that most of the children’s biopsies were normal. He reported to the GMC that the “altered” diagnoses in the Lancet article suggested “an exaggerated view of the histology,” and concluded that “scientific fraud” could not be ruled out.
Four years later, Deer concluded: “These changes—from normal to abnormal, or from healthy to diseased—had also raised concern in the mind of at least one of the paper’s authors [histopathologist Susan Davies].” (5) Davies, as Deer noted, testified at the GMC’s hearings that her concerns were allayed when she discussed them with Dhillon and others.
As a research microbiologist involved with the collection and examination of colonic biopsy samples, I do not believe that Dr. Wakefield intentionally misinterpreted the grading sheets as evidence of “non-specific colitis.” Dhillon indicated “non-specific” in a box associated, in some cases, with other forms of colitis. In addition, if Anthony’s grading sheets are similar to ones he completed for the Lancet article, they suggest that he diagnosed “colitis” in a number of the children.
1 Vaccine safety: evaluating the science. Jamaica, West Indies. 3-8 January 2011. www.vaccinesafetyconference.com/index.html
2 Deer B. How the case against the MMR vaccine was fixed. BMJ 2011;342:c5347.
3 Godlee F, Smith J, Marcovitch H. Wakefield’s article linking MMR vaccine and autism was fraudulent. BMJ 2011;342:c7452.
4 Booth I. GMC Fitness To Practise Panel (Misconduct). Wakefield, Walker-Smith, Murch. Second addendum to overview statement, 8 November 2006.
5 Deer B. Wakefield’s “autistic enterocolitis” under the microscope. BMJ 2010;340:c1127.
Competing interests: Prior to his investigation into Wakefield’s documents, the organisers of the Jamaica conference covered DL’s travel expenses.