THE GMC FORMULA
CONFLATE THE EVIDENCE, CONDEMN THE MESSENGER
An email I received in 2011 from Professor Ian Booth, the General Medical Council’s (GMC) expert pediatric gastroenterologist, shows that the GMC’s solicitors instructed him to compare the Royal Free Hospital’s routine pathology reports with Table 1 of the 1998 Lancet article by Wakefield et al. The purpose was to accuse Andrew Wakefield, and potentially Amar Dhillon and Andrew Anthony, of research fraud.1 Until I knew that, it made no sense why Booth ignored Dhillon and Anthony’s grading sheets, which could help clear up the issue of whether Wakefield fabricated any of the Lancet children’s diagnoses. Brian Deer and the BMJ ultimately carried out the deed assigned to Booth when they published a series of articles that began in 2010 with “Wakefield’s ‘Autistic Enterocolitis’ Under the Microscope.”2
Before I could understand what really happened in Wakefield’s case, I had to comb through transcripts of the GMC’s hearings that lasted from July 16, 2007, until April 14, 2010. I also had to locate some of the GMC’s original evidence, which is still retained in Wakefield’s personal files. Then I had to track down additional documents from one of Wakefield’s attorneys in England. Finally, I had to get Booth to clear up perhaps the most important part of the whole story, which only he and the GMC’s solicitors could resolve. Knowing who was behind the analysis of the Lancet children’s medical records Booth used in his report could explain how Deer came to publish the same analysis as his own work four years later.
Booth’s expert report, which was submitted to the GMC on November 8, 2006, further illuminates this mystery. On its cover, it displays the following acknowledgment: “Prepared on the Instructions of: Field Fisher Waterhouse, 35 Vine Street, London.” According to a letter to Brian Deer from Matthew Lohn, a Partner at Field Fisher Waterhouse (FFW), Deer was an informant for FFW when it handled the GMC’s case against Wakefield and his coauthors.3 In his letter dated May 25, 2005, Lohn clarified Mr. Deer’s role and explained that he was not a complainant. (Complainants would be subject to cross-examination in the GMC’s hearings.) Lohn wrote:
Dear Brian . . . I write further to your telephone conversation with Peter Swain last Thursday seeking clarification in relation to your role in the above General Medical Council (“GMC”) proceedings. . . . As stated in Peter Swain’s letter to you dated 16 December 2004, your role in this matter is that of ‘informant’ rather than ‘complainant.’ . . . We are grateful for information supplied by you and your assistance to date.
It’s easy to understand how Booth’s comparison of Table 1 of the Lancet article with the children’s medical records could have ended up in Deer’s hands to publish as part of his own investigation in the BMJ. It’s also clear why solicitors working for FFW and the GMC never introduced it as evidence in the GMC’s proceedings. As pointed out before, it makes no sense to compare the Lancet children’s routine pathology reports with the diagnoses in Table 1, instead of using Dhillon’s blinded analyses recorded in his grading sheets—which is what Table 1 was based upon. Defense attorneys, I’m sure, would have taken Booth’s analysis apart. It made far more sense to let Deer publish Booth’s analysis as his own investigative report after the GMC’s proceedings concluded.
The advantages were obvious. In Deer’s hands, Booth’s analysis of patient records would look like it was just part of an independent investigation by a news reporter. Brian Deer, its new “author”—who FFW made sure was an informant, not a complainant—wouldn’t be subject to cross-examination at the GMC’s hearings. Lancet editor Richard Horton, who was a witness for the GMC, could easily take care of retracting the Lancet article based on the GMC’s findings regarding ethics violations. Then Brian Deer and the BMJ editors could take it from there. With the GMC proceedings behind them, a public lynching outside the courtroom over “new” allegations of research fraud would finally put the nail in Wakefield’s coffin. As the BMJ editors put it: “The Lancet paper has of course been retracted, but for far narrower misconduct than is now apparent . . . leaving the door open for those who want to continue to believe that the science, flawed though it always was, still stands. We hope that declaring the paper a fraud will close that door for good.”4
Dr. Godlee and her coeditors at the BMJ concluded:5
. . . it has taken the diligent scepticism of one man, standing outside medicine and science, to show that the paper was in fact an elaborate fraud. Building on [Deer’s initial] findings, the GMC launched its own proceedings that focused on whether the research was ethical. But while the disciplinary panel was examining the children’s medical records in public, Deer compared them with what was published in the Lancet. His focus was now on whether the research was true.
Presenting Brian Deer as a brilliant investigative reporter who discovered an elaborate fraud by comparing the children’s medical records with the Lancet article made a great story. But it wasn’t true. Professor Ian Booth, who was also working on the case against Wakefield and his coauthors for Field Fisher Waterhouse, was the real man behind the curtain. He was the first person, but apparently not the last, that the GMC’s lawyers instructed to compare the children’s medical records with the Lancet article to create evidence Wakefield had faked the diagnosis of colitis.
What follows explains how it was all an elaborate illusion created by lawyers, scientists and editors with vested interests in defending the government’s vaccination programs. For the BMJ, I believe protecting the MMR vaccine for its sponsors, Merck and GSK, was a driving force.6 As best as I can tell, Fiona Godlee never disclosed this conflict of interest before publishing the grading sheets and other evidence I submitted. Earlier that year, she admitted before Parliament: “Even on the peer-reviewed side of things, it has been said that the journals are the marketing arm of the pharmaceutical industry. That is not untrue.”7 For Deer, his work with the GMC’s lawyers was richly rewarded with two prestigious British Press Awards for prompting GMC hearings and the downfall of Andrew Wakefield.8
As it turns out, what appeared to be hopelessly complex actually conforms to a very simple formula, which the GMC’s solicitors used to prosecute Wakefield and his coauthors. It is an extraordinarily effective weapon for suppressing research, and one that will undoubtedly be widely used by government, industry, and academic institutions in the future. It has two simple components: conflate the evidence and condemn the messengers. Below, I have outlined how this was used against Wakefield and his coauthors (Part A), and then me (Part B).
Part A: Defaming Wakefield and His Coauthors
— STEP ONE —
To condemn authors of the 1998 Lancet study for allegedly causing measles-related deaths with an “MMR scare,” Deer and the BMJ:
• Conflated Wakefield’s 1995 Lancet study that concluded that measles vaccines cause inflammatory bowel disease (IBD) with his 1998 Lancet study that concluded that IBD causes autism spectrum disorders (ASD), then claimed that the 1998 study concluded that MMR vaccines cause ASD.—Accusers worked for the BMJ, which is sponsored by manufacturers of MMR vaccines, giving the appearance that they were protecting their sponsors’ commercial products. None of the accusers disclosed these conflicts of interest in their articles until I began submitting commentaries to leading science and medical journals with figures and references disclosing them.9
— STEP TWO —
In order to condemn Wakefield, Walker-Smith, and Murch for ethical misconduct, Deer and the BMJ:
• Conflated the research component of the 1998 Lancet study with a different study of twenty-five children with ASD and IBD, then claimed that the research was not covered under ethics approvals as the authors claimed in their article.—The research component (EPC 162-95) was approved by the Ethics Committee on Sept. 5, 1995, but the study of twenty-five children with ASD and IBD (EPC 172-96) wasn’t approved until January 7, 1997, after collecting some biopsies.
In order to condemn Wakefield for research misconduct, Deer and the BMJ:
• Conflated the Royal Free Hospital’s routine pathology reports and other scientifically unreliable medical records to claim that Wakefield exaggerated the grading sheets.—To compare biopsy results with a table of diagnoses in the Lancet article, the accusers combined all of the scientifically unreliable medical records while completely ignoring the GMC’s copies of the actual grading sheets Wakefield used to create the table, which came from an expert histopathologist using a standardized protocol in a blinded study with control samples.
Part B: Defaming Me
In order to claim that I was fired by EPA over research fraud, Deer and the BMJ:
• Conflated EPA documents related to a settlement agreement over my 1996 Nature commentary critical of EPA policies with an industry white paper falsely accusing me and my UGA coauthors of research fraud, while never mentioning that the allegations were withdrawn after EPA determined that they were false.
The reason that the conflate-and-condemn approach is so effective is twofold. First, it’s extremely unlikely that any scientists will search out the original documents behind allegations of research misconduct and read them themselves. Second, unless someone has some specialized knowledge in the area, they won’t understand the documents anyway.
Take Wakefield, for example. Thanks to Brian Deer and the BMJ, scientific and medical journals are filled with allegations of research fraud against him, except, in Wakefield’s case, they’re not called allegations. They’re stated as facts and filled in anger, disgust, hatred, and dismay that he’s still free to walk about on the face of the Earth. Yet no academic institution, governmental body, or court of law has ever tried him, much less convicted him, of research fraud.
To summarize the allegations, Wakefield is accused of fabricating the diagnoses of colitis in eleven children with autism in order to create an “MMR scare” so that parents would stop using Merck and GSK’s MMR vaccines. That, allegedly, is so that he could sell his own measles vaccine. Can you imagine what would happen if anyone in the world actually did such a thing, and ended up costing pharmaceutical companies billions of dollars in profits and killing thousands of children? Have you ever wondered why Merck and GSK haven’t sued Andrew Wakefield, or why he has never been prosecuted for any of these heinous crimes against humanity?
It’s odd, to say the least, that Brian Deer and the BMJ claim that they never saw Dhillon’s and Anthony’s grading sheets until I submitted them for publication. These are the documents they allege that Wakefield intentionally misinterpreted in order to fake the children’s diagnoses of colitis. So we are to believe that Deer, an award-wining investigative reporter, never actually obtained any of the documents he says Wakefield used to create the “fake link” that created the global “MMR scare?” This is doubtful since Deer obtained copies of Wakefield’s documents related to the case.10
Walker-Smith Exonerated
In March 2012, Justice John Mitting of the High Court of England dismissed all of the General Medical Counsel’s (GMC) charges against Professor John Walker-Smith, senior coauthor of Andrew Wakefield’s 1998 Lancet study.11 And the GMC’s counsel acknowledged that there was “serious weakness” in the panel’s reasoning.12
Mitting criticized the GMC panel on numerous counts. He concluded, for example, that the panel made “fundamental errors,”13 distorted evidence,14 and based its findings on an inadequate analysis of the facts.15 The panel provided inadequate and superficial reasoning and explanation for its conclusions,16 inappropriately rejected evidence, relied upon “flawed” and “wrong” reasoning, and “numerous and significant inadequacies” in its conclusions, particularly in its findings in the individual cases of the Lancet children.17
In 2010, editors retracted the Lancet study based upon the GMC’s determination that the patients were not consecutively referred and the study did not have ethical approval. The court, however, ruled that the Lancet children were, in fact, consecutively referred. It also found that medical procedures used in the study, including lumbar punctures and endoscopic biopsies, were clinically indicated and, therefore, did not require approval from an ethics committee. The High Court dismissed both charges upon which Lancet editors retracted the study; however, the journal has not reinstated the paper.
Although Justice Mitting corrected many of the GMC’s errors, his approach to analyzing clinical studies was seriously flawed. He assessed, individually, whether each scientist’s primary goal was to benefit the patients in the study versus patients in general. If the scientist’s primary aim was to benefit the patients in the Lancet study, Mitting concluded that he did not need an ethics approval for his work on the project. Using this approach, Mitting concluded that Walker-Smith’s primary goal was to diagnose and treat the Lancet patients, while Wakefield’s purpose was “undoubtedly research.”18 Ethical approvals, however, are granted to projects, not individuals. They aren’t like driver’s licenses, in other words.
Ethics Statement Criticized
Mitting concluded that the following statement in the Lancet article was “untrue and should not have been included in the paper”:19
LANCET ARTICLE (1998)
Ethical approval and consent Investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust, and parents gave informed consent.
The statement above has two parts: (1) the Ethical Practices Committee (EPC) approved the Lancet study, and (2) parents gave informed consent. According to a Freedom of Information (FOI) response from the London Strategic Health Authority of the National Health Service (NHS), Deer obtained copies of the ethics committee approvals covering the research component of the Lancet study in 2004.20 These approvals are not mentioned in transcripts of the GMC hearings, and Dr. Wakefield confirmed that he was not aware that these records existed until after the hearings concluded. It appears, therefore, that Deer never disclosed these approvals to the GMC.
Absent these approvals, the appearance was created that Walker-Smith collected research biopsies from seven of the Lancet children without any ethics approvals. In other words, it made it appear that Wakefield and his coauthors were dishonest when they stated in the Lancet article, “Investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust, and parents gave informed consent.”
Walker-Smith’s attorney introduced three documents that clearly demonstrated that the research component to the Lancet study had been pre-approved by the Ethics Committee; the GMC simply disregarded them without cause. Judge Mitting stated:
The panel has heard that ethical approval had been sought and granted for other trials and it has been specifically suggested that Project 172-96 was never undertaken and that in fact, the Lancet twelve children’s investigations were clinically indicated and the research parts of those clinically justified investigations were covered by Project 162-95 [the general permission given to Professor Walker-Smith in September 1995]. In the light of all the available evidence the panel rejected this proposition.
To this, Justice Mitting stated:
Its conclusion that Professor Walker-Smith was guilty of serious professional misconduct in relation to the Lancet children was in part founded upon its conclusion that the investigations into them were carried out pursuant to Project 172-96. The only explanation given for that conclusion is that it was reached “in the light of all the available evidence.”
On any view, that was an inadequate explanation of the finding. As it may also have been reached upon the basis of two fundamental errors—that Professor Walker-Smith’s intention was irrelevant and that it was not necessary to determine whether he had lied to the Ethics Committee—it is a determination which cannot stand unless it is justified by the detailed findings made in relation to the eleven relevant Lancet children.
The records concerning EPC 162-95, to which Justice Mitting refers, were not nearly as comprehensive as the approvals Deer had obtained from NHS. While Wakefield struggled to put all the facts together at the beginning of the hearings,21 Deer apparently sat on most of the evidence Wakefield needed.
In the end, the GMC sanctioned Dr. Wakefield and Professor Walker-Smith for not complying with the “conditions for approval and the inclusion criteria” for Project 172-96 (i.e., investigating children before the approval date and failing to keep copies of the signed parental consent forms with EPC approvals for Project 172-96).22 Dr. Wakefield and his senior coauthors, however, steadfastly maintained that EPC 172-96 had nothing to do with the Lancet study.23
Informed Consent
Regarding the issue of informed consent, the Court made no further comment. The record is clear, however, that Walker-Smith’s group transmitted a report to the ethics committee titled “1999 Annual Report on Ethical Submissions 162-95 and 70-97.”24 It states, “Samples, with fully informed parental consent (using the consent forms as detailed in the submissions), were obtained from upper and lower endoscopies. . . .”
I obtained the GMC’s copies of the Lancet patients’ signed consent forms from Wakefield’s files. Patient 11, a US citizen, was not included. Based on other medical records obtained by the GMC, I listed the dates that colonoscopies were performed on each of Lancet children (see Table 1). All of the colonoscopies were performed after parental consent was granted on or before August 24, 1995.
“No Respectable Body”
Justice Mitting concluded, “There is now no respectable body of opinion which supports [Wakefield’s] hypothesis, that MMR vaccine and autism/enterocolitis are causally linked.”25 It’s difficult to believe that the High Court failed to understand that the absence of such a body of science may well be a direct, and intended, result of the GMC’s actions against Wakefield and Walker-Smith. As mice vacate a field at the sight of an owl devouring even a single mouse, so it is with scientists. It’s called the “ecology of fear.”26 If it were not for what was done to Wakefield and Walker-Smith, many outstanding scientists would likely be willing to conduct objective research on vaccine safety, and publish their results regardless of whether they may threaten government policies and industry practices. In response to letters to editor-in-chief Richard Horton calling for the reinstatement of the 1998 Lancet study by Wakefield et al., including from Dr. Wakefield, Dr. Horton stated, “We have no plans to change our decision about this paper.”27
|
Table 1. Lancet study signed consent formsa |
||
| Patient No. | Colonoscopyb | Referencec |
| 01 | 07-21 to 07-26-96 | Day 1, p. 10 |
| 02 | 09-01 to 09-09-96 | Day 1, p. 08 |
| 03 | 09-08 to 09-13-96 | Day 1, p. 11 |
| 04 | 09-29 to 10-04-96 | Day 1, p. 12 |
| 05 | 12-01 to 12-06-96 | Day 1, p. 17 |
| 06 | ~11-01-96d | Day 1, p. 14 |
| 07 | 01-26 to 02-??-97e | Day 1, p. 22 |
| 08 | 01-19 to 01-25-97 | Day 1, p. 21 |
| 09 | 11-17 to 11-22-96 | Day 1, p. 15 |
| 10 | 02-16 to 02-19-97 | Day 1, p. 23 |
| 11 | NAf | NAf |
| 12 | 01-06 to 01-10-97 | Day 1, p. 19 |
a Parental consents were obtained by August 24, 1995 (TA Reed & Co., Note 23)
b Royal Free Hospital admission to discharge dates (TA Reed & Co., Note 8)
c Transcript of GMC hearings (TA Reed & Co., Note 8)
d “On or about” November 01, 1996 (TA Reed & Co., Note 8)
e Discharge day in February 1997 was unrecorded (TA Reed & Co., Note 8)
f Patient 11, a US citizen, was not subject to the GMC investigations
Over time, science has evolved into a sophisticated marketing tool for supporting government policies and industry practices. As mentioned earlier, even Fiona Godlee testified she would not disagree that peer-reviewed journals are “the marketing arm of the pharmaceutical industry.”28 Marketing has a lot more to do with hiding the truth than publishing, whether for promoting government policies or industry products. That’s not to say that most science is untruthful. But, for the most part, the only areas of science that escape government manipulation are those that have little or no impact on government policies, guidelines, or regulations.
For now, the scientific community seems pleased with the outcome with regard to Andrew Wakefield, regardless of whether any or all of the allegations are true. But that’s because there aren’t many research scientists independently working on vaccine safety, and the fear of frightening millions of parents into not vaccinating their children far outweighs any concerns over comparatively small numbers of documented cases of adverse reactions to MMR vaccines. The same is true of research on biosolids. The number of researchers who are independently investigating adverse health effects in this could probably be counted on one hand, and the fear of water bills going up may keep most people from protesting over EPA and land grant universities covering up a few dead bodies here and there.
The problem is that, when government and industry are geared up to cover up, we have no way of knowing what the real toll is on public health or the environment. But one thing is safe to assume. Government agencies, big corporations, and the universities they fund will not confine their use of these tactics to attacking only scientists who represent small areas of interest. Nor will they hesitate to go after areas of science where they lack a broad consensus of support. Protecting government policies and industry practices knows no bounds. Whatever tools prove effective in reaching those goals will, sooner than later, be used with little if any restraint. It is something, as President Eisenhower warned, to be gravely regarded. Our silence now will eventually bring an unbearable price for all to pay.