The Betrayal of Dr. Wakefield
                                             Smoke And Mirrors:
                                              Dr. Richard Horton
                                    And The Andrew Wakefield Affair
                                                       By: John Stone December 2008

                                                    "If we knew then what we know now we
                                                     certainly would not have published the part of
                                                     the  paper which related to MMR, although I do
believe there was and remains validity to the connection between bowel
disease and autism."  

From the moment Richard Horton, editor of The Lancet, spoke these words on
the BBC evening news of Friday 20 February 2004 Andrew Wakefield’s career
lay in tatters.  

For six years Horton and
The Lancet had been under pressure over his
decision to publish in February 1998 an
‘early report’ Ileal-lymphoid-nodular-
hyperplasia, non-specific colitis and autism in children of which Wakefield - a
senior researcher at the
Royal Free Hospital in London - was lead author.  

At publication time Wakefield was already an author of more than a hundred
peer review publications, but none before or since attracted the attention of
this one.  

The paper, a series study of 12 consecutively referred cases, related to a sub-
group children who had suffered adverse reactions to MMR vaccine, and
hypothesized but did not confirm a connection between their symptoms and
the vaccination.  

Nevertheless, by implication the study struck at the heart of public health
policy: the
Royal Free Medical School called a press conference, and there
was instant controversy. The British government and medical establishment
never forgave Wakefield. They weren’t that happy with Horton either, and he
knew it.  

Horton’s decision to go to the BBC in February 2004 had been precipitated by
an extraordinary meeting at
The Lancet offices two days previously.  

Wakefield’s 1998 paper had been investigated by a freelance journalist Brian
Deer on behalf of the
Sunday Times.  

According to Horton – giving evidence the UK
General Medical Council in
August 2007 – Deer had been dispatched with Liberal-Democrat member of
parliament, Dr Evan Harris, in a last ditch attempt to rescue a failing story, held
over from the previous week, and considered too weak to publish.  

Also present there with Wakefield, were Profs John Walker-Smith and Simon
Murch, the two doctors presently on trial with him at the GMC, and another
Royal Free doctor, the neurologist Peter Harvey.  

Deer presented a raft of allegations about the conduct of the study, and
unethical procedures conducted against the children in the study.  These
were rebutted by the doctors, and were neither upheld by the
Royal Free or in
turn
The Lancet.  

The sticking point, however, came over the fact that Wakefield, alone of the
Royal Free doctors, had been hired by the Legal Aid Board to investigate the
possibility of class litigation against the MMR manufacturers.  

Confronted by Deer, Horton denied that he had known of this, and Deer at last
had a story.  Horton’s decision to go public that Friday evening anticipated the
publication of Deer’s article in the
Sunday Times (and comically led to him
being sued by Deer in the small claims court).  

But Horton’s declaration on its own ignited a media explosion and by the
following morning he had also told the BBC that there was
“a fatal conflict of
interest”
and the research was “fatally flawed”.   

By Saturday, teatime, the
Secretary of State for Health, John Reid, had
requested that the
General Medical Council investigate the case “as a matter of
urgency”
.  And all before Deer’s story had gone to press for Sunday morning.  

This episode smacks of gross media manipulation.  Conflicts in medicine and
science are commonplace – something that hitherto would not have raised an
eye-brow was being foisted on the public at large as if it was grave
misconduct – and that was even before considering the truth and validity of
the allegation, which at the time would have been extremely hard to establish
either way, and was certainly denied by Wakefield.  

Four years later when Wakefield finally produced powerful documentary
evidence of his innocence at the
General Medical Council no one in the media
reported, although several journalists – including from the
BBC and The Times
- were present.  

The outlandishness of what had happened was reflected in a remarkable
passage the book which Horton was to publish within months of the episode,
MMR Science and Fiction: Exploring the Vaccine Crisis, in which he recalled
his dinner engagement on the Monday following these events, and result of
the Health Secretary’s immediate request that the GMC investigate:

"In truth, they (the GMC) had not a clue where to begin.  At a dinner I attended
on 23 February 2004, one medical regulator and I discussed the Wakefield
case.  He seemed unsure of how the Council could play a useful part in
resolving the confusion.  

As we talked over coffee while the other dinner guests were departing, he
scribbled down some possible lines of investigation, and passed me his card,
suggesting that I contact him directly if anything sprang to mind.  He seemed
keen to pursue Wakefield, especially given ministerial interest.  Here was
professionally led regulation of doctors in action - notes exchanged over
liqueurs in a beautifully paneled room of one of medicine's most venerable
institutions."

This could almost be a comic parody of the British establishment at work if it
was not for real.  But Horton’s decision to turn on Andrew Wakefield has been
one of the long neglected (and tragic) turning points in the Wakefield affair.  

I have long been curious about Horton’s role in this saga.  When I wrote
recently to the president of the GMC, Sir Graeme Catto, to ask him to explain
Horton’s involvement (and potential misconduct), he declined to respond, but
passed my open letter to their investigatory branch.  I received this reply:

"In short, I can assure you that the instigation of our investigations has
absolutely nothing to do with any conversations which ‘medical regulators’
may have had with Dr Horton at the dinner described in his book.  If such
conversations took place, they were not reported back in to our investigations
team who were looking at the case at the time.  This being the case, the content
of any such discussions had absolutely no impact at all on any of the decisions
made about whether to proceed to investigate the case or, indeed, how such
investigations should be carried forward."

How could they possibly know whether their investigations have been
influenced by the conversations if they have not even asked about it, and are
totally incurious even now that it has been pointed out?  

It does not matter by now what departures we have from ordinary process, or
whether there is even prima facie evidence of misconduct.  The trial must go
on.  

Although the
“medical regulator” Horton met that Monday evening in February
2004 did not seem concerned about the ethics of exploring ways in which
Andrew Wakefield might be prosecuted (and with the star witness), he
certainly did not seem convinced that Wakefield had done anything wrong.  

This may have been because undisclosed conflicts of interest are so common
that you could not practicably start prosecuting them (where would it end?)
but also as he may already have considered that acting as an expert witness
for the courts did not by convention constitute a conflict at all.  

In fact, this argument was helpfully put by a legal counsel in the British system
‘a barrister’ Robert Hantusch in a letter to The Times the following day 24
February 2004:

"The courts do not consider that the engagement of someone to act as an
expert witness in litigation has the effect that that person is then biased.  
Indeed, if this were the legal position, no paid professional could ever at any
time give evidence to a court."

And this defence was also taken up by a witness on the other side of the case,
Elizabeth Miller, when it was pointed out in the satirical journal
Private Eye that
she had a like conflict if it was such:

"There can be no conflict of interest when acting as an expert for the courts,
because the duty to the courts overrides any other obligation, including to the
person from whom the expert receives the instruction or by whom they are
paid."
 (19 March 2004)

But was Horton’s allegation that Wakefield had withheld information about his
work with the
Legal Aid Board really true?  At the end of the week 27 February
2004 the Independent newspaper finally located striking evidence in Wakefield’
s defence: a letter published on 2 May 1998 in the Lancet, nine weeks after the
controversial study, in which Wakefield replied to a correspondent, Andrew
Rouse, who raised the possibility of
“litigation bias”:

"Andrew Rouse suggests that litigation bias might exist by virtue of
information he has downloaded from the internet: from the Society for the
Autistically Handicapped.  Only one author (AJW) has agreed to help evaluate a
small number of these children on behalf of the Legal Aid Board [emphasis
added].
 

These children have all been seen expressly on the basis that they were
referred through normal channels (e.g., from general practitioner, child
psychiatrist, or community pediatrician) on the merits of their symptoms.  AJW
has never heard of the Society for the Autistically Handicapped and no fact
sheet has been provided by them to distribute to interested parties.  The only
fact sheet we have produced is for general practitioners, which describes the
background and protocol for the investigation of children with autism and
gastrointestinal symptoms.  

Finally, all those children referred to us (including the 53 who have been
investigated already and those on the waiting list that extends into 1999) have
come through the formal channels described above.  No conflict of interest
exists."  

The information that Wakefield (and Rouse) were referring to was a fact sheet
compiled by the legal firm Dawbarns who were pursuing a class action
against the MMR manufacturers at the time, downloaded from an independent
website.  

So, while Wakefield denied that the matter constituted a conflict he had clearly
stated his involvement in the litigation at that early stage.  Unfortunately, the
Independent story made little difference.  

The BBC, with its commitment to balance and impartiality long forgotten,
refused to report this (though I for one personally bombarded the head of
news Richard Sambrook with emails), and only the Telegraph doctor James
Le Fanu took up the issue (March 2004).  It is worth quoting the entire passage
from his column, headed
‘The truth about MMR must be revealed’:

"The Government finds itself in an invidious situation over the MMR/autism
controversy, having painted itself into a corner by denying parents the option
of the single measles vaccine.  They, thus, have no alternative other than to
insist the MMR is totally safe - irrespective of evidence that might emerge to
suggest the contrary.  

Their difficulty is that this position is now looking a lot shakier than it did even a
year ago.  Several further independent studies have confirmed the association
of the syndrome of regressive autism with chronic bowel disorder that was
originally described by Andrew Wakefield.  More recently, research has
confirmed the presence of the measles virus in the gut and spinal fluid of
affected children.  

This may not constitute "proof" and, indeed, a former colleague of Dr Wakefield
challenged the significance of these findings in the Lancet a fortnight ago - and
he may be right to do so.  None the less, it is beginning to look as if, as
neurologist Peter Harvey points out in the same issue, there is now "a step-by-
step cascade of evidence" linking the MMR vaccine to some cases of autism.  

This could explain the assault on Dr Wakefield’s integrity.  The validity of his
original findings, it is claimed, may have been compromised by a conflict of
interest involving research funds that he failed to disclose.  

This might be relevant if it were true, but it is not, as anyone can check for
themselves: Dr Wakefield acknowledged the source of his funding in the
Lancet in 1998.  It would seem to be that neither the Government nor the
medical establishment can afford for Dr Wakefield to be vindicated - and they
are getting pretty desperate."
 

But, remarkably, the role of the man at the center of the non-disclosure
allegation has largely escaped public scrutiny.  In
MMR Science and Fiction,
Horton, while elaborating on the circumstances, which led him to throw
Wakefield to the wolves, skirted delicately around the evidence that Wakefield
did indeed disclose his work with the
Legal Aid Board.  

Critically Horton reproduces an apparently heated exchange from a
parliamentary committee meeting of 1 March 2004 between Evan Harris, and
The Lancet’s boss, Crispin Davis, Chief Executive of Reed Elsevier.  

Both men wave the letter of 2 May 1998 around, Davis citing the statement that
there was no conflict of interest, but neither places on the parliamentary
record that Wakefield had stated in that very letter that he was engaged in the
litigation, and whether it was a conflict or not, it had certainly been in the
public domain from that time.  

But while we are on the subject of conflicts of interest, perhaps Davis needed
to point out -and Horton certainly failed to do so – before becoming
sanctimonious about Wakefield that he was appointed a non-executive
director of MMR defendants
GlaxoSmithKline in July 2003.

When he gave evidence to the GMC in August 2007 Horton stated that he had
not understood from the declaration that Wakefield’s involvement pre-dated
the publication of the study two months earlier.  

The only trouble with this was that Rouse’s letter, forwarded by
The Lancet to
Wakefield on 2 April 1998, was according to Wakefield’s testimony actually
dated 4 March, four days after the publication of the study – which would
suggest that any such misunderstanding on Horton’s part was either
disingenuous in the extreme, or simply incompetence.  

The problem with Horton’s evasions was compounded by his transparently
flawed account in his book of the session in
The Lancet offices with Brian
Deer on 18 February 2004:

"There the consensus ended.  Wakefield admitted that he had been
commissioned by the Legal Aid Board to conduct a pilot study on behalf of
parents of allegedly MMR-vaccine-damaged children.  Some of his colleagues
claimed that he had not disclosed this fact to them.  Simon Murch and John
Walker-Smith were visibly shocked by this revelation."
 

How anybody could have been shocked about a matter which had been in the
public domain for six years is a mystery: in fact when presenting his evidence
to the GMC in March 2008 Wakefield read a letter he had written in early 1997 to
Walker-Smith and Murch explaining his decision to act as an expert in the
MMR litigation – a line from it was subsequently quoted in a BMJ report (5
April):

"If these diseases are found to b Smoke and Mirrors: Dr Richard Horton and
the Andrew Wakefield Affair e linked to the MMR vaccine, these children are the
few unfortunate who have been sacrificed to protect the majority."  

Thus, while there may not have been agreement between them on this, the
claim that the matter was hidden from close colleagues would appear to be
fanciful.  

So what really happened at that meeting between the three doctors and
Horton?  At the GMC in August 2007 Horton described the pivotal moment of
revelation as relating to the Dawbarns fact sheet, which Deer had produced,
which promoted the case against the MMR manufacturers and alluded to
Wakefield’s involvement.  

It was Deer’s production of the fact sheet, which purportedly caused
discomfort to Walker-Smith and Murch, and left Horton denying to Deer and
Harris that he had known of Wakefield’s enrollment by the
Legal Aid Board.  

Beyond the Wakefield-Rouse correspondence in May 1998, did Horton have
any other occasion to learn of Wakefield’s Legal Aid work?  Indeed, unlike
Wakefield, Horton’s office itself was involved in a lengthy correspondence
with Dawbarns, long before the publication of the Wakefield’s study in
February 1998.  

In his testimony to the GMC in April 2008 rebutting Horton’s claim, Wakefield
revealed stunning new information from a previously undisclosed 1997
correspondence between
The Lancet and Dawbarns about the Dawbarns fact
sheet to which Horton had been party.  

According to this exchange, at some point in March 1997, or just before, an
employee of the UK
Medicines Control Agency (later MHRA), Dr B D Edwards,
writing in his private capacity, alerted Horton to the use of
Lancet material (not
the unpublished autism study) in the Dawbarns fact sheet – this included
extracts from other articles by Wakefield and some tables.  

The Lancet then wrote to Dawbarns warning them they should apply to the
journal if they wanted to continue to reproduce it.  There then followed an
extended letter from the lead lawyer for the case, Richard Barr, to Horton
dated April 3, 1997, mentioning that Wakefield had given permission to refer to
an article and citing a statement on the fact sheet:

"There is convincing evidence of a link between vaccination and inflammatory
bowel disease (including Crohn’s disease).  It is a serious lifelong illness that
has affected a large number of the children we are helping.  We are working
with Dr Andrew Wakefield of the Royal Free Hospital London.  He is
investigating this condition."

It was important for Barr to draw attention to Wakefield’s involvement,
because it added moral weight to his case that
The Lancet should allow
publication.  

Horton wrote back denying permission and a lengthy correspondence ensued
involving
The Lancet ombudsman Prof Thomas Sherwood, in which a
compromise was reached – this was concluded in the month of July 1997 just
as the controversial study was being passed for publication, and presumably
there would have been communications within
The Lancet between Sherwood
and Horton on the matter.  

While it may have been a shock for John Walker-Smith and Simon Murch
when Brian Deer produced the fact sheet in
The Lancet offices because they
had never seen it before, Horton claims that, in his role as guarantor of the
ethics and reputation of
The Lancet, it came as an even bigger shock to him
because Wakefield had violated ethical guidelines by withholding disclosure
of the Legal Aid connection.  

But when Wakefield finally produced this evidence to the GMC in April 2008
that Horton and
The Lancet’s ombudsman had been engaged in extended
discussions with the Legal Aid attorneys over their desire to cite work from
their expert witness Wakefield in a fact sheet, it was barely reported: not, for
instance, by the
BBC or by The Times (although they had their journalists
present), nor even by Brian Deer.  Only in
British Medical Journal was there a
half-buried account by Owen Dyer (April 19):

"Dr Wakefield’s defence challenged testimony given earlier by Richard Horton,
editor of the Lancet, who said that he had not known before the article’s
publication of Dr Wakefield’s work on behalf of MMR litigants.  

Dr Wakefield alleged that newly uncovered documents reveal an extensive
correspondence between the Lancet and Dawbarns, the firm of solicitors
representing MMR claimants.  These letters, several months before publication
of the 1998 article, described Dr Wakefield’s work on behalf of the MMR
litigants, he said.  While he was "not impugning Dr Horton’s honesty," said Dr
Wakefield, the documents proved "in my opinion beyond a shadow of a doubt
that he was aware of all these factors."
 

Dr Horton, reached by email while traveling abroad, denied any foreknowledge
of the conflict of interest, saying that the correspondence did not make clear Dr
Wakefield’s role in litigation."
 

In most accounts of Wakefield’s Legal Aid connection, the media have
generally accepted Horton’s description of his editorial judgment: if he had
known of the connection before publication of the 1998 study he would not
have approved it.  

But there is another possibility: that Horton only decided it was a significant
matter long after the event.  Indeed, two letters written by Wakefield to
The
Lancet
on the MMR issue in (September 11, 1999 and August 26, 2000) after
the disclosure of May 1998 that he was working for the
Legal Aid Board were
passed for publication without any such declaration.  

Horton’s inconsistency was further exposed when in 2004 – after the
Wakefield affair blew up -
The Lancet held out for 5 months over publishing a
letter from Mark Geier regarding Michael Pichichero’s non-disclosure of
pharmaceutical company funding in another vaccine autism study
‘Mercury
concentrations and metabolism in infants receiving thiomersal: a descriptive
study’
(2002).  

Pichichero’s silence over his competing interests in this paper stood in
contrast to information revealed in an earlier study, which had the following
declaration:

"The author has received research grants and/or honoraria from the following
pharmaceutical companies: Abbott Laboratories, Inc.; Bristol Myers Squibb
Company; Eli Lilly and Company; Merck&Co.; Pasteur Merieux Connaught;
Pfizer Labs; Roche Laboratories; Roussel-Uclaf; Schering Corporation; Smith
Kline Beecham Pharmaceuticals; Upjohn Company; Wyeth-Lederle."  

This lapse was only resolved after I had posted on it twice in British Medical
Journal Rapid Responses
.  To all appearances this non-disclosure – which hid
extensive commercial interests - was far more compromising: but to
The
Lancet
it was barely worth mentioning, and not to be compared to the perfidy
of Wakefield – indeed, they only agreed to publish a version of the Geier letter
if Wakefield was not mentioned in it.  Some conflicts in Horton’s world are
evidently more fatal than others.  

Many months after Wakefield’s evidence a new statement was finally obtained
by the prosecution at GMC from Horton, presumably explaining as best he can
the apparent discrepancies in his earlier evidence, but the hearing was having
trouble pinning down a time for him to be questioned about it.  

Though Horton’s office is less than a mile up the road from the GMC hearing,
he will apparently be engaged in an important peace mission to the Middle
East when it next sits in January.  

It was always the strategy of the British scientific establishment and
government to isolate and destroy Andrew Wakefield – to make him look as if
he was standing scientifically and intellectually on his own, and to make sure
when they crushed him they discredited all further opposition or dissent on
the vaccination issue.  

In the US context Horton’s book
MMR Science and Fiction would be an almost
incomprehensible oddity.  

There is, for instance, only a single mention of
Thimerosal, which apparently is
just another eccentric concern of Wakefield’s.  In essence the alleged
“vaccine
crisis”
of the title is entirely about Wakefield and the supposed gullibility of
people who doubt official science.  

Horton’s book is not ultimately about scientific truth, it is about who is
credible – we are being told not only is Wakefield not credible, most
importantly the parents of vaccine damaged children are not credible either.  

And cleverly nuanced as Horton’s argument is for a liberal readership, his
decision to turn on Wakefield has behind it a highly illiberal and authoritarian
basis, in which the interests and voices of the patients and their families are to
be finally stamped out.  It is ultimately just stage management, and a stab in
the back for open debate.  

By: John Stone, who has an autistic son, and lives in London.  

Article:
Smoke and Mirrors: Andrew Wakefield Affair
www.whale.to/vaccines/smoke_and_mirrors.html