I have just been tidying up a sequence of BMJ Rapid Responses I posted in the autumn of 2004:



MMR - SCIENCE AND FICTION": the Richard Horton story 25 September 2004 ------John Stone 


http://bmj.bmjjournals.com/cgi/eletters/328/7438/528#75516

Richard Horton's new book is evidently an attempt to set the record
straight for a wide readership: I found a stack of copies at our local
bookshop so there are evidently thousands of people out there hanging on
his words.

The book begins with the meeting on 18 February 2004 in the Lancet offices
in which Sunday Times journalist Brian Deer challenges the Lancet, Andrew
Wakefield, and members of the original Royal Free team John Walker- Smith
and Simon Murch with a series of allegations most of which are quickly
shown to be unfounded. The one remaining allegation which was left hovering
above Wakefield and was to prove the basis of the media trial which ensued
in the following days, was that he had failed to disclose a potentially
embarrassing conflict of interest. It is strange in this context that
Horton does not mention the letter that Andrew Wakefield wrote to the
Lancet (published 2 May 1998) in which Wakefield first dealt with the
matter publicly:

"A 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. These childen
have all been seen expressly on the basis that they were referred through
normal channels (eg, from general practitioner, child psychiatrist, or
community paediatrician) 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 exist."

So, what Horton does not tell us here is that this matter had been made
public and had been known by him since May 1998 and had not hitherto - in
nearly six years - been considered embarrassing. It remains extraodinary
that there is no mention that I can see of this letter in Horton's book
until p. 50, where it appears rather incidentally in Horton's account of an
exchange between Dr Evan Harris MP and the proprietor of the Lancet Crispin
Davis at the Commons Science and Technology Committee on 1 March 2004.
Davis tells Harris:

"You can imagine that it is virtually impossible for every editor to
research every single author in terms of conflict of interest, and in this
one Dr Wakefield said there was no conflict of interest, and in fact three
months later in written form repeated that there was no conflict of
interest. In all fairness, I do not hold our editor to blame...",

and again Davis is quoted on p.51 reiterating:

"It actually says: 'There is no conflict of interest'. Should the editor
then-".

Without going into the full context of what Davis is claiming it seems
extraordinary, at least, for Horton to quote Andrew Wakefield's statement
that "there is no conflict of interest" so completely out of context.

The other critical point to be made here was that Andrew Wakefield was
legally correct in stating that there was no conflict of interest. In
defending herself against a parellel claim made in Private Eye (19 March
2004), Professor Elizabeth Miller - presumably with the best legal advice -
wrote:

"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 innstruction or
by whom they are paid".

Interestingly, Horton quotes from this very same letter p. 56, but not this
bit of the letter. This legal view was also given by barrister Robert
Hantusch in a letter to the Times of 24 February 2004:

"But 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"

There are therefore two key points here which Horton's book would seem to
disguise: (a) that Andrew Wakefield's involvement in the court case had be
known by him and not considered embarrassing for nearly six years and (b)
that engagement as an expert witness is not generally regarded as
constituting a conflict of interest. To disclose such an involvement may be
sensible but to disclose it as "a conflict of interest" might suggest that
you were compromised in court.

I note that Richard Horton has not been so super-sensitive to other cases
of non-disclosure which I have recently documented on these boards
concerning the Lancet, Eric Fombonne [1] and Michael Pichichero [2].

[1] Prof Fombonne, Dr Horton and the Lancet: double standards on competing
interests http://bmj.bmjjournals.com/cgi/eletters/329/7463/411#74042 , 12
September 2004

[2] Thimerosal - a case of non-disclosure in the Lancet
http://bmj.bmjjournals.com/cgi/eletters/329/7463/411#71574 ,20 August 2004.

Competing interests: Parent of an autistic child


"MMR - SCIENCE AND FICTION": the Richard Horton story II 27 September 2004


In his account of the meeting at the Lancet offices of 18 February 2004
Richard Horton recounts (p.5):

"There the concensus 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."

The only colleagues present according to Horton's earlier narrative (p.3)
were Walker-Smith, Murch and Peter Harvey. You might think that however
embarrassed Murch and Walker-Smith were - given the present professional
pressures - they could scarcely have been shocked by the revelation of
information which had been in the public domain since 2 May 1998 (see my
previous post of 25 September 2004). In his statement to the Lancet, 6
March 2004 Walker-Smith states:

"None of the children at the time of the referral was known by the team of
paediatric gastoenterologists who cared for and investigated these children
to be involved in a pilot project commisioned by the Legal Aid Board. At
the time of the consultation, I was aware that some of the parents were
engaged in legal proceedings."

Interestingly, neither Walker-Smith or the ten contributors to the original
1998 report (including Walker-Smith) in their joint statement also in the
Lancet of 6 March 2004 makes the claim that Andrew Wakefield witheld
information from them. If there was any disagreement after Wakefield's
letter of 2 May 1998, it has also never come to light.

Perhaps, what is most significant is the apparent extreme motivation to
find irregularities after the event. Thus Horton writes (p.4-5):

"It was true, however, that the referral of some of these children had been
unusual. They had not simply turned up at the Royal Free by chance. Some of
the parents knew of Wakefield's interests and his prior view that measles
was somehow linked to bowel disease."

What would have been odd is if they had all been referred to a chiropodist.
This is surely a skewed narrative.

Competing interests: As above


"MMR - SCIENCE AND FICTION": the Richard Horton story III 30 September 2004

Richard Horton tells us little about Sir Crispin Davis, Chief Executive of
Reed Elsevier plc, publishers of the Lancet, except to give an account of
his evidence to the Commons Science and Technology Committee (1 March
2004). It may be of some interest that Sir Crispin was appointed as a
non-executive director to the board of GlaxoSmithKline - defendants in the
MMR litigation - in July of last year.

Sir Crispin's knighthood was announced in the birthday honours, June 2004.

http://www.gsk.com/about/boardofdirectors.htm

Competing interests: As above


"MMR - SCIENCE AND FICTION": the Richard Horton story IV 1 October 2004

Richard Horton writes rather disparagingly about the pharma/bio-tech lobby
organisation, chaired by Lord Taverne [1], Sense about Science remarking
p.155:

"Unfortunately, Sense about Science has allowed itself to become an easy
target for attack. Its financial donors include GlaxoSmithKline, one of the
manufacturers of MMR vaccine and a defendant in the litigation brought by
claimant families. Among the forty-five people who make up Sense about
Science's board of trustees and advisory council, there are Lords (five),
Knights (seven), Professors (fifteen), luminous Fellows (fourteen),
distinguished doctors (twelve), a Baroness and a Dame."

Richard Horton does not mention that among the "distinguished doctors" is
Michael Fitzpatrick [2], a regular columnist in the Lancet. In the issue of
the Lancet of 21 February 2004 - the very weekend that Richard Horton
decided to throw Andrew Wakefield to the wolves - Michael Fitzpatrick wrote
a polemical piece on the Government's promotion of choice in healthcare:

"Nor is the continuing promotion of choice going to be much help in the
ongoing struggle to improve uptake of the measles, mumps and rubella (MMR)
vaccine, given the government's - entireley legitimate - refusal to allow
parents the choice of separate vaccines." [3]

At no time in all this controversy has Michael Fitzpatrick declared the
Sense about Science-GSK link as a competing interest, he did not on this
occasion, and Richard Horton has taken no public action against him.

THE TROUBLE WITH RICHARD HORTON'S ACCOUNT IS THAT HE AFFECTS TO BE ABOVE IT
ALL BUT THE DOCUMENTS SUGGEST OTHERWISE.

[1] See Rapid Responses to Dick Taverne 'The legal aid folly that damages
us all' (24 July): http://bmj.bmjjournals.com/cgi/eletters/329/7459/239

[2] www.senseaboutscience.org.uk. See also Rapid Responses to Michael
Fitzpatrick 'George and Sam'(26 June 2004):
http://bmj.bmjjournals.com/cgi/eletters/328/7455/1571

[3] 'Choice',The Lancet, 21 February 2004, vol.363 no 9409.


"MMR - SCIENCE AND FICTION": the Richard Horton story V 1 October 2004



The Lancet today publishes a letter from Dr Mark Geier relating to
non-disclosure of interest by Prof Pichichero (2 October 2004 Vol 364 No
9441), as mentioned in my letter above of 25 September 2004 (""MMR -
SCIENCE AND FICTION": the Richard Horton story"). I have electronic copies
of correspondence which show that Dr Geier first wrote to the Lancet on
this matter on 29 April of this year. After much toing and froing the
Lancet agreed to publish a letter from Dr Geier providing it did not draw
parallels with the Andrew Wakefield affair, and Prof Pichichero was given
the opportunity to defend himself (letter of 1 July 2004).

Notwithstanding this, it seems to have taken a further three months for the
Lancet to produce Dr Geier's letter, perhaps embarrassed by my post. If as
they claimed in the correspondence Prof Pichichero had a sound defence it
is hard to understand why they were not anxious to clear the air.

Where, we might ask, are the transparent upholders of the public good?

(Documents provided)

Competing interests: As above

"MMR - SCIENCE AND FICTION": the Richard Horton story VI 4 October 2004#

On page 10 Richard Horton writes:

"On this occasion, we had discovered an error of judgement, an important
error of judgement to be sure: a failure to disclose a perceived conflict
of interest that would almost certainly altered peer reviewers' and
editors' view about a preliminary and controversial finding. Did this
behaviour amount to scientific misconduct? It was hard to tell. But it
certainly invalidated Wakefield's central claim - namely that the link
between MMR vaccine and autism was a serious independently arrived-at
scientific hypothesis that needed to be investigated urgently."

The question might conceivably arise whether professional misconduct was
involved if in fact the paper contained such a hypothesis, but there is no
such passage and Horton does not (cannot) cite it.

Horton goes on (p.10-11):

"We needed a partial retraction, erasing as far as one reasonably could the
interpretation concerning the vaccine and the autism. None of the factual
material in the 1998 paper was in doubt. Twelve children did exist. Their
clinical histories were not disputed..."

But Horton does not tell the reader what is contained in their clinical
history:

"In eight children, the onset of behavioural problems had been linked,
either by the parents or the child's physician with measles, mumps and
rubella vaccination. Five had had an early adverse reaction to
immunisatisation (rash, fever, delirium, and in three cases, convulsions).
in these eight children the average interval from first exposure to the
onset of behavioural symptoms was 6.3 days (range 1-14). Parents were less
clear about the onset of abdominal symptoms because children were not
toilet trained at the time or because behavioural features made children
unable to communicate symptoms..." [1]

But where we have to ask was the claim made which related to Andrew
Wakefield's alleged conflict of interest. The reason for Wakefield's
concern is evident, but the claim that his interest somehow distorted the
paper cannot be substantiated. It would not have been proper to omit such
information. And again Horton does not tell the reader what they need to
know.

[1] Wakefield et al: 'Ileal-lymphoid-nodular hyperplasia, non- specific
colitis, and pervasive developmental disorder in children', The Lancet Vol
351, No 9103, 28 February 1998.

Competing interests: As above

To Spell out the Problem 31 October 2004

http://bmj.bmjjournals.com/cgi/eletters/329/7473/1049#83037

(Response to a review by David Elliman and Helen Bedford 'MMR: Science and Fiction. Exploring the Vaccine Crisis; MMR and Autism: What Parents Need to Know' Double review of books by Richard Horton and Michael Fitzpatrick. http://bmj.bmjjournals.com/cgi/content/full/329/7473/1049)

1) The claim (a) that Andrew Wakefield had failed to diclose an interest is predicated on the claim (b) that the 1998 paper presented a hypothesis that the children's condition had been caused by MMR: "Did this behaviour amount to scientific misconduct? It was hard to tell. But certainly it invalidated Wakefield's central claim - namely that the link between the MMR vaccine and autism was a serious independently arrived at hypothesis that needed to be investigated urgently" (Horton p.10).

2) Richard Horton does not cite any passage in the 1998 paper in which such a hypothesis is formulated. What is recorded very embarrassingly in the paper is the fact that in eight out of the twelve cases symptoms had first manifested themselves following violent local reactions to MMR vaccine. And as Horton states: "Their clinical histories were not disputed" (p. 11). David Elliman and Helen Bedford (above) apparently agree that no such hypothesis was formulated in the paper.

3) The statement of the ten authors who signed up to a partial retraction of the paper refers not to a "hypothesis" but to an "interpretation" (Horton p.12). So it was actually not something that was articulated in the paper, but something you are not allowed to even think. Which is odd enough, but quite a different matter.

4) On top of this Richard Horton does not report that Andrew Wakefield had disclosed his involvement in the case in a letter published in The Lancet on 2 May 1998, so that this could not possibly have been a revelation to Horton, John Walker-Smith or Simon Murch at the meeting in the Lancet offices of 18 February 2004: "Simon Murch and John Walker-Smith were visibly shocked by his (Deer's) revelation" (Horton p.5). Once again David Elliman and Helen Bedford (above) agree that this earlier disclosure ought to have disposed of any ethical issue on that account.

5) There is also the issue of whether acting as an expert witness for the courts constitutes a competing interest at all.

6) Horton has been less than rigorous over other cases of non- disclosure in The Lancet I have cited - notably that the proprietor of The Lancet, Crispin Davis, had recently been made a director of MMR defendants GlaxoSmithKline (July 2003).

* * *

Looked at this way, both on the merits of the case that Deer had presented, and on the basis of ordinary practice concerning disclosure of competing interest, there was no basis for Richard Horton to pursue any action against Andrew Wakefield. In order to take action he apparently had to stretch many points. Why, then, did he do it?

Competing interests: Parent of an autistic child