Intended for healthcare professionals

Observations GMC Wakefield Verdict

Why did the Lancet take so long?

BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c644 (Published 02 February 2010) Cite this as: BMJ 2010;340:c644

The unexplained puzzle of the GMC verdict (and reponses to Peter Flegg)

The panel stated in the short version of their findings on fact read
out to journalists at the GMC last month [1]:

“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 12
children’s investigations were clinically indicated and the research parts
of those clinically justified investigations were covered by Project 162-
95. In the light of all the available evidence, the Panel rejected this
proposition.”

However, it is my understanding that 162-95 was not a "project" in
any normal sense but the ethical approval granted Prof Walker-Smith on his
arrival at the Royal Free Hospital in September 1995 - as probably the
most senior figure in British paediatric gastroenterology - to retain
biopsy samples from colonoscopies for research purposes. If this is the
case it would seem a basic criticism of the panel, that in reaching their
view, they did not explain why this ethical permission did not obtain in
this instance. We are also confronted by the oddity that the panel having
concluded that the study was in fact project 172-96 then found the three
doctors to be in breach of its terms at every twist and turn, instead of
drawing the more obvious inference that it wasn't 172-96 at all, but an
"early report" as stated. (And this, incidentally, is why several of us
think that Ben Goldacre had it right in the first place.)

It is still baffling what is at stake over referral. It is common
experience that when getting a specialist referral from a GP the patient
is asked to which hospital they would like to be referred - an elective
aspect is inherent in the system, as is reputation - and in this instance
this was no ordinary department, so it is not clear what anyone would
expect: it wasn't supposed to be "a scientific sample" or a statistical
measure of anything, which is why I cannot make any sense of S Stanley
Young's comment [2]. You do no not need to be a senior statistician to
conclude that the group in the paper have little or no statistical
significance, but this does not tell you why or how they are ill, and
doesn't answer the parents' legitimate concern about adverse vaccine
reactions and their sequelae. Nor could epidemiology tell you anything
certain about that.

It seems to me that with Peter Flegg's [3] response, as so often with
vaccination, ethics are being turned upside down. The instant position of
those confronted with reports of adverse drug reactions is not to record
them, or investigate but simply to retreat behind denial - which is what
Andrew Wakefield conspicuously didn't do.

So we move to the next stage, which is that the doctor who did
express concern about the safety of a vaccine and took parents on trust is
as a matter of policy turned into a public enemy - and eventually a
gigantic fishing expedition is mounted to see whether anything can be
found against him. And all the time no parent has ever complained!

What we get is neither the practice of ethics or science but the
exercise of social repression. Nothing ensures the unsafety of the system
more certainly than the refusal to investigate sympathetically adverse
reports - and why should a single child be denied investigation if their
medical history indicates it? This is something that Flegg does not seem
to be able to explain. Meanwhile, we get the resort to statistics which
cannot show that it hasn't happened in individual instances, and probably
also don't show that it hasn't happened en masse [4, 5]. Accompanied by
total lack of curiousity as to why autism incidence figures continue to
spin out of control (at the last count 1 in 64)[6].

I think it should remembered in fairness that Andrew Wakefield
supported the then vaccine programme in 1998, endorsing the use of single
vaccines, and the government promptly polarised the issue by making them
unavailable. Also, I believe Flegg is being naieve in contrasting
confirmed cases of measles in 1996, when there was probably only limited
laboratory testing capacity and nothing like the active monitoring, with
the present time.

About the GMC there is a huge problem of transparency - they publish
the allegations and the findings but nothing in between. If you actually
want to find out what the defence case was from the official transcript it
will cost you upwards of £100,000 [7].

[1] Findings of Fact - Summary. General Medical Council, 28 January
2010.
http://www.theoneclickgroup.co.uk/documents/vaccines/GMC%2C%20Findings%2...

[2] S Stanley Young, 'Statistical lessons to be learned as well' BMJ
Rapid Responses 4 February 2010,
http://www.bmj.com/cgi/eletters/340/feb02_4/c644#230877

[3] Peter Flegg, 'Evidence, statistical lessons, and bias' BMJ Rapid
Responses 9 February 2010,
http://www.bmj.com/cgi/eletters/340/feb02_4/c644#231116

[4] Demicheli V, Jefferson T, Rivetti A and Price D, 'Vaccines for
Measles, Mumps and Rubella in Children', The Cochrane Library, Wiley 2005,
http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD004407/fr...

[5] John Stone, 'Re: Evidence is not bullying',
http://www.bmj.com/cgi/eletters/339/sep09_1/b3658#220537

[6] Baron-Cohen et al, 'Prevalence of autism-spectrum conditions: UK
school-based population study', Br J Psychiatry. 2009 Jun;194(6):500-
9,http://www.ncbi.nlm.nih.gov/pubmed/19478287

[7] GMC Publication Scheme, http://www.gmc-
uk.org/publications/right_to_know/publications_scheme.asp

Competing interests:
Autistic son

Competing interests: No competing interests

10 February 2010
John Stone
Contributing editor: Age of Autism
London N22