MP raises new allegations against Andrew Wakefield
BMJ 2004; 328 doi: https://doi.org/10.1136/bmj.328.7442.726-a (Published 25 March 2004) Cite this as: BMJ 2004;328:726All rapid responses
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Sir
I seem to be responsible for a sudden dramatic exchange on the
disclosure of 'competing interests' that one hardly expected - apparently
prompted by my unfortunate typo 'IS' for 'IS/WAS' (referring to the 1999
reference I used) that I mis-transcribed from my original unsubmitted
prose...and that I informed the eBMJ convenor about but that seems hardly
worth amending now that Clifford Miller, Brian McClusky and John Stone
have done such a marvellous job clarifying the issues on behalf of Dr.
Harris.
I do not consider that 'competing interests' soil ones integrity - as
one may think from the way they are often handled - indeed most
disclosures are an indication of a spokesperson's experience in the
subject and may be admired. I know the findings of Sara Schroter et al (1)
suggest that public perception is influenced by 'competing interest'
disclosures as well as subject content, but suspect that the latter
achieves greatest significance with a wise public.
As to Dr Harris's "hardly earth shattering competing interest", to
quote Brian McClosky, whether or not Dr Harris was required by Parliament
to disclose that 'interest' I would hope that, for the eBMJ discussion of
his parliamentary action, the public is deemed worthy of disclosures, past
or present and earth shattering or not, because - unlike parliamentary
debates - our public have direct access to the eBMJ discussion and their
perception can only be enhanced by open disclosures in our liberal and
democratic society.
Were Dr Harris to join the discussion I am sure the public, parents
and families of autistic persons, who are inevitably affected by all
parliamentary actions and debates on the subject, would welcome the
opportunity to interact with a politician who is also a physician with
experience in autism and vaccines whose action could be said to have
founded the discussion.
Regards
John H.
Reference
1. Sara Schroter et al BMJ 2004;328:742-743
Competing interests:
None declared
Competing interests: No competing interests
Medical Facts, Not Politics
While the debate goes on concerning what Dr. Evan Harris did not
mention about the Glaxo Wellcome Fellowship, it is important to comment on
what he did say about the investigations by the Wakefield group at the
Royal Free (1).
Without talking to parents, Dr. Harris suggested that facts had been
misrepresented and that the procedures performed on children were not
safe, beneficial or even indicated. He also endorsed the statement that
research, where there was no likely clinical benefit to children, should
not involve anything worse than a blood test.
As a pediatrician with 34 years of practice and the grandfather of a
boy who was investigated at the Royal Free Unit in June of 1999, I can
assure Dr. Harris and everyone, that the benefits were well worth the
small risk we took and of which we were fully informed. We begged to have
our boy included in the Wakefield study and patiently waited for nine
months for our turn. When his diagnosis was confirmed, we placed him on a
liquid formula for 2 months, progressed him to a gluten-free/casein-free
diet and started him on the appropriate medications with prompt and
sustained improvement of his gastro-intestinal findings, his speech, his
social competence and his immune system. Our targeted therapy was selected
and proved successful only because we knew the specific pathology he had.
We never felt the investigations were aggressive and we are grateful
to this day, for having been included. We believe that the only aggression
inflicted on our boy was from the virus that ruined his life, and ours,
forever. My grandson has evidence of measles genomic RNA in his gut wall.
Hundreds of endoscopies and colonoscopies are performed on children
in order to pinpoint the diagnosis and to formulate the right therapies. A
spinal tap in experienced hands is an easy and safe procedure. Much more
aggressive investigations are actually performed on infants and children
every day and it is safe to state that if the Royal Free program is
reinstated, families will be lining up until Hampstead Park.
Dr. Harris is evidently dedicated to the health and welfare of his
constituents and of the population at large. There is no doubt that he
would be thoroughly distressed if 1 in 100 children died or developed
obscure illnesses. Unfortunately, he has not appreciated that a whole
generation is being lost and that regressive autism may actually be worse
than death, for the children, their families, the communities and the
Country. Dr. Harris should realize that sometime, somewhere, he must find
the huge funds that are needed for the care that these poor individuals
will require for the rest of their lives.
Our children are not simply “autistic” and they do not suffer from a
hopeless psychiatric genetic illness that is effectively an Act of God.
They have Regressive Autism, a multi-system disease with intestinal,
neurological, endocrine and immune manifestations that is precipitated, in
all probability, by environmental causes. It is only when that
distinction is finally made, that the real causes of this epidemic will be
adequately investigated; it is only then that the therapies and
educational modalities necessary to limit the damage and improve the
prognosis, will be supported.
“Vaccinology” has existed for two centuries; Immunology is a very
recent science. Now that more is known about immune disorders and vaccine
damage, we should candidly find out where we went wrong.
Maybe indeed, 1+1+1 does not equal 3, when it comes to live viruses
and small children?
Maybe in fact, Andrew. Wakefield is right?
Maybe we should look for the truth instead of shooting the messenger?
Reference
1. Ferriman, A. MP raises new allegations against Andrew Wakefield. BMJ
2004; 329:726
Competing interests:
Grandfather of a boy with regressive autism
Competing interests: No competing interests
Visitors to the BMJ Rapid Responses will be grateful to Brian
McCloskey for clarifying the relationship of Evan Harris with Glaxo
Wellcome. As he remarks "hardly an earth shattering competing interest" so
it would be nice if he and Dr Harris also acknowledged that Andrew
Wakefield's "competing interest" was also not "earth shattering", even
though it held the news headlines for four days (February 20-23) and he
was not only condemned by Dr Harris, but by the editor of The Lancet Dr
Richard Horton, by senior medical officers Sir Liam Donaldson and Dr David
Salisbury, as well as by the Prime Minister. But Dr Wakefield had no
"interest" as Professor Elizabeth Miller pointed out in her parallel case
"there can be no conflict of interest when acting as an expert for the
courts" [1] and his involvement so far from being "earth shattering" news
had been known about for six years [2].
The columns of the BMJ are now one of the few places left which gives
space to a continuing and open discussion of the complex and multi-faceted
subject of vaccination safety. Contributers are nevertheless aware that if
they made false claims or unfounded criticisms that their letters would
not be posted. So it is perfectly proper that when an incorrect claim is
inadvertently made about Dr Harris a public servant should appear to set
matters straight. But would it not be more impressive if there was some
open attempt to address all those more difficult questions as well? What
about the flawed claims about Dr Wakefield's integrity? What about the
sick children that a minister admits have measles antigen in their gut?
[3] What about the many flaws and failure in Government epidemiology
which have been explored by contributors to the site? [4]
Is it not time we had some open answers about these things?
[1] Private Eye N.1102,19 March-1April 2004
[2] Disclosed in a letter to The Lancet 2 May 1998, and latterly reported
in The Independent 27 February 2004. His participation must also have been
known to the defence.
[3] Interview with Dr Stephen Ladyman, Epolitix, 14 October 2003.
[4] Passim.
Competing interests:
Parent of an autistic child who supports vaccination but has concerns about the safety of the current programme
Competing interests: No competing interests
I agree entirely with Brian G McCloskey, Deputy Director, Local and
Regional Services Health Protection Agency in his response on this topic.
However, he assumes Mr Harris still has the Glaxo Wellcome Fellowship,
which it is not clear he still does, as the information concerned dates
back to 1999.
For the avoidance of doubt, it appears perfectly proper for an MP to
be involved in the IPT as can be seen from
http://www.ipt.org.uk/about/about.html.
Even travel expenses on IPT business can be reimbursable under a
parliamentary scheme as can be seen from http://www.parliament.the-
stationery-office.co.uk/pa/ld/ldpeers/peers04b.htm
"4.3 Industry and Parliament Trust (IPT).
4.3.1 Journeys made on business connected with the Industry and
Parliament Trust may be claimed from the House of Lords as part of the UK
travel scheme, so long as they meet the terms of the scheme set out above.
All other claims should be addressed to the IPT."
There seems to be nothing improper in not disclosing the holding of
the Glaxo Wellcome Fellowship in the MMR/Royal Free debate he initiated on
15th March and particularly not if the Fellowship is no longer held.
However, if Mr Harris still is a Glaxo Wellcome Fellow, it might have been
better for democratic transparency if it had been disclosed. Some might
argue it should still have been disclosed even if the Fellowship had been
relinquished since 1999 as it indicates a close contact with Glaxo
Wellcome in a debate on such a serious topic. After all, Mr Harris did
feel it appropriate to disclose the holding of the Fellowship in 1999, in
a previous debate on a far less controversial matter and even though he
himself admitted then it did not seem to be a disclosable interest. I set
out the quote below from Hansard. The debate related to the delegated
legislation on the Medicines (Advertising and Monitoring of Advertising)
Amendment Regulations 1999.
What, perhaps is far more important for the public to have known, is
what prompted Mr Harris to make his intervention in the MMR/Royal Free
Hospital matter at that particular time and whether it was of his own
volition as a matter of conscience or for some other reason? He does not
say what prompted his intervention and it would have been helpful for
Parliament and the public to know. That is not mentioned at all in the
debate he initiated and as recorded in Hansard of 15th March.
It is worth comparing first what Mr Evan Harris disclosed in the
debate regarding the MMR/Royal Free, under which Mr Harris had
Parliamentary privilege and in which extremely serious allegations were
made, as if they were already established fact, including allegations of a
criminal nature and notwithstanding the matter appears to have been under
GMC scrutiny at the time and in circumstances in which it was highly
likely the press would leap with joy on the allegations as eminently
publishable and newsworthy (ie. sells more papers and advertising).
In the MMR/Royal Free Debate, Mr Harris made the following
disclosures but did not mention the Glaxo Wellcome Fellowship, (perhaps
because he no longer has it and it would be helpful to know definitely):-
"Dr. Evan Harris (Oxford, West and Abingdon) (LD): I wish to discuss
issues around clinical ethics and research ethics in the work done at the
Royal Free hospital by the inflammatory bowel disease group since 1995.
Before I start, I would like to declare my interests. I was a member of an
all-party group that recently visited the American society of clinical
oncology conference for four days in Chicago, which was organised and
funded by the pharmaceutical company Aventis. I am a member of the British
Medical Association medical ethics committee, although I am not speaking
for that body. I also spent a number of years as a member of the central
Oxford research ethics committee, which gave me direct experience of many
of the issues that I will deal with tonight. I am a member of the all-
party group on autism, and my father is a recently retired professor of
paediatrics.
In comparison, in the 1999 debate on the Medicines (Advertising and
Monitoring of Advertising) Amendment Regulations 1999, the disclosure did
include the Glaxo Wellcome Fellowship:-
"Dr. Evan Harris (Oxford, West and Abingdon): I should also like to
start by making a declaration, although I understand that it is not
registrable. Under the industry and Parliament trust scheme, I am a fellow
elect of Glaxo Wellcome. That is not a paid position, but it gives me
useful insight into the workings of the pharmaceutical industry. I
benefit, as have many others, through that scheme. Interestingly, that
company is one of the few that have not corresponded with me on this
issue, although many other companies and individuals have."
I am confused as to why a non disclosable interest is disclosed in a
comparatively minor debate, but why such non disclosable interests are not
disclosed in a major debate, unless the only answer can be that the
interests did not exist at that time, so were 'double non disclosable'?
Some clarity please?
Competing interests:
Close relative with life threatening food allergy.
Competing interests: No competing interests
For the sake of clarity readers might want to know more about the
references in John Heptonstall's Rapid Response.
The reference to Evan Harris being a "Fellow Elect" of Glaxo Wellcome
relate to Dr Harris' participation in the "Industry and Parliament Trust".
This is a body set up to promote links bewteen parliamentarians and
industry (see www.ipt.org.uk). The Speaker of the House of Commons is
joint President and it states its aims as:
• The Trust is dedicated to enabling a better mutual understanding
and better informed policy judgements in business, government and
Parliament.
• We operate as an independent, non-partisan, non-lobbying, non-
profit-making organisation, in which we encourage the concept of
'practitioner learning from practitioner'.
• We place MPs, Peers, Officers of both Houses of Parliament and MEPs
in educational exchange Fellowships and topic-based programmes within a
range of participating companies of all sectors and sizes. We give
business personnel, at all levels within our participating companies, the
opportunity to understand Parliament and the EU institutions better,
through a series of study programmes, workshops and seminars.
Evan Harris is "Fellow" of the Trust - as are some 345 other MPs.
The Company "Fellowship" attaches a Parliamentarian to a
participating company for 18 days over 12-18 months. It provides the
Parliamentarian with a unique understanding of the principles underlying
the running of a major organisation. The "elect" means that at the time of
the quote referenced (1999) the fellowship had not yet commenced.
It should also be noted that: "The Trust meets all expenses incurred
during Fellowships and topic-based programmes; no money passes between
companies and Parliamentarians for any of our activities".
Hardly an earth shattering competing interest....
Competing interests:
Public Health Doctor who supports vaccination
Competing interests: No competing interests
Sir
I agree with the suggestion that the BMJ should advise its readers
that Dr Evan Harris, Lib Dem Spokesman on Health who has a close interest
in vaccines and suppliers attending meetings sponsored by them (1), made
his allegations about Wakefield and others under Parliamentary privilege.
I would add that, as is customary with the BMJ, it only right that Dr
Evan Harris's 'Competing Interests' are also not excluded. He is a Fellow
Elect of Glaxo Wellcome (2) - a major supplier of vaccines.
Reference
1. http://www.acmedsci.ac.uk/20020522prog.htm
2. http://www.parliament.the-stationery-
office.co.uk/pa/cm199899/cmstand/deleg9/st99
Regards
John H.
Competing interests:
None declared
Competing interests: No competing interests
It may come as a shock to Evan Harris and Brian Deer but the
Government has already admitted that Andrew Wakefield's patients have
measles antigen in their gut. In an interview some months ago Dr Stephen
Ladyman, Minister of Health and autism expert, talking about autism turned
spontaneously to the question of the MMR:
"But what I am as certain of as I can be is that it has nothing to do
with MMR and there is no reliable piece of science that links MMR and
autism."
"The work that Andrew Wakefield did, if you discuss it with Andrew as
I have, even he does not make a direct link."
"All he has done is he's identified portions of measles antigen in
gut tissue of people with autism."
"Well he doesn't have any reason to believe that that measles came
from MMR, it could just as easily have come from single vaccinations, from
native, from wild measles, and if it did come from a vaccination
programme, he's got no reason to link it to the autism itself, he simply
makes an intuitive leap without evidence as part of his process of
hypothesising."
"And he would be the first to say that he has no scientific evidence
to make that link." [1]
Quite why Dr Ladyman feels able to scientically exclude the
commonsense possibility that the measles antigen came from the MMR rather
than single vaccine or wild measles, which the children are historically
unlikely to have had, is a mystery. An equal mystery is how he feels
competent to exclude the possibility that the condition of the children is
linked to the presence of the measles antigen (particularly without all
the tests which Harris and Deer are so eager to prevent happening). But he
does admit that the children have measles antigen in their gut. AND HE
SHOULD KNOW!
[1] Epolitix, 14 October 2003
Competing interests:
Parent of an autistic child
Competing interests: No competing interests
Sir - Dr Evan Harris' claims against Dr Andrew Wakefield, his
colleges and the Royal Free ethical practices committee, for their part in
the research that produced the 1998 Lancet paper, were made under the
protection of parliamentary privilege (Annabel Ferriman, 28 March). The
BMJ might remind its readers of this. After all, Harris has chosen not to
make them without this protection.
It is important that parents, without this privilege, with children
with autism and bowel disease should also be heard in this ongoing debate.
Some of our children were the subjects of the research Harris refers to
and some subjects of later research. We are also claimants in the MMR
vaccination litigation against its pharmaceutical producers.
Far from our children being subject to invasive investigations that
were of no diagnostic or therapeutic value, as Harris alleges, the use of
endoscopy and ileocolonoscopy revealed that our children have inflammatory
bowel disease with repeated cycles of diarrhoea and constipation, frequent
bouts of intense pain and limited motility. We cannot be certain of their
prognosis as some are developing new and worsening conditions. These
children have autism and disintegrative disorder - a complex of symptoms
Harris' allegations also ignore.
They were subsequently treated with anti-inflammatory drugs and
restricted diet that brought about some improvement in their condition. In
addition, the investigations revealed the presence of persistent measles
virus in their gut and blood, which has been certified by Professor John
O'Leary, Professor of Molecular Biology, Trinity College Dublin. These
findings have been peer-reviewed and published in medical journals, (1)
corroborated by other independent researchers, (2) and suggest underlying
autoimmune disease. (3) The process of corroboration and further research
continues. Anecdotally we know that none of our children suffered from
wild measles or was likely to be exposed during years of few recorded
outbreaks.
The importance of Wakefield et al's 1998 Lancet paper is clear. It
led to the identification of a new condition and offered several
hypotheses that others could validate or refute according to established
scientific protocols.
Harris' repeated claim that Wakefield failed to disclose in the 1998
peer-reviewed paper a conflict of interest and payment received whilst
undertaking work for the Legal Aid Board is one that raises standards of
disclosure that apply to expert witnesses working for the pharmaceutical
producers of MMR as well as the claimants. In a revealing exchange between
'Private Eye' (19 March 2004) and Professor Elizabeth Miller, Head of the
Immunisation Division at the Health Protection Agency and expert witness
for the producers, she defends her non-disclosure in 2003 publications
about MMR, by saying "there can be no conflict of interest when acting as
an expert witness for the courts, because the duty to the courts overrides
any other obligation, including to the person from whom the expert
receives instruction or by whom they are paid".
Yet Dr Harris and other parties - such as the Chief Medical Officer
and the Health Secretary who insisted that the GMC investigate the
allegations against Wakefield - have responded to what remains a matter of
scientific dispute about MMR safety, by publicly questioning Wakefield's
moral integrity as a scientists, whilst evading the scientific issues
themselves.
Yet Harris breaks rank in one respect, his demand for a wider public
inquiry of Wakefield and the Royal Free's conduct. There is every reason
to welcome a public inquiry, for it would raise the wider questions of MMR
safety. But it is highly unlikely that the government and medical
mandarins would welcome this, despite the strong public interest shown.
It is a shame that, as a member of a medical profession that adheres
to the protocol of investigating scientific disputes in the full light of
public scrutiny, Dr Harris should choose to pursue his concerns under the
veil of parliamentary privilege, and that others use their executive
authority to resist all calls for a public inquiry. It would be a tragedy
if medical scientists, understandably mindful of their research funding
and career prospects, saw the condemnations waged on Wakefield as a sign
that research critical of vaccination policy must be avoided at all costs.
Such a development would further undermine public trust in vaccination
policy.
1) Uhlmann, V. et al (2002) 'Potential viral mechanism for new
variant inflammatory bowel disease', Molecular Pathology, No. 55, pp 0-6).
2) Buie T. (2001) 'Initial autism research findings at Harvard,
Massachusetts'. Presented at Oasis Conference for Autism. Portland,
Oregon, USA: November, 2001. http://www.autismnwaf.com/harvard
project2.htm.
Krigsman, A (2002) Testimony by Dr Arthur Krigsman MD before the Committee
on Government Reform. Presented to US Congressional Committee on
Government Reform's hearing, The Status of Research into Vaccine Safety
and Autism. Washington DC: Congressional Committee on Government Reform,
2002.
(3) Torrente, F (2002) 'Enteropathy with T cell infiltration and
epithelial IgG deposition in autism', Molecular Psychiatry, vol.7, pp375-
82.
Competing interests:
parents of children with autism and bowel disease and claimants in MMR litigation
Competing interests: No competing interests
Dave Weldon, MD, the US Representative to Congress from District 15
in Florida, is a member of the influential House Committee on Government
Reform. Like Dr. Evan Harris, he has not been personally touched by
autism.
The following are portions of what Dr. Weldon told the Institute of
Medicine Special Committee on Vaccines and Autism on February 9, 2004 [1]: “…I
continue to be guided by a strong desire to get at the truth in these
matters and I believe passionately that we need to protect the integrity
of our national vaccine programs…
I am very disturbed by the continued number of reports I receive from
researchers regarding their experiences in pursuing these answers. It is
past time that individuals are persecuted for asking questions about
vaccine safety…
Many have described encountering apathy from government officials charged
with investigating these matters, difficulty in getting their papers
published, and the loss of other research grants. Others report overt
discouragement, intimidation and threats, and have abandoned this field of
research. Some have had their clinical privileges revoked and others have
been hounded out of their institutions.
An example of the latter is Dr. Andy Wakefield who has described to
me how the intellectual climate at the Royal Free in London became
intolerable for him and he was forced to depart…Mind you, half of Dr.
Wakefield’s theory has been proven correct and accepted in the medical
community...
Hundreds of children with regressive autism and GI dysfunction have
been scoped and clinicians are seeing the inflammatory bowel disease he
first described. The NIH (National Institutes of Health) is finally
funding an attempt to repeat Dr. O’Leary’s findings of measles RNA in
Wakefield’s biopsy specimens, though I am disappointed it has taken this
long. A clinician in New York was poised to repeat Wakefield’s work two
years ago, but he ultimately was refused by his IRB (Internal Review
Board) and then subsequently had his clinical privileges withdrawn.
This atmosphere of intimidation even surrounds today’s hearing. I
received numerous complaints that this event is not a further attempt to
get at the facts but rather a desire to sweep these issues under the rug…
With regard to MMR and Autism, I urge the Committee to build upon its
2001 conclusions and recommendations. A strong signal from you could
lessen the intimidation obstructing this research. You concluded that
since the MMR was mandatory it was the responsibility of the government to
ensure its safety, even if hypothesized adverse outcomes are rare. I
concur. As with thimerosal, my concerns about MMR have not subsided: The
NIH is presently funding an effort to duplicate Wakefield. Vaccine strain
measles virus has been identified in the inflamed GI tract of children
with regressive autism. Measles virus antibodies have been found in the
CSF of children with regressive autism…
The medical community has largely accepted a new form of bowel
disease in children with regressive Autism. Federal research funding has
not been directed to investigating many of your MMR research
recommendations. Also, a significant shortcoming of today’s meeting is
that Dr.Wakefield was not invited. In 2001 you found that cases of MMR
”rechallenge” would provide evidence in favor of causality. It is my
understanding that Dr. Wakefield has developed such a case series. The
lack of an invitation is puzzling…
I am concerned about the ability of the CDC’s National Immunization
Program to objectively investigate this matter. The CDC has a built-in
conflict of interest that is likely to bias any reviews. CDC is tasked
with promoting vaccination, ensuring high vaccination rates, and
monitoring the safety of vaccines. They serve as their own
watchdog - neither common nor desirable when seeking unbiased research...
Unfavorable safety reports lead to lower vaccination rates. An
association between vaccines and autism would also force CDC officials to
admit that their policies irreparably damaged thousands of children. Who
among us would easily accept such a conclusion about ourselves? Yet, this
is what the CDC is asked to do. Also, the relationship between the CDC and
vaccine manufactures has become extremely close. Given these facts,
studies conducted for or by the CDC should be evaluated with in this
context. Evaluating how best to eliminate this conflict of interest would
be a worthwhile endeavor for the IOM. I urge the IOM to take this matter
under review…” (End of quote)
It is unfortunate that Drs. Harris and Weldon are so far apart!
1 http://www.aapsonline.org/iom/weldon.pdf
Competing interests:
Grandfather of a boy with regressive autism, enterocolitis and evidence of measles genomic RNA in the gut wall.
Competing interests: No competing interests
Re: Re: Re: Parliamentary Protection and Open Science
Mr. McCloskey,
You signed your Rapid Response to BMJ as vaccine supporter. As a parent of
an autistic kid, I just wanted to remind you that I and all the other
parents of autistic kids were also supporters of vaccines since we
unfortunately vaccinated our kids.
We were dumb enough (something that we will regret our whole life) to
believe that there were MD's in Governmental Health Protection Agencies
with enough integrity and knowledge to check the safety of the vaccines
and protect our kids.
We held our kids tightly in our arms when the nurses were injecting them
with poisons, 2 in each tiny leg.
No wonder why we dont believe in vaccines anymore, they are just poisons.
It is the same thing as saying to somebody who was hit by lighting that
lighting does not exist. Better be happy that nothing has hit your family
yet because at the rate that autism is increasing (1 in 166 kids in US per
CDC web site) we will never know who is next.
Competing interests:
Kid with Autism
Competing interests: No competing interests