Doctor Fixed Data on Autism-MMR Shot Link
Andrew Wakefield, the doctor who initially sparked concerns over the safety of the MMR vaccine for children is said to have changed and misreported results in his research, which created the appearance of a possible link with autism. Interviews with witnesses as well as confidential medical documents reveal that Wakefield manipulated patients' data. The MMR vaccine to protected against measles, mumps and rubella was thus then feared to be linked to autism.
Wakefield's research was published in February 1998 in an article in The Lancent medical journal, which claimed that families of eight out of twelve children that attended a routine clinic at the hospital had blamed MMR for their autism. It also claimed that problems arose within days of receiving the vaccine, and researchers claimed to have discovered a new inflammatory bowel disease underlying the children's conditions.
Investigations show that in most of the 12 cases, the children's symptoms as described in The Lancet were much different than from their hospital or primary physician. In only one case did the records indicate that problems arose within days of receiving the MMR vaccine. Hospital pathologists also showed that in the majority of the cases the gut was normal, but The Lancet report indicated they were abnormal.
Although only 12 children were included in Wakefield's study, the study's impact was huge. After its publication, according to the Times of London, inoculations rates fell from 92% to below 80%. When more than 95% of people have been vaccinated, populations are said to have acquired "herd immunity" from measles. The number of cases of measles reported since 1998 has also been on the rise.
Wakefield, along with John Walker-Smith and Simon Murch, are defending themselves against the allegations of serious professional misconduct bought up by the General Medical Council in the UK. The charges brought against them relate to ethical aspects of the project, not the findings, but all three men deny any misconduct. An investigation by the Times found the discrepancies between their published report and the records of the doctors and hospitals of the children involved in the study.









Comments
Wrong Title
Dr. Wakefield credibility has been attacked by so-called journalist paid by pharmaceutical industries since he published an article in the Lancet. This article is just another cheap shot that wont deter him and parents of autistic kids from telling the truth the way it is.
To get his response check the following link:
http://childhealthsafety.wordpress.com/2009/02/08/sunday-times-sinks-to-new-low-with-yet-more-mmr-junk-journalism/
Hey, Julie....Ever heard of libel? I suspect you will.......
http://www.sarnet.org/lib/Deer%20response.pdf
Autism, bowel disease, and MMR vaccination
In his desperation, Deer gets it wrong once again
By Andy Wakefield
Below is a list of the allegations made by Brain Deer against me, received
on Friday 6th February 2009, 2 days prior to his publishing in the UK’s
Sunday Times newspaper (my response is provided in Arial font).
Dear Dr Wakefield,
I'm directed by editors managing my investigation of the MMR matter for The Sunday
Times to inform you that we intend to publish further on this topic, and particularly on
your role in it. It is now some five years since I first sought to discuss with you your
work, and I've made numerous attempts to do so. As you will appreciate, the safety of
children by means of vaccination is an unparalleled issue of public interest and concern.
As you will know, not least as a result of our concurrent attendance at the General
Medical Council fitness to practise hearing into your conduct, I'm now extremely familiar
with the precise medical histories, diagnoses and so forth of the children enrolled for your
study, published in the Lancet on 28 February 1998. Based on this knowledge, and other
sources of information, including the cooperation of families enrolled in your research, I
must put to you, for your response, a number of serious matters.
(1) That you repeatedly, and without justification, changed and misreported
findings from those children for publication in the Lancet.
I cite, for instance, three children who you represented as having regressive autism, who
in fact had Asperger's disorder, or in one of those cases PDAS, which are not regressive
and involve no loss of language or other basic skills. You claim that the paper is a series
of "previously normal" children, but medical records - which you had a duty to read and
understand - show that some five of the 12 children were subject to concerns prior to
vaccination, and were not "normal". Other children, who you claimed to have suffered
their first "behavioural symptoms" within days of vaccination, in fact had none for
months. In the cases of some 8 children - two thirds of the total - you changed normal
histopathology results to abnormal results, in a so-called "research review", despite
claiming that the series was merely a clinical report.
The diagnoses reported in the Lancet were accurate based upon the
information provided to the clinicians and review of the available records1.
1 Health Visitor checks: a routine regular developmental and physical in-home assessment of children by
the National Health Service in the UK
2
Where there was considered to be a pre-existing developmental problem,
this was accurately reported in the Lancet paper2. This is not the place to
get into a detailed discussion on developmental regression which is still a
subject of debate by experts in child development and is certainly not
something about which Deer has any expertise.
It is a matter of fact that I did not play any part whatsoever in making the
microscopic diagnoses of inflammation on any biopsy from any child
investigated at the Royal Free Hospital. Intestinal tissues were examined,
and the children’s pathology documented, by two doctors (not me)
employed in the Department of Histopathology who were experienced in
bowel disease, using an agreed protocol to ensure rigor and consistency .
These doctors were co-authors on the paper. The same tissues were
reviewed by Professor Walker-Smith and his team. I merely entered the
documented findings into the Lancet paper. I did not “change” any findings
as alleged. The paper was then reviewed by the relevant authors prior to
submission to the Lancet in order to confirm that the diagnoses were
correct. The findings reported in the Lancet are, in the opinion of the
relevant authors, correct. This is a matter of record at the GMC.
(2) That, without justification, you omitted parental links to MMR in the case of one
quarter of the children, in order to reach your unsubstantiated claim in the paper
that problems came on within days.
Contrary to your claim that the parents of 8 of 12 children linked MMR to their child's
problems, in fact the parents of 11 of the children made this connection whilst at the
Royal Free. The additional, unreported, children are Child Five, Child Nine and Child
Twelve. Their parents said that problems came on between one and four months after
MMR, and their hospital records, which you had access to (and in one case wrote), show
this. Through the device of their omission, you contrived to create the appearance of a
clearcut temporal link between MMR and autism, when there was none such.
Furthermore, by their omission, you contrived to create the appearance that these children
were routine clinical cases passing through the hospital, when in fact, as you knew, they
were recruited, marshalled and referred in collaboration between you, JABS and a
solicitor. As such, they were bound to blame MMR when they came to the hospital.
This is a particularly tortuous argument that reflects Deer’s grasp (or lack
of it) on both the scientific process and the evidence. Parents of 8 of the 12
children made the link between MMR vaccination and onset of symptoms
contemporaneously. Other parents made the link retrospectively, that is,
some years later. We reported on those 8 who made the link at the time of
their child’s deterioration and excluded those who made the link later in
order to remove any bias associated with recall that may have been
prompted by, for example, media coverage. To have done otherwise would
have been potentially misleading.
2 Lancet 1998:351;637-41
3
In fact, when all of the medical and parental records were made available
via the GMC many years later, it became apparent that one further parent
had made the link with MMR contemporaneously, but had remained silent
on this at the request of her husband because it had led to doctors
dismissing their concerns about their child’s medical problems on the
basis that they were “just looking for something to blame.” This in itself is
a telling indictment of how a possible cause risks being overlooked
because of the prejudice of some physicians.
The second part of this allegation, which is dependent upon the fallacy in
the first part, is nonsense. The route by which the children came to the
Royal Free was one driven by clinical need and had nothing whatsoever to
do with the lawyer Richard Barr. The facts of this matter and in particular
the route by which the children came to be seen by Professor Walker-
Smith, have been reported to the GMC. This allegation – one which Deer
has rehashed in spite of the evidence – has no basis in fact.
It need hardly be stated again after so many occasions in the GMC but the
leading, primary and principal reason all twelve children ended up at the
Royal Free, was that they had bowel or 'stomach' problems. The matter of
vaccination was brought up by parents because they thought that it was
relevant to the clinical diagnosis.
(3) That the paper you wrote and published in the Lancet was a device, assisting you
in obtaining money from the Legal Aid Board.
I draw to your attention your prior contractual undertaking with Mr Barr, and your joint
undertaking to the Legal Aid Board to attempt to find a "new syndrome". This latter
undertaking was entered into before any of the children were admitted to the Royal Free,
or you could ever have known of any syndrome. Eighteen months later, you would
declare that you had found precisely such a syndrome, based on the 8/12 temporal link,
and an alleged coincidence of regressive autism and inflammatory bowel disease. The
records show that neither of these are valid. Without the public ever suspecting, the route
by which you reached this claim required the wholesale changing and misreporting of
data. Following your claims, to which you attached the reputations of 12 other, generally
unwitting, doctors, you successfully extracted substantial sums of money from the legal
aid fund, not least for the business Unigenetics, of which you were a director, and for
yourself personally. We have previously reported that the Legal Services Commission
says that you pocketed more than £435,000, plus expenses. The amounts you received
increased as the scare you created continued: the grossest possible conflict of interest.
Deer is wrong on all counts. The purpose of the contract with Mr Barr was
to conduct a scientific study to look for measles virus proteins in the bowel
of children (initially those with Crohn’s disease and later, to include those
with autism and intestinal symptoms (such as abdominal pain and
4
diarrhea) that required endoscopic examination and biopsy. On the other
hand, the clinical basis for the investigation of the autistic children has
been established by my pediatric colleagues – two of the most experienced
pediatric gastroenterologists worldwide - beyond any reasonable doubt.
Deer has completely missed the point; the “syndrome” that we have
accurately and reproducibly described is the combination of autistic
regression, swelling of the lymph glands in the last part of the small
intestine (ileum) and inflammation of the colon. Any association of this
syndrome with MMR vaccine remains to be confirmed and, in contrast with
Deer’s claim, the syndrome does not require any temporal link to MMR
vaccination at all. This has been made clear to the GMC.
The children who turned out to suffer from the “syndrome” were referred
as early as May 1995, long before I had ever heard of Richard Barr or
vaccine litigation. Deer is aware of this fact.
Any payment that I received over the course of working for more than 7
years as a expert to the UK courts in the MMR litigation – substantially less
than the sum Deer claims – was donated to an initiative to build a new
center for the investigation and care of patients with inflammatory bowel
disease at the Royal Free. This matter is described in more detail in a
forthcoming essay by Bill Long, access to which will be posted in due
course at http://www.drbilllong.com/index.html.
I resigned from Unigenetics and was not involved in the dealings of this
company with the Legal Aid Board.
Finally, I did not “create” a scare but rather, I responded to a scare that
parents brought to my attention. To have ignored their concerns would
have been professional negligence.
(4) That, additional to the above, in recent years you have reviewed your changes
and misreportings in the Lancet, and yet you have neither withdrawn your claims in
the paper, nor sincerely and publicly apologised for your conduct, as you should
have done.
As a result of the GMC hearings, you have been supplied with all the documentation,
and, indeed, were last year taken by counsel through the changes and misreportings.
There can be no question that you know the precise details of these children. Particularly
given outbreaks of measles, widely reported in UK media most recently today, and the
appalling burden of guilt laid on the parents of autistic children who believe it was their
own fault for vaccinating their child, you had an absolute duty to come forward at the
earliest opportunity and make the position clear. You have not done so, but indeed
continue to display the paper's claims on your website, and to campaign against MMR.
5
The evidence presented by me to the GMC described precisely and
accurately the basis of the findings reported in the Lancet. The absence of
any ‘misreporting’ is a matter of record both in my oral testimony and in
that of my clinical colleagues. There is absolutely nothing either to
withdraw or to apologize for in this matter. It is, however, a tragedy that the
continued misrepresentation of the facts has had a negative impact on the
ability of affected children to get access to the care that they so
desperately need.
(5) That, overall, you created the appearance of a possible link between MMR and
autism, when you knew, or should have known, that there was no reasonable basis
for this in the histories of those children, and, as a result have caused immense and
growing harm, unnecessary concern and waste of public money.
In summary, not one of the 12 children is free of serious doubt as to the manner in which
their case has been reported by you. Indeed, there is no real evidence that any of the
children were as you reported in the Lancet. When lack of evidence of previous
normality, lack of evidence of regression, lack of evidence of inflammatory bowel
disease, and lack of any temporal link as you describe, are taken into account, there was
no basis in the records for your claim to have discovered any new syndrome at all.
Based upon the parental histories of regression in their children after MMR
vaccine, the known link between measles and brain damage including
autism3 and the findings in the children, there was and continues to be
every reasonable basis for suspecting a possible link between MMR
vaccination and autistic regression.
The reporting of the children in the Lancet paper is an accurate account of
the clinical histories as reported to Professor Walker-Smith and his clinical
colleagues. The normality or otherwise of the children’s development was
evident in the medical history taken by these clinicians, and backed up by
the Health Visitor’s4 contemporaneous record of the respective child’s
development. The claim to have detected a possible new syndrome was
valid and, in contrast with Deer’ false claim, is supported by confirmation
of the original findings by others5.
3 Deykin EY, MacMahon B, Viral exposure and autism. Am J Epidemiol, 1979;109:628–38.
Ring A, Barak Y, Ticher A, et al. Evidence for an infectious etiology in autism. Pathophysiology, 1997;
4:91–96.
4 Health Visitor checks: a routine regular developmental and physical in-home assessment of children by
the National Health Service in the UK
5 Gonzalez, L., et al., Endoscopic and Histological Characteristics of the Digestive Mucosa in Autistic
Children with gastro-Intestinal Symptoms: A Preliminary Report. GEN Suplemento Especial de
Pediatria, 2005;1:41-47.
Balzola, F., et al., Panenteric IBD-like disease in a patient with regressive autism shown for the first time
by wireless capsule enteroscopy: Another piece in the jig-saw of the gut-brain syndrome? American
Journal of Gastroenterology, 2005. 100(4): p. 979- 981.
6
As you will see, the issues we raise with you are not the same as the charges you face
before the GMC, although the fitness to practise hearings have, as expected, yielded
important insights and evidence. It is clear that, particularly in the context of measles
outbreaks in the UK, US, Europe and now Australasia, it is important that the public be
urgently informed of the true position at the earliest possible date.
On the contrary, the issues raised by Deer are, in many respects, identical
to those raised by him on previous occasions. One can only imagine that,
as the evidence has emerged at the GMC, the fallacy of Deer’s original
allegations has become clear. The timing and content of Deer’s latest
allegations and the published article, his behavior at the GMC hearing (See
“The Incident” by Martin Walker6), and recent admissions of failings in the
area of vaccine safety by the US National Vaccine Advisory Committee,
suggest a degree of desperation on the part of Deer and those with whom
he is working.
Measles outbreaks are preventable, immediately, by offering to parents
with entirely valid concerns about the safety of MMR vaccine, a choice of
single measles vaccine; not to do so is unethical and puts the vaccine
policy, “our way or no way”, before the wellbeing of children.
There is absolutely no question of the continuing investigation and
treatment of these children coming to a halt because of this or any other
kind of subversive tactic.
Krigsman A et al.
http://www.cevs.ucdavis.edu/Cofred/Public/Aca/WebSec.cfm?confid=238&webid=1245 last accessed
June 2007) (paper submitted for publication)
6 http://www.cryshame.co.uk//index.php?option=com_content&task=view&id=113&Itemid=192
Autism and its signs are
Autism and its signs are present since birth. Its primary social avoidance and reproachament symptoms are notable on attempted breast feeding and contact. Therefore much or this debate is ludacris and for anyone except those looking for something external to blame for their misfortune.
Wakefield's probity, integrity and scientific incompetence.
So there are several things going on here. They include:
1. Evidence that Wakefield was employed by vaccine claim lawyers to help find a syndrome of damage from vaccines.
2. Evidence that suitable cases were subsequently directed to Wakefield for inclusion in a study.
3. Evidence that Wakefield conducted or oversaw a series of unnecessary invasive investigations on these cases under the guise of clinical need (what autistic child needs a colonoscopy and bowel biopsy under general anesthetic and a spinal tap?).
4. Evidence that Wakefield did not have correct valid consent and ethical approval for the study/procedures.
5. Evidence that Wakefield / his team caused serious side effects in at least one child, perforating his bowel multiple times, resulting in him ending up in ITU and suffering long term disability.
6. Evidence that Wakefield quite improperly paid children at his own son's birthday party to have blood tests to act as controls in his study, and even joked about this at public lectures.
7. Evidence that Wakefield misrepresented the clinical histories of most of the children in his study, suggesting they all developed autism immediately following vaccination with MMR when in fact the hospital and GP records show most had neurological problems before vaccination, and the remainder took as long as 4 months to develop signs of autism, making a causal role for MMR highly suspect.
8. Evidence that Wakefield's histopathology colleagues doubted the gut biopsy specimens had any abnormal changes present, whereas the published paper states they all had significant inflammation (being attributed by Wakefield to measles virus damage from the vaccine).
9. Evidence that Wakefield's samples of gut tissue were falsely identified as having measles virus in them, when in fact there was no virus and all the results were laboratory errors.
10. Evidence that Wakefield knew prior to publication of his paper that these results were errors, but still went ahead and published them as being positive for measles.
11. Evidence that 10 (of 12) of Wakefield's colleagues disassociated themselves from him and his Lancet journal publication as soon as they knew the extent of the significant financial conflict of interest that existed (from his association with the vaccine damage lawyers and the $700,000 he received for his work in preparing reports on these few cases).
12. Evidence that despite several attempts to do so, no-one has yet replicated Wakefield's findings.
13. Evidence that Wakefield and Krigsman say they have replicated their own findings, but somehow 5 years later this work remains unpublished, despite being referred to several times by Wakefield.
14. Evidence that Wakefield took out a patent for a new single measles vaccine just before he held a press conference denouncing the combined Measles, Mumps and Rubella vaccine and suggesting single vaccines would be safer.
This is ample evidence of why Wakefield's scientific standing is virtually nonexistent. How anyone can read about the major financial conflicts of interest, the litany of abysmal research methodology, and what appears to be deliberate manipulation of data and not come to the conclusion that this man is a total charlatan is quite beyond me.
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