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PRIVATE EYE 5 March - 18 March 2004
MMR: INTERESTING
CONFLICTS
The vilification of Dr Andrew Wakefield in recent days has been a side
show
to the important issue of whether the mumps, measles, and rubella triple
vaccine (MMR) poses a risk to a small sub set of children. But the
attacks
have served a purpose. They have highlighted the need to preserve
independent medical research - and reminded the public that there is
one
rule for an off-message messenger like Dr Wakefield and quite another
for
the government and drug companies.
For example, one leading health official responsible for immunisation
has
been working as an expert for the three defendant drug companies in
the UK
MMR court case since July 2002. Yet as far as the Eye can ascertain,
she
has never declared that potential ''conflict'' on any of her
research papers.
Dr Elizabeth Miller, head of immunisation at the government''s Health
Protection Agency (HPA), last year alone published three papers in
the
Archives of Disease in Childhood directly related to the MMR controversy.
One suggested that the combined triple live virus does not overload
the
immune system, so there is no need for single vaccines. Two others
suggested that parents have been more likely to attribute their children's
autism to MMR since 1998, when Dr Wakefield and his team at the Royal
Free
hospital in north London published their controversial paper.
Nowhere on Dr Miller's papers does she declare that she is also an expert
witness for the drug companies GlaxoSmithKline, Aventis Pasteur and
Merck.
Moreover, the Eye has begun trawling through scientific and medical
journals to examine papers published over the last two years by other
defendant drug company experts. So far we have not found a single
declaration on any paper that the author also acts as an expert for
the
defendant drug companies - even though at least two of the experts
(Dr
Diane Griffin, an American, and Professor Volker ter Meulen, a German),
have produced research papers directly associated with vaccination.
Unlike in the case of Dr Wakefield, there have been no screaming headlines
attacking their credibility or honesty; no demands for an inquiry by
the
General Medical Council; no snipes at their ''fatally flawed'' research.
Instead, such authors continue to enjoy the support of government and
big
business. By contrast, Dr Wakefield only has the support of harrassed
parents who believe their children were damaged by MMR, and, until
recently, the impoverished Legal Services Commission - hardly powerful
or
influential.
Dr Miller maintains that neither she nor her department was paid by
the
three pharmaceutical companies for the detailed and lengthy report
she
submitted on their behalf to the court last June. She prepared their
evidence in her own time, her department says, and did not declare
it on
any papers because there was no financial interest.
Nevertheless, it is known that money from those companies finds its
way
into the agency, formerly the Public Health Laboratory Service, through
other research channels. In a recent annual report, Dr Miller listed
five
''non-personal'' interests - ie payments which benefited her department
rather than herself. Two of the companies featured were MMR defendants.
The rules on conflict are weak, open to interpretation and generally
not
enforced - so should any criticism not be dished out in equal measure?
As
one leading journal states ''examples of potentially conflicting interests
that should be disclosed include relationships that might detract from
an
author's objectivity in presentation of study results and interests
whose
value would be enhanced by the results presented.''
How can Sir Liam Donaldson, chief medical officer, and his deputy
responsible for immunisation, Dr David Salisbury, justify their attacks
on
Dr Wakefield for non-disclosure of an interest when their own staff
appear
equally compromised? No doubt Dr Miller sought clearance before agreeing
to
act for the defendant drug companies. But every time she now opens
her
mouth the question arises: Is she speaking from the ''impartial ''view
of
the health department, open to all new research that comes to its
attention; or for that of the defendant drug companies? As Eye readers
will
recall, Dr Miller also conducted the first ever trial of MMR among
10,000
children before its introduction in the UK nationwide.
It is clear the medical establishment and ministers had been waiting
for an
opportunity to attempt to discredit Dr Wakefield. Thus they seized
on the
Sunday Times's resurrection of a debate about conflict which emerged
in the
Lancet six years ago when Dr Wakefield published his controversial
1998
study.
Shortly after publication the Lancet carried a letter from Dr Wakefield
on
behalf of all the authors in response to suggestions that there may
have
been ''litigation bias'' in their paper. It said that Dr Wakefield
had
agreed quite separately to evaluate a small number of children on behalf
of
the Legal Aid Board. ''These children have all been seen expressly
on the
basis that they were referred through the normal channels (eg. GP,
child
psychiatrist or community paediatritican) on the merits of their symptoms.''
Nothing about that ''conflict'' has changed but Lancet editor Richard
Horton seemed to panic in the face of more serious - and completely
unsubstantiated - allegations from the Sunday Times about subjecting
the
children to invasive procedures without ethical approval and questions
about the Lancet's role in the affair - allegations the newspaper was
forced to ditch.
Interestingly, Horton's condemnation of the Royal Free paper as ''fatally
flawed'' ( which gave oxygen to the Sunday Times ''scoop'') was dropped
by
the time the Lancet published its statement about the affair the following
week. It stated that it was ''regretful'' that the Lancet had not been
made
aware that the parallel legal aid had not been disclosed as it should
have
been '' because it would have been material to our decision-making
about
the paper's suitability, credibility and validity for publication''.
It did
not withdraw the paper or say it was fatally damaged.
Of course the issue of potential conflicts of interest - whether by
Dr
Wakefield or those acting as experts for the defendant drug companies
-
only flags up the possibility of research flawed by bias. Before
a study
can be ''fatally flawed'', as health chiefs maintain Dr Wakefield's
is, the
research itself must be shown to be faulty.
Aside from the fact that even Horton accepts that the Royal Free team
identified a new syndrome suffered by children with gut disease and
autism
( something so scientifically and medically significant, one might
think it
worthy of investment and further investigation), that original paper
is now
the equivalent of scientific chip wrappings. Science has moved on;
and the
Royal Free team has published more papers detailing the unique
pattern of
disease in these children's guts.
In both the UK and the US, meanwhile, measles virus, some of it vaccine
strain, has now been found at the site of inflammation in the guts,
in the
blood and in the spinal fluid of some autistic children but not in
''normal'' children. Separate studies at Utah State University have
found
that some autistic children have auto-antibodies which are attacking
the
protein sheath that protects the nerve and brain in those children,
researchers found a higher level of measles virus antibodies and an
''unusual MMR'' antibody, whereas their response to other vaccines
did not
differ between autistic and normal children.
None of this proves causation or a link; but combined they do provide
a
mechanism for brain damage and one potential trigger that might lead
to
autism. And that surely needs further investigation.
Last week, while some newspapers and the medical establishment queued
up to
kick Dr Wakefield, a new US study of children defined as autistic by
the US
department of education and the biological surveillance summaries of
the
Center for Disease Control found ''a biological plausibility and
epidemiological evidence showing a direct relationship between... measles
containing vaccines and serious neurological disorders''. It also found
a
relationship between mercury containing vaccines and neurological
disorders, the subject of litigation in the US. At the top of the study
the
authors, Dr Mark Geier and David Geier, both declare a potential conflict
of interest in that they have been expert witnesses or consultants
in areas
involving adverse reactions to vaccines in civil litigation.
In May last year Dr Miller - in her role as head of immunisation at
the
HPA, rather than as an expert for the drug companies - was critical
of the
Geiers' earlier work. As indeed was Britain's Committee on Safety of
Medicines, which found ''serious methodological'' flaws. But as the
Daily
Mail and other newspapers reported last week, that committee and the
Joint
Committee on Vaccination and Immunisation is packed with experts who
either
have shares in the defendant drug companies, receive funding for research
from them or are paid advisers to them.
As the Eye reported in 2002, three of the members who sat on the Medical
Research Council's review of the ten-fold rise in autism were advisers
to
the defendant drug companies. Even the chair had shares in one of the
companies.
The point is that potential conflicts of interest are common in medical
and
scientific research and development and Dr Wakefield's is but a puff
in the
wind. Ninety percent of research depends on big business and the
pharmaceutical companies - and this is set to rise. The big companies
already have a direct line to the prime minister through the Pharmaceutical
Industry Competitive Task Force (PICTF), which Tony Blair set up after
a
meeting with the heads of AstraZeneca, GlaxoWellcome and SmithKlineBeecham.
The companies have already stated that they see the NHS as a huge
unexploited resource. And the government's own reforming NHS Plan 2000
states that; ''The pharmaceutical industry is a UK success story, employing
over 60,000 skilled workers and maintaining an annual trade surplus
of over
£2 billion. The industry is also the UK's leading investor in
research and
development. The NHS has a major role to play in ensuring that the
UK
remains an attractive base for the industry.''
Hence it has set about removing barriers to big business in the drug
industry, encouraging hospitals and universities to enter into joint
ventures and create mini-companies to exploit their research. They
will
inevitably become even more dependant on drug company influence - and
even
more at risk of serious conflicts of interest. Yet no one is
shouting
about that.
'MMR SAFE' DOCS
HAVE LINKS WITH DRUG FIRMS
Sunday Mercury; 2/29/2004; FIONNUALA BOURKE
FOUR leading Midland doctors who deemed the controversial MMR vaccine
safe have links to the drug giants who make or supply the jab.
Campaigners have called for the General Medical Council to investigate
the senior Government advisors, who all hold scientific posts in the
Midlands and sat on key committees which declared the vaccine safe.
Professor James Chipman from Birmingham University, a member of the
Committee on Safety of Medicines, received research funding from
GlaxoSmithKline, suppliers of the MMR vaccine Priorix.
Consultant cardiologist Dr Colin Forfar from John Radcliffe Hospital
in
Oxford, a shareholder in GlaxoSmithKline, is also a member of the
influential committee.
Professor Terence Stephenson, from the Queen's Medical Centre in
Nottingham, sits on the same committee but his travel expenses are
paid
by the same drugs giant.
Professor Michael Langman from Birmingham University is the Chairman
of
the Joint Committee on Vaccination and Immunisation.
His team received research support from Merck Sharp and Dohme, which
manufactures MMR vaccine.
Now Jonathan Harris, West Midlands campaigner for vaccination awareness
group JABS (Justice Awareness and Basic Support) is calling for the
GMC
to investigate the work of the medics.
Autistic
Only two of Mr Harris's six children had the MMR vaccine and both of
them are autistic.
'A total of 19 Government experts are connected to the drugs industries
that deal with the MMR vaccines,' he said. 'Shouldn't this be considered
a conflict of interests?
'These experts are advising the Government about the safety of the MMR
vaccine at the same time as receiving payments or holding shares in
the
companies selling the jab.
'The Government requested that the GMC investigate the work of Dr Andrew
Wakefield, who first proposed the link between MMR and autism.
'They declared it was 'a matter of urgency' when it emerged that he
had
received funding from lawyers representing parents of children who
felt
they had been damaged by the vaccine.
'So why shouldn't they investigate these doctors who have links to the
drugs industry while they are at it?'
The doctors' watchdog GMC agreed to consider a full investigation into
the work of Dr Wakefield last week at the request of the Health Minister
John Reid.
The medical researcher provoked a furore when he first proposed a link
between MMR and autism in a paper published in The Lancet magazine
in
1998. In a press conference later he also recommended parents opt for
single jabs.
The editor of The Lancet has since said that he would not have printed
the study if he had known Dr Wakefield had received funding for it
from
the Legal Aid Board. It emerged that Dr Wakefield received pounds 55,000
from the Board to investigate claimsby parents that their children
had
been damaged by the measles, mumps and rubella jab.
And the GMC has agreed to consider a full inquiry into the study
following a request from the Secretary of Health John Reid stating
that
it 'was a matter of urgency'.
A spokesman for the GMC confirmed that the four Midland medics were
registered with them but declined to say whether it would consider
opening an investigation into their work and links with the drugs firms.
None of the doctors were available for comment last night. Their
personal and non-personal interests have all been openly declared to
the
independent advisory committees on which they sit.
C2004 Independent Newspapers
(UK) Limited.
Doctor's diary: a jab in the dark
(Filed: 02/03/2004)
source
The truth about MMR must
be revealed, says Dr James Le Fanu
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.
source
Unfair hounding of MMR
researcher
FOLLOWING the latest claim from The Lancet over the safety of MMR, quickly
endorsed by Dr John Reid, people should be aware of the campaign to
vilify
Dr Andrew Wakefield. The latest ‘wheeze’ tries to discredit his research
by
alleging a financial interest was not declared when his report was
published. His co-author, Dr Harvey, interviewed on TV, said the claim
was
trivial.
At most, the authors may have omitted to mention the Legal Aid Board
in the
acknowledgements which typically accompany scientific papers. This
begs the
question as to whether The Lancet exercised its own editorial role
properly
by asking the authors if all acknowledgements had been included.
Also, if The Lancet wishes to imply the content of the work was somehow
influenced by the receipt of Legal Aid monies, then they are tearing
down
the chimera of ‘peer review’. Dr Wakefield was working in a public
sector
hospital, receiving money from a public sector body. How many other
authors
of scientific papers receive money from private sector sources?
The Lancet is also on shaky ground because there are major problems
with the
reporting of adverse reactions to medications, including vaccines.
I continue to be puzzled by the opprobrium heaped on Dr Wakefield, who
has
simply undertaken standard scientific enquiries. After finding live
measles
vaccine in the gut of children he has considered the options for where
that
virus may have come from, and set up the hypothesis that it came from
something which had previously been administered, namely the MMR vaccine.
This hypothesis is then subject to further investigation to prove or
disprove the theory.
In a more considered environment, his finding would have prompted research
into whether the single measles vaccine could provoke the same reaction
in
the gut, and indeed, what the incidence of measles is in the gut of
the
general population.
D Hodgson, Cumbria
THE furore over Dr Wakefield appears to have reached Huttonesque
proportions. The implication? He made it up to make money. So why didn’t
The
Lancet discover this "fatal flaw" when peer-reviewing his paper? How
does it
"flaw" the discovery of the measles virus?
The Health Secretary, John Reid, demands an "urgent" inquiry, but only
after
the press ask him. Wasn’t it "urgent" until then? He raises two questions,
though: Why no urgency to discover why the measles virus gets in the
gut and
why no urgency to determine the reasons for steep increases in the
numbers
of autistic children? Better diagnosis? If so, is there a decrease
in those
with general non-attributable retardation?
The government’s Chief Medical Officer, Sir Liam Donaldson, rushes to
judgment before the study of Wakefield is undertaken and peer-reviewed.
The
General Medical Council will investigate the "conflict of interest".
But to
what extent, since some members will have shares in, or funding from,
MMR
manufacturers and GPs receive bonuses for MMR targets?
How do these people sleep at night? Is it because they don’t have a
child
keeping them up till 5am obsessed with watching the History Channel?
J M MacInnes, Muir of Ord
"At least 19 experts have interests in firms involved in the measles,
mumps and rubella triple vaccine, campaigners said. They sit on two key
committees which declared the vaccine safe: the Committee on Safety of
Medicines and the Joint Committee on Vaccination and Immunisation. Some
of the doctors and scientists have shareholdings in the companies, while
others have received grants for research from them. "
Government's double standards
over MMR
[by Tim Utton, Daily Mail.]
source
link
Attempts by the Government to "smear"
a doctor at the centre of the
MMR controversy provoked claims of double standards last night.
Dr Andrew Wakefield, who first proposed
a link between MMR and autism,
has been accused by chief medical officer Sir Liam Donaldson of a conflict
of interest over his work.
Dr Wakefield was also receiving £55,000
legal aid to investigate such
links for parents who thought their children had been damaged by the
triple
jab.
But health chiefs were immediately accused of hypocrisy by parents and
campaigners - who pointed out that many of the Government's top scientific
advisers have links with drug firms that make or supply the vaccine.
At least 19 experts have interests in
firms involved in the measles,
mumps and rubella triple vaccine, campaigners said.
They sit on two key committees which
declared the vaccine safe: the
Committee on Safety of Medicines and the Joint Committee on Vaccination
and
Immunisation.
Some of the doctors and scientists have
shareholdings in the
companies, while others have received grants for research from them.
Families who are suing the manufacturers
and suppliers of the vaccine
said these links cast doubt on official assurances that the jab is
safe, and
suggest a huge conflict of interest among the forces ranged against
Dr
Wakefield.
Bill Welsh, of the anti-MMR group Action
Against Autism, said: "The
people who say the vaccine is safe have links to the people who manufacture
it.
"The whole thing stinks, and something
needs to be done. If the
Government wants to start looking for conflicts of interest, they only
have
to look at their own house.
"The number of experts on their so-called
independent panels who have
stakes in drug companies is incredible.
"It is rank hypocrisy for them to criticise
Dr Wakefield over the
funding he received."
Rosemary Kessick, of the group Allergy
Induced Autism, said: "It's
ludicrous - why shouldn't the same standards apply across the board?
The
duplicity is breathtaking."
Dr Wakefield's original report, published
in The Lancet medical
journal in 1998, "lit the blue touchpaper" of what has become a huge
public
health issue.
Rates of immunisation with MMR have
fallen as low as 67.4 per cent in
parts of London as parents worried about a link between the jab and
autism
turn to single vaccines. Two companies - GlaxoSmith-Kline Biologicals
and
Aventis Pasteur MSD - each supply a different MMR vaccine, both of
which are
made in the U.S. by Merck.
The Department of Health contracts to
buy around 1.4million doses each
year for babies at 12 months and a pre-school booster.
A thousand British families have been
hoping to sue all three
companies, but last October their legal aid was cut off. They have
appealed
for a judicial review of the decision.
An autism expert yesterday condemned
the Government for "sneering" at
concerned parents after Tony Blair dismissed fears of a link between
the MMR
vaccine and autism.
Paul Shattock, director of the autism
research unit at Sunderland
University, said: "The Government has got to carry out thorough research
on
this.
"They have attacked Dr Wakefield personally
but they are not able to
attack the science. Dr Wakefield does not have a vested interest."
Subject:
[AVN] Online email to BMJ
Date:
Mon, 15 Mar 2004 07:10:26 +1000
From:
"Pamela Valenti" <pamelav@cairns.net.au>
Reply-To:
AVN@yahoogroups.com
To:
<Undisclosed-Recipient:;>
"Hiding the Truth"
Some years ago I wrote to the Department of Health and asked a simple
question.
Is the MMR vaccine a product of Genetic Engineering?
They refused to respond but admitted that most testing of the MMR vaccine
is
done short term and by the manufacturers.
I therefore wrote suggesting that it must be assumed that the vaccine
was a
product of genetic engineering if they failed to answer.
Again there was no response.
It is highly likely, in my view, that if the viruses in the MMR
are of a
genetically altered form then the immune system of the child would
not react
as it should to the "wild strains".
Interestingly a US pharmacological publication dated 1995 refers
to the
use of single vaccines which give life-long immunity. There in no mention
of
MMR or the need for "booster" vaccinations.
I understand that children given the MMR have then contracted measles
from
siblings given single vaccines so clearly the MMR does not offer life-long
immunity.
I would like to add that it is quite wrong for people to attack
the work of
Dr Wakefield unless they have personally performed his tests and worked
with
autistic children.
It was also wrong for the Legal Services Commission to pull the plug
on the
legal action just when evidence of harm was being discovered.
Perhaps we should remember that the Legal Services Commission is part
of
Government and that, as with Gulf War Syndrome, the Porton Down Volunteers,
and the organophosphorus litigation, the Government was seen as a
co-defendant in the litigation.
Does that explain the reluctance to allow the facts to be heard in
court?
Incidentally if the MMR is a genetically engineered vaccine then the
government is guilty of an offence against humanity under the Nuremberg
Code
since the children and their parents were forced into an experiment
without
their informed consent and, by pressurising GPs to force the MMR on
parents
and by withholding single vaccines, there was effectively no right
to opt
out as required under the code.
Richard. A.R. Bruce. 13th March 2004
Competing interests:
None declared
From Money Magazine, Dec '96 - Expose on Vaccine
Industry. (Andrea Rock).....
"1980 through 1988. Cherry got about $400,000 in unrestricted grants
that he
termed “gifts” from Lederle. From 1988 through 1993, he was given $146,000
by Lederle for pertussis research, and from 1986 through 1992, UCLA
received $654,418 from Lederle for pertussis research. Additionally,
drug
manufacturers paid Cherry and UCLA $34,058 for his testimony as an
expert
witness. in 15 DPT lawsuits brought against the companies. The National
Vaccine Information Center, among other consumer groups, protested
that
because of possible conflicts of interest Cherry should not be allowed
on
vaccine policy committees at the Centers for Disease Control. When
asked
whether his acceptance of funding and payments from Lederle created
a
conflict of interest, Cherry told MONEY, “I got nothing out of it,
If
having a feeling for children is the charge, then I’m guilty. None
of this
was done for the companies.” The CDC no longer permits members of vaccine
advisory committee to vote on issues involving any company with whom
they have
a financial relationship. But they can participate in discussions-which
allows them to continue influencing policy. Minutes of a June 1995
CDC
advisory committee meeting, at which members ‘voted to delay recommending
use of a safer polio vaccine, show that five of the nine members present
had financial ties to vaccine manufacturers. "
Subject:
[AVN] Dr. Yazbak responds in BMJ - MMR/Wakefield
Date:
Sat, 20 Mar 2004 22:26:48 +0000
From:
Sheri Nakken <vaccineinfo@tesco.net>
Reply-To:
AVN@yahoogroups.com
To:
Sheri Nakken <vaccineinfo@tesco.net>
KEY!!!!!!!!!!! Make a note of this, store it, file it, share
it.............this is in the UK BEFORE measles vaccine was invented!]
Sheri
"I respectfully submit that measles deaths had decreased precipitously
before the introduction of the measles vaccine because of better nutrition
and hygiene. The following can be checked with the DOH. In 1901, there
were
9,019 deaths attributed to measles in a population of 32,612,1000 in
England and Wales, giving a mortality rate of 276.5 per million. In
1960,
there were 80 deaths and the population was 45,775,000. The measles
mortality rate in England and Wales was therefore 1.75 per million
in 1960.
In other words, the mortality rate from measles had decreased by 99.12%
before the introduction of the measles vaccine."
AND re: Wakefield............for those who are still not
clear..........."From Andrew Wakefield’s point of view, there was neither
a
real nor a perceived financial conflict. Funds from the Legal Aid Board
were never used for any part of the study that was published in The
Lancet,
in February 1998. In addition, Dr. Wakefield did not personally receive
any
portion of the much-publicized Legal Aid Board grant of £55,000
to the
Royal Free Hospital Special Trustees."
http://bmj.bmjjournals.com/cgi/eletters?lookup=by_date&days=1#53957
'Not Really'
From
F. Edward Yazbak, Pediatrician, Director
TL Autism Research, Falmouth, Massachusetts 02540
Please allow me to comment on certain statements in Ms. Clare Dyer’s
piece
http://bmj.bmjjournals.com/cgi/content/full/328/7438/483-a
(I have copied
this at the end of the email....Sheri):
Statement I: “Andrew Wakefield's study of 12 children, published in
the
Lancet (1998;351: 637) …provoked a huge media controversy that was
followed
by a substantial fall-off in the percentage of children given the triple
vaccine.”
Comment: Not Really. The fact is that Andrew Wakefield never suggested
that
vaccination against measles, mumps and rubella be stopped. On the contrary,
his recommendation to have the monovalent vaccines available, alongside
the
MMR, would have improved vaccination rates in the United Kingdom, because
all parents, including those concerned about the safety of the triple
vaccine, would have rushed to have their children vaccinated. Furthermore,
MMR uptake in the United Kingdom had already decreased substantially
before
the February 1998 article by Dr. Wakefield.
The source of the following information is a document entitled “NHS
Immunisation Statistics, England: 1997-1998”
[www.doh.gov.uk/pub/docs/doh/imstat98pdf].
If it cannot be accessed online,
the document is available from the UK Department of Health.
Between 1994 and 1998, MMR (first dose) vaccination rates decreased
at a
faster rate (16.1%) than all other vaccines.
In 1993-94, 588,000 children received three doses of pertussis vaccine
and
640,000 received the first dose of MMR. In 1997-98, 589,000 children
received the pertussis vaccine series of three injections and only
563,000
received one dose of MMR. Put in perspective, British parents were
more
likely in 1997 to bring their children back THREE times to receive
the
pertussis vaccine, a vaccine that has historically been a concern in
the
United Kingdom, than once for the MMR vaccine. The authors’ comment
was:
“In the case of pertussis, coverage rates have regained the ground
lost in
the mid-1970’s due to public anxiety about the safety and efficacy
of the
vaccine. The recent fall in MMR coverage may be the result of similar
concern over the vaccine”.
Examining the vaccination rates in the year of second birthday, 93.7%
of
eligible UK children received 3 doses of pertussis and 91.9% received
their
first MMR in 1995-96 compared to 94.2% for 3 doses of pertussis vaccine
and
90.8% for MMR in 1997-98.
When one looks at coverage rates, at age 24 months, by health district
in
England, only 4 of the 100 health authorities reported a coverage rate
of
less than 90% for diphtheria, tetanus and polio in 1997- 98 and 72
reported
rates of 95% or over. For MMR, 28 health authorities reported coverage
rates of less than 90% including 9 with rates below 85% and only 6
reported
rates of 95% or over.
The United Kingdom district range vaccination coverage at age 2 years
in
1997-98 was a low of 82.6% and a high of 97.6% for three doses of pertussis
vaccine compared to a low of 75.2% and a high of 95.9% for one MMR.
Statement II: “The chief medical officer for England, Professor Liam
Donaldson, told BBC radio's Today programme that Dr Wakefield's research
had led to a loss of confidence in a vaccine that had saved millions
of
children's lives”.
Comment: Not Really. I respectfully submit that measles deaths had
decreased precipitously before the introduction of the measles vaccine
because of better nutrition and hygiene. The following can be checked
with
the DOH. In 1901, there were 9,019 deaths attributed to measles in
a
population of 32,612,1000 in England and Wales, giving a mortality
rate of
276.5 per million. In 1960, there were 80 deaths and the population
was
45,775,000. The measles mortality rate in England and Wales was therefore
1.75 per million in 1960. In other words, the mortality rate from measles
had decreased by 99.12% before the introduction of the measles vaccine.
If
Professor Donaldson were talking about measles control (and not deaths)
then indeed vaccination would be most helpful. He offers two options:
MMR
or “nothing”. Dr. Wakefield offers two other options: MMR or single
vaccines. I submit that single vaccines are immensely better than
“nothing”. Unfortunately, for many English parents, it has been “nothing”
for years before Dr. Wakefield’s article.
Statement III: Professor Donaldson added: "We have always thought that
Dr
Wakefield's original study was poor science, but it is not just us
that
thought that. Individual experts and individual medical bodies around
the
world criticised it,"
Comment: Not Really. Six years after the study in question, there is
ample
evidence by several independent investigators, from respectable scientific
centers, in support of Wakefield’s research. Identical endoscopic findings
have been described, measles virus persistence in diseased tissues
has been
documented and abnormal measles immunity, in a specific subset of children
with regressive autism, has been repeatedly detected.
Many of the individual experts and medical bodies who criticized Wakefield
had ties with the health authorities, the immunization programs or
the
vaccine manufacturer. In adition, most of the epidemiological studies
they
quoted had serious flaws and were funded by the CDC or the vaccine
manufacturer. (1)
Two of those anti-Wakefield studies actually reported increases in autism
after the introduction of the MMR vaccine in the UK and in one, a
regression after MMR vaccination was also documented.
In the first by Taylor and Associates, (2) the authors stated: “We looked
for evidence of a change in trend in incidence or age at diagnosis
associated with the introduction of MMR vaccination to the UK in 1988…
There was a steady increase in cases by year of birth… No significant
temporal clustering for age at onset of parental concern was seen for
cases
of core autism or atypical autism with the exception of a single interval
within 6 months of MMR vaccination.” Two co-authors of this study are
employees of the Immunisation Division, Public Health Laboratory Service
Communicable Disease Surveillance Centre, London. In addition, Dr.
Taylor’s
inter-personal conflict with Dr. Wakefield should have been declared.
The second study by Kaye and Associates (3) is based on information
from
the UK general practice research database (GPRD). The authors reported
that: “The incidence of newly diagnosed autism increased sevenfold,
from
0.3 per 10 000 person years in 1988 to 2.1 per 10 000 person years
in
1999.” Dr. Kaye is employed at the Boston Collaborative Drug Surveillance
Program. He disclosed the following: Funding: No specific funding.
Competing interests: The Boston Collaborative Drug Surveillance Program
is
supported in part by grants from AstraZeneca, Berlex Laboratories,
BoehringerIngelheim Pharmaceuticals, Boots Healthcare
International,Bristol-Myers Squibb Pharmaceutical Research Institute,
GlaxoWellcome,Hoffmann-La Roche, Janssen Pharmaceutica Products, R
W
JohnsonPharmaceutical Research Institute; McNeil Consumer Products,
andNovartis Farmaceutica. Dr. Kaye did not perceive that he had a conflict
because GlaxoSmithKline was a defendant in the MMR litigation in the
UK.
Statement IV: “The furore was sparked by a Sunday Times investigation
(22
February, pp 1, 12, 13) which also cast doubt on whether research ethics
approval had been properly granted for the study”
Comment: Not Really. Statements by the Editor of the Lancet also sparked
much of the furor. Now that the dust has settled, here are the facts.
A
class action suit brought by hundred of parents, who believed that
the MMR
vaccination was responsible for their children’s regressive autism,
was
getting to Court at last, when suddenly legal aid funds were cut.
Simultaneously, the researcher, who dared to suggest that there was
a link
between the triple vaccine and autism, was attacked and vilified. His
pioneer research was also deemed flawed because he did not disclose
to the
Lancet that a minority of the 12 children in his original study was
included in a separate study that was partly funded by the Legal Aid
Board.
According to the editor of The Lancet, such a disclosure should have
been
made, because of the potential perception of a conflict of interest.
>From Andrew Wakefield’s point of view, there was neither a real nor
a
perceived financial conflict. Funds from the Legal Aid Board were never
used for any part of the study that was published in The Lancet, in
February 1998. In addition, Dr. Wakefield did not personally receive
any
portion of the much-publicized Legal Aid Board grant of £55,000
to the
Royal Free Hospital Special Trustees. In a letter published in the
Lancet
in May 1998, Dr. Wakefield reported that he was undertaking a pilot
study
on behalf of the Legal Aid Board to examine the merits of parental
claims
of an association between their child’s exposure to the MMR vaccine
and
subsequent autistic regression and intestinal symptoms.
It is evident that the editor of The Lancet did not perceive, for six
long
years, that any conflict of interest existed because neither did he
question the principal investigator nor did he disavow the research.
He
only made his recent accusations just before the Sunday Times report
of
February 22, 2004 for reasons that we can only conjecture.
The fact is that the first 12 children reported in the Lancet study
were
properly referred to the Royal Free specialized unit solely because
of
their intestinal symptoms. The physicians, who examined and investigated
them and later reported their findings, had no interest in, and probably
no
knowledge of, any future litigation.
The February 1998 Lancet article (4) consisted of a summary of each
child’s
history as reported by the parents and the relevant clinical and laboratory
findings. The authors, including Andrew Wakefield, did not claim that
a
causal association with MMR vaccination existed and only suggested
further
research and investigation of the findings. When most of Wakefield’s
co-authors simply repeated that fact recently, the Press and the vaccine
lobby and its puppets hailed their statement as an earth- shattering
event.
The clearly orchestrated efforts by numerous parties to halt the MMR-
Autism litigation in the UK had to target the man who appeared to have
some
answers. Being unable to refute his findings by clinical studies,
Wakefield’s enemies targeted him personally and attacked his integrity
and
his character. Such attack will not change the beliefs of many parents
who
are seeing their legal cases stalled and the UK Government investing
over
£3 million to promote the MMR vaccine and not a penny to-date
towards
autism research.
So is the Government going to convince parents that the MMR vaccine
has
never caused autism in a small percentage of predisposed children?
Not
Really.
Is Andrew Wakefield going to just go away? Not Really.
Will the truth ever come out? Absolutely.
References
1. Regressive Autism and MMR Vaccination F. Edward Yazbak, MD, FAAP,
TL
Autism Research. http://www.redflagsweekly.com/yazbak/2003_nov01_1.html
2. Taylor B, Miller E, Farrington, Cetropoulos M, P, Favout-Mayaud,
JL,
Waight P, Autism and measles, mumps, and rubella vaccine: no
epidemiological evidence for a causal association. Lancet 1999; 353:
2026-
29.
3. Kaye JA, del Mar Melero-Montes M. Mumps, measles, and rubella vaccine
and the incidence of autism recorded by general practitioners: a time
trend
analysis. BMJ 2001; 322: 460-463 (24 February.)
4. Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular
hyperplasia, non-specific colitis, and pervasive developmental disorder
in
children. Lancet 1998; 351: 637-41.
Competing interests: Grandfather of a boy with two documented regressions,
autistic enterocolitis and evidence of measles genomic RNA in the gut
wall
******
http://bmj.bmjjournals.com/cgi/content/full/328/7438/483-a
BMJ 2004;328:483 (28 February), doi:10.1136/bmj.328.7438.483-a
Pressure mounts for inquiry into MMR furore
Clare Dyer, legal correspondent
BMJ
Pressure was mounting this week for a full inquiry after the revelation
that the lead investigator in a controversial UK study on alleged links
between autism, bowel disease, and the measles, mumps, and rubella
(MMR)
vaccine had failed to disclose that he was also carrying out investigations
for lawyers hoping to sue over vaccine damage.
Andrew Wakefield's study of 12 children, published in the Lancet (
1998;351: 637)[CrossRef][ISI][Medline], provoked a huge media controversy
that was followed by a substantial fall-off in the percentage of children
given the triple vaccine.
Last week the Lancet's editor, Richard Horton, said he would not have
published the paper had he known that Dr Wakefield had a contract for
up to
£55 000 ($102 700; 81 800) from the legal aid board (now the
legal services
commission) to carry out tests on 10 children for a group action against
vaccine manufacturers. Dr Wakefield admitted that at least four, possibly
five, of the children featured in both studies.
Dr Wakefield said in a statement that the two studies had been quite
separate. The Lancet study was a clinical investigation; only the study
funded by the legal aid board—looking at whether the measles virus
was
present in the children's intestinal tissue—had been designed to explore
the issue of causation.
The health secretary, John Reid, called for an inquiry by the General
Medical Council "as a matter of urgency." A GMC spokeswoman said the
council had spoken to Dr Wakefield, who was happy to cooperate with
any
investigation.
But Evan Harris, a liberal democrat MP who sits on both the BMA's ethics
committee and the House of Commons science and technology committee,
said
that a GMC inquiry would not go far enough. "There needs to be a wider
inquiry. The GMC can only hear existing allegations against medically
qualified people. There may be people who have made errors who are
not
legally qualified and there may need to be recommendations as to research
ethics in the future."
The furore was sparked by a Sunday Times investigation (22 February,
pp 1,
12, 13) which also cast doubt on whether research ethics approval had
been
properly granted for the study, carried out at the Royal Free Hospital
in
London, which subjected autistic children to such invasive procedures
as
lumbar puncture and ileocolonoscopy.
The Royal Free and University College Medical School and the Royal Free
Hampstead NHS Trust said in a statement: "We are entirely satisfied
that
the investigations performed on the children reported in the Lancet
paper
had been subjected to appropriate and rigorous ethical scrutiny."
The chief medical officer for England, Professor Liam Donaldson, told
BBC
radio's Today programme that Dr Wakefield's research had led to a loss
of
confidence in a vaccine that had saved millions of children's lives.
"We have always thought that Dr Wakefield's original study was poor
science, but it is not just us that thought that. Individual experts
and
individual medical bodies around the world criticised it," he added.
The legal services commission withdrew funding for the MMR group action
last year ( BMJ 2003;327: 640[Free Full Text]), announcing at the same
time
that it would no longer fund research for litigation purposes. (See
p 528.)
Conflicts of interests and cover-ups can be
illustrated in orthodox medicine ad nauseum.
The question is, how long will they choose
or be allowed to carry on with this amorality and hypocrisy?
also see, for example
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