http://bmj.bmjjournals.com/cgi/eletters?lookup=by_date&days=1#53957

[Letter to BMJ] '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.)


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