Spinning the truth
The truth
Immunization Safety Review: Thimerosal - Containing Vaccines and Neurodevelopmental Disorders (2001) - Institute of Medicine
The committee concludes that although the hypothesis that exposure to thimerosal-containing vaccines could be associated with neurodevelopmental disorders is not established and rests on indirect and incomplete information, primary from analogies with methylmercury and levels of maximum mercury exposure from vaccines given to children, the hypothesis is biologically plausible.
Thus the committee concludes that the evidence is inadequate to accept or reject a causal relation between exposure to thimerosal from vaccines and the neurodevelopmental disorders of autism, ADHD, and speech or language delay.
Immunization
Safety Review:
Measles-Mumps-Rubella Vaccine and Autism (2001) -
Institute of Medicine
Thus the committee
concludes that the evidence favors rejection of a causal relationship at the
population level between MMR vaccine and autistic spectrum disorder (ASD).
The committee based this conclusion on the following evidence:
A consistent body of
epidemiological evidence shows no association at a population level between MMR
vaccine and ASD.
The original case
series of children with ASD and bowel symptoms and other available case reports
are uninformative with respect to causality.
Biologic models
linking MMR vaccine and ASD are fragmentary.
There is no relevant
animal model linking MMR vaccine and ASD.
However the committee notes that its conclusion does not exclude the possibility that MMR could contribute to ASD in a small number of children, because the epidemiological evidence lacks the precision to assess rare occurrences of a response to MMR vaccine leading to ASD and the proposed biological models linking MMR vaccine to ASD, although far from established, are not disproved.
Chairman Burton Requests Recall Of Childhood Vaccines with Thimerosal
Chairman Dan Burton (R-IN) today renewed his request to the Department of Health and Human Services to recall all childhood immunizations containing a mercury-based preservative known as Thimerosal. Burton made his request a day after the Institute of Medicine (IOM) issued a report concluding that there is not enough evidence to prove or disprove the theory that mercury-containing vaccines cause neurological conditions such as learning disabilities, Attention Deficit Disorder, or autism. Calling the theory "biologically plausible," the IOM urged that vaccines and other products containing mercury not be given to infants, children or pregnant women when alternatives are available.
The adverse effects from intrauterine low-dose methylmercury exposure are not detected early in life and include alterations in attention, fine motor, and cognitive function that fit in the overall category of learning impairment. The NRC noted that all sources of mercury must be considered when determining the need for interventions. For infants born to women who have high levels of methylmercury, the possible additive effects from subsequent exposure to ethylmercury (from thimerosal) are not known but are of potential concern, especially given that so many children start out life with mercury levels that exceed recommended guidelines. Moreover, the potential exposures to ethylmercury from thimerosal alone were in excess of 0.1 µg/kg/d at the time that doses were administered, and such bolus administration would likely result in higher blood levels and subsequent transmission to the brain.9
Seal and Daum implied that exposures to thimerosal were known to be safe in July 1999; however, ethylmercury had not been studied in animals or humans from the standpoint of toxicity to the developing brain. In particular, there were no epidemiologic studies of intellectual development, learning disabilities, or other adverse effects that might be associated with ethylmercury exposure in utero or early in life. Preliminary studies from West Coast health maintenance organizations revealed dose-related evidence of increased risk of learning disabilities, delayed speech, and other abnormalities, but no such relationship was found in an East Coast population.11
Vaccines may pose mercury hazard for kids
Yet the
panel couldn't dismiss possible problems related to thimerosal, a preservative
added to vaccines. Thimerosal contains ethylmercury, a form of the heavy metal
mercury that at high levels can lead to neurological problems.
The
panel found that the scientific evidence was not conclusive, yet the group did
find cause for concern about these vaccines.
In
addition, the panel noted that some scientists had found a connection between
very high doses of thimerosal (much higher than the amounts found in vaccines)
and neurological problems in adults and children.
Andy Waters, the lead attorney in the cases, announced that his firm is now in possession of a previously unreleased confidential report authored by Centers for Disease Control scientists which studied autism as a potential neurological injury caused by mercury in children's vaccines.
A different
version of the report was made public and has been cited by the recent Institute
of Medicine study as inconclusive on the issue of whether the mercury-based
vaccine preservative known as thimerosal has contributed to cause a nationwide
epidemic of regressive autism and other neurological disorders in small
children. The
confidential version of the study, however, clearly demonstrated that an
exposure to more than 62.5 micrograms of mercury within the first three months
of life significantly increased a child's risk of developing autism.
Specifically, the study found a 2.48 times increased risk of
autism - that is to say, children with the exposure were more than twice as
likely to develop autism as children not exposed.
The spin
Federal Panel: No Link Between MMR Shot and Autism
A
federal expert committee said Monday it has concluded there is no link between
the measles, mumps and rubella (MMR) combination vaccine and autism.
Parents
should not stop vaccinating their children, and there should be no change in
federal or state MMR recommendations, the committee said.
“No vaccine is 100%
safe,” said Marie McCormick, chair of Harvard Public Health School’s
Maternal and Child Health department and chair of the federal Committee on
Immunization Safety Review. But she said, the
MMR vaccine “is as safe as a vaccine can get.”
The 15-member panel,
convened by the prestigious Institute of Medicine (news - web sites) (IOM), did
leave open the possibility that the vaccine might in rare cases cause autism,
based on early research showing a potential link between the measles virus and
the developmental disorder. Autism
is a neurological disorder that impairs language development and prevents
patients from socializing normally.
The
biologic data are “fragmentary,” said McCormick, but down the road, studies
might bear out the link. “Because there is this beginning study that needs to
be worked through, we left the door open,” she said.
Offering reassurance to millions of parents, an expert panel has concluded there is no evidence of a connection between a standard childhood vaccine and the development of autism.
“The advice is that there should be no change in the policies with regard to receiving measles, mumps, rubella vaccine — that it is as safe as a vaccine can get,” said Dr. Marie McCormick of the IOM.
I find the views
expressed in the AAP press release to be directly misleading to pediatricians,
other physicians, and to the American public.....
It quotes only one line from the IOM report: “No
evidence currently exists that proves a link between thimerosal-containing
vaccines and autism, attention deficit hyperactivity disorder and speech and
language delay”; and then takes that quote out of the context in which it
appeared by concluding that: “’Parents
should be reassured about the safety of vaccines’, according to AAP President
Elect Louis Z. Cooper, MD. ‘Children should be immunized according to
the recommended age-appropriate schedule.’”
The reaction
In
actuality, the IOM report states in the Executive Summary (page 3): “The
committee concludes that although the hypothesis that exposure to thimerosl
containing vaccines could be associated with neurodevelopmental disorders is not
established, and rests on indirect or incomplete information, primarily from
analogies with methyl mercury and levels of maximum mercury exposure from
vaccines given in children, the hypothesis is biologically plausible.”
As you well know, acknowledging biological plausibility is the first
step necessary in establishing a causal relationship.
·
The
report goes on to state (page 4): “The
evidence is inadequate to accept or reject a causal relationship between
exposure to thimerosal from vaccines and the neurodevelopmental disorders of
autism, ADHD, and speech and language delay.”
It is not surprising that the large case controlled studies that are
necessary, according to IOM standards, to either prove or disprove causality
have not yet been done. This issue
surfaced two years ago at FDA and none of the logical funding agencies have
allocated the time or resources to complete the required investigations. The IOM
strongly recommended that such studies be undertaken. Toxicokinetic and
treatment studies were also recommended – details not touched on in your media
release.
· The comment made by AAP that “children should be immunized according to the age-appropriate schedule” was not even an issue addressed by the report. The question was if children should be receiving mercury in their vaccines and the answer was a resounding no. “The committee recommends the use of thimerosal-free DTaP, Hib and Hepatitis B vaccines in the United States, despite the fact that there might be remaining supplies of thimerosal-containing vaccine available.” (page 7)
Leading
Vaccine Safety Group Questions Interpretation of IOM Report on Autism and MMR
Vaccine
The
National Vaccine Information Center (NVIC), a non-profit organization
representing families with vaccine injured children have endorsed some of the
conclusions of the report released yesterday by the newly created Institute of
Medicine (IOM) Immunization Review Committee on the hypothesized link between
MMR vaccine and autism. But the nation’s largest and oldest vaccine safety and
informed consent advocacy group is questioning whether misinterpretation and
misuse of the Committee’s conclusions will compromise public health agency
commitment to funding vaccine safety research.
The
Institute of Medicine Committee concluded that “the evidence favors rejection
of the causal relationship at the population level between MMR vaccine and
autistic spectrum disorders” but also stated that “the proposed biological
models linking MMR vaccination to autism spectrum disorders, although far from
established, are nevertheless not disproved.”
The Committee also called for further scientific research on the
occurrence of autism in children following MMR vaccination.
“The Committee clearly acknowledged the biologic plausibility that MMR vaccine could be a co-factor in causing autism in some children. But the message this report may send out, in practical terms, is that there is absolutely no association between vaccination and autism and that the case is closed. It can be used by those in industry, government and medical organizations with a vested interest in protecting the status quo.” said NVIC co-founder and president Barbara Loe Fisher. “This would be tragic because it could fatally compromise the making of vaccine safety research a priority in our society and delay the search for identification of biological markers that could predict which children are more vulnerable to vaccine-induced neuroimmune dysfunction that can, in some, take the form of autism.”
“The conclusion of the IOM Committee that current scientific evidence favors rejection of a causal association between autism and MMR vaccine should not be taken out of context. There has been limited scientific research to date to investigate the relationship between vaccination and autism and until a more rigorous examination is conducted, the case is open, not closed,” said Fisher. (Note: Apparently not as limited as the IOM publicly claimed -Wakefield says the IOM panel requested information on his observations in a closed session, but it didn't wind up in the final report. At the time, his latest studies were still being reviewed for scientific publication, so he couldn't present them in public. - MMR Shots Under Fire at Autism Hearing)
The
MMR/autism controversy: should we believe the IOM? by Bernard Rimland, M.D.
You have
seen the headlines:
Is
it true? Has the autism/MMR link been scientifically disproved? Absolutely not!
The above headlines refer to a report published
by the heretofore respected Institute of Medicine (IOM), a branch of the
National Academy of Sciences. You may be thinking: If a prestigious independent
group such as the IOM rejects the autism/MMR connection, there must be good
reason for doing so. Why shouldn’t I accept that verdict?
You
shouldn’t accept the verdict for several reasons. One is that the headlines
are wrong-the IOM did not reject the hypothesis that the MMR is a
possible cause of autism. The headlines were based on a press release
written by individuals with suspected links to the vaccine manufacturers, and
did not accurately reflect the actual statement by the IOM itself.
Representative Dan Burton, who has conducted intensive investigations of the
evidence linking vaccines to autism, and had insisted on excluding from the IOM
panel those with a conflict of interest, was furious when he found that
individuals with ties to the vaccine manufacturers had distorted the position of
the IOM report to make it appear to wholly reject the autism/MMR link. He noted
that two of those who issued the press release appeared to have ties with the
vaccine manufacturers, and he has vowed to determine the extent of their
conflict of interest. Burton’s very normal grandson became autistic soon
after receiving in one day multiple vaccines containing 40 times the acceptable
level of mercury.
The IOM
report actually said: “Although the committee has concluded that the
evidence favors rejection of the causal relationship at the population level
between MMR vaccine and ASD, the committee recommends that this issue receive
continued attention.... its conclusion does not exclude the possibility that MMR
vaccine could contribute to ASD in a small number of children...”
This is an exceedingly weak statement, considering the evidence at hand (see below), but it certainly does not reject a causal link. (And what does “at the population level” mean?)
It is the medical establishment’s burden to have proven that the vaccines are safe, not the critics’ burden to prove them unsafe. Safety testing should have been done 20 years ago, when the MMR triple vaccine replaced the measles, mumps, and rubella vaccines which were given separately, over a period of time, and when the number of vaccines was 8 rather than 22.
In
the course of travel in Europe, I read a surprising headline in USA Today,
“Vaccine is off the hook as the cause of autism. But panel won’t dismiss
possibility.”(See 1. below)
The
two parts of the headline are contradictory. I had just finished reading
the 74-page Report of the Institute of Medicine’s Immunization Safety Review
Committee (the panel) released on 4-23-01. There was nothing in the Report or
its executive summary to justify such a headline in a reliable national
newspaper. I can only link the headline’s .”off the hook as the cause of
autism” to a public statement of Dr. Marie McCormick, the chairperson of the
Committee. In the Institute of Medicine (IOM) press conference she stated:
“it [MMR] is as safe as a
vaccine can get “(See 2. below) As an individual evaluator, my view is that
the IOM Report itself is 70% to 90% correct in its descriptions of the evidence
and in its judgments. The Report concludes: “.evidence favors rejection of a
causal relationship at the population level between MMR vaccine and autistic
spectrum disorders.”(See 3. below) The foregoing is all based on lacking
evidence. The Committee concedes
that it could not “.exclude the possibility that MMR vaccine could contribute
to ASD in a small number of children..”(See 3.
below)
What is a small number of
children? If the number were 5% of diagnosed autistics in any large developed
country, that would be thousands of persons. The Report recommends: “Conduct
further clinical and epidemiological studies of sufficient rigor to identify
risk factors and biological markers of ASD.”(See 4. below)
I do not disagree with the Committee’s opinions as cited except in degree. Expressed in simpler but consistent language, the IOM Report reads as follows: We do not know whether there is any link between MMR and any autistic disorder. The evidence is inconclusive. More study is needed. I agree with the three conclusions. But for McCormick to say in the releasing press conference, “ it is as safe as a vaccine can get” imputes the Chair’s personal opinion to the Committee as a whole. It is understandable that the lay press picked the wrong message from the wrong source. As an epidemiologist who has been a Member of the IOM since 1986, I have been proud of IOM reports in my field that I have examined or co-authored. I am embarrassed by the process of this latest Report and would urge President Shine of the IOM to retract the Report until the message has been clarified. What was released, the IOM Report or the McCormick Position? I am a worried agnostic on the matter of MMR linked with autism just for reasons given by the IOM Committee. “. because .the proposed biological models linking MMR vaccine to ASD, although far from established, are nevertheless not disproven.”3 I believe that immunization is the strongest pillar of public health and prevention. I have no family members with ASD. I would be delighted if effective MMR were also demonstrated to be safe in scientifically admissible safety studies. But let that be the result of the kind of rigorous science that has been called for by the IOM, not unsubstantiated exoneration of MMR by one person.
Rimland Slaps Back Over Retraction Request
Last Tuesday we
published a letter by Susanna Stoiber, Executive Director Institute of Medicine
(IOM) that requested a retraction of comments made by Bernard Rimland Director
of the Autism Research Institute ARI). Rimland
accused the IOM of mischaracterizing one of their reports on MMR, vaccine
connection at a press conference. Stoiber
asserted that the IOM only announced the study and did not add any spin.
Here now is Dr. Rimland’ s response to the retraction request.
-LS]
Dear Ms. Stoiber,
I
am responding to your letter of July 25, 2001 requesting that I publicly retract
my recent editorial in the Autism Research Review concerning the IOM report on
MMR, vaccines and autism.
Let
me instead suggest that you follow the advice of fellow IOM member Professor
Walter O. Spitzer: retract the report itself.
Dr.
Spitzer, who has been a member of the IOM since 1986, wrote in a letter
published in London Sunday Times, May 27th, that he is embarrassed by
the process of the IOM report and urges its retraction “until the message has
been clarified.”
Dr.
Spitzer is particularly distressed, as am I, by the remarks by the Committee
Chairperson, Dr. Marie McCormick at the press conference announcing the release
of the report. He objects, as do I,
to Dr. McCormick ’s “spin” on the findings of the Report, which amounted
to the “unsubstantiated exoneration of the MMR by one person.”
The IOM suffers a self-inflicted wound.
I
think several retractions are in order, but by the IOM and Dr. McCormick, and
not by me.
Evidence of a Science Bending Rogue Group Within CDC?
As
summarized by Rosie Waterhouse’s news item, a transcript of the CDC’s secret
meeting about thimerosal effects indicates that a small group within the CDC
acknowledges major flaws within its initial study of the autism epidemic’s
link to vaccinal ethylmercury.
Despite
this awareness, this small but influential group within the CDC (ie, the group
that enacted the fatally flawed “study”) has touted and continues to use the
study’s “conclusions”—eg, on the webpages of the American Academy of
Pediatrics (spring, 2000) and at the recent Institute of Medicine (IOM) hearing
(July 16, 2001).
What
the CDC’s secret meeting transcript conveys is that the study’s data about
autism were insufficient.
As
a result, conclusions about rates of autism in the pediatric cohort from several
HMOs in the study are fictional.
Yet invalid findings do not stop this CDC group from continuing to disseminate misleading conclusions.
The reason?
The congressman was also angered that two of the report's reviewers are believed to have had financial ties to the pharmaceutical industry. The IOM's committee on immunization safety was created as an independent body without conflicts of interests.
Susanne Stoiber, the IOM's executive officer, said the reviewers only offered suggestions. They didn't change the report's basic conclusion. "To the best of our knowledge, aside from the fact that [the reviewers] may own mutual funds that hold pharmaceutical stocks, there is no reason to believe that there are any financial ties," she said.
Nonetheless, Burton insisted on seeing the financial records of the vaccine committee members, as well as the reviewers. He vowed to use his subpoena power if necessary.
I wonder if people know that general practitioners are given financial incentives to deliver a certain proportion of vaccinations.