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.

RE:  Safe Minds Response to AAP Press Release Concerning IOM Report on Thimerosal in Vaccines by Lyn Redwood, R.N.

I find the views expressed in the AAP press release to be directly misleading to pediatricians, other physicians, and to the American public.  The highlights of the IOM report were (a) there is insufficient evidence to support or refute the safety of thimerosal in vaccines; (b) the association between thimerosal and neurodevelopmental disorders is biologically plausible; (c) thimerosal should be removed from medical products; and (d) further research is necessary.

Balancing Risks and Benefits: Primum non nocere Is Too Simplistic by Neal Halsey, M.D. and Lynn Goldman, M.D.

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.

Waters & Krauss Press Release

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.

No Vaccine-Autism Link Found

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.

RE:  Safe Minds Response to AAP Press Release Concerning IOM Report on Thimerosal in Vaccines by Lyn Redwood, R.N.

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

RE:  Safe Minds Response to AAP Press Release Concerning IOM Report on Thimerosal in Vaccines by Lyn Redwood, R.N.

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:

• Panel Finds No Link Between Childhood Vaccines, Autism (New York Times)
• No Links Found Between Childhood Vaccine, Autism (Los Angeles Times)
• US Expert Group Rejects Link Between MMR and Autism (The Lancet)

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.

Letter from Professor Walter 0. Spitzer, Ph.D.

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 27^th, 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?

MMR Shots Under Fire at Autism Hearing: Lawmakers Dispute Accuracy and Fairness of New Vaccine Report

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.

Dealing with uncertainty

I wonder if people know that general practitioners are given financial incentives to deliver a certain proportion of vaccinations.