Autism and Vaccine Safety - Has the Scientific Method Been Abandoned?

There is currently a persistent and strenuous effort being made to end discussion of possible vaccine connections to autism spectrum disorders. Led by vaccine patent holder Dr. Paul Offit the mainstream media and Internet based forums alike have been regurgitating ad nauseum Offit's position that the science is done, the evidence is in, that it has been proven conclusively, forever and ever and ever and ever, that vaccines and vaccine ingredients do not and can not ever cause autism disorders in children. But is that how science actually works? Does the scientific method actually involve arriving at an absolute truth not to be challenged forever? Or is such a position more properly characterized as idol worship?

Those who ask questions about the golden calf, about vaccine programs, are denounced as heretics, irresponsible and selfish types that refuse to protect the herd, and their own children, by having their children immunized for everything recommended, this month, or the next, by public health authorities. If someone, somewhere, dies from some disease whether it be measles or swine flu, there will be someone will blame the death on parents concerned about the safety of injecting chemical and biological materials directly into their child's bloodstream on a frequent basis. But is demonizing those concerned about vaccine safety part of the scientific method? Is rejecting forever challenges to the theory that vaccines do not cause autism in any children the way the scientific method is supposed to proceed?

TutorVista.com has an article on the Scientific Method simple enough for this lowly parent to follow. It lists a number of steps which it describes as constituting the scientific method. One of the points highlighted in the article is the provisional nature of a scientific theory or law :



Provisional essentially means temporary, conditional or transitional:

provisional adjective 1. temporary, interim, transitional, stopgap, pro tem <<> Collins Essential Thesaurus 2nd Edition 2006 © HarperCollins Publishers 2005, 2006 .

The scientific method recognizes that further evidence may refute a generally accepted theory. The scientific method encourages further evidence and challenge to accepted theories. Dr. Bernadine Healy, who has pointed out some of the limits of the existing epidemiological studies has also questioned the policy set out in the IOM 2004 report on vaccine safety, and pushed in the media by Dr. Paul Offit, of discouraging further research of possible vaccine autism connections as being contrary to the scientific method.

TutorVista also emphasizes the importance to scientific investigation of control sets:



Dr. Bernadine Healy, Dr. Julie Gerberding and Dr. Duane Alexander have all called for comparison of autism rates in vaccinated and unvaccinated groups. Those who oppose such research complain of costs and complexity. Some claim that the science is done, the evidence is in.

To this humble parent, and small town lawyer, it seems that the voices who have declared that the science is complete have in fact abandoned science when it comes to vaccine autism issues. Because of the important role played by vaccines in fighting diseases it is no longer acceptable to raise concerns about the chemical and biological agents which we inject, with increasing frequency, into the bloodstreams of our children. No one may ask whether autism, and other neurological disorders, may be triggered by these chemical and biological agents. No more research may be done on vaccine safety. The theory that vaccines do not contribute in any way to the onset of autism disorders will not be tested any further. Vaccine safety will be exempt, for public policy reasons, from further research or challenge as the scientific method contemplates.

Dr. Paul Offit is the high priest of the official public health religion that worships the golden calf of vaccine programs. In this religion no questioning of the golden calf will be permitted. The ultimate form of questioning, scientific investigation, will be forbidden.

The comparative studies of autism rates amongst vaccinated and unvaccinated populations will not be conducted.

If Dr. Offit prevails idol worship will replace scientific method.

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Vaccine-Autism War : Will Vaccine Safety Make A Comeback?

The Offit Offensive branding parents concerned about vaccine safety issues as kooks, dangerous to the public health, and suppressing democratic discussion of vaccine safety issues by attributing disease increases to parents expressing such concerns has been been unrelenting since the release of the vaccine patent holder's book False Prophets. David Kirby, one of those vilified by Offit for raising vaccine safety concerns, reports in the Huffington Post that the highly influential National Vaccine Advisory Committee has this past week made a number of vaccine safety research recommendations including two that focus on possible vaccine-autism connections. The Offit Offensive may finally meet an opponent it can not dismiss with demeaning insults and unproven allegations. The Offit Offensive may encounter open minded, credible study of vaccine safety issues.

One recommendation is for an "observational study comparing vaccinated, unvaccinated, and "alternatively vaccinated" groups of children for a number of immunological and neurological disorders -- including autism." A second panel recommendation that could include vaccine autism issues was that "Consideration should be given to broad biomedical research including laboratory studies, and animal studies."

Kirby also reports that the NVAC recommendations are subject to external review by an agency such as the IOM, the Institutes of Medicine. Unfortunately this could result in the implementation of recommendations being unduly delayed or scuttled completely. It was the same IOM that issued a 2004 report which expressly discouraged further research of vaccine autism issues.

Kirby attributes the NVAC recommendations to a number of sources without singling out the names of specific individuals. Personally I believe that three people deserve special credit for the vaccine safety issues being taken seriously. Jenny McCarthy, mocked and vilified, at times cruelly, for her campaign for vaccine safety acted as a lightning rod for media attention to the issues. Whether positive or negative the comments about Ms. McCarthy have kept the issue in the realm of public discussion. To the same effect David Kirby himself has been a powerful voice offering the skills and ability of a professional journalist to document the issue fully for public consumption. Neither Ms. McCarthy nor Mr. Kirby have buckled under to the immense pressure exerted by Dr. Offit and the medical establishment.

Ultimately though I believe that it is the input of Dr. Bernadine Healy that has had the most influence in arriving at the NVAC (and IACC) recommendations for further vaccine autism safety and general vaccine safety research. As the former head of the NIH Dr. Healy could not be dismissed as a crackpot. Her presentation of the need for further vaccine autism research was clear, cogent and compelling. She risked disenfranchisement from the medical and research establishments by pointing out the need for vaccine safety research. Her specific recommendations are clearly identifiable in the two NVAC recommendations above as well as her focus on vulnerable population subsets and the inadequacy of the epidemiological studies in examining the possible impact of vaccines on such groups.

The mainstream media is still enrolled in the Offit Offensive dismissing any need for vaccine safety research and dismissing as kooks anyone who suggests that there should be discussion and research of vaccine safety issues generally or vaccine autism issues specifically. The IACC strategic research plan and now the NVAC recommendations are powerful counter forces to the Offit offensive. Hopefully they will carry the day.

There should be no illusions though. The attempt to prevent research of vaccine autism safety issues is not over. The vaccine autism war is not over. The IOM, if it conducts an external review will be mindful, if not bound, by its own 2004 report discouraging the type of research recommended by the NVAC.

Look too for vaccine patent holder Dr. Paul Offit to step up his media tours demeaning those who dare ask questions of vaccine safety. Dr. Offit will once again don his "regular guy" flannel shirts and grandfatherly sweaters for interviews by adoring mainstream media. And Neurodiversity bloggers will be counted on to echo his demeaning characterizations of concerned parents around the world wide web.

If the IOM does do a replay of its 2004 strategy of discouraging serious research of vaccine safety issues it will be making a very big mistake. It is time to end the vaccine-autism war. Let the research be done, let the concerns be address and if those concerns are upheld or new ones found, let the vaccines and vaccine programs be adjusted accordingly.

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Vaccine-Autism War: Teresa Binstock's Prophetic Hunch

The dramatic events of the past two months in the vaccine-autism war were predicted a decade ago by researcher Teresa Binstock in her article IGNAZ SEMMELWEISS and AUTISM: when prevailing paradigms resist change in which she reported the funding bias in favor of genetic based theories of autism causation. She also indicated that studies of potential environmental causes of autism, including vaccines and vaccine ingredients, were unlikely to receive funding. Studies which reinforced the prevailing "it's gotta be genetic" model of autism were favored. Binstock described the health establishment's disregard for parents' observations of their children's reactions to vaccine, the demeaning marginalization of parents and professionals who question the official autism paradigm and the disregard for contrary evidence. Ms Binstock noted that:

"when a medical model becomes institutionalized and its primary spokespersons become set in
their well funded ways, such institutions and individuals strongly resist change"

No medical model is anymore entrenched then the vaccine model of public safety. And few spokespersons are better funded than vaccine patent holder Dr. Paul Offit who has been on a never ending tour promoting his book about what he calls autism's false prophets. There are a number of indisputable good reasons for the entrenchment of the vaccine model: the reduction and near elimination of serious diseases, some of which can kill, are very powerful reasons in support of public vaccination programs. But few systems or models are perfect. Most require adjustment when problems are found.

If vaccines do cause harm in some cases then those harmful, and potentially harmful, effects should be studied and adjustments made. Unfortunately the vaccine programs have been elevated to a sacred level by public health authorities to such an extent that people who ask questions or voice concerns are dismissed as hysterical, as cranks, quacks, charlatans and any number of other pejoratives.

Dr. Wakefield has been the subject of an ongoing investigation by the GMC for several years. Journalist Brian Deer who has had some serious involvement with the laying of charges against Dr. Wakefield has recently published an article in the Sunday Times in which he "convicted" Dr. Wakefield of data tampering. Other imperious journalists like Andre Picard at the Globe and Mail have decreed that the debate over vaccine safety must end now. Imagine, a journalist dictating that free public discussion of public safety issues must end now?

Of course THE primary spokesperson for the entrenched medical model, the entrenched "speak no evil of vaccines model" is Dr. Paul Offit. Dr. Offit is the vaccine patent holder whose genial face, cozy sweaters and "regular guy" flannel shirts appear every other day in a major media interview describing his own heroics on behalf of the children of the world and demonizing the evil parents who have voiced their concerns about vaccines thereby contributing to the growth of disease and death.

In 1999 Teresa Binstock offered the following hunch which has proved prophetic:

My own hunch is that the NIH and NIMH will not change from within; the senior practitioners of the "it's gotta be genetic" model have too much influence. Just as Semmelweiss and his data were suppressed, so too will the NIH/NIMH autism-research insiders continue to act against the the growing body of new data in autism; the NIH's pro-genetic old-timers will cling to their paradigm and its funding. As a result, change within the NIH and NIMH will have to be initiated from outside those tax-supported corporations.

The Institute of Medicine (IOM) Immunization Safety Review: Vaccines and Autism (2004) proved Ms Binstock's hunch to be correct when it expressly discouraged further investigation of vaccine safety. Last month the Interagency Autism Coordinating Committee (IACC) confirmed her hunch as prophecy when it reversed its own decision reached only weeks earlier to authorize funding for research of vaccine-autism connections, research that might have provided the kind of evidence found to be non-existent in the recent Vaccine Court Autism Trilogy.

As Teresa Binstock predicted in 1999 any research of non-genetic causes of autism, including and especially, potential vaccine causes, will have to come from outside the public health establishment. Of course the ability to conduct such research will be further hampered by well orchestrated media campaigns led by Dr. Paul Offit with journalists from institutions like the Sunday Times, the New York Times and the Globe and Mail scurrying about helping to suppress public discussion of concerns which raise any doubts about the deeply entrenched vaccine health model.

Personally it is the suppression of research and public discussion which causes me the greatest concern about the safety of vaccine programs. Ultimately, as the Semmelweis case reviewed by Teresa Binstock shows, the truth will out. In the meantime though some vulnerable children might be harmed by vaccines and vaccine ingredients. harm that might have been avoided with some adjustments. The vaccine program itself will most definitely be harmed by the campaign to suppress research and discussion of vaccine safety concerns.

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Vaccine-Autism Research and the Vaccine Court Autism Decisions: The Circle is Complete

After the trilogy of Vaccine Court decisions the fact remains that the necessary research into a possible vaccine-autism connection still has not been done.

Vaccine-autism research has been actively discouraged by public health authorities. While they consistently discouraged the research that might have provided evidence of a vaccine-autism connection public health authorities have also pointed to lack of evidence to support its decisions to refrain from conducting the necessary research. The circular reasoning of the NIH, the IOM and the IACC is now reflected in the decisions of the Vaccine Court which complete the circle by pointing out that there is no evidence of a vaccine-autism connection.

Despite all the resulting headline hyperbole, and despite the setback for the families involved, the US Vaccine Court decisions did not disprove a vaccine-autism link. The Masters reviewed existing science and concluded there was no evidence of a vaccine-autism link. As I understand, in all three cases the Masters accepted official understanding of that science and nothing more was done than that. This remark is not intended in any way as a slight on these decisions. Given current research on the vaccine issues it is difficult to imagine they could have reached any other conclusions.

The problem is that public health authorities have never funded the research which might substantiate claims that vaccines cause autism in some cases. To the contrary any such research has been expressly and actively discouraged by those same authorities as:

(1) was reported by researcher Teresa Binstock in 1999:

By clinging to an oversimplified and outmoded model of autism (ie, it's gotta
be genetic), the stubborn persistence of several research administrators in the NIH
and NIMH means that funding for autism and autism-spectrum syndromes remains
funneled into the hands of a small group of researchers who pledge (via NIH-grant
contracts) to conduct their research in accord with the model wherein "it's gotta
be genetic" (1). This funding pattern imposes a serious limitation on research that
ought be occurring, given the growing amount of new data which indicate that *more than* genetic-aspects need be considered.

The relationship between (a) the offically approved though outmoded paradigm
and (b) subsequent funding patterns is worth re-stating: The persistence of the NIH
and the NIMH in focusing almost entirely upon a genetic-theory of autism
means that a goodly amount of data continues to be ignored, shunted from view, and unfunded -- even as the primary genetics-model researchers are blessed with abundant funding despite decades of non-success (1).

...

Let us consider two parallels between how Semmelweiss was treated and how the NIH and NIMH react to new data in autism-spectrum syndromes:

1: Initially and for many years, new data are strongly ignored; then, they are
resisted; and finally, if a person espouses those data and is persistent in seeking
to explore their ramifications, then he or she becomes shunned and excluded. That
these reactions occur leads to a second ramification significant to autism research
in the 1990s and beyond.

2: Despite the new data and its acceptance by many individuals, the data and
*ramifications* of that data tend to remain ignored by highly placed medical
bureaucrats. As a result, medical practices that ought change because of the new
data's significance do not change; and people entrenched within the old
paradigm (now made outmoded by the new data) do their best to enforce
the old paradigm -- and do so despite the fact that the new data suggest better
methods of treatment, diagnostics, or research.

(2) was candidly acknowledged and further research again discouraged by the IOM in 2004:

BOX 2
Committee Conclusions and Recommendations

SCIENTIFIC ASSESSMENT

Causality Conclusions

The committee concludes that the evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism.

The committee concludes that the evidence favors rejection of a causal relationship between MMR vaccine and autism.

Biological Mechanisms Conclusions

In the absence of experimental or human evidence that vaccination (either the MMR vaccine or the preservative thimerosal) affects metabolic, developmental, immune, or other physiological or molecular mechanisms that are causally related to the development of autism, the committee concludes that the hypotheses generated to date are theoretical only.

SIGNIFICANCE ASSESSMENT

The committee concludes that because autism can be such a devastating disease, any speculation that links vaccines and autism means that this is a significant issue.

PUBLIC HEALTH RESPONSE RECOMMENDATIONS

The committee recommends a public health response that fully supports an array of vaccine safety activities. In addition the committee recommends that available funding for autism research be channeled to the most promising areas.

Policy Review

At this time, the committee does not recommend a policy review of the licensure of MMR vaccine or of the current schedule and recommendations for the administration of the MMR vaccine.

At this time, the committee does not recommend a policy review of the current schedule and recommendations for the administration of routine childhood vaccines based on hypotheses regarding thimerosal and autism.

Given the lack of direct evidence for a biological mechanism and the fact that all well-designed epidemiological studies provide evidence of no association between thimerosal and autism, the committee recommends that cost-benefit assessments regarding the use of thimerosal-containing versus thimerosal-free vaccines and other biological or pharmaceutical products, whether in the United States or other countries, should not include autism as a potential risk.

(3) was reported by former NIH head Dr. Bernadine Healy in 2008:

(a) US News and World Report, April 10, 2008

There is no evidence that removal of thimerosal from vaccines has lowered autism rates. But autism numbers are not precise, so I would say that considerably more research is still needed on some provocative findings. After all, thimerosal crosses the placenta, and pregnant women are advised to get flu shots, which often contain it. Studies in mice suggest that genetic variation influences brain sensitivity to the toxic effects of mercury. And a primate study designed to mimic vaccination in infants reported in 2005 that thimerosal may clear from the blood in a matter of days but leaves inorganic mercury behind in the brain.

The debate roils on—even about research. The Institute of Medicine in its last report on vaccines and autism in 2004 said that more research on the vaccine question is counterproductive: Finding a susceptibility to this risk in some infants would call into question the universal vaccination strategy that is a bedrock of immunization programs and could lead to widespread rejection of vaccines. The IOM concluded that efforts to find a link between vaccines and autism "must be balanced against the broader benefit of the current vaccine program for all children."

(b) CBS News, May 12, 2008:

"I think that the public health officials have been too quick to dismiss the hypothesis as irrational ... There is a completely expressed concern that they don't want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people. "First of all, I think the public’s smarter than that. The public values vaccines. But more importantly, I don’t think you should ever turn your back on any scientific hypothesis because you’re afraid of what it might show."

(4) was exhibited by the Interagency Autism Coordinating Committee shenanigans in 2009

when the IACC reversed a previous decision to authorize funding of the very research that might prove a vaccine-autism connection.

The Vaccine Court Autism Trilogy decisions are based on incomplete research. The deficient state of vaccine autism research was carefully, persistently and actively mainstained by public health authorities. As part of this process parental observations of their children's reactions to vaccine injections are dismissed with a blanket statement that they are coincidences. Parents who go further and publicly advocate for safer vaccines are villified and have their sanity questioned. Professionals who do the same are denounced as frauds by journalists writing in prominent publications. "Celebrity" parents like Jenny McCarthy are subject to unconscionable and even blatantly sexist abuse.

The circular reasoning of the public health authorities "there is no biological or experimental evidence that vaccines cause autism, so there is no point in doing biological or experimental research to determine whether vaccines cause autism" appeals to the converted but not to those who trust their own parental observations and can not blithely dismiss the reactions they saw in their children.

If the IOM, NIH and the IACC really, really wanted to reach out past the pews of the converted to the unwashed, ignorant masses who do not worship at their alters, they would fund the necessary research to address the legitimate concerns of parents. If these health authorities choose not to do so THEY will continue to imperil, as THEY have done for so many years, the very vaccine programs they pretend to protect.

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Vaccine-Autism War: Offit Over and Over ... and Over Again

Dr. Paul Offit has been the lead warrior for the empire's forces in the vaccine-autism war. If there is a media interview to be had on the subject of vaccines and autisms Dr. Offit is sure to be there dismissing concerns about the injection of mercury into children and pregnant women as dangerous and delusional. Dr. Offit cites, over and over and over and over .... and over again the fact that several epidemiological studies have disclosed no discernible link between vaccines and autism. The Offit Over and Over and Over Again Offensive is the primary public relations weaon in the recent Interagency Autism Coordinating Committee (IACC).

Yes, the the good Dr. Offit is at it again, obviously believing that if he repeats the same points ad nauseum, and ignores contrary perspectives, he will wear down those darn contrarians. They will submit to his arguments out of pure weariness and agree, much like a forced confession, that there is no vaccine-autism link. In an UPI article, February 2, 2009 , Researchers see no autism-vaccine link Dr. Offit throws out the usual epidemiological studies without mentioning the limitations of those studies as described by Dr. Bernadine Healy, former American Red Cross and NIH head, who points out that such studies do not necessarily address at risk population subsets. See (Fighting the Vaccine-Autism War, Leading Dr.: Vaccines-Autism Worth Study).

In his February 2 UPI lecture to the ignorant masses Dr. Offit teaches those of us who have not properly bathed in the waters of the scientific method how to apply the scientific sounding soap to contrary views - a) ignore contrary hypotheses or concerns such as Dr. Healy's b) dismiss them before they arise c) argue that it is all just one great big coincidence and d) repeat the offical dogma over and over ....... and over again:

"When one hypothesis of how vaccines cause autism is refuted, another invariably springs up to take its place," .... "The correlation is coincidental because the MMR vaccine is given at the age when autism symptoms usually appear, they concluded." .... "The researchers also examined seven studies from five countries that showed the presence or absence of thimerosal -- an ethylmercury-containing preservative -- in vaccines did not affect autism rates."

Just in case anyone actually believes that Dr. Offit has a monopoly on vaccine-autism truths here are some of the reasonable concerns about such rigid faith in vaccine safety as expressed by former NIH head Dr. Bernadine Healy:

"There is no evidence that removal of thimerosal from vaccines has lowered autism rates. But autism numbers are not precise, so I would say that considerably more research is still needed on some provocative findings. After all, thimerosal crosses the placenta, and pregnant women are advised to get flu shots, which often contain it. Studies in mice suggest that genetic variation influences brain sensitivity to the toxic effects of mercury. And a primate study designed to mimic vaccination in infants reported in 2005 that thimerosal may clear from the blood in a matter of days but leaves inorganic mercury behind in the brain.

The debate roils on—even about research. The Institute of Medicine in its last report on vaccines and autism in 2004 said that more research on the vaccine question is counterproductive: Finding a susceptibility to this risk in some infants would call into question the universal vaccination strategy that is a bedrock of immunization programs and could lead to widespread rejection of vaccines. The IOM concluded that efforts to find a link between vaccines and autism "must be balanced against the broader benefit of the current vaccine program for all children."

Wow. Medicine has moved ahead only because doctors, researchers, and yes, families, have openly challenged even the most sacred medical dogma.

Dr. Bernadine Healy,Fighting the Vaccine-Autism War, US News and World Report, April 10, 2008

In case anyone missed the last point, Dr. Healy indicated that the IOM in 2004 expressly discouraged research of a possible vaccine-autism war because of fear over the potential impact of such research on public confidence in vaccines. Teresa Binstock, in 1999 also pointed out that vaccine-autism research, and environmental causes of autism research, were expressly discouraged by pressure to conduct genetic oriented bases of autism research. To receive research funding researchers had to subscribe to the "it's gotta be genetic" autism paradigm.

And, as of February 2, 2009 Dr. Paul Offit has done yet another media presentation repeating the same tired arguments that have addressed none of the real concerns raised by Dr. Healy, Teresa Binstock and many other parents and medical professionals. On February 15 his no doubt "objective" (sarcasm fully intended) review of "summarizing the many studies refuting the claim of a link between vaccines and autism" will be published.

The Offit Over and Over and Over Again Offensive is a key element in the PR campaign by the IACC to hide its decision to reverse itself and deny support for vaccine autism research on January 14 only weeks after having approved of such research funding. The clandestine machinations of the IACC were denounced by Autism Speaks and no credible sources have spoken out to explain or justify such manouevres.

Dr. Paul Offit though is more than prepared to use an unquestioning mainstream media to repeat over and over again the arguments used for a decade to suppress research of possible vaccine-autism connections.

Unfortunately such efforts are old and tired and do not address serious concerns held by many parents and health care professionals. The Offit Over and Over and Over Again Offensive is not persuasive to those who hold vaccine-autism concerns or have an open mind on the subject. Quite the contrary.

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On Autism and Vaccines I Have Changed My Mind

Undecided

I have changed my mind about autism and vaccines. That fact alone probably puts me in a very small group amongst the many people who have discussed, debated and fought over the question of whether vaccines cause autism.

For many years I accepted without serious question the assertions of various health authorities that there is no vaccine-autism connection and that the possibility of such a connection had been disproved by epidemiological studies. Events over the past couple of years have caused me to reconsider my thinking about a possible vaccine-autism connection. I have not reached the point where I think it is proved that vaccines cause or contribute to autism but I have reached the point, once unthinkable for me, that I believe that such a connection is possible. If CNN's John King was doing one of his Magic Wall commentaries he would move me from the "vaccines do not cause autism" camp to the "undecided" camp.

Most of the events that have moved me to question the official position on vaccines and autism are well known:

1. The Poling case

2. The reaction to the Poling case by Dr. Julie Gerberding and other officials and the dubious attempt to distinguish between "autism" and "autism like symptoms".

3. Dr. Bernadine Healy's comments concerning the limitations on the epidemiological studies, the need to conduct lab and clinical studies, the fact that mercury/thimersoal is still contained in some vaccines, including some given to pregnant women.

4. The fact that there are still "trace" amounts of thimerosal in most vaccines and more than trace amounts in others (see the FDA web site) including those given to pregnant women. (What studies actually prove that "trace" or "small" amounts of a mercury based substance injected directly into a child can not cause neurological damage?).

5. The fact, and it is a fact, that public health authorities discouraged clinical /biological research into possible vaccine autism connections as they expressly did at page 152 of the 2004 IOM Report on vaccine safety.

6. The demonization by health authorities and professionals, Dr. Offit for example, of parents, and professionals, who assert a vaccine-autism connection.

These are the facts that have led me to move away from my acceptance of official proclamations that a vaccine autism connection has been disproved. I have not accepted yet that vaccines or thimerosal cause or trigger autism. But I do have an open mind on the subject and I do believe that more research, beyond epidemiological studies must be done, on vaccine, thimerosal and other possible environmental causes and triggers of autism.

It is foolhardy to pretend that we know all there is to know on the complex questions surrounding the causes of autism disorders. Unless we do the research we will never know and will never find possible preventative measures and cures for autism disorders.

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Autism Research Folly

"the NIH and NIMH are impeding progress in research about causes, diagnostics, and treatment in autism and similar syndromes.

By clinging to an oversimplified and outmoded model of autism (ie, it's gotta be genetic), the stubborn persistence of several research administrators in the NIH and NIMH means that funding for autism and autism-spectrum syndromes remains funneled into the hands of a small group of researchers who pledge (via NIH-grant contracts) to conduct their research in accord with the model wherein "it's gotta be genetic" (1).

This funding pattern imposes a serious limitation on research that ought be occurring, given the growing amount of new data which indicate that *more than* genetic-aspects need be considered.

The relationship between (a) the offically approved though outmoded paradigm and (b) subsequent funding patterns is worth re-stating:

The persistence of the NIH and the NIMH in focusing almost entirely upon a genetic-theory of autism means that a goodly amount of data continues to be ignored, shunted from view, and unfunded -- even as the primary genetics-model researchers are blessed with abundant funding despite decades of non-success (1). For instance, the data from Wakefield, Warren, Singh, Shattock, Oleske et cetera are important, as are patterns amidst parental anecdotes -- eg, gastrointestinal atypicalities, vaccination effects, extraodrinarily recurrent otitis et cetera.

However, as recent years have shown, despite the many new data and anecotes, the NIH and NIMH are resistant to change. The new data remain virtually ignored, the parents' anecdotes treated as if mere hearsay. Not surprisingly, in the face of this bureaucratic intransigence, the goal of changing and improving the NIH and NIMH in regard to autism funding will require increased effort."

Teresa Binstock, Researcher in Developmental and Behavioral Neuroanatomy, in IGNAZ SEMMELWEISS and AUTISM: when prevailing paradigms resist change, 1999

The Binstock article, referenced above, was a review of Jeanne Achterberg's book Woman as Healer and the sad story of Ignaz Semmelweiss who challenged medical orthodoxy of his time (1818-1865) by gathering data and arguing that peuperal (childbed) fever was caused by the unclean hands of those who delivered, or assisted, delivery of children. Hospital wards staffed by midwives had a 3% mortality rate due to fever while those staffed by medical students who often came straight from autopsy rooms to the maternity rooms, and either did not wash their hands, or wiped them on already bloody, dirty clothes, had a 10% rate.

The medical establishment of the time did not believe Semmelweiss and he was professionally punished by lowering his academic standing and restricting his hospital privileges. Ultimately he became depressed and committed to an asylum where he died of blood poisoning. Binstock noted similarities between the treatment afforded Semmelweis, his conclusions, and his data and what has happened today to the anecdotal evidence of parents and researchers who followed up on that anecdotal evidence.

Teresa Binstock's contention that research of a possible vaccine-autism conection has been discouraged by public authorities is in fact confirmed in the Institute of Medicine (IOM) Immunization Safety Review: Vaccines and Autism (2004) . In that document the public health authorities expressly discouraged research of vaccine-autism connections as shown at p. 152:

Biological Mechanisms Conclusions

In the absence of experimental or human evidence that vaccination (either the MMR vaccine or the preservative thimerosal) affects metabolic, developmental, immune, or other physiological or molecular mechanisms that are causally related to the development of autism, the committee concludes that the hypotheses generated to date are theoretical only.

SIGNIFICANCE ASSESSMENT

The committee concludes that because autism can be such a devastating disease, any speculation that links vaccines and autism means that this is a significant issue.

PUBLIC HEALTH RESPONSE RECOMMENDATIONS

The committee recommends a public health response that fully supports an array of vaccine safety activities. In addition the committee recommends that available funding for autism research be channeled to the most promising areas.

Policy Review

At this time, the committee does not recommend a policy review of the licensure of MMR vaccine or of the current schedule and recommendations for the administration of the MMR vaccine.

At this time, the committee does not recommend a policy review of the current schedule and recommendations for the administration of routine childhood vaccines based on hypotheses regarding thimerosal and autism.

Given the lack of direct evidence for a biological mechanism and the fact that all well-designed epidemiological studies provide evidence of no association between thimerosal and autism, the committee recommends that cost-benefit assessments regarding the use of thimerosal-containing versus thimerosal-free vaccines and other biological or pharmaceutical products, whether in the United States or other countries, should not include autism as a potential risk.

Apart from the express discouragement of funding of research of a possible vaccine autism connection it is interesting to note the first paragraph of the above quote. The highlighted portion states "In the absence of experimental or human evidence " that vaccines are causally related to autism any such hypothesis can be theoretical only. Having noted an absence of evidence the IOM then discouraged any research that might have produced such evidence. It is also becoming less certain that the epidemiological studies were as well designed as the IOM contended given the continued presence of thimerosal in vaccines, including some vaccines given to pregnant women.

In the last year the Poling case upset the IOM 2004 strategy. Government had to acknowledge that, at least in some subsets of children vaccines could trigger "autism like symptoms" :

if you're predisposed with the mitochondrial disorder, it can certainly set off some damage. Some of the symptoms can be symptoms that have characteristics of autism.

Dr. Julie Gerberding, Director, CDC, CNN Interview with Dr. Sanjay Gupta, March 29, 2008

As many have noted there is no intelligent distinction between autism and autism like symptoms. Autism is currently diagnosed by symptomatic behavior. In addition to Dr. Gerberding's reluctant acknowledgement of a vaccine-autism connection, Dr. Bernardine Healy, former director of the American Red Cross and the NIH, exposed limits of the epidemiological studes and expressed the need for further research of possible vaccine-autism connections in April 2008.

It is sheer folly to discourage research into possible environmental triggers or causes of autism. Not doing the research means that we might have missed out on possible treatments or preventative measures for autism. Teresa Binstock pointed out the folly of such a course of action in her 1999 comment. Now Irva Hertz-Picciotto, an author of the recent California study, has called for increased funding of research of possible environmental causes of autism.

It is time to move away from the "it's gotta be genetics" paradigm of autism research that Binstock described in 1999. It is time to move ahead with the autism research paradigm shift that the University of Minnesota called for in 2007, a paradigm based on the premise that autism is caused by a combination of environmental influence and genetic vulnerabilities.

It is time to end the "its gotta be genetics" autism research folly.

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Autism's Vaccine War Should Be Ended

I am a "neutral" in autism's vaccine wars.

I do not accept that a connection between autism and vaccines has been established by medical and scientific study. Nor do I believe that such a connection has been conclusively dis-proven by epidemiological study. I find it disconcerting that both camps in the autism-vaccine wars throw increasingly angry rhetoric, including cheap insults, at anyone who offers an opinion on the issue. Public Health authorities should encourage the research necessary to obtain evidence to resolve and bring an end to the autism vaccine wars.

I am the father of a 12 year old boy with Autistic Disorder, assessed with profound developmental delays. I am not a scientist or a scientific researcher of any kind. I am also a humble small town lawyer who looks primarily to those who do the research, and to medical and psychological professionals, for understanding of my son's Autistic Disorder.

The responsible authorities tell us that there is no vaccine autism connection and I accept that - for now. With that acceptance I am not in the anti-vaccine camp in the autism wars. I read with interest the information posted on the Age of Autism web site but do not subscribe to much of it.

Unlike those firmly entrenched in the other army in the vaccine-autism war though, I do not close my mind to the possibility that further research could establish such a connection. As a lawyer it is axiomatic that I must look at all the evidence, not just the evidence that suits a client's position, in order to properly represent that client. It has always been my understanding that science too re-examines its conclusions in the face of fresh evidence and that hypotheses are not excluded for policy reasons.

I remain open to the possibility that vaccines may contribute to, or trigger, the onset of autism in some children. I thought the comments of Dr. Bernardine Healy in her CBS interview with Sharyll Attkisson were worthy of follow up and rebuttal by responsible professionals. Dr. Healy is a former head of the National Institutes of Health in the United States who told Ms Attkisson that the vaccine autism could not be ruled out, that further research had been declined by health authorities for fear of what might be found:

"I think that the public health officials have been too quick to dismiss the hypothesis as irrational," Healy said. "But public health officials have been saying they know, they've been implying to the public there's enough evidence and they know it's not causal," Attkisson said. "I think you can't say that," Healy said. "You can't say that."

Healy goes on to say public health officials have intentionally avoided researching whether subsets of children are “susceptible” to vaccine side effects - afraid the answer will scare the public. "You're saying that public health officials have turned their back on a viable area of research largely because they're afraid of what might be found?" Attkisson asked. Healy said: "There is a completely expressed concern that they don't want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people.

"First of all," Healy said, "I think the public’s smarter than that. The public values vaccines. But more importantly, I don’t think you should ever turn your back on any scientific hypothesis because you’re afraid of what it might show." As an example, Healy points to the existing vaccine court claims.

CBS News has learned the government has paid more than 1,300 brain injury claims in vaccine court since 1988, but is not studying those cases or tracking how many of them resulted in autism. The branch of the government that handles vaccine court told CBS News: “Some children who have been compensated for vaccine injuries…may ultimately end up with autism or autistic symptoms, but we do not track cases on this basis.”

"What we’re seeing in the bulk of the population: vaccines are safe," said Healy. "But there may be this susceptible group. The fact that there is concern, that you don’t want to know that susceptible group is a real disappointment to me. If you know that susceptible group, you can save those children. If you turn your back on the notion that there is a susceptible group… what can I say?"

Government officials would not respond directly to Healy’s views… but reiterated, vaccines are safe.

Dr.Healy's comments about public health officials discouraging research into the vaccine hypothesis are clearly confirmed by reading the recommendations of the Institute of Medicine (IOM) Immunization Safety Review: Vaccines and Autism (2004) referenced in the CBS interview with former NIH Head Dr. Bernadine Healy ot the National Academies Press site. The document is 214 pages with hundreds of references to autism. Some comments in the Review:

At page 152:

BOX 2
Committee Conclusions and Recommendations

SCIENTIFIC ASSESSMENT

Causality Conclusions

The committee concludes that the evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism.

The committee concludes that the evidence favors rejection of a causal relationship between MMR vaccine and autism.

Biological Mechanisms Conclusions

In the absence of experimental or human evidence that vaccination (either the MMR vaccine or the preservative thimerosal) affects metabolic, developmental, immune, or other physiological or molecular mechanisms that are causally related to the development of autism, the committee concludes that the hypotheses generated to date are theoretical only.

SIGNIFICANCE ASSESSMENT

The committee concludes that because autism can be such a devastating disease, any speculation that links vaccines and autism means that this is a significant issue.

PUBLIC HEALTH RESPONSE RECOMMENDATIONS

The committee recommends a public health response that fully supports an array of vaccine safety activities. In addition the committee recommends that available funding for autism research be channeled to the most promising areas.

Policy Review

At this time, the committee does not recommend a policy review of the licensure of MMR vaccine or of the current schedule and recommendations for the administration of the MMR vaccine.

At this time, the committee does not recommend a policy review of the current schedule and recommendations for the administration of routine childhood vaccines based on hypotheses regarding thimerosal and autism.

Given the lack of direct evidence for a biological mechanism and the fact that all well-designed epidemiological studies provide evidence of no association between thimerosal and autism, the committee recommends that cost-benefit assessments regarding the use of thimerosal-containing versus thimerosal-free vaccines and other biological or pharmaceutical products, whether in the United States or other countries, should not include autism as a potential risk.

The above recommendations noted that because there was an absence of experimental or human evidence concerning a vaccine autism link any such link remained theoretical only. It did not say that there was no possibility of such a link or that such a link had been dis-proven. The recommendations expressly discouraged investigation of a possible autism vaccine link for cost-benefit reasons. The IOM expressly discouraged the type of research that might have provided the evidence that it said was lacking and necessary to establish a vaccine autism link.

The IOM strategy of abandoning investigation of a possible autism-vaccine link has not enhanced public confidence in the safety of vaccines. The denials and insults thrown at leaders of the "vaccines cause autism" camp will only increase the suspicions of those who distrust public health authorities and their assurances that vaccines do not cause, contribute to, or trigger autism.

It is time for the IOM and other public health authorities to investigate and obtain the "experimental or human evidence" to either refute or confirm, in whole or in part, the autism vaccine hypothesis that it referenced in 2004.

It is time to end the autism vaccine war.

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Washington Post Omits Historic Date, Important Information, From Autism Key Dates List

The Washington Post has published a list of Some Key Dates in Autism History. The list has an important omission and is inaccurate or misleading on some controversial assertions. The article also repeats, without qualification, some oft repeated official positions that are not entirely accurate or are subject to serious dispute.

1) 1987 Lovaas Study On Effectiveness of ABA

The article, by Brittney Johnson, makes no mention of the publication in 1987 of the Lovaas study indicating that 90% of children substantially improved when utilizing Applied Behavior Analysis, compared to a control group with close to half attaining normal IQ and testing within the normal range on adaptive and social skills.


2) Alleged Thimerosal Removal

2000 In response to broad government concerns, vaccine makers remove thimerosal, a mercury-based preservative, from all routinely given childhood vaccines.

That statement is not entirely accurate. As stated by Dr. Robert Schecter, lead author of the recent California epidemiological study on rising autism incidence:

"Autism rates increased consistently ... throughout this period, despite the exclusion of mercury from nearly all childhood vaccines,"[Bold highlighting added -HLD]

As for Haley's argument that some children still might be getting some mercury from vaccines, Schechter said that could be true.

"I would not claim that children are getting no mercury from vaccines," Schechter said."

- Lexington Herald Leader, February 4, 2008


3) 2004 IOM Report - No credible evidence of a link between thimerosal and autism . . . or between the measles-mumps-rubella vaccine and autism.


2004: The Institute of Medicine, which advises the government on scientific matters, finds no credible evidence of a link between thimerosal and autism . . . or between the measles-mumps-rubella vaccine and autism.

The 2004 IOM report and the processes used in preparing it have been criticized; including recently by former NIH Head Dr. Bernadine Healy who stated that the IOM expressly discouraged research and investigation of a possible vaccine/thimerosal link to autism and that the IOM report authors did so because of fear of vaccination rejection by the general population. Dr. Healy's contentions appear to be supported by some of the IOM report statements at page 152.

4) Autism Spike

2007: The Centers for Disease Control and Prevention reports autism affects 1 in 150 children. Medical experts say the changed number reflects better detection, broader diagnostic criteria and increased public awareness -- not a spike in the disease.

Some medical experts attribute the spike entirely to diagnostic criteria change and increased public awareness ...... and some do not. Research is continuing into possible environmental causes of autism and their potential contribution to current rates of autism diagnosis.

5) Bettelheim's Refrigerator Mother Theory

1971: Eminent psychologist Bruno Bettelheim promotes the "refrigerator mother" theory, which holds that "cold," unurturing parents, especially moms, are to blame for autism.

The article describes Bettelheim as an eminent psychologist and makes no mention of the fact that his "theory" is totally discredited today .... or to the harm that it caused to families.

All in all, a less than sterling effort by Brittney Johnson and the Washington Post.

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Fomer NIH Head Says Question of Whether Vaccines Cause Autism Has Not Been Answered

Dr. Bernadine Healy, former head of the US National Institutes of Health, has claimed in an interview with CBS News that the question of whether there is a causal connection between vaccines and autism has not yet been answered. There is not yet enough evidence to say that there is no causal connection.

Dr . Healy notes that there have been no major studies of autistic children who developed autistic symptoms shortly after vaccination to see if there is such a connection. Animal Lab tests on mice and primates showing concerns about mercury and vaccine preservatives have been disregarded. Population studies do not test causation the indicate associations. Controlled lab studies are required. Dr. Healy also indicates that an Institute of Medicine (IOM) report in 2004 discouraged investigation of a possible link between susceptibility groups, autism and vaccines. Dr. Healy claims that the IOM report expressed a concern that pursuing the vaccine autism hypothesis would scare the public.

"I think that the public health officials have been too quick to dismiss the hypothesis as irrational," Healy said.

"But public health officials have been saying they know, they've been implying to the public there's enough evidence and they know it's not causal," Attkisson said.

"I think you can't say that," Healy said. "You can't say that."

CBS News has learned the government has paid more than 1,300 brain injury claims in vaccine court since 1988, but is not studying those cases or tracking how many of them resulted in autism.






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