Autism Treatment Study Using ABA and TMS - Repetitive Transcranial Magnetic Stimulation

The University of Louisville has received NIH funding to conduct a clinical trial of an autism treatment that combines magnetic stimulation with ABA therapy. My first reaction when I read about magnetic stimulation as a possible autism treatment was to assume it was some wonky swimming with dolphins type of autism "treatment". But the University of Louisville news release provides an interesting explanation for the theory behind magnetic stimulation as a possible autism treatment.

A previous pilot study had shown that "repetitive transcranial magnetic stimulation (TMS), creates an electric current that enhances specific cells’ ability to protect the brain from sensory overload in one region of the brain". The researchers believe this eases sensory overload permitting greater focus on learning. The new study will use a higher frequency, twice the number of sessions and will also utilize ABA therapy.

Obviously TMS is not, at this time, an evidence based treatment for autism. The only way that new treatments can be developed and acquire an evidence based status is through study and experimentation. I assume that with the involvement of the NIH and the University of Louisville all necessary ethical and safety protocols for the participants will be followed. Hopefully the results will indicate a way to help enhance the learning abilities of persons with autism. As I read the press release the study may also disclose more information generally about brain connectivity issues and autism disorders:

NIH to fund U of L clinical trial of autism treatment

EUREKA award recognizes high impact, innovative research

LOUISVILLE, Ky. – A promising treatment of autism has earned National Institutes of Health funding for University of Louisville researchers. This award will fund a clinical trial that combines magnetic stimulation with behavior therapy in people with autism. Researchers believe this approach will ease major symptoms of autism, which in turn will help participants focus on therapy to improve social interactions.

“This study, which builds on discoveries made here at UofL in the last five years, offers a new kind of hope for people with autism. It has the potential to change science’s way of thinking about autism treatment,” said Larry Cook, UofL executive vice president for health affairs.

“We have focused on using our new understanding of brain function to treat autism, instead of using medications to remediate its consequences,” explained neuroscientist Manuel Casanova.

The $900,000 NIH award will fund a four-year clinical trial.

Casanova and a team of researchers previously mapped the way tiny strands of brain tissue called cortical cell minicolumns develop and connect. Their research suggests that minicolumn defects interfere with information processing because a lack of “sound-proofing” between minicolumns leads to sensory overload, which magnifies underlying social and communication deficits.

A pilot study confirmed that people with autism have fewer tantrums and repetitive behaviors symptomatic of sensory overload after a low-frequency magnetic field is pulsed around their brains through a coil placed near the scalp. This process, known as repetitive transcranial magnetic stimulation (TMS), creates an electric current that enhances specific cells’ ability to protect the brain from sensory overload in one region of the brain.

“Neurological and psychological test results and brain activity measurements tell us that TMS helps with the symptoms that people with autism find most distressing,” Casanova said. “We believe that relief will give them the opportunity to learn to be more social adept and emotionally responsive.”

In this trial, patients will receive a higher frequency of magnetic stimulation and more than twice the number of sessions administered in the pilot study. This treatment will be paired for the first time with applied behavior analysis (ABA) to help participants learn and practice socially appropriate methods of relating to other people.

This study also makes use of new understanding about the brain’s innate connectivity. The brain of a person with an autism spectrum disorder is structured to make short, local connections between minicolumns as it processes information. The TMS treatment focuses on cells in specific regions of the brain and then relies on the cells’ connectivity to communicate the change to other regions.

“This connectivity allows us to train other regions of the autistic brain to manage the noise that causes sensory overload without sacrificing the talents that result from the natural brain structure,” Casanova said.

The National Institutes of Health’s EUREKA (Exceptional, Unconventional Research Enabling Knowledge Acceleration) program funds researchers who are testing exceptionally novel, unconventional research that could yield an extremely high impact on research.

Researchers are targeting children from the Louisville metropolitan area for this trial. Parents who want to inquire about the study should call 502-852-0404.

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An Open Letter to the Globe and Mail: The Vaccine Autism Debate Is Far From Over, The Research Is Not Complete

The following email was sent earlier today to Andre Picard of the Globe and Mail:

I am the father of a 13 year old boy diagnosed with Autistic Disorder assessed with profound developmental delays. I have never attributed his autistic disorder to vaccines or vaccine ingredients although I currently have an open mind on the subject. I was very disappointed with your opinion piece declaring that the vaccine autism debate should end now and that the science is clear. I submitted a comment on that piece listing some of the many pieces of information and evidence that you simply ignored in articulating your opinion. That comment was not accepted for publication by your moderators.

As a "neutral" in the vaccine autism war I would like to see the proper research done to resolve the issues that are very much alive in respect of these issues. Several prominent health authorities have now declared that the epidemiological studies to which you referred and which are used to support claims that vaccines do not cause autism are not in fact specific enough to explore the possible impact of vaccines in causing autism in vulnerable population subsets. These authorities include former NIH and American Red Cross head Dr. Bernadine Healy, recent CDC director Dr. Julie Gerberding and Dr. Duane Alexander, Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), an NIH agency. As of February 24, 2009, as reported at the Huffington Post Dr. Alexander has acknowledged in connection with autism spectrum disorders and vaccines that:

"scientists must investigate susceptible subpopulations of children, including kids with mitochondrial disorders and those who have trouble metabolizing mercury."

Dr. Alexander himself stated in the interview with Autism Speaks' Chief Science Officer, Geraldine Dawson, Ph.D:

"One question (is) whether there is a subgroup in the population that, on a genetic basis, is more susceptible to some vaccine characteristic or component than most of the population, and may develop an ASD in response to something about vaccination. We know that genetic variations exist that cause adverse reactions to specific foods, medications, or anesthetic agents. It is legitimate to ask whether a similar situation may exist for vaccines,"


As you probably know a decision of the US Vaccine Court was released since your opinion was expressed decreeing an end to vaccine autism debates. In Banks v HHS the Special Master accepted the plaintiff's claim that as a result of the MMR vaccination received on 14 March 2000, his child suffered a seizure and Acute Disseminated Encephalomyelitis (“ADEM”) which led to Pervasive Developmental Delay (one of the autism spectrum disorders), a condition from which he continues to suffer. I am sure you are aware of the Poling case in which the government acknowledged that vaccine caused the child's 'autism like symptoms". Autism as you may know is defined entirely by symptoms. CBS has reported that more than 1320 vaccine cases alleging brain injury, some including autism disorders, have resulted in government settlements.

I ask that the Globe and Mail, and you personally, exercise some journalistic balance, and inform the Canadian public, that the Vaccine Autism debate is, contrary to your previous opinion, far from over. Nor does the science make clear your claim that there is no vaccine autism connection. Three senior members of the American public health authority establishment have lent there voices to those of thousands of parents and many health care professionals who want to see the necessary research done to explore these issues.

Research, not the opinion of Andre Picard or the Globe and Mail, will provide the information that will help children, whatever the results of the research.

Respectfully,


Harold L Doherty
Fredericton New Brunswick

cc Facing Autism in New Brunswick

NOTE: As subsequently pointed out by jypsy, the Banks decision itself was made public some time ago and commented on by some involved in autism discussions. The compensation awarded to the injured child was announced last week for that decision.

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Vaccine-Autism War: WHY Won't They Do The Research?

Apart from the many thousands of allegedly hysterical, delusional parents and allegedly fraudulent, huckster professionals who have raised safety concerns, particularly autism concerns, about vaccines two high ranking members of the American public health system have stated a need for more research of possible vaccine-autism connections.

Dr. Julie Gerberding, former head of the CDC and Dr. Bernadine Healy, former head of the NIH and the American Red Cross have BOTH indicated that more research of vaccine-autism issues COULD and SHOULD be done.

So WHY are public health authorities like the Interagency Autism Coordinating Committee REFUSING to authorize funding to research possible vaccine-autism connections?

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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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Has Thimerosal Actually Been Removed From Vaccines? If Not, Of What Value Are the Epidemiological Studies?

Are the epidemiological studies relied upon by public authorities to refute assertions that the mercury based vaccine preservative thimerosal is responsible for some or all autism cases reliable?

These studies tend to show that autism rates did not decline after removal of thimerosal from vaccines. This past year the epidemiological defense of vaccines took a hit with the Poling case and with assertions by Dr. Bernardine Healy, a former director of the American Red Cross and the US National Institutes of Health, that the necessary clinical research to refute such a connection had not been done, particularly into subsets of children who might be genetically vulnerable or prediposed to develop when autism triggered by mercury or other toxins? Dr. Healy stated in Fighting the Autism-Vaccine War, US News & World Report, April 10, 2008, that:

“vaccine experts tend to look at the population as a whole, not at individual patients. And population studies are not granular enough to detect individual metabolic, genetic, or immunological variation that might make some children under certain circumstances susceptible to neurological complications after vaccination.

She also stated, amongst other points, that:

thimerosal crosses the placenta, and pregnant women are advised to get flu shots, which often contain it.

I find that last statement very troubling. If the epidemiological studies are based on the premise that thimerosal has been removed from vaccines and in fact they have not then what is the probative value, if any, of the epidemiological studies? Particularly given the pregnancy context cited by Dr. Healy.

I am only a humble small town lawyer in Fredericton, New Brunswick, Canada but my concern is prompted in significant part by the information provided by a prominent and accomplished member of the US medical establishment. Other credible sources also lead me to the same concern about whether thimerosal has, or has not, been removed from vaccines as claimed in the public health authorities' refutations of vaccine-autism connections.

As of this posting the web site of the US Food and Drug Administration states: Over the past several years, because of an increasing awareness of the theoretical potential for neurotoxicity of even low levels of organomercurials and because of the increased number of thimerosal containing vaccines that had been added to the infant immunization schedule, concerns about the use of thimerosal in vaccines and other products have been raised. Indeed, because of these concerns, the Food and Drug Administration has worked with, and continues to work with, vaccine manufacturers to reduce or eliminate thimerosal from vaccines.

Thimerosal has been removed from or reduced to trace amounts in all vaccines routinely recommended for children 6 years of age and younger, with the exception of inactivated influenza vaccine (see Table 1). A preservative-free version of the inactivated influenza vaccine (contains trace amounts of thimerosal) is available in limited supply at this time for use in infants, children and pregnant women. Some vaccines such as Td, which is indicated for older children (≥ 7 years of age) and adults, are also now available in formulations that are free of thimerosal or contain only trace amounts. Vaccines with trace amounts of thimerosal contain 1 microgram or less of mercury per dose.

The above, current statements from the US FDA, raise several concerns for me:

1) Theoretical potential for neurotoxicity of even low levels of organomercurials

The use of the term "theoretical potential for neurotoxicity" tells me that potential toxcity of organomercurials has NOT been definitively ruled out by the FDA. I appreciate that the expression is used in an historical context to explain the decision to remove mercury based preservatives from vaccines but surely the FDA web site would have immediately stated after that comment that there was no longer even a theoretical potential if such were the case.

2) continues to work with, vaccine manufacturers to reduce or eliminate thimerosal from vaccines.

Again, this information is taken from the web site of the US FDA as it exists today. Why are they continuing to reduce or eliminate thimerosal from vaccines if the epidemiological studies were based on the premise that thimerosal had already been removed? I appreciate that some of the studies are from other countries but have those countries all completely removed thimerosal from vaccines? If so, why were those other countries able to completely remove thimerosal when the US can not?

In the United States a study by the California Department of Health released in February 2008 found that autism rates remained steady after the removal of thimerosal from vaccines. That study conclusion was qualified though by Dr. Robert Schechter, a health officer with the California health department and lead author on the report of the study as reported in the Lexington-Herald, February 5, 2008:

As for Haley's argument that some children still might be getting some mercury from vaccines, Schechter said that could be true. But he said the general removal of thimerosal from vaccines still should have caused autism rates to fall -- if mercury were the culprit in the disease. "I would not claim that children are getting no mercury from vaccines," Schechter said. "But the average exposure for the population has been substantially decreased over the past decade. If mercury from vaccinations was a primary cause of autism, you would expect rates to be dropping substantially."

Substantial decrease is not the same as total removal of mercury from vaccines. The California epidemiological study, at least, is not based on removal of mercury from vaccines.

3) Trace amounts

The FDA site, as quoted above, states that vaccines with trace amounts of thimerosal contain 1 microgram or less of mercury per dose. That certainly sounds like a very small amount and the implication appears to be that the amount is too small to have any effect. But the FDA also referred to the theoretical potential for neurotoxicity of even low levels of organomercurials.

It seems dubious to claim that epidemiological studies show no autism increase after removal of mercury-thimerosal if all elements of the material have not in fact been removed when the potential for neurotoxicity is recognized even in small amounts. Partcularly since the FDA, as stated above, considers vaccines with trace amounts to be vaccines with the mercury removed:

A preservative-free version of the inactivated influenza vaccine (contains trace amounts of thimerosal) is available in limited supply at this time for use in infants, children and pregnant women.

Why leave trace amounts in the vaccines to begin with? If trace amounts of thimerosal can still have a preservative effect on bacteria in the vaccines then why can't they also have a neurotoxic effect on children receiving the vaccines? And some of the flu vaccines, the ones not considered thimerosal free, contain more than trace amounts of thimerosal.

I am not a medical authority and do not pretend to be. Nor do I claim that vaccines or thimerosal cause autism. As some one who does earn his living by some degree of critical thinking and analysis I find the statements of public health authorities about epidemiological studies refuting a vaccine-autism link open to question.

Their own statements appear to contradict their claims that the studies refuting a vaccine-autism link are based on periods when thimerosal was removed from vaccines.

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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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Autism Consultation: US (Transparent) v Canada (Secretive)

Lisa Jo Rudy, host of About.com Autism posted a comment informing the public that the National Institute of Health (NIH) wants public feedback on autism research issues. In The NIH Wants YOU to Provide Recommendations for Future Autism Research! Ms Rudy provides the following information:

"Do you have specific ideas or direction for the NIH, as it implements the Combatting Autism bill? If so, now is the time to take action. The NIH has just issued an "RFI" (request for information) to the autism community, and they are seeking your input on next steps for research. Here's the essential information: Description

The purpose of this time-sensitive RFI is to seek input from ASD stakeholders such as individuals with ASD and their families, autism advocates, scientists, health professionals, therapists, educators, state and local programs for ASD, and the public at large about what they consider to be high-priority research questions."

As a Canadian active in autism advocacy I am impressed with the American openness and true public consultation as reflected in the above referenced Request for Information. By contrast I am disgusted with the secretive, elitist, and politicized approach taken by the Canadian Institute of Health Research. In Canada the CIHR cancelled a planned National Autism Symposium when it found out that autism parent advocates wanted to play a real part in the symposium. It was rescheduled and described as a "research" symposium, with secretive, limited invitees, and with the implication that the parents who live 24/7, 52 weeks a year with autism realities could not possibly offer any intelligent contribution to the discussion. Oh Canada, we can do better than that.

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