Autism Stem Cell Treatment Research: Who is the Real Quack? Gorski (ORAC) or the FDA?

Real Quackery: Duck Flapping and Splashing  

Photos by HLDoherty 

In any commentary in which I dare question the self appointed protector of all things scientific, the ORACle known as Dr. David H. Gorski,  I have to begin with the statement that I recognize the public health importance of vaccines and that both of my sons, and I for that matter, have received all vaccines recommended by our local public health authorities in New Brunswick.  This statement is necessary because Dr. Gorski almost invariably alleges that anyone who questions the wisdom he brings down from the mountain top for us, the ignorant unwashed, is really just a closet anti-vaxxer.  I don't think vaccines are perfect though and it is my understanding that neurological damage has been caused by some vaccines in some individuals. I am aware also that Dr. Bernadine Healey had recommended further study of possible vaccine autism connections before her death ... and that some had vilified her for doing so.

Yesterday I commented on the fact that the FDA had approved a study to determine whether umbilical cord blood derived stem cells might be effective tools in treating autism. The article I quoted from contains some professional quotes indicating that the study is well designed and also contained a number of quotes expressly indicating that it is a very PRELIMINARY study.  I was happy to see research aimed at establishing or assessing possible treatments for autism disorders.  I was also happy that the study was, as reported in the article, approved by the US FDA.  To my thinking, as a humble autism dad,  FDA approval confirmed that the study would be conducted by appropriate guidelines, professionally and ethically. My commentary attracted a comment from MJ, author of the Autism Jabberwocky blog:

"Did you notice that the self-appointed high priest of science wrote (at least) two pieces on stem cells and autism? In the first he calls it quackery because it isn't evidence based and in the second says that studying the issue at all is unethical. He really seems to want to have it both ways. No treatments without proper research, which is reasonable, but no research because there is no evidence that it would work...."

I think MJ has made an excellent point.  How are we supposed to determine what is evidence based, effective treatment for autism or any other disorder, if no research is done to determine effectiveness?

Gorski`s objection to the ethics of a preliminary study of stem cells in treating autism disorders is set out in Is a trial of stem cell therapy in autism scientifically and ethically justified? :

``Think of it this way: Do you think that the evidence implicating a hyperactive immune system is strong enough to justify treating autistic children with prednisone? Cyclosporine? Other immunosuppressive drugs? If not, then why would anyone advocate using autologous stem cells, which appear to be immunosuppressive? Why on earth would an institute like the Sutter Neuroscience Institute carry out such a trial based on low prior probability? What sort of preclinical evidence did they have to justify this trial? The scientists in the article who say that the likelihood of a positive result from this trial is low are, if anything, too optimistic. The likelihood of a positive result is almost homeopathically low. When it comes to clinical equipoise, this trial looks to me as though it’s all risk with too little prospect of benefit to be justifiable without a lot more clinical evidence.``

While he is notorious for splashing for attention by flapping his wings and quacking out cheap insults at those who disagree with him, I have no doubt that surgical oncologist Dr. David H. Gorski (ORAC) is much better placed than I am to assess the ethical basis for conducting this preliminary study.   He questions the internal review board (IRB), apparently unknown to him at the time, in  a reasonably courteous, serious  manner.  What is not really clear from Gorski's comments is whether he would ever view any autism treatment study as justifying  supervision by an IRB or approval by the FDA.  In the comment linked above he did state with reference to pharmaceutical companies seeking drug approval:

"Similarly, any private entity (such as a pharmaceutical company) seeking FDA approval for its drug or device have to register with the FDA and abide by the Common Rule, whose most important set of rules mandate IRB approval and monitoring of the research. Some states also mandate that all human subjects research carried out within their borders, regardless of funding source, must abide by the Common Rule."

Since there is an IRB in place for this preliminary study, and since the FDA has given its approval for it to proceed, I assume Dr. Gorski (ORAC) will, if he has not already done so, acknowledge that this study is being conducted in accordance with recognized public health authority backing. As a mere layperson I assume that the US FDA has conducted the usual inquiries and that they are best placed, even better placed than surgical oncologist and autism expert Dr. Gorski, to determine the ethical appropriateness of the study. 

I assume that Dr. Gorski who feels FDA approval is a comforting requirement for  approval of new pharmaceutical company drugs or devices is also comforted by the FDA approval of the stem cell preliminary study. Surely he does not now consider the FDA to be governed by the quacks he so detests?

Regardless, if Gorski, the FDA or any other health professional or authority is simply going to ridicule and dismiss attempts to conduct any research into possible autism treatments and cures they will simply lose credibility with many autism parents when they try to convince them that they should stick with evidence based treatments for their autistic children.  That is not quackery. That is reality.

FDA Approved Stem Cell Autism Treatment Preliminary Study

I was surprised to see that a preliminary study of stem cell treatment of autism disorders is proceeding with FDA approval in the United States.  Stem Cells as possible treatments for autism have been mentioned for some time but have been subjected to disparaging commentary for several reasons including the usual anti cure attacks from Neurodiversity self interest groups. To see a preliminary study actually examining a possible source of treatment and cure for autism disorders is startling.  To see such a preliminary study receive FDA approval and thereby receive some protection from the anti cure autism extremists and self anointed protectors of the one true science at Respectful Insolence and similar sites is almost shocking.

Philly.com carries a HealthDay article by Mary Brophy Marcus, Could Stem Cells Treat Autism? Newly Approved Study May Tell  which indicates that: 

"Thirty children with the disorder, aged 2 to 7, will receive injections of their own stem cells from umbilical cord blood banked by their parents after their births. All of the cord blood comes from the Cord Blood Registry, the world's largest stem cell bank. Scientists at Sutter Neuroscience Institute, in Sacramento, Calif., said the placebo-controlled study will evaluate whether the stem cell therapy helps improve language and behavior in the youngsters."

The article  is careful not to over hype the study emphasizing that although it is a well designed study it is still a preliminary study which will in effect help decide whether further such studies concerning stem cell treatment of autism are warranted and that it is very early in this process.  The article also points out that there are mixed views  with some researchers being skeptical about the value of stem cells in treating autism. 

The cautions expressed are  helpful to my mind.  Those who oppose research that might lead to knowledge of autism causation, or to treatments and cures will seize on any excuse to attack and derail such research.  The disciplined, professional approach will help ward off such attacks.  In the end we should ALL want proper procedures, proper protocols to be followed to ensure that ANY results, positive, negative or neutral to anyone's perspective can be relied upon.

Personally, I am very happy that there is actual  research being done, in proper fashion, by credible professionals, under appropriate authorization aimed at finding treatments and cures for autism disorders. After years of  pointless, meandering,  autism research it is encouraging to see researchers who still live in the real world, who do not view parents as the enemy, and who realize that despite the protests of a few very high functioning persons  autism disorders are very debilitating, limiting and even dangerous for many who suffer from them.  Autism disorders require treatment as advocated by parents seeking treatment and cure for their children and for those who suffer from them and want treatment and cure for themselves.  Let the research be done and be done properly. 

FDA Warns of Possible Autism and Depakote Link

The Dow Jones Newswire today reports an FDA warning of a possible link between autism and Depakote, a drug used to treat seizures, migraines and bipolar manic episodes:

In a review of Depakote, the agency said it identified six reports of developmental delay in children that were not related to birth defects, including two cases of autism in one family. However, the agency said, "other factors such as genetic and environmental factors may have played a role, especially in the two sibling cases coded as autism."

Agency staff said birth defects are well described in the drug label, but said developmental delays and learning disabilities are not mentioned.

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US Regulators FDA and EPA Cover Up Chemical Dangers

Warning: Chemicals in the packaging, surfaces or contents of many products may cause long-term health effects, including cancers of the breast, brain and testicles; lowered sperm counts, early puberty and other reproductive system defects; diabetes; attention deficit disorder, asthma and autism. A decade ago, the government promised to test these chemicals. It still hasn't.

Chemical Fallout: A Journal Sentinel Watchdog Report

Autism is certainly not the only possible negative consequence of the untested chemicals which surround us and lurk inside each of us. Anyone interested in getting up to speed quickly on these common dangerous products and how protective agencies such as the FDA and the EPA failed their responsibilities and subordinated their roles to the companies that manufactured and profited from these harmful materials should consult the Milwaukee Journal Sentinel On Line Series, Chemical Fallout, which has been published over the past year and a half.

In a recent entry published May 16, 2009 the JSOnline reports direct evidence of the degree to which the FDA worked hand in hand with the chemical industry lobbyists and failed to protect the public:

"As federal regulators hold fast to their claim that a chemical in baby bottles is safe, e-mails obtained by the Journal Sentinel show that they relied on chemical industry lobbyists to examine bisphenol A's risks, track legislation to ban it and even monitor press coverage.

In one instance, the U.S. Food and Drug Administration's deputy director sought information from the BPA industry's chief lobbyist to discredit a Japanese study that found it caused miscarriages in workers who were exposed to it. This was before government scientists even had a chance to review the study.

"I'd like to get information together that our chemists could look at to determine if there are problems with that data in advance of possibly reviewing the study," Mitchell Cheeseman, deputy director of the FDA's center for food safety and applied nutrition, said in an e-mail seeking advice from Steven Hentges, executive director of the trade association's BPA group.

The FDA relied on two studies - both paid for by chemical makers - to form the framework of its draft review declaring BPA to be safe.

The Journal Sentinel reported last year that the trade group wrote entire sections of that draft. But the revelations contained in these e-mails show a pattern of preferential treatment over the past nine years that was not afforded to independent scientists."

If anyone thinks there is no such thing as conspiracies they should read the JSOnline series and think again. Dangerous chemicals inhabit our bodies and the bodies of our children. And regulatory agencies in the US have worked with the chemical industry lobbyists to prevent the public from knowing of these dangers.

Following are links to articles in the JSOnline Series Chemical Fallout:

Bill would ban BPA in baby products

FDA relied heavily on BPA lobby

BPA leaches from 'microwave safe' products

EPA veils hazardous substances

Plastics industry behind FDA research, study finds

Donation raises questions for head of FDA’s bisphenol A panel

EPA fails to collect chemical safety data

Hazardous flame retardant found in household objects

EPA drops ball on danger of chemicals to children

Are your products safe? You can't tell.

autism

Vaccine-Autism War: Globe & Mail's Andre Picard Decrees Vaccines Safe

Andre Picard of the Globe and Mail has decreed that vaccines do not cause autism. In Picard's own words:

Vaccines do not cause autism.

The science proving this point has been quite clear for a number of years.

There is nothing new in Picard's decree. He relies on the recent vaccine court decisions and resorts to the usual demeaning dismissals of parents and professionals who express concerns about vaccines:

That's because a whole industry of hucksters has sprung up to promote alternatives to vaccines, and the vocal (and Web-savvy) minority of conspiracy theorists will see these thorough, thoughtful rulings as, well, just another part of the conspiracy by Big Pharma to poison kids for profit.

I submitted a comment about Picard's opinion piece to the Globe and Mail but it was not accepted as a comment on the moderated opinion section. I did not insult Mr. Picard or use any inappropriate language. What I did do was:

1) point out that there have in fact been thousands of settlements of vaccine lawsuits where brain injuries and neurological damage including autistic like symptoms have been claimed and that the US government has paid to settle those claims and that there have been many reports in learned journals informing of serious vaccine reactions;

2) point out that in the Poling case which the government settled the government (former CDC head Dr. Julie Gerberding) acknowledged that the vaccine could result in autism like symptoms);

3) point out that Dr. Bernadine Healy has stated that the studies which did not find a vaccine-autism connection were epidemiological studies which were not able to examine possible vaccine-autism results amongst vulnerable population subsets;

4) point out as Dr. Healy stated in 2008, as researcher Teresa Binstock did in 1999 and as shown at p. 152 of the IOM Vaccine Safety Report (2004) and in the recent cancellation of vaccine-autism studies by the Interagency Autism Coordinating Committee (2009) that government health authorities have actively discouraged and suppressed the type of research which might show a vaccine-autism connection amongst some population subsets;

5) point out that Dr. Julie Gerberding has stated that studies of unvaccinated children have never been done but could and should be done;

6) point out that contrary to Andre Picard's claim, and the frequently stated claim that thimerosal has been removed from all children's vaccines the FDA web site says otherwise:

(FDA Website: "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").

I also put on the record for the Globe and Mail, in my rejected comment submission, that I am the parent of a 13 year old autistic boy who has never attributed his autism to vaccines. I have changed my mind from the belief that a vaccine-autism connection has been disproved to being undecided.

I am undecided because of the facts set out above. If Andre Picard and the Globe and Mail wish to dismiss me as a conspiracy theorist fine but they should rebut the facts that I have set out in this comment or show that my reasoning in relation to those facts is flawed.

Of course they can use their bully pulpit to issue Picardian decrees about vaccine safety and simply ignore facts and reason.

And they can still continue to pretend to be journalists while they are at it.


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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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Environmental Causes of Autism - It Is Time To Get The Research Done

The new UC Davis Mind Institute study indicating the likelihood of environmental factors in the dramatic increases in autism cases in California is a step forward in the still developing autism research paradigm shift that investigates autism disorders and their causes from the perspective that autism is caused by a combination of environmental influence and genetic vulnerabilities:

Autism research is poised for another paradigm shift, from an irreversible condition to a treatable disease. In the revolutionary paradigm, autism is not a rare disorder with a constant rate but frequent condition with a rising incidence. It is a combination of environmental influence and genetic vulnerabilities. It is both preventable and treatable, not by any one method but by a combination of behavioral and biomedical approaches. Autistic kids are not defective, they are sick but otherwise normal kids, and thus, recoverable. 

University of Minnesota, Press Release, July 2007

The move to a combined environmental-genetic research model seems to be long overdue. The vaccine-autism controversy may well have pushed public authorities away from possible environmental causes of autism generally but it is difficult to understand why anyone ever assumed that autism is entirely genetically determined. In a December 2007 interview piece published on TimesOnLine, Freedom of Expression, Professor Simon Baron-Cohen made the following salient observiation:

Studies of twins have established that it is not 100 per cent genetic, since even among identical twins, when one has autism, the likelihood of both twins having autism is only about 60 per cent. This means there must also be an environmental component, but what it is remains unknown. 

The vaccine-autism controversies have generated entrenched positions and ideologies on all sides of those controversies.  One of the unfortunate tendencies has been a tendency to berate and ridicule any mention of possible environmental causes of autism disorders. Another has been a focus on genetic research to the near exclusion of environmental factors.  That has begun to change, as called for in the University of Minnesota 2007 press release but the change is not as fast as it could be.  

The vaccines we give children still contain the mercury based preservative thimerosal, according to the FDA web site and children are exposed to a variety of toxic materials in toys and jewelry including mercury, lead, and arsenic.  If specific environmental factors are causing or contributing to autism, whether in isolation, or in concert, then preventative measures can be taken and research into curing autism can, and should,  incorporate those factors.

It is time to drop the rigid, ideological belief that autism is 100% genetic and get the environmental research done to help our children.

autism

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.

autism