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

Posted Oct 14 2012 12:52pm

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.
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