Tuesday, August 6, 2013

What Really Cured Ted Harada?

Note: Mr. Harada correctly pointed out on Twitter that he is not cured. I concur and apologize but it's too late for me to change the title. This does not take away from the spirit of the original message. (8/28/13)

This is a question that must be asked because nobody seems to really know for sure. Ted Harada, an ALS patient, experienced a miraculous recovery after undergoing stem cell treatments in 2011 and 2012 as part of an FDA-approved trial. Neuralstem Inc., the company that derived the stem cells from the spinal cord tissue of a fetus, wasted no time in capitalizing on the apparent success of their technology. Ted Harada became an overnight celebrity.

But not everybody is convinced that Ted Harada got well as a result of the stem cell injections. Some people pointed out that Harada's improvements occurred too quickly after the procedures. The neurotrophic factors in the stem cells do not work that fast. Others noted that his improvements did not correspond to the areas of his spinal cord that received the stem cells. Dr. Angela Genge of the Montréal Neurological Institute and Hospital, expressed doubts according to a January Alzforum article, "suggesting that any benefit might have resulted from the immunosuppressant drugs the participants received, that is, their ability to quell neuroinflammatory pathology."

Dr. Genge had, so to speak, thrown a huge fly in Neuralstem's ointment, so much so that, in May of this year, Neuralstem CEO, Richard Garr was forced to make an interesting admission on his blog:
It is also possible that an “unknown unknown” is responsible for Ted’s long term improvement and the stabilization of the other patients. The argument here is that just because WE can’t figure out what else it might possibly be, doesn't mean there isn't another explanation. However unlikely we feel this could be, it is why large, well-controlled trials are always required and justified. We need to continue and enlarge our clinical trials to refute this argument.
Indeed, in July, Dr. Jonathan Glass and Dr. Christina Fournier of the Emory ALS Center announced plans for a new study in order to eliminate the possibility that Ted Harada might have been cured by the immunosuppressants (anti-rejection drugs) that he received as part of the stem cell procedures. But those of us who have followed ALS research over the years know that it's a useless trial because the outcome is already known: immunosuppressing drugs have already been shown to be ineffective against ALS. So why the study? In my opinion, it's really Mr. Garr's way of calming the fears of his company's investors. Garr plans to wrestle that straw man to the ground and declare victory. He'll be able to triumphantly announce at the next shareholders meeting, "You see, we told you it was our stem cells that cured Ted Harada."

If I were a Neuralstem investor, this is where I would raise my hand and ask, "Uh, are you really sure about that?" I mean, did not Ted Harada receive another powerful immune suppressing drug that has not been tested in this latest study? But of course, he did. Mr. Harada was anesthetized for 5 + hours during each procedure. In other words, he received a massive dose of anesthetics in order to keep him completely immobilized during the delicate operation. Most anesthetics have powerful anti-inflammatory properties. Several ALS patients have asked Mr. Harada to reveal the type of anesthetic he received but he declined to do so. No matter. We can guess that it was probably sevoflurane, isoflurane or a similar volatile anesthetic. Why? Only because these are the anesthetics of choice used to keep a patient perfectly immobilized. So why did those in charge of the new study omit the anesthetics from the list of immunosuppressing drugs to be tested? I am asking because both Glass and Fournier were aware of reports that some ALS patients are seeing improvements after undergoing anesthesia. What's up with that? Inquiring shareholders and all that.

Something smells fishy at the Emory ALS Center in Atlanta, Georgia. One wonders what CEO Richard Garr has to say about all this. Join the discussion.

See Also:

The ALS/Anesthetics Hypothesis
ALS Anesthetics Prediction Confirmed: ALS Patient Sees Major Improvements from Sevoflurane

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