DoNoHarm: Is It Lies or Is It..... um, Lies...

I sent the following letter to five of the seven esteemed founders of the site DoNoHarm today. The founders are:

Kevin FitzGerald, SJ, PhD
C. Christopher Hook, MD
Ralph Miech, MD, PhD
Robert D. Orr, MD
David A. Prentice, PhD
Frank E. Young, MD, PhD
Joseph Zanga, MD, FAAP

Click here to see the "fact" sheet in question, and click here to see the studies cited to support the whacked out assertion that adult stem cells are being used to treat Parkinson's.

Dear Sirs,

I am writing to make you aware of gross inaccuracies in the Parkinson’s “fact” sheet on the DoNoHarm site and to request that Parkinson's be removed from the site's list of disease being treated with adult stem cells, as it is not being treated with adult stem cells.

The ESC (embryonic stem cell) research section is actually not bad. The five studies cited a) were actually published, b) had a suitable number of subjects, c) actually used ESCs, and d) resulted in improvement, benefit, and alleviation of symptoms to some degree in each and every instance. There are always obstacles that need to be resolved when an area of medical research is in its infancy, as ESC research is, and it is actually quite encouraging that tumors only developed in two of the five studies listed.

However, the ASCs (adult stem cell) section is all wrong, and I mean that quite literally. Of the seven items listed, four do not utilize ASCs at all, one cannot be said to be a study, never mind a treatment, and one cannot be verified at all as it is not clear it has been published. The seventh item actually is a published study, and it actually used ASCs, but being a study cannot be put forth as supporting a claim of “”treatment,” not to mention the fact that the study concludes that more study is necessary.

I will be more specific.

The 2003 study by Gill examined the effect of a neurotrophic factor - GDNF, to be exact - on people with Parkinson’s. The 2005 pathology follow-up to the Gill study by S. Love revealed that the brain treated with GDNF showed signs of neuronal sprouting. GDNF is not ASCs. Likewise, the 2000 Fallon study utilized a “growth protein,” not ASCs.

Further, the 2002 Akerud study did not use ASCs, either. As it says in the study, “To stably deliver PSP in vivo we engineered a c17.2 NSC line,” and the C17.2 NSC (neuronal stem cell) line was derived from “neonatal mouse cerebellar external germinal zone cells.” (jvi.asm.org) Now, technically, the neuronal stem cells are not embryonic, but somehow I don’t think any of you would condone the use of neonatal human cerebellar external germinal zone cells, either - would you? [It is with great embarrassment that I add, after the fact, that this was an animal study, to boot.]

These studies should be removed from the “fact” sheet first of all because they do not even evaluate ASCs for their therapeutic potential, never mind constituting ASC-based "treatments" for Parkinson's.

The inclusion of Dr. Levesque’s work is problematic on several levels. First, to date, Dr. Levesque has merely presented his work at a conference - he has not published his completed study results in a peer-reviewed journal. Secondly, the results he presented to the conference (his only known results) were based on observations of a single subject - as all of you are well aware, one subject is not a meaningful data source. Moreover, because there was only one subject, the study could not have been double blind, placebo (or sham surgery) controlled. Each of these concerns taken on its own is cause for removing this information from the ”fact” sheet.

Taken together, the inclusion this information as a “treatment” in the “fact” sheet is baffling. This information should be removed.

I am unable to confirm the information said to have been presented to the Japan Neurological Society by Okayama University in 2001, as the only corroboration provided is a newspaper article, as opposed to, say, a study published in a peer-reviewed journal. This information should be removed.

Thus, the 2004 Mari Dezawa study is the only item that actually used ASCs on a meaningful number of subjects and was published in a peer-reviewed journal. However, given that it was a study, and especially given that it concluded that “further studies are needed...to ensure the long-term safety and efficacy of manipulated MSCs,” to call it evidence of ASCs “treating” Parkinson’s disease is grossly premature. [Again, it is with great embarrassment that I add, after the fact, that this, too, was an animal study.]

The fact of the matter is that there are no treatments for Parkinson’s utilizing ASCs. I wish there were. But until there are, if credibility is at all important to you, you will make sure that all the DoNoHarm's claims to that effect are removed from the site.