Recently, there has been a brewing controversy surrounding a journal called American Journal of Bioethics (AJOB), a company called CellTex, a bioethicist named Dr. Glenn McGee who founded and used to run AJOB until he recently resigned, and two University of Minnesota professors, Drs. Carl Elliott and Leigh Turner who have been publicly critical of Celltex and/or McGee.
Dr. Elliott wrote a piece in Slate, later retracted, that discussed McGee and Celltex.
Dr. Turner, wrote a letter to the FDA describing his concerns about Celltex.
Recently Nature magazine chimed in with an extremely critical piece of their own on Celltex called The darker side of stem cells. It is unclear if Nature has been contacted by Celltex in response to the piece. The Minnpost also published a piece.
Now reportedly Celltex is flexing its potential legal muscle in response according to a piece on Pharmalot. Celltex has written to the FDA and The University of Minnesota trying to counter the claims of Drs. Elliott & Turner.
I’m not an expert on Celltex nor particularly familiar with their business so I won’t comment on that.
However, I will say that Drs. Elliott and Turner are highly respected, serious scientists and are not known to publicly raise frivolous concerns about companies. From the feedback from my readers on this blog, which includes key members of the international stem cell community, they support these scientists.
Let me say unequivocally, I respect and support Drs. Elliott and Turner.
Interestingly, someone calling him Glenn McGee (who most likely is the real guy) posted a comment on the Pharmalot piece that is quite scathing:
The following statement, which was also in the Slate article and among the false statements that caused Carl’s article to be retracted, has been repeated again, so I will again correct the record. The article states: “RNL Bio, which has marketed its stem cell treatments in various countries, made headlines nearly two years ago after patient deaths were reported in China and Japan. The International Cellular Medicine Society conducted a review, co-headed by McGee, which largely exonerated RNL.” I did not co-head a review for ICMS of anything at any time. I did not participate in a review of deaths associated with RNL. I did not evaluate a review of deaths associated with RNL. I conducted a review, by myself, FOLLOWING the actions of ICMS. From the ICMS’ web page “Follow Up Ethics Review of RNL” (http://www.cellmedicinesociety.org/home/news/latest/319-follow-up-ethical-review-of-rnl-bio ): “ICMS initiated an on-site evaluation of ethical and clinical practices of RNL Bio, conducted by Dr. Glenn McGee, John B. Francis Endowed Chair of Bioethics at the Center for Practical Bioethics.”
This review may not please you, but what it decidedly does not do is exonerate RNL. It required a total change in the way RNL would have to do business, relate to physicians and engage ethical requirements. The document states that RNL had not created a system to ensure that risks and benefits were explained to anyone, and gave a standard for risks and benefits. It said that physicians can no longer be employees or RNL. It said that physicians removing adipose cells must have general medical training not the highly restricted training they had had, and it also said that prospective patients must see a physicians in the specialty of their diagnosis before any notion of receiving cells is on the table. Said physician I argued must also be trained in MSCs and relevant clinical issues. I disallow the use of a “we just bank” excuse for failing to have such conversations or failing to ensure that there is no therapeutic misconception, and I say point blank that the entire RNL system using “Codi” salespersons must be scrapped in favor of physicians capable of getting real informed consent and who must understand it. I said that there should be ethnographic study of the knowledge of those who consent to banking, and that it should be evaluated not by the company but by peer reviewed journals like Hastings. Gosh you can imagine how thrilled RNL was to receive that “whitewash” that “exonerated” the deaths I didn’t investigate.
I hope it is not too much to expect a correction, Mr. Silverman. Furthermore, I did not state that Mr. Turner caused me to resign from Celltex. Mr. Turner has caused me to wonder how it is possible that the University of Minnesota allows professors to spend all day tweeting, but little more. You will correct your assertion as to why I resigned, unless you can read my mind better than can I.
This controversy is likely to get worse before it gets better.