Wednesday, March 14, 2012

Stem Cell Treatment Monitor calls on McGee to clear the air and explain his review

Doug Sipp's Stem Cell Treatment Monitor was the first to notice the troubled connections between RNL Bio, Celltex, and Glenn McGee, especially McGee's bioethical review of RNL Bio in 2010, following the deaths of two patients.  In his latest post, "Celltex lawyers up," Sipp calls on McGee to explain himself.  He writes:

"And just as Celltex could do right by making a full disclosure of its practices, now that McGee has quit the company, the editor-in-chief role at AJoB, his position at the Center for Practical Bioethics, and his position on the board of directors at the ICMS, he could certainly use his inside knowledge to help clear the air and make a valuable contribution to understanding the factors at play in this contentious case by providing verifiable documentary evidence detailing:

The official positions of RNL staff members and others he spoke with in developing his findings (i.e., whether he had unfettered access)

The nature of questions he asked and data he examined during the course of his investigation, and the nature of the responses on the part of RNL Bio representatives (i.e., whether he performed due diligence).

Specifically, whether he questioned the company regarding the justification for performing thousands of clinical interventions (many of which were for nebulous "anti-aging treatments" that were not supported by scientific evidence and outside the context of regulated clinical trials , and if so, the nature of their responses.

Whether he had access to full English translations or bilingual versions of regulatory, procedural and informed consent documents, and other important primary data (many of which presumably were originally in Korean).

Whether he consulted any outside, independent experts not linked to the RNL Bio case or ICMS in developing his recommendations.

Whether he is aware of the reasons for RNL Bio's non-compliance with the various ICMS recommendations; specifically, whether RNL refused to pay pay the "the negotiated, onetime, per patient procedure fee of $50" required by ICMS for participation in its Complications Treatment Registry program. (Presumably this would have cost RNL Bio $400,000 or more to register the 8,000+ patients it is reported to have treated.)

Whether he or members of his family subsequently received direct or indirect income or other financial considerations as representatives of the Center for Practical Bioethics (an NPO with which McGee and his wife were both affiliated at the time of his investigation) to conduct comprehensive ethics training, and if so, at what amount(s), for subsequent consulting or other services."

His full post can be found here.

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