Celltex lawyers up

The Celltex/Glenn McGee/AJoB/RNL Bio/ICMS fiasco has snowballed into a much bigger story than I ever expected it would back when I first blogged about it in January. This is largely thanks to the efforts of Carl Elliott and Leigh Turner, both of whom are faculty members of the Center for Bioethics at the University of Minnesota. Elliott published a detailed article of the situation in Slate, with explanations of why the relationship between Glenn McGee (who was listed as editor in chief of the American Journal of Bioethics for at least part of the time that he was serving as president of ethics and strategic initiatives at Celltex) raised legitimate conflict of interest concerns. I for one share in Elliott's views, but Slate retracted the story following allegations of factual error and defamatory content by David Eller, the millionaire who serves as Celltex CEO (to which Elliott sent a rebuttal), and later by a law firm hired by McGee (which I also blogged about here).

Threatening academics with litigation since 2012.

More recently, a different law firm, representing Celltex, has sent a letter to the office of the president of the University of Minnesota making similar complaints about a letter that Ellliott's colleague Turner had sent to the FDA raising concerns about Celltex's activities. This has been covered extensively elsewhere, so I encourage readers interested in the details to read Turner's letter to the FDA, the complaint from the Celltex attorney, and a number of accounts of the legal threats that have been published elsewhere (Pharmalot has the most extensive writeup; others can be found here, here, and here). For the record, I think that both Elliott and Turner should be commended and supported by their university and the community at large for their courageous critiques. 


Celltex's carping over Turner's use the word "administer" in particular seems to be a dodge around larger problems alluded to by Turner and exposed in the excellent investigative work of David Cyranoski at Nature, who found that Celltex not only supplies cells to at least one local physician for unapproved uses, but in fact pays him a $500 commission for each use. (To my knowledge, there have been no threats of legal action against Nature for this or other articles it has published about the Celltex affair, suggesting this apparently litigious company accepts them as factual and true). So, rather than resorting to legalistic suppressive fire, it seems to me the company should be open about what it does with the cells it banks and processes, what it tells patients they can be used for, how they are described and delivered to physicians, and how it perceives its regulatory position with respect to current U.S. laws governing, inter alia, the banking and provision for clinical use of human cells and tissues. 


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 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. 

As with much of the ugly, unscrupulous business of stem cell marketing in the absence of regulation or evidence, the whole Celltex affair smells bad, and no amount of waving briefs and threats of injunctions in people's faces will make that go away. Hopefully the U Minn administration and the FDA will recognize the stench of corruption, and not give in to strong-arm legal defenses of otherwise indefensible practices. And we should all look forward to McGee living up to his promise to provide "timely, lengthy, pointed comments on the matter."