Not many people are eager to challenge Celltex these days. The stem-cell company has political clout, plenty of money, and an unpleasant habit of threatening legal action against its critics. Last month, Leigh Turner, my colleague at the University of Minnesota Center for Bioethics, wrote a letter to the FDA requesting an investigation. Turner told the FDA he was concerned that Celltex was planning to administer adult stem cells to seriously ill patients without sound evidence that the treatments were safe and effective.
Upon learning of the letter, attorneys for Celltex wrote to the president of the University of Minnesota and demanded a retraction. Noting that Turner’s letter was written on university letterhead, the Celltex attorneys asked what steps the university was taking to “disclaim sponsorship of the Turner letter,” remove it from the Internet, and make sure Turner did not try anything like it again. The point of the Celltex letter was apparently to intimidate Turner’s potential allies from speaking out and to isolate him from legal backing by the university.
Enter Charles L. Bosk, an internationally recognized expert on medical error, a professor of sociology and medical ethics at the University of Pennsylvania, and the author of the classic book, Forgive and Remember: Managing Medical Failure. Yesterday Bosk sent his own letter to the FDA, echoing Turner’s request for an investigation. Bosk repeats the eight specific issues that Turner asked the FDA to investigate, ranging from the lack of evidence for the safety and efficacy of treatments using Celltex stem cells, to two reported deaths of patients who were given stem cells processed by Celltex’s South Korean partner, RNL Bio. Yet the substance of the letter by Bosk is probably less significant than its symbolism. By formally backing Turner’s request to the FDA, Bosk has said, in effect: If Celltex wants to go after Turner, they will need to go after me as well.
Obviously, I stand with Turner and Bosk. I have sent my own letter to the FDA (though the gesture is probably less important, since I’ve already gotten a legal threat of my own). If anyone else is inclined to stand up: Our letters are easy to replicate, and I can be reached here. I asked Bosk if he wanted to make a statement, maybe something defiant delivered with a clenched fist. He said, “You might mention that I used to be respected before this.”
Update: Matt McGeachy says to Bosk and Celltex, “No, I’m Spartacus.” His letter to the FDA is here. McGeachy writes, ""Normally I hold bullies in contempt, but in this case the stakes are too high: academic freedom, public trust, and the public health warrant a response from anyone who cares about this stuff. I don’t look kindly on corporations telling universities - and the government - what to do.”
New Update: Francoise Baylis, Professor and Canada Research Chair in Bioethics and Philosophy at Dalhousie University, says, “I’m Spartacus.” Her letter to the FDA is here. An excerpt: “The concerns he raises reflect fundamental issues surrounding the commercial use of stem cells for therapeutic purposes, about which I have grave concerns. I write on the ethics of stem cell research and was one of the original authors of the Canadian stem cell research guidelines; as such, I know whereof I speak.”
New Update, March 20, 2012: The Center for Genetics and Society says, “We are Spartacus.” An excerpt from its letter to the FDA: “We are troubled both by the indications about Celltex’s conduct that led to Professor Turner’s requests, and by Celltex’s apparent efforts to discourage Professor Turner from communicating his concerns to an appropriate federal agency. We urge you to shed light on this matter and make certain that neither Celltex, nor any other company, is exploiting desperate people by administering non-FDA-approved stem cells to clients.”
New Update, March 26, 2012: Laurie Zoloth of Northwestern University and Jan Helge Solbakk of the University of Oslo say, “We are Spartacus.” Solbakk is the current chair of the Ethics and Public Policy Committee of the International Society for Stem Cell Research; Zoloth is a former chair of the committee. Their letter can be found here. An excerpt: “We are also concerned about the climate that has come to surround this request, for we understand that scholars who have raised questions about CellTex in the last few weeks have received threats of litigation from the company`s legal counsel. We wish to affirm that freely raising our most critical and rigorous questions seems to be precisely the point of our fields of bioethics and moral philosophy. Efforts to silence debate or to limit inquiry raises serious problems in a field that seeks honest and transparent processes.”