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.”
Monday, March 19, 2012
University of Pennsylvania professor to Celltex: “I'm Spartacus” - Brainstorm - The Chronicle of Higher Education