Charles L. Bosk, Ph.D.

Professor of Sociology and Medical Ethics 278 McNeil Building 3718 Locust Walk Philadelphia, PA 19104-6299 Tel 215.898-7673 Fax 215.573.2081

16 March 2012 Karen Midthun, MD Director, Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike Rockville, MD, 20852 karen.midthun@fda.hhs.gov Re: Request for FDA Investigation of CellTex Therapeutics Corporation and RNL Bio Dear Dr. Midthun: As you know, on February 21, 2012, my colleague at the University of Minnesota, Professor Leigh Turner, made a formal request for an FDA Investigation of CellTex Therapeutics Corporation and RNL Bio. Professor Turners request was for an investigation into specific practices of CellTex and RNL Bio. Below please find a copy of Professor Turners specific requests. I request that the FDA investigate whether there is credible evidence demonstrating that the adult stem cells Celltex and RNL Bio propose administering to their customers are safe and efficacious. I request that you investigate reported deaths of individuals who were administered stem cells prepared by RNL Bio. I request that the FDA review and if necessary test the legal authority of the recent Texas Medical Board draft ruling concerning administration of stem cells. I request that the FDA investigate whether RNL Bio, either in the form of the parent corporation or an affiliated RNL Bio company, is already arranging for US citizens to receive non-FDA approved stem cells at clinics located in such countries as China, Japan, and Mexico. I request that the FDA investigate whether Celltex is already administering stem cells to clients. I request that the FDA or regulatory authorities with ties to the FDA investigate RNL Bios efforts to market adult stem cells to prospective customers. I request that the FDA investigate how Celltex and RNL Bio propose to address fundamental questions concerning informed consent and adequacy of protections for individuals receiving non-FDA-approved stem cells.

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I request that you investigate whether Dr. Stanley Jones was in compliance with FDA regulations when he administered adult stem cells to his patient, Governor Rick Perry. I write because I share each of Professor Turners concern based upon reports that I have read in the mainstream media and the more specialized domain of science journalism. I believe that the FDA exists as a Federal Regulatory Agency to investigate the very issues that Professor Turner enumerates. In fact, I believe that the FDA does not need Professor Turner to instruct it on the need to investigate the questions raised by each of the requests that Professor Turner makes. Each of the requests raises fundamental issues that surround the commercial use of stem cells for therapeutic or experimental purposes that they speak for themselves. I might not normally take the trouble of seconding as a private citizen a colleagues request for an investigation but for the response of CellTex to Professor Turners appropriately filed request for an investigation. From the reports that I have read CellTex acting through its counsel requested that Professor Turner not communicate on official University of Minnesota stationery. This was, I thought, a troubling over reaction. Further, the eagerness of CellTex to silence Professor Turner made me all the more interested in what the results from an investigation such as the one Professor Turner requests would be. Sincerely, Charles L. Bosk, PhD Professor of Sociology University of Pennsylvania Philadelphia, PA 19104 cbosk@sas.upenn.edu cc: Peter Marks: peter.marks@fda.hhs.gov Stephanie L. Simek: stephanie.simek@fda.hhs.gov Mary Anne Malarkey: mary.malarkey@fda.hhs.gov Celia Witten: celia.witten@fda.hhs.gov

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