20 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, RNL Bio, and other Companies claiming therapeutic benefit for stem cell therapy Dear Dr. Midthun: In the last several years, there has been considerable concern about the activities of biotechnology companies who make claims on the internet about cures or treatments using stem cells. Some of these claims are made about serious and intractable illnesses such as Alzheimers, autism, or MS. These claims are intend to, and do, lure the most desperate patients, often offshore. to dubious and possibly harmful clinics where they are charged thousands of dollars for untested and unregulated injections of what are named as stem cells. In the last several weeks, many in the international bioethics community have been particularly concerned about a company that uses RNL Bio technology, a company that has a history of severe adverse incidents, to deliver their interventions. As you know, on February 21, 2012, University of Minnesota professor, Dr. Leigh Turner, made a formal request for an FDA Investigation of CellTex Therapeutics Corporation and RNL Bio. Several senior members of our field have written to your office to support this request for a formal investigation by the FDA of these companies. Dr. Turner has raised some specific requests. We have no way of knowing what the facts are in this case, since charges have been made by many stakeholders, however, we believe that Dr. Turner and other have raised questions about this company that should be asked and answered by an objective agency with the expertise to evaluate such claims. When it is reported in Nature, a prestigious scientific journal, that a company is paying physicians to inject their products, and when the product comes from a company that is willing to claim such dramatic therapeutic results, it gives reasons for raising es questions. As participants in the international effort by stem cell biologists, regulators, physicians and ethicists who sought to establish norms for translational research, and who considered the issue of innovative and investigational trials, we would ask you to assess whether the standards agreed upon by the International Society for Stem Cell Research, the leading academic organization, or the standards suggested by the National Academy of Sciences are being upheld in this case. Dr. Turner has raised the following questions:

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 (physicians hired by- ed. note) Celltex are 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, (reviewing their website claims, for example, ed. note). 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. 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.
We also write you because we share Professor Turners concerns. We have read with alarm the reporting in the academic science journals and we note with special attention the reports from Dr. Douglas Sipp and others whose academic specialty is careful research on international abuses of stem cell research. In fact, concern that offshore clinics, and now these in Texas could mislead or harm vulnerable patients was precisely why bioethicists met to seek regulatory norms for stem cell research. We believe that the FDA exists as a Federal Regulatory Agency to investigate the very issues that Professor Turner enumerates and to find out where the facts of the case can be verified or rejected. Because concerns about safety, reliability, efficacy, justice and fair consent are so critical to the public trust of emerging research, your office has an important role to play as stem cell research is translating into clinical use. We have written on this topic, describing the need for courage and fidelity in the process of first use clinical trials, thus we write to you with special concern. We would like to second Dr. Turner's request. His concerns reflect fundamental issues surrounding the commercial use of stem cells for therapeutic purposes. Wehope that you will take them very seriously. 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. Without a clear understanding of the facts we cannot discern or decide among the competing moral appeals in this case. That is why we need your investigation. Sincerely, Laurie Zoloth, Ph.D Professor of Medical Humanities and Bioethics and of Religion Northwestern University cc: Peter Marks: peter.marks@fda.hhs.gov Mary Anne Malarkey: mary.malarkey@fda.hhs.gov Celia Witten: celia.witten@fda.hhs.gov Jan Helge Solbakk, MD, ThM, PhD Professor of Medical Ethics Centre for Medical Ethics University of Oslo