20 March 2012Karen Midthun, MDDirector, Center for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike Rockville, MD, email@example.com
Re: Request for FDA Investigation of CellTex Therapeutics Corporation, RNL Bio, and other Companiesclaiming 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 Alzheimer’s, autism, or MS. Theseclaims 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 youroffice to support this request for a formal investigation by the FDA of these companies. Dr. Turner hasraised some specific requests. We have no way of knowing what the facts are in this case, since charges havebeen made by many stakeholders, however, we believe that Dr. Turner and other have raised questionsabout this company that should be asked and answered by an objective agency with the expertise to evaluatesuch 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 claimsuch dramatic therapeutic results, it gives reasons for raising es questions. As participants in the international effort by stem cell biologists, regulators, physicians and ethicists whosought to establish norms for translational research, and who considered the issue of innovative andinvestigational trials, we would ask you to assess whether the standards agreed upon by the InternationalSociety for Stem Cell Research, the leading academic organization, or the standards suggested by theNational 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.