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20 March 2012 Karen Midthun, MD Director, Center for Biologics Evaluation and Research Food and

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

Pike Rockville, MD, 20852 karen.midthun@fda.hhs.gov Faculty of Medicine Re: Request for FDA Investigation of

Faculty of Medicine

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. Below please find a copy of Turner’s 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 Bio’s efforts to market adult stem cells to prospective customers.

I request that the FDA investigate how Celltex and RNL Bio propose to address fundamental

Prof. Françoise Baylis

Tel:

902.494.2873

Dalhousie University

Fax:

902.494.2924

Faculty of Medicine Novel Tech Ethics

Email:

francoise.baylis@dal.ca

1379 Seymour Street

Web:

P.O. Box 15000 Halifax, Nova Scotia Canada B3H 4R2

Email: nte@dal.ca

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.

I have known Professor Turner for more than ten years and he is not in the habit of making frivolous requests. 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 stem cell research and was one of the original authors of the Canadian stem cell research guidelines; as such, I know whereof I speak. I have followed media reports of the CellTex affair with increasing concern.

I trust that you will take the concerns raised by Professor Turner very seriously, especially in light of what appear to be recent attempts to silence him for the proper exercise of his academic freedom. Failure to do so might be perceived as undermining the academic freedom of anyone who would dare to ask for accountability and transparency in the regulatory process.

Sincerely

Françoise Baylis, PhD, FRSC, FCAHS Professor and Canada Research Chair in Bioethics and Philosophy

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