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April 8, 2012 Leigh Turner Letter to Texas Medical Board

April 8, 2012 Leigh Turner Letter to Texas Medical Board

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Published by: LeighTurner on Apr 11, 2012
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April 8, 2012Texas Medical BoardRules DevelopmentP.O. Box 2018Austin, TX78768-2018
Re: Rationale for Voting Against Chapter 198. Use of Investigational Agents
To Whom It May Concern:I am writing because I wish to urge members of the Texas Medical Board to reject in its current formChapter 198. Use of Investigational Agents. This proposed rule change is scheduled for presentation tothe Texas Medical Board April 13, 2012. The imprecise and unscientific use of the phrase, “stemcells”; numerous ethical, clinical, scientific, and regulatory issues that the guidelines treat in inadequatefashion or fail to address; and lack of forthrightness concerning whether the guidelines are supposed tocomplement or subvert federal regulations governing administration of stem cells all provide reasonablegrounds for rejecting the guidelines in their current form. Chapter 198 does not adequately addressnumerous moral, legal, and medical concerns even though several members of the Adult Stem CellResearch/Treatments Stakeholder Workgroup Group cautioned that the guidelines required additionalrevisions before being considered for approval by the Texas Medical Board. Prudent and informedcounsel, though provided by physicians, researchers, university administrators, and scientists familiar with ethical norms and regulations governing both medical practice and clinical research, was notadequately heeded during the process of preparing the proposed rule change for presentation to theTexas Medical Board. Approval of these guidelines in their current form risks compromising the safetyof patients and research subjects in Texas.I want to draw the attention of Texas Medical Board members to seven serious shortcomings withChapter 198. Use of Investigational Agents. These problems are:
1) Defining and describing “stem cells” as “investigational agents” falling within the practice of medicine undermines protections for research participants and patients;2) Most (though not all) interventions involving administration of stem cells require submitting an Investigational New Drug Application to the FDA and having study protocols approved by Institutional  Review Boards;
3) Investigational Agents are used in the context of clinical studies involving human research participants and should not be described as “therapies” falling within “the practice of medicine";4) Chapter 198 fails to provide clear guidance concerning regulation of adult stem cells at a time whennumerous businesses in Texas are marketing stem cells;5) The guidelines must clearly state that research subjects should not pay for participating in clinical  studies;6) The guidelines must clearly state that research protocols involving administration of adult stem cellscannot be reviewed and approved by private, for-profit Institutional Review Boards;7) Financial conflicts of interest put into question the integrity of regulatory frameworks.
In the sections that follow I elaborate upon the preceding points.
1) Defining and describing “stem cells” as “investigational agents” falling within the practice of medicine undermines protections for research participants and patients.
According to 198.3 (a), “Administering or providing investigational agents constitutes the practice of medicine, and, therefore, must be performed under the direction of a licensed physician who isresponsible for compliance with the Medical Practice Act…. Use of stem cells in humans shall beconsidered investigational unless they are used in the conduct of an FDA-approved protocol or untilsuch time as they are approved by the FDA.” Section 198.1 states that physicians can administer “investigational agents” among the “therapies” that physicians “offer their patients.”It is worrisome that as a result of Chapter 198’s classification of “stem cells” as “investigational agents”that are also “therapies,” Chapter 198 conveys the impression that physicians offering such “therapies”as part of “the practice of medicine” need not submit to the FDA Investigational New Drug (IND)applications before administering stem cells to their patients. Submission of study protocols toInstitutional Review Boards meeting specified criteria is apparently sufficient. However, Chapter 198.2states, “An investigational agent shall not include…(3) products processed or manufactured as humancell, tissue or cellular-or-tissue-based product (“HCT/P”) pursuant to Sections 351 and 361 of thePublic Health Service Act (“PHSA”) (42 U.S.C. 264; nor (4) a drug, device or biologic pursuant to thefederal Food Drug and Cosmetic Act (FDCA). Taken in its entirety, it is unclear exactly how Chapter 198 is supposed to regulate different types of stem cells and procedures involving administration of adult stem cellsWhen referring to administration of stem cells Chapter 198 does not clearly specify what types of stemcells are “investigational agents” that—despite their investigational status—do not require submissionof Investigational New Drug applications to the FDA. Chapter 198 uses the phrase “stem cells” butdoes not differentiate among various types of stem cells. This failure to make distinctions and specifywhat types of stem cells can be administered to research subjects without first submitting INDapplications to the FDA risks leaving physicians, patients, researchers, Institutional Review Boardmembers, and administrators at universities and hospitals understandably confused about what types of stem cells can be administered as “therapies” that are part of “the practice of medicine.” The
3guidelines—if the Texas Medical Board thinks it necessary to develop guidelines intended tosupplement federal regulations— must include a far more detailed account of what types of interventions involving different kinds of stem cells require submission of IND applications to theFDA.
2) Most (though not all) interventions involving administration of stem cells require submittingan Investigational New Drug Application to the FDA
having study protocols approved byInstitutional Review Boards
Comments made by several members of the Adult Stem Cell Research/Treatments Stakeholder Workgroup as well as correspondence sent by various individuals to the Texas Medical Board suggestthat one major reason for classifying “stem cells” as investigational agents is to permit physicians toadminister to patients adult autologous stem cells without first having to submit to the FDAInvestigational New Drug applications. As members of the Texas Medical Board presumably know, 21Code of Federal Regulations 1271 (See Appendix) makes important distinctions concerning howdifferent stem cells, tissues, and cellular and tissue-based products (and methods of processing them)are regulated.Some procedures involving administration of stem cells do not require submission of an INDapplication to the FDA. For example, physicians are not required to submit IND applications to FDA if they perform procedures in which stem cells are minimally manipulated, are intended for homologoususe, are removed from an individual and implanted into the same person during the same surgical procedure, and meet additional standards listed in 21 CFR 271. However, according to 21 CFR 1271,“If you are an establishment that manufactures an HCT/P that does not meet the criteria set out in1271.10(a), and you do not qualify for any of the exceptions in 1271.15, your HCT/P will be regulatedas a drug, device, and/or biological product under the act and/or section 351 of the PHS Act, andapplicable regulations in title 21, chapter I.” What this standard means is that use of many differenttypes of stem cells requires
submission of an Investigational New Drug application to the FDA
approval of research protocols by Institutional Review Boards.According to 198.3 (b), “Prior to administering or providing of investigational agents, physicians musthave their proposed use either included in an FDA/NIH approved protocol/study or approved by anIRB.” This language is misleading. If researchers wish to administer an Investigational New Drug inthe context of a clinical trial, there are two major regulatory pathways that must be navigated.Researchers are not free to select whichever option they prefer. First, researchers must submit to theFDA an Investigational New Drug (IND) application. The FDA then has 30 days to decide whether or not to put a hold on the application. Second, research involving investigational agents must bereviewed, evaluated, and approved by an Institutional Review Board. By not being precise about theextent to which “investigational agents” are similar to or different from what the FDA describes as“Investigational New Drugs” and by asserting that researchers can submit to the FDA/NIH
an IRB, itappears that Chapter 198, if approved, would dramatically reduce protections for research participants.It is possible that the proposed guidelines are not intended to subvert federal regulations specifying thatresearchers planning to conduct clinical studies involving Investigational New Drugs must first submitIND applications to FDA. If the guidelines are meant to support this longstanding protection for research projects and are not intended to pose a challenge to federal regulations governing medical

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