Saturday, September 10, 2005

Text of Halpern Letter

Here is the text of the letter sent to the California stem cell agency by Charles Halpern. It is not available elsewhere on the Web.

I reviewed the agenda for the September 9 ICOC meeting with interest and concern. My comments are addressed to Agenda Item 8, to the criteria for grants and for the procedure by which they have been processed. At this meeting, the ICOC should devote its time to genuine deliberation on the criteria for awarding grants—both training grants and research grants. The fact that these are Interim Criteria should not obscure the fact that the early rounds of grants will shape the Prop. 71 stem cell initiative for years to come. The criteria recommended by the Scientific and Medical Research Funding Working Group (WG), while a good starting point, are woefully incomplete. The ICOC should also reconfigure the process by which grant recommendations are presented to the ICOC in a manner which permits true deliberation on grant awards by the ICOC. In particular, the ICOC should assure that none of the work in California laboratories and none of the training it funds will benefit those who are working on reproductive cloning outside the state. (See the second numbered paragraph below.) The ICOC can take this opportunity to reassure Californians that all steps are being taken to make sure that no scientist trained with our tax dollars will take his/her skills out of state to help to clone human beings.The ICIC should refuse to ratify the recommendations for training grants which have been improperly presented to the ICOC before it has approved Interim Criteria, in violation of statute. The ICOC should carefully review the criteria for training grants recommended by the WG and make appropriate substantive additions, including the critically important matters discussed below. Finally, it should return the amended Interim Criteria to the WG to be applied to the applicant pool. This procedure is required by Prop. 71 and sound scientific practice. It will not lead to significant delay in developing training programs or research grants since it appears that there is no money available at this time for distribution to designated grantees. There is time to do the job right. Agenda # 8 Statutory Process for Adoption of Grant Criteria The starting point is the text of the Prop. 71, specifically, Sec. 125290.60(b) which states: “The Working Group shall perform the following functions: (1) “Recommend to the ICOC interim and final criteria, standards and requirements for considering funding applications and for awarding research grants and loans.” It is hard to imagine clearer language. This section delineates the first order of business for the Scientific and Medical Research Funding Working Group The WG deliberates on the critically important matter of criteria and makes recommendations to the ICOC. The ICOC, in turn, considers the WG recommendations and adopts criteria which it transmits to the WG to be applied. Of course, the WG cannot apply its proposed criteria to pending applications until these criteria have been reviewed, amended, and approved by the ICOC—nor can the WG assume that the ICOC will simply rubberstamp its proposed criteria.The WG proceeded with its review process for training grants in early August as if their recommended criteria had been approved by the ICOC. In doing so, the WG violated the procedures established by Prop. 71. The ICOC should remand the applications to the WG for consideration in light of the Interim Criteria adopted after due consideration by the ICOC at this meeting. Supplemental Interim Criteria for Training Grants Concerning the substantive content of the Interim Criteria, the sketchy criteria proposed by the WG are a good start but they are seriously deficient. Issues that were simply not dealt with by the WG go to the heart of the stem cell program under Prop. 71. They must be addressed by the ICOC. The following additional Interim Criteria would fill many of the gaps: First, training grants should be awarded only to institutions that agree (a) to conform to the Revised Interim NAS Guidelines for Stem Cell Research, which will be considered at this meeting of the ICOC, and (b) in due course, to adopt the Final Guidelines that will be approved by the ICOC after going through a formal APA public comment process. This undertaking should be a primary criterion in evaluating applications. Obviously, the institutions cannot be fully in compliance at this time, because even the Interim Guidelines have not yet been adopted. The process of establishing ESCROs, for example, with their procedures and policies, will take some time to be completed at most institutions. In fact, the WG didn’t know how far the applicant institutions have progressed, since the application did not even raise the question. The WG should consider how well the past practices in stem cell research of each institution have conformed to the general norms set forth in the NAS Guidelines. If institutions have diverged from the NAS norms or been casual about informed consent, about protecting egg donors, about permitting chimeric research, about embryo banking practices, they are unsuitable to be training the next generation of researchers. If they have been particularly scrupulous in addressing these issues, they should be rewarded for their past practice. An evaluation of past performance, as compared to the NAS norms, should be added into the Scientific Score for each applicant. Second, institutions should be funded as training sites only if they agree to follow best practices—i.e., to apply the Interim and Final Guidelines for Stem Cell Research to all of the stem cell research that takes place within the institution and in cooperating academic and corporate laboratories, not just to research that is funded by CIRM grants. Third, the WG should only consider grants to institutions that have taken effective action to assure that none of the work in its labs and none of the training it provides will benefit those, outside the state, who are working on reproductive cloning. This requires at least two commitments: (a) Each institution should train only applicants who will commit not to work on reproductive cloning for five years after the end of the training period. (b) Each institution should commit to enter into partnerships or agreements to share information, techniques, or personnel only with institution that have committed to do no work on reproductive cloning. Each applicant should explain how it will police these commitments, and in particular, how it will work to assure that people trained in CIRM-funded programs will not take their knowledge into reproductive cloning research. Californians have expressed the strongest opposition to reproductive cloning. The ICOC must take all possible steps to assure that California resources and personnel trained with our dollars do not help to further this awful practice. Needless to say the technical problems being addressed in our state’s laboratories to make research cloning a feasible methodology can be used to further the ends of those who do not share our state’s commitment to prevent the cloning of human beings. Fourth, each applicant should be seriously evaluated on the basis of its training program’s benefit to the state of California. For some reason, the WG summaries have treated this issue cavalierly, putting in identical empty boilerplate language in each summary making it impossible to make discriminating distinctions. Institutions might have said, for example, that they will try to place their graduating fellows in positions within the state; or they might have gone further and required their fellows to make “best efforts” to find positions in the state after the end of their training period. The institutions might have stressed that their CIRM-funded training program would enhance their institutional commitment to serving the health needs of the poor in the state. Many people were distressed by the recent report suggesting that the State should not expect any royalty or license revenues from CIRM-funded research, when the promoters of the Prop. 71 and their economists had painted a rosy picture of the money flowing to the state. The ICOC must make it clear that it takes the “benefit to the state” issue seriously, not like the applicants and WG which apparently chose to disregard it. The WG should resubmit this question to applicants, and responses should bereflected in their overall scores. In addition, the ICOC should find out how it happened that this issue was not taken seriously, inform the public, and take remedial action. Supplemental Interim Criteria for Research Grants The same supplemental criteria listed above should be inserted into the Interim Criteria for research grants. The WG recommendations are good so far as they go—but they are incomplete. The WG draft does not assure that all funded research will be carried out in complete conformity with the Revised Interim NAS Guidelines for Stem Cell Research as they are issued by the ICOC. They do not assure that all the research in the funded institutions conforms to the high scientific and ethical standards demanded for research funded by CIRM. They do not take the vigorous steps needed to assure that research funded by the California taxpayers never goes to advance reproductive cloning. They do not make benefit to the state a criterion to be evaluated in making awards. All of these omissions should be addressed by the ICOC at this meeting. When money becomes available for research grants, a framework will be in place. In the meantime the state’s institutions can prepare to become viable candidates for grants with a clearer sense of the criteria they will have to address. The Process for Reviewing Grants The information being provided to the ICOC members and to the public is woefully inadequate. It is insufficient to permit ICOC members to make informed judgments, and it undermines the commitment to the state’s voters that the ICOC will exercise careful stewardship of the grants made with the public’s money. Moreover, the ICOC members are put in an impossible conflict of interest dilemma. They cannot know if they are being asked to vote to fund a training program that is headed by a close relative or by a person with whom they have an advantageous financial relationship. So they cannot know when to recuse themselves; and, of course, the public has no way to assess whether there has been inappropriate influence. A voting system that permits intelligent participation by the ICOC in the grants selection process and informs the public must be developed before any grants are awarded. The system presented in this Agenda does not measure up.
These are not issues of mere procedural nicety. They set the terms of the relationship between the vitally important WG and the ICOC. Will the Working Group be treated properly as an advisory group as promised to the voters by Prop. 71 or will it effectively exercise full decision-making authority with the ICOC simply rubberstamping its actions? If the WG is functionally a decision–making body and not an advisory body, that would, of course, raise significant legal issues about CIRM and about the application of the state’s conflict of interest rules to WG members.

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