Wednesday, August 22, 2012

Text of Klein's Response to Questions Concerning His Advocacy on Rejected Grant Applications

Here is the text of Robert Klein's response today to the California Stem Cell Report concerning his appearance before the governing board of the California stem cell agency July 26, 2012. Klein, former chairman of the agency, real estate investment banker and attorney, promoted two applications seeking $20 million each from the agency. Both applications had been rejected by the agency's reviewers. Here is a link to an item on the subject.
"Dear David,
"You have posed two questions related to my continuing role as a Patient Advocate in contributing information to the Board of the California Institute for Regenerative Medicine, in an effort to optimize decisions on medical and scientific grants and loans for research that could mitigate and/or cure chronic diseases or injuries. 
"Q: Do you have any sort of financial ties to StemCells Inc. or any of the individuals or firms that would benefit from approval of those awards by the ICOC(the CIRM governing board)?
"A: I have no financial interest in StemCells Inc. or any of the individuals or firms that would benefit from approval of those awards by the ICOC. In fact, I have no financial interest in any biomedical research company.

"Q: Do you think it is appropriate for the former chairman of the ICOC to lobby that body on behalf of awards to specific companies or individuals?
"A: First, it is fundamental that the terms be defined to properly respond to your question. A “Patient Advocate” is a member of a patient family or a medical/scientific care /support group who advocates for medical and scientific advances that might potentially mitigate and/or cure a patient’s chronic disease or injury. A “Patient Advocate” is not paid for his/her advocacy, unless they are staff members of a non-profit institution dedicated to a specific disease or group of diseases or injuries. 
"Second, a “lobbyist” is a paid representative of a company or a for-profit institution(s) with a financial interest in the outcome of a governmental decision. 
"I am serving as a Patient Advocate in my presentations to the Board of the California Institute for Regenerative Medicine. As the former Chairman of the Board, I have a particular responsibility to contribute my background knowledge and experience for the Board to consider, along with all new information, in reaching their best decision. I hope other former Board members, who possess a wealth of scientific, medical, and institutional knowledge that can benefit the Board, would consider the value they can contribute to future decisions. As Board terms expire, it will be important not to lose that institutional knowledge and medical/scientific expertise that has been built up over the last seven plus years of the Agency’s existence. 
"In an outline format, I would suggest the following areas where the knowledge of former Board members can be especially valuable in optimizing the input for Board decisions in the future. 
"A number of Board members have participated in up to 20 or more Peer Review meetings, some of which cover multiple days. Current grant or loan requests represent the result of scientific and medical advancement that has been intensely vetted in prior peer reviews; the information gained in those peer reviews should not be lost, when a subsequent grant or loan request – built on the earlier research outcomes – is considered. Each peer review session has the benefit of different specialists and scientists and/or biotech representatives with unique backgrounds and areas of expertise. The value of the prior contributions may be pivotal, in considering a later application, developed from the earlier medical or research advances funded through CIRM’s grants or loans. The current peer review, scientific staff presentation, and Board expertise, is not the limit of the Board’s information, in reaching the best current decision. To the extent the Board can draw from prior peer reviews (unique insights), prior scientific staff presentations, and prior Board expertise, additional information that can enhance a potential decision, the Board has the opportunity to optimize its decision making process. This is particularly valuable, when there is a high standard deviation – a substantial split – in the scoring positions from the current peer review. 
"Beyond peer review participation, Board members have intensely engaged in another 35 plus Working Group sessions on Facilities and Standards, in addition to more than 70 Board meetings and over 125 Subcommittee meetings, as of August 2012. Retiring Board members possess a treasury of information on policy development, process, federal and state laws and regulations, and the regulations of the agency, as well as in depth information on research facilities and capabilities throughout California, the nation, and the world. It takes a substantial length of time for a new Board member to gain a comprehensive knowledge in all of these areas and each Board member will develop unique insights, which it would be a tragedy to lose. As Chairman, I frequently reached back to consult with former Board members on areas of their special expertise and I would hope that all current and future Board members utilize the significant asset in developed knowledge of the prior Board members. To the extent prior members can be available for public meetings, this would be a substantial benefit to the agency to broadly inform the Board, the scientific staff, and the public. 
"The Board has a unique contribution to make on programmatic resource allocations and risk management of the research and clinical investments in each disease area. The opportunities in some disease areas for major advancement are numerous, whereas there are major diseases and/or critical research areas where the potential, high-value advancement options are relatively limited. For Board members who have participated in over 20 peer reviews and 70 Board meetings, the programmatic perspective on the opportunities in each disease area has been highly developed. Concurrently, those Board members or former Board members have substantial knowledge that is of critical value in reaching programmatic decisions on the number of opportunities for advancement in any specific disease area and the relative risk that needs to be taken to accomplish meaningful breakthroughs in advancing the research and clinical opportunities in a disease and/or injury area. 
"I hope these examples of how former Board members can contribute to the current Board’s information in reaching decisions on the best medical/scientific grants and loans are helpful. As I stated earlier, it would be a tragedy if the expertise of Board members built up over six or more years is lost. The field is extremely complicated and the Board needs the opportunity to consider all of the information available. The Board can choose to accept or reject any past advice or opinions gained from prior peer review sessions or Board meetings, but the Board should have access to the full spectrum of information and the treasury of scientific and medical advice the agency has received since its inception.
"There are areas that I have not addresses in this short response, such as the institutional value of applicants being able to rely upon prior scientific and/or policy direction, in their current applications. From a historical perspective, prior Board members and/or the Chairman can have significant information that is relevant to these evaluations, especially if the individual Board member served on a special Task Force , Subcommittee or peer review. These more complicated areas of individual contribution by former Board members I can address in a future communication; but, this specific subject – alone – could comprise several pages and I would like to obtain critical advice and perspective from other former Board members and the scientific community before discussing this area in greater detail.
"Bob Klein
"Chair Emeritus
"California Institute for Regenerative Medicine"

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