Sunday, November 11, 2007

Text of Statement from Robert Klein

As part of the reporting for the Nov. 11 article in The Bee, we asked Robert Klein, chairman of the California Institute for Regenerative Medicine, for a statement on the accomplishments and challenges facing the agency. Here is the text of what he provided.
"For families suffering from chronic disease or injury, Proposition 71 has brought hope; for medical scientists who have dedicated their lives to reducing human suffering, it has been an inspiration; and for patient organizations, it has created a model for a paradigm change in the structure, scope and term of medical research funding in America. To date, approximately $210 million in grants have been approved by the governing board after a competitive, scientific peer review process, and another $300 million is in process. All elements of the court system in California, including the Supreme Court, have exhaustively reviewed this grant making system, the medical and ethical standards, the conflicts policies and the constitutional authority of the governing board and the agency and the Supreme Court has found all of the initiative’s aspects to be constitutional and operated through the agency and the board in a manner completely consistent with the statutory intent and all state laws.

"California has become the largest funding agency in the world for embryonic stem cell research, creating history in funding medical research, as the intellectual health care capital of the society, with long-term state bonds. The great universities, research hospitals, and research institutions of California have recruited world class scientists and clinicians to lead and inspire the medical research programs of California. At the funding agency itself, Dr. Richard Murphy, the former President of the Salk Institute, is building an extraordinary scientific organization and Dr. Alan Trounson, a global leader in stem cell research, will assume the Presidency by the end of this year.

"Globally, California’s performance under Proposition 71 has earned the state agency a world class leadership position, with California serving as a member of the International Stem Cell Forum on an equal membership standing with 19 member nations. Within the United States, California’s grant approvals in 2007 alone are approximately seven times the funding by the National Institutes of Health for embryonic stem cell research. California’s medical and ethical research standards, drawn up in collaboration with the National Academy of Sciences, have become an international model and the new “gold standard” for our nation, with the state of Illinois adopting them in their entirety just four months ago.


"Proposition 71, its governing board, and the funding agency created by Prop 71 face a number of immediate challenges as the momentum of stem cell medical research funding increases.

"First, its preliminary strategic plan must be examined and strengthened as the new President of the agency, Dr. Alan Trounson, brings global scientific credentials and insights to broaden the strategic path while closing research gaps in the plan like immunology, which is so critical to implementing stem cell replacement therapies for Parkinson’s, HIV/AIDS, diabetes and heart disease. As another example, strategic initiatives in immunology might broaden the feasible applications of existing adult stem cell therapies, by utilizing embryonic stem cells as a source of immune tolerance cell transplants. Adult stem cell therapies have raised survival rates for patients with leukemia or multiple myeloma (a bone cancer) from six percent to the 70% plus range; but, these therapies currently only reach the 40% of patient candidates for whom a sufficient immune system match can be found. By strategically focusing on immunology challenges to expand the reach of adult stem cell therapies, more lives may be saved when scientific breakthroughs in immunology are combined with the immune tolerance of embryonic stem cells and/or the possibility of immune system matches through SCNT (immune matched stem cells) breakthroughs.

"Second, stretching the resources approved by the voters - to fund more grants (over time) – by creating a revolving loan fund (to compliment the grant program) could have a dramatic impact on the range of therapeutic advances the agency can fund. The board has just begun phase two of the financial plan by studying how to implement the loan provisions of the initiative. A basic model of revolving seven year loans, as a substitute for some grants when dealing with the private sector, will be investigated over the next year. Potentially, a loan program could recycle over $1.5 billion – in the first 15-17 years of the agency’s life – bringing the total effective resources to fund medical research up to $4.5 billion.

"Third, the board and the agency need to launch a major public information program, including a specific focus on the upcoming human embryonic stem cell clinical trials. These clinical trials, over time, bring the possibility of remarkable medical advancement, but they also bring the potential for initial tragedies, despite the best safety procedures. Even with the benefit of extensive animal, pre-clinical trials, setbacks may occur – particularly given the broad spectrum of therapies and chronic disease challenges. The patients will have independent medical doctors advising them, along with family and friends; but, pre-clinical animal trials are not completely predictive of human outcomes. We must respect each patient’s decision to take “managed and reasonable” risks that may redeem their futures or save their lives. Medical therapies for the patients in the trials and all future generations are dependent upon the courage of individual patients, if medicine is to advance. With a deep reverence for life, we must inform the California public and every patient about these risks and build the patience and understanding that will be critical elements of medical research risk tolerance, if we are to secure the path to therapeutic success, which will involve many attempts and many 'trials.'"

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