The Obama Administration has just shown that it gets the importance of genomics, and that it sees the field as a vital part of health care and the health care business. That seems clear from the administration's decision to appoint a Harvard geneticist with strong business acumen to a new White House panel on bioethics.
Dr Raju Kucherlapati, 67, is not only a professor in the Harvard Medical School Department of Genetics, he is also the founder of several cutting edge companies, including Cell Genesys, Abgenix and Millennium Pharmaceuticals. He also served as the editor-in-chief of the journal Genomics.
Discoveries in genomics are driving the future of health care, but they also raise big (and unanswered) questions about personal privacy, insurance coverage, and the life changing health decisions that can result from new gene discoveries and genetic testing products. Such decisions range from whether to undergo a mastectomy if a woman is found to carry the BRACA1 or BRACA2 gene , terminate a pregnancy if an embryo is found to carry a deleterious mutation, or take a particular drug or dosage of a drug.
Policymakers complain the federal government has neglected genomics, and to this day there is little regulation around genetic testing. The FDA has approved only a handful of the genetic tests on the market. A report written by Gail H. Javitt, a policy analyst at the Genetics and Public Policy Center published in the Spring, 2006 Issues in Science and Technology said:
Currently, the government exercises only limited oversight of the analytic validity of genetic tests (whether they accurately identify a particular mutation) and virtually no oversight of the clinical validity of genetic tests (whether they provide information relevant to health and disease in a patient). To the extent that oversight exists, it is distributed among several agencies, with little inter agency coordination. As a result, no clear regulatory mechanism exists to guide the transition of tests from research to clinical practice, or to ensure that tests offered to patients are analytically or clin- ically valid. In order to protect consumers, and to help advance the potential benefits offered by genetic testing, government action is urgently needed.According to the White House, the new commission will explore the bio-ethical issues that will emerge from advances in bio medicine and related areas of science and technology (read: genetic science), including cloning, embryonic stem cell research, robotics, and artificial intelligence. A blog post from The White House Office of Science and Technology said that the President challenged the commission to make "practical, policy-oriented, ethics-based recommendations" to the President rather than devoting its time to ''arcane philosophical discussions.''
The commission also includes Anita Allen, a law professor at the University of Pennsylvania who specializes in privacy law; Nita A. Farahany, an Associate Professor of Law and Philosophy at Vanderbilt University who specializes in behavioral genetics and neuroscience, and Stephen L. Hauser, M.D, a neuro-immunologist at the University of California San Francisco whose research has focused on the genetic basis of diseases. According to the White House, the formation of the commission is an attempt to streamline Federal policy-making processes and procedures.
As the genetics business evolves, it will raise vital questions about accuracy and reliability, commercialization, and medical ethics. It should make companies and consumers more comfortable to know that leading experts in the field are shaping future policy. The drawback, however, could be if the policies end up stifling business innovation. That's why the appointment of an entrepreneur like Dr. Kucherlapti sends an important signal to business leaders there's a true innovator on their side.
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