STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS -- (Senate - August 03, 2006)
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By Mr. OBAMA:
S. 3822. A bill to improve access to and appropriate utilization of valid, reliable and accurate molecular genetic tests by all populations thus helping to secure the promise of personalized medicine for all Americans; to the Committee on Finance.
Mr. OBAMA. Mr. President, I rise today to introduce the Genomics and Personalized Medicine Act of 2006. This bill will expand and accelerate scientific advancement in the field of genomics, which is already beginning to change the paradigm of medical practice as we know it and will have profound implications for health and health care in this Nation.
Almost 150 years ago, Gregor Mendel made history when he established the Laws of Heredity, which detailed his early knowledge about the fundamentals of inheritance. As has happened so many times throughout history, Mr. Mendel's fellow scientists didn't fully understand, support or necessarily agree with his hypotheses on genes, specifically how they are transmitted from one generation to the next, and how they help to define who we are. But he persevered--growing, observing and experimenting on 10,000 pea plants for almost a decade--and we know now that his ideas were right.
I mention Mr. Mendel not just because he was an early pioneer in the field of genetics, and is considered by many to be the father of genetics, but also because he had vision, intellectual curiosity, courage to think independently and question the status quo, and of course tenacity, all of which ultimately opened the door to a scientific revolution.
Since that time, our knowledge about genetics has dramatically increased. We have unlocked many of the mysteries about DNA and RNA, their structure and function, and how their code is translated into the proteins that make up the tissues and organs of the human body. Researchers have also made discoveries about DNA replication, and genetic recombination and regulation, just to name a few, and have developed the necessary technologies to do all of this work.
This knowledge isn't just sitting in books on the shelf. We have used these research findings to pinpoint the causes of many diseases, such as sickle cell anemia, cystic fibrosis, and chronic myelogenous leukemia. Moreover, scientists have used genetic information to develop several treatments and therapies.
We have made so many achievements and come a long way in our understanding and application of genetics knowledge. And yet we are just beginning to realize the full potential of this science to predict the onset of disease, diagnose earlier, and develop therapies that can treat or cure Americans from so many afflictions.
Just 3 years ago, scientists at the National Institutes of Health and the Department of Energy reached another major landmark, with the completion of the sequencing of the entire human genome, described by many as the Holy Grail of biology.
The completion of the Human Genome Project, HGP, has paved the way for a more sophisticated understanding of disease causation. HGP has expanded focus from the science of genetics, which refers to study of single genes, to genomics, which describes the study of all the genes in an individual, as well as the interactions of those genes with each other and with that person's environment.
We know that all human beings are 99.9 percent identical in genetic makeup, but differences in the remaining 0.1 percent hold important clues about the causes of disease and response to drugs. Simply put, the study of genomics will help us learn why some people get sick and others do not and will allow us to use this information to better prevent and treat disease.
The relatively new field of genomics is the key to the practice of personalized medicine. Personalized medicine is the use of genomic and molecular data to better target the delivery of health care, facilitate the discovery and clinical testing of new products, and help determine a patient's predisposition to a particular disease or condition. Personalized medicine represents a revolutionary and exciting change in the fundamental approach and practice of medicine
Pharmacogenomics--the study of how genes affect a person's response to drugs--is a critical component of personalized medicine. Even so-called blockbuster drugs are typically effective in only 40 to 60 percent of patients who take them. Other studies have found that up to 15 percent of hospitalized patients experience a serious adverse drug reaction, resulting in more than 100,000 deaths each year. Pharmacogenomics has the potential to dramatically increase the effectiveness and safety of drugs, both of which are major health care concerns.
We have a few examples already of how pharmacogenomics research has helped to save lives. For example, the chemotherapy Purinethol is a lifesaver for kids with leukemia, but in 11 percent of cases, patients suffer severe, sometimes fatal, side effects. In the 1990s, researchers identified the gene variant that prevents affected patients from properly breaking down Purinethol, allowing doctors to screen patients and adjust dosages for safer use of the drug.
Herceptin is a breast cancer drug that initially failed in clinical trials. However, researchers discovered that 1 in 4 breast cancers have too many copies of a certain gene that helps cells grow, divide, and repair themselves. Extra copies of this gene cause uncontrolled and rapid tumor growth. As it turns out, Herceptin is an effective drug for patients with this type of cancer, with significantly improved survival for affected women.
Our Federal agencies have shown leadership in this area, as have many of our private sector partners. I have introduced the Genomics and Personalized Medicine Act today to support their efforts and to encourage them to do even more and do it faster. Realizing the promise of personalized medicine will require: continued Federal leadership and agency collaboration; expansion and acceleration of genomics research; a capable genomics workforce; incentives to encourage development of genomic tests and therapies; and greater attention to the quality of genetic tests, direct-to-consumer advertising, and use of personal genomic information.
The Genomics and Personalized Medicine Act of 2006 will address each of these issues. The bill requires the Secretary of Health and Human Services to establish the Genomics and Personalized Medicine Interagency Working Group to expand and accelerate genomics research, and application of findings from such research, through enhanced communication, collaboration and integration of relevant activities.
Genetic and genomics research will be expanded to increase the collection of data that will advance both fields. The Secretary will also develop a plan for a national biobanking research initiative and a national distributed database, and provide support for local biobanking initiatives.
This bill requests that the Administrator of the Health Resources and Services Administration support efforts to recruit and retain health professionals in the genomics workforce through educational and research opportunities, financial incentives, and modernization of training programs. In addition, the Secretary will promote initiatives to increase the integration of genetics and genomics into all aspects of medical and public health practice, with specific focus on training and guideline development for providers without expertise or experience in the field of genomics.
A financial incentive is included to encourage the development of companion diagnostic tests. Specifically, this Act provides a 100-percent tax credit for research and development costs associated with companion diagnostic tests. This bill also requests the National Academies of Science to formally study this issue in order to provide expert guidance about the level of incentives and potential approaches to really move this area forward.
The safety, efficacy, and availability of information about genetic tests, including pharmacogenetic and pharmacogenomics tests, is another focus of this bill. The Secretary will contract with the Institute of Medicine to conduct a study and make recommendations regarding Federal oversight and regulation of genetic tests. After this study is complete, the Secretary will develop a decision matrix to help determine which types of tests require review and the level of review needed for such tests as well as the responsible agency. The Secretary will also establish a specialty area for molecular and biochemical genetics tests at CMS and direct a review the practice of direct-to-consumer marketing.
Last but not least, the bill includes a sense of the Senate regarding genetic nondiscrimination and privacy. The Genetic Information Nondiscrimination Act of 2005, which passed the Senate with a vote of 98 to 0 in February of 2005, contained a number of important provisions to protect the use of personal genetic information and prevent discrimination based on such information. This section reaffirms the importance and the necessity of that act for the responsible advancement of personalized medicine.
Mr. President, we stand at this new frontier of personalized medicine, and like Gregor Mendel, we must explore and test the hypotheses and innovations in the area of genomics that can protect and promote our health. Genomics holds unparalleled promise for public health and for medicine, and the Genomics and Personalized Medicine Act of 2006 will help us to fulfill this promise. I urge my colleagues to support me in passing this critical legislation.