[Congressional Record Volume 152, Number 106 (Thursday, August 3, 2006)]
[Senate]
[Pages S8840-S8841]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      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

[[Page S8841]]

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.
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