[Congressional Record Volume 153, Number 51 (Friday, March 23, 2007)]
[Senate]
[Pages S3708-S3710]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. OBAMA (for himself and Mr. Burr):
  S. 976. A bill to secure the promise of personalized medicine for all 
Americans by expanding and accelerating genomic research and 
initiatives to improve the accuracy of disease diagnosis, increase the 
safety of drugs, and identify novel treatments; to the Committee on 
Health, Education, Labor, and Pensions.

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  Mr. OBAMA. Mr. President, I rise today joined by my colleague Senator 
Richard Burr, to reintroduce the Genomics and Personalized Medicine Act 
of 2007. 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 has profound 
implications for health and health care in this nation.
  The ``miracles of medicine'' have been demonstrated since early man. 
Many of the traditional medicines used today, such as aspirin and 
morphine, are derivatives of plants ancient people used to treat 
illnesses and injuries centuries ago. Since those ancient times, our 
knowledge of medicine and disease has expanded tremendously. Today, 
modern breakthroughs in the fields of genetics and genomics have 
uncovered another layer of complexity in the way we treat and prevent 
disease.
  Over the past decade, we have unlocked many of the mysteries about 
DNA and RNA, their structure, 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 the various functions of 
DNA such as replication, 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 nor is it 
confined to the work benches of laboratories. 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 translated this genetic knowledge into 
several treatments and therapies prompting a bridge between the 
laboratory bench and the patient's bedside.
  We've 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 4 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, our genetic 
blueprint described by many as the Holy Grail of biology and hailed as 
one of the greatest scientific achievements to date.
  The completion of the Human Genome Project has paved the way for a 
more sophisticated understanding of disease causation. The HGP has 
expanded focus from the science of genetics, which refers to the study 
of single genes, to include genomics, which describes the study of all 
the genes in an individual, as well as the interactions of those genes 
with each other. The role environmental factors play in promoting 
disease and the potential influence they have at the genetic level is 
also an area of interest.
  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 use this information to better prevent and treat 
disease.
  The relatively new field of genomics is 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, or the study of how genes affect a person's 
response to drugs, is a critical component of personalized medicine. 
Currently, 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, causing an estimated 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 growing number of examples of how pharmacogenomics research 
has helped to save lives. For example, the chemotherapy Purinethol is a 
lifesaver for kids with leukemia, but in some cases, patients suffer 
severe, sometimes fatal, side effects. In the 1990's, 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, another example, 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, which helps 
cells grow, divide and repair themselves. Extra copies of this gene 
cause uncontrolled and rapid growth resulting in tumor formation. As it 
turns out, Herceptin is an effective drug for patients with this type 
of cancer, with significantly improved survival for affected women. 
Herceptin offers a clear illustration of the power of personalized 
medicine and highlights the importance of incorporating genetic 
analysis in the development and application of new therapies.
  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 2007 will address many 
of these issues. The bill requires the Secretary of the Department of 
Health and Human Services to establish the Genomics and Personalized 
Medicine Interagency Working Group to expand and accelerate genomics 
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, through the support 
of the biobanking initiative aimed at increasing and improving genomic 
screening tools, diagnostics and therapeutics. The Secretary will also 
establish a national distributed database so data finding can be 
shared.
  This bill requests that the Secretary support efforts to improve the 
adequacy of genetics and genomics training through modernized curricula 
and review of relevant certifications, and by identifying alternative 
education options such as distance or on-line learning 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.
  This bill also requests the National Academies of Science to formally 
study the development of companion diagnostic tests and to provide 
expert guidance about the level of incentives and potential approaches 
to really move this area forward.
  Last but not least, the bill focuses on the safety, efficacy and 
availability of information about genetic tests, including 
pharmacogenetic and pharmacogenomics tests. 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 
by the CDC of direct-to-consumer marketing practices.
  In conclusion, we stand at this new and expansive frontier of 
personalized medicine 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 2007 will 
help us to fulfill this promise. I

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urge my colleagues to support me in passing this critical legislation.
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