Genomics research catches Congress' eye

Published February 5, 2007

In preparation for my weekly column, I scan several medical journals and the Internet. On the cover of the January issue of Clinical Advances in Hematology and Oncology, I saw an article entitled "The Genomics and Personalized Medicine Act of 2006."

Furthermore, I saw U.S. Sen. Barack Obama's name under it. Because it is somewhat unusual to see a politician's name in a medical journal, I got inquisitive and looked at the main text. This was indeed an interview of Democratic Sen. Obama of Illinois by the editor, Dr. Mark Ratain.

When asked what spurred his interest in genomics, the senator replied that he thinks genomics is revolutionizing every aspect of medicine, and that research is ushering in new tests and treatment, especially in the field of cancer, where genomics-based medications are already in widespread use.

He mentioned Herceptin, a monoclonal antibody, and a product of genomic-based drug formulation that suppresses Her2Nu, a gene that is abnormally expressed in about 20 percent of breast cancer patients.

He also talked about the algorithms that help determine the bleeding potential of patients receiving Warfarin, a blood thinner.

With regards to the Genomics and Personalized Medicine Act's impact on research, the senator said that the bill directs the secretary of Health and Human Services to expand areas of genomics research, and also aims to increase coordination and integration of research efforts between the National Institute of Health, the Centers for Disease Control and Prevention and the Food and Drug Administration.

Asked about the type of research the bill would fund, he said that it will support genomics research broadly but with a focus on "biobanking."

Biobanking involves collecting a large collection of DNA samples and health information of donors and then correlating genetic makeup and its impact on the onset and outcomes of various diseases.

He said that the NIH is already on a large national biobanking plan and that many academic institutions across the country are also developing their own centers. The knowledge learned and the information collected will form a large database that will be available to all researchers.

The bill also addresses ethics and privacy. It suggests that for-profit and academic institutions should have advisory committees, informed consent protocols and expert consultations regarding ethical and legal issues.

The Genetic Information Nondiscrimination Act, likely to pass in Congress this year, will protect patients from discrimination based on genetic makeup and help keep information obtained through research and clinical practice private and safe.

It also focuses on modernization of the FDA and the Centers for Medicare and Medicaid Services in order to clarify federal requirements for development of tests and standardization of the results between various institutions and labs performing these tests.

Such tests are currently processed through the FDA and Clinical Laboratory Improvement Act.

The bill will also include modest funding for research prioritized by the secretary for Health and Human Services.

Research has always progressed faster than government machineries. The Genomics and Personalized Medicine Act of 2006 did not pass the Congress last year. It will be reintroduced this year with some modifications. Only time will tell if it will pass.

If it does, whether there will be adequate funds available through this bill will largely be a matter of speculation. But we can be more than assured that there will be many regulations. One can only hope that the regulations will not hinder progress.

V. Upender Rao, MD, FACP, practices at the Cancer and Blood Disease Center in Lecanto.