Statement of J. Craig Venter, PhD, President, Celera Genomics

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Mr. Chairman and members of the Subcommittee, thank you for the opportunity to testify today about this critically important topic.

Good afternoon. My name is Craig Venter. I am President and Chief Scientific Officer of Celera Genomics, headquartered in Rockville, MD. In August of 1998, the PE Corporation, now known as the Applera Corporation, and I launched Celera Genomics. Our initial goal was to sequence the human genome and to build an information business to provide researchers in industry and academia with an integrated information and discovery system for genomic information. Today we are using that information and an industrial scale effort to understand the products of our genes proteins to build a new kind of therapeutic company that will integrate genomic, proteomic and genetic variation information together with new technologies for faster and cheaper disease-related discoveries. I am testifying on behalf of myself and the Biotechnology Industry Organization (BIO). BIO represents almost 1000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations.

We have all been dazzled over the past few years at the pace of scientific discovery. At Celera we are very proud of our role in sequencing the human genome and the mouse genome. That was just the beginning. Using this information, even more will become known about how our bodies develop, function, and change.

This information will be enormously powerful. Armed with these data, scientists will be able to identify the biological basis of disease.

Understanding the function of genes in key cellular processes has become an important basis for creating new drugs and therapies. This information could, for example, tell us how and why certain diseases afflict certain people. It could also tell us why certain medications are safe and effective for some people, but cause adverse reactions or are ineffective for other people with the same diagnosis. This information could lead to the development of cures and treatments for diseases that affect tens of millions of Americans and their families.

The results of this research are likely to be a more "personalized" medical paradigm than exists today. Drugs and therapies are likely to be more targeted as we learn more about the impact and role of genes. While medicine will become more individualized based in part on the genetic code it will be based on statistical information in contrast to deterministic information. I believe, as does BIO, that this new paradigm is likely to be extremely effective in improving the lives of millions of Americans and their families.

We are on the verge of a true revolution in medicine. But there is a chance it will not happen as we hope. It will not be a failure of the science. There is increasing evidence people fear their genetic information will be used to deny them health insurance or a job. This fear is keeping them from seeking medical help. If people believe that a new system of individualized medicine will lead to denial of health insurance or other benefits, they will not take advantage of what the new system could offer. The revolution at hand may not be realized because people are afraid to take part in it.

BIO has long supported federal legislation aimed at alleviating these fears. At Celera we started the push for legislation on genetic discrimination long before we announced the first assembly of the human genome. People must have confidence they can take advantage of technological developments without fear that the information gained from this technology will be used against them.

Mr. Chairman, we want to encourage people to get information about their health and take necessary steps to improve their lives.

BIO, as I have in the past, supports national legislation to ensure that individuals’ personal medical information, including genetic information, is safeguarded against misuse. For example, BIO strongly supported barring discrimination on the part of group health plans based on "genetic information" during congressional consideration of the Health Insurance Portability and Accountability Act (HIPAA). We must assure the public that the great promise of biotechnology research will not be tarnished by abuses of this technology. I am proud of the fact that BIO worked effectively in 1996 to secure enactment of an amendment to HIPAA that provided these important protections against discrimination by health insurance companies based on "genetic information" about the individual. But HIPAA does not cover the individual insurance market. On behalf of BIO and myself I believe these protections should be expanded to this market.

BIO has also consistently supported federal legislation and now regulations that create federal standards to protect the confidentiality of, and safeguard against misuse of, all personal medical information including genetic information.

With the implementation of the HIPAA medical privacy regulations, individuals have much greater assurance that genetic information created and used in the health care context will not be disclosed to employers, insurance companies or other third parties without the specific authorization of the individual. Protecting individuals from the misuse of this information genetic discrimination is complimentary to HIPAA regulations that make the information harder to get.

As with most complex issues, however, as Congress debates legislation to protect individuals from genetic discrimination, there are other critical issues to consider. Please keep the following issues in mind:

• In legislating to prevent genetic discrimination be careful not to restrict biomedical research
• Leave the debate about price controls for another day
• Use updated definitions

As noted, BIO believes that individuals’ personal medical information must be safeguarded against misuse. While we must protect patients’ rights, however, it is critical to allow important medical research to go forward. We are already beginning to see the results of biomedical research. As of today, 117 biotech products have helped a quarter billion people worldwide. Another 350 biotech medicines targeting more than 250 diseases are in late stage development. These products target unmet medical needs.

Mr. Chairman, BIO and I believe protecting patients and promoting critical research are mutually attainable goals. Federal policy must ensure the achievement of both.

Health researchers often use and share health care information, including genetic information. Therefore, federal policy must not impose barriers to use of these data. Consequently, any federal proposal to prohibit genetic discrimination must be carefully written to ensure that research uses of information are not inhibited.

Just as BIO cannot support price controls on products of its members, it have has concerns about federal legislation that would regulate the price of insurance products.

Genetics is a new and dynamic field. By legislating on genetic discrimination, Congress is charting new territory. Whatever action Congress takes will have large ramifications. Future regulations and legislation at the federal and state levels are likely to be based on this proposal.

As Congress addresses this complex issue, therefore, it is essential that it draft legislation carefully define terms such as "genetic information".

In sum, genetic information is extremely valuable. Armed with the information these technologies will provide, patients could make lifestyle and medical care choices that would have otherwise been unavailable. In addition, the knowledge gained by research used to develop new tests and the information gleaned from those tests will lead to new drugs and therapeutics to treat disease and maintain health.

However, public anxiety could limit its potential. BIO and I have long supported federal legislation that will ensure that a person’s individual medical information, including genetic information, cannot be misused. Consequently, we support carefully drafted legislation prohibiting discrimination in health insurance based on genetic information.

Thank you for the opportunity to testify today. I’ll be happy to answer any questions you may have.

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