Comments submitted to Secretary's Advisory Committee on Genetic Testing in response to the public consultation

Dear Dr. McCabe:

The Biotechnology Industry Organization (BIO) represents 850 companies, academic institutions and state biotechnology centers engaged in biotechnology research on medicines, diagnostics, agriculture, pollution control and industrial applications. We appreciate the opportunity to comment during your "public consultation" on genetic testing.

In general, BIO companies believe that genetic information is not different from other health care information. This view is the underlying theme of our comments. Our specific comments are:

  • It is critical to protect the confidentiality of all of an individual’s personal medical information including genetic information, and prevent misuse of that information. It is also important to recognize that medical researchers use, and sometimes share, an individual’s medical information during the course of their research.
  • Genetic tests have broader utility than discussed in the December "public consultation" report and this should not be overlooked.
  • The existing Clinical Laboratory Improvement Act (CLIA) framework constitutes a sufficient oversight mechanism for organizations providing genetic testing.
  • Better education of the public, physicians, and others is needed to allow individuals to make informed decisions about the use of genetic tests, allay public fears, and provide a framework for the benefits of genetic information.

Genetic Information is Not Different from Other Medical Information

Genetic information is an integral part of medical information and cannot be separated from it. Moreover, genetic testing provides information that is comparable to that which may be obtained by using other diagnostic methods, forming part of the continuum of medical information. For example, testing for the presence of a gene yields information that is similar to testing for the protein that is encoded by that gene. Even something as basic as taking a family medical history, which provides the physician with information critical to the diagnosis, prevention and treatment of disease, generates genetic information.

Singling out "genetic information" and "genetic tests" for separate regulatory treatment could inappropriately stigmatize genetic information in the public's mind and inhibit the benefits it could potentially provide to individuals and society.

We Must Prohibit Misuse of All Information, Including Genetic Information

BIO supports the creation of federal standards to protect the confidentiality of an individual's medical information, including the results of genetic tests.

BIO has been a supporter of national legislation to protect the confidentiality of medical information. However, the legislation must be carefully written to allow the continuation of vital medical research. This research is essential if we are to realize the promise of developing new treatments and cures for many diseases. Legislation or regulations that unreasonably restricts researchers’ access to and use of medical information will slow, and could halt, research efforts, thereby creating a barrier to the development of new drugs and biologics. Without these developments, society will not benefit from the advances in genetic understanding.

Insight into the genetic and other biological bases of disease holds great promise for alleviating the suffering associated with many human diseases. BIO believes that information resulting from clinical genetic testing and genetic research must be treated responsibly, and safeguarded against its discriminatory misuse, if these new advances in medical knowledge are to achieve their full potential for improving human health.

BIO recognizes that there is great public concern about the potential for discriminatory misuse of medical information in all areas of life, including health insurance, employment, education and general societal interactions. Therefore, we support legislation to protect Americans from this type of misuse of medical information, including genetic information.

Utility

The December report focused primarily on single gene tests and in our opinion understated the current as well as potential benefits of testing. There are already tests to genotype tumors and guide therapy. We will be seeing more and more use of tests to target and individualize therapies as the field of phramacogenomics and toxicogenomics develop. Although there may not be treatments available for many single gene disorders patients are already benefiting from other types of genetic testing. The development and use of herceptin and cancer vaccines are examples. We must not stifle development of these new fields simply because genetic testing is seen as producing information without "answers." Medical knowledge continues to advance and the information gained by testing will be critical to finding eventual therapies.

Existing Oversight Methods Can be Adapted

Just as we believe that genetic information is one type of medical information, BIO believes that genetic tests are one type of medical test. Therefore, they should not be regulated in a manner that is different from other medical tests. Ensuring that organizations carrying out a medical test are doing so in an accurate and responsible fashion is within the purview of government institutions, but such oversight should be exercised on all medical tests, independent of the technology used to arrive at the result. Rather than creating a new regulatory structure, therefore, it is essential to make sure the current system keeps up with scientific advancement. Consequently, BIO’s view is that appropriate oversight is already provided by the current CLIA system. The CLIA system has successfully promoted quality in laboratory tests for many years and we are confident it can continue to do so.

Genomics is a developing science. As our knowledge this field increases, the utility of genetic tests will change. The scope of genetic testing will not only be predisposition to disease but also knowledge about the body’s metabolism and other general conditions. We need an oversight system that is flexible enough to adapt to technological developments. These technologies will provide patients with new types of beneficial information about their health and the most appropriate therapeutic to maintaining their health.

Moreover, singling out genetic tests for separate and increased regulation could hurt the development of new technologies that hold great promise for patients. Armed with the information these technologies will provide, they can 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. Increased regulation could stifle this critical work and the ability to apply genetic understanding for all potential applications.

More Education is Needed About Genetic Information

The public needs to be better informed about genetic tests. This includes patients as well as physicians and other health care professionals. Better education is needed so all Americans understand the potential for genetic tests to improve human health. BIO members are concerned that ignorance will lead to fear about the use of genetic information without a full understanding of its benefits.

During the Facilitated Public Perspectives at the recent Public Consultation, we heard panelists describe several stories of individuals who had a fundamental misunderstanding of the implications of their genetic test. Such stories point to a clear need for additional education. However, it is important to note that a similar scenario could ensue from receiving results from any medical test. It would be a mistake to inhibit medical advances, or to restrict access to diagnostic services, even though there is a need for increased education.

Conclusion

Our understanding of genomics and the use of genetic tests holds the promise of preventing and curing disease and improving the lives of millions of Americans. The combination of necessary patient protections, appropriate oversight and public education that we have recommended will help pave the way for medical and technological breakthroughs in the coming years. These discoveries will help us accomplish that goal.

Thank you for the opportunity to submit comments. BIO stands ready to work with you as you develop proposals.

Sincerely,

Michael J. Werner

Bioethics Counsel