State Task Force Issues Recommendations to Promote Safe, Effective Genetic Testing

Albany, February 23, 2001 – In a comprehensive and timely report released today, Genetic Testing and Screening in the Age of Genomic Medicine, the New York State Task Force on Life and the Law, a nationally recognized commission on medical ethics, made extensive recommendations to promote safe and effective genetic testing to detect disease risks and guide preventive and treatment efforts for individuals.

In a 411–page report, the Task Force provides the groundwork to guide policy decisions by lawmakers, regulatory agencies, and professional associations about issues surrounding the growth of genetic tests. The Task Force recommendations support the development and clinical implementation of safe and useful genetic tests in a framework that allows individuals and their doctors to make informed testing choices free of fear of discriminatory use of test results or other genetic information.

The Human Genome Project, a ten–year–old international research effort to decipher the three billion DNA letters and the tens of thousands of genes that all humans inherit, is leading to an explosion of information about how genes affect health and to rapid development of genetic testing technologies. Researchers are identifying many of the several thousand genes that, when mutated, can cause rare and serious inherited diseases such as cystic fibrosis, sickle cell disease, and Canavan disease.

Genetic research also is identifying more common gene mutations, or variations, that are present in the tens of thousands of genes that all individuals inherit and which may contribute to increased risks for common complex disorders of adulthood, such as cancer, heart disease, and diabetes.

Contact: John F. Signor, Director of Public Affairs
(518) 474–7354
Fax (518) 473–7071

The Task Force report, the result of a three–year project funded by the National Human Genome Research Institute's Ethical, Legal and Social Implications (ELSI) Program and the Greenwall Foundation, notes that many people exaggerate the role of inherited gene variations for health and behaviors. It further acknowledges a history of discrimination against individuals and groups based on such misperceptions, in the United States and elsewhere.

The report also notes that many people misunderstand the results from some of the new genetic tests that can detect increased individual risks, or propensities, for certain diseases – for example, breast cancer – relative to the rest of the population, but which do not provide certainty that an individual will, in fact, develop that disease.

The Task Force concludes that efforts to educate the general public and health care providers about genetics and to prevent misunderstandings and misuse of genetic test information are needed.

One question the Task Force members – including leading health care professionals, lawyers, bioethicists, clergy, and consumer advocates – addressed was whether predictive genetic testing is different from other forms of medical testing and whether genetic testing merits special treatment by health care professionals and the law.

Such testing, and decisions about whether to undergo testing, can cause anxiety and pose dilemmas due to a complex array of preventive options, none fully effective, available to women testing positive. Decisions about testing also can raise family issues, since family members have defined probabilities of sharing inherited gene mutations; whereas some family members may seek genetic information provided by testing, others may not. Testing also raises real fears that information that a person has inherited a BRCA gene mutation may be used against them by insurers or employers.

In New York State, the Task Force concludes, those fears may be lessened by the knowledge that state laws governing health insurance and employment generally prevent the use of genetic test results in decisions about individual health insurance coverage or premiums or employment decisions.

Implementation of Task Force recommendations to strengthen the confidentiality of genetic test information and to impose a moratorium on the use of genetic information for life, disability, and long–term care insurance also could allay fears and promote appropriate participation of individuals in research and clinical genetic testing.

Other key recommendations in the report include the following:

  • Developmental practice guidelines for offering genetic tests as population screening tests to apparently healthy individuals;
  • Strengthening of the already–strong New York State Newborn Screening Program;
  • Establishing requirements for the use of clinical tissues in genetics research that will promote research while safeguarding the interests of individuals from whom tissue is obtained;
  • Improving access of all individuals to needed clinical genetic services;
  • Improved genetics education for physicians, other health care professionals, and the general public;
  • State certification and promotion of genetic counseling as a profession;
  • Improved oversight of clinical laboratory genetic testing;
  • Increased community involvement in policy decisions that involve genetic testing; and
  • Caution in the use of predictive genetic testing of children.

The Task Force was convened in 1985 and charged with developing public policy on a host of issues arising from medical advances. Since its creation, seven of the Task Force's recommendations for legislation or regulation have been enacted in New York State. Task Force recommendations have also been embraced as a model for legislation in other states. The United States Supreme Court cited several reports by the Task Force in its 1997 opinions on physician–assisted suicide.

For copies of the Genetic Testing and Screening in the Age of Genomic Medicine report, please contact the New York State Department of Health at 518–474–7354.

2/23/01–17 OPA