Working group offers screening guidelines
A multidisciplinary committee formed a year ago to study the ethics surrounding genetic testing for breast cancer has announced recommendations it says need to be implemented as policy and made flexible as science outdates them.
"These recommendations are explicitly based on the state of scientific knowledge and legal and cultural constraints as of the present," says Henry T. Greeley, JD, chairman of the working group and director of the Stanford University program in genomatics, ethics, and society that assembled the group. "As both science and society change, the recommendations will need to be modified," he notes. The recommendations were released in late November at a day-long symposium at the Third World Congress of Bioethics held in San Francisco.
A general summary of the 10 recommendations is as follows:
1. The potential value of genetic testing must be judged in the context of the meaning of the disease for those affected, taking into consideration the social, cultural, political, and economic environments of testing, as well as its medical implications.
2. The effects of genetic testing for BRCA 1 and 2 mutations are complicated. The tests may have both positive and negative consequences for individuals and families. At our present level of knowledge, the tests should be offered, and taken, only with great care.
3. For most people, BRCA 1 and 2 mutation testing is not appropriate. For people at high risk for carrying a mutation, either as a result of their family history or their own early onset of disease, testing is an option and should be discussed. Even for those not at high risk, testing, though not encouraged, should not be prohibited.
4. Whenever undertaken, testing should be done by competent professionals who have received specialized training. Testing programs should encompass adequate informed consent, genetic counseling, and multidisciplinary follow-up care, including psychological counseling for the individual and family when appropriate.
5. Additional research on the full implications of BRCA 1 and 2 mutations and testing is crucial. Testing need not be limited solely to research protocols, but all testing programs, whether conduced by research groups or commercial laboratories, should meet the standards set out in general recommendation 4 and should include a confidential data collection component.
6. Improved knowledge about BRCA 1 and 2 mutation is essential to appropriate testing programs. Education programs need to be undertaken for people at risk, for the general population, and for health care providers. Education programs need to reflect the currently understood advantages and disadvantages of testing and to make clear that not being tested can be a wise decision.
7. Marketing of genetic tests for BRCA 1 and 2 should be carefully limited.
8. Health plans should cover genetic testing for BRCA 1 and 2 mutations for appropriate plan members. When genetic testing is covered, the full scope of an appropriate program must be covered.
9. Federal and state laws should clearly prevent the use of information about genetic testing such as BRCA 1 and 2 mutation testing in health coverage or employment decisions. The fact that a genetic test has been administered should be protected in the same way as the information gleaned from the test. Governments should study carefully limiting uses of genetic information in other contexts.
10. The federal government should regulate the introduction and use of genetic tests for conditions, disease susceptibility, or carrier status.
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