Ethics and the Law Try To Keep Pace With Genetic Testing

RESEARCH on human genetics is prompting federal and state governments to take a fresh look at ethical and legal safeguards for the use of DNA testing in medical care.

At issue: How to protect patients from being denied jobs or insurance coverage based on the presence of genes that scientists associate with specific disorders.

Today, a task force on genetic testing set up by the National Center for Human Genome Research wraps up its first meeting in a two-year effort to develop recommendations for safeguarding the rights of people who undergo genetic testing.

The two-day session is largely aimed at organizing the effort and gathering initial information on the state of the genetic-testing field, which is still in its infancy. In health care -- a sector of the economy that measures activity in the hundreds of billions of dollars -- the genetic-testing market last year amounted to about $7.5 million, says Ann Merrifield, vice president for marketing and business development at Integrated Genetics, a Framingham, Mass., firm.

''At this time, most of what we're talking about does not affect most people,'' says Cassandra Smith, deputy director of the Center for Advanced Biotechnology at Boston University. She says the tests are expensive and that only about 20 diseases have been linked to specific genes.

Yet research is taking geneticists beyond the quest for genes that scientists believe trigger maladies long identified as inherited. As it does, ''We're getting into tests to predict the probability of having a certain type of disease that's not necessarily a genetic condition,'' says Steve Push, a spokesman for Genzyme Inc., a biotech firm also based in Framingham.

In addition, the federal government has aimed $145 million at developing DNA diagnostic techniques through the National Institute of Standards and Technology's Advanced Technology Program -- but funding may shrink with budget cuts.

The anticipated expansion of genetic testing raises individual and public issues, Dr. Smith says. On an individual level, the benefits of genetic testing are uncertain. ''People who take the tests want to hear: 'You don't have it' -- whatever 'it' is. If they do have 'it,' you have to be careful in explaining to people what the test really means.'' Moreover, she adds, few of the testable disorders so far have treatments, ''So it's not clear what the benefits of the test would be.''

More broadly, ''who has a right to the information?'' she asks.

Some would answer with a qualified: We do. Harvie Raymond, director of the managed care and insurance operations department of the Health Insurance Association of America in Washington, D.C., says, ''Insurance companies should have access to the results of tests when people come to them voluntarily for coverage. In our view, this affects a relatively small number of people since most people get their coverage through their employers and do not have to supply evidence of insurability.''

Even so, ''You want to get safeguards in place as the price of testing drops,'' broadening its potential appeal to patients, insurers, and employers, concludes Smith.

As the federal task force examines the issues, legal firewalls are being built elsewhere. Last month and with little fanfare, the US Equal Employment Opportunity Commission (EEOC) determined that job discrimination based on genetic makeup is illegal under the Americans with Disabilities Act. The EEOC ruling is ''great progress,'' says a spokeswoman for the Council for Responsible Genetics, based in Cambridge, Mass.

Thirteen states have also enacted laws proscribing the use of genetic testing, according to the National Conference of State Legislatures in Denver, Colo. At least one, Ohio, prohibits insurance companies from requiring genetic tests of applicants. At least three more states are working on the issue this year.

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