A new report released last week by the Institute of Medicine(IOM) called "Assessing Genetic Risks: Implications for Healthand Social Policy" sets federal guidelines addressing howinformation is gathered through genetic testing and whocontrols it.
"Genetic testing policies must stress informed consent,confidentiality and voluntary participation," the report said.
Henri Termeer, chief executive officer of Genzyme Corp.,praised the report. "We are dealing with a whole new field ofgenetic diagnosis, and it can't develop in the absence of peopleunderstanding better the consequences of this kind ofinformation," he said.
The IOM also called for "the highest level of federal oversight,"stating that the legislative authority of the FDA and the HealthCare Financing Administration to evaluate new genetic testsand oversee the quality of testing laboratories is not beingapplied to genetic testing at all.
Termeer welcomed the call for high-level oversight. "Genetictesting currently takes place in the U.S. in literally hundreds oflaboratories," he said. "It's very fragmented, and as a result,(standardized) quality control that you would expect in a muchmore developed situation is not available."
High standards would help biotechnology companies competeagainst these small labs because they are accustomed tomeeting federal standards, said Termeer. "They currently aredeveloping these tests, often in collaboration with academicinstitutions, and will play a very significant role ... in this area,"he said.
Recognizing this, the Biotechnology Industry Organization (BIO)has recently formed a subdivision on genetic diagnosis, whichTermeer said consists of about six members.
The IOM report's chapter on social, legal and ethicalimplications had the longest set of recommendations. Broadly,it said that all forms of genetic information should beconsidered confidential and should not be disclosed without theindividual's consent. "Where necessary, current statutes shouldbe amended so that disclosure of genetic information is notrequired."
Furthermore, "new laws on a variety of other topics may alsobe necessary to protect autonomy, privacy and confidentialityin the genetics field, and to protect people from inappropriatedecisions based on their genotypes."
More specifically, it said, "health insurance reform proposals(should) be evaluated to determine whether they adequatelyprotect genetic information and persons with genetic disordersfrom discrimination."
The IOM eschewed mandatory screening, which "has not beenshown to be essential to achieve maximum public healthbenefits. However, it is appropriate to mandate the offering ofestablished tests (such as for hyperthyroidism) where earlydiagnosis leads to improved treatable outcomes."
Health-care personnel also need more genetics education, thereport said, including training in social, legal and ethical issues,since ordering genetic tests would become routine for primaryproviders.
The report also recommended an increase in popular education.The general public would need to understand genetics not justto comprehend its role in health and disease, "but also formaking decisions on issues such as the use of foods developedwith DNA technologies," wrote committee Chairman ArnoMotulsky, a professor of medicine and genetics at theUniversity of Washington.
The release of the report follows by several weeks the IOM's23rd annual meeting, which focused on "The Genetic Revolutionin Medicine." Jessica Davis, co-director of the division of humangenetics at Cornell University Medical College Hospital, warnedthat policy-makers were ignoring the genetic revolution toeveryone's peril.
The September version of the national health-care reformdocument had "no single mention of genetics," said Davis,although "screening of newborns is salvaged as a whole lineitem."
"The Americans with Disabilities Act (ADA) does not recognizegenetic disabilities," added Robert Murray, professor ofpediatric medicine and genetics at Howard University College ofMedicine, who said that a recommendation on the subject hadbeen categorically denied.
The IOM report addressed some of these concerns. It saidinsurance companies' definitions of what conditions arereimbursable (so-called "medically necessary" conditions)should be defined to include appropriate genetic testing andrelated education and counseling, and that specific diagnosticcodes should be established and updated for genetic services.
-- David C. Holzman Washington Editor
(c) 1997 American Health Consultants. All rights reserved.