Stanford Ethics Panel Rejects Genetic Testing for ...

BW 02.06.99 20:09

Stanford Ethics Panel Rejects Genetic Testing for Alzheimer's Disease

Business Editors/Health & Medical Writers

STANFORD, Calif.--(BW HealthWire)--June 2, 1999--Genetic testing for Alzheimer's disease currently is not appropriate for most people, a Stanford biomedical ethics group has concluded after studying the issue for nearly two years.
Scientific understanding of the genetics of Alzheimer's disease is advancing rapidly, and commercial tests are now available for some genes that have been associated with the disease. In most cases, however, these tests do not provide enough information to be useful except in research, according to a working group assembled by Stanford's Program in Genomics, Ethics and Society (PGES).
For nearly two years, the working group grappled with the ethical issues raised by genetic tests for Alzheimer's. The 38 members are experts in a number of fields, including medicine, genetics, nursing, psychology, biomedical ethics, and the law. The group presented the full version of its policy recommendations, along with 17 background papers, in a special issue of the journal Genetic Testing released last week. Guest editors for the issue were Laura M. McConnell, former PGES associate director; Barbara A. Koenig, PhD, co-director of PGES and executive director of the Stanford Center for Biomedical Ethics; Henry T. Greely, JD, Stanford professor of law and co-director of PGES; and Thomas A. Raffin, MD, professor of medicine and PGES co-director.
Alzheimer's disease involves a gradual, irreversible deterioration in mental abilities such as memory and reasoning. Most of the 4 million Americans who have the disease are over 60. As the American population ages, the number of sufferers is expected to rise and is projected to reach 10 million by the year 2050.
The introduction of genetic tests for Alzheimer's disease over the past few years has raised concerns on a wide range of issues, from the impact of knowing one's own genetic susceptibility to an incurable disease, to the potential for discrimination in access to long-term care, said Koenig.
The availability of skilled genetic counseling is another serious concern. There are relatively few trained genetic counselors in the United States, and the need for them is bound to increase as scientists learn more about the genetics of human disease, said Greely. "It's not easy to provide good counseling on these issues, and the people who do it need substantial training not only in genetics but also in the social issues," he said.
Genetic testing, said Greely, has two potential applications in Alzheimer's disease: predicting an asymptomatic person's risk of developing the disease and helping to establish a diagnosis in a person with symptoms. But the link between Alzheimer's and genetics has turned out to be very complicated.
Either predictive or diagnostic genetic testing may be appropriate for individuals from families with a clear pattern of inherited, early-onset Alzheimer's disease, the PGES working group concluded. But this disease pattern accounts for only a small percentage of Alzheimer's cases.
Mutations in three genes have been associated with these rare, inherited forms of Alzheimer's disease. The mutations are considered highly "penetrant," which means they correlate strongly with the occurrence of the disease. A commercial test is available for one of the three genes, called presenilin 1 (PS1). PS1 mutations account for about half the cases of early-onset, familial Alzheimer's disease perhaps 1 percent of all Alzheimer's cases.
The most common form of Alzheimer's does not show a familial pattern of inheritance. Numerous studies, however, have linked variations in a gene called APOE with susceptibility to this "sporadic" form of the disease.
The APOE gene produces a protein called apolipoprotein E, which transports cholesterol in the blood. Each individual carries two copies of the APOE gene, one from each parent. There are three versions, or alleles, of the gene, called APOE 2, 3 and 4. People who carry one copy of a particular version of this gene, APOE4, have an increased risk of developing the disease. People who inherit the APOE4 allele from both parents run an especially high risk of developing Alzheimer's disease. However, many individuals with the disease do not have the APOE4 allele, and people who do carry APOE4 can live to advanced age without any detectable signs of the disease.
The PGES working group recommended that genetic testing not be used to aid diagnosis of the sporadic form of Alzheimer's disease. The test improves the accuracy of diagnosis only slightly, and a positive result does not change prognosis or treatment for the patient. But for family members, who could learn of their own potential susceptibility from a relative's test, the results can impose psychological burdens and social costs even if good genetic counseling is available, the working group argued.
To obtain a copy of Genetic Testing, call Esther Bicovny at Mary Ann Liebert, Inc., the journal's publisher, at 914/834-3100 ext. 623.
PGES, part of the Stanford Center for Biomedical Ethics, was launched in 1995 with a three-year unrestricted gift from SmithKline Beecham Corp. Other sources of funding for PGES include the Arnold and Mabel Beckman Foundation and the United States Department of Energy.

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CONTACT: Stanford
Mitchell Leslie, 650/725-5371 (Media)
mleslie@leland.stanford.edu
Henry T. Greely, JD, 650/723-2517 (Comment)
Barbara Koenig, PhD, 650/725-6103 (Comment)

KEYWORD: CALIFORNIA
INDUSTRY KEYWORD: MEDICINE BIOTECHNOLOGY

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