WASHINGTON _ One day after the National Institutesof Health (NIH) announced the discovery that manyEastern European Ashkenazi Jews have a mutation in theBRCA1 breast cancer gene for which screening is readilyavailable, a panel of experts told Congress to examine theissues surrounding genetic testing carefully beforelegislating a national health policy that, in the long run,could adversely affect genetic screening.

The NIH announcement on Thursday (See BioWorldToday, Sept. 29, 1995, p. 1) had particular resonance forcongressional Cancer Caucus Co-Chair Dianne Feinstein(D-Calif.). Reflecting on the history of breast cancer inher family, she asked rhetorically if several members ofher family should be screened for the gene mutation. Co-chair Connie Mack (R-Fla.), whose family also has a highincidence of cancer, noted the far-reaching ramificationson the employability and insurability of his familymembers because of their genetic predisposition.

The Friday morning meeting was called by the CancerCaucus _ a group of self-appointed legislators interestedin cancer research _ purely as an informational session.

One of the nation's largest genetic screening companiesurged a deliberate approach to national policy. ElliottHillback, president of Integrated Genetics Inc., ofFramingham, Mass., told the caucus on Friday that adelineation of the appropriate federal role will take time.

"The evolution of genetic diagnostics is an iterativeprocess that needs a high level of flexibility to cope withconstant change," he said. "Test validation, laboratoryperformance and genetic information must all beaddressed in appropriate ways but excessive federalregulation must be avoided."

Integrated Genetics, which operates 12 genetic testinglaboratories around the country and offers an array ofdiagnostic and genetic counseling services, advocates agovernmental laissez faire approach to test developmentand monitoring.

"Placing additional regulatory requirements on theprocess at this time could undermine the investmentrequired to make these potential clinical benefits a timelyreality," Hillback said. "Existing voluntary collaborationsbetween the commercial and academic laboratories andresearchers work well and have successfully moved testslike those for cystic fibrosis and Huntington's disease intogeneral use." He predicted that cancer screening canlikewise be moved into general use.

However, Hillback advocated a role for government toprohibit health insurers from excluding individualsbecause of pre-existing conditions and curbing benefitsthrough a variety of exclusions and lifetime caps onbenefits.

While Hillman did not address the issue of whether thefederal government has a role in ensuring theconfidentiality of genetic testing, the issue is critical tothe health insurance industry. Harvie Raymond, assistantvice president of the Health Insurance Association ofAmerica (HIAA), of Washington, told the caucus thatinsurers need access to genetic testing so that they willnot "be at a disadvantage and at financial risk if they donot have access to the same information as applicants."

HIAA is concerned that genetic testing would exacerbatethe problems associated with adverse selection, aphenomenon in which sick patients who consume morehealth resources congregate in individual health insuranceplans that have mandatory open enrollment.

"If insurance carriers are required to accept allindividuals, those who have existing medical problemsare more likely than those who are not able to availthemselves of the opportunity to buy it. As a result, theaverage cost for people in the individual insurance poolwill rise, driving up premiums for individual healthinsurance, including those who currently have coverage,"Raymond said.

This in turn will force those who can no longer affordhealth insurance to drop their coverage. The subsequentloss of these healthier individuals from the pool willcause premiums to edge upward, causing a spiral that in ashort time will make the cost of individual coverageunaffordable, Harvey said.

While Congress has not enacted any prohibitions on theuse of genetic information, the possibility of misuse ofgenetic information by insurers has prompted severalstates to enact privacy laws. Several states now prohibitinsurers from denying coverage based on genetic testsresults. Others prohibit insurers from using thisinformation to establish premiums, charge differentialrates or limit benefits.

Frances Collins, director of the National Center forHuman Genome Research in Bethesda, Md., told thecaucus that genetic research will be deterred if healthinsurers or employers discriminate against individualsbased on genetic information. n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.