By Lisa Seachrist
WASHINGTON - With the pace of gene discovery increasing rapidly, the number of genetic tests for diagnosing and predicting the occurrence of new diseases has increased in kind.
The problem for physicians and regulators is the fact that the purveyors of such tests range from established and experienced companies to the local academic lab. As a result, some have questioned whether there is appropriate oversight of tests delivering potentially emotionally laden information. Health and Human Services Secretary Donna Shalala convened a panel to look at the issue.
The charge for the Secretary's Advisory Committee on Genetic Testing (SACGT) is to balance the need for oversight with the need to encourage the types of research that will make emerging genomic information useful to physicians and patients. In doing so, the committee has come up with a series of recommendations and principles to determine how best to ensure the tests have adequate regulatory oversight. At a meeting Monday, the SACGT heard from various parties in its attempt to refine its recommendations.
The SACGT is proposing a system that would assess the benefits and risks of genetic tests and assign them to categories. Those categories will be based on whether the test is diagnostic or predictive, is for research or general clinical practice, has a potential for stigmatization of individuals based on the result of the test, is an adequate intervention to prevent or treat disease and other criteria. The level of oversight would be based on the category the test occupies.
One problem is the system is terribly complicated. Elliot Hillback Jr., senior vice president of corporate affairs for Genzyme Corp. in Cambridge, Mass., and SACGT member, suggested the committee lacked the expertise to adequately create such distinctions.
"I agree that all these tests are not the same, but I don't think we are the right group to determine the classifications," Hillback said. "I think we should embrace the concept that there are going to be different classifications and leave it at that. We need to give people a comfort level that we recognize not all categories are the same."
Committee member Wylie Burke, associate professor of medicine at the University of Washington in Seattle, concurred. "The devil is in the details, and we may need to make this an iterative process," she said.
The committee also called for federal anti-discrimination legislation to ensure people don't lose their jobs or health insurance as a result of a genetic test. The need for legislation is perhaps the one area of agreement the Biotechnology Industry Organization (BIO) has with the committee's plan.
Michael Werner, bioethics counsel for BIO, highlighted the need for federal legislation to protect not only genetic information, but also all medical information.
"BIO reiterates its position that genetic information is not different from other medical information," Werner told the committee. "The committee treats genetic information and tests differently from other medical information and inappropriately emphasizes the widespread perception that genetic tests are different. From BIO's perspective this is the fundamental flaw of the report."
Werner said such emphasis could result in a cycle of fear in which the creation of a stigma about genetic tests and/or excessive regulation of those tests could hurt the development of technology. In addition, he highlighted that the committee's report to date focuses on issues such as discrimination, privacy and the social impact of genetic tests. The problem, he said, is the charge of the committee is to consider regulation of these tests. Werner noted the report had no meaningful discussion of the regulation of the tests and the implication of different regulatory approaches on the development, availability and access to genetic tests.
"I want to be very clear: BIO has always supported legislation to protect Americans from the misuse of medical, including genetic, information," Werner said. "But, regulating the quality of genetic tests won't solve the problem of genetic discrimination."
The committee will continue on Tuesday and Wednesday to look at issues such as informed consent, educating health care professionals and the implication on gene patenting to the regulation of genetic tests.