Originally Published IVD Technology June 2003
INDUSTRY NEWS
Apprehension rises over direct-to-consumer genetic tests
Governments around the globe have expressed concern over direct-to-consumer (DTC) advertising of genetic tests and over home- use genetic tests. The marketing and sale of genetic tests directly to the public in the UK may be hampered by a report from the Human Genetics Commission (HGC; London) titled Genes Direct: Ensuring the Effective Oversight of Genetic Tests Supplied Directly to the Public. The HGC is the independent advisory body in the UK that provides information to the government on social and ethical issues in human genetics.
Although the report does not recommend a statutory ban on direct genetic tests, it does advocate stricter controls on DTC genetic testing and discourages predictive tests that rely on home testing or home sampling. In addition, HGC believes that the advertising of direct genetic tests should be discouraged. The report concludes: "Most genetic tests that provide predictive health information should not be offered as direct genetic tests."
The British In Vitro Diagnostics Association (BIVDA; London) responded positively to the HGC report. BIVDA will draw up a code of practice for industry relating specifically to genetic tests, and supports the notion that action should be taken against diagnostics suppliers that do not comply with UK law. However, Doris-Ann Williams, director general of BIVDA, reminded the UK of the importance of genetics-based diagnostics, stating "Genetics will bring a huge wealth of benefits to our healthcare . . . Diagnostics have a significant role to play in this [and] increased knowledge through genetics will empower people to make decisions about their own health and their own future."
Members of the United States IVD industry have been supportive as well. Glen Freiberg, vice president for regulatory, quality, and government affairs at Gen-Probe Inc. (San Diego) believes that the report's conclusion should have included "a stipulation that the information received from a test must be validated. In the evolution of our knowledge about the BRCA genes, it took a while before the multigene component of breast cancer risk was recognized." However, Freiberg expressed some reservations about the report's suggestion that when there is a risk of harm, the government should restrict access to direct tests. Freiberg states, "Where there is clear cause and effect and consumers know enough to request a specific test, they should be allowed to do so. The government should not cater to the lowest common denominator of perceived intelligence."
The Australian government has also become tentative about the widespread, underregulated, and under-informed use of genetic testing. In a report released in May titled Essentially Yours: The Protection of Human Genetic Information in Australia, the Australian Law Reform Commission (ALRC; Sydney) and Australian Health Ethics Committee (AHEC; Sydney) call for the creation of a new advisory body, the Human Genetics Commission of Australia, to implement stronger oversight for genetic tests.
The ALRC raises concerns over home-use genetic testing in its Discussion Paper 66 Protection of Human Genetic Information, in which it points out problems with DTC tests including "quality assurance, a lack of consent to testing, and a real possibility of harm where individuals are not provided with appropriate information about the interpretation and implications of genetic test results." In this paper, the ALRC recommends that the Australian government prohibit the sale and advertising of home-use genetic tests in Australia, except when the Therapeutic Goods Administration expressly approves the tests.
The United States may follow suit and restrict DTC advertising and use of genetic tests. The Centers for Disease Control and Prevention (CDC) has distributed a survey to physicians and the general public to assess their knowledge and attitudes about genetic testing. The survey will be used, in part, to determine the impact of a DTC advertising campaign launched by Myriad Genetics (Salt Lake City) to promote the use of their BRCAnalysis test, which indicates the presence of breast cancer risk genes. The CDC Office of Genomics and Disease Prevention will use the survey data to conclude whether DTC advertising campaigns have a largely beneficial effect of increasing the knowledge and awareness about genetic testing among women, or whether they simply lead to confusion and anxiety.
The issue of whether marketing genetic tests directly to the public is constructive may be addressed by the Secretary's Advisory Committee on Genetics, Health, and Society (SACGS) in the next few months. SACGS will hold its inaugural meeting in June. Last fall SACGS replaced the Secretary's Committee on Genetic Testing.
However, the genetic testing industry in the United States may soon receive some leeway with regard to the public use of genetic tests. In May, the Senate Health, Education, Labor, and Pensions Committee approved a bill prohibiting insurance companies and employers from discrimination on the basis of a person's genetic makeup. The Genetic Information Nondiscrimination Act of 2003 (S. 1053) encourages the use of genetic testing by outlawing bias.
A more definitive victory for genetic testing was realized on May 29 when The Center for the Advancement of Genomics (Rockville, MD) partnered with Duke University Medical Center (Durham, NC) to develop the first medical practice based on the use of human genetics to predict, detect, and prevent disease. The collaboration centers around the concept that genomics-based medicine offers the advantage of predicting which people are susceptible to a disease, and implementing preventive action before a patient develops the condition.
By providing comprehensive services, the new practice may allay concerns over the protection of privacy, lack of genetic counseling, and quality control that spring from the proposed widespread use of genetic tests. Multigene tests that are likely to be more effective and accurate than single-mutation tests that are currently available are on the horizon. It may be too soon to ask the public to rely on the tests that are currently available to them, or to encourage the general use of genetic tests before adequate counseling services are provided.
Apparently more groundwork must be laid before a balance between appropriate regulation of and access to genetic tests is achieved. According to Freiberg, "The bottom line is that regulation should be minimal, yet enough to ensure safety. It should not be overbearing or use outlier examples of possible misfortune as reasons to prohibit direct testing."
The HGC report can be accessed on-line at http://www.hgc.gov.uk/genesdirect/#report. The ALRC/AHEC report can be purchased on-line at http://www.alrc.gov.au/publications/recentpubs.htm.
Illustration Courtesy Human Genome Project
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