The nascent direct-to-consumer genetic-testing industry has so far kept physicians on the sidelines by asserting that individuals have a right to view their genetic information, but the nation's leading physicians’ group recently said that MDs should play a central role in determining when and on whom a genetic test may be performed.
The American Medical Association during its annual meeting in June adopted a new set of policy recommendations that seek to heighten the role physicians play in administering genetic testing by making them the go-between separating genetic testing companies and consumers.
“The AMA is currently opposed to DTC genetic testing,” the association states in a report to its board of trustees. “AMA policy states that clinical testing should be performed under the care of a qualified health care professional; discourages DTC genetic testing; and states that genetic susceptibility testing, which in some cases is being advertised directly to consumers, should be provided only in the context of fully informed consent and comprehensive pre- and post-test counseling.”
The AMA said it plans to work with other organizations to develop guidelines for DTC advertising of genetic tests, and educate physicians so they are able to counsel patients more appropriately on the potential harms of available genetic tests.The association also encourages consumers interested in getting genetic testing to contact a healthcare professional.
By the AMA’s own estimates, in 2004, the organization represented 244,569 retired and practicing physicians, including medical students, residents, and fellows, According to MedPage, however, as of 2005, the AMA’s membership accounts for 15 percent, or 135,000 out of 900,000, of all practicing physicians in the US,
“The potential for patients to be harmed by DTC genetic tests is magnified without a physician acting as a learned intermediary,” the AMA states in its report to the board of trustees. “Without the guidance of a physician, genetic counselor, or other genetics specialist, results could be misinterpreted, risks miscalculated, and incorrect health and lifestyle changes pursued.”
According to the AMA, more than 1,400 genetic tests are marketed to the general public without the need for a prescription or involvement from a healthcare professional. A recent survey by Cogent Research found that while most Americans would take a genetic test without the recommendation of a doctor, they do not understand how to interpret test results, how their genetic data can be used by insurers, and when to convey test results to family members and doctors [see PGx Reporter 08-13-2008].
Before adopting its new recommendations, the AMA had more general policies discouraging DTC genetic testing. Last year, the American College of Obstetricians and Gynecologists' Massachusetts Delegation introduced a resolution during the annual meeting asking the AMA to study the issue. Following this, the AMA staff reviewed the current DTC testing industry and presented a report at this year's AMA annual meeting. The AMA adopted its new directives out of this report.
The AMA's recommendations follow similar directives adopted by other professional medical societies, including the American College of Medical Genetics and the American Society for Human Genetics. However, the AMA's recommendations take the strongest stance by seeking to restrict DTC sale of all genetic tests and limit DTC marketing of such products.
“It is unlikely that a company-employed physician is what states had in mind when then enacted laws to prevent direct ordering of laboratory tests, but the laws as currently drafted may be sufficiently broad to encompass this situation.”
The ACMG has recommended that genetics experts be hired to order and interpret genetic tests; that there be greater customer education regarding the capabilities of genetic tests and privacy issues associated with DTC genetic testing; that test vendors provide more clarity about how they present the scientific evidence on which their tests are based; and that laboratories performing the genetic tests acquire necessary accreditations, such as CLIA.
The ASHG’s recommendations leave room for some genetic tests to be sold directly to consumers with certain safeguards in place to ensure test quality and privacy protections. The group recommends DTC genetic-testing firms inform consumers about the limitations of their tests and privacy issues associated with their service, as well as clearly present the scientific evidence supporting the claims being made about their test and potential risks associated with testing.
The society also asks healthcare professional organizations to educate their members on how to counsel patients on the risk and benefits of genetic testing, and urges government agencies to ensure the analytic and clinical validity of DTC genetic tests.
The AMA's recommendations are also part of a wave of concern voiced by industry observers, state health regulators, and prominent scientists who have expressed reservations about the lack of regulation guiding the burgeoning DTC genetic-testing industry.
At least two state health agencies are trying to ban DTC genetic testing by asserting that consumers in their state can only take a genetic test with the advice of a doctor.
In June, Navigenics, 23andMe, and Decode Genetics' DecodeMe business unit were among 13 genetic-testing companies to receive warning letters from the California Department of Public Health ordering them to stop marketing their genetic tests to California residents without a state license and the involvement of a state-licensed physician [see PGx Reporter 06-25-2008].
The CDPH’s letters followed similar cease-and-desist orders the New York State Department of Health sent in April to 23 DTC genomics-services and genetic-testing companies.
In their defense, companies like 23andMe and Navigenics have held that they are in line with state regulations since their services employ state-licensed doctors. Meanwhile, Decode has maintained that it is not marketing to the residents of states that ban DTC testing, and so complaints against it are moot.
Gail Javitt, director of law and policy at Johns Hopkins University's Genetic and Public Policy Center, sides with the states and claims that diagnostic companies that deploy in-house physicians to help individuals make genetic-testing decisions are manipulating unclear state laws.
“The issue turns on the meaning of 'authorized provider,' (or similar terms), found in state laws,” Javitt said in an e-mail to Pharmacogenomics Reporter this week. “It is unlikely that a company-employed physician is what states had in mind when they enacted laws to prevent direct ordering of laboratory tests, but the laws as currently drafted may be sufficiently broad to encompass this situation.”
Most industry stakeholders feel that individual state regulations are confusing and guidance from the federal government in this regard would be helpful. For its part, the US Food and Drug Administration has said that it is watching the evolution of the burgeoning personal genomics industry with interest, but has yet to take a position on the regulatory front.
However, Steven Gutman, director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety, noted at a recent public hearing that the agency has sufficient authority to regulate DTC genetic testing services and acknowledged that federal legislation could give the agencies more clarity.
Speaking during a roundtable discussion in June hosted by Sen. Gordon Smith (R-OR), Gutman pointed out that 23andMe is making what appear to be health claims on its Web site. It is unclear, however, whether Gutman’s views are widely held within the agency and to what extent such a view would inspire the agency to take regulatory action.
23andMe and Navigenics have maintained that the genetic information they provide to customers is for educational- or research-use only and not intended for medical decision making [see PGx Reporter 06-25-2008].
Also at the Senate roundtable, Matthew Daynard, senior attorney in the Federal Trade Commission’s Bureau of Consumer Protection, Advertising Practices Division, said his agency has broad authority to prohibit what it refers to as false and misleading marketing claims and is currently investigating two DTC genetic testing companies.
Daynard could not provide Pharmacogenomics Reporter any details regarding these investigations, saying the facts will remain non-public until the FTC takes administrative or legal action.
In its recommendations, the AMA also issued a directive to the FTC to oversee the accuracy of DTC genetic-testing advertisements.
Although for the time being DTC genetic testing companies argue that people have a right to their genetic information with or without the advice of a doctor, the Personalized Medicine Coalition has said it is working with industry leaders to develop voluntary guidelines to standardize genetic testing validation and promote consistency in genetic testing results. A draft version of the guidelines will be presented during a PMC meeting in December.
The AMA could not provide a spokesperson to comment for this article prior to deadline.