DNA testing online: marketing hype or medical breakthrough?
DNA shampoo? Diet and exercise regimes tailored to your own genetic makeup? Cosmetics blended to address your particular ‘wrinkle genes’? A DNA test to determine which sport best suits your child? DNA tests available on the internet to calculate your genetic risk for breast cancer, diabetes or Alzheimer’s disease?
This is no longer the stuff of science fiction—rapid advances in genetic science and technology are greatly expanding the range of DNA tests available, and dramatically reducing the costs. While genetic testing has been the preserve of medical specialists and major teaching hospitals, private laboratories are now advertising their services directly to consumers via the Internet, with costs ranging from $250 for ‘dermagenetics’ to $300,000 for a fully sequenced personal genome with 3.2 billion bits of genetic information.
National Health and Medical Research Council (NHMRC) and the Australian Law Reform Commission (ALRC) joined forces to explore these issues at a free Public Meeting hosted by ABC TV’s Bernie Hobbs in Sydney on 7 August 2008: Direct-to-consumer DNA testing: marketing hype or medical breakthrough? Around 95 people attended the forum.
These developments were foreshadowed by the ALRC in its landmark 2003 report, Essentially Yours: The Protection of Human Genetic Information in Australia. Speaking at the forum ALRC President Professor David Weisbrot, said this area is moving even faster than expected: “Just five years ago, no one was advertising medical DNA testing over the Internet. However, there are now over 30 labs offering about 40 tests directly to consumers in the USA.
“To the extent that the soft end of this just involves new fashions and fads, then maybe community education, consumer law and ‘buyer beware’ will be sufficient. Are these so-called ‘lifestyle DNA tests’ the 21st century version of the ‘mood ring’?
“But more importantly, many of the DNA tests being offered have serious implications, since people will rely on them to make critical decisions about their health and well-being. So, do we need tougher laws and more stringent regulation by government authorities?”
Professor Ron Trent of Sydney University, Chair of the NHMRC’s Human Genetics Advisory Committee, told the seminar “We have serious concerns about DNA tests being offered to individuals without the advice of a health professional. And are these cleverly marketed tests actually based on real medical research? Do these private overseas labs meet our high ethical and technical standards? And who will interpret the complex results of a DNA test, or provide the necessary counselling?”
Prof Weisbrot added, “We want community participation in developing sound policies for regulating this area in the public interest. We will be using the feedback we receive at this public meeting to provide advice to Government which will help shape these policies into the future.”
Consumer law expert Vijaya Nagarajan of Macquarie University said “current Australian laws to protect consumers will have limited impact in Australia, and none overseas, where many of the Internet companies are based. For example, if someone had a DNA test for bipolar disorder, and is told by the company, which is based in Vanuatu, that bipolar disorder has a significant genetic component, what action will they take? They could decide not to have children. How can you calculate the loss sustained? Does Vanuatu have consumer protection laws? If you look at the fine print in these companies the claims are ambiguous, with little specificity. It really is buyer beware.”
A lively discussion followed with a range of detailed questions around the reliability or otherwise of such tests, who owns DNA samples, the importance of consumer education and genetic counselling, and the possible distress that genetics results could cause, as well as discussion on the need for regulation.
Summary of key discussion points (public forum)
- The law surrounding ownership of DNA is uncertain. One view expressed was that if DNA is manipulated, it may no longer “be yours”. However, the key issue was not necessarily ownership, but a person’s control over his/her DNA and how it may be used.
- Where should we draw the line between consumer protection and “buyer beware”? There is a need for more education on DTC DNA testing, the real possibilities for what it can determine, and the implications so that consumers can make more informed choices.
- There are issues about understanding the significance of DNA test results purchased online (without going through a doctor), because some of the tests are difficult to interpret.
- Better education can help consumers make informed choices, and minimise harm caused by incorrect interpretation or application of results.
- Regulations surrounding online tests in Australia would be difficult to apply to overseas companies—especially if these are located in countries with minimal consumer protection laws. Industry codes of conduct may be a more effective way of protecting consumers.
- DNA testing should be based on sound science, but even then, the predictability for some tests is variable and so likely to impact on the significance of the results.
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Consumer education needs to be multi-faceted to account for the complexity of issues surrounding DNA testing. As part of any education campaign, consumers should be able to obtain information from:
- their local doctor or general practitioner (GP). Doctors will be aware of family history, and can refer consumers to a genetic counsellor in the event that a test shows susceptibility to a particular condition
- media coverage, including talk shows, and
- agencies on employment rights and privacy issues.
- The ALRC recommends that there be no predictive DNA testing for employment unless it can be shown in the very exceptional circumstance that it is an essential step needed to protect the employee’s health. As Australia has universal health care coverage, the issue of DNA testing impacting negatively on health insurance premiums is not relevant compared to countries such as the USA. However, in the life insurance industry (which is risk rated), individuals who have a DNA test must disclose its result if seeking life or income protection insurance policies.
- “Over-regulation” concerns: over-regulation of online testing may inhibit research findings being implemented in clinical practice. Conversely, any refusal to regulate DNA tests (as they are not considered to be a medical devices or treatments) may cause the issue to “fall through the cracks”, leaving consumers vulnerable.
Hear more about genetic profiling on ABC Radio National’s program, The Law Report.