Your DNA: a case of 'buyer beware'?


Vijaya Nagarajan

21 August 2008

Where is the line between consumer protection and ‘buyer beware’ when it comes to direct-to-consumer DNA tests?

Consumer law expert Vijaya Nagarajan of Macquarie University believes current Australian laws to protect consumers have limited impact in Australia and none overseas, which is where many DNA-testing internet-based companies are located. Here she explains to Marilyn Chalkley why there is a crying need for more education on DNA testing so consumers can make better-informed choices and minimise the harm that can be caused by incorrect interpretation of test results.

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Voice-over: Welcome to the National Health and Medical Research Council podcast. Our podcasts aim to keep you in touch with major health and medical research issues and the people who shape them.

Introduction: Hello I’m Marilyn Chalkley. The DNA testing industry is a multi-million dollar business with many on-line companies offering you DNA tests on subjects as diverse as, which sport best suits your child, to whether you have a genetic tendency to breast cancer. If you’re a consumer is there any legal protection from the consequences of finding out what’s wrong with your DNA, and what kind of tests can you buy on-line?

I put this question to Vijaya Nagarajan, a senior lecturer in law at Macquarie University.

Vijaya: There’s a variety of tests you can buy and if you go to a company called ‘21 and Me’[1] you’ll find that there are more than 50 or 60 tests that you can buy. Some of them are still, they indicate, are preliminary tests so there isn’t that much evidence to support the conclusions they make but there are others which are well established. So there are tests which range from things like heart disease and of course the usual thing which is breast cancer, all those serious sort of ailments which are well discussed, to other ones which are life style I suppose such as ADD, weight loss, memory improvement, muscle repair, addiction to heroin, addiction to alcohol and cigarettes, sports ability. It’s a wide variety.

Interviewer: That’s extraordinary. So I mean if I was seriously worried about for example my children inheriting a tendency to breast cancer I could go and order that on-line but I could also look and see whether they might become overweight. Is that really what we’re talking about?

Vijaya: That’s exactly right. So if you were a very caring mother you could go all out and try to really map out what your children are good at. You could figure out what sort of ailments they might be prone to, so of course whether their genetic make up will mean that they are more likely to be obese, more likely to have heart disease later in life and you could also figure out if they’re better off concentrating on short distance running or perhaps concentrate on becoming a marathon runner. You could map it all out for them.

Interviewer: Really, how reliable are they. I mean if I do find out the results of my DNA test and find that the test tells me that my children are possibly likely to inherit breast cancer, how reliable is that?

Vijaya: There are a variety of tests. The breast cancer one is scrutinised reasonably carefully but it still says very little. If it tells you that you have 80 per cent risk of catching breast cancer or not having breast cancer, what does that mean? Or that you can pass this gene onto your children, what does that mean? If you get a NO result, what does that mean? Well it just means that now they have the same risk as everybody else. It doesn’t really mean anything at all. A lot of this information really requires a medical practitioner to assist you in interpreting it. A lot of this information is also not so conclusive; it’s just telling you one of the factors that might be relevant so you can’t often make all these conclusions just on checking out this particular gene or this particular risk.

Interviewer: And I suppose you also might be also quite distressed at the findings?

Vijaya: Exactly. There are many stories about — well there is one story that we all know about — which is of course the woman finds out that she’s prone to breast cancer, she’s in the high risk category, so she has a mastectomy and one of the points that I make is the bi-polar gene. If you decide to have a test for bi-polar gene and you find that you have a susceptibility to that and that you might be passing this gene onto your children it might actually mean that you might decide to make an informed decision not to have children, not pass on this terrible, terrible thing to somebody else. And so it can have dire consequences if allowed just to be interpreted with no other supervision at all.

Interviewer: So what are you recommending? I mean what protections are there for consumers, there are very few I gather at the moment.

Vijaya: This is a new field so of course like most new fields there’s a lot of unscrupulous practices. It’s been for ever like this I suppose. At every century we have different areas that are wonderful sites, fertile ground for all sorts of different sales pitches and that’s what’s happening at present. The laws that exist aren’t specifically trying to regulate this area at all. We have the Therapeutic Goods Administration, which does have a little bit of input into some tests, but the only one that they’re regulating at present is the HIV test and the Hep C test, so that’s the only ones that are regulated. Everything else remains unregulated and they would come within the Trade Practices Act, which is the main Consumer Protection Legislation we have in Australia, and there are some provisions there in division one and division two, which is primarily dealing with misleading and deceptive conduct. So if a seller makes misleading statements and if these statements are believable by a reasonable person — if a reasonable person would be expected to rely upon them, then those statements, they’re buying the seller, so that’s the way section 52 of the Trade Practices Act works. But of course what most of these sellers do is they have an exclusion clause within them and the exclusion clause is both general and the more specific the test the more specific the exclusion clause. So if you have something like a DNA diet test the exclusion clause just says a number of different factors will effect your weight loss, which will include not just the food you eat but also the kind of other climates you live in, the other environmental factors, the sport activities you undertake. So that kind of gives the seller a route to get out of liability. But the more specific a test, such as the diabetes 2 test, the more specific the exclusion clause, the exclusion clause actually says this is not a test this is simply giving you some risk factors that you can go and find out a bit more about.

Interviewer: But what about overseas tests because quite a lot of these tests you actually order them from overseas? Presumably there’s no legislation that could cover that.

Vijaya: You’ve raised the exact point, the very, very important point that right now in Australia there are three companies that are marketing to consumers, but as we sit down and we Google all these companies and try to find out about these tests of course it isn’t necessarily the domestic market that we’re looking at. We’re looking at an international market. In fact ’23andMe’ is a company that comes up right up there in the Google website. It’s no accident the owners of Google and ‘21 and me’[1] — there are a lot of commonalties between them, a lot of them actually there’s co-ownership. So yes most of these tests are done overseas. So if they’re done overseas then you have to bring the action in the country where the test is done, or the country where the corporation is registered. This might be fine if it’s in the United States for example where there are some consumer protection laws but you certainly don’t have any avenue of relief if it’s in a country like Vanuatu where there’s no consumer protection laws.

Interviewer: And in fact there are Vanuatu companies are there?

Vijaya: That’s correct. A lot of companies are establishing their base in Vanuatu mainly because there’s a tax free zone. Vanuatu actually attracts — this is their claim to fame, this is the way they make their jurisdiction popular because they’re a tax free zone, so companies established there pay no tax at all which is why there are numerous companies including of course gambling companies that have their base there.

Interviewer: So to sum it all up really what advice would you give to someone considering an on-line DNA test. Should they have one?

Vijaya: Well firstly they’ve got to proceed with care. If they do go for one of those life style tests they’ve got to remember that there’s going to be very little relief. It’s just like buying a perfume or going to the gym, it’s just not something that you can count on. It’s just a promise, it’s a “puff” as they say in law. But if it’s something more serious it’s important to have some sort of medical advice about it. We’re hoping that the law will recognise that this is a need, there’s a great need in this area to re-think the kind of regulation we have and it’s got to be a multi-pronged approach — both help the consumer get savvy, understand the information a bit better and also give the consumer a bit more protection.

Interviewer: Vijaya Nagarajan, Senior Lecturer in Law from Macquarie University talking about direct-to-consumer DNA tests.

Vijaya: Thank you very much.

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