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Should consumers have the right to buy any genetic test?

The views expressed are those of the author and are not necessarily those of Scientific American.

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should genetic tests be marketed directly to consumers?Earlier this year, consumers were close to being able to pick up a saliva-based genetic test for disease risk the next time they ran to the drug store for aspirin or sunscreen. But even though the tests are still available for purchase online, consumers, geneticists and other groups quickly started to ask questions about the reliability of these off-the-shelf, over-the-counter genetic tests—and whether consumers would be savvy enough to digest results on their own.

In April the U.S. Food and Drug Administration (FDA) raised questions about the tests, and Walgreens elected not to sell them in stores. And in June the agency sent letters to four makers of direct-to-consumer (DTC) medical genetic tests alerting them that they might soon be subject to regulation.

Should consumers be able to send away for their genetic profile that purports to tell them more about the extent to which they might need that aspirin to cut their risk for heart trouble or a stronger SPF to stave off skin cancer? Should only tests with certain health implications, such as cancer risk or drug metabolism estimates, be regulated by the government?

The debate continues, highlighted by two opinion essays published online August 11 in Nature. (Scientific American is part of Nature Publishing Group.) Some argue that health and medical-related tests should be provided only by certified professionals (akin to allowing only licensed radiologists to interpret MRI brain scans). But others assert that tests should be regulated based on the level of risk they pose to the consumer (as medical devices are ranked and evaluated).

The regulatory framework for the FDA’s many charges is a tangled one, influenced by consumer and industry lobbies, government funding trends and innovation-driven changes. Some products, such as prescription drugs, are subject to years of rigorous, peer-reviewed research, whereas others, such as cosmetics, are largely left for makers to determine safety and efficacy.

So far, DTC genetic tests have largely fallen into the latter category. But some tests already have proven scientific track records, such as those that look for an established mutation with firm correlations as in the case of cystic fibrosis. "A categorical ban on DTC testing using validated tests would be difficult for the FDA to justify," Gail Javitt, of the Berman Institute of Bioethics at Johns Hopkins University, wrote in her opinion piece.

Because current genetic tests range from firm mutation-disease risk correlation to murkier gradients of probability, Javitt argued that tests should be regulated accordingly. Simple, clear-cut tests could be sold much like pregnancy tests, making them widely available to consumers. Others with more complex analyses or implications should be administered more like counseling-centered HIV tests or more clinically based diagnostic procedures, she noted. And to ensure consumers aren’t subjected to overstated—or misstated—promises about test results or accuracy, she recommends the U.S. Federal Trade Commission be involved in keeping an eye on the industry.

Others, however, do not think a stepwise approval program is practical. "If the FDA follows through on the approach that it seems to be pursuing—and regulates the interpretation of genetic tests in impractical detail—at best, a huge amount of government time and money will be wasted," Arthur Beaudet, of the Department of Molecular and Human Genetics at Baylor College of Medicine, wrote in his opinion essay. "At worst, genetic diagnostics will grind to a halt." He echoes others in the field who note that many general genetic test results need interpretation and "a level of expertise that is currently the capacity of even most physicians." The easiest approach, for now, he explained, might instead be for the government to relegate all genetic testing to health care settings, where certified professionals can assess and help interpret results.

Perhaps the one thing that both sides of the debate can agree on, however, is that the data generated by these tests will look very different very soon, and "we will be able to interpret them more accurately in one, five or 10 years from now," Beaudet wrote. Impending regulation, however, could have a large influence on how the industry evolves in the future, Javitt noted: "In such a fast-changing landscape, striking the right balance between protecting the public and promoting innovation is crucial."

But trying to make policies today based on estimated progress in the future can be much like calculating long-term health risks with only sketchily understood genetic correlates.

Image courtesy of iStockphoto/zmeel

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  1. 1. outsidethebox 6:53 pm 08/11/2010

    The idea that the FDA is standing between you and your knowledge of your own health situation is obscene. Fascism is alive and well and living in Washington. You’re not an adult. The government will tell you what you can do with your body.

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  2. 2. genegeek 7:30 pm 08/11/2010

    The right to buy a genetic test is really not the issue here. It’s the right to have truly informed consent where the buyer is fully informed about the benefits, risks, and limitations of genetic testing. A form letter signed by a consumer & sent to a DTC company just really doesn’t cut it. It’s disingenuous of DTC companies to frame the issue as the big bad FDA keeping consumers from accessing health information.

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  3. 3. mikecimerian 7:35 pm 08/11/2010

    It is a slippery slope. These tests would be marker specific, not making difference between recessive and expressed traits.

    What is the plan for tailored children, for instance? What about the rebellion genes?

    We are not ready yet to redefine ourselves through applied genetics. Only the wealthy will be able to afford it.

    In vivo gene therapy has moral grounds where life and quality of life is concerned but given the choice parents will seek to alter their children toward what are considered successful genes.

    This form of inequality will compound existing ones.

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  4. 4. galaxy thinker 2:36 am 08/12/2010

    I agree with that everyone has the right to do the genetic test, but the question is not everyone want to accpet the tests.

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  5. 5. galaxy thinker 2:43 am 08/12/2010

    I agree with that everyone has the right to do the genetic tests, however, the question is not everyone will accept the tests, in that, what the purpose of the tests , which realm of the tests results should be apply to? Everyone , of course me, has anxious about that.

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  6. 6. jtdwyer 2:52 am 08/12/2010

    No, I think it’s quite enough for the professional health care industry and government agencies to understand our genetic profiles – we can rely on them to make any genetic decisions in the best interest of the populace, right?.

    Perhaps they could finally develop those long sought after serf genes, producing a future world full of good, happy, productive citizens.

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  7. 7. VixTor 3:36 am 08/12/2010

    Most of the real issues with such tests are with their use by other than the individual; if an individual tests themselves and finds they have genetic markers for heart trouble it may only encourage them to eat better and take asprin. If a company tests an individual they may decide not to give them employment or health insurance.

    If a test later proves to be less accurate than claimed then if only used by individuals on themselves the harm will be less than if used by companies to determine exclusion.

    Regulation should concentrate more on protecting individuals from what could become very intrusive testing based on flawed, immature technology than on restricting who can supply these pee in a pot tests.

    Regulation may only serves to legitimise the industry to a level which at this stage may be premature. If anything it might be safer to have all such tests labelled "for entertainment purposes only" and regulate against use as part of a screening regime.

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  8. 8. dbtinc 8:34 am 08/12/2010

    FDA does a lot of stupid things no doubt but I believe the issue with genetic test kits is a science-based question being asked by FDA. After all, if you listen to some of the opinions here, consumers should have the right to by over the counter prescription medications. I’m hoping reasonable people disagree.

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  9. 9. VixTor 9:20 am 08/12/2010

    What is wrong with letting people have genetic testing kits for their own use on the understanding that this is still an immature technology and in many cases it only gives indicators of certain predispositions based on current understanding?

    Some tests might advise you that you really should take extra care with what you eat while others might suggest you have a known genetic disorder that requires early intervention.

    If the test is for a serious genetic disorder and it comes up positive obviously the first thing you do is go to your doctor for a confirmation test and discussion of treatment / management.

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  10. 10. John_Toradze 5:53 pm 08/14/2010

    These tests should be freely available to anyone who wants to buy them. What should be regulated is the claims that can be made my sellers of the tests.

    Look, I have a PhD. When I get test results back on, say, a blood panel, it has all the numbers with interpretation ranges. Having been involved in setting such ranges, I know how fuzzy they really are. But, most MDs just use them with no better understanding in real terms than the general public has.

    Fact is though, that these results are good enough, nobody has a perfect diagnosis record (nobody who is honest). So those sheets are good enough to just use straight. If they are good enough for MDs, folks, they are good enough for the general public.

    Most people are pretty smart. I learned a long time ago that mostly, the difference between a PhD and a construction worker or anybody else is picking that direction. People can pick up on things and understand them.

    So these tests should be freely available to anybody. They should be required to have interpretation keys and caveats on them, just like anything else. And that’s it. This will lower the cost of health care overall (to insurance companies and medicare) because of earlier interventions.

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  11. 11. John_Toradze 5:57 pm 08/14/2010

    Regarding over the counter prescription buying, people should be allowed to do that. They should be able to apply for a license to buy them. If they have a bachelors or better in biosciences, they should be allowed. I think restrictions on quantity of medication is reasonable – for example, there should be a ceiling on quantity of narcotics, and some should require a prescription. That license would not be protection if a person was reselling medications.

    Others should be able to take a board exam, and if they pass it, they should be able to get the license to buy on their own.

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  12. 12. albeit 2:53 am 08/16/2010

    The government is really, really smart and you the average person are really, really dumb. So of course, they must decide these things for you. Pay no attention to the fact that they were elected by the average, really, really dumb person.

    Perhaps the government should concern itself with cleaning up the disasters it keeps creating in our economy and leave us to individual manage our own affairs. Our health actually matters to us, whereas to politicians it is just something to exploit for their own career advancement.

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  13. 13. snidely222 3:07 pm 08/16/2010

    Why don’t you run a poll on issues like this?

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