Caroline and I have an opinion piece in this week’s New Scientist arguing that regulators should consider the benefits of personal genomics (in terms of increasing genetic literacy and innovation) before imposing excessive regulation on the direct-to-consumer genetic testing industry. Here’s the take-home message:
We don’t yet know what role personal genomics will play in the future of medicine. However, we do know that it has great potential for innovation and education, and we must ensure that neither excessive regulation nor medical paternalism get in the way.
Unfortunately due to space restrictions several sections of our argument were cut – for instance, we spent some time arguing against the idea of arbitrary divisions of tests into “medical” and “non-medical” categories, with the former requiring supervision of a medical professional to receive results. Here’s the original wording:
Unlike many commentators, including the HGC, we do not support an unsustainable division of tests into separate categories, one for health-related tests that require counselling from a medical professional and another for everything else with no such requirement. It is hard to justify the argument that results suggesting a mildly elevated predisposition to obesity require a professional intermediary to provide support, while those indicating unexpected paternity do not.
In general, we would argue that people should be free to access their own genetic data unless there is good reason to believe that doing so will cause them real harm – and as long as the information is accurate and transparent. Companies should ensure that customers have access to expert advice if they want it, but medical supervision should not be a requirement for access to your own genome.
But three things argue against wholesale regulation. First, the level of interference needs to be based on the level of risk a test represents. The government does not need to be involved if someone decides to trace his ancestry or discover what type of earwax he has. Second, the laws on fraud should be sufficient to deal with the snake-oil salesmen who promise to predict, say, whether a child might be a sporting champion. And third, science is changing very fast. Fairly soon, a customer’s whole genome will be sequenced, not merely the parts thought to be medically relevant that the testing companies now concentrate on, and he will then be able to crank the results through open-source interpretation software downloadable from anywhere on the planet. That will create problems, but the only way to stop that happening would be to make it illegal for someone to have his genome sequenced—and nobody is seriously suggesting that illiberal restriction.
Instead, then, of reacting in a hostile fashion to the trend for people to take genetic tests, governments should be asking themselves how they can make best use of this new source of information. Restricting access to tests that inform people about bad reactions to drugs could do harm. The real question is not who controls access, but how to minimise the risks and maximise the rewards of a useful revolution.
It’s great to see these issues getting sensible discussion in the wider media; let’s hope the FDA is paying attention.