genetics

Beyond 23andMe’s Shutdown: The Role of the FDA in the Future of Direct-to-Consumer Genetic Testing

Kyle Edwards, Uehiro Centre for Practical Ethics and The Ethox Centre, University of Oxford

Caroline Huang, The Ethox Centre, University of Oxford

On November 22, in a harshly worded “warning letter,” the US Food and Drug Administration (FDA) informed the direct-to-consumer genetic testing (DTC-GT) company 23andMe that it had 15 working days to discontinue marketing of its services. By December 5, 23andMe had canceled television, radio, and online advertising and stopped selling its $99 ‘spit kit’ DNA test online.

To put it mildly, the FDA and 23andMe have some communication issues to resolve. A working relationship dating back to 2008 appears to have soured after a six-month period of silence from 23andMe, prompting the warning letter and causing many observers to comment on the apparent stupidity and mystifying nature of 23andMe’s communication ”strategy.” While the FDA’s letter is quite clear that 23andMe must communicate better, particularly in reporting the accuracy of its tests, it is not at all clear on how the FDA plans to regulate companies like 23andMe after these accuracy results are in. Moreover, it hints strongly that some tests may be banned even if they are as accurate as the tests you could receive through a physician. 

Assuming 23andMe follows through on its promise to cooperate with the FDA, how exactly should these DTC-GT services be regulated to best serve the public?

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Caught in the genetic social network

Direct to consumer genetic testing is growing rapidly; 23andMe has hired Andy Page to help the company scale – especially since it aims at having one million members by the end at the year (currently, since its launch, 23andMe has tested over 180,000 people around the world). While most ethics discussion about personal genomics has focused on the impact on individuals (is the risk of misunderstanding or bad news so bad that people need to be forced to go via medical gatekeepers or genetics counsellors? is there a risk of ‘genomization’ of everyday health? and so on), the sheer number of tested people and their ability to compare results can result in interesting new ethical problems, as a friend found out.

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Sin Taxes and Biomarkers

            For years, ‘sin taxes’ – taxes on socially undesirable and/or addictive substances/activities like smoking, alcohol and gambling – have been a source of controversy.  On the one hand, they have been seen as an effective means to raise revenue and reduce consumption of addictive (and generally unhealthy) substances.  On the other hand, sin taxes are generally regressive and are rather paternalistic.  But beyond these typical disputes, recent research has found a new and important dimension to the sin tax debate: genetics.  A study by Jason Fletcher has found that whether or not taxes reduce cigarette consumption depends on the presence of a particular genotype.  This suggests an interesting and novel policy: only apply the cigarette tax to those whose genotype indicates they will respond to the tax.  But is this a sound policy, or should we be keeping biomarkers out of policy debates over sin taxes?  Continue reading

The Myth of Elite Sport

In an interesting article, “Why we’re the best”, Oliver Poole writing in the Evening Standard yesterday claims:

Culture, environment and genes are all cited as reasons for sporting success. But it is practice that really makes perfect.

He cites evidence that it not some genetic advantage that makes Kenyan runners so great but the fact that they run barefoot from an early age. Usain Bolt? It is not that he is biologically very different – his brilliant performances are apparently due to eating yams.

It is a mistake to draw the conclusion that genetic factors are not important in sporting performance from the fact that science has not so far identified genetic contributors to sporting performance.  Our understanding of our own biology is exponentially increasing but still limited. We don’t know what most genes do or even really why humans age. How much of a sporting performance is the result of innate talent, mental determination or training is difficult to say.

It’s certainly true to be a good high jumper you have to train a lot at high jump. But you also have to be tall. And how tall you can be is limited by your personal biology. It may be that elite athletes could come from any country in the world, if only they had the specialized training to bring out the potential of their gifted citizens. But one of the myths of elite sport that many of us cherish is that anyone could be the best, if only he or she tried hard enough. That, I believe, is sadly not true.

Sporting performance is likely to be mixture of innate biological capacity, training and mental application. The opportunity to be the best, or even self-supporting professional, is likely to be open to a small minority. This drives some to take dangerous performance enhancing drugs or give up or be a spectator.

If we were concerned about human well-being, we would shift our concern from elite sport to making sport a part of culture and everyday life, like tai chi. We have become a culture of elite sportspeople, investors in sport, and unhealthy spectators. Sport should be fun, good for you, the opportunity to develop talents and social. And most of all, something which is really open to all. Elite sport is not.

A great sporting performance is a beautiful and admirable thing. But it is better to be a player than a spectator, in sport and in life.

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