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Published online 25 June 2008 | Nature | doi:10.1038/4531148a
Gene-testing firms face legal battle
The state of California is clamping down on companies that offer direct-to-consumer genetic testing in a move that threatens the burgeoning industry. Meredith Wadman looks at a grey area in US regulation.
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Stefansson is right, telling people 'you cannot order a test like this for yourself without going to a physician' is a violation of rights. Like many other "government approved/licensed/regulated" things, there is no value added. If a state provided a guarantee it might be adding value. A consumer obtaining such a service with a firm who followed the rules and regulations to the T, cannot sue the state for malpractice if that service doesn't do what the state says the service must be. Its still Buyer Beware. When the consumer obtains no practical and proven value with state interference in a matter, the only value added is to the state. They might as well require a local mechanic to order any diagnostic exam of your automobile..."for the protection of the consumer." This just means the state gets a slice of the commerce in addition to any sales tax...to employ more people to protect you who can't.
Although I would usually agree that less governmental regulation is better, I have to disagree in this case. Direct to consumer genetic testing has great potential for harm to the consumer, in ways the consumer may not immediately recognize when he/she requests testing. A big concern is that genetic information could result in loss of eligibility for health insurance coverage, whether legally or illegally. Another very important issue is followup; if an individual is a carrier for certain genetic traits, cancer susceptibility for instance, medical counselling and followup is essential. People are likely to either over- or under-react to genetic information if they aren't given appropriate counselling about the meaning of the result. I have a hard time believing that a company doctor, who has no access to the patient's medical record, and who is remotely situated, could come anywhere close to providing appropriate counselling.
There are already several laws preventing the use of genetic information such as these in discriminatory practices in the realm of employment, benefits, insurance, and pretty much anything conceivable. This has been in place for some time now and has successfully blocked malicious use of any such information. Either way, the information provided by these companies is only made available to the consumer and of course, if the consumer wants to, his/her physician. Proper counseling is provided by several of the companies either through physicians, genetic counselors, or both. Furthermore, this is not tantamount to the regular bloodwork that comes out of a hospital lab - it isn't riddled with scientific jargon. Rather, the information is processed and presented in a consumer friendly manner so people understand what it means and not just the numbers. Finally, people are much more scientifically savvy nowadays - you don't need to be a PhD to understand a simple risk assessment about yourself. People routinely shop around for oncologists when they are diagnosed with cancer and are intelligent enough to choose a physician who addresses their needs. Does it really make sense that they wouldn't be able to query about their genetic information without a doctor holding their hand?
Restrictive rules for genome companies is a poor decision unless these rules truly protect people. If I had a few thousand to spare I would have my genome "done." It's better than buying lottery tickets with little hope of getting anything in return.As it is now, most people know very little about their DNA except for familial conditions. Knowing something is bettr than knowing next to nothing.As with all businesses, do your homework, educate yourself, choose the company wisely & buyer beware. There is abundant information on the internet. I envision the day when genome testing will be commonplace and done at various intervals over a person's lifetime in order to detect any changes--epigenetic, for example--which could be remedied before these changes have severe consequences.Insurance companies may not want to cover the costs , but it will, in the long run, be more cost-effective than repeated CTscans, MRI's, expensive medication, etc. It's the wave of the future. If the chocolate genome can be sequenced, why not the human!