My Genes, not a Doctor's

California has sent cease-and-desist letters to firms offering Web gene tests to consumers. The legal reason is that California law requires a licenced physician to order any lab tests. This follows from a similar crackdown in New York. Wired responds by top 10 reasons that regulators should not hinder genetic testing. Is there any good reason to limit public access to genetic testing besides protecting incumbents and gatekeepers?

A common argument against free access to genetic information is that bad news may be harmful. Karen Nickel, chief of laboratory field services for the California Department of Public Health, says about the tests "they are scaring a lot of people to death." But that seems to be an exaggeration; I know no evidence that many people are being stressed out by what they are finding out. On the contrary, most appear disappointed by the conventional medical risks they get in their evaluations.

If the psychological risk of getting a negative prediction about future health is so bad that it merits preventing the ability for anyone to get a prediction, it would seem to apply with the same strength to many other kinds of tests like blood pressure - or home pregnancy tests. Most people appear relatively phlegmatic about possible risks unless they are a rare message of mortality like Huntington's disease. The direct effect of knowing that one has a higher risk of a certain cancer type is relatively minor - there will be many other factors in life that matter. Emotionally, paternity tests are probably far more risky than gene tests.

A more relevant criticism is that the tests may not be accurate or have medical utility. It is still early days both in terms of DNA chips and interpreting the results in terms of medical information. Hence there is a valid case for ensuring that consumers of health information are not fooled by exaggerated claims. The crackdown appears in part to have been triggered by consumer complaints about low accuracy and high cost. But this is no good argument to prevent testing, just to prevent bad business practice. Similarly lack of medical utility is not a show-stopper. I might want to know my genes just out of curiosity, as a way of self-expression or to compete with my brother in who is the least likely to get arteriosclerosis. As long as the test is paid for by the consumer there is no reason to prevent it. This is going to be even more relevant as personal sequencing becomes common, since  new ways of interpreting the information in a person's genome will become available in the future: the utility of a scan is going to be increasing over time.

One reason to limit personal genetic testing is that it could worsen information imbalances between customers and insurance companies. If I learn things about my health my insurer is not allowed to inquire about (as per the anti-genetic discrimination laws in most western countries) I will be able to profit relative to the insurer. However, it is not clear that this would be a major problem given the uncertainties in gene testing and the margins of insurance companies. If it were a problem the anti-genetic discrimination laws could be changed, either giving insurers legal access to the results, or the market could segment between companies that do not test and companies that test. 

The strongest argument for free genetic testing is personal autonomy and integrity. I have a right to know my own bodily/medical information regardless of why I wish to know, and a right to control who gets access to this information. My genetic information is clearly mine in a very strong sense. Requiring a physician to act as a gatekeeper to personal information infringes on my integrity and limits my autonomy. As Thomas Goetz says, "Regulation should protect me from bodily harm and injury, not from information that's mine to begin with."

Even if genetic testing was the realm of schysters and incompetents, even if people were often frightened by inaccurate predictions that were of no practical use except playing against insurance companies, the right to control and understand one's own body would trump these concerns. We might certainly wish to reduce the problems, but we cannot do that by blocking autonomy and integrity.

Comments

[Mr. Gunn]

I think you've pretty much nailed the main points. It's your DNA, so it's your data. Also, SNP analysis reveals non-medical information such as ancestry, so it's nonsensical to make overworked doctors the gatekeepers of that info. As I expected, it's a regulatory dinosaur that is confusing this technology with DTC genetic tests that they've had issues with in the past. Someone will speak to Mrs. Nickels and if she's as sharp as they say she is, she'll realize the difference between the two. Hopefully by then the fraudsters will have moved on, too.