Personalized medicine is touted as the wave of the future, but recent government action points to problems for Americans looking to join the health revolution. Last week, California’s Department of Public Health issued cease-and-desist letters to 13 genetic testing startups, threatening to deny service to consumers curious about their DNA.
“Any laboratory offering genetic tests to California residents must be licensed as a clinical laboratory in California. The tests must be ordered by a licensed physician and validated,” reads a statement on the department’s Web site. 23andMe didn’t require a physician’s note when this author and many others used its service, so it seems the company, along with most of the others, may be in trouble.
Despite this threat, 23andMe this week maintained that it is in compliance with California law and is continuing to operate in the state at this time. However, not all genomics firms are taking such an aggressive stance.
Sciona, which tests genes in order to offer nutritional and fitness advice, also received a cease-and-desist letter. The company’s reaction was to yank its US$299 products off the market in both California and New York, another state that is targeting the industry.
Old Rules
Those attempting to read their own genetic data, not somebody else’s, find it appalling that government would stand in the way. One’s genome contains important personal information that each individual should be able to access, without a doctor acting as gatekeeper. Tests like the ones 23andMe supply not only imply possible futures, but also reveal a lot about one’s past. There is something frighteningly Orwellian about government bureaucrats deciding that individuals are not allowed to view their body’s map without official permission.
It is appropriate, of course, for government agencies to enforce the laws on the books, which is what the California’s Department of Public Health is doing. However, when the old rules are so out of sync with the current health landscape provided by new technology, that calls for new rules. As with anything in the technology industry, the faster things are fixed, the better.
At least 13 companies are willing to compete in the genome testing space. Not all firms test for exactly the same things, but the marketplace is vibrant, and that pushes entrepreneurs to innovate. This innovation, if allowed to flourish, will increase the quality of the services and drive prices down over the long run, creating enormous benefit for a population ever more concerned with health issues. If policymakers stall and don’t address the clear mismatch between current reality and old statutes, these benefits will disappear, and the result will be less competition and innovation in the marketplace.
Time for an Update
It would be easy, for example, to imagine bureaucratic dictates and long, drawn-out examinations of the sector that would ensure that only the current leaders, and those with the most money, survive the inquiry. That would mean an artificial shrinking of competition and choice not only for Californians and New Yorkers, but also likely for all Americans, as any company that gets a lock on those two markets will hold a huge advantage.
Governor Arnold Schwarzenegger recently said that “If you have anything to do with biotech, California is one of the best places to set up shop.” At least 13 biotech firms might take issue with that statement after dealing with California’s Health Department.
It’s time for California’s policymakers to address this glaring mismatch between old laws and new technology. Californians need a Freedom of Information Act for their own genetic data, and the sooner they get it, the better.
Sonia Arrison, a TechNewsWorld columnist, is senior fellow in technology studies at the California-based Pacific Research Institute.
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Are you sure that you want the goverment and doctors to have your DNA analyasis?
Lets assume that you want to practice preventive medicine. You truely believe that taking care of yourself will add years to your life. You go to your Doctor and have a DNA test done. The test shows that you have a partial gene for heart disease. Your doctor checks your homocysteine level and advises you to take extra B vitamins. Great you are taking responsibility for your health and your physician is helping.
You are driving home and your car is hit which causes you to fracture your arm. You go to the hospital and follow up with you doctor. For whatever reason you sue the other driver for expenses you incurred. The insurance company request a copy of your file from your doctor. Did you really read the consent form? It normally allows for all information to be release not just information from the accident. Your DNA results have just been sent to an insurance company. Remember you have a Gene that could possibly lead to heart disease. You have just released that information to people who don’t need to know. Yes Congress passed a law that you cannot use genetic results in a way that would harm a person. ie: increased life insurance premiums ect. But there are laws in every state that the use of a gun in a robbery carries a higher level of crime associated with it. I sure that the law stops people from using guns in a robbery.
Also remember that the person that pays the bill for something has the right to it. Insurance companies that pay for genetic testing have the right to the results. Are you sure you want them to have this information?
Once you give away your freedom, it is almost impossible to get it back.
I AM for keeping the government, doctors and insurance companies out of my personal life.
Sure, its great to know about your genome and any pitfalls you may face throughout your life, but what is stopping others from using "genome devices", similar to those in the 1997 movie Gattaca, to enforce discrimination based on your genome.
It is just a movie, but I AM sure it will be used to discriminate if this type of classification is left unregulated.
This article did not consider that the devices which give information about your genome are inaccurate and lead to false conclusions. The fact is most people may not know how to interpret genome information, and worse they can be misled by someone who is not a doctor.
In my view, California is doing the right thing by regulating this emerging field by imposing restriction of validation.
The "new rules" should be imposed to take in to account how the new technology produces genome analysis conclusions. Furthermore, they should hold those responsible for creating the conclusions, to some degree, if they are incorrect.
We should all be weary of the possibility of another type of discrimination fueled in the name of technology. Information is power, but not many people know how to use it, and this often leads to the loss of knowledge and ignorance.