According to this Union Tribune article: FDA halts sale of 23andMe DNA tests | UTSanDiego.com, (and NBC News) the FDA has stopped 23andMe from selling their personal DNA analysis "kits." (FDA Letter Posted on Internet) In this case, 23andMe could simply not report on some of the controversial findings and continue to do business. I'd bet that's what they'll do, until the more controversial findings are resolved. However, I think this is a major issue,and it is sort of at the center of a major junction of issues involving DNA testing. Issues may need to be resolved by legislation or court decisions. Those issues include moral, ethical, financial, and personal rights. The decision is also fascinating because it involves investments made by Google, and a recently highly successful San Diego company Illumina. Illumina makes the "chips" that are used in DNA testing, and the company's stock has had an immense run-up recently. 23AndMe was founded in 2006 in San Diego by Anne Wojcicki, Linda Avey, and Paul Cusenza. Wojciki married Google co-founder Sergey Brin, which is probably why Google has investment in the company. In 2008 Time magazine identified 23AndMe's testing as the best invention of the year.
When 23AndMe first started out, the FDA wasn't really interested. All of the sudden in 2010 they wanted definitive proof that all of the DNA testing is accurate. Why the sudden "change of heart?" Should the FDA even be involved with DNA testing? DNA testing could be considered to be similar to fortune telling. You give the fortune teller a lock of hair, and are told what might happen to you in the future. In this case, you spit in a bottle, send it in and are told the probabilities that you might be diagnosed with different diseases. Fortune telling isn't regulated by the FDA -- why should this? There is also some belief that there are rivalry between various doctors, jealousy, and issues of competition from other start-up companies who would like to throw stumbling blocks in front of the leader (23 and Me) so they can catch up. Should 23 and Me be forced to make public all of their DNA work and analysis that they use in making their assessments? If so, that gives away all of their expensive research, so that other companies can use it to compete directly with 23 And Me. Much of that sort of information is also complicated by the lack of ability to patent information about DNA markers, and the recent US Supreme Court decision.
Just a few years ago, the company charged about $400 and evaluated about 90 medical conditions. Now it only costs $99 and does many more (250) conditions. I'm sure the FDA expects the number of genetic markers evaluated to continue to increase, and the cost may even continue to fall. Possibly other companies, and companies in other countries will also begin to do genetic testing. At a $100 price, it would seem that it's within the price range that everyone would want to know. If the price continued to drop, I would think for sure that everyone would have DNA testing done for themselves and their children.
The FDA is apparently concerned about affects on "public health" -- which seems rather vague. I speculate that could mean:
1. FDA is concerned that people who are told they might be susceptible to certain diseases could request treatments or medications based upon that information, which could overload the US public health "system."
2. Some percentage of those treatments or medications may be unnecessary or harmful to patients
3. Patients who have knowledge gained from DNA testing will have an unfair advantage in buying life and health insurance. If a patient knows they have a high probability of being diagnosed with an "expensive" or fatal disease, they would, in effect, be cheating when they bought expensive insurance policies. Should they be required to disclose to insurance providers? Should insurance providers do their own testing?
4. There are also moral & ethical issues related to DNA testing. For example: Should a person disclose to a potential spouse their DNA test results if they know they are likely to encounter a serious medical condition?
I think it will be very interesting to see how these issues are resolved in the future. I wonder how other countries will react to the same situation. Could US Citizens go to another country to have their DNA tested? Could we send a bottle of spit to another country to have it tested outside of the FDA authority?
When 23AndMe first started out, the FDA wasn't really interested. All of the sudden in 2010 they wanted definitive proof that all of the DNA testing is accurate. Why the sudden "change of heart?" Should the FDA even be involved with DNA testing? DNA testing could be considered to be similar to fortune telling. You give the fortune teller a lock of hair, and are told what might happen to you in the future. In this case, you spit in a bottle, send it in and are told the probabilities that you might be diagnosed with different diseases. Fortune telling isn't regulated by the FDA -- why should this? There is also some belief that there are rivalry between various doctors, jealousy, and issues of competition from other start-up companies who would like to throw stumbling blocks in front of the leader (23 and Me) so they can catch up. Should 23 and Me be forced to make public all of their DNA work and analysis that they use in making their assessments? If so, that gives away all of their expensive research, so that other companies can use it to compete directly with 23 And Me. Much of that sort of information is also complicated by the lack of ability to patent information about DNA markers, and the recent US Supreme Court decision.
Just a few years ago, the company charged about $400 and evaluated about 90 medical conditions. Now it only costs $99 and does many more (250) conditions. I'm sure the FDA expects the number of genetic markers evaluated to continue to increase, and the cost may even continue to fall. Possibly other companies, and companies in other countries will also begin to do genetic testing. At a $100 price, it would seem that it's within the price range that everyone would want to know. If the price continued to drop, I would think for sure that everyone would have DNA testing done for themselves and their children.
The FDA is apparently concerned about affects on "public health" -- which seems rather vague. I speculate that could mean:
1. FDA is concerned that people who are told they might be susceptible to certain diseases could request treatments or medications based upon that information, which could overload the US public health "system."
2. Some percentage of those treatments or medications may be unnecessary or harmful to patients
3. Patients who have knowledge gained from DNA testing will have an unfair advantage in buying life and health insurance. If a patient knows they have a high probability of being diagnosed with an "expensive" or fatal disease, they would, in effect, be cheating when they bought expensive insurance policies. Should they be required to disclose to insurance providers? Should insurance providers do their own testing?
4. There are also moral & ethical issues related to DNA testing. For example: Should a person disclose to a potential spouse their DNA test results if they know they are likely to encounter a serious medical condition?
A Scientific American Forum Blog by Charles Seife says: "The genetic-testing company’s real goal is to hoard your personal data." He believes that the ultimate purpose of 23andMe is to collect the genetic information for a database. That database could become extremely valuable for genetic research, similar to Google's search database. From a public health perspective, I think the optimum situation would be to have a massive global database that contains everyone's family history of diseases, and everyone's DNA evaluations. That extremely valuable database could then be "mined" to determine the effect of the many DNA markers on disease, and most likely help in preventing the diseases. However, there would be major issues of privacy and security involved in such a database. Also, since the DNA testing is just in its infancy, there are probably lots of errors. So any such database would be "contaminated" by the errors.
I think it will be very interesting to see how these issues are resolved in the future. I wonder how other countries will react to the same situation. Could US Citizens go to another country to have their DNA tested? Could we send a bottle of spit to another country to have it tested outside of the FDA authority?
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