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</o:shapelayout></xml><![endif]--></head><body lang=EN-US link=blue vlink=purple><div class=WordSection1><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'>From:</span></b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'> extropy-chat-bounces@lists.extropy.org [mailto:extropy-chat-bounces@lists.extropy.org] <b>On Behalf Of </b>Mike Dougherty<br><b>Sent:</b> Wednesday, November 27, 2013 7:14 AM<br><b>To:</b> ExI chat list<br><b>Subject:</b> Re: [ExI] FDA Tells Google-Backed 23andMe to Halt DNA Test Service<o:p></o:p></span></p><p class=MsoNormal><o:p> </o:p></p><div><div><div><p class=MsoNormal>On Wed, Nov 27, 2013 at 6:14 AM, BillK <<a href="mailto:pharos@gmail.com" target="_blank">pharos@gmail.com</a>> wrote:<o:p></o:p></p><div><p class=MsoNormal><o:p> </o:p></p></div><p class=MsoNormal style='margin-bottom:12.0pt'><span style='color:#1F497D'>>>…</span>However the FDA are getting annoyed after four years of discussion, so<br>may take other actions like an injunction to stop the business and<br>civil monetary penalties. Google are probably not worried about<br>monetary penalties, but going by history it is not wise to pick a<br>fight with the FDA.<o:p></o:p></p><div><p class=MsoNormal><o:p> </o:p></p></div><div><p class=MsoNormal><span style='color:#1F497D'>>…</span>So you can "ask your doctor" about drugs for your scaly, red, itching skin that has a side effect of "death" or some heartburn meds that give you low magnesium levels and risk of bone fractures - but you can't swab some spit into a cup because the resulting test(s) has the effect of education about information you might not be prepared to learn?<o:p></o:p></p></div><div><p class=MsoNormal><o:p> </o:p></p></div><div><p class=MsoNormal><span style='color:#1F497D'>>…</span>Seems like the addition of disclaimers like "for entertainment purposes only" or "not intended to diagnose or treat..." would be sufficient to tell the FDA to get the hell out of my business.<o:p></o:p></p></div><div><p class=MsoNormal><o:p> </o:p></p></div><div><p class=MsoNormal><span style='color:#1F497D'>>…</span>But I guess that IS the FDA business, isn't it?<span style='color:#1F497D'><o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>BillK, in the USA, it can cost over 500 million dollars to get FDA approval for a new drug or medication. For decades, the USA was doing the heavy lifting on developing new drugs and proving efficacy, with its medicine-for-profit system. The entire world benefitted. The price of that FDA approval eventually got high enough that it is not profitable for a company to develop new antibiotics, so that ended. The bugs are evolving around our older drugs. That is a perfect example of a violation of the Hippocratic notion of doing no harm.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>23andMe is related to Google. Now there’s company. It just showed up one day, back in the late 90s. I have used it nearly every day since that time. It is competent in figuring out what you want even if you don’t really know yourself, then finding it for you, and it is FREEEEEE! It’s the libertarian’s dream: it empowered the proletariat with KNOWLEDGE! A pauper could be living in a cardboard box and eating out of the dumpster behind Kentucky Fried Chicken, wrapping the body in discards from the Salvation Army, yet could walk over to the public library, get on their computers on Google and there is the world’s wisdom, right there, just as accessible to the completely penniless pauper as it is to the Italian-suited executive. In some ways, it is more accessible to the pauper: she has plenty of time. The executive is busy as hell and has no time for Googling.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>23andMe is a product which does no harm but does plenty of good. Example: 23andMe reveals you have both markers for Farklestein’s schnarkoma, an obscure disease which your former doctor never heard of (your former doctor is the doctor you liked and can keep period end of story.) Even if penniless and living in a box down by the tracks, the pauper can go to the library, google on Farklestein’s and educate herself on how to deal with it, and while she is there, she can google on where some local will give her food. A pauper *<b>might</b>* be able to scrape together a hundred bucks for a spit kit. I see people handing cash to clearly phony will-work-for-fooders, I have done it myself (I try to not make a habit of it.)<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>So let’s see a showdown between 23andMe vs the FDA. This is a fight which has been long brewing. There appears to be a clear moral right and wrong here. It does to me. What does it look like from that side of the Atlantic?<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoPlainText>>…Note that the FDA is not complaining about the genealogical DNA analysis. You can still trace your relatives and there are other companies doing this analysis. No problems with that.<o:p></o:p></p><p class=MsoPlainText><o:p> </o:p></p><p class=MsoPlainText>>…It is the medical 'snake-oil' that the FDA doesn't like. And it has a lot of medical and scientific support.<o:p></o:p></p><p class=MsoPlainText>Do these DNA risk factors mean anything? What about all the other genes and epigenetic factors not checked? What about false positives and false negatives? Do these tests actually work? It is all unverified.<o:p></o:p></p><p class=MsoPlainText><o:p> </o:p></p><p class=MsoPlainText>>…I think it is too early to be making health recommendations. We don't know enough about how our DNA affects us and how genes interact with each other. More research is required.<o:p></o:p></p><p class=MsoPlainText><o:p> </o:p></p><p class=MsoPlainText>>…Maybe if 23andMe enhanced the genealogy side and toned down the medical side to vague 'worth asking your doctor about' hints, they might keep the FDA happy…BillK<o:p></o:p></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Ja to all. I received this seconds before I hit send. I think you are right, but at this point I am not sure we want to keep the FDA happy. I think it is time to stand and fight. We have let the FDA strangle us for too long. Time to stand and show some of that good old American don’t-tread-on-me grit in the face of a battle I think the people can win. In the setting of a spectacular failure of bureaucratic control over medicine, and a spectacular success of a private enterprise, the time is right for a test case, especially considering it is an odd year, so the halls of congress will soon be vacated, the representatives off campaigning for re-election.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>spike<o:p></o:p></span></p></div><div><p class=MsoNormal><o:p> </o:p></p></div><div><p class=MsoNormal> <o:p></o:p></p></div></div></div></div></div></body></html>