tag:blogger.com,1999:blog-61733933622237420122024-03-12T20:03:19.767-07:00Gene Sherpas: Personalized Medicine and YouTo usher in the new paradigm of personalized medicine we will need to travel a perilous path. Much like the route through the Himalayas it has punished the naive and self-reliant. That is why I have dedicated my life to being a Gene Sherpa. What is a gene sherpa? The Sherpa speaks the language of the trail, he/she knows short cuts and dangerous paths to avoid. This blog is for those wishing to take the journey and those wishing to become Gene Sherpas.Steve Murphy MDhttp://www.blogger.com/profile/11774190000307343476noreply@blogger.comBlogger670125tag:blogger.com,1999:blog-6173393362223742012.post-36034748368005937642013-12-05T19:55:00.000-08:002013-12-05T19:55:07.583-08:0023andMe grows up. Works to obtain 510k<div class="separator" style="clear: both; text-align: center;">
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<a href="https://www.23andme.com/health/" target="_blank">23andMe</a> has agreed to comply with the laws of the country in which they operate. Congratulations.<br />
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"<span style="background-color: white; color: #111111; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif, serif; font-size: 14px; line-height: 22px;">At this time, we have suspended our health-related genetic tests to comply with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process. In the future, you may be able to receive health-related results, dependent upon FDA marketing authorization."</span><br />
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<span style="background-color: white; color: #111111; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif, serif; font-size: 14px; line-height: 22px;">I remember speaking with Jim Woodman when he was at Pathway Genomics. We were discussing how fantastic it would be to work with physicians to develop a NGS testing service that would work seamlessly. I told him, that it is the best mass marketing they could do, because I felt their test was a medical device and that if they landed a big distribution deal, they could be subject to FDA scrutiny. He laughed and said, "We appreciate your point". <a href="http://www.huffingtonpost.com/2010/05/13/walgreens-will-not-stock_n_574538.html" target="_blank">2 days later they announced the Walgreens Deal</a>. </span><br />
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<span style="background-color: white; color: #111111; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif, serif; font-size: 14px; line-height: 22px;">In less than 24 hours,<a href="http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm211866.htm" target="_blank"> the FDA chimed in</a>. I knew this simply and<a href="http://thegenesherpa.blogspot.com/2009/09/why-dtc-genomics-is-medicine_9931.html" target="_blank"> posted on this in 2009</a>. Heck, <a href="http://friendfeed.com/the-life-scientists/b54e43da/genetic-future-cat-fight-over-california" target="_blank">everyone was pissed at me for saying this 5 years ago</a>. SNP+ Interpretation is medicine.</span><br />
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<span style="background-color: white; color: #111111; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif, serif; font-size: 14px; line-height: 22px;">I remember watching the first 23andMe ad on television. I was drinking a nice IPA. It nearly came out of my nose. I saw another one a day later. Then another. I said to myself, Oh My God! Google has bought the FDA.......</span><br />
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<span style="background-color: white; color: #111111; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif, serif; font-size: 14px; line-height: 22px;">I was actually wrong. The<a href="http://www.bloomberg.com/news/2013-11-25/fda-tells-google-backed-23andme-to-halt-dna-test-service.html" target="_blank"> FDA said, stop marketing your test</a>. Then, I really followed this closely, as you can imagine. Some like Misha Angrist may say with some schadenfreude. But no, no. I am pained yet again. Companies keep making the same mistake. Arrogance, neglect for laws. Remember, this is the team, that<a href="http://thegenesherpa.blogspot.com/2009/03/23andme-says-have-no-use-for-your-laws_5662.html" target="_blank"> I had to force to get an IRB</a> and also had to force to use a CLIA approved lab.</span><br />
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<span style="background-color: white;"><span style="color: #111111; font-family: Helvetica Neue, Helvetica, Arial, sans-serif, serif;"><span style="font-size: 14px; line-height: 22px;">They set back personalized medicine. Some fools climb the mountain without a Sherpa. This is what happens. For all those entrepreneurs who don't want this mistake. Email me thegenesherpa@gmail.com</span></span></span><br />
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Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com2tag:blogger.com,1999:blog-6173393362223742012.post-44819394642263806322013-11-25T17:38:00.004-08:002013-11-25T17:39:35.913-08:0023andMe received the FDA CRL. Response letter. Cease and Desist to follow?<br />
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<a href="http://2.bp.blogspot.com/-imJRYAcKW-Q/UpP7cZxAOQI/AAAAAAAAANk/UHRG3aCI3qQ/s1600/photo+(6).JPG" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="320" src="http://2.bp.blogspot.com/-imJRYAcKW-Q/UpP7cZxAOQI/AAAAAAAAANk/UHRG3aCI3qQ/s320/photo+(6).JPG" width="213" /></a></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><a href="http://thegenesherpa.blogspot.com/2009/11/argument-23andserge-can-win23andme-but_4221.html" target="_blank">Like I said</a>. </span><br />
<a href="http://thegenesherpa.blogspot.com/2009/03/23andme-says-have-no-use-for-your-laws_5662.html" target="_blank"><span style="font-family: Arial, Helvetica, sans-serif;">They Blew Off Laws</span></a><br />
<a href="http://thegenesherpa.blogspot.com/2009/03/23andme-to-do-research-one-question_3893.html" target="_blank"><span style="font-family: Arial, Helvetica, sans-serif;">Ignored Age Old Research Protocols, like an IRB</span></a><br />
<a href="http://scienceblogs.com/geneticfuture/2009/03/23/steve-murphy-23andme-are-terro/" target="_blank"><span style="font-family: Arial, Helvetica, sans-serif;">I was made fun of.....</span></a><br />
<a href="http://thegenesherpa.blogspot.com/2012/07/23andme-proves-sherpa-right-and-kisses.html" target="_blank"><span style="font-family: Arial, Helvetica, sans-serif;">They Played nice with the FDA</span></a><br />
<a href="http://www.forbes.com/sites/matthewherper/2013/11/25/23andstupid-is-23andme-self-destructing/" target="_blank"><span style="font-family: Arial, Helvetica, sans-serif;">Then Blew Them Off</span></a><br />
<a href="http://www.adweek.com/news/advertising-branding/23andme-has-new-personal-genetics-pitch-arnold-ny-151705" target="_blank"><span style="font-family: Arial, Helvetica, sans-serif;">Advertised on TV</span></a><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">And really expected to<a href="http://www.usatoday.com/story/news/nation/2013/11/25/23andme/3699329/" target="_blank"> get away Scott Free</a>??? Really??? <a href="http://www.fastcompany.com/3018598/for-99-this-ceo-can-tell-you-what-might-kill-you-inside-23andme-founder-anne-wojcickis-dna-r" target="_blank">Fire Anne Woj......</a></span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;"><a href="http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm" target="_blank">FDA says, no way</a>! Stop Selling, just like they did with <a href="http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm211866.htm" target="_blank">Pathway and Walgreens</a>.....</span><br />
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<b><span style="color: red; font-family: Arial, Helvetica, sans-serif;">The Sherpa Says: Don't play games with the FDA</span></b><br />
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<br />Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com1tag:blogger.com,1999:blog-6173393362223742012.post-62279228678512397762013-10-20T08:02:00.001-07:002013-10-20T08:02:28.706-07:0023andMe GATTACA children Patents, Google Master Race<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span>
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<a href="http://2.bp.blogspot.com/-i6f1n4N0yhY/UmPvyr09IRI/AAAAAAAAALU/YoSTmjaC43c/s1600/sergey-brin-anne-wojcicki-23andme-google.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="128" src="http://2.bp.blogspot.com/-i6f1n4N0yhY/UmPvyr09IRI/AAAAAAAAALU/YoSTmjaC43c/s320/sergey-brin-anne-wojcicki-23andme-google.jpg" width="320" /></a></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">(Sergey and Anne, divorced now)</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">I have not posted in forever. Before I used to post on novel efforts for Personalized Medicine I thought would be promising. Some of those are coming closer, like CardioDX or HCV genotypic treatment.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">I also would post on things I thought would stall and distract us. One of the biggest culprits to this in my humble opinion was the model of Direct to Consumer testing that offered medical test results. </span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Why did I opine on this? Why was I so concerned? In 2007 I stared at Linda Avey and I saw the <a href="http://thegenesherpa.blogspot.com/2009/03/23andme-says-have-no-use-for-your-laws_5662.html" target="_blank">total lack of concern to duty for the noble calling</a>. I also saw a lack of concern for patient lives. 23andMe repeatedly have <a href="http://thegenesherpa.blogspot.com/2011/09/back-again-23andme-still-hits-bed-with.html" target="_blank">incorrect testing results</a>, their <a href="http://thegenesherpa.blogspot.com/2012/01/23andme-buyer-beware-internet-doesnt.html" target="_blank">desire to use a database for genomic patents</a>, their desire to <a href="http://thegenesherpa.blogspot.com/2009/03/23andme-to-do-research-one-question_3893.html" target="_blank">end around research ethics by first doing research without an IRB</a>. This information prompted me to write a scathing warning in Nature Biotechnology in May of 2009. "<a href="http://www.nature.com/nbt/journal/v27/n5/full/nbt0509-422.html" target="_blank">In need of a reality Check</a>" serves as a reminder that mega-lord <a href="http://www.nature.com/nbt/journal/v27/n5/full/nbt0509-422.html" target="_blank">Tech companies are dedicated to profit, not to the hippocratic oath</a>. Not that I begrudge them for that. I just feel my country should contemplate what a company should be doing in the human care and healthcare space.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">When asked what is the duty of a DTC company to offer follow up or change of a variant of uncertain significance or interpretation. Joanna Mountain looked at Linda Avey, Linda nodded and Joanna said "We don't have a duty to follow up!"</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">I was incredulous and countered this assertion. I said, as a physician when I do genetic testing, I have a duty to follow up. Dietrich Stephan from Navigenics said "We have a subscription model which will do this"</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Navigenics is now dead. Why? They weren't funded by Google. Let me tell you something about the company that is now 1000 USD per share. They are dedicated to bringing the future. This is valuable.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">What is scary? The future<a href="http://www.youtube.com/watch?v=9zKXCQpUnMg" target="_blank"> they are bringing is THEIR future</a>. The companies they fund, like 23andMe and their CEO "Forbes' most daring" to bring about <a href="http://www.youtube.com/watch?v=9zKXCQpUnMg" target="_blank">what they THINK we all should be doing and thinking</a> and <a href="http://www.yourgeneticgenealogist.com/2011/12/23andme-changes-tos-for-expired-pgs.html" target="_blank">gobbledeegook of a terms of service states these things</a>!</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">As a business it is brilliant. As an ethical company to grow mankind.....well, not so much IMHO.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Now the evidence I missed. 23andMe a Google funded company has applied for Patents that cover creating a master race according to <a href="http://www.nature.com/gim/journal/vaop/ncurrent/full/gim2013164a.html" target="_blank">parent specifications via preimplantation genetic diagnosis</a>. Not rare, fatal diseases. Rather, eye color, hair color, height. How can they do this? <a href="http://venturebeat.com/2013/09/20/how-to-use-23andme-without-giving-up-your-genetic-privacy/" target="_blank">You have given up your genetic privacy!</a> Even Venture Beat mentions is. Heck, I wonder <a href="https://www.23andme.com/about/privacy/" target="_blank">how many Genomes</a> were given up to the <a href="http://venturebeat.com/2013/06/17/snowden-apple-facebook-denials/" target="_blank">NSA via PRISM</a>.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;"><a href="http://www.nature.com/gim/journal/vaop/ncurrent/full/gim2013164a.html" target="_blank">I didn't believe it when I read it </a> but then I went and did a patent search. It is indeed correct. <span style="background-color: white; color: #333333; font-size: 14px; line-height: 23.90625px;">US Patent No. 8543339</span></span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">So when you are spammed with the heavy amount of tweeting ads that @23andme is pumping out or the ads on FoxNews (Rupert Murdoch investor?) and other channels, think about what my warning. When hoping that Google or 23andMe will keep their customers safe and healthy, don't hold your breath. While physicians have taken an oath to first do no harm, <a href="http://www.nature.com/nbt/journal/v27/n5/full/nbt0509-422.html" target="_blank">Technology companies nor the "Internet" have taken no such oath!</a></span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;"><b><span style="color: red;">The Sherpa Says: Do we want an America that <a href="http://www.nature.com/gim/journal/vaop/ncurrent/full/gim2013164a.html" target="_blank">grants 23andMe patents for creating Master Races?</a> Really?</span></b> </span><br />
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<br />Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com0tag:blogger.com,1999:blog-6173393362223742012.post-11038367376158389592013-02-19T19:18:00.002-08:002013-02-19T19:18:24.253-08:00Coriell Spinoff Allows Biobanking of Patient Genomes!<div class="separator" style="clear: both; text-align: center;">
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<span style="font-family: Arial, Helvetica, sans-serif;">Has anyone <a href="http://www.technologyreview.com/news/510901/the-bank-where-doctors-can-stash-your-genome/" target="_blank">seen this cool idea</a>? Coriell Institute is spinning off a very cool idea. </span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Coriell and IBM will be collaborating to store patient genomes for cloud based analysis. </span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">While it is certain to face detractors due to security concerns and perhaps competing systems.......</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;"><span style="line-height: 20px;"> “I am a bit concerned if we really start to outsource data to the cloud without any regulation,” says </span><a href="http://www.emilianodc.com/" style="border: 0px; color: #206f96; font: inherit; line-height: 20px; margin: 0px; padding: 0px; vertical-align: baseline;" target="_blank">Emiliano De Cristofaro</a><span style="line-height: 20px;">, a cryptography scientist with Xerox’s PARC who is developing a genomic data storage and sharing platform. “We must not forget that the sensitivity of genomic information is quite unprecedented,” he says"......</span>It is highly likely to succeed. </span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">While I agree security is paramount......you really can't go wrong with IBM. Seriously. I am certain, given Coriell's stance on their research collaborative (Full disclosure, I sit on both the ICOB and PAG boards) which is utmost science and peer review, that they will also be just as scrupulous with this new spin off company!</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">This of course had all been in the works for months now, as it was telegraphed in November of last year <a href="http://www.smartplanet.com/blog/ideas-insights/the-case-for-putting-genomic-data-in-the-cloud-securely/194" target="_blank">ON IBM's blog SmartPlanet</a></span><br />
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<span style="color: red; font-family: Arial, Helvetica, sans-serif;"><b>The Sherpa Says: This cloud based storage and analysis is the future. Given the security challenges, you must have an excellent IT partner. Coriell has chosen wisely as will succeed with this venture</b></span>.<br />
<br />Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com0tag:blogger.com,1999:blog-6173393362223742012.post-35495541868367465232012-12-30T18:52:00.004-08:002012-12-30T18:52:54.653-08:002013 what predictions? Eh Sherpa<div class="separator" style="clear: both; text-align: center;">
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<span style="font-family: Arial, Helvetica, sans-serif;">Ok. I just put this here because I like Andrew Dice Clay. Here's my take. Let's look at what happened in 2012 and my predictions.</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">Here's what I said</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><span style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;">1. In regards to DTC Genetics, the <a href="http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM215240.pdf" style="color: #223344;" target="_blank">FDA won't shut you down if you are google</a>.<a href="http://thenextweb.com/lifehacks/2011/04/11/23andme-offers-free-dna-testing-on-sale-today-only/" style="color: #223344;" target="_blank">But you will have to give your test away for free to build your database</a></span><br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><span style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;"><br /></span>If 99 dollars isn't giving it away, I have no clue what is</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br style="background-color: #eeeecc;" /><span style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;">2. In regards to Pharmacogenomic testing, most doctors won't use the service <a href="http://www.ncbi.nlm.nih.gov/pubmed/21460130" style="color: #223344;" target="_blank">despite studies showing utility</a> that have existed for 2 years.</span></span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;"><span style="color: #333333; line-height: 18.899999618530273px;"><span style="background-color: white;">They still didn't in 2012</span><span style="background-color: #eeeecc;">.</span></span><br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><span style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;">3. In regards to GWAS predisposition testing, <a href="http://www.psych.umn.edu/courses/fall10/psy8935/readings/latham2010.pdf" style="color: #223344;" target="_blank">it is mostly useless</a>. It doesn't scare or heal you.......most of the time</span></span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Nothing has changed science wise with this statement<br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><span style="color: #333333;"><span style="line-height: 18.883333206176758px;">So Now, after months off I have to come up with brilliance. Really?</span></span></span><br />
<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;"><span style="line-height: 18.883333206176758px;">Navigenics=Dead DecodeMe=Dead Pathway=Weight Loss genetics 23andMe=Giving tests away next to free</span></span><br />
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<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;"><span style="line-height: 18.883333206176758px;">DTC Genomics is not the play here. </span></span><br />
<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;"><span style="line-height: 18.883333206176758px;"><br /></span></span>
<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;"><span style="line-height: 18.883333206176758px;">For personalized medicine to succeed, the clinicians still need to learn and the students need to teach.</span></span><br />
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<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;"><span style="line-height: 18.883333206176758px;">Prediction 1. A true 1000 USD genome will come out in 2013, late November, early December</span></span><br />
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<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;"><span style="line-height: 18.883333206176758px;">Prediction 2. Someone will sue 23andMe for privacy violations</span></span><br />
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<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;"><span style="line-height: 18.883333206176758px;">Prediction 3. A big set of PGx data will be released....and ignored.</span></span><br />
<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;"><span style="line-height: 18.883333206176758px;"><br /></span></span>
<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;"><span style="line-height: 18.883333206176758px;">Prediction 4. Hillary Clinton will have either cancer or a stroke. Her health reports are suspect at best.</span></span><br />
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<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;"><span style="line-height: 18.883333206176758px;">Prediction 5. Nutrigenomics will begin to have much more press coverage.</span></span><br />
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<span style="color: red; font-family: Arial, Helvetica, sans-serif;"><span style="line-height: 18.883333206176758px;"><b>The Sherpa Says: I am here, blocking and tackling. Awaiting the next phase of the climb. </b></span></span>Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com3tag:blogger.com,1999:blog-6173393362223742012.post-8818831904997713202012-08-31T18:53:00.002-07:002012-08-31T19:02:12.220-07:005 years later, Navigenics fulfills my prophecy<br />
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<span style="background-color: #eeeecc; color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 18.899999618530273px;">From August 24 2007 (5 years ago)</span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><span style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;">Just wanted to give a shout out to David Hamilton from </span><a href="http://venturebeat.com/" style="background-color: #eeeecc; color: #223344; line-height: 18.899999618530273px;">Venture Beat </a><span style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;">who wrote about </span><a href="http://venturebeat.com/2007/08/19/personal-genetics-startup-navigenics-a-potential-23andme-competitor-unstealths/" style="background-color: #eeeecc; color: #223344; line-height: 18.899999618530273px;">Navigenics</a><span style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;"> a while ago. To me whether 23andMe has a competitor or not does not matter. All that it sounds like is another non-clinical company trying to be clinical..........</span><br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><span style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;">From his article</span><br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><span style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;">"In other words, Navigenics essentially intends to get people to have their genomes scanned in a rough-and-ready fashion — in other words, they’ll scan your genes with chips that look for single-letter variations in the genetic code, instead of laboriously reading it out letter by letter — and then to match up what they find with the latest information on the diseases to which your genes might predispose you. Navigenics so far seems focused on the question of what your genes might say about disease, whereas 23andMe is apparently also interested in helping people trace their genealogy and creating social networks where they can compare and contrast their genetics."</span><br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><span style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;">And my favorite quote: "</span><em style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;"><strong>At the very least, though, it’s clear Navigenics has come loaded for bear</strong>. In addition to the blue-chip VC backing......</em><span style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;">"</span><br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><span style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;">The thing my mother always taught me.......the more money you need to market and sell something, the more likely it is that people don't need it........</span><br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><br style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;" /><span style="background-color: #eeeecc; color: #333333; line-height: 18.899999618530273px;">Thoughts????? </span></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">It appears, my thoughts were correct.....</span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"> From August 2012 HT D.C.</span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">Dear Navigenics Member,<u></u><u></u></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">Navigenics was recently acquired by Life Technologies. As the Navigenics team transitions its focus to Life Technologies’ developing molecular diagnostic business, we want to thank you for your patronage and making genetics a part of your health.<u></u><u></u></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">This email will be the final communication from Navigenics. Here are some important things to know about your Navigenics account:<u></u><u></u></span></div>
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<li class="MsoNormal" style="margin: 0px 0px 0px 15px;"><span style="font-family: Arial, Helvetica, sans-serif;"><i>Your genetic information is yours</i>. Your genetic results will be available to you in your secure online account for three years, and you may <a href="https://www.navigenics.com/member/login" style="color: #1155cc;" target="_blank">log in</a> to the Navigenics portal as usual to access your genetic information: <a href="https://www.navigenics.com/member/login" style="color: #1155cc;" target="_blank">https://www.<wbr></wbr>navigenics.com/member/login</a>. <wbr></wbr>Please bookmark the link to your account for future reference. After August 2015, to ensure the privacy and security of your information, your genetic results will be deleted and will no longer be available to you online. Any remaining genetic samples you may have stored with us will have already been destroyed and discarded.<u></u><u></u></span></li>
<li class="MsoNormal" style="margin: 0px 0px 0px 15px;"><span style="font-family: Arial, Helvetica, sans-serif;"><i>Your privacy is our priority</i>. In compliance with its existing policies and informed consent, Navigenics will not sell or share customers’ personally identifiable or genetic data.<u></u><u></u></span></li>
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<span style="font-family: Arial, Helvetica, sans-serif;">You can find additional information in our online FAQs: <a href="https://www.navigenics.com/visitor/about_us/acquisition_faqs/" style="color: #1155cc;" target="_blank">https://www.navigenics.<wbr></wbr>com/visitor/about_us/<wbr></wbr>acquisition_faqs/</a>.<u></u><u></u></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">Wishing you the best of health,<u></u><u></u></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">Navigenics Member Service<u></u><u></u></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><i>Navigenics Member Service can be reached directly at <a href="tel:1-866-522-1585" style="color: #1155cc;" target="_blank" value="+18665221585">1-866-522-1585</a> or<a href="mailto:memberservice@navigenics.com" style="color: #1155cc;" target="_blank">memberservice@navigenics.com</a>. If you do have questions or need to contact us for any reason, please do so before September 21, 2012. After that time Navigenics Member Service will no longer be available by email or phone.</i><u></u><u></u></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">4 Embarcadero Center, Suite 1400. San Francisco CA, 94111<u></u><u></u></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><a href="mailto:member.service@navigenics.com" style="color: #1155cc;" target="_blank">member.service@navigenics.com</a><u></u><u></u></span></div>
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<a href="tel:1-866-522-1585" style="color: #1155cc;" target="_blank" value="+18665221585"><span style="font-family: Arial, Helvetica, sans-serif;">1-866-522-1585</span></a></div>
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<b><span style="color: red; font-family: Arial, Helvetica, sans-serif;">The Sherpa Says: No matter how much money you spend in SoHo, you shoulda made sure you could test the people in NYC.</span></b></div>
Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com0tag:blogger.com,1999:blog-6173393362223742012.post-12898695544063966222012-07-30T19:24:00.002-07:002012-07-30T19:36:03.633-07:0023andMe proves the Sherpa right and kisses the ring!<span style="font-family: Arial, Helvetica, sans-serif;">In case you have been wondering where the Sherpa has been.<a href="http://thegenesherpa.blogspot.com/2012/05/whats-sherpa-up-to.html" target="_blank"> Have a read.</a></span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">I have been following the DTCG and FDA closely and it appears, my theory and logic is correct!</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">23andSerge has decided to <a href="http://www.mercurynews.com/business/ci_21193405/gene-testing-firm-23andme-seeks-ground-breaking-fda" target="_blank">stop being silly and stop fighting "The Man"</a> Instead they kiss the ring and FINALLY acknowledge what I have said over and over again. If you are testing for medical conditions, if you are doing medical tests, you must be regulated as such.</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">Despite this, Anne W and 23andSerge fought for years. "It's research" "It's for fun" "It's not medical"</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">Further, 23andSerge's move <a href="http://thegenesherpa.blogspot.com/2010/05/thomas-goetz-has-wrong-debate-fda.html" target="_blank">proves the "brilliant" Thomas Goetz dead wrong and me, the little "ol Sherpa, spot on correct.</a></span><br />
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<a href="http://www.bloomberg.com/news/2012-07-30/google-backed-23andme-asks-fda-to-clear-dna-evaluation-service.html" target="_blank"><span style="font-family: Arial, Helvetica, sans-serif;">23andSerge will be asking for FDA approval of their medical device known as the 23andMe test.</span></a><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">Why does a service like this need FDA oversight? Because it is a medical device. Simple enough. Also, oversight is needed for this service as they<a href="http://thegenesherpa.blogspot.com/2012/01/23andme-buyer-beware-internet-doesnt.html" target="_blank"> cannot be trusted to police themselves</a>.</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">Further, <a href="http://thegenesherpa.blogspot.com/2011/09/back-again-23andme-still-hits-bed-with.html" target="_blank">with inaccurate information, the FDA will have a very close look at what 23andSerge is offering</a>.</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">IMHO, this move by 23andSerge is exactly what is needed to prove to all the skeptics wrong. 23andMe is doing medical testing and needs to be regulated as such. END OF STORY.</span><br />
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<b><span style="color: red; font-family: Arial, Helvetica, sans-serif;">The Sherpa Says: I hate to say I told you so. But, I did. Just like I warned the guys at Pathway not to launch DTC via a major retailer. They did 2 weeks later and then got shut down. </span></b>Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com0tag:blogger.com,1999:blog-6173393362223742012.post-68350254204001293522012-05-07T18:13:00.004-07:002012-05-07T18:13:50.179-07:00What's the Sherpa Up To?<div class="separator" style="clear: both; text-align: center;">
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<span style="font-family: Arial, Helvetica, sans-serif;">I have decided to write an update to what the Sherpa is Up To. Why? Well, after 5 years of hard work, Lee Gutkind is about to <a href="http://www.publishersweekly.com/978-1-937163-06-8" target="_blank">publish a work of creative nonfiction</a>. I am one of the main characters. The other characters are also very compelling. </span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">I was able to preview a copy and am very excited. </span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">But, after reading, I thought I should give you an update on what the Sherpa is doing. Let me explain my madness. Here is my thought. As my good friend John Setaro MD would say. </span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">"There isn't any genetic advantage that can't be overcome with aggressive environmental modification."</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">This was me. I was overweight, the practice was stressing me and killing me. I needed to lose weight. I did. 30 pounds of weight. Mostly fat. This changed my life. How did I do it? FitBit, metabolic testing using gas exchange, calorie tracking, some things that a guy like Eric Topol MD would call mobile health.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">I began to pay attention to obesity. I noticed that obesity is a huge familial disease and an epidemic in the US. But, the genetic markers soft at best. So I say again, family history matters more. I studied fat metabolism and began to realize this disease was very similar to some mitochondrial deficiencies. I began to align genetics, family history, obesity and preventative care. Truly personalized medicine. I will sit for the obesity boards this year.</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">I understand the future of medicine and the potential of personalized medicine to enhance disease cure and prevention. In this case, I have been able use my understanding of metabolic genetics, clinical genetics, bariatric medicine, pedigree analysis, mobile health, medicine and wellness, to help cure diabetes, hypertension and depression. It is amazing how people feel better when they are no longer obese.</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">I along with 2 other physicians, my 3 nurse practitioners and our 3 offices (yes, a long way from a genetic counselor and a part time office on Park Avenue, NYC) devote every day to early detection of disease and prevention of disease.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">You will soon be able to see the fruits of our labors. We are modifying environment aggressively to overcome genetic and familial risks. We take family history, environmental history, genetic testing (if indicated), mobile health tools, technology, social history and use these tools to maximize human life.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">A concept we call Arete (R-eh-Tee). The Sherpa is creating the best system to cure disease, using the model developed from his own 30 pounds of weight loss and journey to health. Come see us, we are still in Greenwich, 115 East Putnam Avenue, 23 Maple Avenue, 49 Lake Avenue. 203-869-0451.</span><br />
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<b><span style="color: red; font-family: Arial, Helvetica, sans-serif;">The Sherpa Says: We have made camp, 1/3rd up the mountain, beans and lamb are on the fire, with quite an ascent coming. Genomes, Environmental, Technology. Coming soon! <a href="http://www.barnesandnoble.com/w/an-immense-new-power-to-heal-lee-gutkind/1106587605" target="_blank">But for now, go buy Lee's book!</a></span></b><br />
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<br />Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com1tag:blogger.com,1999:blog-6173393362223742012.post-7663841987859329552012-03-21T18:19:00.001-07:002012-03-21T18:19:43.654-07:00Personalized Medicine, AML and Diaprognostics<span style="font-family: Arial, Helvetica, sans-serif;">When driving of flying with the kids, I hear "Are we there yet?" It has to be one of the most annoying things these little angels do.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">I had a wonderful patient. A fantastic friend. He was diagnosed with AML. 21 days later he died.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">The family, upon learning the diagnosis said, "Is he going to do ok?" Sadly, given his age, I said probably not. But......his cytogenetics looked good. </span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Way back when, we classified this disease according to microscopic morphology. It was classified on how it looked visually. This led to some good, albeit not perfect classification.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">We then used our <a href="http://www.ncbi.nlm.nih.gov/pubmed/21810400" target="_blank">rudimentary cytogenetics studies</a>. This led to some helpful poor and good prognostic help. Again, not perfect, but better. Well, my friend's cytogenetics were great. So I suggested that, we may be surprised........</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Despite this, he died. 21 Days later. Why? Was there something else? Perhaps some genetic alteration that was not screened for. <a href="http://www.ncbi.nlm.nih.gov/pubmed/22072438" target="_blank">Could I have had some better prognostic tools</a>?</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Well, we sent for some experimental marker, which returned too late. <a href="http://www.blogger.com/goog_1182329442">NEJM has recently published </a></span><span style="font-family: Arial, Helvetica, sans-serif;"><a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1112304?query=TOC" target="_blank">a study on these markers</a>. Yes, I did something experimentally. Why? My friend was dying and I needed some insight.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">"<span style="background-color: white; line-height: 18px;">We identified at least one somatic alteration in 97.3% of the patients. We found that internal tandem duplication in </span><em style="background-color: white; border-bottom-width: 0px; border-color: initial; border-image: initial; border-left-width: 0px; border-right-width: 0px; border-style: initial; border-top-width: 0px; line-height: 18px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: initial; outline-width: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; vertical-align: baseline;">FLT3</em><span style="background-color: white; line-height: 18px;"> (</span><em style="background-color: white; border-bottom-width: 0px; border-color: initial; border-image: initial; border-left-width: 0px; border-right-width: 0px; border-style: initial; border-top-width: 0px; line-height: 18px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: initial; outline-width: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; vertical-align: baseline;">FLT3</em><span style="background-color: white; line-height: 18px;">-ITD), partial tandem duplication in </span><em style="background-color: white; border-bottom-width: 0px; border-color: initial; border-image: initial; border-left-width: 0px; border-right-width: 0px; border-style: initial; border-top-width: 0px; line-height: 18px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: initial; outline-width: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; vertical-align: baseline;">MLL</em><span style="background-color: white; line-height: 18px;"> (</span><em style="background-color: white; border-bottom-width: 0px; border-color: initial; border-image: initial; border-left-width: 0px; border-right-width: 0px; border-style: initial; border-top-width: 0px; line-height: 18px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: initial; outline-width: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; vertical-align: baseline;">MLL</em><span style="background-color: white; line-height: 18px;">-PTD), and mutations in </span><em style="background-color: white; border-bottom-width: 0px; border-color: initial; border-image: initial; border-left-width: 0px; border-right-width: 0px; border-style: initial; border-top-width: 0px; line-height: 18px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: initial; outline-width: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; vertical-align: baseline;">ASXL1</em><span style="background-color: white; line-height: 18px;"> and</span><em style="background-color: white; border-bottom-width: 0px; border-color: initial; border-image: initial; border-left-width: 0px; border-right-width: 0px; border-style: initial; border-top-width: 0px; line-height: 18px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: initial; outline-width: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; vertical-align: baseline;">PHF6</em><span style="background-color: white; line-height: 18px;"> were associated with reduced overall survival (P=0.001 for</span><em style="background-color: white; border-bottom-width: 0px; border-color: initial; border-image: initial; border-left-width: 0px; border-right-width: 0px; border-style: initial; border-top-width: 0px; line-height: 18px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: initial; outline-width: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; vertical-align: baseline;">FLT3</em><span style="background-color: white; line-height: 18px;">-ITD, P=0.009 for </span><em style="background-color: white; border-bottom-width: 0px; border-color: initial; border-image: initial; border-left-width: 0px; border-right-width: 0px; border-style: initial; border-top-width: 0px; line-height: 18px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: initial; outline-width: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; vertical-align: baseline;">MLL</em><span style="background-color: white; line-height: 18px;">-PTD, P=0.05 for </span><em style="background-color: white; border-bottom-width: 0px; border-color: initial; border-image: initial; border-left-width: 0px; border-right-width: 0px; border-style: initial; border-top-width: 0px; line-height: 18px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: initial; outline-width: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; vertical-align: baseline;">ASXL1,</em><span style="background-color: white; line-height: 18px;"> and P=0.006 for </span><em style="background-color: white; border-bottom-width: 0px; border-color: initial; border-image: initial; border-left-width: 0px; border-right-width: 0px; border-style: initial; border-top-width: 0px; line-height: 18px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: initial; outline-width: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; vertical-align: baseline;">PHF6</em><span style="background-color: white; line-height: 18px;">); </span><em style="background-color: white; border-bottom-width: 0px; border-color: initial; border-image: initial; border-left-width: 0px; border-right-width: 0px; border-style: initial; border-top-width: 0px; line-height: 18px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: initial; outline-width: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; vertical-align: baseline;">CEBPA</em><span style="background-color: white; line-height: 18px;"> and </span><em style="background-color: white; border-bottom-width: 0px; border-color: initial; border-image: initial; border-left-width: 0px; border-right-width: 0px; border-style: initial; border-top-width: 0px; line-height: 18px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: initial; outline-width: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; vertical-align: baseline;">IDH2</em><span style="background-color: white; line-height: 18px;"> mutations were associated with improved overall survival"</span></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><span style="background-color: white; line-height: 18px;"><br /></span></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><span style="background-color: white; line-height: 18px;">Despite good cytogenetics, my friend died, 21 days after diagnosis.</span></span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;"><span style="background-color: white; line-height: 18px;">FLT3-ITD positive.........results returned 5 days after death.</span></span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;"><span style="background-color: white; line-height: 18px;">Why can't we do these faster? Why didn't it get sent right away? I should have forced the provincial Oncologist to send ASAP. </span></span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;"><span style="background-color: white; line-height: 18px;">I will from now on. In remembrance of my friend.</span></span><br />
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<span style="color: red; font-family: Arial, Helvetica, sans-serif;"><span style="background-color: white; line-height: 18px;"><b>The Sherpa Says: We have to get these studies out in publication quicker. We can't move the ship of personalized medicine forward without quicker peer review and publication!</b></span></span><br />
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<br />Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com0tag:blogger.com,1999:blog-6173393362223742012.post-4095650076975833372012-03-08T06:56:00.000-08:002012-03-08T07:51:49.942-08:00Personalized Oncology? Congratulations, you have 20 different cancers!<span style="font-family: Arial, Helvetica, sans-serif;">Has anyone followed the literature on these companies that offer personalized genetic testing to customize oncologic treatments? In a recent study <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1113205?query=featured_home" target="_blank">published in the NEJM</a> a thought that has launched millions of Venture Capital Ships has encountered some very rough waters.</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">In fact I know of one Consumer Genetics founder whose "Second Pivot" was this whole theory of personalizing cancer therapeutics to a series of genetic tests. A simple premise you see. One cannot characterize the molecular activity and weaknesses of a tumor through a microscope. With staining, you can see some insight but not all. Thus, you need to molecularly profile your cancer. </span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">The solution, we create an amazing molecular lab to take your tumor sample and "Personalized Treatment" based on our tests. Just make sure you get the tumor sample.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Simple enough to do one would think.</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">Except when you have multiple different tumors at multiple different sites. Worse yet, what if in the same sample you have different tumors?</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Well, there is a flaw in the business plan.......</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">Enter March 8, 2012. <a href="http://www.blogger.com/goog_390258980">"</a><span style="background-color: white; color: #333333; line-height: 18px;"><a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1113205?query=featured_home" target="_blank">63 to 69% of all somatic mutations not detectable across every tumor region"</a> Quote from NEJM Further "</span><span style="background-color: white; color: #333333; line-height: 18px;">Mutational intratumor heterogeneity was seen for multiple tumor-suppressor genes converging on loss of function"</span></span><br />
<span style="background-color: white; color: #333333; line-height: 18px;"><span style="font-family: Arial, Helvetica, sans-serif;"><br /></span></span><br />
<span style="background-color: white; color: #333333; line-height: 18px;"><span style="font-family: Arial, Helvetica, sans-serif;">Ok, before you start the shorting and divestiture......</span></span><br />
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<span style="background-color: white; color: #333333; line-height: 18px;"><span style="font-family: Arial, Helvetica, sans-serif;">Caveats</span></span><br />
<span style="background-color: white; color: #333333; line-height: 18px;"><span style="font-family: Arial, Helvetica, sans-serif;">1. This was only in Metastatic Renal Cell Carcinomas</span></span><br />
<span style="background-color: white; color: #333333; line-height: 18px;"><span style="font-family: Arial, Helvetica, sans-serif;">2. This is only in four patients</span></span><br />
<span style="background-color: white; color: #333333; line-height: 18px;"><span style="font-family: Arial, Helvetica, sans-serif;">3. This can be mitigated if you take multiple tumor samples and sequence multiple areas, I hope.</span></span><br />
<span style="background-color: white; color: #333333; line-height: 18px;"><span style="font-family: Arial, Helvetica, sans-serif;"><br /></span></span><br />
<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;"><span style="line-height: 18px;">What does this mean really? Something that in our heart of hearts we already suspect we know. Once cells become cancerous and mutate, they are more likely to mutate more. Why would they be restricted in their mutations over time?</span></span><br />
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<span style="color: red; font-family: Arial, Helvetica, sans-serif;"><span style="line-height: 18px;"><b>The Sherpa Says: You can really personalized a tumor's treatment by removing the entire tumor. If you can't do that, you risk missing personalization by 50%.</b></span></span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;"><span style="background-color: white; color: #333333; line-height: 18px;"><br /></span></span>Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com3tag:blogger.com,1999:blog-6173393362223742012.post-58473762843367122802012-03-03T17:34:00.001-08:002012-03-03T17:34:26.351-08:00Laying down the Gauntlet, Royalty Time!<div class="separator" style="clear: both; text-align: center;">
<a href="http://3.bp.blogspot.com/-SmGTleOnV80/T1LFnGc8yMI/AAAAAAAAACo/vi_w_rs3m2s/s1600/murphy+2011+headshot2.jpeg" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" src="http://3.bp.blogspot.com/-SmGTleOnV80/T1LFnGc8yMI/AAAAAAAAACo/vi_w_rs3m2s/s1600/murphy+2011+headshot2.jpeg" /></a></div>
<span style="font-family: Arial, Helvetica, sans-serif;">After having many discussions about this. First one in 2007 with Matt Tindall and others with a host of people, you know who you are!</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">I am even more convinced as we are a "<a href="http://www.amazon.com/Creative-Destruction-Medicine-Digital-Revolution/dp/0465025501/ref=ntt_at_ep_dpt_1" target="_blank">GIVE ME MY DAMN BIOMETRIC DATA</a>" society. Are patients really to be expected to give up their data to Google for "The good of the cause"?</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">The answer: Absolutely not. </span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">You have heard of Google AdSense right?</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">Google has clients that want to advertise, Google needs data to display these ads. In the internet world, this is known as content. What does Google do for this "content"? They pay you. They cut you checks for your blog/website/etc. (i.e. data)</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Well, I have a question to those "early adopters (read- suckers)" Why did you give google/etc. your genomes for baubles? </span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">Why? For the good of it? Because you bought into AnneW's story?</span><br />
<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span style="font-family: Arial, Helvetica, sans-serif;">GoogleAdsense existed before 23andMe. Most of you are smart silicon valley types. Why did you not demand a Google check?</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">My thoughts. For every piece of biometric data you pay some company to give you, the MOMENT, yes the MOMENT they sell it to a third party, you should get yourself a royalty check.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">EVERY TIME!</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">I wanted to give shares of my company to research subjects. But, after speaking with IRBs, this was a conflict of interest. But not if the data were sold AFTER research was done.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">My advice, if you are smart and are a lawyer, give me a call. I have some ideas of what area of law you should research!</span><br />
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<b><span style="color: red; font-family: Arial, Helvetica, sans-serif;">The Sherpa Says: Stop Paying someone to sell your data and make profit. Sell your data and ask for a royalty!</span></b>Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com0tag:blogger.com,1999:blog-6173393362223742012.post-9300027389088160922012-02-25T08:56:00.000-08:002012-02-25T08:56:38.177-08:00Family History Works in Cardiac Disease!<div class="separator" style="clear: both; text-align: center;">
<a href="http://1.bp.blogspot.com/-grKK8XSAoD4/T0kSbX0rX0I/AAAAAAAAACg/w16t2LLTCak/s1600/thank-god-november-challenge-then-there-was-the-time-i-tried-demotivational-poster-1258056148.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="304" src="http://1.bp.blogspot.com/-grKK8XSAoD4/T0kSbX0rX0I/AAAAAAAAACg/w16t2LLTCak/s320/thank-god-november-challenge-then-there-was-the-time-i-tried-demotivational-poster-1258056148.jpg" width="320" /></a></div>
<span style="font-family: Arial, Helvetica, sans-serif;">Thank God that <a href="http://blogs.cdc.gov/genomics/2012/02/23/emerging-evidence/" target="_blank">Muin Khoury is blogging</a>! I would have totally missed this!</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">When the CDC held a conference to evaluate Family History, they found "insufficient evidence" that this was a useful tool.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">At that time I was quite dismayed about this, because I know that I have helped SAVE LIVES by integrating family history in our daily <a href="http://www.greenwichdocs.com/" target="_blank">personalized medicine practice</a>.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">So I knew in my clinical heart of hearts that soon we would find "sufficient data" to prove that family history should be integrated into every encounter clinically!</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Here is<a href="http://annals.org/content/156/4/253.abstract" target="_blank"> some of the first data</a> and evidence that integrating <a href="http://annals.org/content/156/4/253.abstract" target="_blank">family history helps clarify high risk individuals</a></span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Some of this evidence suggests that for every 5000 patients in a practice we would find an extra 200-250 patients at risk for heart disease!</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">From Dr Berg:</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;"><a class="external" href="http://www.annals.org/content/156/4/315.full" style="background-color: white; color: #4a006e; line-height: 15px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: left; text-decoration: none;" target="_blank">Dr Berg further states<img alt="External Web Site Icon." class="externalImg" src="http://blogs.cdc.gov/TemplatePackage/images/icon_out.png" style="border-bottom-style: none; border-color: initial; border-color: initial; border-color: initial; border-image: initial; border-left-style: none; border-right-style: none; border-top-style: none; border-width: initial; border-width: initial; border-width: initial; display: inline-block; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; max-width: 600px; padding-bottom: 0px; padding-left: 0.25em; padding-right: 0px; padding-top: 0px; top: 0px; vertical-align: baseline;" title="External Web Site Icon." /></a><span style="background-color: white; line-height: 15px; text-align: left;">: “The complex design and analysis were meticulously planned and rigorously executed… That this study was done at all speaks to the better support for high-quality research in primary care in the United Kingdom; finding support for a study like this would be extraordinarily difficult in the United States … I look forward to further research and quality improvement evaluations documenting clinical results, and I hope that more work in this clinical domain can be done in the United States.“</span></span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;"><span style="background-color: white; line-height: 15px; text-align: left;">I am happy that despite massive cuts in the budget Dr Khoury is all over this!</span></span><br />
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<span style="color: red; font-family: Arial, Helvetica, sans-serif;"><span style="background-color: white; line-height: 15px; text-align: left;"><b>The Sherpa Says: Still much cheaper than 23andMe or Navigenics or any fly by night Direct to Consumer Genetic testing company! </b></span></span><br />
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<span style="color: red; font-family: Arial, Helvetica, sans-serif;"><span style="background-color: white; line-height: 15px; text-align: left;"><b>P.S. I will be hosting a panel at the Consumer Genetics Conference in June. Any ideas on who I should invite????</b></span></span><br />
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<br />Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com0tag:blogger.com,1999:blog-6173393362223742012.post-36708663588827090792012-01-08T10:49:00.000-08:002012-01-08T11:06:37.996-08:00The case for hippocratic oath in web health services<div class="separator" style="clear: both; text-align: center;">
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<span style="font-family: Arial, Helvetica, sans-serif;">Today I want to tell you why I think that health related applications on the internet should have not only some "Good Housekeeping Seal of Approval" but should also take an oath similar to the one I took when I graduated from medical school.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">On it's face, there will likely be 3-4 camps reading this. One will automatically dismiss this as the "<a href="http://www.geneticsandsociety.org/article.php?id=5306" target="_blank">Web services" aren't providing diagnosis or treatment</a>. My counter to them is that I said "similar to" the hippocratic oath I swore to. We'll call it the HippocraticWeb oath. </span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">The second camp of people will say "This is a fantastic idea but aren't there services like this that certify web content?" My answer to them is that this is not a certification of web content. Further,<a href="http://www.hon.ch/HONcode/Visitor/visitor.html" target="_blank"> we all know those services like HONcode that certifies trustworthy information</a>. Instead this will act as a code of ethics which the consumer of the health service will understand to mean a reputable business who has taken an oath which will work in the interests of the consumer.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">The third camp will say "Shouldn't the government be doing this?" My answer is:<a href="http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2176" target="_blank"> It hasn't. And how could one government govern the world and the internet?</a> That is foolish. Instead, the web should do as those in the professions have done. Govern themselves with codes of honor and oaths which are publicly available. And no I don't mean <a href="http://masterplanthemovie.com/" target="_blank">"Don't be evil"</a></span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">I mean a certifiable oath that speaks about the actions of the business housing your health and medical data. I mean an oath that governs corporate decision making about whom to sell or share your data with. Not in a way that will make them the most money, but in a way that protects you, the person. After all, you paid to have access to your data, whether that be an LDL cholesterol, a blood pressure, a REM sleep cycle, a whole genome or what have you.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Why do we need such a code?</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">In my Nature Biotech piece I <a href="http://www.nature.com/nbt/journal/v27/n5/full/nbt0509-422.html" target="_blank">explain the dilemma with using web services for health purposes</a>. Corporate interests are not designed primarily for the benefit of customers. They are primarily designed for the benefits of the corporation, whether that be <a href="http://blog.eogn.com/eastmans_online_genealogy/2012/01/23andme-generates-controversy-with-new-subscription-policy.html" target="_blank">23andMe who just made a hash of an unnanounced TOS change</a> (In this way there should be an offset to consumer.Which 23andSerge finally came around to because of public outcry)</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Or it be flagrant sharing of your data without your permission through privacy leaks or hacking. (IMHO <a href="http://www.utsandiego.com/news/2011/mar/14/insurer-health-net-says-it-had-huge-data-breach/" target="_blank">Insurers should have given millions of dollars back to members for their leaks and gaffes</a>)</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Why? Health companies have to do this already. But where does that money go? Further, how do I know that someone will do the right thing with my data when there is a breach? This Oath would allow the best of class to accept responsibility for their actions.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">Don't think it doesn't happen? <a href="http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/postedbreaches.html" target="_blank">Check it out here.</a> And this exempts companies like 23andMe or Livestrong.com. Why. Because they are not governed by <a href="http://www.hhs.gov/ocr/privacy/hipaa/administrative/statute/index.html" target="_blank">HIPAA or HiTECH</a>!</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">I am not proposing further regulation here. All I am asking for is that these businesses purporting to help us maximize our health "Man Up" so to speak and all swear an Oath, The HippocraticWeb Oath.</span><br />
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<span style="font-family: Verdana, sans-serif;">The HippocraticWeb Oath</span></div>
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<span style="background-color: white; font-family: Verdana, sans-serif; line-height: 19px;">I swear by that which I hold most sacred, that I will fulfill according to my ability and judgment this oath and this covenant:</span><br />
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<span style="font-family: Verdana, sans-serif;">I will apply reasonable measures to protect the welfare of the customers whose information I keep; I will keep in mind that this data they have granted me access to is theirs. Should I wish to own this, I will compensate the customer fairly.</span></div>
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<span style="font-family: Verdana, sans-serif;">I will neither use this data as means of blackmail or coercion of customer. Nor will I engage in business with a company who has or intends to.</span></div>
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<span style="font-family: Verdana, sans-serif;">I will not use the information in a legal proceeding unless receiving subpoena and properly notifying the customer of such request. In reasonable and fair time frame to the customer.</span></div>
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<span style="font-family: Verdana, sans-serif;">I will not change terms or service, business plans or custodians of data without giving proper notice to affected customers, allowing them time to air grievances prior to making the business decision.</span></div>
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<span style="font-family: Verdana, sans-serif;">What I may see or hear in the course of business in regard to the life of customers, which on no account one must spread abroad, I will keep myself holding such things shameful to be spoken about.</span></div>
<span style="background-color: white; font-family: Verdana, sans-serif; line-height: 19px;">If I fulfill this oath and do not violate it, may it be granted to me to enjoy life and art, being honoured with fame among all men for all time to come; if I transgress it and swear falsely, may the opposite of all this be my lot inclusive of compensation to my customers.</span><br />
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<span style="line-height: 19px;"><span style="background-color: white; font-family: Arial, Helvetica, sans-serif;">That's it. Who would be averse to having something like this? It is a simple statement ensuring that the people who have access to your data will use it properly and compensate you if the transgress.</span></span><br />
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<span style="line-height: 19px;"><span style="background-color: white; font-family: Arial, Helvetica, sans-serif;">If you believe in what I am proposing please email me steven(dot)murphy(at)Greenwichdocs(dot)com I am currently working out how to implement this very important piece of trust into corporate ethic and standards when it comes to health and medical companies that provide health and medical services over the internet. This company should not be owned or part of any corporate consortium to "Get out in front" of this. Rather it should be a non for profit headed by a well balanced board of advisors. So, are you interested?</span></span><br />
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<span style="background-color: white; font-family: Arial, Helvetica, sans-serif; line-height: 19px;">Warmly,</span><br />
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<span style="background-color: white; font-family: Arial, Helvetica, sans-serif; line-height: 19px;">Steven A.R. Murphy MD</span><br />
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<span style="background-color: white; font-family: Arial, Helvetica, sans-serif; line-height: 19px;">p.s. That 4th camp is full of people like me!</span><br />
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<br />Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com1tag:blogger.com,1999:blog-6173393362223742012.post-30339258926566656592012-01-06T13:47:00.000-08:002012-01-06T13:47:22.548-08:0023andMe Buyer Beware, The Internet doesn't equal hippocrates<div class="separator" style="clear: both; text-align: center;">
<a href="http://2.bp.blogspot.com/-RTZ4BvMHdts/TPUODgdrNvI/AAAAAAAAAAs/KX-xSxHykLg/s1600/big-brother-is-watching.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="320" src="http://2.bp.blogspot.com/-RTZ4BvMHdts/TPUODgdrNvI/AAAAAAAAAAs/KX-xSxHykLg/s320/big-brother-is-watching.jpg" width="216" /></a></div>
<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;">Ok, ok. I am not gonna tell you I told you so. But, I did.</span><br />
<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;">Did anyone read my article in<a href="http://www.nature.com/nbt/journal/v27/n5/full/nbt0509-422.html" target="_blank"> Nature Biotechnology</a>? Did ya? </span><br />
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<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;">Here is your freaking reality check. 23andME has your DNA. It has it hostage and it has your datapoints. And it can do whatever the hell it pleases. Including locking or cancelling your account.</span><br />
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<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;">They have enough data points for their robust database. They only need you sheep to keep paying 9 dollars per month or 108 dollars per year and 99 to start. 10 years? 1080 dollars. Even more than the first 999 USD they started with.</span><br />
<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;"><br /></span><br />
<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;">Well guess what? <a href="http://www.yourgeneticgenealogist.com/2011/12/23andme-changes-tos-for-expired-pgs.html" target="_blank">People everywhere are waking up to the charlatanism</a> that was<a href="http://medgadget.com/2008/10/time_magazine_panders_to_google_overlords_silicon_valley_czars_hollywood_charlatans.html" target="_blank"> peddled by Silicon Valley Overlords</a>.....</span><br />
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<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;">They have you, you are stuck. You have to pay FOREVER!!!!! BWAHAHAHAHAHAHAHAHAHAHAHA!!!!!!</span><br />
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<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;">Even if you quit, they don't care. They Pwned you. And they still do. </span><br />
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<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;">So what did the Sherpa say all of those years? Huh? No, not that their health reports are bull $hi!.<a href="http://thegenesherpa.blogspot.com/2011/09/back-again-23andme-still-hits-bed-with.html" target="_blank"> But I did say that.</a> No not that I was done posting on <a href="http://thegenesherpa.blogspot.com/2010/06/no-more-23andme-blog-posts-sherpa-has.html" target="_blank">23andMe. Clearly I am not.</a></span><br />
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<a href="http://www.youtube.com/watch?v=9zKXCQpUnMg" target="_blank"><span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;">But I told you about the Master Plan!</span></a><br />
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<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;">Even if you pull out your data, they still have it. End of story. You are powerless and have been duped. I am sorry. I wish you had listened</span><br />
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<b><span class="Apple-style-span" style="color: red; font-family: Arial, Helvetica, sans-serif;">The Sherpa Says: Buyer Beware web sites giving you tests and testing your DNA. 23andMe and its company are not to be trusted. Sorry, but the web has not take the hippocratic oath!</span></b><br />
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<br />Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com1tag:blogger.com,1999:blog-6173393362223742012.post-92024446808692846522011-12-20T17:56:00.000-08:002011-12-20T18:13:31.592-08:002011 Comes to a close. What we know about Personalized Medicine<a href="http://1.bp.blogspot.com/-MiOUzSS1cf8/TvE9ZQToaCI/AAAAAAAAABs/OniBTs3lzyY/s1600/murphy%2B2011%2Bheadshot2.jpeg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5688395308428978210" src="http://1.bp.blogspot.com/-MiOUzSS1cf8/TvE9ZQToaCI/AAAAAAAAABs/OniBTs3lzyY/s320/murphy%2B2011%2Bheadshot2.jpeg" style="cursor: hand; cursor: pointer; float: right; height: 199px; margin: 0 0 10px 10px; width: 151px;" /></a><br />
<span style="font-family: Arial, Helvetica, sans-serif;">I wanted to write a wrap up of what we know in the last 4 years regarding personalized medicine </span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">1. In regards to DTC Genetics, the <a href="http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM215240.pdf" target="_blank">FDA won't shut you down if you are google</a>. <a href="http://thenextweb.com/lifehacks/2011/04/11/23andme-offers-free-dna-testing-on-sale-today-only/" target="_blank">But you will have to give your test away for free to build your database</a></span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">2. In regards to Pharmacogenomic testing, most doctors won't use the service <a href="http://www.ncbi.nlm.nih.gov/pubmed/21460130" target="_blank">despite studies showing utility</a> that have existed for 2 years.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">3. In regards to GWAS predisposition testing, <a href="http://www.psych.umn.edu/courses/fall10/psy8935/readings/latham2010.pdf" target="_blank">it is mostly useless</a>. It doesn't scare or heal you.......most of the time</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">4. Classical Cancer Genetics, Cardiogenetics, GI Genetics and preconception genetics have growing concerns as I am seeing more and more of these over the last 2 years.</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">5. When Whole genome or exome testing come out, <a href="http://jama.ama-assn.org/content/296/2/212" target="_blank">we will have a mess load of data</a>. This is an opportunity if someone can create subtractive algorithms to the "normal" data. Which may help us out....IFF we have a true "Normal Genome"</span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;">6. The Sherpa has been slow in posting, but these points are facts now.</span><br />
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<b><span style="color: red; font-family: Arial, Helvetica, sans-serif;">The Sherpa Says: 4 years, a lot of hype, lots of sideways climbing. Next year will show big moves, just like 2007/2008 and we'll still be here.</span></b>Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com3tag:blogger.com,1999:blog-6173393362223742012.post-29939146122418455832011-09-03T13:39:00.001-07:002011-09-05T16:01:34.369-07:00Back again, 23andMe still $hits the bed with their reports<span class="Apple-style-span"><a href="http://2.bp.blogspot.com/-gMOEPY2q9LE/TmOS3iE6XxI/AAAAAAAAABk/9NFskrA98Lo/s1600/Dr%2BMurphy%2BCoat%2Bof%2BArms%2Bfinal.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><span style="font-family:arial;"><img style="MARGIN: 0px 0px 10px 10px; WIDTH: 320px; FLOAT: right; HEIGHT: 201px; CURSOR: hand" id="BLOGGER_PHOTO_ID_5648519840390602514" border="0" alt="" src="http://2.bp.blogspot.com/-gMOEPY2q9LE/TmOS3iE6XxI/AAAAAAAAABk/9NFskrA98Lo/s320/Dr%2BMurphy%2BCoat%2Bof%2BArms%2Bfinal.jpg" /></span></a><span style="font-family:arial;">
<br />In case you haven't noticed. I dropped off the blog radar for a while. I had some growing to do of the practice and some streamlining. I read </span><a href="http://www.genomesunzipped.org/2011/09/direct-to-consumer-genetic-test-results-in-a-clinical-setting-a-case-report.php"><span style="font-family:arial;">Daniel MacArthur's post with great interest this week.</span></a><span style="font-family:arial;"> It describes clinical utility of 23<span id="SPELLING_ERROR_2" class="blsp-spelling-error">andMe</span> testing......</span></span><span style="font-family:arial;"> </span>
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<br /><div><span class="Apple-style-span"><span style="font-family:arial;">The one thing I haven't stopped doing </span><a href="http://www.usatoday.com/yourlife/health/medical/2010-10-25-Genetics24_CV_N.htm"><span style="font-family:arial;">is counselling patients on <span id="SPELLING_ERROR_3" class="blsp-spelling-error">DTC</span> Genomic reports</span></a><span style="font-family:arial;">.</span></span></div>
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<br /><div><span class="Apple-style-span" style="font-family:arial;">Just yesterday I was consulting a very nice patient. They told me they just had to speak with a doctor because the report indicated that they were at increased risk of stomach and esophageal cancer. They had been up for several nights reading about it. Further, when brought to their <span id="SPELLING_ERROR_4" class="blsp-spelling-error">PMD</span>, the <span id="SPELLING_ERROR_5" class="blsp-spelling-error">PMD</span> smiled and didn't offer up any advice.</span></div>
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<br /><div><span class="Apple-style-span" style="font-family:arial;">Well, first let me preface by saying, 23<span id="SPELLING_ERROR_6" class="blsp-spelling-error">andMe's</span> <span id="SPELLING_ERROR_7" class="blsp-spelling-error">SNPs</span> which they list 4 huge freaking stars of "CON"<span id="SPELLING_ERROR_8" class="blsp-spelling-error">fidence</span> for, on Esophageal and Stomach Cancer risk, while <span id="SPELLING_ERROR_9" class="blsp-spelling-error">BTFW</span> only ranking studies on Han Chinese. And only 2 studies at that.......</span></div>
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<br /><div><span class="Apple-style-span" style="font-family:arial;">This report had this patient seriously concerned. Until of course I took a G-D Damn pedigree and found out they had ZERO, I repeat ZERO Asian ancestry/ethnicity, let alone Han Chinese....</span></div>
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<br /><div><span class="Apple-style-span" style="font-family:arial;">The risk report from 23<span id="SPELLING_ERROR_10" class="blsp-spelling-error">andSerge</span> listed them as high risk. How in the world did that work?</span></div>
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<br /><div><span class="Apple-style-span" style="font-family:arial;">(BTW, if you don't believe me, just ask and I will send you the time stamped <span id="SPELLING_ERROR_11" class="blsp-spelling-error">pdfs</span>, with name redacted of course)</span></div>
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<br /><div><span class="Apple-style-span" style="font-family:arial;">You know why that worked? Because the brainchildren at the Google owned company forgot to put an ethnicity/ancestry filter on their reports. Instead they just felt that an asterisk would work just fine.....</span></div>
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<br /><div><span class="Apple-style-span"><span style="font-family:arial;">Well Guess what 23<span id="SPELLING_ERROR_12" class="blsp-spelling-error">andMe</span>, you haven't changed at all. </span><a href="http://thegenesherpa.blogspot.com/2010/07/fda-tuesday-congress-today-more-letters.html"><span style="font-family:arial;">Even after the FDA got on your A$$</span></a><span style="font-family:arial;">. Your reports still are misleading and are causing undue angst.</span></span></div>
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<br /><div><span class="Apple-style-span"><span style="font-family:arial;">Lucky for you,</span><a href="http://www.greenwichdocs.com/"><span style="font-family:arial;"> Myself and Dr <span id="SPELLING_ERROR_13" class="blsp-spelling-error">Lubin</span></span></a><span style="font-family:arial;"> are around to pick up after your mess......</span></span></div>
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<br /><div><span class="Apple-style-span" style="font-family:arial;">Can you see why someone needs to look at and police these reports? This poor patient had serious concerns and when brought to a clinician who couldn't understand the <span id="SPELLING_ERROR_14" class="blsp-spelling-error">SNP</span> studies could end up with not needed <span id="SPELLING_ERROR_15" class="blsp-spelling-error">endoscopies</span> which would put the patient at risk. Primarily due to physician malpractice avoidance behavior?</span></div>
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<br /><div><span class="Apple-style-span" style="font-family:arial;">Don't think that hasn't happened? Think Again.</span></div>
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<br /><div><b><span class="Apple-style-span" style="font-family:arial;color:#ff0000;">The Sherpa Says: I am back again at it because clearly the millionaires with a penchant for DNA peddling and CPU coding can not get this right......Clearly a #FAIL</span></b></div>
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<br />Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com2tag:blogger.com,1999:blog-6173393362223742012.post-84061606163272419212011-03-25T14:06:00.000-07:002011-03-25T14:38:14.351-07:00Non-Clinician Misinterpretation of DTC Genetic testing<span class="Apple-style-span" ><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="http://1.bp.blogspot.com/-gQ8OLV1AQCo/TY0JZCW1qVI/AAAAAAAAABQ/czffosL_G08/s1600/fail-whale.jpg"><img style="float:right; margin:0 0 10px 10px;cursor:pointer; cursor:hand;width: 320px; height: 200px;" src="http://1.bp.blogspot.com/-gQ8OLV1AQCo/TY0JZCW1qVI/AAAAAAAAABQ/czffosL_G08/s320/fail-whale.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_5588133038370695506" /></a><br /><span class="Apple-style-span" >Ok,</span></span><div><span class="Apple-style-span" >In case you haven't all figured it out. Blogs are dead. Mine is too, sorta. I have less and less time to blog as my practice explodes. But there are some things that just merit a blog post.</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >I am on twitter, you can follow me there @genesherpas</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >But now I am on the Sherpa. Yes, the blog that nearly got me on 60 Minutes and definitely won me the hearts of USA Today to be interviewed...BTW the practice got super busy after that......</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >Today I want to talk about something more serious. </span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >The <a href="http://www.genomeweb.com/dxpgx/dtc-genomics-firms-say-they-want-comply-fda-regs-maintain-direct-access">FDA hearings</a> have laid the course clear. Direct To Consumer Genetic testing will be regulated.</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" > Why? </span></div><div><span class="Apple-style-span" >1 part potential harm</span></div><div><span class="Apple-style-span" >2 parts irreverence for laws and medical regulation </span></div><div><span class="Apple-style-span" >3 parts flagrant misrepresentation of what genetic tests can do.......</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >See <a href="http://www.genomicslawreport.com/index.php/2011/03/24/closer-scrutiny-ahead-for-dtc-claims/">Kari S. Disavowal of his company's stupid tag line.....</a>..</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >Today on twitter <a href="http://shirleywho.wordpress.com/">Shirely Wu</a> @shwu retweeted something that <a href="http://twitter.com/#!/dgmacarthur/status/51337757531975680">was the picked up by</a> @dgmacarthur..... great geneticist, but not a medical geneticist........</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >That was:</span></div><div><span class="Apple-style-span" ><b><br /></b></span></div><div><span class="Apple-style-span" style="color: rgb(68, 68, 68); line-height: 30px; "><span class="Apple-style-span" ><b>A thoughtful and eloquent case-study petition to keep genetic testing DTC:<a href="http://bit.ly/dL3qar" target="_blank" rel="nofollow" class="twitter-timeline-link" style="margin-top: 0px; margin-right: 0px; margin-bottom: 0px; margin-left: 0px; padding-top: 0px; padding-right: 0px; padding-bottom: 0px; padding-left: 0px; color: rgb(47, 194, 239); text-decoration: none; ">http://bit.ly/dL3qar</a> from @<a class=" twitter-atreply" name="celticcurse" href="http://twitter.com/celticcurse" rel="nofollow" style="margin-top: 0px; margin-right: 0px; margin-bottom: 0px; margin-left: 0px; padding-top: 0px; padding-right: 0px; padding-bottom: 0px; padding-left: 0px; color: rgb(47, 194, 239); text-decoration: none; ">celticcurse</a><a href="http://twitter.com/#!/search?q=%23FDADTC" title="#FDADTC" class=" twitter-hashtag" rel="nofollow" style="margin-top: 0px; margin-right: 0px; margin-bottom: 0px; margin-left: 0px; padding-top: 0px; padding-right: 0px; padding-bottom: 0px; padding-left: 0px; color: rgb(47, 194, 239); text-decoration: none; ">#FDADTC</a></b></span></span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >The problem?</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" > I respect Shirley a lot, but this article is not thoughtful, nor is it eloquent. </span></div><div><span class="Apple-style-span" >Instead it is full of misinterpretation and IMHO an ignorance of the role of genetic testing in hereditary hemochromatosis.....</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >In no way is HFE genetic testing required or indicated to pick up a person with hereditary hemochromatosis.</span></div><div><span class="Apple-style-span" ><br /></span></div><div><a href="http://www.uspreventiveservicestaskforce.org/uspstf06/hemochromatosis/hemochrs.htm"><span class="Apple-style-span" >USPSTF says the harms outweigh the risks of genetic testing for screening</span></a></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" ><a href="http://www.ncbi.nlm.nih.gov/pubmed/21150441">There are multiple genes involved in hereditary hemochromatosis</a> only testing HFE and thinking you are "off the hook" is stupid.....</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >There are <a href="http://www.ncbi.nlm.nih.gov/pubmed/21355094">also modifier genes likely too</a>.....</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >In other words, perhaps the cheerleaders for DTCG are misinformed about the true utility of this type of testing. Further, if they knew the literature, perhaps they would be less angry that the <a href="http://www.genomeweb.com/dxpgx/dtc-genomics-firms-say-they-want-comply-fda-regs-maintain-direct-access">FDA(who know the data BTW) want to regulate against these types of misinformed claims</a> that could lead to misinterpretation by consumers and end up fleecing their pockets for fools gold.</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >Let's take this little gem from @celticcurse</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" ><i>"<span class="Apple-style-span" style="color: rgb(17, 17, 17); line-height: 22px; ">A simple genetic test is all it takes to know if hereditary hemochromatosis, the most common genetic killer in America, is in your genes."</span></i></span></div><div><span class="Apple-style-span" style="color: rgb(17, 17, 17); line-height: 22px; "><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span" style="color: rgb(17, 17, 17); line-height: 22px; "><span class="Apple-style-span" >Bull$h!t buddy....<a href="http://www.ncbi.nlm.nih.gov/pubmed/19907150">.less than 30% of HFE variant persons ever develop the disease</a>. Do me a favor, partner with a doctor to hack your health next time please......</span></span></div><div><span class="Apple-style-span" style="color: rgb(17, 17, 17); line-height: 22px; "><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span" style="color: rgb(17, 17, 17); line-height: 22px; "><span class="Apple-style-span" >In case you wondered, iron studies are the key to screening. I get them in every northern european or any family history of liver disease, gonadal failure, arthritis, etc......</span></span></div><div><span class="Apple-style-span" style="color: rgb(17, 17, 17); line-height: 22px; "><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span" style="color: rgb(17, 17, 17); line-height: 22px; "><span class="Apple-style-span" >But, the lab heads wouldn't know that. Which is why lab heads shouldn't release discoveries into the wild......</span></span></div><div><span class="Apple-style-span" style="color: rgb(17, 17, 17); line-height: 22px; "><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span" style="line-height: 22px; "><span class="Apple-style-span" ><b>The Sherpa Says: This retweet blog post by CelticCurse is an eloquent reason WHY DTC genetic testing should be regulated for claims and use......regulate the medical as a medical test, let the ancestry buffs do their thing sans FDA. End of story guys.....</b></span></span></div><div><span class="Apple-style-span" ><span class="Apple-style-span" style="line-height: 22px;"><br /></span></span></div>Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com4tag:blogger.com,1999:blog-6173393362223742012.post-52064161826925498452011-02-02T18:04:00.000-08:002011-02-08T07:18:27.411-08:00Coriell and OSU integrate GWAS into an EMR!<a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="http://2.bp.blogspot.com/_yjiN8LObzxE/TUoPzpgDzrI/AAAAAAAAAA8/kU1z6XZJQC4/s1600/Dr%2BMurphy%2BCoat%2Bof%2BArms%2Bfinal.jpg"><img style="float:right; margin:0 0 10px 10px;cursor:pointer; cursor:hand;width: 320px; height: 201px;" src="http://2.bp.blogspot.com/_yjiN8LObzxE/TUoPzpgDzrI/AAAAAAAAAA8/kU1z6XZJQC4/s320/Dr%2BMurphy%2BCoat%2Bof%2BArms%2Bfinal.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_5569281269185105586" /></a><br /><span class="Apple-style-span" >Ok, so enough with the acronyms.....</span><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >I am back and will be blogging more often again. So for those who still lurked around, tell the others that the Howard Stern of Genomics is back. I took a social networking holiday for a solid 2 months, plus the addition of having my practice change quite a bit after my <a href="http://www.usatoday.com/yourlife/health/medical/2010-10-25-Genetics24_CV_N.htm">USA Today</a> and follow ups in the<a href="http://www.greenwichtime.com/local/article/Doctor-dips-into-the-gene-pool-to-assist-patients-834101.php"> local papers</a>.....</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >Today I want to announce that <a href="http://cpmc.coriell.org/">Coriell Personalized Medicine Collaborative</a> and <a href="http://www.cphc.osu.edu/">Ohio State University</a> will be using data from an arm of the CPMC and OSU to integrate genetic risk data into the medical record.</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >Correct me if I am wrong, but I don't know of anyone else doing this exact same thing.</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >Ideally they will also continue to roll things in like PGx data. (I know this data will be coming soon)</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >By integrating things like Plavix response, you can make more gametime decisions easily.</span></div><div><span class="Apple-style-span" >I.E. Patient presents to the ED with a heart attack. Armed with prior knowledge about plavix nonresponder, you pick Effient.</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >What is so awesome about this arm is that Primary Care Physicians, Cardiologists AND patients will be participating and receiving results.....</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >They will be studying the behavior and knowledge of participants in the study, we have seen other data on this sort of thing, I wonder if we will see the same thing here.</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >For risk data? Probably. For PGx Data? Probably not.</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >Why? A plavix response in the medical record is a game changer.</span></div><div><span class="Apple-style-span" >3 Reasons</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >1. The clinician will be hit in the face with a "Plavix doesn't work here"</span></div><div><span class="Apple-style-span" >2. The physician may even find they are a nonresponder</span></div><div><span class="Apple-style-span" >3. There has got to be some hustling attorney out there, who will be lurking once they see the CPMC/OSU release. I am certain at least the physicians will be thinking so.....</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >You can <a href="http://cpmc.coriell.org/docs/PressRelease_Coriell_OhioState_CPMCHeartDisease_020811.pdf">read the Presser Here</a></span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" ><b>The Sherpa Says: Study of clinical use and behaviors will be key to know how vital this data is and thus how tightly we should regulate its use in medical records i.e. 23andMe clinical BRCA testing! P.S. Like our new crest?</b></span></div><div><span class="Apple-style-span" ><br /></span></div>Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com4tag:blogger.com,1999:blog-6173393362223742012.post-54504489169139606842010-12-21T05:26:00.000-08:002010-12-21T05:40:42.311-08:00Genetic test may refine PSA or it may not!<span class="Apple-style-span" >I am going to read this article for the seventh time and get back to you this week. </span><div><span class="Apple-style-span" >In case you missed it, the PR Firm hired by DeCode pumped out a presser (press release), which I refuse to link to directly.....which <a href="http://www.valleynewslive.com/Global/story.asp?S=13678805">essentially said </a></span></div><div><span class="Apple-style-span" ><br /></span></div><div><b orgfont><span class="Apple-style-span" >"Analysis of Four SNPs, in Tandem With Genetic Risk Factors Detected by the deCODE ProstateCancer(TM) Test, Yields Substantial Improvement in Efficacy of PSA Screening"</span></b></div><div><b orgfont><span class="Apple-style-span" ><br /></span></b></div><div><span class="Apple-style-span" >OK, 4 SNPs tells us whose PSA value is a bad 2.8 vs. good 5.8?</span></div><div><span class="Apple-style-span" ><br /></span></div><div><span class="Apple-style-span" >Or at least that's what the Kari S. tells us</span></div><div><span class="Apple-style-span" ><b><br /></b></span></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" ><span class="Apple-style-span" style="font-family: Georgia, serif; font-size: 16px; "><b><span class="Apple-style-span" >"This is straighforward genetics with direct clinical utility." -Kari S. (Yes they rushed the release out with the misspelling of "straightforward")</span></b></span></span></span></b></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" ><span class="Apple-style-span" style="font-family: Georgia, serif; font-size: 16px; "><b><span class="Apple-style-span" ><br /></span></b></span></span></span></b></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" >Ok, so tell me, how has this straightforward genetic test performed in a prospective analysis?</span></span></b></div><div><span class="Apple-style-span" ><br /></span></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" >What do you mean you haven't done that yet? So how can we have you assert that there is direct clinical utility?</span></span></b></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" ><br /></span></span></b></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" >We can't. Maybe you meant STRAY FORWARD?</span></span></b></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" ><br /></span></span></b></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" >Secondly, this study was carried out on Caucasian men, leaving African Americans, who often have earlier and more aggressive prostate cancer out in the dark.......</span></span></b></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" ><br /></span></span></b></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" >But what really got my Ire was when respected Tweeters started parroting this presser.........</span></span></b></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" ><br /></span></span></b></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" >Here is some high heat for us genome critics, read the study and read the presser. If the presser hypes the study, we should tear it apart and present the true facts for all to see on the internet.</span></span></b></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" ><br /></span></span></b></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" >Read and analyze the study, not the presser. I know we are all busy these days, but we owe that to our readers and the public. Hell, that makes us even better than a whole host of journalists who seem to quote Kari as if his opinion is the final take.</span></span></b></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" ><br /></span></span></b></div><div><b><span class="Apple-style-span" >The Sherpa Says: On seventh read I will have a take on what these "SNPs that strengthen the predictive power of PSA" really mean.</span></b></div><div><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-style-span" ><br /></span></span></b></div><div><span class="Apple-style-span" ><span class="Apple-style-span" style="font-size: 12px;"><b><span class="Apple-style-span" style="font-weight: normal; "><span class="Apple-tab-span" style="white-space:pre"> </span></span></b></span></span></div>Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com2tag:blogger.com,1999:blog-6173393362223742012.post-24080107972795809242010-11-30T05:49:00.000-08:002010-11-30T06:50:12.289-08:0023andKari, what the 99 USD subsidy means for Personal Genomics<a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="http://1.bp.blogspot.com/_yjiN8LObzxE/TPUODgdrNvI/AAAAAAAAAAs/BNe5e8nLEaw/s1600/big-brother-is-watching.jpg"><img style="float:right; margin:0 0 10px 10px;cursor:pointer; cursor:hand;width: 217px; height: 320px;" src="http://1.bp.blogspot.com/_yjiN8LObzxE/TPUODgdrNvI/AAAAAAAAAAs/BNe5e8nLEaw/s320/big-brother-is-watching.jpg" border="0" alt="" id="BLOGGER_PHOTO_ID_5545353969593431794" /></a><span class="Apple-style-span" ><br /><span class="Apple-style-span">Yes, Yes.....</span></span><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" >Everyones' little heart is a-twitter for the subisdized cost of 23andSerge, now to be known as 23andKari (will tell you why soon) a whopping 99 USD. Which I had been saying is the correct price point for about 2 years now.</span></span><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" >Yes, finally, something other than a <a href="http://techcrunch.com/2009/07/11/23andme-zeppelin-hanging-out-above-my-house-creeping-me-out/">blimp and million dollar parties</a> will actually pull out the lurkers.....</span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" >Here's my take. There was a company in a galaxy far far away, Iceland. That was the toast of the town in 2004. Why? They were collecting genomes for a grand experiment. They were going to discover fantastic links to disease and sell access to the highest bidder. </span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" >While they did produce some great Nature papers......what happened to DeCode?</span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" >I think we all know.</span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" >23andKari has now emerged. The front end.....happy shiny ancestry and disease links.....</span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" >I have forgotten to mention that the <a href="http://www.gao.gov/new.items/d10847t.pdf">FDA still hasn't finished working on these companies</a>, have I?</span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" >The back end? A database of genomes to cull for disease links to be sold at the highest bidder?</span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" >Sound familiar??</span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" >In case you forgot, <a href="http://dealbook.nytimes.com/2010/01/22/exiting-bankruptcy-decode-lands-in-hands-of-vcs/">Kari did this with Gulcher and went belly up.......</a></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" >And BTW, who owns that genetic data now? Is it getting resold?</span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><a href="http://classactionlawsuitsinthenews.com/class-action-notices/pe-corporation-celera-genomics-securities-class-action-lawsuit-settlement/"><span class="Apple-style-span"><span class="Apple-style-span" >Celera too?</span></span></a></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" >Also in case you forgot, this is a <a href="http://www.genetic-future.com/2008/04/navigenics-vs-23andme-drawing-battle.html">rock bottom version of Navigenics game...How's that working?</a></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" >I think 23andKari will actually survive. Why? Huge megacorporation investment. That's why.</span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span"><a href="http://masterplanthemovie.com/"><span class="Apple-style-span" >GOOG et.al. own 23andKari now. Your data? Wrong! Theirs.</span></a><span class="Apple-style-span" > Now that they are being investigated for <a href="http://www.foxnews.com/scitech/2010/11/30/eu-launches-antitrust-probe-google-searches/">antitrust in the EU</a>, they have to <a href="http://www.timesonline.co.uk/tol/life_and_style/health/article597046.ece">move quickly on this phase</a>......</span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" >I have said it before and will again. Why sell Manhattan for bobbles and trinkets?</span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" >Because it's cheap, that's why........Hell. IMHO, 23andKari should be paying you for your genome.</span></span></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><a href="http://scienceblogs.com/geneticfuture/2010/06/23andme_provides_more_details.php"><span class="Apple-style-span"><span class="Apple-style-span" >I hope the lab 23andKari is using is up to snuff this time.....after that whole sample swap issue, they are about to get a whole lot more volume.</span></span></a></div><div><span class="Apple-style-span"><span class="Apple-style-span" ><br /></span></span></div><div><b><span class="Apple-style-span"><span class="Apple-style-span"><span class="Apple-style-span" ><span class="Apple-style-span" >The Sherpa Says: Democratization is about to go the way of Russia and it's oligarchs...</span></span></span></span></b></div></div>Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com0tag:blogger.com,1999:blog-6173393362223742012.post-101976891473303252010-11-24T09:30:00.001-08:002010-11-24T09:36:07.252-08:0023andMe going infomercial style!<a href="http://4.bp.blogspot.com/_yjiN8LObzxE/TO1MB08p8OI/AAAAAAAAAAk/tvJAP54TfuA/s1600/qvc.png"><img style="MARGIN: 0px 0px 10px 10px; WIDTH: 287px; FLOAT: right; HEIGHT: 310px; CURSOR: hand" id="BLOGGER_PHOTO_ID_5543170310639579362" border="0" alt="" src="http://4.bp.blogspot.com/_yjiN8LObzxE/TO1MB08p8OI/AAAAAAAAAAk/tvJAP54TfuA/s320/qvc.png" /></a><br /><a href="http://www.genomicslawreport.com/index.php/2010/11/23/a-thanksgiving-tradition-23andme-repackages-product-raises-prices/">Dan Vorhaus </a>points out the <a href="http://contraception.about.com/b/2009/02/02/ru486-vs-plan-b.htm">Plan B</a> for 23andSerge!<br /><br />Personally I love the irony of naming it "Plan B"<br /><br />MSRP 499, but yours for the low, low price of 99 USD.<br /><br />QVC, here we come!!!!Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com0tag:blogger.com,1999:blog-6173393362223742012.post-8322021645038923182010-11-18T18:14:00.000-08:002010-11-18T19:14:21.478-08:00Respiragene Test and CT Screening for Lung Cancer?<a href="http://3.bp.blogspot.com/_yjiN8LObzxE/TOXq0FTLrvI/AAAAAAAAAAc/J6QJKs_PYxA/s1600/flimflam.jpg"><img style="MARGIN: 0px 0px 10px 10px; WIDTH: 225px; FLOAT: right; HEIGHT: 312px; CURSOR: hand" id="BLOGGER_PHOTO_ID_5541093097045995250" border="0" alt="" src="http://3.bp.blogspot.com/_yjiN8LObzxE/TOXq0FTLrvI/AAAAAAAAAAc/J6QJKs_PYxA/s320/flimflam.jpg" /></a><br /><div><span style="font-family:arial;"><a href="http://www.usatoday.com/yourlife/health/medical/2010-10-25-Genetics24_CV_N.htm">I love personalized medicine.</a></span></div><br /><div><span style="font-family:arial;">I absolutely think it is beyond fantastic to be able to say to a patient "This is the drug for you"</span></div><br /><div><span style="font-family:arial;">Or, we need to screen for disease X because of Gene Y and your family history</span></div><br /><div><span style="font-family:arial;">But what I don't love is companies purporting the import of their <a href="http://www.genomicslawreport.com/index.php/2010/06/16/breaking-fda-moves-to-broadly-regulate-ldts/">special home brew test</a> to do personalized medicine without any sort of data backing them up.</span></div><br /><div><span style="font-family:arial;">A news report and "AACR Feature" highlighted precisely that. A test with no data......</span></div><br /><p><span style="font-family:arial;">From the article:</span><br /></p><div><span style="font-family:arial;"></span></div><br /><p><span style="font-family:arial;">Researchers administered a gene-based predisposition test that incorporates 20 genetic markers associated with smoking-related lung damage and propensity to lung cancer along with clinical factors including age, family history and diagnosis of </span><a class="hasTip" href="http://www.healthimaging.com/_news/topic/chronic+obstructive+pulmonary+disease"><span style="font-family:arial;color:#000000;">chronic obstructive pulmonary disease</span></a><span style="font-family:arial;"> to derive a risk score on a 1 to 12 scale with higher scores correlating with higher risk.<br /></span></p><br /><p><span style="font-family:arial;">Ok, new score with 20 markers, family history and age and clinical data....sounds reasonable. Has anyone else validated this tool????</span></p><br /><p><span style="font-family:arial;">Ahem. <em>Crickets.....</em></span></p><br /><p><br /><span style="font-family:arial;">“At scores of 6 or more … only 25 percent of otherwise eligible smokers would be screened but over half of lung cancers would potentially be detected, many in a treatable stage,” concluded Young and colleagues, who suggested that increasing the detection rate of lung cancer per number of patients screened could improve the cost-effectiveness of CT screening.<br /><br />Ok, so did you get the jump? Did you catch it? "Who Suggested"</span></p><br /><p><span style="font-family:arial;">This guy who designed a genetic panel AND NEVER TESTED IT IN CONJUNCTION WITH CT CHEST SCREENING, is suggesting that using the test could increase the cost effectiveness of CT Screening, without one single solitary IOTA or shred of evidence of this.</span></p><br /><p><span style="font-family:arial;">This would be the same Dr. Young who found that genetic testing for a smoking cessation program likely </span><a href="http://www.ncbi.nlm.nih.gov/pubmed/20843376"><span style="font-family:arial;">doesn't have cost effectiveness </span></a><span style="font-family:arial;">or at best is uncertain.</span></p><br /><p><a href="http://www.ncbi.nlm.nih.gov/pubmed/19390575"><span style="font-family:arial;">Last year they were still researching this panel</span></a></p><br /><p><span style="font-family:arial;">Yet </span><a href="http://www.respiragene.com/"><span style="font-family:arial;">Respiragene</span></a><span style="font-family:arial;"> is being held up as a great test!</span></p><br /><p><span style="font-family:arial;">One word that makes me suspicious is the word </span><a href="http://www.respiragene.com/News/Testimonial"><span style="font-family:arial;">"Testamonials"</span></a></p><br /><p><span style="font-family:arial;">That word alone reminds me of the time I was bamboozled into going to multi level marketing events for proton pills and the like. You know, they all had lots of </span><a href="http://www.respiragene.com/about/Our-Research"><span style="font-family:arial;">"Research"</span></a><span style="font-family:arial;"> behind them.</span></p><br /><p><span style="font-family:arial;">Put simply, we do not know if gene screening PRIOR to CT Chest screening for lung cancer does any of the following things</span><br /></p><p><span style="font-family:arial;">1. Make CT Screening more cost effective</span><br /></p><p><span style="font-family:arial;">2. Personalizes medicine, targeting radiation to only those who need the test</span><br /></p><p><span style="font-family:arial;">3. Improves outcomes and detection rates of lung cancer.</span><br /></p><p><span style="font-family:arial;">That research is not available today. Nor will it be in one year. </span><br /></p><p><span style="font-family:arial;"><strong>My Advice, hold off on this one for now.</strong></span><br /></p><p><strong><span style="font-family:arial;color:#ff0000;">The Sherpa Says: Parroting an esteemed researchers OPINION as if it were scientific fact is a great way to get yourself in trouble and an even greater way to confuse the community! But it is the best way to get a test sold.</span></strong><br /></p><div><span style="font-family:arial;"></span></div>Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com2tag:blogger.com,1999:blog-6173393362223742012.post-9772002306826086072010-11-11T17:59:00.000-08:002010-11-11T18:39:20.713-08:00Pulitzer Prize Winner Amy Harmon hosting ethical dilemmas!How do you face life as a 22 year old if you carry a genetic variant for an incurable illness that will most likely strike in middle age?<br /><br />That's right,<br /><br />Amy Harmon is hosting a fantastic course that will be starting November 15th. You better hurry up and register because <a href="http://www.nytimesknownow.com/index.php/dna-ethical-dilemmas/">space is limited and closing on the 14th of November</a>.<br /><br />What will be covered?<br /><p>The course will have weekly live online sessions with the instructor as well as self-paced lessons filled with original content covering the weekly topics. All live sessions and course material can be accessed directly within the online course.</p><p>Prenatal testing can go into deep detail about an unborn baby’s prospects for the future. How much of this do we want to know? To share?</p><p>These questions and more will be addressed. If there is one thing I know. Amy is certainly a fantastic teacher, educator, and discussion leader! </p><p>I do miss conversations like those with her!</p><p>You too can have that kind of expertise. <a href="http://www.nytimesknownow.com/index.php/dna-ethical-dilemmas/">Register before November 14th!</a></p><p>I am certain you will enjoy this set of topics and have directed many people this way already.</p><p><strong><span style="color:#ff0000;">The Sherpa Says: Family history picks up life threatening disease, DTCG tests probably not so much. That being said, what's the ethical quandry with either? </span></strong><a href="http://www.nytimesknownow.com/index.php/dna-ethical-dilemmas/"><strong><span style="color:#ff0000;">Ask Amy and find out!</span></strong></a></p><p> </p><p> </p>Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com0tag:blogger.com,1999:blog-6173393362223742012.post-60443097452287839622010-11-10T17:50:00.000-08:002010-11-10T18:35:49.255-08:00Consumer Genetic Testing for heart attack risk? Worthless!<img style="MARGIN: 0px 0px 10px 10px; WIDTH: 320px; FLOAT: right; HEIGHT: 214px; CURSOR: hand" id="BLOGGER_PHOTO_ID_5538112279296169634" border="0" alt="" src="http://1.bp.blogspot.com/_yjiN8LObzxE/TNtTxp2tVqI/AAAAAAAAAAU/P9cwqtlf6kA/s320/dead%2Bin%2Bthe%2Bwater.jpg" /><br /><p align="left"><span style="font-family:arial;"></span></p><p align="left"><span style="font-family:arial;"></span></p><p align="left"><span style="font-family:arial;"></span></p><p align="left"><span style="font-family:arial;"></span></p><p align="left"><span style="font-family:arial;"></span></p><p align="left"><span style="font-family:arial;"></span></p><p align="left"><span style="font-family:arial;">Here are the top ten reasons why in its current state, direct to consumer or otherwise, genomic testing for cardiovascular disease risk is dead in the water</span> </p><br /><span style="font-family:arial;"></span><br /><span style="font-family:arial;">1. Family History Risk paints a far better picture and <strong>IT IS FREE</strong></span><br /><br /><span style="font-family:arial;">2. </span><a href="http://www.ncbi.nlm.nih.gov/pubmed/19153409"><span style="font-family:arial;">Reynolds and <span id="SPELLING_ERROR_0" class="blsp-spelling-error">Framingham</span> risk paint a more accurate picture</span></a><br /><br /><span style="font-family:arial;">3. </span><a href="http://www.ncbi.nlm.nih.gov/pubmed/21042222?dopt=Abstract"><span style="font-family:arial;">An independent panel has reviewed 58 variants, 29 genes, and gave the thumbs down.</span></a><br /><br /><span style="font-family:arial;">4. The highest increased risk from any of these tests is 30%, <span id="SPELLING_ERROR_1" class="blsp-spelling-error">Fam</span> <span id="SPELLING_ERROR_2" class="blsp-spelling-error">Hx</span> can be </span><a href="http://www.ncbi.nlm.nih.gov/pubmed/16912584"><span style="font-family:arial;">as high as 500%</span></a><br /><br /><span style="font-family:arial;">5. </span><a href="http://www.usatoday.com/yourlife/health/medical/2010-10-25-Genetics24_CV_N.htm"><span style="font-family:arial;"><span id="SPELLING_ERROR_3" class="blsp-spelling-error">Kif</span>6 was just shot down</span></a><span style="font-family:arial;"> as a useful marker.</span><br /><br /><span style="font-family:arial;">6. Clinical Utility has not been evaluated in ANY of these tests. </span><br /><br /><span style="font-family:arial;">7. </span><a href="http://gawker.com/5049488/spit-parties-the-trend-piece-that-will-destroy-the-world"><span style="font-family:arial;">Spit Parties don't lower cholesterol</span></a><br /><br /><span style="font-family:arial;">8. </span><a href="http://thegenesherpa.blogspot.com/2010/07/fda-ldt-meeting-bigger-than-just-dtcg.html"><span style="font-family:arial;">The FDA is hunting down</span></a><span style="font-family:arial;"> these type of </span><a href="http://www.newscientist.com/article/dn11779-heart-attack-gene-variants-may-double-risk.html"><span style="font-family:arial;">crazy claims</span></a><span style="font-family:arial;">!</span><br /><br /><span style="font-family:arial;">9 .</span><a href="http://www.usatoday.com/tech/science/genetics/2004-12-22-cardiac-genetic-link_x.htm"><span style="font-family:arial;"> <span id="SPELLING_ERROR_4" class="blsp-spelling-error">Topol's</span> heart attack gene didn't pan out</span></a><span style="font-family:arial;">, why would these?</span><br /><br /><span style="font-family:arial;">10. </span><a href="http://www.phgfoundation.org/news/5780/"><span style="font-family:arial;">A recent 23 gene panel failed to make the grade as well.</span></a><br /><br /><span style="font-family:arial;">Let me be crystal clear. </span><br /><br /><span style="font-family:arial;">I am glad that the number one reason for ordering a <span id="SPELLING_ERROR_5" class="blsp-spelling-error">DTCG</span> test was curiosity and not true medical concern in the "early adopters"</span><br /><br /><span style="font-family:arial;">But I am concerned that may not be the case for the next wave. I am concerned they will take these genetic tea leaves and use them. </span><br /><br /><span style="font-family:arial;">The problem, most of these tests are <span id="SPELLING_ERROR_6" class="blsp-spelling-error">disproven</span> or will be in the next couple of years.</span><br /><br /><span style="font-family:arial;">Loose associations with small increased risks sounds <span id="SPELLING_ERROR_7" class="blsp-spelling-error">a lot</span> like fortune telling or phrenology. Or hell, even birth order....</span><br /><br /><span style="font-family:arial;">Someday we will have good predictive models, 10-15 years from now. But NOT Now! Do you hear that <span id="SPELLING_ERROR_8" class="blsp-spelling-error">VC</span> country, <span id="SPELLING_ERROR_9" class="blsp-spelling-error">SV</span>, NYC, <span id="SPELLING_ERROR_10" class="blsp-spelling-error">Hedgies</span>?</span><br /><br /><span style="font-family:arial;">10 year exit strategy. Not 2 not 8. <a href="http://www.bizjournals.com/sanjose/news/2010/11/09/google-others-help-23andme-raise-22m.html">So stop hyping this bull$h!t and go invest in Gold or Commodities or something for the love of god</a>!</span><br /><br /><strong><span style="font-family:arial;color:#ff0000;">The Sherpa Says: Did you hear the one about the research geneticist? He keeps telling his wife how great their sex life WILL BE! Someday we will have this tool, let's try not to burn out and <span id="SPELLING_ERROR_11" class="blsp-spelling-error">cynicize</span> the public yet.....HT Francis Collins</span></strong>Steven Murphy MDhttp://www.blogger.com/profile/14591520761803672451noreply@blogger.com7tag:blogger.com,1999:blog-6173393362223742012.post-82695695736714817422010-11-05T18:07:00.000-07:002010-11-05T18:59:44.729-07:00Family History Better than Navigenics/DTCG Shill for Cancer Genes?<a href="http://3.bp.blogspot.com/_H2O5TGQzVII/TNSwykRW-UI/AAAAAAAABR0/84YxVZrWmGA/s1600/missed_opportunity.jpg"><img style="MARGIN: 0px 0px 10px 10px; WIDTH: 200px; FLOAT: right; HEIGHT: 145px; CURSOR: hand" id="BLOGGER_PHOTO_ID_5536244224721615170" border="0" alt="" src="http://3.bp.blogspot.com/_H2O5TGQzVII/TNSwykRW-UI/AAAAAAAABR0/84YxVZrWmGA/s200/missed_opportunity.jpg" /></a><span style="font-family:arial;">Yes,</span><br /><div><span style="font-family:arial;">You heard it here. A recent study abstract and </span><a href="http://www.cleveland.com/healthfit/index.ssf/2010/11/cleveland_clinic_research_show.html"><span style="font-family:arial;">pressed about</span></a><span style="font-family:arial;"> from my friend <a href="http://www.lerner.ccf.org/gmi/eng/">Charis Eng MD PhD</a>, Clinical Geneticist, Internist and all around really smart lady spoke today about her findings of a head to head, DTCG vs Family History at discovering cancer risk.</span></div><div><span style="font-family:Arial;"></span> </div><div><span style="font-family:Arial;">You can <a href="http://www.ashg.org/familyhistoryassessment/">watch the webcast about it here!</a></span><br /></div><div><span style="font-family:arial;">I actually sent some data <a href="http://www.mskcc.org/prg/prg/bios/161.cfm">Ken Offit's</a> way about a similar thing way back when, Ken is yet another, really smart guy. He wasn't surprised. Nor was I when I heard Dr. Eng's findings.</span></div><br /><div><span style="font-family:arial;">First, Caveat Emptor </span></div><br /><div><span style="font-family:arial;">This is an abstract! Repeat after me......</span></div><br /><div><span style="font-family:arial;">What does that mean? </span></div><br /><div><span style="font-family:arial;">1. It is not peer reviewed fully</span><br /></div><div><span style="font-family:arial;">2. It is not published yet</span><br /></div><div><span style="font-family:arial;">3. It is preliminary data</span></div><br /><div><span style="font-family:arial;">This test was Navigenics Compass vs Family History in 22 females with breast cancer, 22 males with prostate cancer and 44 people with colorectal cancer.</span><br /></div><div><span style="font-family:arial;"></span></div><br /><div><span style="font-family:arial;">What was the result?<strong> Family History placed far more people in the proper high risk category. 8:1</strong></span></div><br /><div><span style="font-family:arial;"><strong>Family History put 22 people in the appropriate High Risk Hereditary Category, DTCG only one</strong>.</span></div><br /><div><span style="font-family:arial;"></span></div><br /><div><span style="font-family:arial;">Further, it looks to me that <strong>the Navi "Gene" Scan missed several high risk patients who actually had MMR mutations (I.E. Genetic Cancer)</strong>.....D'Oh.</span></div><br /><div><span style="font-family:arial;">First off, this is like a case study. But it signals a HUGE shortcoming of DTCG. False reassurance.</span></div><br /><div><span style="font-family:arial;">I have been beating this over the head for 3 years now! These tests that have "medical" relevance need to be couched with proper medical guidance.</span></div><br /><div><a href="http://thegenesherpa.blogspot.com/2010/08/reporter-mary-carmichael-will-she-do-it.html"><span style="font-family:arial;">I told Mary Carmichael of Newsweek this!</span></a></div><br /><div><a href="http://thegenesherpa.blogspot.com/2010/05/thomas-goetz-has-wrong-debate-fda.html"><span style="font-family:arial;">This stuff is medical data and I Told Thomas Goetz of Wired this!</span></a></div><br /><div><a href="http://blogs.wsj.com/health/2010/07/23/listen-to-consumer-dna-test-company-sales-reps-behaving-badly/"><span style="font-family:arial;">Even the WSJ has gotten it!</span></a></div><br /><div><span style="font-family:arial;">There are huge shortcomings in the current offering of DTCG tests and those offering medical information need to be regulated as medical. This is a classic case in point of potential and REAL missed cases.</span><br /></div><div><span style="font-family:arial;"></span></div><br /><div><span style="font-family:arial;">Not Good. </span></div><br /><div><span style="font-family:arial;">That being said. It is November AKA Family History Month. You should absolutely</span><a href="https://familyhistory.hhs.gov/fhh-web/home.action"><span style="font-family:arial;"> take your family history</span></a><span style="font-family:arial;"> and bring it to your doctor.</span><a href="http://www.usatoday.com/yourlife/health/medical/2010-10-25-Genetics24_CV_N.htm"><span style="font-family:arial;"> If they don't know what to do with it, call us. We do.</span></a><br /></div><div><span style="font-family:arial;"></span></div><br /><div><strong><span style="font-family:arial;color:#ff0000;">The Sherpa Says: No surprises Charis, I saw this with some DTC cases I have had, passed it on to Ken who passed it on to NIH and The IOM. This is the huge problem with hype and over promise. It always fails to deliver, unfortunately in this case at a great risk to consumers.</span></strong></div><br /><div><span style="font-family:arial;"></span></div>Steve Murphy MDhttp://www.blogger.com/profile/11774190000307343476noreply@blogger.com8