tag:blogger.com,1999:blog-8480427453110572235.post7465258786241045677..comments2008-06-27T00:23:36.875+10:00Danielhttp://www.blogger.com/profile/07276690118219000204noreply@blogger.comBlogger4125tag:blogger.com,1999:blog-8480427453110572235.post-39128886104339177532008-06-27T00:23:00.000+10:002008-06-27T00:23:00.000+10:00Daniel,<BR/><BR/>This is an interesting debate. As someone who has been involved in genetic testing now for many years, this California decision to make an overly broad interpretation of law represents a greater concern in my mind and that's how consumers handle health information. <BR/><BR/>Let me first start off with stating that I know a thing or two about this debate. I worked at Prometheus Labs where we built the first blockbuster pharmacogenetics testing (TPMT genetics and 6-TGN/6-MMPN therapeutic drug metabolites) that 1 out 3 new scripts (NRxs) in the U.S. gets and we introduced Celiac disease testing in the U.S. (serologies and genetics). Even though the testing did not have FDA approval, it was performed in a CLIA-certified laboratory, ordered by a physician, and we were even able to get the TPMT testing added to the FDA-approved package insert labels of the drugs in the affected class without the test being FDA-approved. <BR/><BR/>Now, from a nutrigenetics standpoint, you state that it is a "maligned" industry. Maybe... remember not all the companies you mention were included in the damning GAO report - namely Salugen. <BR/><BR/>As the founding CEO of Salugen, we have taken a pragmatic approach of leveraging 30 years of research, conducting our own R&D and commercial pilots, and have published over 15 studies/articles in peer-reviewed scientific journals over the past three years - far more than any other player in the industry. <BR/><BR/>We have performed every single test - within a study or commercially - in a CLIA-certified laboratory, credentialed by CAP and inspected by the State of California. Through our piloting, we have tested various different iterations of the technology to figure out commercially what works, while also tacitly evaluating the clinical effectiveness of those commercial studies by conducting observational studies of those outcomes with protocols approved by an independent IRB. <BR/><BR/>We have tried many pilots including large resort spas, direct to consumer, through the court system in alternative sentencing, online, direct mail, through physicians offices, and through addiction treatment centers. By doing these pilots, we have garnered a tremendous amount of experience of what works and what does not work. <BR/><BR/>On May 29, 2008, Salugen issued a press release (http://www.24-7pressrelease.com/press-release/salugen-begins-implementation-of-its-strategically-restructured-business-plan-51414.php) explaining how it will be focused moving forward, which includes providing its testing and products primarily through clinicians. <BR/><BR/>We received the letter from the CDOPH dated June 9th and appreciated their concern about the public health and believe we share in the motivations to do the right thing. We explained that we believe we have been in compliance with the law, apologized for any unintentional transgressions, and moving forward, we believe that we are in compliance with their even more broad restrictions (http://www.salugen.com/assets/documents/Salugen%20Statement%20of%20CA%20Ltr.pdf).<BR/><BR/>But here's the thing? At the end of the day, what is the CDOPH really concerned about here? Genetic testing generally just provides information. As Navigenics states, they are taking gene testing and using algorithms to provide information. What is harmful about giving information? Isn't more information better?<BR/><BR/>Seperate from my role at Salugen, I personally believe that giving consumers and physicians more information is good. If CDOPH is worried that consumers may be scared about the information they receive, this already happens everyday with the Internet - genetics or not. <BR/><BR/>You don't need to imagine this scenario: a 50 year old woman is diagnosed with early stage rheumatoid arthritis. She is prescribed the most widely-used disease modifying anti-rheumatic drug - methotrexte. She goes to the pharmacy on her way home, picks up the script, and heads home. She sits down in front of her computer and searches for the term "methotrexate" to learn more about this drug. Bam! She sees that methotrexate is actually a chemotherapy agent. "Oh No! Chemotherapy?" She says, "Does that mean I am going to lose my hair?" Then she continues to read, "methotrexate is part of the regimen involving RU-486 - medical abortions". She says "Abortions? What is the drug doing to me?" And so the narrative goes that this woman may not be as likely to take her medication because of information she finds online at a crucial time of her therapy when early DMARD intervention is critical to her treatment. She then does not have the results her doctor wanted and she is then put on a biologic treatment (like a TNF-alpha inhibitor) which costs 20 times the amount, yet has not been found to be any more clinically effective in monotherapy than methotrexate alone. <BR/><BR/>So, is that a public health concern? 2M RA patients in America? You tell me... If the concern is about consumers getting information that they may misinterpret or may be considered far too complex for them to understand, this already exists with the Internet - whether genetics is involved or not. There is no way to stop it. It existed before the CDOPH letter and it will exist after their interpretation of the law. Personally, what I think is most important, is that regulators in every state and probably at the federal level, work with those of us who understand this market and come to a mutual understanding of the facts, the risks and other issues so that the regulators feel comfortable that they are doing their best job to protect the public good in this very nascent market of consumer genetic testing.<BR/><BR/>Anyway, I think it is a good debate to be having, if well-intentioned people can come to a consensus.Brian Meshkinhttp://www.blogger.com/profile/10293790313041953812noreply@blogger.comtag:blogger.com,1999:blog-8480427453110572235.post-10942199819301049642008-06-26T23:54:00.000+10:002008-06-26T23:54:00.000+10:00Daniel<BR/><BR/>Great post. It will definitely be interesting to see how this shakes out. Yes there are enough shamsters out there, and they should/will have to fold out, but in the end I doubt that the Big 3 + KNOME will have to cease operations<BR/><BR/>I'd like to add one thing. Linda Avey gave the keynote at BioIT World. She and Dietrich Stephan were panelists in a very interesting discussion. Within the scientific community, there are many who think its too early, and I am not sure it isn't, but almost no one I know would consider these companies anything but legit and providing anything more than information services (or in the case of pharma a long term treasure trove of information)Deepakhttp://mndoci.myopenid.com/noreply@blogger.comtag:blogger.com,1999:blog-8480427453110572235.post-39003920838747850962008-06-26T06:00:00.000+10:002008-06-26T06:00:00.000+10:00I doubt anyone's going to be moving to India, Dr. Murphy, and other states will almost certainly follow CA and NY's lead. As Daniel mentioned, the most likely scenario is that the fly-by-nighters will pack up and the non-scam business will remain, and that would indeed be a win-win.<BR/><BR/>Have you considered that hiring you on as a consultant might be growing less and less likely with every post you write?Mr. Gunnhttp://www.blogger.com/profile/17434342767819948877noreply@blogger.comtag:blogger.com,1999:blog-8480427453110572235.post-58960423752948912872008-06-26T01:26:00.000+10:002008-06-26T01:26:00.000+10:00Daniel,<BR/>Great post. But I think there are quite a few more outcomes....Including<BR/>1. A 2 year long legal battle where these companies continue to operate<BR/>2. They turn into the Viagra scam, where a doctor blindly writes scripts<BR/>3. Other states squeeze them too...i.e. Texas, NY, NJ, CT putting them in the fight in several states...This is a very likely scenario.<BR/>4. They all move to India, You gotta hate that commute to Mumbai<BR/>5. They call a consultant (Like Me) and we can help them with some other solutions.<BR/>6. They Win....and the Gov't loses completely, allowing all of these fly by nights to stand along side of the big 3 and pretend they are doing similar things....<BR/><BR/>I can think of a few others.....<BR/><BR/>-Steve<BR/>www.thegenesherpa.blogspot.comSteve Murphy MDhttp://www.blogger.com/profile/11774190000307343476noreply@blogger.com