{"id":11698,"date":"2010-03-13T01:10:43","date_gmt":"2010-03-13T01:10:43","guid":{"rendered":"http:\/\/euvolution.com\/futurist-transhuman-news-blog\/the-fda-2c19-and-the-acc\/"},"modified":"2010-03-13T01:10:43","modified_gmt":"2010-03-13T01:10:43","slug":"the-fda-2c19-and-the-acc","status":"publish","type":"post","link":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/genetic-medicine\/the-fda-2c19-and-the-acc.php","title":{"rendered":"The FDA, 2c19 and the ACC"},"content":{"rendered":"

\"\"<\/a>Did anyone see the FDA issuance of the better warning that as many as 14% of patients will not benefit from Plavix<\/span>\/Clopidogrel<\/span>?<\/a><\/span><\/p>

<\/span> <\/div>
Did anyone see the cold shower being poured on by the press and the cardiologists?<\/span><\/div>

<\/p>

This from WSJ<\/span> blog<\/span><\/a><\/div>

<\/p>

Christopher Cannon Assoc. Prof at Harvard says:<\/span><\/div>
The ACC<\/span> will need to develop protocols, \"Thus a real conundrum\"<\/span><\/div>

<\/p>

He then says \"I expect mass confusion in response to this FDA warning\"<\/span><\/div>

<\/p>

Well Chris, It's not as if we haven't been shouting from the rooftops about this for over a year now.......<\/span><\/div>

<\/p>

And from WebMD<\/span><\/span><\/a><\/div>

<\/p>

\"The test costs about 500 USD<\/span> according to Courtney Harper PhD, Director of the FDAs<\/span> division of chemistry and toxicology devices. But cost isn't the only issue.\"<\/span><\/div>

<\/p>

Which BTW is false 23andME<\/span> is cheaper......But wait, isn't that medicine?<\/a><\/span><\/div>

<\/p>

\"The time to get a result varies. It may be a few hours to a day or two, or other labs may take a few weeks\"<\/span><\/div>

<\/p>

This is absolutely true. It takes me 3 weeks for a test from Quest. I am certain that there has to be some lab to do it quicker.......<\/span><\/div>

<\/p>

BUT, the FDA has only approved AmpliChip<\/span> for this testing.....<\/span><\/div>

<\/p>

This sounds to me like the FDA needs to approve some kits and PDQ with the ACC<\/span> meeting coming up like, <\/span><\/div>

<\/p>

Next Monday!!!! Oh, Shiz<\/span>!<\/span><\/a><\/div>

<\/p>

My guess<\/span><\/div>

<\/p>

1. The ACC<\/span> will address and release its prelim algorithm<\/span><\/div>

<\/p>

2. The ACC<\/span> conference will have even further data regarding this released.<\/span><\/div>

<\/p>

3. The last step is to FDA in some kits to do this test, quicker and more standardized.<\/span><\/div>

<\/p>

We need a company that can direct us to<\/span><\/div>

<\/p>

The Right Lab, for The Right Test, For the Right Patient For the Right Drug.......<\/a><\/span><\/div>

<\/p>

So the question, why all the cold water on this killer app<\/a>? Well, because it is getting lumped in with DTC<\/span> genomics<\/span>, which is feeling a backlash from hype and failed promises<\/a>. Or trying to play medicine.<\/a><\/span><\/div>
<\/span> <\/div>
As well as a flat disregard for medicine. So when the press and the healthcare<\/span> providers are against you, you can feel it<\/a>.<\/span><\/div>

<\/p>

But this is what I have been frustrated about all along. I saw this coming. Doctors blowing off PGx<\/span> thinking it is SNPChip<\/span> Hype. Journalists pouncing on overpromising<\/span> and intellectually dishonest DTC<\/span> Genomics<\/span> companies.....<\/a><\/span><\/div>

<\/p>

This is why I was so mad about the blimp<\/a>. <\/span><\/div>

<\/p>

When something really awesome comes around, <\/span>people are burned out from Open Bars......<\/span><\/a><\/div>

<\/p>

<\/span><\/div>

<\/p>

The Sherpa Says: Let's really do this. Genomics<\/span> and PGx<\/span> IS medicine. Let's say it proud, Let's ay<\/span> it loud. Quit screwing around to avoid regs. Let's how the world how we can use this to help mankind!<\/strong><\/span><\/div>
<\/div>

<\/p>

<\/div>
\"\"<\/div>","protected":false},"excerpt":{"rendered":"

Did anyone see the FDA issuance of the better warning that as many as 14% of patients will not benefit from Plavix\/Clopidogrel? Did anyone see the cold shower being poured on by the press and the cardiologists?This from WSJ blogChristopher … Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"limit_modified_date":"","last_modified_date":"","_lmt_disableupdate":"","_lmt_disable":"","footnotes":""},"categories":[5],"tags":[],"class_list":["post-11698","post","type-post","status-publish","format-standard","hentry","category-genetic-medicine"],"modified_by":null,"_links":{"self":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts\/11698"}],"collection":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/comments?post=11698"}],"version-history":[{"count":0,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts\/11698\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/media?parent=11698"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/categories?post=11698"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/tags?post=11698"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}