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110225 tn?1272727888

WIll you get involved politically to speed up new treatment access?

The FDA is accepting comments regarding expanded access to the Direct acting anti-virals for Hep C at http://www.regulations.gov/search/Regs/home.html#submitComment?R=0900006480ab98ce. Will those of us who cannot or will not take interferon post comments demanding greatly expanded trials with combinations of the best STAT-C drugs, in the public health interest? Highly safe and effective treatments for hepatitis C are already developed, they just need to be combined correctly to prevent resistance from developing. Lets tell the FDA remove all obstacles from the speedy delivary of these  treatments to patients.
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179856 tn?1333547362
I totally agree - if we don't care enough to do it who is going to?!!!!

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Avatar universal
While i understand where you are coming from, if the FDA speeds things up and it back fires people would be lining up to sue who ever they could....... Best to you
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Avatar universal
You do not have to post a long document or PowerPoint presentation. Two sentences will do it. Here is a sample comment.

FDA Question 3) Under what circumstances and in which populations would early access to multiple DAAs be appropriate?

Early access to multiple DAAs would be appropriate for HCV infected patients with cirrhosis. Patients with cirrhosis who failed to respond to interferon and ribavirin therapy should be strongly considered along with patients who are intolerant to interferon or ribavirin.

What will happen to your comment? FDA will write new guidelines for HCV. In a typical FDA report, they would say something like "83 comments requested that patients with cirrhosis who failed interferon and ribavirin should be eligible for expanded access. Based on our analysis, FDA's position is ....."

FDA reads and considers all comments. They respond with guidelines based on all available evidence. If you write a comment on http://www.regulations.gov you may be helping yourself and thousands of others in a similar situation. At the website, search on FDA-2010-N-0107.
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Avatar universal
Heck no, Politics has NO place in medicine nor war. Getting paper pushers involved only mucks everything up as they often are clueless on the details of these matters.

The FDA on the other-hand is a bit different in that they appear to stradle the fence between politics and being knowledgeable of the subject area.
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