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Ask FDA to better serve the needs of diabetes patients   Message List  
Reply | Forward Message #578 of 634 |
Re: [nathanfaustmantrials] Ask FDA to better serve the needs of diabetes patients


I don't agree with your petition at all!

First, the letter only applies to medicines that treat type-2 diabetes, so it will not slow down a cure for type-1 at all.

Second, there have been a couple of drugs which actually got approved for type-2 diabetics which had bad side effects in terms of raising the chance of heart attacks.  The FDA reacted to these  problems by fixing their process: by requiring the drug companies to do testing focused specifically at heart risks.  That is the right thing to do! 

Prior to these new regulations, type-2 diabetic drugs could be approved after clinical trials lasting only 3-6 months.  That's nuts!  Those drugs are typically taken for years (maybe even decades).  Requiring them to be tested for a year is long over due.  The extra time is required to get a statistically valid sample of heart risk.

If we want a safe drug supply in this country, the FDA should go farther, and require post-approval  (called "postmarket") safety testing lasting as long a the expected use of the drug.  That is basic common sense.  That would shake out a lot of safety issues before people got hurt, without slowing down drug approvals.  But in the mean time, the FDA's rule change is a good step in the right direction.  In my opinion.

Joshua Levy


From: Bernard Farrell <bernard.farrell@...>
To: nathanfaustmantrials@yahoogroups.com
Sent: Monday, January 5, 2009 8:15:01 PM
Subject: [nathanfaustmantrials] Ask FDA to better serve the needs of diabetes patients

A large group of us has started an online petition to the FDA.

We're asking them to remove new requirements they recently placed on
diabetes drugs.

Please sign. The petition is at: http://HealTheFDA. com/

If you want more details, I've posted them on my blog at
http://is.gd/ eEMB.




Tue Jan 6, 2009 5:27 pm

joshua2levy
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Message #578 of 634 |
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A large group of us has started an online petition to the FDA. We're asking them to remove new requirements they recently placed on diabetes drugs. Please...
Bernard Farrell
bernfarr
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Jan 6, 2009
11:52 am

I don't agree with your petition at all! First, the letter only applies to medicines that treat type-2 diabetes, so it will not slow down a cure for type-1 at...
Joshua Levy
joshua2levy
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Jan 6, 2009
6:20 pm

With all due respect, Joshua, I have to disagree with you on several elements. First, you should be advised that the FDA guidance [Docket No. FDA-2008-D-0118...
Scott Strumello
sstrumello
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Feb 2, 2009
2:00 am

Hi Joshua. I have a new one for you. Please take a look and advise. Thanks for all your research analysis. Please see their latest news. http://www.curedm.com/...
gr8discjck
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Jan 29, 2009
3:38 pm

Diabetes Breakthrough May Lead to New Treatment for Children and Adults Wynnewood, PA, February 05, 2009 --(PR.com)-- A team of researchers from CureDM, Inc,...
gr8discjck
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Feb 6, 2009
12:51 am
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