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	<title>Comments on: FDA Panel: Tighter Standards For Diabetes Drugs</title>
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	<link>http://www.pharmalot.com/2008/07/fda-panel-tighter-standards-for-diabetes-drugs/</link>
	<description>News, Comment and Conversation</description>
	<pubDate>Fri, 10 Feb 2012 20:41:37 +0000</pubDate>
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		<title>By: Ed Silverman</title>
		<link>http://www.pharmalot.com/2008/07/fda-panel-tighter-standards-for-diabetes-drugs/#comment-365448</link>
		<dc:creator>Ed Silverman</dc:creator>
		<pubDate>Fri, 04 Jul 2008 13:10:26 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14446#comment-365448</guid>
		<description>Hi CMC,

Sorry for the belated reply. I agree that COI form is standard, but I posted it because folks like to see that sort of thing anyway. I don't know for a fact that he's close to Grassley's staff or others in DC, so I chose not to include that for the obvious reason. Same thing for any aspirations; he's never confirmed the speculation, or accusation, as it comes across when some discuss it. 

Of course, the Cleveland Clinic may benefit when industry conducts tests. But there's no guarantee what will happen as a result of the commmittee recommendation. I'll leave that one to others to debate, because I'm sure there will be strong views, given the emotions Nissen generates anytime he's at the center of the action. 

Cheers
ed</description>
		<content:encoded><![CDATA[<p>Hi CMC,</p>
<p>Sorry for the belated reply. I agree that COI form is standard, but I posted it because folks like to see that sort of thing anyway. I don&#8217;t know for a fact that he&#8217;s close to Grassley&#8217;s staff or others in DC, so I chose not to include that for the obvious reason. Same thing for any aspirations; he&#8217;s never confirmed the speculation, or accusation, as it comes across when some discuss it. </p>
<p>Of course, the Cleveland Clinic may benefit when industry conducts tests. But there&#8217;s no guarantee what will happen as a result of the commmittee recommendation. I&#8217;ll leave that one to others to debate, because I&#8217;m sure there will be strong views, given the emotions Nissen generates anytime he&#8217;s at the center of the action. </p>
<p>Cheers<br />
ed</p>
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		<title>By: Justice in MI</title>
		<link>http://www.pharmalot.com/2008/07/fda-panel-tighter-standards-for-diabetes-drugs/#comment-365402</link>
		<dc:creator>Justice in MI</dc:creator>
		<pubDate>Thu, 03 Jul 2008 20:46:51 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14446#comment-365402</guid>
		<description>Obviously, I know what we all mean by the terms, but (again, in the interest of avoiding reductionism!), I think there are very few people who are "against pharma."  

Yes, there are those out there in the world who think that statin is satan spelled backward, who believe it's all a conspiracy against garlic supplementation, etc..  But here we're talking about specific policy issues - DTC, preemption, reps, etc. - upon which we have a wide range of views.  But I see very few that that the pro/anti pharma dichotomy covers.

The best threads are when we see the range of views within a core consensus about what the issues are and, within whatever differences, learn from other.

Kumbaya.

(And agree with Nathan that we need specifics here about what is being recommended.)</description>
		<content:encoded><![CDATA[<p>Obviously, I know what we all mean by the terms, but (again, in the interest of avoiding reductionism!), I think there are very few people who are &#8220;against pharma.&#8221;  </p>
<p>Yes, there are those out there in the world who think that statin is satan spelled backward, who believe it&#8217;s all a conspiracy against garlic supplementation, etc..  But here we&#8217;re talking about specific policy issues - DTC, preemption, reps, etc. - upon which we have a wide range of views.  But I see very few that that the pro/anti pharma dichotomy covers.</p>
<p>The best threads are when we see the range of views within a core consensus about what the issues are and, within whatever differences, learn from other.</p>
<p>Kumbaya.</p>
<p>(And agree with Nathan that we need specifics here about what is being recommended.)</p>
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		<title>By: Margaret</title>
		<link>http://www.pharmalot.com/2008/07/fda-panel-tighter-standards-for-diabetes-drugs/#comment-365399</link>
		<dc:creator>Margaret</dc:creator>
		<pubDate>Thu, 03 Jul 2008 20:12:11 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14446#comment-365399</guid>
		<description>If I could vote, I would sure vote for Nissen to become our future FDA Commissioner.  Yes, he has an ego, but he also has more than his share of ethics and morality - qualities sorely missing in the industry, medicine, and government.

And, yes.  Grassley is THE leading light battling Pharma. Thank heavens for him, at least.</description>
		<content:encoded><![CDATA[<p>If I could vote, I would sure vote for Nissen to become our future FDA Commissioner.  Yes, he has an ego, but he also has more than his share of ethics and morality - qualities sorely missing in the industry, medicine, and government.</p>
<p>And, yes.  Grassley is THE leading light battling Pharma. Thank heavens for him, at least.</p>
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		<title>By: CMC guy</title>
		<link>http://www.pharmalot.com/2008/07/fda-panel-tighter-standards-for-diabetes-drugs/#comment-365397</link>
		<dc:creator>CMC guy</dc:creator>
		<pubDate>Thu, 03 Jul 2008 19:54:56 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14446#comment-365397</guid>
		<description>Ed I was aware of posting of the Nissen COI waiver but had not taken time to read earlier.  The financial stuff is fairly typical of what have seen.  Most interesting are comments about his known pharma (&#38; FDA?) criticisms and how he provides an opposing and/or diversity point of view (not sure ever seen so blatantly stated invitee rationale).  So for balance of opinions think they should have invited PHARMA's Tauzin?

Actually I believe I recall reading Nissen has close ties with certain strong anti-pharma Beltway Politicos but not sure who (Grassley?)?  Also suggestion has been made he is positioning to become future FDA Commissioner.  These would be relevant COIs as underlying motivations that would not be expressed in the waiver letter.</description>
		<content:encoded><![CDATA[<p>Ed I was aware of posting of the Nissen COI waiver but had not taken time to read earlier.  The financial stuff is fairly typical of what have seen.  Most interesting are comments about his known pharma (&amp; FDA?) criticisms and how he provides an opposing and/or diversity point of view (not sure ever seen so blatantly stated invitee rationale).  So for balance of opinions think they should have invited PHARMA&#8217;s Tauzin?</p>
<p>Actually I believe I recall reading Nissen has close ties with certain strong anti-pharma Beltway Politicos but not sure who (Grassley?)?  Also suggestion has been made he is positioning to become future FDA Commissioner.  These would be relevant COIs as underlying motivations that would not be expressed in the waiver letter.</p>
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		<title>By: Nathan</title>
		<link>http://www.pharmalot.com/2008/07/fda-panel-tighter-standards-for-diabetes-drugs/#comment-365347</link>
		<dc:creator>Nathan</dc:creator>
		<pubDate>Thu, 03 Jul 2008 09:19:07 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14446#comment-365347</guid>
		<description>So, the way I read it, the new CV risk trials just need to be *started* (not completed) before approval.  Is that the way you guys understand it?  If so, then this really is just an added cost - not a delay.  Also, per the previous comment thread, it seems to apply only to diabetes drugs -- not to all drugs for cardiovascular and metabolic disease (as seemed to be implied in the previous article).  

Bottom line IMHO: It's an additional burden for drugmakers, but not as bad as it could be.</description>
		<content:encoded><![CDATA[<p>So, the way I read it, the new CV risk trials just need to be *started* (not completed) before approval.  Is that the way you guys understand it?  If so, then this really is just an added cost - not a delay.  Also, per the previous comment thread, it seems to apply only to diabetes drugs &#8212; not to all drugs for cardiovascular and metabolic disease (as seemed to be implied in the previous article).  </p>
<p>Bottom line IMHO: It&#8217;s an additional burden for drugmakers, but not as bad as it could be.</p>
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		<title>By: Justice in MI</title>
		<link>http://www.pharmalot.com/2008/07/fda-panel-tighter-standards-for-diabetes-drugs/#comment-365343</link>
		<dc:creator>Justice in MI</dc:creator>
		<pubDate>Thu, 03 Jul 2008 05:46:13 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14446#comment-365343</guid>
		<description>CMC Guy - You are entirely right - to really understand what was being endorsed we need more info.  I think that's why I said somewhere on the Nissen thread that I wasn't sure _what_ was being recommended (by him).  So I plead guilty to reductionism in the absence of knowing more.  It's a good word to use, especially here!

Re: the last bit, I was being "ironic" in a probably indulgent way.  I read some of the Nissen thread comments as having their own reductionism - not only that potential COIs should be considered (which I said there I agreed with) - but there was a little trashing going on too.  Presumption of guilt, at least as I read it.

is Nissen really a "pharma critic" or at least the opposite of those who are "pro-pharma"? That, too, seems a bit reductionist to me.  But I do agree that "ego" does not seem to be one of his deficiencies.</description>
		<content:encoded><![CDATA[<p>CMC Guy - You are entirely right - to really understand what was being endorsed we need more info.  I think that&#8217;s why I said somewhere on the Nissen thread that I wasn&#8217;t sure _what_ was being recommended (by him).  So I plead guilty to reductionism in the absence of knowing more.  It&#8217;s a good word to use, especially here!</p>
<p>Re: the last bit, I was being &#8220;ironic&#8221; in a probably indulgent way.  I read some of the Nissen thread comments as having their own reductionism - not only that potential COIs should be considered (which I said there I agreed with) - but there was a little trashing going on too.  Presumption of guilt, at least as I read it.</p>
<p>is Nissen really a &#8220;pharma critic&#8221; or at least the opposite of those who are &#8220;pro-pharma&#8221;? That, too, seems a bit reductionist to me.  But I do agree that &#8220;ego&#8221; does not seem to be one of his deficiencies.</p>
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		<title>By: Ed Silverman</title>
		<link>http://www.pharmalot.com/2008/07/fda-panel-tighter-standards-for-diabetes-drugs/#comment-365338</link>
		<dc:creator>Ed Silverman</dc:creator>
		<pubDate>Thu, 03 Jul 2008 04:19:26 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14446#comment-365338</guid>
		<description>Hi CMC,

If you go to this link, you can read the COI waiver given Nissen. It doesn't name specific drugmakers, but you can get an idea...

http://www.fda.gov/ohrms/dockets/ac/08/waivers/2008-4368w1-00-index.htm

ed</description>
		<content:encoded><![CDATA[<p>Hi CMC,</p>
<p>If you go to this link, you can read the COI waiver given Nissen. It doesn&#8217;t name specific drugmakers, but you can get an idea&#8230;</p>
<p><a href="http://www.fda.gov/ohrms/dockets/ac/08/waivers/2008-4368w1-00-index.htm" rel="nofollow">http://www.fda.gov/ohrms/dockets/ac/08/waivers/2008-4368w1-00-index.htm</a></p>
<p>ed</p>
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		<title>By: CMC guy</title>
		<link>http://www.pharmalot.com/2008/07/fda-panel-tighter-standards-for-diabetes-drugs/#comment-365337</link>
		<dc:creator>CMC guy</dc:creator>
		<pubDate>Thu, 03 Jul 2008 04:05:33 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14446#comment-365337</guid>
		<description>JIM I think your 14-2 endorsement statement may be an over simplification (or reductionism to borrow from Dr. Helm) as need to see the specific questions plus the discussion that took place to understand the vote (questions should be part of meeting package, transcript typically follows in few weeks). Generally these meetings are very narrow so what may appear solid in the context does not consider broader issues of importance. I will generalize myself and say "Ask a scientist if they want more data and invariably expect the answer to be yes".  I don't have enough info to reach any conclusion you have and would assume people are mostly honorable so your final question lacks substance.

Based on available past information Nissen should require a level of scrutiny as a pharma critic in the same way occurs with pro-pharma people.  I don't know much about his particular COIs but comments I have seen out of him seem more ego enhancing than patient concerns.</description>
		<content:encoded><![CDATA[<p>JIM I think your 14-2 endorsement statement may be an over simplification (or reductionism to borrow from Dr. Helm) as need to see the specific questions plus the discussion that took place to understand the vote (questions should be part of meeting package, transcript typically follows in few weeks). Generally these meetings are very narrow so what may appear solid in the context does not consider broader issues of importance. I will generalize myself and say &#8220;Ask a scientist if they want more data and invariably expect the answer to be yes&#8221;.  I don&#8217;t have enough info to reach any conclusion you have and would assume people are mostly honorable so your final question lacks substance.</p>
<p>Based on available past information Nissen should require a level of scrutiny as a pharma critic in the same way occurs with pro-pharma people.  I don&#8217;t know much about his particular COIs but comments I have seen out of him seem more ego enhancing than patient concerns.</p>
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		<title>By: Justice in MI</title>
		<link>http://www.pharmalot.com/2008/07/fda-panel-tighter-standards-for-diabetes-drugs/#comment-365331</link>
		<dc:creator>Justice in MI</dc:creator>
		<pubDate>Thu, 03 Jul 2008 03:14:08 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14446#comment-365331</guid>
		<description>Thanks CMC Guy and Ed - As will probably not surprise you, I was curious how many of the panelists had ties to cardiology or, in some other way, some potential conflict of interest in voting as they did.

At least as I understand it, they voted 14-2 essentially endorsing the same view that Naissen articulated.  In the thread about him, a number of folks ridiculed him personally and suggested that his opinions should be scanned for COIs.

I'm all for scanning.  But here are 16 people of whom 14 said, in essence, the same thing.  They are mostly endocrinologists (not the sort of people you would think would want to fight the development of diabetes drugs).  Plus a statistician, health educator, and one lipids/cardio person.

Anybody think they were "going after" pharma to line their own pockets?</description>
		<content:encoded><![CDATA[<p>Thanks CMC Guy and Ed - As will probably not surprise you, I was curious how many of the panelists had ties to cardiology or, in some other way, some potential conflict of interest in voting as they did.</p>
<p>At least as I understand it, they voted 14-2 essentially endorsing the same view that Naissen articulated.  In the thread about him, a number of folks ridiculed him personally and suggested that his opinions should be scanned for COIs.</p>
<p>I&#8217;m all for scanning.  But here are 16 people of whom 14 said, in essence, the same thing.  They are mostly endocrinologists (not the sort of people you would think would want to fight the development of diabetes drugs).  Plus a statistician, health educator, and one lipids/cardio person.</p>
<p>Anybody think they were &#8220;going after&#8221; pharma to line their own pockets?</p>
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		<title>By: Ed Silverman</title>
		<link>http://www.pharmalot.com/2008/07/fda-panel-tighter-standards-for-diabetes-drugs/#comment-365326</link>
		<dc:creator>Ed Silverman</dc:creator>
		<pubDate>Thu, 03 Jul 2008 02:25:01 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14446#comment-365326</guid>
		<description>Hi JIM,

Here is the committee roster...

http://www.fda.gov/ohrms/dockets/ac/08/roster/2008-4368r1-FDA-committee.pdf

Cheers
ed</description>
		<content:encoded><![CDATA[<p>Hi JIM,</p>
<p>Here is the committee roster&#8230;</p>
<p><a href="http://www.fda.gov/ohrms/dockets/ac/08/roster/2008-4368r1-FDA-committee.pdf" rel="nofollow">http://www.fda.gov/ohrms/dockets/ac/08/roster/2008-4368r1-FDA-committee.pdf</a></p>
<p>Cheers<br />
ed</p>
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