<?xml version="1.0" encoding="UTF-8"?><rss version="2.0"
	xmlns:content="http://purl.org/rss/1.0/modules/content/"
	xmlns:dc="http://purl.org/dc/elements/1.1/"
	xmlns:atom="http://www.w3.org/2005/Atom"
	>
<channel>
	<title>Comments on: Clinical Trials Data Should Be Disclosed: Poll</title>
	<atom:link href="http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/feed" rel="self" type="application/rss+xml" />
	<link>http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/</link>
	<description>News, Comment and Conversation</description>
	<pubDate>Fri, 10 Feb 2012 22:35:15 +0000</pubDate>
	<generator>http://wordpress.org/?v=2.6.2</generator>
		<item>
		<title>By: Reality</title>
		<link>http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/#comment-20136</link>
		<dc:creator>Reality</dc:creator>
		<pubDate>Fri, 21 Sep 2007 16:59:02 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/#comment-20136</guid>
		<description>Adam,

The PhRMA database is more than just a place to publish the studies -- it is an agreement by member companies to post results there (http://www.clinicalstudyresults.org/primers/Clinical_Study_Results_Database.pdf). While the PhRMA database is technically voluntary, the companies that I'm familiar with treat posting as mandatory and take it quite seriously.

There will be those in the industry opposed to a mandatory database for any number of reasons, but there are legitimate reasons for opposing certain aspects (e.g., investigational compounds, provisions that posting will not endanger publication in journals, etc.). I have not read the bill, but I know that these were issues with the PhRMA database. That said, I'm sure there are those who have less-than-honorable reasons for not wanting the database, and they are the ones who perpetuate the industry's subversive reputation.</description>
		<content:encoded><![CDATA[<p>Adam,</p>
<p>The PhRMA database is more than just a place to publish the studies &#8212; it is an agreement by member companies to post results there (http://www.clinicalstudyresults.org/primers/Clinical_Study_Results_Database.pdf). While the PhRMA database is technically voluntary, the companies that I&#8217;m familiar with treat posting as mandatory and take it quite seriously.</p>
<p>There will be those in the industry opposed to a mandatory database for any number of reasons, but there are legitimate reasons for opposing certain aspects (e.g., investigational compounds, provisions that posting will not endanger publication in journals, etc.). I have not read the bill, but I know that these were issues with the PhRMA database. That said, I&#8217;m sure there are those who have less-than-honorable reasons for not wanting the database, and they are the ones who perpetuate the industry&#8217;s subversive reputation.</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: Reality</title>
		<link>http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/#comment-20134</link>
		<dc:creator>Reality</dc:creator>
		<pubDate>Fri, 21 Sep 2007 16:40:16 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/#comment-20134</guid>
		<description>Ed,

Let's not forget that there are plenty of pharma employees who publicly agree as well.</description>
		<content:encoded><![CDATA[<p>Ed,</p>
<p>Let&#8217;s not forget that there are plenty of pharma employees who publicly agree as well.</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: Adam</title>
		<link>http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/#comment-20073</link>
		<dc:creator>Adam</dc:creator>
		<pubDate>Fri, 21 Sep 2007 04:56:54 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/#comment-20073</guid>
		<description>Someone said that there is already a database for this. However, the issue here is the legislation that will require that studies are posted, not whether there is already a place to publish them. The question to ask is: why was there pressure to remove the requirement from the legislatoin, do they have something to hide?</description>
		<content:encoded><![CDATA[<p>Someone said that there is already a database for this. However, the issue here is the legislation that will require that studies are posted, not whether there is already a place to publish them. The question to ask is: why was there pressure to remove the requirement from the legislatoin, do they have something to hide?</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: Ed Silverman</title>
		<link>http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/#comment-20025</link>
		<dc:creator>Ed Silverman</dc:creator>
		<pubDate>Thu, 20 Sep 2007 19:20:22 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/#comment-20025</guid>
		<description>Dear Reality,

Understood. And so we've added a line indicating that pharma employees may privately agree and voted that way. Thanks to you and Lori for underscoring this point.

ed at Pharmalot</description>
		<content:encoded><![CDATA[<p>Dear Reality,</p>
<p>Understood. And so we&#8217;ve added a line indicating that pharma employees may privately agree and voted that way. Thanks to you and Lori for underscoring this point.</p>
<p>ed at Pharmalot</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: Reality</title>
		<link>http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/#comment-20008</link>
		<dc:creator>Reality</dc:creator>
		<pubDate>Thu, 20 Sep 2007 16:12:54 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/#comment-20008</guid>
		<description>Somewhat tangential to Lori's comment, isn't it possible that Pharma folks also value transparency and disclosure? And that's regardless of consumer vs. commercial interests. The 2 ARE NOT mutually exclusive. Let's please not paint all Pharma employees with such a broad brush.</description>
		<content:encoded><![CDATA[<p>Somewhat tangential to Lori&#8217;s comment, isn&#8217;t it possible that Pharma folks also value transparency and disclosure? And that&#8217;s regardless of consumer vs. commercial interests. The 2 ARE NOT mutually exclusive. Let&#8217;s please not paint all Pharma employees with such a broad brush.</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: Reality</title>
		<link>http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/#comment-19995</link>
		<dc:creator>Reality</dc:creator>
		<pubDate>Thu, 20 Sep 2007 13:24:34 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/#comment-19995</guid>
		<description>Maybe industry people sat it out because they know that such a database ALREADY EXISTS (i.e., www.clinicalstudyresults.org)? Boy, I'm sounding like a broken record, but no one seems to want to acknowledge that this has been going on since 2004.

As I said previously, having only read the blurbs about the proposed FDA database (and not the text of the bill), I fail to see what the FDA database adds to what already exists.

As for the snooping aspect, I think that only really applies to investigational prodcuts, and I think drug companies have every right to keep that data confidential until the drug is approved/marketed. Even for investigational compounds, serious safety issues have to/will be reported -- early phase trials are stopped all the time for safety reasons, sometimes with substantial coverage.</description>
		<content:encoded><![CDATA[<p>Maybe industry people sat it out because they know that such a database ALREADY EXISTS (i.e., <a href="http://www.clinicalstudyresults.org" rel="nofollow">http://www.clinicalstudyresults.org</a>)? Boy, I&#8217;m sounding like a broken record, but no one seems to want to acknowledge that this has been going on since 2004.</p>
<p>As I said previously, having only read the blurbs about the proposed FDA database (and not the text of the bill), I fail to see what the FDA database adds to what already exists.</p>
<p>As for the snooping aspect, I think that only really applies to investigational prodcuts, and I think drug companies have every right to keep that data confidential until the drug is approved/marketed. Even for investigational compounds, serious safety issues have to/will be reported &#8212; early phase trials are stopped all the time for safety reasons, sometimes with substantial coverage.</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: Lori</title>
		<link>http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/#comment-19992</link>
		<dc:creator>Lori</dc:creator>
		<pubDate>Thu, 20 Sep 2007 13:06:56 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/09/clinical-trials-data-should-be-disclosed-poll/#comment-19992</guid>
		<description>Perhaps those in the pharmaceutical industry voted their personal feelings as consumers, rather than representing their companies.</description>
		<content:encoded><![CDATA[<p>Perhaps those in the pharmaceutical industry voted their personal feelings as consumers, rather than representing their companies.</p>
]]></content:encoded>
	</item>
</channel>
</rss>

<!-- Dynamic Page Served (once) in 0.214 seconds -->

