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	<title>Comments on: Did Lilly&#8217;s New CEO Urge Off-Label Promotion?</title>
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	<link>http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/</link>
	<description>News, Comment and Conversation</description>
	<pubDate>Tue, 14 Oct 2008 10:58:40 +0000</pubDate>
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		<title>By: Grieving</title>
		<link>http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-225805</link>
		<dc:creator>Grieving</dc:creator>
		<pubDate>Tue, 25 Mar 2008 15:03:35 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-225805</guid>
		<description>Interesting you would pick up on, and negate, the word I used about my son "death" from profound hyperglycemia from Zyprexa.  As time has gone on, and as I have learned more about the industry, doctors, and the government, I usually use the word "killed" or "murdered".  My son was murdered, no question about it, and his murderers belong where all murderers belong.  That it is prison.  Not a white collar, country club prison.  A REAL prison.

I compare this crime with Enron sometimes.  Large corporation; executives went to prison over matters having to do only with money.  While Lilly's crime has to do with the killing of innocent, sweet, loving, family members who with their families were taken by surprise.  Stealth murders.</description>
		<content:encoded><![CDATA[<p>Interesting you would pick up on, and negate, the word I used about my son &#8220;death&#8221; from profound hyperglycemia from Zyprexa.  As time has gone on, and as I have learned more about the industry, doctors, and the government, I usually use the word &#8220;killed&#8221; or &#8220;murdered&#8221;.  My son was murdered, no question about it, and his murderers belong where all murderers belong.  That it is prison.  Not a white collar, country club prison.  A REAL prison.</p>
<p>I compare this crime with Enron sometimes.  Large corporation; executives went to prison over matters having to do only with money.  While Lilly&#8217;s crime has to do with the killing of innocent, sweet, loving, family members who with their families were taken by surprise.  Stealth murders.</p>
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		<title>By: pg</title>
		<link>http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211727</link>
		<dc:creator>pg</dc:creator>
		<pubDate>Sun, 16 Mar 2008 01:14:46 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211727</guid>
		<description>THERE IS NO EXCUSE. Drug fronts can argue and spin - WHY ARE WE LISTENING.  THEY HAVE KNOWINGLY KILLED OUR CHILDREN.

They continue to do so.

STOP MURDERING OUR CHILDREN, OUR FUTURE. OUR SPECIES.  IN OUR LIFETIME DRUG COMPANIES HAVE KNOWINGLY KILLED CHILDREN, PARENTS, GRANDPARENTS, AUNTS, UNCLES. 

Why are stupid enough to let them continue by giving them time to continue while we discuss why, how, whether?

IT IS MURDER.</description>
		<content:encoded><![CDATA[<p>THERE IS NO EXCUSE. Drug fronts can argue and spin - WHY ARE WE LISTENING.  THEY HAVE KNOWINGLY KILLED OUR CHILDREN.</p>
<p>They continue to do so.</p>
<p>STOP MURDERING OUR CHILDREN, OUR FUTURE. OUR SPECIES.  IN OUR LIFETIME DRUG COMPANIES HAVE KNOWINGLY KILLED CHILDREN, PARENTS, GRANDPARENTS, AUNTS, UNCLES. </p>
<p>Why are stupid enough to let them continue by giving them time to continue while we discuss why, how, whether?</p>
<p>IT IS MURDER.</p>
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		<title>By: pg</title>
		<link>http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211713</link>
		<dc:creator>pg</dc:creator>
		<pubDate>Sun, 16 Mar 2008 01:00:41 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211713</guid>
		<description>Perhaps, when citizens recognise and call a deed done knowingly by the name it is given when anyone else does that - MURDER - perhaps then, when the 'drug company' influence is lost, the people will do what should have done decades ago.

DEMAND A STOP TO MURDERING OUR CHILDREN.</description>
		<content:encoded><![CDATA[<p>Perhaps, when citizens recognise and call a deed done knowingly by the name it is given when anyone else does that - MURDER - perhaps then, when the &#8216;drug company&#8217; influence is lost, the people will do what should have done decades ago.</p>
<p>DEMAND A STOP TO MURDERING OUR CHILDREN.</p>
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		<title>By: pg</title>
		<link>http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211712</link>
		<dc:creator>pg</dc:creator>
		<pubDate>Sun, 16 Mar 2008 00:56:45 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211712</guid>
		<description>"Even “deaths” is probably the wrong word under these circumstances. It implies a “natural” process."

So, lets call a spade a spade.  It is death of children due to corruption, lies, hidden data by a company that knew what would happen.

Its name is MURDER. In any other walk of life, that is MURDER.  There is absolutely no reason to let drug makers be the only people on this planet who can GET AWAY with doing what anyone else ends up in prison for.

IT IS MURDER.
THE MURDER OF CHILDREN.</description>
		<content:encoded><![CDATA[<p>&#8220;Even “deaths” is probably the wrong word under these circumstances. It implies a “natural” process.&#8221;</p>
<p>So, lets call a spade a spade.  It is death of children due to corruption, lies, hidden data by a company that knew what would happen.</p>
<p>Its name is MURDER. In any other walk of life, that is MURDER.  There is absolutely no reason to let drug makers be the only people on this planet who can GET AWAY with doing what anyone else ends up in prison for.</p>
<p>IT IS MURDER.<br />
THE MURDER OF CHILDREN.</p>
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		<title>By: Melody</title>
		<link>http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211356</link>
		<dc:creator>Melody</dc:creator>
		<pubDate>Sat, 15 Mar 2008 20:30:28 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211356</guid>
		<description>Ed's March 3 article, "Nursing Homes And Chemical Straightjackets" shows another side of the story. The story states: "Connecticut has consistently ranked in the top four states in the prevalence of antipsychotic drugs dispensed to nursing home residents who have no psychotic or related conditions." Obviously there is NO market these pharmaceuticals are unwilling to exploit.</description>
		<content:encoded><![CDATA[<p>Ed&#8217;s March 3 article, &#8220;Nursing Homes And Chemical Straightjackets&#8221; shows another side of the story. The story states: &#8220;Connecticut has consistently ranked in the top four states in the prevalence of antipsychotic drugs dispensed to nursing home residents who have no psychotic or related conditions.&#8221; Obviously there is NO market these pharmaceuticals are unwilling to exploit.</p>
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		<title>By: Justice in Michigan</title>
		<link>http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211353</link>
		<dc:creator>Justice in Michigan</dc:creator>
		<pubDate>Sat, 15 Mar 2008 20:26:20 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211353</guid>
		<description>FME - Much thanks for taking your time on this, and for your thoughtful reflections.  As noted, as an outsider, it is particuarly difficult to understand how "things go down" in the relevant range of circumstances.

I know a few WBs who have gone through the hell to which you refer - not only in the context of pharma.  Only a few, and the very lucky ones who get a good deal support, luck, and related, would do it again.  Vindication alone is rarely reward enough.

That's why I stay focused on how to support those people as well as things like external modes of accountability.  

Your thoughts about docs right to the point.  I hear their war stories too...

Again thanks.</description>
		<content:encoded><![CDATA[<p>FME - Much thanks for taking your time on this, and for your thoughtful reflections.  As noted, as an outsider, it is particuarly difficult to understand how &#8220;things go down&#8221; in the relevant range of circumstances.</p>
<p>I know a few WBs who have gone through the hell to which you refer - not only in the context of pharma.  Only a few, and the very lucky ones who get a good deal support, luck, and related, would do it again.  Vindication alone is rarely reward enough.</p>
<p>That&#8217;s why I stay focused on how to support those people as well as things like external modes of accountability.  </p>
<p>Your thoughts about docs right to the point.  I hear their war stories too&#8230;</p>
<p>Again thanks.</p>
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		<title>By: Former pharma Marketing Exec</title>
		<link>http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211338</link>
		<dc:creator>Former pharma Marketing Exec</dc:creator>
		<pubDate>Sat, 15 Mar 2008 20:10:57 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211338</guid>
		<description>JIM:

I haven't forgotten what your question is, but I am spending a great deal of time thinking about it.  How do we protect the people who want to do the right thing.  The WB rule, doesn't work as we can see that every time someone tries to bring a really big ethical question up to upper management the person usually gets tossed, then they have to go through the Qui Tam (Qui tam pro domino rege quam pro se ipso in hoc parte sequitur) process, which takes a lot of money and time and takes a serious human toll on the person who launches it.

Maybe the government should make it mandatory that there be a human rights/ethics audit of companies.  Pharma first.  They must report yearly an overview of their actions and be subject to unannounced inspections of personnel.  Any fines or wrong doing recorded for any give company puts them on a list that is more closely monitored.  Sales and marketing activities are more closely scrutinized.  R&#38;D and regulatory as well.

The point being, if you have nothing to hide, then implementing this process isn't difficult at all.  It gets really easy when you just do the right thing.  Anything that you have to think about and reconstruct and repackage is probably something that you shouldn't be doing. 

I guarantee you  that if you start calling prescribing physicians to the witness stand and asking them to specifically provide details of the product educational information such as time, place, date and contents and what honorarium or payments of any kind they might have received will be quite effective.  If doctors realize that they will be brought in and held just as accountable, much of this activity will stop.  Ask the doctors to provide exactly the information they received that assured them that prescribing the drug for this particular use was the right thing to do.

Anytime any drug is promoted with un-published material or for indications other than what it has been originally prescribed should be questioned thoroughly.  

There are instances (although not in this case) when off label use is justified, but as long as the doctors know that at some point they may need to provide more details and information this will certainly make many physicians think twice about what they are doing.

I have said it before and I say it again - nothing less than full disclosure.  Patients should be able to look up a website of the product, find the disclosures and find any warnings from the FDA and all studies should be there.  If you put something up with sales and marketing initiatives, maybe then the patient will have half a chance to really have informed consent.

Just my thoughts for a Saturday...</description>
		<content:encoded><![CDATA[<p>JIM:</p>
<p>I haven&#8217;t forgotten what your question is, but I am spending a great deal of time thinking about it.  How do we protect the people who want to do the right thing.  The WB rule, doesn&#8217;t work as we can see that every time someone tries to bring a really big ethical question up to upper management the person usually gets tossed, then they have to go through the Qui Tam (Qui tam pro domino rege quam pro se ipso in hoc parte sequitur) process, which takes a lot of money and time and takes a serious human toll on the person who launches it.</p>
<p>Maybe the government should make it mandatory that there be a human rights/ethics audit of companies.  Pharma first.  They must report yearly an overview of their actions and be subject to unannounced inspections of personnel.  Any fines or wrong doing recorded for any give company puts them on a list that is more closely monitored.  Sales and marketing activities are more closely scrutinized.  R&amp;D and regulatory as well.</p>
<p>The point being, if you have nothing to hide, then implementing this process isn&#8217;t difficult at all.  It gets really easy when you just do the right thing.  Anything that you have to think about and reconstruct and repackage is probably something that you shouldn&#8217;t be doing. </p>
<p>I guarantee you  that if you start calling prescribing physicians to the witness stand and asking them to specifically provide details of the product educational information such as time, place, date and contents and what honorarium or payments of any kind they might have received will be quite effective.  If doctors realize that they will be brought in and held just as accountable, much of this activity will stop.  Ask the doctors to provide exactly the information they received that assured them that prescribing the drug for this particular use was the right thing to do.</p>
<p>Anytime any drug is promoted with un-published material or for indications other than what it has been originally prescribed should be questioned thoroughly.  </p>
<p>There are instances (although not in this case) when off label use is justified, but as long as the doctors know that at some point they may need to provide more details and information this will certainly make many physicians think twice about what they are doing.</p>
<p>I have said it before and I say it again - nothing less than full disclosure.  Patients should be able to look up a website of the product, find the disclosures and find any warnings from the FDA and all studies should be there.  If you put something up with sales and marketing initiatives, maybe then the patient will have half a chance to really have informed consent.</p>
<p>Just my thoughts for a Saturday&#8230;</p>
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		<title>By: Justice in Michigan</title>
		<link>http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211216</link>
		<dc:creator>Justice in Michigan</dc:creator>
		<pubDate>Sat, 15 Mar 2008 18:01:06 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211216</guid>
		<description>Strongly concur with both Dod and Grieving.  Re: Doc's comment, I believe the key will be to find ways to enforce accountability externally (through criminal investigation, civil liability, transparency requirements) _and_ to support the many industry insiders who are committed to doing the right thing.  There are no shortage of these people, and, as I've said before, we (and they) are toast if we have _only_ external means of accountability.

Even "deaths" is probably the wrong word under these circumstances.  It implies a "natural" process.</description>
		<content:encoded><![CDATA[<p>Strongly concur with both Dod and Grieving.  Re: Doc&#8217;s comment, I believe the key will be to find ways to enforce accountability externally (through criminal investigation, civil liability, transparency requirements) _and_ to support the many industry insiders who are committed to doing the right thing.  There are no shortage of these people, and, as I&#8217;ve said before, we (and they) are toast if we have _only_ external means of accountability.</p>
<p>Even &#8220;deaths&#8221; is probably the wrong word under these circumstances.  It implies a &#8220;natural&#8221; process.</p>
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		<title>By: Grieving</title>
		<link>http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211185</link>
		<dc:creator>Grieving</dc:creator>
		<pubDate>Sat, 15 Mar 2008 17:22:03 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211185</guid>
		<description>Well, there's another name of a Lilly exec (soon to be head of the company)who needs to be tried in a criminal case and sent to prison.  Or do we want to quit pretending that over 1000 innocent young people died from Zyprexa, leaving massive devastation in their families.  The word "death" has pretty much been dropped from news stories and labels, as if it really hasn't happened.</description>
		<content:encoded><![CDATA[<p>Well, there&#8217;s another name of a Lilly exec (soon to be head of the company)who needs to be tried in a criminal case and sent to prison.  Or do we want to quit pretending that over 1000 innocent young people died from Zyprexa, leaving massive devastation in their families.  The word &#8220;death&#8221; has pretty much been dropped from news stories and labels, as if it really hasn&#8217;t happened.</p>
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		<title>By: Doc</title>
		<link>http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211071</link>
		<dc:creator>Doc</dc:creator>
		<pubDate>Sat, 15 Mar 2008 16:00:11 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/03/did-lillys-new-ceo-urge-off-label-promotion/#comment-211071</guid>
		<description>How much smoke does the public, judges, congress, regulators, et al need to see before they realize there is a forest fire of unethical behavior in these big pharma companies. They have many good people trying to do the right thing, but they also have many aggressive sales and marketing reps, managers and VPs that are only about a buck - no matter how it is received. Without STRICT govenrment oversight these companies will spin out of control even more.</description>
		<content:encoded><![CDATA[<p>How much smoke does the public, judges, congress, regulators, et al need to see before they realize there is a forest fire of unethical behavior in these big pharma companies. They have many good people trying to do the right thing, but they also have many aggressive sales and marketing reps, managers and VPs that are only about a buck - no matter how it is received. Without STRICT govenrment oversight these companies will spin out of control even more.</p>
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