Attorney J Gottstein subpoenas Lilly, J&J & AstraZ for hidden antipsychotics data

Attorney J Gottstein subpoenas Lilly, J&J & AstraZ for hidden antipsychotics data

Joined: April 19th, 2005, 7:01 pm

September 11th, 2007, 9:10 am #1

<H1 style="MARGIN-BOTTOM: 2px"><FONT size=2>http://www.lawyersandsettlements.com/ar ... html</FONT></H1>
<H1 style="MARGIN-BOTTOM: 2px"><FONT size=5>Attorney Subpoens J&J, AstraZeneca and Lilly for Hidden Antipsychotic Data Part I </FONT></H1>
<P style="MARGIN-BOTTOM: 2px">
<TABLE style="MARGIN-BOTTOM: 6px" cellSpacing=0 cellPadding=0 width="100%" border=0>
<TBODY>
<TR>
<TD class=date>September 10, 2007. By Evelyn Pringle</TD>
<TD class=date align=right>&nbsp; <A href="http://www.newsvine.com/_tools/seed?pop ... drugs.html" target=_blank></A></TD></TR></TBODY></TABLE>

<BLOCKQUOTE class=standard>Washington, DC:Alaska attorney Jim Gottstein has issued subpoenas for the discovery of any suppressed data on the atypical antipsychotic drugs <EM>Zyprexa, Risperdal, and Seroquel </EM>which he says is necessary before a Forced Drugging Petition can possibly be considered for approval for a client he is representing.

Mr Gottstein contends that the information sought from Eli Lilly, AstraZeneca and Johnson & Johnson will show that the side effects of the drugs were well-established by the drug makers' own clinical trials and therefore, his client should not be forced to take such medications against his will.

<IMG style="MARGIN: 0px 15px 3px 0px" alt="Antipsychotic medical research" src="http://www.lawyersandsettlements.com/im ... poenas.jpg" align=left border=0>According to Mr Gottstein, various off-label combinations of Risperdal, Seroquel, Zyprexa and the anti-seizure drug Depakote have been administered to his client in the past, over his objections, which have not been FDA approved as safe or effective for use in any patient.

The subpoena issued to Sidney Taurel, Chairman and CEO of Eli Lilly calls for the production of the same documents requested by Congressman Henry Waxman (D-Cal), as chairman of the House Oversight and Government Reform Committee, on March 1, 2007.

On March 1, 2007, Rep Waxman sent letters to both Lilly and AstraZeneca, requesting extensive information about their marketing practices. The letter to Lilly states in part, "Allegations have been raised that Eli Lilly misled physicians and inappropriately promoted off-label uses of Zyprexa," and requests information relevant to these allegations.

The letter asks for a list of <STRONG>all Zyprexa trials, studies, or reports; all presentations given to employees who promoted Zyprexa; information shown to physicians; presentations related to prescribing patterns, continuing medical education, and off-label use; and all documents and correspondence related to funding for nonprofit professional organizations or consumer patient groups.
</STRONG>
The letter to Astra basically asks for the same documents except that Rep Waxman asks for more information related to the physicians and authors involved in company sponsored studies on Seroquel and writing the reports.

However, Rep Waxman also asked Lilly to turn over a batch of documents that were kept under seal for years with a court order issued by a federal court in New York, but were provided to him by Attorney Gottstein in December 2006, which Rep Waxman subsequently returned to Lilly on December 21, 2006, to honor the court order.

Mr Gottstein originally obtained the documents by subpoenaing <STRONG>Dr David Egilman</STRONG>, who served as a plaintiffs expert witness in the Zyprexa Products Liability litigation, pending in the United States District Court in the Eastern District of New York (MDL 1596), for a case unrelated to the Products Liability case.

The MDL 1596 litigation involved tens of thousands of lawsuits filed by Zyprexa victims who alleged that Lilly illegally marketed the drug for off-label uses and concealed the serious side effects known to be associated with Zyprexa for a decade.

<STRONG>As soon as Mr Gottstein received the documents he provided copies to reporter, Alex Berenson, at the New York Times, and to a number of other journalists, patient rights activists and advocacy groups and several leading experts on psychotropic drugs.
</STRONG>
Once a medication is approved to treat one condition, doctors may prescribe it off-label for other indications if they think it will be effective, but drug makers are barred by law from encouraging physicians to prescribe a drug for uses other than those listed on the FDA approved label. But in recent years, its a well-known fact that off-label promotion has become the industries primary marketing tool when it comes to psychiatric drugs.

"Off-label" use also includes treating an approved condition for a longer duration of time, or in combination with other drugs, or at a different dosage, or with a different patient population such children or the elderly, than are listed on the label.

Zyprexa (Lilly), Risperdal (J&J) and Seroquel (AstraZeneca) belong to a class of drugs known as "atypical" antipsychotics. The other atypical drug include Abilify (Bristol Meyers Squibb), Geodon (Pfizer) and Clozril (Novartis).

The drugs were FDA approved only to treat schizophrenia and the manic phase of bipolar disorder in adults and have never been approved for use in combination with each other.

The many lawsuits filed against Lilly allege that the company's off-label marketing campaigns included influencing doctors to prescribe the drug to millions of patients ranging from toddlers to the elderly for an exhaustive list of unapproved uses such as anxiety, sleep disruption, mood swings, post-partum depression, autism, attention deficit hyperactivity and dementia.

According to Harrisburg Pennsylvania psychiatrist, Dr Stefan Kruszewski, the atypical drugs can increase the risk of drastic weight gain, diabetes, pancreatitis, hypertension, heart attacks and stroke.

"The drugs can cause both a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems," he explains, "at the same time that they cause the neurological side effects as the older antipsychotics such as akathesis, a severe restlessness and tardive dyskinesia an often irreversible movement disorder."

As an expert witness in the case, Dr Egilman reviewed the Lilly documents kept under seal by the court order and learned that Lilly had indeed engaged in a massive off-label marketing scheme to increase profits by encouraging doctors to prescribe the drug for unapproved uses and had concealed the drug's serious side effects.

As a physician, after learning what was in the documents and knowing the harm that was sure to come to patients who continued to take Zyprexa, <STRONG>Dr Egilman was clearly facing a major ethical dilemma.
</STRONG>
At the time, Lilly had already managed to <STRONG>keep the documents hidden by settling out of court with about 8,000 Zyprexa victims in 2005 by paying close to $700 million</STRONG>, after only five plaintiffs had provided depositions and before any substantive depositions could be taken from any of the Lilly defendants.

And the first batch out of court settlements did nothing to deter the off-label sales of Zyprexa. According to Lilly's SEC filings, sales in the second quarter of 2006 totaled $1.12 billion, or a 2% increase over the second quarter of 2005.

In addition, <STRONG>Dr Egilman was aware that the company was getting ready to settle with about 18,000 more Zyprexa victims, and that the second round of settlements would guarantee that the secret documents would remain sealed.
</STRONG>
And as a condition of settlement, the 28,000 plaintiffs had to sign agreements promising never to discuss the charges made against the company related to Zyprexa.

According to several plaintiffs who settled out of court, <STRONG>they were not aware that there were documents that showed in many instances that Lilly knew full well that the injuries suffered could occur and had intentionally concealed the information from doctors and patients because it would have had a negative impact on Zyprexa sales.
</STRONG>
In fact, these plaintiffs said <STRONG>they were never told that these secret documents even existed much less that by signing settlement agreements they would be allowing more patients to be injured or killed because the documents would remain sealed.
</STRONG>

They also said that they were completely <STRONG>surprised to learn that their attorneys had access to documents that could have been presented to a jury to prove that the allegations in their lawsuits were true </STRONG>when the media began reporting the story in December 2006.

For instance, a November 12, 1999, letter from a Dr Albert Marrero, to Lilly's medical director, described the blood sugar problems occurring in patients. "We have had eight patients out of possibly thirty-five patients on Zyprexa show up with high blood sugars," he stated.

Dr Marrero also told Lilly: "Two patients had to be hospitalized due to out of control diabetes....We have certainly never seen this with Haldol, Navane, Risperdal and others to this extent," he wrote.

A November 1999 report showed that after examining 70 clinical trials, Lilly found that 16% of patients on Zyprexa for a year had gained over 66 pounds but instead of informing doctors of this information, the company used data from a smaller group of trials to say about 30% of patients gained only 22 pounds.

Another document showed that in 2000, after a group of diabetes doctors retained by Lilly substantiated the diabetes risk, <STRONG>a Lilly manager stated in an email, "unless we come clean on this, it could get much more serious than we might anticipate."
</STRONG>
A email dated two years later in March 2002, shows that <STRONG>Lilly shot down a plan to provide doctors with information about diabetes, because it would draw too much attention to the risk</STRONG>. "Although M.D.'s like objective, educational materials, having our reps provide some with diabetes would further build its association to Zyprexa," the email stated.

Although the documents clearly show that Lilly had knowledge of these life-threatening health risks in 1999, it did not add a warning about blood sugar levels and diabetes to the Zyprexa label until <STRONG>the FDA forced it to in the fall of 2003</STRONG>. In fact, Japan and the UK issued warnings about the increased risk of diabetes in 2002.

According to Ellen Liversridge, whose son took Zyprexa and gained 100 pounds before he fell into a coma and died of profound hyperglycemia in 2002, "<STRONG>both the FDA and Lilly fought putting a warning on the label, until articles on the front pages of the New York Times, Baltimore Sun, and Wall Street Journal so embarrassed the FDA that they finally gave in to adding the warnings</STRONG>."

But even then she says, the FDA required the same warning on the labels of all atypical drugs, "when <STRONG>Zyprexa was associated with a 37% higher increase in the risk of diabetes when compared to other medications</STRONG>."

However, the secret documents show that Lilly was hard at work behind the scenes to make sure that the new warnings would have minimal effects on Zyprexa sales. <STRONG>A July 7, 2003, memo titled, "Diabetes Update," described a plan to protect doctors who were afraid of being sued for prescribing Zyprexa after the news of the diabetes risk became public that would indemnify doctors who continued to prescribe drug </STRONG>

"We must embrace the fact that many physicians are curtailing their use of Zyprexa (particularly in the moderately-ill patient and in the maintenance phase)," the Update said,
"solely on the basis of personal fear (<STRONG>of being sued</STRONG>)."

"Indemnification represents the most meaningful demonstration of confidence in Zyprexa--both with our customers and with our employees," it stated.

The memo also discussed a plan to <STRONG>pay millions of dollars to the National Alliance on Mental Illness, the most notorious industry backed front group in the nation</STRONG>, to help <STRONG>downplay the news </STRONG>about the diabetes risk.

The public health crisis created by patients who developed diabetes as a result of using Zyprexa is real. A Medicaid fraud lawsuit filed against Lilly by the attorney general of Mississippi in July 2006, alleges that about <STRONG>10% of patients who used Zyprexa in that state have developed insulin-dependent diabetes and some are children</STRONG>, the complaint says.

When forced to make a decision on whether to warn the public about Zyprexa or abide by a court order that could result in the death and injury of thousands upon thousands of more people, <STRONG>Dr Egilman obviously followed the natural instinct of any <FONT size=5>decent</FONT> human being and gave up the documents</STRONG>.

Whether or not he actually realized what consequences he might face is anyone's guess, but he no doubt recognizes the consequences of crossing the drug giant today.

On September 7, 2007, Lilly issued a press release with the headline: "Egilman Admits Wrongdoing in Illegally Releasing Documents to New York Times and Resolves Case to Avoid Possible Civil and Criminal Sanctions".

The release said that Dr Egilman will pay $100,000, and in return, the company "agreed to forego seeking criminal and civil penalties against Dr. Egilman for his illegal activities."

<STRONG>Although it will be interesting to see how many "Good Samaritans" will stick their neck out for the common good after hearing about Dr Egilman's fate, it is apparently still easy to find doctors willing to prescribe Zyprexa off-label because SEC filings show Lilly earned $4.36 billion from the drug in 2006
</STRONG>
With all that said, on September 6, 2007, it was certainly a Deja Vue moment when the judge in Mr Gottstein's latest case against forced drugging in Alaska, <STRONG>issued an order to have the court hearing and file closed, even though the client had elected to have it open</STRONG>. "
</BLOCKQUOTE>
Last edited by SSRIAdmin on September 11th, 2007, 11:36 am, edited 1 time in total.
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Joined: April 19th, 2005, 7:01 pm

September 11th, 2007, 9:13 am #2

<EM>Another document showed that in 2000, after a group of diabetes doctors retained by Lilly substantiated the diabetes risk, </EM><EM><STRONG>a Lilly manager stated in an email, "unless we come clean on this, it could get much more serious than we might anticipate."
</STRONG>
</EM>
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Joined: April 19th, 2005, 7:01 pm

September 11th, 2007, 9:19 am #3


<EM>However, the secret documents show that Lilly was hard at work behind the scenes to make sure that the new warnings would have minimal effects on Zyprexa sales. A July 7, 2003, memo titled, "Diabetes Update," described a plan to protect doctors who were afraid of being sued for prescribing Zyprexa after the news of the diabetes risk became public that would indemnify doctors who continued to prescribe drug</EM>

<EM>"We must embrace the fact that many physicians are curtailing their use of Zyprexa (particularly in the moderately-ill patient and in the maintenance phase)," the Update said, "solely on the basis of personal fear (<STRONG>of being sued</STRONG>)." </EM>

<EM></EM>&nbsp;

<EM><STRONG>Zyprexa Documents:&nbsp;&nbsp; ZY1 00026321</STRONG></EM>

<EM><STRONG>Page 4:</STRONG></EM>

<EM>"...We must embrace the fact that many physicians are curtailing their use of Zyprexa (particularly in the moderately-ill patient and in the maintenance phase), solely on the basis of personal fear (of being sued). In order to address these concerns, we are evaluating several options, including:</EM>

<EM>1. Indemnification. We have asked our legal colleagues to revisit this controversial topic. The AMA has published its view (Ethical Opinion 802.6, June 2002) that indemnification represents an “<STRONG>inappropriate</STRONG> incentive” to physicians. We are evaluating avenues to explore this indemnification with the Office of the Inspector General. Indemnification represents the most meaningful demonstration of confidence in <STRONG>Zyprexa</STRONG> — both with our customers and with our employees. Our experience with <STRONG>Prozac </STRONG>confirms the impact and goodwill of such an initiative. We are investigating the viability of this action, and are preparing a business case analysis for senior management’s consideration — ASAP..."



</EM>
Last edited by peagee on September 13th, 2007, 7:24 am, edited 1 time in total.
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Joined: April 19th, 2005, 7:01 pm

September 11th, 2007, 9:24 am #4


<EM>The memo also discussed a plan to <STRONG>pay millions of dollars to the National Alliance on Mental Illness, the most notorious industry backed front group in the nation</STRONG>, to help <STRONG>downplay the news </STRONG>about the diabetes risk. </EM>

<EM></EM>&nbsp;
<EM>
<EM><STRONG>Zyprexa Documents:&nbsp;&nbsp; ZY1 00026321</STRONG></EM>

<EM><STRONG>Page 4:</STRONG></EM>

<EM>"...We must embrace the fact that many physicians are curtailing their use of Zyprexa (particularly in the moderately-ill patient and in the maintenance phase), solely on the basis of personal fear (of being sued). In order to address these concerns, we are evaluating several options, including:</EM>

<EM>1. Indemnification. We have asked our legal colleagues to revisit this controversial topic. The AMA has published its view (Ethical Opinion 802.6, June 2002) that indemnification represents an “<STRONG>inappropriate</STRONG> incentive” to physicians. We are evaluating avenues to explore this indemnification with the Office of the Inspector General. Indemnification represents the most meaningful demonstration of confidence in <STRONG>Zyprexa</STRONG> — both with our customers and with our employees. Our experience with <STRONG>Prozac </STRONG>confirms the impact and goodwill of such an initiative. We are investigating the viability of this action, and are preparing a business case analysis for senior management’s consideration — ASAP</EM>

<EM>2. NAMI National Screening Month. <STRONG>By providing NAMI a multimillion dollar grant </STRONG>to stage a national screening, we help educate physicians and patients on the inherent risks of diabetes — <STRONG>regardless of the antipsychotic</STRONG>..."
</EM>

</EM>

Last edited by SSRIAdmin on September 13th, 2007, 7:29 am, edited 1 time in total.
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September 11th, 2007, 9:31 am #5

<H1 style="MARGIN-BOTTOM: 2px"><FONT size=2>http://www.lawyersandsettlements.com/ar ... html</FONT></H1>
<H1 style="MARGIN-BOTTOM: 2px"><FONT size=5>Attorney Subpoens J&J, AstraZeneca and Lilly for Hidden Antipsychotic Data Part I </FONT></H1>
<P style="MARGIN-BOTTOM: 2px">
<TABLE style="MARGIN-BOTTOM: 6px" cellSpacing=0 cellPadding=0 width="100%" border=0>
<TBODY>
<TR>
<TD class=date>September 10, 2007. By Evelyn Pringle</TD>
<TD class=date align=right>&nbsp; <A href="http://www.newsvine.com/_tools/seed?pop ... drugs.html" target=_blank></A></TD></TR></TBODY></TABLE>

<BLOCKQUOTE class=standard>Washington, DC:Alaska attorney Jim Gottstein has issued subpoenas for the discovery of any suppressed data on the atypical antipsychotic drugs <EM>Zyprexa, Risperdal, and Seroquel </EM>which he says is necessary before a Forced Drugging Petition can possibly be considered for approval for a client he is representing.

Mr Gottstein contends that the information sought from Eli Lilly, AstraZeneca and Johnson & Johnson will show that the side effects of the drugs were well-established by the drug makers' own clinical trials and therefore, his client should not be forced to take such medications against his will.

<IMG style="MARGIN: 0px 15px 3px 0px" alt="Antipsychotic medical research" src="http://www.lawyersandsettlements.com/im ... poenas.jpg" align=left border=0>According to Mr Gottstein, various off-label combinations of Risperdal, Seroquel, Zyprexa and the anti-seizure drug Depakote have been administered to his client in the past, over his objections, which have not been FDA approved as safe or effective for use in any patient.

The subpoena issued to Sidney Taurel, Chairman and CEO of Eli Lilly calls for the production of the same documents requested by Congressman Henry Waxman (D-Cal), as chairman of the House Oversight and Government Reform Committee, on March 1, 2007.

On March 1, 2007, Rep Waxman sent letters to both Lilly and AstraZeneca, requesting extensive information about their marketing practices. The letter to Lilly states in part, "Allegations have been raised that Eli Lilly misled physicians and inappropriately promoted off-label uses of Zyprexa," and requests information relevant to these allegations.

The letter asks for a list of <STRONG>all Zyprexa trials, studies, or reports; all presentations given to employees who promoted Zyprexa; information shown to physicians; presentations related to prescribing patterns, continuing medical education, and off-label use; and all documents and correspondence related to funding for nonprofit professional organizations or consumer patient groups.
</STRONG>
The letter to Astra basically asks for the same documents except that Rep Waxman asks for more information related to the physicians and authors involved in company sponsored studies on Seroquel and writing the reports.

However, Rep Waxman also asked Lilly to turn over a batch of documents that were kept under seal for years with a court order issued by a federal court in New York, but were provided to him by Attorney Gottstein in December 2006, which Rep Waxman subsequently returned to Lilly on December 21, 2006, to honor the court order.

Mr Gottstein originally obtained the documents by subpoenaing <STRONG>Dr David Egilman</STRONG>, who served as a plaintiffs expert witness in the Zyprexa Products Liability litigation, pending in the United States District Court in the Eastern District of New York (MDL 1596), for a case unrelated to the Products Liability case.

The MDL 1596 litigation involved tens of thousands of lawsuits filed by Zyprexa victims who alleged that Lilly illegally marketed the drug for off-label uses and concealed the serious side effects known to be associated with Zyprexa for a decade.

<STRONG>As soon as Mr Gottstein received the documents he provided copies to reporter, Alex Berenson, at the New York Times, and to a number of other journalists, patient rights activists and advocacy groups and several leading experts on psychotropic drugs.
</STRONG>
Once a medication is approved to treat one condition, doctors may prescribe it off-label for other indications if they think it will be effective, but drug makers are barred by law from encouraging physicians to prescribe a drug for uses other than those listed on the FDA approved label. But in recent years, its a well-known fact that off-label promotion has become the industries primary marketing tool when it comes to psychiatric drugs.

"Off-label" use also includes treating an approved condition for a longer duration of time, or in combination with other drugs, or at a different dosage, or with a different patient population such children or the elderly, than are listed on the label.

Zyprexa (Lilly), Risperdal (J&J) and Seroquel (AstraZeneca) belong to a class of drugs known as "atypical" antipsychotics. The other atypical drug include Abilify (Bristol Meyers Squibb), Geodon (Pfizer) and Clozril (Novartis).

The drugs were FDA approved only to treat schizophrenia and the manic phase of bipolar disorder in adults and have never been approved for use in combination with each other.

The many lawsuits filed against Lilly allege that the company's off-label marketing campaigns included influencing doctors to prescribe the drug to millions of patients ranging from toddlers to the elderly for an exhaustive list of unapproved uses such as anxiety, sleep disruption, mood swings, post-partum depression, autism, attention deficit hyperactivity and dementia.

According to Harrisburg Pennsylvania psychiatrist, Dr Stefan Kruszewski, the atypical drugs can increase the risk of drastic weight gain, diabetes, pancreatitis, hypertension, heart attacks and stroke.

"The drugs can cause both a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems," he explains, "at the same time that they cause the neurological side effects as the older antipsychotics such as akathesis, a severe restlessness and tardive dyskinesia an often irreversible movement disorder."

As an expert witness in the case, Dr Egilman reviewed the Lilly documents kept under seal by the court order and learned that Lilly had indeed engaged in a massive off-label marketing scheme to increase profits by encouraging doctors to prescribe the drug for unapproved uses and had concealed the drug's serious side effects.

As a physician, after learning what was in the documents and knowing the harm that was sure to come to patients who continued to take Zyprexa, <STRONG>Dr Egilman was clearly facing a major ethical dilemma.
</STRONG>
At the time, Lilly had already managed to <STRONG>keep the documents hidden by settling out of court with about 8,000 Zyprexa victims in 2005 by paying close to $700 million</STRONG>, after only five plaintiffs had provided depositions and before any substantive depositions could be taken from any of the Lilly defendants.

And the first batch out of court settlements did nothing to deter the off-label sales of Zyprexa. According to Lilly's SEC filings, sales in the second quarter of 2006 totaled $1.12 billion, or a 2% increase over the second quarter of 2005.

In addition, <STRONG>Dr Egilman was aware that the company was getting ready to settle with about 18,000 more Zyprexa victims, and that the second round of settlements would guarantee that the secret documents would remain sealed.
</STRONG>
And as a condition of settlement, the 28,000 plaintiffs had to sign agreements promising never to discuss the charges made against the company related to Zyprexa.

According to several plaintiffs who settled out of court, <STRONG>they were not aware that there were documents that showed in many instances that Lilly knew full well that the injuries suffered could occur and had intentionally concealed the information from doctors and patients because it would have had a negative impact on Zyprexa sales.
</STRONG>
In fact, these plaintiffs said <STRONG>they were never told that these secret documents even existed much less that by signing settlement agreements they would be allowing more patients to be injured or killed because the documents would remain sealed.
</STRONG>

They also said that they were completely <STRONG>surprised to learn that their attorneys had access to documents that could have been presented to a jury to prove that the allegations in their lawsuits were true </STRONG>when the media began reporting the story in December 2006.

For instance, a November 12, 1999, letter from a Dr Albert Marrero, to Lilly's medical director, described the blood sugar problems occurring in patients. "We have had eight patients out of possibly thirty-five patients on Zyprexa show up with high blood sugars," he stated.

Dr Marrero also told Lilly: "Two patients had to be hospitalized due to out of control diabetes....We have certainly never seen this with Haldol, Navane, Risperdal and others to this extent," he wrote.

A November 1999 report showed that after examining 70 clinical trials, Lilly found that 16% of patients on Zyprexa for a year had gained over 66 pounds but instead of informing doctors of this information, the company used data from a smaller group of trials to say about 30% of patients gained only 22 pounds.

Another document showed that in 2000, after a group of diabetes doctors retained by Lilly substantiated the diabetes risk, <STRONG>a Lilly manager stated in an email, "unless we come clean on this, it could get much more serious than we might anticipate."
</STRONG>
A email dated two years later in March 2002, shows that <STRONG>Lilly shot down a plan to provide doctors with information about diabetes, because it would draw too much attention to the risk</STRONG>. "Although M.D.'s like objective, educational materials, having our reps provide some with diabetes would further build its association to Zyprexa," the email stated.

Although the documents clearly show that Lilly had knowledge of these life-threatening health risks in 1999, it did not add a warning about blood sugar levels and diabetes to the Zyprexa label until <STRONG>the FDA forced it to in the fall of 2003</STRONG>. In fact, Japan and the UK issued warnings about the increased risk of diabetes in 2002.

According to Ellen Liversridge, whose son took Zyprexa and gained 100 pounds before he fell into a coma and died of profound hyperglycemia in 2002, "<STRONG>both the FDA and Lilly fought putting a warning on the label, until articles on the front pages of the New York Times, Baltimore Sun, and Wall Street Journal so embarrassed the FDA that they finally gave in to adding the warnings</STRONG>."

But even then she says, the FDA required the same warning on the labels of all atypical drugs, "when <STRONG>Zyprexa was associated with a 37% higher increase in the risk of diabetes when compared to other medications</STRONG>."

However, the secret documents show that Lilly was hard at work behind the scenes to make sure that the new warnings would have minimal effects on Zyprexa sales. <STRONG>A July 7, 2003, memo titled, "Diabetes Update," described a plan to protect doctors who were afraid of being sued for prescribing Zyprexa after the news of the diabetes risk became public that would indemnify doctors who continued to prescribe drug </STRONG>

"We must embrace the fact that many physicians are curtailing their use of Zyprexa (particularly in the moderately-ill patient and in the maintenance phase)," the Update said,
"solely on the basis of personal fear (<STRONG>of being sued</STRONG>)."

"Indemnification represents the most meaningful demonstration of confidence in Zyprexa--both with our customers and with our employees," it stated.

The memo also discussed a plan to <STRONG>pay millions of dollars to the National Alliance on Mental Illness, the most notorious industry backed front group in the nation</STRONG>, to help <STRONG>downplay the news </STRONG>about the diabetes risk.

The public health crisis created by patients who developed diabetes as a result of using Zyprexa is real. A Medicaid fraud lawsuit filed against Lilly by the attorney general of Mississippi in July 2006, alleges that about <STRONG>10% of patients who used Zyprexa in that state have developed insulin-dependent diabetes and some are children</STRONG>, the complaint says.

When forced to make a decision on whether to warn the public about Zyprexa or abide by a court order that could result in the death and injury of thousands upon thousands of more people, <STRONG>Dr Egilman obviously followed the natural instinct of any <FONT size=5>decent</FONT> human being and gave up the documents</STRONG>.

Whether or not he actually realized what consequences he might face is anyone's guess, but he no doubt recognizes the consequences of crossing the drug giant today.

On September 7, 2007, Lilly issued a press release with the headline: "Egilman Admits Wrongdoing in Illegally Releasing Documents to New York Times and Resolves Case to Avoid Possible Civil and Criminal Sanctions".

The release said that Dr Egilman will pay $100,000, and in return, the company "agreed to forego seeking criminal and civil penalties against Dr. Egilman for his illegal activities."

<STRONG>Although it will be interesting to see how many "Good Samaritans" will stick their neck out for the common good after hearing about Dr Egilman's fate, it is apparently still easy to find doctors willing to prescribe Zyprexa off-label because SEC filings show Lilly earned $4.36 billion from the drug in 2006
</STRONG>
With all that said, on September 6, 2007, it was certainly a Deja Vue moment when the judge in Mr Gottstein's latest case against forced drugging in Alaska, <STRONG>issued an order to have the court hearing and file closed, even though the client had elected to have it open</STRONG>. "
</BLOCKQUOTE>
<FONT size=2>http://www.lawyersandsettlements.com/ar ... html</FONT>

<H1 style="MARGIN-BOTTOM: 2px">Attorney Subpoenas J&J AstraZeneca and Lilly for Hidden Antipsychotic Data Part II </H1>
<P style="MARGIN-BOTTOM: 2px">September 10 2007 Evelyn Pringle

<BLOCKQUOTE class=standard>Washington, DC: Attorney Jim Gottstein is the director of the Law Project for Psychiatric Rights, a public interest law firm that has mounted a campaign against forced psychiatric drugging all over the country. He represents mostly indigent clients through his non-profit organization and is not involved in the lawsuits filed against the atypical makers by patients or their families.

In turning the secret Eli Lilly documents over to the press, Mr Gottstein's goal was the same as Dr David Egilman's, <STRONG>to alert the public about Lilly's off-label marketing schemes aimed at getting doctors to prescribe Zyprexa to more patients who were unaware of the serious health risks associated with the drug</STRONG>.

Zyprexa was approved only for the treatment of adults with schizophrenia in 1996, and it wasn't until several years later, that it was approved for short-term treatment of adults with manic episodes associated with bipolar disorder.

In a February 13, 2007, interview with the Anchorage Daily News, Mr Gottstein explained that the secret document showed <STRONG>the rate at which Zyprexa caused diabetes, massive weight gain and other metabolic problems and how Lilly trained sales staff to mislead doctors about the drug's association with diabetes and illegally promoted Zyprexa for off-label use with children and the elderly.</STRONG>

As the playing field stands today, the average American alone would be lucky to find any law firm financially strong enough to take a drug giant like Lilly with its billions of dollars of power and a well that will never run dry in large part because the illegal off-label marketing of Zyprexa is ongoing and continues to earn billions of dollars each year.

However, a small group of patient advocates that included some of the most well-known psychiatric drug experts, journalists, and attorneys in the US went head to head with Lilly in the public battle in a US District Court in New York that dragged out over <STRONG>2 months to lift an injunction that barred the public disclosure of information about the serious adverse effects of Zyprexa that Lilly had successfully kept hidden under a court order until the documents were leaked to the press in December 2006.
</STRONG>
<STRONG>Lilly filed the motion for the injunction in attempt to get the documents back under seal and succeeded in muzzling just about every expert in the US involved in the fight to dismantle the mass-drugging schemes put in place by the pharmaceutical industry over the past 10 years including Dr Peter Breggin, Dr Grace Jackson, Dr David Cohen, and Dr Stefan Kruszewski, as well as the award winning journalist, Robert Whitaker, who wrote "Mad in America," and revealed all the negative information that showed up in the clinical trials conducted on Zyprexa and the other atypicals.
</STRONG>
The score looked bad for the home team early on when <STRONG>Lilly won the second round by getting the court to add the names of two of the world's most powerful patient advocacy groups to the injunction, along with their internet web sites and leaders, including Vera Sharav, director of the Alliance for Human Research Protection, and Judy Chamberlin and David Oaks from the international organization MindFreedom, a coalition of about 100 advocacy groups in 13 different countries.

At the time, Mr Oaks said, "This appears to be about Eli Lilly using its billions of dollars to try to intimidate grassroots critics."
</STRONG>
The New York legal battle turned into an all out war when <STRONG>Ms Sharav and Dr Cohen</STRONG> brought in the high profile attorney, Alan Milstein, <STRONG>to file their own motion asking the judge to unseal the documents because they should have never been designated confidential to begin with.
</STRONG>
"What is abundantly clear," Mr Milstein told the judge in a hearing, "is that they are <STRONG>not trade secrets."
</STRONG>
"Lilly in no way fears dissemination of these documents to their competitors, to Merck or to Glaxo," he said.

"<STRONG>What Lilly wants to prevent, is the public at large, the consumers of its products, from seeing these documents and learning the truth about the product that Lilly produces and the way it markets it</STRONG>," Mr Milstein said in the hearing.

Alaskan Attorney, John McKay, stepped in to <STRONG>represent Mr Gottstien and his wife Terrie, and then attorney, Fred von Lohmann of the Electronic Frontier Foundation</STRONG>, widened the battlefield by filing a brief on behalf of John Doe, described as a citizen-journalist who wanted to publish the secret documents on web sites because they were "plainly related to a matter of overriding public concern."

California attorney, <STRONG>Ted Chabasinski, jumped in the ring on behalf of Robert Whitaker, Judi Chamberlin, and David Oaks.</STRONG> "While the injunction purports to be an attempt to recover the documents," he wrote in a letter to the judge, "<STRONG>it is clear that its real purpose is to intimidate Lilly's critics, and the court should refuse to cooperate with this."
</STRONG>
Mr Chabasinski told the court that criminal charges should be filed against Lilly executives for illegally marketing Zyprexa for unapproved uses, with <STRONG>full knowledge that thousands of patients were being injured and killed</STRONG>. "<STRONG>If executives can go to prison for stealing their companies' money," he told the judge in a letter, "surely those who steal people's lives deserve at least the same fate</STRONG>."

Mr Chabasinski informed the court that the secret documents were <STRONG>evidence of Lilly executives' "criminal behavior" and their "willingness to kill people for profit.</STRONG>" He also made it known that he was encouraging members of the public to contact state attorney generals and was directing private citizens to a list of current contact information for each state posted on the Mindfreedom web site.

And some citizens did just that. Richard Bleecker, whose nephew <STRONG>died unexpectedly of hyperglycemia due to Zyprexa</STRONG>, wrote to the New Jersey attorney general and stated: "In your capacity as New Jersey's Attorney General, I ask that you launch an investigation into Eli Lilly's violation of the public interest by its concealment of the risks of Zyprexa."

"<STRONG>Despite the FDA restrictions on use and warning labels," he wrote, "the drug continues to be vigorously promoted by Lilly and prescribed for patients in record numbers, including children."
</STRONG>

He pointed that the state itself had an interest in the matter "<STRONG>since government programs like Medicare and Medicaid purchase over 70% of the Zyprexa sold in the USA, taxpayers in our State as well as across the nation are footing most of the bill."
</STRONG>
"I appeal to you, to investigate Eli Lilly's willingness to see patients suffer and die to enhance its profits," Mr Bleeker wrote.

<STRONG>Over 10 states have now sued Lilly for Medicaid fraud over the off-label marketing of Zyprexa. </STRONG>And for good reason according to a report in the March 23, 2007, New York Times, that said <STRONG>Zyprexa costs more than $300 a month and is the single biggest drug expense for state Medicaid programs </STRONG>with spending of more than $1.3 billion in 2005.

During court hearings, several people restrained by the injunction testified about why the documents should be made public which resulted in media reports about what was in them before the legal battle even ended.

For instance, at a January 17, 2007, hearing, Mr Gottstein was asked, "at the time you subpoenaed Dr. Egilman, had you the impression that Eli Lilly had deliberately withheld from the public and from physicians adverse side effects of Zyprexa?"

And he answered: "Absolutely."

He was then asked whether he feared there would be thousands more cases of harm to people from Zyprexa, while Lilly was settling cases out of court, and Mr Gottstein said yes, and that he wanted the documents released "to protect people from this drug."

Mr Milstein told the judge that <STRONG>the documents were critically important to saving human lives and said, "this Court should in no way assist Lilly in keeping them from the public."
</STRONG>
At the same hearing, Lilly attorneys asked Ms Sharav why she was interested in the documents and she said because they documented the fact that Lilly knew in 2000, that Zyprexa caused diabetes, "from a group of doctors that they hired who told them you have to come clean."

"And instead of warning doctors who are widely prescribing the drug, Eli Lilly set about in an aggressive marketing campaign to primary doctors," she testified.

Ms Sharav told the court, "<STRONG>This is a safety issue," and "to continue to conceal these facts" from the public "is not in the public interest."

She said, "this is about the worst that I have seen."
</STRONG>
"It borders on <STRONG>indifference to human life</STRONG>," she told the judge. "Eli Lilly <STRONG>knew</STRONG> that Zyprexa causes <STRONG>hypoglycemia, diabetes, cardiovascular damage </STRONG>and they set about both to market it unlawfully for off label uses to primary care physicians."

She said <STRONG>Lilly taught primary care doctors to diagnose patients as bipolar if they experienced mania after taking antidepressants.</STRONG> "That is absolutely outrageous and that is one of the reasons that I felt that this should involve the Attorney General," she testified.

Mr Sharav also objected to the off-label sale of Zyprexa to kids. "<STRONG><FONT size=4>Little children are being exposed to horrific diseases that end their lives shorter</FONT></STRONG>," she testified.

She said, "the reason the drug became a four and a half billion dollar seller in the United States is because <STRONG>they encouraged the prescription for children, for the elderly, for all sorts of reasons</STRONG>."

"I consider that a <STRONG><FONT size=4>major crime</FONT></STRONG>," she told the judge and said she asked Mr Gottstein for 2 copies of the documents so that she could deliver one copy to the New York attorney general.

By the time of that hearing, Ms Sharav no doubt was aware that the crime was ongoing because in <STRONG>January 2006, USA Today reported that although the atypicals are not approved for any use with children, the prescription rate for children "is growing dramatically faster than the rate for adults</STRONG>," quoting Robert Epstein, chief medical officer for Medco Health Solutions, pharmacy benefit managers.

In addition, an assessment by Christoph Correll, of the Child and Adolescent Psychiatric Clinics of North America, showed <STRONG>Zyprexa to be the worst of the atypicals for kids and listed the side effects of diabetes and weight gain with the drug as "severe.</STRONG>"

Technically, on February 13, 2007, Lilly scored a knock-out punch when<STRONG> <FONT size=4>the judge </FONT>issued a permanent injunction prohibiting Mr Gottstein and Dr Egilman from further disseminating the documents and allowed Lilly to keep them sealed under a court order.
</STRONG>
However, the judge also acknowledged in his written ruling that there was <STRONG>no way he could not enjoin the world by extending the injunction to the internet and by that time the worldwide web was flooded with all the damning information</STRONG>.

And Lilly would soon learn that the push to make the information public extended far beyond the courtroom. On February 23, 2007, a grass roots advocacy group issued a press release to rally support for Mr Gottstein for providing the documents to the media and to announce the "The Just Say "Know" to Prescription Drugs Campaign," with a goal of getting one million people reevaluate the prescription drugs they were taking.

"If there is a case that dramatically highlights the need to stop blindly taking prescriptions drugs, this is it," said Dr Greg Tefft, co-founder of the Campaign.

"<STRONG><FONT size=5>We're talking 20 million people potentially at risk</FONT></STRONG> and more being added daily," he added.

The group set out to educate the public about off-label prescribing and what consumers must do to protect themselves against Zyprexa, or other drugs, when they are prescribed without warnings about side effects or unapproved uses.

"We are convinced that the way to solve this problem is to work the demand side of the market," Dr Tefft said. "We are going directly to consumers and encouraging them to know what they are taking."

Chairman of the Campaign, Dr Dominick Riccio, hosted a Zyprexa radio series and Dr Laurence Simon provided information to consumers about the drug and they set up an official web site for the Campaign is http://justsayknow.kpncradio.com

A month and a half later, on April 4, 2007, the ranking Republican on the Senate Committee on Finance, Senator Charles Grassley (R-Iowa), was knocking on Lilly's door with a letter to the CEO saying, "<STRONG>I have an obligation to ensure that the public's money is properly spent to provide safe and effective treatments to the vulnerable populations that are beneficiaries of the Medicare and Medicaid programs."

"I am aware of several pending products liability actions regarding Zyprexa</STRONG>," he said, "<STRONG>and questions have been raised regarding safety information and marketing practices relating to that drug</STRONG>."

Senator Grassley also wrote, "<STRONG>I understand that Eli Lilly produced certain documents in the course of these litigations that shed light on issues of interest to the Committee," referring to leaked documents and said, "please provide to the Committee all documents and materials, including, but not limited to, emails, letters, reports, and memoranda, that were made available ... pursuant to pretrial discovery in In re Zyprexa Prods. Liab. Litig</STRONG>."

And in the end, it could be said that injunction or no injunction, the small group of warriors led by <STRONG>Mr Gottstein and Dr Egilman, who bravely banded together against the billion dollar giant </STRONG>helped make Lilly's worst nightmare come true by fighting against the injunction and keeping the spotlight on the documents that the company fought so hard to keep hidden, not so much from the public, but from the stockholders.

According to legal experts, Lilly's desperate filing for the injunction had nothing to do with the lawsuits filed by private plaintiffs because that litigation was the least of its worries being the company was settling the cases for peanuts with plaintiffs signing confidentiality agreements that would shut them up for life.

However, following the public disclosure of <STRONG>proof that Lilly had engaged in a 10-year illegal off-label marketing scheme while concealing the adverse effects of Zyprexa</STRONG>, the company was hit with the big Kahoona, when 4 class action lawsuits were filed in April 2007 on behalf of shareholders, alleging the fraud by Lilly and its top executives had cost them more than $30 billion, and the evidenced cited to support the allegations was the information from the secret documents that resulted in the battle over the injunction.

It remains to be seen whether these shareholder lawsuits <STRONG>will do anything to stop the drugging of kids in the US because as it stands right now the mass drugging campaign appears to be unstoppable</STRONG>. On September 5, 2007, Rob Waters reported that the <STRONG><FONT size=4>number of antipsychotic prescriptions for children </FONT></STRONG>doubled to 4.4 million between 2003 and 2006, citing data provided to Bloomberg News by Wolters Kluwer NV, a drug-tracking firm.

Mr Waters also reported that the growth was <STRONG>most dramatic in the youngest children with 20,280 prescriptions written for kids <FONT size=5>aged 4 and younger</FONT>, a five-fold increase over 2003, and with 5- to 9-year-olds, prescriptions increased almost six-fold to 710,937 in 2006. "
</STRONG>
</BLOCKQUOTE>
Last edited by SSRIAdmin on September 11th, 2007, 11:36 am, edited 1 time in total.
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September 11th, 2007, 9:56 am #6


<EM>Ms Sharav told the court, "</EM><EM><STRONG>This is a safety issue," and "to continue to conceal these facts" from the public "is not in the public interest."

She said, "this is about the worst that I have seen."
</STRONG>
"It borders on <STRONG>indifference to human life</STRONG>," she told the judge. "Eli Lilly <STRONG>knew</STRONG> that Zyprexa causes <STRONG>hypoglycemia, diabetes, cardiovascular damage </STRONG>and they set about both to market it unlawfully for off label uses to primary care physicians."

She said <STRONG>Lilly taught primary care doctors to diagnose patients as bipolar if they experienced mania after taking antidepressants.</STRONG> "That is absolutely outrageous and that is one of the reasons that I felt that this should involve the Attorney General," she testified."</EM>


&nbsp;

<STRONG>Zyprexa Document</STRONG>:&nbsp; ZY1 000<STRONG>27106</STRONG>

Page 11

"...<STRONG>RETAIN</STRONG>

<STRONG>*Sales and DTP Message
</STRONG>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *<STRONG>Prevalence of Bipolar</STRONG>

Evidence suggests that people with bipolar disorder remain undiagnosed or misdiagnosed anywhere from 7-12 years. Evidence also suggests that about 20-30% of patients on anti- depressants, who have been diagnosed with depression, are indeed bipolar..."

Last edited by SSRIAdmin on September 13th, 2007, 8:36 am, edited 1 time in total.
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Joined: April 19th, 2005, 7:01 pm

September 11th, 2007, 9:59 am #7

<EM>Technically, on February 13, 2007, Lilly scored a knock-out punch when</EM><EM><STRONG> <FONT size=4>the judge </FONT>issued a permanent injunction prohibiting Mr Gottstein and Dr Egilman from further disseminating the documents and allowed Lilly to keep them sealed under a court order.
</STRONG>
However, the judge also acknowledged in his written ruling that there was </EM><STRONG><EM>no way he could not enjoin the world by extending the injunction to the internet and by that time the worldwide web was </EM>flooded<EM> with all the damning information</EM></STRONG><EM>.
</EM>
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Joined: April 19th, 2005, 7:01 pm

September 11th, 2007, 10:05 am #8


<SPAN name="Konabody"><FONT size=2>"</FONT><STRONG><FONT size=4>Individual Justice in Mass Tort Litigation</FONT></STRONG><FONT size=2>"&nbsp; </FONT></SPAN>

<SPAN name="Konabody"><FONT size=2>(February 2005, Page 70)</FONT>

<FONT size=4><EM></EM></FONT>&nbsp;

<FONT size=4><EM>"[p]rotective orders may have a legitimate role when there is no public impact or when true trade secrets are involved. But we can strike a fairer balance between privacy interests of corporations and the <STRONG>health and safety of the public</STRONG>.&nbsp; A publicly maintained legal system </EM></FONT>

<FONT size=4><EM><STRONG>ought not protect those who engage in misconduct, conceal the cause of injury from the victims, or render potential victims vulnerable.&nbsp;</STRONG> </EM></FONT>

<FONT size=4><EM>Moreover, such secrecy <STRONG>defeats the deterrent function of the justice system</STRONG>."&nbsp;&nbsp;&nbsp; </EM></FONT>

<FONT size=4><STRONG>Judge Weinstein</STRONG></FONT>

<FONT size=4><STRONG><IMG alt=individualjustice.JPG src="http://www.network54.com/Realm/peageepi ... JPG">&nbsp;
</STRONG></FONT></SPAN>
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Joined: April 19th, 2005, 7:01 pm

September 11th, 2007, 10:14 am #9


<EM>However, following the public disclosure of <STRONG>proof that Lilly had engaged in a 10-year illegal off-label marketing scheme while concealing the adverse effects of Zyprexa</STRONG>, the company was hit with the big Kahoona, when 4 class action lawsuits were filed in April 2007 on behalf of shareholders, alleging the fraud by Lilly and its top executives had cost them more than $30 billion, and the evidenced cited to support the allegations was the information from the secret documents that resulted in the battle over the injunction.

It remains to be seen whether these shareholder lawsuits <STRONG>will do anything to stop the drugging of kids in the US because as it stands right now the mass drugging campaign appears to be unstoppable</STRONG>. On September 5, 2007, Rob Waters reported that the <STRONG><FONT size=4>number of antipsychotic prescriptions for children </FONT></STRONG>doubled to 4.4 million between 2003 and 2006, citing data provided to Bloomberg News by Wolters Kluwer NV, a drug-tracking firm.

Mr Waters also reported that the growth was </EM><STRONG><EM>most dramatic in the youngest children with 20,280 prescriptions written for kids <FONT size=5>aged 4 and younger</FONT>, a five-fold increase over 2003, and with 5- to 9-year-olds, prescriptions increased almost six-fold to 710,937 in 2006. "
</EM></STRONG>

<STRONG>Are those figures US only?&nbsp; Or globally?&nbsp;
</STRONG>
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Joined: April 19th, 2005, 7:01 pm

September 11th, 2007, 10:26 am #10

<H1 class=articleTitle id=ctl00_ctl00_cphAllPageContent_cphMainContent_ucArticleView_articleTitle>How can that be right, or just?&nbsp; </H1>
<H3 class=post-title><FONT color=#000066>Lilly Settles with Dr. David Egilman Over Zyprexa Documents</FONT>&nbsp;<EM><FONT size=3>(AHRP blog Link)</FONT></EM></H3>
<DIV class=post-body>
<DIV><FONT color=#000066><IMG height=407 hspace=10 src="http://www.thejabberwock.org/blog/2/lilly4.png" width=346 align=left vspace=10 border=0></FONT>The latest chapter in the legal saga involving Eli Lilly and its sealed Zyprexa documents that became the center of a contentious battleground involving not just litigating parties but drug safety advocates, a patient rights attorney, and the New York Times. [<STRONG><FONT color=#000066>Link</FONT></STRONG>]

Eli Lilly announced that Dr. David Egilman has entered a settlement regarding the sealed Zyprexa documents, admitting wrongdoing, and selectively releasing documents that "He intentionally and illegally provided to attorney James Gottstein an incomplete subset of material that was covered by a confidentiality agreement - as it had been produced by Lilly in good faith in the process of discovery in the Zyprexa litigation."

Dr. Egilman has agreed to pay Lilly $100,000 which the company announced it would donate to International Center for Clubhouse Development.
However, Dr. Egilman's attorney, Alex Reinert, dispute Lilly's version. He told Pharmalot, that Dr. Egilman DID NOT admit to anything illegal and Ed Silverman, who read the agreement, corroborates this to be the case. [<STRONG><FONT color=#000066>Link</FONT></STRONG>]

In a statement, Dr. Egilman challenged Lilly to release the full set of documents. "I've never heard of a company hiding documents that prove its drug is safer than others." Given that Lilly faces multi-state litigation involving its marketing of Zyprexa, this is unlikely.

Oregon is the latest to So far, 9 states are investigating Lilly's Zyprexa marketing tactics: such as: downplaying the risks of diabetes and other debilitating effects, and marketing the drug for off-label, unapproved uses--a crime.

The other states are: Alaska, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, Utah, West Virginia</DIV></DIV>
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