Pfizer Turned NAMI Into "Trojan Horse" to Push Geodon Off-Label to Kids, Suit Claims
BNET.com
By Jim Edwards | Sep 16, 2009
Pfizer funded the National Alliance for the Mentally Ill in order to turn the nonprofit into a “Trojan Horse” that would promote the antipsychotic drug Geodon for off-label use in children, according to a former pharmaceutical sales rep.
Mark R. Westlock of Fenton, Mo., was a rep for Pfizer from 1991 to 2007, when he claims he was forced to resign. His whistleblower suit against Pfizer was included in the $2.3 billion Bextra settlement.
Pfizer denied Westlock’s claims:
Pfizer denies all federal, state and qui tam allegations, with two exceptions. We
acknowledge certain improper actions related to the past promotion of Bextra and
Zyvox. Beyond those two exceptions we deny all federal and state and qui tam claims.
Following Pfizer’s funding, the NAMI web site suggested that Geodon be used in children even though the FDA had approved it only for adults, Westlock claims:
"79. Pfizer became one of the largest contributors among pharmaceutical
manufacturers to NAMI, turning Defendant NAMI into a Trojan Horse for the illegal
marketing scheme to promote Geodon. As but one example, NAMI's website unabashedly
25
Filed Under Seal
129894.00601/35928051v.1
goes so far as to promote the off-label use of Geodon in children and the elderly, as well as
for long-term use in the treatment of bipolar disease, a potential violation of NMI's stated
policy against endorsing any drug product:
While not approved by the FDA for other uses, ziprasidone may be used
alone or with other medications to treat other symptoms such as agitation
or other behavior problems in older persons with memory loss or people
with developmental disabilities, children with mental illnesses like
schizophrenia or bipolar disorder, or depression. It may also be used for
long-term management of bipolar disorder."
Westlock’s suit breaks down Big Pharma’s funding of NAMI like this. From 1996-1999, companies gave NAMI $11.72 million:
* Janssen $2.08 million
* Novartis $1.87 million
* Pfizer $1.3 million
* Abbott Laboratories $1.24 million
* Wyeth-Ayerst Pharmaceuticals $658,000
* Bristol-Myers Squibb $613,505
From 2002-2003, companies gave NAMI a further $4 million per year, the suit alleges:
… the organization operates through significant financial support from Defendant Pfizer and other drug makers. Defendant NAMI reciprocates Defendant Pfizer’s support by the promotion of the off-label use of Pfizer products, including Geodon …
Even the president of NAMI, James McNulty, was on Pfizer’s payroll, the suit alleges:
During the time he was president of NAMI, James McNulty received thousands of dollars for regularly speaking on behalf of Pfizer and other drug makers at various company sponsored events. In an arrangement ethicists say is highly irregular, McNulty would process the “grants” through NAMI Rhode Island. In order to reduce paperwork, according to McNulty, the drug maker would then give NAMI Rhode Island a check and NAMI Rhode Island would in turn give McNulty a check. At no time did McNulty disclose to the audiences at his various speaking engagements, or to NAMI’s membership, that he was being paid to speak by drug makers.
The number of antipsychotic scripts written for children doubled to 4.4 million between 2003 and 2006, Westlock claims.
* Previously:
* “Pfizer Math” Showed Lyrica Superiority Even Though Studies Never Said That, Rep Claims
* Pfizer Rep Claims Bextra Pushed on NHL’s Blue Jackets
* Pfizer Rep Claims Zoloft Touted for Failed Cheerleaders; Viagra for Women
* Pfizer Rep Alleges Viagra Promoted With Unapproved Materials: “Get Those Things Cleaned Up!”
* Pfizer Stock Shrugs Off $2.3B Bextra Fine; Can Anything Deter Off-Label Promotion?
* Pfizer Rep Describes Pushing Zyvox With Flawed Data
* Pfizer’s West Side Story: How “the Sharks” Sold Bextra Off-Label
* 10 Amazing Facts About Pfizer’s $2.3B Bextra Settlement
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.
***Qui Tam Action (Dictionary.com - Function: noun
: an action that is brought by a person on behalf of a government against a party alleged to have violated a statute esp. against defrauding the government through false claims and that provides for part of a penalty to go to the person bringing the action qui tam action against the contractor for presenting fraudulent claims for payment.)
***Geodon is an antipsychotic
***Bextra is used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. Bextra is also used to treat painful menstruation. It was withdrawn from the market by its manufacturer in 2005 due to side effects.
By Jim Edwards | Sep 16, 2009
Pfizer funded the National Alliance for the Mentally Ill in order to turn the nonprofit into a “Trojan Horse” that would promote the antipsychotic drug Geodon for off-label use in children, according to a former pharmaceutical sales rep.
Mark R. Westlock of Fenton, Mo., was a rep for Pfizer from 1991 to 2007, when he claims he was forced to resign. His whistleblower suit against Pfizer was included in the $2.3 billion Bextra settlement.
Pfizer denied Westlock’s claims:
Pfizer denies all federal, state and qui tam allegations, with two exceptions. We
acknowledge certain improper actions related to the past promotion of Bextra and
Zyvox. Beyond those two exceptions we deny all federal and state and qui tam claims.
Following Pfizer’s funding, the NAMI web site suggested that Geodon be used in children even though the FDA had approved it only for adults, Westlock claims:
"79. Pfizer became one of the largest contributors among pharmaceutical
manufacturers to NAMI, turning Defendant NAMI into a Trojan Horse for the illegal
marketing scheme to promote Geodon. As but one example, NAMI's website unabashedly
25
Filed Under Seal
129894.00601/35928051v.1
goes so far as to promote the off-label use of Geodon in children and the elderly, as well as
for long-term use in the treatment of bipolar disease, a potential violation of NMI's stated
policy against endorsing any drug product:
While not approved by the FDA for other uses, ziprasidone may be used
alone or with other medications to treat other symptoms such as agitation
or other behavior problems in older persons with memory loss or people
with developmental disabilities, children with mental illnesses like
schizophrenia or bipolar disorder, or depression. It may also be used for
long-term management of bipolar disorder."
Westlock’s suit breaks down Big Pharma’s funding of NAMI like this. From 1996-1999, companies gave NAMI $11.72 million:
* Janssen $2.08 million
* Novartis $1.87 million
* Pfizer $1.3 million
* Abbott Laboratories $1.24 million
* Wyeth-Ayerst Pharmaceuticals $658,000
* Bristol-Myers Squibb $613,505
From 2002-2003, companies gave NAMI a further $4 million per year, the suit alleges:
… the organization operates through significant financial support from Defendant Pfizer and other drug makers. Defendant NAMI reciprocates Defendant Pfizer’s support by the promotion of the off-label use of Pfizer products, including Geodon …
Even the president of NAMI, James McNulty, was on Pfizer’s payroll, the suit alleges:
During the time he was president of NAMI, James McNulty received thousands of dollars for regularly speaking on behalf of Pfizer and other drug makers at various company sponsored events. In an arrangement ethicists say is highly irregular, McNulty would process the “grants” through NAMI Rhode Island. In order to reduce paperwork, according to McNulty, the drug maker would then give NAMI Rhode Island a check and NAMI Rhode Island would in turn give McNulty a check. At no time did McNulty disclose to the audiences at his various speaking engagements, or to NAMI’s membership, that he was being paid to speak by drug makers.
The number of antipsychotic scripts written for children doubled to 4.4 million between 2003 and 2006, Westlock claims.
* Previously:
* “Pfizer Math” Showed Lyrica Superiority Even Though Studies Never Said That, Rep Claims
* Pfizer Rep Claims Bextra Pushed on NHL’s Blue Jackets
* Pfizer Rep Claims Zoloft Touted for Failed Cheerleaders; Viagra for Women
* Pfizer Rep Alleges Viagra Promoted With Unapproved Materials: “Get Those Things Cleaned Up!”
* Pfizer Stock Shrugs Off $2.3B Bextra Fine; Can Anything Deter Off-Label Promotion?
* Pfizer Rep Describes Pushing Zyvox With Flawed Data
* Pfizer’s West Side Story: How “the Sharks” Sold Bextra Off-Label
* 10 Amazing Facts About Pfizer’s $2.3B Bextra Settlement
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.
***Qui Tam Action (Dictionary.com - Function: noun
: an action that is brought by a person on behalf of a government against a party alleged to have violated a statute esp. against defrauding the government through false claims and that provides for part of a penalty to go to the person bringing the action qui tam action against the contractor for presenting fraudulent claims for payment.)
***Geodon is an antipsychotic
***Bextra is used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. Bextra is also used to treat painful menstruation. It was withdrawn from the market by its manufacturer in 2005 due to side effects.
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