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By Evelyn Pringle (about the author)
Become a Fan -- Page 3 of 7 page(s)
Pharmacia 's sales were also a shot in the arm to Pfizer. According to Pfizer 's 2003 Annual Report: "Revenues increased 40% to $45,188 million in 2003 ... Revenue increases in 2003 were primarily due to the inclusion of Pharmacia products, " it said.
The off-label sales paid off extremely well. Between 1997 and 2003, Genotropin generated more than $550 million in sales in the US alone and the company 's database shows that about 60% of adult sales, and 25% to 30% of pediatric sales, were for off-label use.
On May 22, 2003, Dr Rost became aware of the pervasive nature of ongoing illegal activity when he met with a manager of the Bridge Program and was shown documents that confirmed that a massive number of patients were listed with an off-label diagnosis.
In fact, 25% to 30% of the pediatric prescriptions were for off-label use. Dr Rost understood that pediatric patients received significant funding from Medicaid and other government programs.
He was alarmed at the extent of pediatric use - a staggering number, he says, not only due to the medial implications to children but also because it demonstrated that a great percentage of the cost was reimbursed by Medicaid or other governmental programs.
Disturbed by these findings, he decided to file a lawsuit and with Attorney Erika Kelton, and another Phillips & Cohen attorney, started drafting a complaint.
On June 3, 2003, Ms Kelton, informed an assistant US Attorney that Dr Rost would be filing a qui tam action alleging fraud relating to the off-label marketing of Genotropin and delivered a copy of the complaint to the US Attorney 's Office on June 4, 2003.
In the Complaint, Dr Rost provides details of a complex scheme including the nature of the fraud - where it occurred, how it occurred, when it occurred and the persons responsible for its commission. The following is a summary of the complaint 's specific factual allegations:
Approximately 60% of adult sales and 25% of its pediatric sales were for off-label uses.
Pharmacia bribed 16 named distributors to promote off-label usage of Genotropin.
Under the pretext of participating in a "study, " Pharmacia paid doctors $200 for every patient they prescribed to, including off-label subscriptions, and paid doctors an additional $200 for every year that such patients continued to use Genotropin.
Pharmacia sponsored junkets for physicians and their spouses and awarded substantial "honoraria " as inducements/kickbacks to promote the off-label usage of Genotropin.
Pharmacia provided discounts to doctors working exclusively in the anti-aging area, knowing that they would sell Genotropin off-label for anti-aging treatment and least 18 named doctors signed contracts for such price discounts.
Through contracts and "retainer " agreements, Pharmacia hired persons and entities, some named in the Complaint, to promote off-label use of Genotropin and such "consultants " provided no other services.
The false claims were submitted from 1997 to June 5, 2003 across the US and included false claims and statements made by dozens of named distributors and doctors, and Pfizer 's Bridge Program lists the patients for which the false claims were submitted.
But come to find out, off-label marketing seems to habitual with Pfizer. At the same time that Dr Rost reported the illegal activities, Pfizer was fighting off a whistleblower lawsuit arising out of the off-label marketing of the drug Neurontin, by another company acquired through a merger, in promoting the drug for pain control and Attention Deficit Disorder.
Become a Fan -- Page 3 of 7 page(s)
The off-label sales paid off extremely well. Between 1997 and 2003, Genotropin generated more than $550 million in sales in the US alone and the company 's database shows that about 60% of adult sales, and 25% to 30% of pediatric sales, were for off-label use.
On May 22, 2003, Dr Rost became aware of the pervasive nature of ongoing illegal activity when he met with a manager of the Bridge Program and was shown documents that confirmed that a massive number of patients were listed with an off-label diagnosis.
In fact, 25% to 30% of the pediatric prescriptions were for off-label use. Dr Rost understood that pediatric patients received significant funding from Medicaid and other government programs.
He was alarmed at the extent of pediatric use - a staggering number, he says, not only due to the medial implications to children but also because it demonstrated that a great percentage of the cost was reimbursed by Medicaid or other governmental programs.
Disturbed by these findings, he decided to file a lawsuit and with Attorney Erika Kelton, and another Phillips & Cohen attorney, started drafting a complaint.
On June 3, 2003, Ms Kelton, informed an assistant US Attorney that Dr Rost would be filing a qui tam action alleging fraud relating to the off-label marketing of Genotropin and delivered a copy of the complaint to the US Attorney 's Office on June 4, 2003.
In the Complaint, Dr Rost provides details of a complex scheme including the nature of the fraud - where it occurred, how it occurred, when it occurred and the persons responsible for its commission. The following is a summary of the complaint 's specific factual allegations:
Approximately 60% of adult sales and 25% of its pediatric sales were for off-label uses.
Pharmacia bribed 16 named distributors to promote off-label usage of Genotropin.
Under the pretext of participating in a "study, " Pharmacia paid doctors $200 for every patient they prescribed to, including off-label subscriptions, and paid doctors an additional $200 for every year that such patients continued to use Genotropin.
Pharmacia sponsored junkets for physicians and their spouses and awarded substantial "honoraria " as inducements/kickbacks to promote the off-label usage of Genotropin.
Pharmacia provided discounts to doctors working exclusively in the anti-aging area, knowing that they would sell Genotropin off-label for anti-aging treatment and least 18 named doctors signed contracts for such price discounts.
Through contracts and "retainer " agreements, Pharmacia hired persons and entities, some named in the Complaint, to promote off-label use of Genotropin and such "consultants " provided no other services.
The false claims were submitted from 1997 to June 5, 2003 across the US and included false claims and statements made by dozens of named distributors and doctors, and Pfizer 's Bridge Program lists the patients for which the false claims were submitted.
But come to find out, off-label marketing seems to habitual with Pfizer. At the same time that Dr Rost reported the illegal activities, Pfizer was fighting off a whistleblower lawsuit arising out of the off-label marketing of the drug Neurontin, by another company acquired through a merger, in promoting the drug for pain control and Attention Deficit Disorder.
Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.
The views expressed in this article are the sole responsibility of the author
and do not necessarily reflect those of this website or its editors.
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Parallel Market for Prescription Drugs?
by Edward Lewis on Thursday, Jan 4, 2007 at 6:51:51 PM