1
1
1
Brian Kenney and Tavy Deming of the Pennsylvania firm of Kenney Egan McCafferty & Young, represented the Geodon whistleblowers. The off-label marketing allegations were first made in a lawsuit filed on behalf of Harrisburg psychiatrist, Dr Stefan Kruszewski.
The antipsychotic was approved only for adults with schizophrenia or acute manic or mixed episodes of bipolar disorder, but Pfizer illegally promoted it for off-label conditions that included depression, bipolar maintenance, mood disorder, anxiety, aggression, dementia, ADHD, obsessive compulsive disorder, autism, PSTD, and for pediatric, adolescent and geriatric patients, according to the complaint.
Less than "5% of the United States population is diagnosed with schizophrenia or bipolar disorder, yet in 2008 Geodon surpassed the blockbuster benchmark of $1 billion in sales," Attorney Deming reported in a September 2, 2009 press release.
As part of its marketing campaign, Pfizer claimed that Geodon had a safe metabolic profile when compared to other antipsychotics, such as Zyprexa, Seroquel and Risperdal, and urged doctors to switch patients to Geodon. The switching campaign "endangered patients by ignoring or materially understating Geodon's serious, and even life threatening, side effects," Attorney Kenney said in the press release.
On September 3, 2009, Kruszewski told the Philidelphia Inquirer that Pfizer sales representatives pushed him to prescribe Geodon to children for such symptoms as anxiety and agitation.
"Pfizer targeted pediatrics and adolescents to expand off-label use and maintained on its payroll an army of more than 250 child psychiatrists nationwide," Kenney reported in the press release.
"Pfizer regularly paid generous speaking fees to these child psychiatrists to give what were basically promotional lectures about the benefits of Geodon to their peers, who were naturally also child psychiatrists," he said.
Apparently, NAMI will continue on with business as usual, except now it will disclose the amounts of Pharma gifts. In 2009, NAMI received 84 payments over $5,000 from different sources, according to an April 2010, analysis by John Mack, on his popular Pharma Marketing Blog. Of payments totaling $4,737,610, Mack found $3,836,750, or 81%, came from major drug companies, with the largest amounts coming from antipsychotic makers, including $1,255,000 from AstraZeneca, followed by Lilly with $750,500, and Bristol-Myers giving 506,250. Wyeth's 2009 grant report shows donations to all NAMI groups totaling $268,000.
In October 2009, Grassley sent letters to all fifty state NAMI chapters asking them to disclose income from pharmaceutical companies and their foundations. On April 26, 2010, Grassley sent a letter to the leaders of NAMI National and included a chart showing the top 10 state chapters receiving the most money from January 2005 to October 2009, totaling $3.84 million.
Also in October 2009, NAMI CEO Fitzpatrick told the New York Times: "For at least the years of '07, '08 and '09, the percentage of money from pharma has been higher than we have wanted it to be," and promised the industry's share of NAMI fund raising would drop "significantly" in 2010.
However, NAMI's grant report for the first quarter of 2010, shows the group received $1,247,128 from drug companies and foundations, or only $2,212 less than the $1,249,340 it received in the first quarter of 2009. So far this year, Lilly gave NAMI groups over $84,000, and Pfizer's report shows $78,000 went to NAMI groups.
Conspicuously missing from NAMI's 2010 first quarter report is AstraZeneca, being the Seroquel maker gave the National group $905,000 in the last quarter of 2009. It may be that Astra was too busy rounding up the more than $520 million it agreed to pay the Federal government and State Medicaid programs in April 2010, to resolve fraud allegations related to the off-label marketing of Seroquel.
"Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers' pockets," said Attorney General, Eric Holder, in an April 27, 2010, DOJ press release.
But Astra can't be hurting financially because in 2008, even though it makes up only about 5% of the world population, the US accounted for over $3 billion of the roughly $4.45 billion in world-wide Seroquel sales. It was Astra's second-best selling drug that year, behind the heartburn drug Nexium, and the fifth top selling drug in sales overall in the US. The price of Seroquel at DrugStore.com that year was $839 for hundred middle dose tablets in December 2008. By August 23, 2009, the price had increased by $50 to $890 for the same number of pills.
"A half a billion dollar one-time settlement is just a small cost of doing business for a company that sold $17 billion worth of the offending drug in the last five years," Dr Roy Poses points out on the Health Care Renewal website.
"This was a well thought out marketing campaign that operated on many levels," said Brian Kenney, one of the attorneys who again represented, Dr Kruszewski, one of two whistleblowers in this case as well, in an April 28, 2010 press release.
