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"AstraZeneca orchestrated scientific studies, ghost written articles, and the payment of large fees to academic psychiatrists to act as 'thought leaders' to promote the drug off label," he noted.
"The success can be seen in the huge numbers the campaign generated with 4.9 billion in sales in 2009," Kenney pointed out.
"It's particularly disconcerting that AstraZeneca successfully co-opted large portions of psychiatric academic community," he added.
"The manipulation and misuse of Seroquel scientific data to support AstraZeneca's off-label marketing campaign was the most disturbing aspect of the case to me," Kruszewski said in the press release. "There were strong indications from AstraZeneca's earliest clinical trials that Seroquel increased the risk of diabetes and induced profound sedation out of proportion to its weak antipsychotic effects."
"In
the elderly population, they basically marketed Seroquel as an
expensive sleeping pill and put hundreds of thousands of patients at
risk for serious medical complications, premature cardiovascular
disease, pneumonias, and premature death," he reported.
In addition to paying $520 million, Astra had to enter into a 5-year corporate integrity agreement that requires the company to post information about payments to doctors on its website, which no doubt will include payments funneled through front groups like NAMI, for Continuing Medical Education programs, speaker fees, research grants, and the various awards given out each years.
Because according to the DOJ press release, the government contends that Astra "promoted the unapproved uses by improperly and unduly influencing the content of, and speakers, in company-sponsored Continuing Medical Education programs."
"The company also engaged doctors to give promotional speaker programs on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel," it says. "In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel."
According to a recent report by Jim Edwards on BNET, former NAMI policy director and board member, Jim Dailey, was a paid consultant for Astra's Seroquel marketing team, and was paid $600, plus airfare and limousine service, to attend one Seroquel consultant meeting in December 2003.
A picture taken at the meeting shows Daily, along with current NAMI CEO, Fitzpatrick, and Chuck Harmon, NAMI director of corporate relations, meeting with several Astra sales executives. The agenda for the meeting was: Seroquel vision, Role of Advocacy Groups, Increasing role of State/Medicaid with MH issues and MAP initiatives, and Ensuring access for patients.
Edwards explains that "MAP" sometimes stands for "Medication Algorithm Project." NAMI, along with J&J's Robert Wood Johnson Foundation, is identified in a Medicaid fraud lawsuit filed against J&J by former federal fraud investigator, Allen Jones, and joined by the Texas attorney general, as participating in off-label marketing schemes to increase the sales of Risperdal, including the "Texas Medication Algorithm Project," and "Texas Children's Medication Algorithm Project."
Latest Plan of Attack
On June 17, 2010, under the headline, "Psychotropic Drug Abuse in Foster Care Costs Government Billions," Politics Daily reported that the Senate Subcommittee on Federal Financial Management, has asked the Government Accountability Office to look into the drugging of foster care children, who are typically concurrently enrolled in Medicaid.
"The investigators will attempt to account for estimates in the hundreds of millions of dollars of possible fraud arising from prescriptions for drugs explicitly barred from Medicaid coverage," according to the report.
"Often young patients under state supervision are also prescribed three or four high-risk drugs at a time -- all paid for by Medicaid," it pointed out.
"The GAO is collecting data from Oregon, Massachusetts, Florida, Maryland, Minnesota and Texas, to search for patterns of abuse," Politics said. "This effort marks the first time suspicion of Medicaid fraud related to psychotropic drugs has been examined at the federal level."
