Illegal Drug Pushing
Pharmaceutical Giant, AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million after being fined by the federal government for illegally marketing the anti-psychotic drug, Seroquel.
Seroquel, also known as quetiapine fumarate, was approved by the FDA in 1997 to treat psychotic disorders. By October 2006, its use had expanded for use for bipolar depression and mania.
The Department of Justice alleges AstraZeneca illegally marketed Seroquel for uses other than those approved by the FDA such as Alzheimer’s disease, anger management, anxiety, ADD, dementia, depression, PTSD, mood disorders, among other uses considered “off-label.”
In 2008, Bloomberg reported that teenagers and the elderly were increasingly being given a class of anti-psychotic drugs not cleared by regulators. In adolescents, the medications are given for depression, autism and hyperactivity, and in the elderly for dementia and insomnia.
Half of Seroquel sales in 2006 were reportedly for off-label use.
In doing so, the company submitted false claims for payments from federal insurance programs including Medicaid, Medicare and TRICARE programs, Veterans Affairs, the Bureau of Prisons, and the Federal Employee Health Benefits Program.
In a statement, Kathleen Sebelius, Secretary of the Department of Health and Human Services said, “Today’s settlement sends a clear warning to any individual or company seeking to defraud our health care system and returns hundreds of millions of dollars of taxpayer money to the Medicare trust fund where they belong."
The federal government receives $301 million from the civil settlement, and the state Medicaid programs and District of Columbia will share up to $218 million, reports Health and Human Services in a statement.
How It Worked
AstraZeneca targeted doctors who work in nursing homes, pediatricians and adolescent physicians, and paid them to become spokespeople for AstraZeneca to promote unapproved uses for Seroquel. Some doctors were sent to resort locations to speak to other doctors. Additionally, doctors were recruited to serve as authors for professional articles actually ghostwritten by the company, a violation of the federal Anti-Kickback Statute.
“Consumers are entitled to rely on the claims pharmaceutical companies make about the drugs they sell,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice.
In addition to the fine, AstraZeneca and the Office of Inspector General of the Department of Health and Human Services have entered a Corporate Integrity Agreement which must be monitored by the company'sboard of directors to keep it comliant with the program. AstraZeneca is also subject to being excluded from receiving money from federal health care programs including Medicare and Medicaid for breaching the CIA.
Thousands of Lawsuits
This isn’t the first problem with Seroquel. AstraZeneca is facing thousands of lawsuits charging it failed to warn consumers that Seroquel can cause diabetes while the company promoted the drug for unapproved uses such as schizophrenia and bipolar disorder.
In October 2008, Seroquel received FDA approval for its extended-release version to be used to treat bipolar disorder, making Seroquel XR (“XR” indicates extended release), the first medication cleared for depressive and manic episodes associated with bipolar disorder. Recreating the drug with an XR as a once-daily treatment means that the patent is protected until 2017. The original formula was set to expire in 2011.
Antipsychotic drugs such as Seroquel have been linked to two serious complications known as Neuroleptic Malignant Syndrome (NMS) and Tardive Dyskinesia. NMS is a potentially fatal syndrome involving muscle rigidity, an altered mental state and symptoms of cardiac instability (irregular blood pressure, tachycardia, irregular pulse). Tardive Dyskinesia is a central nervous system disorder characterized by involuntary movements of the limbs as well as twitching of the face and tongue. #