Yet Another Case of Glorified Dope Dealing

My perfect trifecta
Is perfect no more
Trifecta means three
But now there are four

The U.S. Department of Justice just announced that they have fined AstraZeneca $520 million for off-label marketing of its atypical antipsychotic drug, Seroquel. Seroquel is a highly sedating and powerful "atypical" antipsychotic medication that is the second worst offender of all antipsychotic medications for causing a dangerous side effect called metabolic syndrome. Metabolic syndrome leads to an increase in sugar, cholesterol, and/or triglycerides (fat)in the patient's blood. It can lead to actual diabetes.

AstraZeneca is the fourth drug company recently made subject to huge fines for phony marketing schemes for their psychiatric drugs (the other three were the subjects of previous posts).

Among the "conditions" that Seroquel was touted for, beside schizophrenia and mania for which it is indicated, were aggression, Alzheimer’s disease, anger management, anxiety, ADHD, depression, post-traumatic stress disorder, and - get this - insomnia. I have personally seen several patients given the drug by other docs who were prescribing it for sleep. It works, but there are much safer alternatives in most cases.

According to the Justice Department official website, "The United States contends that AstraZeneca 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. 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.

The United States also contends that AstraZeneca violated the federal Anti-Kickback Statute by offering and paying illegal remuneration to doctors it recruited to serve as authors of articles written by AstraZeneca and its agents about the unapproved uses of Seroquel. AstraZeneca also offered and paid illegal remuneration to doctors to travel to resort locations to "advise" AstraZeneca about marketing messages for unapproved uses of Seroquel, and paid doctors to give promotional lectures to other health care professionals about unapproved and unaccepted uses of Seroquel. The United States contends that these payments were intended to induce the doctors to prescribe Seroquel for unapproved uses in violation of the federal Anti-Kickback Statute."

Of course, a half billion dollar fine is chicken feed for the company, which made billions off of this drug. It is just a cost of doing business for them.