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⭒ New Developments

Drug Giant AstraZeneca Pays Half-Billion Dollar Penalty for Illegal Marketing of the Antipsychotic Seroquel to Drug Elders with Dementia

On April 27, 2010, the U.S. Department of Justice announced that AstraZenaca will pay $520 million to resolve allegations it illegally marketed Seroquel for uses never approved by the FDA. Among other illegal activities, it promoted Seroquel to doctors for treatment of Alzheimer’s disease, dementia, depression, anxiety, anxiety and sleeplessness.

Seroquel, like other antipsychotics, is an extraordinarily dangerous drug. The FDA has issued a “black box” warning that its use greatly increases the risk of death for elders with dementia.  Notwithstanding repeated FDA warnings that the drugs are not approved for this use and have deadly consequences, doctors and nursing homes continue to use Seroquel and other antipsychotic drugs to sedate and subdue hundreds of thousands of U.S. nursing home residents.

AstraZeneca is the fourth giant drug company to pay huge fines for illegally marketing antipsychotic drugs. In January 2009, Eli Lilly paid $1.4 billion for illegal marketing of the antipsychotic Zyprexa. In September 2009, Pfizer paid $2.3 billion due to illegal promotions of several drugs, including its antipsychotic drug, Geodon.  Bristol-Myers Squibb paid $515 million for marketing abuses involving its antipsychotic drug Abilify in September 2007.

The drug czars have taken the large fines in stride, seemingly writing them off as the cost of getting ahead in the drug trade. Antipsychotics are now the nation’s top-selling drug category with nearly $15 billion in annual sales, most of it paid by government programs. This is a remarkable development because only a tiny percent of the population suffers from schizophrenia, the condition antipsychotics are designed to treat. Their best selling status was achieved through enormously successful (and illegal) campaigns to persuade or bribe doctors to prescribe these drugs for unapproved purposes. To date, the Department of Justice actions have not deterred the epidemic misuse of these drugs in nursing homes.

Waiting in the wings is Johnson & Johnson, whose Risperdal is one of the most commonly prescribed antipysychotics used to drug nursing home residents. In January 2010, the U.S. Department of Justice sued Johnson & Johnson for illegally marketing Risperdal. J&J is accused of paying tens of millions of dollars in kickbacks to Omnicare, the nation’s largest long-term care pharmacy, to induce it and its pharmacists to recommend Risperdal for nursing home residents who have dementia.

April 27, 2010 U.S. Department of Justice Press Release

DOJ Settlement Agreement with AstraZeneca

New York Times article on settlement agreement