Sen. Charles Grassley recently sent a letter to the administrator of the U.S. Centers for Medicare and Medicaid Services. He wants some answers after a federal report Grassley requested found many nursing home residents with dementia are given antipsychotic drugs. These drugs are not approved to treat dementia. They can be lethal for those afflicted with it, and Medicare has been paying for them.
Nearly one in seven elderly nursing home residents, nearly all of them with dementia, are given powerful atypical antipsychotic drugs even though the medicines increase the risks of death and are not approved for such treatments, a government audit found. More than half of the antipsychotics paid for by the federal Medicare program in the first half of 2007 were “erroneous,” the audit found, costing the program $116 million for those six months. “Government, taxpayers, nursing home residents as well as their families and caregivers should be outraged and seek solutions,” Daniel R. Levinson, inspector general of the Department of Health and Human Services, wrote in announcing the audit results.
A federal judge has refused to toss out a whistleblower lawsuit backed by the Department of Justice (DOJ), which accuses Johnson & Johnson of involvement in an illegal kickback scheme to push their antipsychotic drugs on elderly nursing home residents that did not need them. The DOJ filed a civil False Claims Act compliant against J&J on January 15, 2010, saying that the company paid millions to Omnicare, Inc. as kickbacks for selling Risperdal to nursing home patients.
According to a recent report from the United Kingdom, side effects of Risperdal and other similar antipsychotics, like Seroquel, Zyprexa and Abilify, could be linked to as many as 1,800 deaths and 1,620 strokes per year in elderly patients with dementia.
Since direct-to-consumer drug advertising was legalized 13 years ago, Americans have become a nation of pill poppers — choosing the type of drug they desire like a new toothpaste, sometimes whether or not they need it. But if patients want the drugs, doctors and pharma executives want them to have the drugs and media gets full page ads and huge TV flights (when many advertisers have dried up), is the national pillathon really a problem? Yes, when you consider the cost of private and government insurance and the health of patients who take potentially dangerous drugs like these.
Seroquel, Zyprexa, Geodon, atypical antipsychotics—Even though the antipsychotic Seroquel surpasses 71 drugs on the FDA’s January quarterly report with 1766 adverse events, even though it’s linked to eight corruption scandals, even though military parents blame Seroquel for unexplained troop deaths, it is the fifth biggest-selling drug in the world and netted AstraZeneca almost $5 billion last year. Atypicals were originally promoted to replace side-effect prone drugs like Thorazine but soon became pharmaceutical Swiss Army Knives for depression, anxiety, insomnia, bipolar and conduct disorders and other off label uses — and betrayed the same side effects as older antipsychotics. (Especially tardive dyskinesia-linked Abilify.)
FOR decades, antipsychotic drugs were a niche product. Today, they’re the top-selling class of pharmaceuticals in America, generating annual revenue of about $14.6 billion and surpassing sales of even blockbusters like heart-protective statins. Lawyers suing AstraZeneca say documents they have unearthed show that the company tried to hide the risks of diabetes and weight gain associated with the new drugs. Positive studies were hyped, the documents show; negative ones were filed away. According to company e-mails unsealed in civil lawsuits, AstraZeneca “buried” — a manager’s term — a 1997 study showing that users of Seroquel, then a new antipsychotic, gained 11 pounds a year, while the company publicized a study that asserted they lost weight. Company e-mail messages also refer to doing a “great smoke-and-mirrors job” on an unfavorable study.