First Up: J&J’s Antipsychotic Risperdal
Illegal marketing of Risperdal for unapproved uses will cost Johnson & Johnson (J&J) at least $1.5 billion in a settlement with the U.S. Justice Department, but sources say the final amount could actually end up exceeding $2 billion.
Earlier this year, J&J agreed to pay more than $1 billion in a civil settlement involving fraudulent marketing of their antipsychotic drug Risperdal – but federal prosecutors decided to hold out for more.
Risperdal was heavily promoted for unproven off-label uses for more than a decade, even after the U.S. Food and Drug Administration (FDA) issued warnings against the misleading claims. Doctors are well within their legal rights to prescribe a drug for off-label use; it’s actually a common, albeit sometimes dangerous, practice. However, drug companies may not promote them for uses other than those that are FDA-approved.
Research has shown that up to two-thirds of prescriptions for Risperdal were for unapproved uses that had little or no scientific support.
Apparently, J&J sent out an army of salespeople to doctor’s offices, nursing homes, Veteran’s Administration facilities, and jails to tout Risperdal as a proverbial miracle drug for mental illness and dementia, thus resulting in the outlandish numbers.
The FDA told the company to stop the false and misleading marketing claims not once, not twice, but three times from 1994-2004, but J&J reportedly continued to include marketing the drug for unapproved uses right in their business plan.
In the years to follow, the FDA did eventually approve Risperdal for bipolar disorder and autism symptoms, but it was never approved for dementia, even though it was heavily marketed as a dementia drug.
Another off-label use for which Risperdal was marketed was post-traumatic stress disorder (PTSD) – even though research in JAMA found Risperdal is no more effective than a placebo, and is associated with a long list of potentially devastating side effects, some of which may be permanent.
Next Up: GSK’s Paxil, Wellbutrin and Avandia
But the above seems to be acceptable behavior evidently, because as stated, GSK has just announced their record breaking $3 billion dollar settlement that involved the unlawful promotion of antidepressant drugs Paxil and Wellbutrin and for failing to report safety data about its controversial diabetes drug Avandia.
Documents released concerning that settlement showed the extent of kickbacks paid to doctors, from Hawaiian vacations to tickets for Madonna concerts.
The prior record-setting case involved Pfizer, the world’s biggest drugmaker. Pfizer paid the government $2.3 billion in criminal and civil fines for improperly marketing 13 different drugs, including Viagra and cholesterol fighter Lipitor. Pfizer was accused of encouraging doctors to prescribe its drugs with free golf, massages, and junkets to posh resorts.
In the last few years, the Justice Department has become much more aggressive in pursuing such fraud, often in whistleblower cases taken on by a handful of U.S. attorneys focused on such fraud.
It is illegal to promote uses for a drug that have not been approved by the FDA — a practice known as off-label marketing.
“Let me be clear, we will not tolerate health care fraud,” Deputy Attorney General James M. Cole told a news conference at the Justice Department.
“For far too long, we have heard that the pharmaceutical industry views these settlements merely as the cost of doing business,” Acting Assistant Attorney General Stuart F. Delery, head of Justice’s civil division, said at the news conference. “That is why this administration is committed to using every available tool to defeat health care fraud.”