The imposition of $634.5 million in fines against the makers of the potent painkiller OxyContin should serve as a warning for drug company executives who are faced with questions about drug safety issues.
The fines were levied in federal cases out of Virginia, in which three current and former executives of drug maker Purdue Pharma pleaded guilty Thursday to allegations they misled doctors, patients and regulators about the drug’s risk of addiction. In an unusual move, the current and former officials also faced individual criminal charges and fines.
The case, in combination with a measure passed by the U.S. Senate Wednesday that would boost monitoring of prescription drug side effects and drug marketing, demonstrate the public appetite for a tightening of drug safety efforts.
In the OxyContin case, company officials pushed a fraudulent marketing campaign between 1995 and 2001, claiming OxyContin was a time-released drug that was less likely than other similarly strong painkillers to cause addiction or abuse problems.
In truth, company officials didn’t have proof of that claim, yet they presented it to prescribing doctors as fact. They even concocted false charts that were given to doctors to bolster their statements.
OxyContin, a trade name for oxycodone, was a huge profit center for Purdue Pharma in the late 1990s, producing $2.8 billion in revenue for the Stamford, Conn., company. At roughly the same time, deaths related to oxycodone use increased nearly 400 percent, according to a report by the U.S. Drug Enforcement Administration. The drug, often called hillbilly heroin, is highly addictive and produces a euphoric high similar to opiates such as heroin or opium.
The Senate, on a 93-1 vote, this week passed a measure that would require the Food and Drug Administration to monitor prescription drugs after they have been approved, chronicling any side effects. The legislation also would give the FDA the ability to fine drugmakers for inaccurate or misleading drug advertising. Drug makers spent nearly $5 billion on advertising last year, an exponential increase since 1997, when the FDA loosened long-standing restraints on television drug commercials.
It’s imperative that drug companies provide truthful and complete information about their products to doctors and patients. The events of this week should serve as shock therapy for drug makers who are tempted to practice profiteering at the expense of public health.
