Many doctors across the country are angry over what they consider an inadequate $700 million fine for the maker of OxyContin.
In a strongly worded press statement issued Thursday, the U.S. Food and Drug Administration's Office of Criminal Investigations charged the Purdue Frederick Co. with a "conspiracy" to promote, market and sell the drug using several illegal schemes.
Today, the drug is one of the most common opioid painkillers on the market.
Despite the settlement and the admission of wrongdoing, a spokesman for Purdue still defends the company's marketing and promotion practices.
"The instructions contained in the prescribing information for the medication, which are approved by the FDA, have always contained express warnings and precautions about abuse, addiction, tolerance and withdrawal," says James Heins, senior director of public affairs for Purdue Pharma.
Not all pain experts agree that Purdue should have to pay for its promotion practices.
"I think the government has gone overboard in prosecuting those who try to offer options for those in pain," says Pamela Kedziera, clinical director of pain and palliative care at Fox Chase Cancer Center in Philadelphia. "The drug is not the problem. Addiction is a disease. Any opioid or tranquilizer, or alcohol, can be abused. … [To] blame Purdue is a cop out."
"There is a tremendous pressure to market, and every pharmaceutical company markets," says Dr. Joseph Shurman, chairman of the Pain Clinic at Scripps Memorial Hospital La Jolla. "I believe it was a bit of an overkill."
But some say the punishment is warranted, if not inadequate.
"There are companies who cross the line, and in my view, Purdue Pharma very often crossed the line," says Dr. Joel Saper, founder and director of the Michigan Head Pain and Neurological Institute in Ann Arbor. "I don't know if $700 million is enough."
"I think it is probably fair," says Dr. Edward Boyer, associate professor of emergency medicine at the University of Massachusetts.
"The company did a number of things to wiggle out of responsibility, like starting a surveillance group," which still exists, but is in others' hands, "and by hiring consultants."
The development shines additional light on a drug that since its introduction has changed the face of prescription drug abuse in the country.
Following its debut on the market in 1996, the drug quickly became a billion-dollar-per-year offering, widely known as a godsend for those suffering from persistent pain.
OxyContin was unique among pain relief offerings on the market due to its slow release of a powerful narcotic over a 12-hour time span. At the time of its introduction, the government allowed Purdue Pharma to claim OxyContin was less likely to be abused, since it lacked the quick hit found with some shorter-term painkillers.
However, those hoping to abuse the drug quickly learned that by grinding or chewing the pill, its active ingredient would be released all at once, leading to a tremendously addictive high.
Once this knowledge spread, so too did its abuse.
Unfortunate as well is the fact that the entrance of OxyContin into the market coincided with increasing rates of abuse of prescription pain medications throughout the country, particularly by teens and young adults.