May 11, 2007— -- 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.
According to a 243-page report released by the National Center on Addiction and Substance Abuse at Columbia University in March, the abuse of drugs such as Vicodin, Percocet and Oxycontin by college students rose 342.9 percent between 1993 and 2005.
Moreover, a number of deaths related to OxyCodone have been reported since its introduction. According to reports by the U.S. Drug Enforcement Administration, the drug caused 146 deaths and contributed to another 318 through 2002.
Hundreds of additional deaths have been reported since, and the impact of the drug continues to be scrutinized.
Despite increased monitoring and crackdowns, however, it is still possible to purchase OxyContin through numerous online pharmacies. Others resort to getting the drug through those with prescriptions who sell their pills for money, or they even head to other countries where enforcement is comparatively lax.
Saper says that the marketing and promotion practices adopted by Purdue Pharma directly contributed to this problem.
He further maintains that Purdue did this by working to change the way doctors prescribe the drug. He says the company worked with professional medical organizations to change prescription guidelines for OxyContin to include patients with chronic pain, rather than those with temporary pain.
This, he says, led to increased prescriptions, and in turn increased availability of the drug, both for the patients using it legitimately and those abusing it.
"Once that door got open to use narcotics liberally in benign, or chronic, pain conditions, [Purdue] created a whole new world to sell into," Saper says.
But pain experts say regardless of the legal deliberations, the drug is still an important source of relief for patients who experience pain.
"[It] would be a real shame if their product ended up being the villain here," says Lee Vermeulen, director of the Center for Drug Policy at University of Wisconsin Hospital and Clinics.
"Appropriate pain management is a public health priority," he continues. "Too many patients live (and some die) in pain unnecessarily due to misconceptions about the safety and value of appropriate pain care."
June Dahl, professor of pharmacology at the University of Wisconsin-Madison, agrees.
"This drug has very important therapeutic value," she says. "The charges against the company and the decision rendered in this case have no bearing on the clinical usefulness of this drug."
Heins of Purdue Pharma says the settlement will not affect the availability of OxyContin, and the FDA-approved indications for the drug will remain the same.
And even Saper says OxyContin has benefits for those in legitimate need of pain relief.
"Would I take OxyContin if I needed a narcotic for a week? I would," he says.
But Saper adds that the drug stands as a classic example of a good drug marketed in a bad way.
"They have taken a good drug and protected its downsides by not being open about its risks," he says.