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Workers compensation observers say they hope that a $635 million settlement of criminal and civil charges against the maker of OxyContin will help deter overuse of addictive and costly painkillers.
The workers comp industry has warned for years that OxyContin and other narcotics have been prescribed too often to workers suffering from injuries not severe enough to require the use of such potent drugs.
Following a four-year investigation, the U.S. Food and Drug Administration, along with federal prosecutors, the IRS, Health & Human Services Department and state officials announced on May 10 that Stamford, Conn.-based Purdue Pharma L.P. and Purdue Frederick Co. Inc. had agreed to pay $600 million as part of a settlement of allegations that Purdue sought to profit from "a long-term illegal scheme to promote, market and sell OxyContin," the FDA said in a statement.
Under settlement terms, the company pleaded guilty to felony charges of misbranding the "addictive and highly abusable drug," the FDA said.
Its president, chief legal officer and a former medical officer pleaded guilty to misdemeanor charges "as being the responsible corporate officers" during illegal promotion of the prescriptive, the FDA said. The three executives agreed to pay nearly $35 million to Virginia as part of the $635 million total, federal prosecutors said.
Use of narcotics in workers comp cases is widespread. Preliminary results of a study by the California Workers' Compensation Institute, for example, point to an "alarmingly high" use of narcotics, including OxyContin, to treat "garden variety" lower back sprains and strains (see related story).
Litigation, lost work days and claims costs all increase dramatically when narcotics are prescribed, CWCI's preliminary results show.
Problems with the abuse or misuse of OxyContin are not unique to workers comp cases, observers point out. Similar abuses occur in other areas of health care.
OxyContin is a synthetic narcotic that resembles natural opiates. Its abuse and misuse was publicized several years ago, prompting different organizations to question whether the drug was being overprescribed.
In early 2004, Washington state's Department of Labor and Industries, for example, cautioned more than 10,000 doctors about overprescribing opiate-based pain relievers, including OxyContin, to injured workers.
In a letter to the doctors, Washington's monopoly workers comp insurer said the misuse of prescribed painkillers led to 40 to 60 deaths of injured workers in the state over an eight-year period.
The Boca Raton, Fla. based National Council on Compensation Insurance Inc. has studied OxyContin usage patterns in workers compensation cases and group health plans.
"We have long been concerned about the prevalent use of OxyContin," said Barry Lipton, senior actuary and practice leader for NCCI. "If you include OxyContin and its generic equivalent, it's the No. 1 drug prescribed in workers compensation ranked by cost. It's used often in chronic pain management, which, given its addictive properties, we are concerned about."
Federal prosecutors said Purdue trained its sales force to lie to doctors about OxyContin's addictive nature, its likelihood for abuse, its ability to cause euphoria and withdrawal symptoms.
Purdue did not return a telephone call seeking comment. But in a statement, Purdue Pharma blamed "some employees," who made or told other employees to make certain statements to doctors about OxyContin's risks for addiction, abuse and withdrawal.
Purdue accepts responsibility and regrets past misstatements, the company said. During the past six years, it changed its training, compliance and monitoring systems while adding warnings and prescribing information for doctors, the company said.
Because OxyContin is not the only narcotic in widespread use among workers comp claimants, the NCCI's Mr. Lipton and others say they hope the action against Purdue will serve as a warning about drug marketing and increase awareness about potential addiction.
Opioids such as OxyContin were created for acute pain or "end of life" conditions, said Keith Bateman, vp of workers compensation for the Property Casualty Insurers Assn. of America in Des Plaines, Ill.
But a number of factors have led to their frequent "off-label" prescribing for ailments for which they were not originally intended, Mr. Bateman said.
As far as OxyContin, marketing by the drug's manufacturer helped increase its use, he said.
"There is an awful lot of off-label use of medications in this country, and a lot of it is in workers comp," Mr. Bateman said.