Alexander DeLuca, M.D.
At Painkiller Trouble Spot, Signs Seen as Alarming Didn't Alarm Drug's Maker
The line, often 15 to 20 people long, used to spill from a pain management clinic at a strip mall in this beachside city. Other visitors, many from out of town, waited in cars that jammed the mall's parking lot from morning to night.
Some came to the clinic for legitimate treatment. But others came to feed another need, a hunger for narcotics.
The clinic's drug of choice was OxyContin, the powerful painkiller that federal officials say has been a factor in 282 overdose deaths since January 2000 and may have played a role in dozens more. No other drug in the last 20 years has been abused more widely so soon after its introduction, those officials say. Its addicts have broken into pharmacies, clogged treatment centers and sent lawmakers scrambling to find ways to keep the drug from those who use it to get a heroinlike high.
As reports of OxyContin abuse spread early this year, the drug's manufacturer, Purdue Pharma of Stamford, Conn., began a national campaign to convince the public that it was doing everything possible to combat the problem and to make sure that only patients with legitimate needs got the drug.
But while some pharmacists and a law enforcement official in Myrtle Beach, a major trouble spot for OxyContin, said they had warned Purdue Pharma that the clinic was an apparent hotbed of abuse, the company did little, if anything, about it.
In addition, Purdue Pharma's own records, obtained by The New York Times, show that first-quarter sales of OxyContin in a sales territory that includes Myrtle Beach grew by more than $1 million. During that period, sales in the territory with the next-biggest growth in the country grew by $700,000. Federal officials say the drug maker should have investigated whether the surge in the territory here was caused by doctors' overprescribing the drug or by people's misusing it.
"There was total disregard for what was going on over there," said Cheri Crowley, the federal Drug Enforcement Administration agent in charge of the agency's investigation into the clinic, the Comprehensive Care and Pain Management Center. Speaking of prescriptions, she said, "Script after script after script was coming from the clinic."
Comprehensive Care closed in June after the drug agency suspended the narcotics licenses of six doctors who worked there, saying the doctors posed an "immediate danger to public health and safety." Five of the clinic's patients died of drug overdoses, government investigators said. The doctors deny any wrongdoing.
Terry Woodworth, a D.E.A. official in Washington, said the drug maker had a moral obligation to alert state and federal authorities to the warnings its sales representatives had received even though it was not legally required to do so. And Representative James C. Greenwood, a Pennsylvania Republican who presided over a Congressional hearing on OxyContin, said that in general, companies that made narcotics should monitor their sales data and investigate patterns suggesting inappropriate use.
"A company that collects data to see how well its marketing programs are working ought to be able to accept a responsibility to see where relatively obvious instances of abuses are occurring," Mr. Greenwood said.
Purdue Pharma executives declined requests to be interviewed for this article. But in written responses to questions, the company said its officials had acted responsibly in dealings with the clinic. A large number of prescriptions does not necessarily mean that doctors are improperly prescribing a drug, the company added.
"At Purdue we strongly support local, state and federal law enforcement efforts to combat the abuse and misuse of OxyContin and other pain medications," the company said in a statement. "Everyone committed to the best interest of patients in pain is a victim of prescription drug abuse."
OxyContin, a time-release medication, has proved effective for cancer patients and others suffering from severe, chronic pain. But drug abusers quickly discovered that crushing the pill immediately released its narcotic.
For more than a year, Comprehensive Care was the epicenter of OxyContin abuse in Myrtle Beach, law enforcement officials said. The ease of getting a prescription became so well known that people arrived by the carload from more than 100 miles away, those officials added.
Soon, a pattern of crime and misery, already associated with OxyContin abuse in states like Maine and West Virginia, unfolded. One rehabilitation center in Myrtle Beach has experienced a nearly fourfold increase in the number of OxyContin addicts it has treated in the last 18 months.
"I lived in hell," said Robin Anderson, a former clinic patient who sought treatment twice for her addiction, "and some days I feel like I'm still in hell." In July, she sued Comprehensive Care and Purdue Pharma in a South Carolina state court, contending that they did not adequately warn about the drug's hazards. They deny those accusations.
Some pharmacists in Myrtle Beach say they told the drug maker of their suspicions about Comprehensive Care months before the clinic closed.
Thomas Ayres, an owner of the Medicine Shoppe in Darlington, S.C., said he had become suspicious when patients from Comprehensive Care began to arrive at his store, 75 miles from the clinic, to fill large OxyContin prescriptions. Mr. Ayres said he had passed on his concerns to a Purdue Pharma salesman around the beginning of this year.
He said the salesman, Maurice Heisig, had appeared to know about the clinic's problems already. "Mo said, 'We are trying to talk with them, but Myrtle Beach is not my area,' " Mr. Ayres said.
Another druggist, Ron Mason, an owner of the Northside Pharmacy in Myrtle Beach, said that he confronted the OxyContin salesman for this area, Eric K. Wilson, around March, not long after his store had been burglarized for OxyContin.
"I told him, 'You know where this is going and that people are abusing this drug, but you are getting your commission on sales,' " Mr. Mason said.
Several druggists said they also complained about the clinic this spring during meetings sponsored by Purdue Pharma. Roddy Williams, owner of the Oceanlakes Pharmacy in Surfside Beach, a town near here, said he had voiced his concern to Mr. Wilson before one meeting. He said Mr. Wilson had responded by telling him that the company was issuing, among other things, prescription pads that could not be duplicated or used for forgeries.
"It was a joke," Mr. Williams said. "People didn't need to copy prescriptions. They were going to doctors who were writing them."
Ms. Crowley, the D.E.A. agent, said she described the havoc that OxyContin was causing in a "heated" telephone conversation with Mr. Wilson in March.
"I told him, Your product is being diverted onto the streets of South Carolina, that it is being sold on the streets of South Carolina and that people are dying from it in South Carolina," Ms. Crowley said.
She said that she did not recall his specific response but that he had said that Purdue Pharma was holding meetings with local pharmacists and doctors about pain management.
Both salesmen, Mr. Wilson and Mr. Heisig, initially referred a reporter's telephone calls to Purdue Pharma headquarters. In written responses to questions, the company acknowledged that both men had been told by "health care professionals" of their "concerns about certain activities at the clinic" -- in Mr. Wilson's case, as early as late last year.
Both men, the company added, told their managers about the reports, but Purdue Pharma said the information "did not give the managers reason to take action" other than to tell Mr. Wilson to "continue to stress the proper use" of OxyContin during visits to Comprehensive Care. The company did not elaborate.
Three doctors who worked at the clinic, including Dr. David Michael Woodward, its owner, said they had never been told by any Purdue Pharma official that they were improperly prescribing OxyContin. The doctors also say patients were monitored to make sure that they were not abusing drugs and that those suspected of doing so were reported to state authorities. All the doctors whose licenses were suspended by the D.E.A. are contesting the action.
In a statement, Mr. Wilson said that the situation at the clinic was not "simple or clear" and that many pain patients had received legitimate care there. "If any of the doctors at this clinic have abused their prescribing privileges, then they have exploited all of us," Mr. Wilson said.
Dr. Woodward recently surrendered his state medical license voluntarily. The clinic remains the subject of a criminal investigation, the authorities said. Dr. Woodward denies any wrongdoing.
"Some have suggested that when such suspicions are raised about a particular physician or practice, our sales representatives should stop calling on them," the company said. "That certainly would have been better from a perception standpoint, but if a doctor is intent on prescribing our medication inappropriately, such activity would continue regardless."
As part of its effort to stop the drug's abuse, top Purdue Pharma executives have crisscrossed the country to meet with local officials and offer their help. They have also started programs to help doctors better identify drug abusers. Most recently, the company produced television ads warning teenagers about prescription drug misuse.
Company officials also said that while many prescription drugs were abused, OxyContin had been unfairly singled out, making some doctors afraid to prescribe it for patients who need it. But experts say that OxyContin, while beneficial to many, is extremely powerful: a single tablet can contain up to 16 times the level of the same narcotic found in other painkillers.
In an August interview, two months after Comprehensive Care closed, three top Purdue Pharma executives said the company did not have any prescription data that would have alerted them to problems in Myrtle Beach. But this year's first-quarter sales of OxyContin in Mr. Wilson's territory, which includes Myrtle Beach, showed the highest increase of any sales territory in the country, records show.
During that period, those records show, sales of OxyContin in Mr. Wilson's area increased as much in three months as the sales in some other territories of the country increased during all of last year. A local doctor said in an interview that Mr. Wilson told him that 40 percent of those sales had gone to Comprehensive Care.
The company said in a statement that the sales figures for Mr. Wilson's territory did not suggest anything unusual. "It is not unusual for the volume of prescriptions for OxyContin and other pain medications to change significantly from quarter to quarter in different areas," Purdue Pharma said. The company, which declined to elaborate on the sales documents, added that Myrtle Beach and the surrounding area had growing numbers of older people who used pain medications.
When Mr. Woodworth, the D.E.A. official in Washington, was told about the sales data, he said the company should have investigated.
"It was only one indicator," said Mr. Woodworth, who is the drug agency's deputy director for the division of diversion control. "But it was a hell of an indicator."