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OxyContin probe: Drug maker downplayed risk
DORIS BLOODSWORTH
The Orlando Sentinel
ORLANDO - In November 2001, Florida Attorney General Bob Butterworth opened an investigation into the prescription painkiller OxyContin after calling it "a major threat to public health." He was concerned that Purdue Pharma's marketing of the drug may have contributed to accidental overdoses and widespread addiction - and even told a group of doctors that he wanted to ban it.
A year later Butterworth closed his investigation, praising OxyContin as "one of the most remarkable and most prescribed painkillers in the nation today."
What happened to the probe? In the end it was little more than a paper-gathering exercise, even in the midst of mounting evidence reported by the state of overdoses and deaths linked to OxyContin. A single state investigator interviewed only a few people.
Purdue never turned over all the records the attorney general wanted. But the records that were produced suggest that Butterworth's office missed an opportunity. The documents indicate that Purdue minimized the potential dangers of OxyContin while pushing broader use of the drug, boosting sales from about $50 million in 1996 to nearly $1.5 billion in 2001.
But Purdue was never called to account. In a settlement that ended the probe on Nov. 1, 2002, the company offered $2 million toward a prescription-tracking system for Florida, and Butterworth promised that Florida would never sue the company for any actions up to the time of the settlement.
If the program fails to gain approval before July, Purdue won't be held to the $2 million promise. However, the state's obligation not to sue would still stand.
Butterworth also said the agreement with Purdue did not mean "the issues were over with for the pharmaceutical company."
He said that before he left office he wanted to gain as much as possible from Purdue and then "pass the baton" to the other states, such as Connecticut, that continue to investigate the company.
"There was delay, delay, delay," Butterworth said about trying to get records from the company. "We were losing lots of lives. Somebody had to break the ice, and we made the first major inroads."
Former Assistant Attorney General Dave Aronberg, the initial lead investigator, said Purdue benefited from timing in the state's probe. He and Butterworth were both running campaigns for state Senate seats in 2002.
The attorney general's investigation contained documents that showed the company aggressively promoted OxyContin, a time-release medication with the same potential for abuse and addiction as morphine.
The newspaper obtained 5,000 pages of records from the Fort Lauderdale office of the attorney general. Included in the files were seven years of Purdue's marketing plans, which the company went to court to try to keep secret. The Sentinel sought to keep them public records, and a judge agreed.
Among the attorney general's records:
� More than 600 "adverse event" reports from patients and doctors to the U.S. Food and Drug Administration, detailing medical problems they attributed to OxyContin - including nausea, dizziness, shortness of breath, stupor, hallucinations, addiction and death.
� A Purdue-funded study that challenges the company's own claim that addiction to opioids such as OxyContin is rare - "less than 1 percent." Dr. Lawrence Robbins, who runs an Illinois headache clinic, found in the study that 13 percent of his chronic-headache patients became addicted to the OxyContin he prescribed.
� Statements by a Purdue attorney who said there had been no studies of the drug's potential for addiction, calling them unnecessary.
� Details of expense-paid trips to golf resorts used to recruit doctors paid by Purdue to talk to their colleagues about the benefits of OxyContin. Although such practices might have been common for other drugs, health-care professionals said they were inappropriate for Schedule II narcotics, which have a high potential for abuse.
� Samples of Purdue's strategy to push OxyContin as a replacement for less-potent and less-abused drugs. The company handed out pens that included conversion tables that showed doctors how to switch from other medications to OxyContin. Purdue's marketing slogan was "OxyContin - the one to start with and stay with."
� Documents showing the training materials and bonus plans of the company's sales force. In a case involving a Palm Beach County doctor, a deposition revealed that a Purdue sales representative doubled her commission from $50,000 to $100,000 between 1999 and 2000. One of her top-prescribing doctors, who is accused of overprescribing OxyContin to his patients, now faces first-degree murder and trafficking charges.
� Allegations by a former Purdue employee who claimed the company's sales force had used unauthorized material to promote OxyContin. William Gergely, the company's district manager for western Pennsylvania and West Virginia for 27 years, said Purdue furnished him with materials he did not think were approved by the FDA. Gergely, who was fired in 2000 over a disputed harassment issue, was the only one of about 100 former or current Purdue employees Florida investigators contacted.
Purdue spokesman Jim Heins said the company had looked at the allegations attributed to Gergely and found "they have absolutely no merit."
� Marketing plans from 1995 to 2002 that laid out the company's strategy for promoting OxyContin. In recent years, Purdue spent more than $150 million to market the painkiller. The annual reports made it clear that profit was a big part of the company's desire to expand use of its medication beyond the cancer patients originally targeted.
Marketing had been the focus of the investigation, and Butterworth said he was especially incensed about one item that he thought was aimed at patients. It was a compact disc of big-band music that showed an elderly couple dancing on the cover over the words "Swing in the right direction with OxyContin."
In a May 2002 directive, the U.S. Drug Enforcement Administration said that "direct-to-consumer advertising of controlled substances not only stimulates more than legitimate demand for drugs but may intensify the problems of diversion and abuse."
Butterworth said he had a "contentious" meeting with Purdue officials during which he threatened them with subpoenas if they didn't turn over marketing plans the state requested. The company sent the plans along with a demand that they be kept secret.
Shortly after that Tallahassee meeting, Aronberg left to run his successful campaign for state senator. Purdue pressed the state to end its investigation, offering $2 million toward the prescription-tracking system, double the amount Butterworth had requested. The state promised never to sue the company for any actions up to Nov. 1, 2002, when the agreement was signed.
That day was a Friday; Butterworth left office the following Monday because of term limits. The next day, he lost his first election in 30 years.
As controversy about OxyContin has grown nationwide, Purdue Pharma voluntarily has taken steps in a number of areas. The company has destroyed marketing props, such as the compact discs and videotapes of patient testimonials. And it has come up with a 10-point plan to try to stop abuse and diversion of OxyContin. Diversion is the rerouting of drugs from medical to illegal uses.
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