Pubdate: Wed, 19 Nov 2003 Source: Sun Herald (MS) Copyright: 2003, The Sun Herald Contact: http://www.sunherald.com Details: http://www.mapinc.org/media/432 Author: Doris Bloodsworth, The Orlando Sentinel Bookmark: http://www.mapinc.org/oxycontin.htm (Oxycontin/Oxycodone) PAINKILLER INGREDIENT LINKED TO MORE FLORIDA DEATHS THAN HEROIN ORLANDO, Fla. (KRT) -- Sylvia Cover remembers her husband telling the physician, "Just fix me up, Doc, so I can get back to work and take care of my family." Six months later, Gerry Cover was dead. Hooked on a powerful painkiller called OxyContin, the 39-year-old handyman and father of three died from an accidental overdose. The drug had been prescribed by his doctor for pain from a mild herniated disc. The Kissimmee, Fla., man's death in September 2000 was an individual family's tragedy. But a nine-month investigation by the Orlando Sentinel found a broader, more disturbing pattern: During 2001 and 2002, more than 200 deaths statewide have been linked to the highly potent painkiller that has been criticized as being aggressively marketed and eagerly prescribed with only routine oversight from government regulators. OxyContin, made by Purdue Pharma of Stamford, Conn., is a 12-hour time-release drug with the same potential for abuse and addiction as morphine. The active ingredient in OxyContin and dozens of other strong painkillers is oxycodone, which comes from the opium poppy. The drug is so powerful it is sometimes called "heroin in a pill" and most recently has been linked to a prescription-drug investigation involving conservative commentator Rush Limbaugh. The Sentinel's investigation tracked how three key forces - Purdue's strong marketing campaign, the government's lax controls and a medical community unschooled in OxyContin's true power - have contributed to a wave of addiction and death. In turn, illegal use of the medicine has grown as more patients have become dependent on the drug and a new black market has emerged. Jim McDonough, head of the governor's Office of Drug Policy, said he found the results troubling in light of unreleased reports that show oxycodone overdoses in Florida for the first half of this year continue to rise. He plans to respond with a number of legislative and educational proposals to counter what he called "overwhelming salesmanship to expound on the benefits of these drugs without enough cautions." "There always was that suspicion when you did have data surrounding the death scene that the predominant drug that seemed to be there was OxyContin," McDonough said. "If this was a rash of crimes resulting in death we wouldn't stand for it." The U.S. Food and Drug Administration, which approved OxyContin in 1995 and which has come under fire for failing to respond adequately to safety concerns about the drug, turned down repeated requests to comment on the Sentinel's findings. Purdue denies its marketing ever put the public's safety at risk. "Allegations that Purdue's marketing contributed to diversion and abuse are simply not true," said company spokesman Jim Heins, referring to the rerouting of drugs from medical to illegal use. "No evidence has been found to support these allegations." Purdue executives, battling hundreds of lawsuits and several investigations throughout the country, blame bad publicity on a few criminal doctors and drug abusers who used their pain medication illegally. In fact, the company says, there are about 2 million patients nationwide being helped by the painkiller. Purdue says no one has ever become addicted to OxyContin when taking it as prescribed. The Sentinel's investigation, however, found evidence that dozens of oxycodone overdoses in Florida involved patients such as Gerry Cover. The newspaper launched its inquiry after the Florida Attorney General's Office ended a tobacco-industry-style investigation last year of Purdue's marketing practices. The yearlong investigation ended Nov. 1, 2002, when Florida Attorney General Bob Butterworth signed an agreement promising never to sue Purdue for any actions up to that point. Purdue pledged $2 million toward a prescription-tracking program that has failed to gain legislative approval. Butterworth and one of his assistants who helped in the probe, Dave Aronberg, acknowledged that their enthusiasm was dampened by calls from pain patients who feared the drug might be pulled from the market and by an online poll that showed little support for a lawsuit. In its research, the newspaper examined 500 autopsy reports from across Florida, reviewed more than 5,000 pages from the state's inquiry and interviewed scores of health-care professionals, law-enforcement officers, OxyContin patients, addicts and drug-rehabilitation experts. The Florida Department of Law Enforcement tracks drug-related deaths based on toxicology tests performed during autopsies. Everyone from doctors to law-enforcement officers follows deadly drug trends outlined in semiannual reports. Illegal substances such as heroin once topped the charts. Today, prescription drugs turn up more often than street drugs. Drugs with oxycodone were not tracked as a separate class until 2001, after state officials said they became alarmed about anecdotal reports of OxyContin overdoses. From Jan. 1, 2001, to Dec. 31, 2002, Florida's 24 medical-examiner districts reported that oxycodone overdoses caused 573 deaths. But because oxycodone is available in almost 60 medications, no one knew which specific painkillers were involved in the overdose deaths. To find out, the Sentinel obtained copies of the 500 autopsy reports in the 573 overdose cases. Some deaths are still under active law-enforcement investigation and autopsy results were not public record. The newspaper also reviewed hundreds of police records and talked to relatives or witnesses to identify the pain medication involved. The key findings: .Oxycodone was more deadly than heroin during 2001 and 2002 in Florida. The 573 deaths reported as caused by oxycodone overdoses compare with 521 deaths caused by heroin overdoses during the same period. .The most recent statistics publicly available, from 2000, show OxyContin accounted for 25 percent of the market for oxycodone prescriptions. But the Sentinel's research showed OxyContin was the drug identified in about 83 percent of the 247 cases linked to a specific medication. In the remaining 253 oxycodone deaths, the Sentinel was unable to determine a brand-name drug. .The Sentinel review of the 500 oxycodone deaths found 87 people who had a history of back pain, 19 who were recuperating from surgery and 157 others with health conditions that included arthritis, AIDS, cancer and car-crash injuries. By contrast, 38 cases could be identified in which users had no health issues beyond recreational drug abuse. .Purdue has directed drug-education efforts mostly toward teenagers. But the average oxycodone overdose victim is 40 years old, the autopsy reports show. And white, middle-aged men between the ages of 30 and 60 - many with back pain or other medical problems - accounted for 254 oxycodone deaths. Purdue officials would not comment on the details of the Sentinel's autopsy review, referring instead to the company's own study of more than 1,000 "drug-abuse deaths" nationwide involving oxycodone from 1999 to 2002. That study, published in March, found only 30 of the deaths involved oxycodone alone, and only 12 of those were specifically tied to OxyContin. The newspaper's approach differed from the Purdue study in many ways. One key difference: The Sentinel pinpointed cases in which medical examiners had determined oxycodone to be the cause of death, not simply "involved." And Purdue's study relied on a scattershot sampling of cases from 23 states, not a comprehensive review of a single category of overdoses in one state. Meanwhile, Purdue is set to launch another painkiller that is 10 times more powerful than morphine. Purdue's Palladone, which the FDA reviewed in September, is a time-released version of hydromorphone, sold under the brand name Dilaudid. A drug-enforcement official called Dilaudid "the drug of choice for addicts." The FDA is weighing the drug's potential for abuse before making a final decision. OxyContin was approved before consideration of abuse forgetting conversations and dates. He was obsessed with counting pills. He made sure his OxyContin was always close at hand, fearing the horrendous withdrawal symptoms that might kick in otherwise. On Sept. 19, 2000, it looked as though the Covers' lives were turning around. Gerry Cover had been seeing a pain-management specialist who was helping him reduce his medication to 20-milligram doses. Just what happened that night might never be fully known. Sylvia Cover and her son Gerry Jr., 18, were watching television while Gerry Sr. was napping. Sylvia checked on her husband and heard him snoring. When she returned a little later, she found him blue and cold. An autopsy determined that he had a lethal dose of oxycodone. Cover's death left his wife and children emotionally and financially devastated, and they are suing Purdue Pharma. Foreclosure of their modest home hangs over their heads. Last Christmas, Cover made a homemade card for her son. Inside was an IOU until the day comes she can afford to buy a present. "Our house used to always be full of family and friends," Sylvia Cover said. "We even had a party for Groundhog Day. "But I no longer have a life." - --- MAP posted-by: Jackl