Pubdate: Wed, 17 Dec 2003 Source: New York Times (NY) Copyright: 2003 The New York Times Company Contact: http://www.nytimes.com/ Details: http://www.mapinc.org/media/298 Author: David F. Musto Note: David F. Musto is co-author with Pamela Korsmeyer of "The Quest for Drug Control" (Yale University Press, 2002). Bookmark: http://www.mapinc.org/oxycontin.htm (Oxycontin/Oxycodone) Books Of The Times: 'Pain Killer' BOON FOR PAIN SUFFERERS, AND THRILL SEEKERS Pain Killer: A "Wonder" Drug's Trail Of Addiction And Death By Barry Meier, 323 pages. Rodale. $24.95 In the 1860's a new drug-delivery system, the hypodermic syringe, was perfected. An injection of a small amount of morphine was found to produce the same effect as a larger dose by mouth. Physicians assumed, therefore, that hypodermic injections offered more protection against addiction. Patients with chronic but not life-threatening pain, say osteoarthritis, were provided with morphine and a syringe and told to inject themselves when there was pain. It took some years to appreciate the mistake, but the sad outcome was that the hypodermic syringe not only did not protect from addiction, but it also facilitated it. By 1920 the president of the American Medical Association, Dr. Alexander Lambert of Cornell, somberly stated that "nearly 80 percent of the morphine addicts have acquired the habit from legitimate medication" provided by physicians. During the 1920's the fear of prescribing addictive medicine permeated American medical practice. Pain medication had to be doled out with great care and parsimony. Inadequate pain relief characterized the life of some cancer sufferers as well as postoperative patients. In the 1960's a movement to bring adequate pain relief attracted both researchers and practitioners. This brings us to the years covered by "Pain Killer," an outgrowth of Barry Meier's reports for The New York Times on OxyContin misuse. His fascinating account of OxyContin's story has echoes of the hypodermic syringe episode in the 19th century. OxyContin was initially marketed as less addicting than other opioids because of a special mechanism that made the tablet release the active ingredient slowly, a characteristic, it was assumed, that would make OxyContin unattractive to misusers who wanted a big jolt. This assumption was a big mistake. Recreational users discovered that merely chewing the pill would release all of the active ingredient, and produce a powerful high. Mr. Meier specifically takes aim at the company that makes OxyContin, Purdue Pharma of Stamford, Conn. He suggests that it was slow to address reports of OxyContin's misuse because the drug brings in revenue of about a=\ billion dollars annually. The Food and Drug Administration also comes in for strong criticism for permitting the early marketing of OxyContin as a relatively nonaddicting pain medication. OxyContin entered the market in 1996 and quickly found favor as an excellent pain medication for cancer patients. Up to 12 hours of pain relief allowed patients to get a night's rest rather than experience the return of pain every three or four hours with shorter-acting medicines. If the drug had remained limited to patients with the most severe pain, the story would probably be different, but advocates for pain treatment minimized the danger of addiction and recommenced prescribing OxyContin for milder and chronic pains. Mr. Meier cites other physicians, who said the drug was being marketed too broadly and uncritically for such a powerful anodyne. Respected pain authorities estimated that OxyContin's addiction rate among those in pain could be a mere 1 percent, perhaps less. The low figure came from postoperative hospital patients, not from out-patients on long-term opioid therapy. No studies on prolonged treatment with OxyContin had been conducted. Nevertheless, doctors acted as if OxyContin had solved the difficult balancing act between offering pain relief and avoiding addiction, and began prescribing it for many kinds of pain for which milder pharmaceuticals would be much more appropriate. Then the problems began. By early 2000 in the southwest corner of Virginia and in four or five other areas of the country, an explosion of OxyContin misuse had spread among teenagers and their parents. With some doctors prescribing the drug liberally and purveyors hawking it on the street, families were being devastated and nonmedical users of OxyContin swamped drug treatment programs. Doctors and other health workers appealed for help and also wrote to Purdue Pharma telling the company of the multiple problems that were occurring in their area. Purdue Pharma officials said that the company first heard of these problems in February 2000, although Mr. Meier says that information reached the company a year earlier. When Purdue knew about the difficulties is relevant to Mr. Meier's contention that the company dragged its feet in making changes in the drug's description and indications. Because Purdue is privately owned, access to its records is much more restricted than would be the case with a publicly owned company. The Food and Drug Administration, which was so cooperative with Purdue in the early stages of its marketing, is now taking a closer look at its responsibilities. Purdue agreed that after July 2001 it would no longer state that OxyContin was less addictive because it was a slow-release tablet. In fact, in 1998 The Journal of the Canadian Medical Association reported that drug abusers actively sought slow-release pain medication. A related editorial warned that assuming slow-release protected against recreational use would lead to serious problems. OxyContin's nonmedical use has now spread much more widely. The company has changed its description of the drug and has mounted a major public relations campaign to improve its image. Pain experts have apologized for their uncritical advocacy of OxyContin. Yet their early assurances of the 99 percent safety from addiction may, to their regret, have set the stage for a revival of extreme caution among doctors in providing relief to the afflicted. Long-term administration of pain remedies is facing mounting criticism. A recent review article in The New England Journal of Medicine concluded that "evidence now suggests that prolonged, high-dose opioid therapy may be neither safe nor effective." Mr. Meier, in spite of difficulties obtaining records and the considerable time required to scour isolated rural areas, has given us a rare insight into interactions between government and the pharmaceutical industry - and the extraordinary impact of their decisions upon our lives. - --- MAP posted-by: Beth Wehrman