Pubdate: Fri, 23 Jan 2004 Source: York Daily Record (PA) Copyright: 2004 The York Daily Record Contact: http://www.ydr.com/ Details: http://www.mapinc.org/media/512 Author: SHARON SMITH FEDS NEED MORE DETAILS TO ADDRESS OXYCONTIN ABUSE Until More Data Is Gathered, It Cannot Be Known If Heavy Marketing Is Linked To High Abuse Rates. At the request of federal lawmakers, the U.S. General Accounting Office last year set out to discover whether an aggressive marketing campaign by the makers of OxyContin contributed to a high rate of abuse and fatal overdoses of the powerful prescription pain killer. In a report issued Thursday, the GAO noted that sales of the drug grew rapidly as Purdue Pharma doubled its sales force after introducing OxyContin in 1996. However, the GAO, which is the investigative arm of Congress, said the right data does not exist to determine whether the marketing efforts should share blame for any abuse or deaths. "We are not saying we find no relationship," said Marcia Crosse, author of the GAO's report. "The data is not there." To make that determination, GAO investigators needed to know what kind of abuse was taking place at the county level, Crosse said. Researchers needed to know whether a drug death was brought on by OxyContin alone - and not another prescription that contains oxycodone, the opioid that numbs the pain. "We could find out what the sales were," Crosse said. "But, we couldn't find out what the abuse was." After studying Purdue Pharma's marketing practices for a little more than a year, the GAO did find that by 2003, nearly half of all OxyContin prescribers were primary care physicians. That fact caused the U.S. Drug Enforcement Administration concern because primary care physicians may not have been adequately trained in pain management. After OxyContin came onto the market, the company doubled its sales force from 300-plus representatives in 1996 to 700 representatives in 2000, according to the study. That allowed the company to increase the number of doctors to whom it was promoting OxyContin from about 33,400 to 44,500 in 1996 to 70,500 to 94,000 in 2000. The company's salespeople also were rewarded well for their efforts. "As OxyContin's sales increased, Purdue's growth-based portion of the bonus formula increased the OxyContin sales quotas necessary to earn the same base sales bonus amounts," the report states. "In 2001," according to the report, "the average annual salary for a Purdue sales representative was $55,000 and the average bonus was $71,500." U.S. Rep. James C. Greenwood, R-Bucks County, who requested the report, said lawmakers pushed the company to end the practice of tying financial rewards to sales volumes. However, the practice of promoting OxyContin to primary care physicians continues. "Primary care physicians are at the forefront of treating patients," said James Heins, spokesman for the Stamford, Ct.-based company. "Primary care physicians have to treat pain." Part of Purdue's marketing campaign also included distributing several branded promotional items to healthcare workers, GAO report states. Those items included: fishing hats, stuffed toys, coffee mugs with heat-activated messages, compact discs and pens with pullout conversion charts that show doctors how to calculate the dosage to convert a patient from other opioid painkillers to OxyContin. Because such items have a low value, doctors at York Hospital are allowed to accept those types of promotional gifts, said Barry Sparks, spokesmen for the hospital. The Pennsylvania Attorney General's Office took issue with Purdue Pharma's pen and got the company to stop using it as a marketing tool in the Keystone state. Investigators also looked at how the company educated those doctors. According to the report, the company conducted 40 national pain management and speaker training conferences, usually in resort locations such as Boca Raton, Fla., and Scottsdale, Ariz. The conferences were used to recruit and train healthcare workers for the company's national speaker bureau. The trained speakers were then made available to speak about the appropriate use of opioids to their colleagues, the report states. The company has made efforts to inform the doctors it's marketing to about pain and its treatment, Heins said. "For probably 20 years or more, we've been a leader in pain education guidelines," he said. The conferences, despite their locations, were a part of those efforts. "It wasn't a trip to Disneyland," Heins said. "We were more conservative than other companies. We're trying to avoid the perception that we're paying physicians." The face of medicine, he said, is changing every day. "Industry-funded medical education is important," he said. The GAO did not recommend any changes concerning how drug manufacturers market drugs. But it did recommend that the U.S. Food & Drug Administration should encourage companies with new drug applications to submit plans that contain a strategy for identifying potential problems with abuse. The FDA did not require that of Purdue Pharma when it brought OxyContin onto the market. But, the company has since implemented such a plan. The company and Greenwood both agree with the GAO's risk management recommendation. - --- MAP posted-by: Keith Brilhart