Pubdate: Fri, 11 May 2007 Source: Charlotte Observer (NC) Copyright: 2007 The Charlotte Observer Contact: http://www.charlotte.com/mld/observer/ Details: http://www.mapinc.org/media/78 Author: Sue Lindsey, Associated Press Bookmark: http://www.mapinc.org/oxycontin.htm (Oxycontin/Oxycodone) DRUG EXECS PLEAD GUILTY Oxycontin Makers Misled Public About Addictive Painkiller ROANOKE, Va.. - The maker of the powerful painkiller OxyContin and three of its current and former executives pleaded guilty Thursday to misleading the public about the drug's risk of addiction, a federal prosecutor and the company said. Purdue Pharma LP, its president, top lawyer and former chief medical officer will pay $634.5 million in fines for claiming the drug was less addictive and less subject to abuse than other pain medications, U.S. Attorney John Brownlee said. The plea agreement settled a national case and came two days after the Stamford, Conn.-based company agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to overprescribe OxyContin. "With its OxyContin, Purdue unleashed a highly abusable, addictive, and potentially dangerous drug on an unsuspecting and unknowing public," Brownlee said. "For these misrepresentations and crimes, Purdue and its executives have been brought to justice." Privately held Purdue learned from focus groups with physicians in 1995 that doctors were worried about the abuse potential of OxyContin. The company then gave false information to its sales representatives that the drug had less potential for addiction and abuse than other painkillers, the U.S. attorney said. Ken Jost of the Justice Department's Office of Consumer Litigation said this case should put pharmaceutical companies on notice that they won't be able to get away with breaking the law to make a profit. "The things that they plot in their boardrooms, the things that they do behind closed doors will not stay behind closed doors," Jost said. "We have the people, we have the resources. We'll take the time and we'll take the effort to find out what they did and how they did it." Purdue Pharma said it accepted responsibility for its employees' actions and has implemented changes to prevent a similar occurrence. Company Chief Executive Officer Michael Friedman, general counsel Howard Udell and former chief medical officer Paul Goldenheim each pleaded guilty to a misdemeanor count of misbranding the drug. Of the total fine, $34.5 million was levied on those three. The fines will be distributed to state and federal law enforcement agencies, the federal government, federal and state Medicaid programs, a Virginia prescription monitoring program and individuals who had sued the company. About $5 million will go toward a six-year compliance program. Drug Fatalities OxyContin, a trade name for oxycodone, is a time-release painkiller that can be highly addictive. Designed to be swallowed whole and digested over 12 hours, the pills can produce a heroinlike high if crushed and then swallowed, snorted or injected. From 1996 to 2001, the number of oxycodone-related deaths nationwide increased five-fold while the annual number of OxyContin prescriptions increased nearly 20-fold, according to a report by the U.S. Drug Enforcement Administration. In 2002, the DEA said the drug caused 146 deaths and contributed to an additional 318. - --- MAP posted-by: Derek