A week later, Judge Stephens ordered one more document withdrawn from public view: His Nov. 5 ruling that there was enough evidence against Purdue to warrant a trial. The Times reviewed a copy of the ruling. The settlement did not require Purdue to admit any wrongdoing or change the way it told doctors to prescribe the drug. ‘A significant competitive advantage’ While Purdue’s litigators were working in courthouses around the country to fend off civil suits, its regulatory attorneys in Washington, D.C., made a blunt admission to the FDA: The 12-hour dosing schedule is, at least in part, about money. The issue arose in a regulatory dispute that attracted little attention. The Connecticut attorney general had complained to the FDA that doctors prescribing OxyContin every eight hours, rather than the recommended 12, were unintentionally fueling black market use of the drug. In a 2004 letter to the FDA, Purdue lawyers responded that the company had no evidence that hour prescribing contributed to abuse or was unsafe. They went on to make a case far different than the one Purdue sales reps were making to doctors. Eight-hour dosing, the attorneys wrote, could “optimize treatment” for some patients and should level out the narcotic roller coaster. Nonetheless, they said the company planned to continue telling doctors OxyContin was a 12-hour drug. The lawyers gave a list of reasons: Purdue hadn’t submitted studies to the FDA to support more frequent dosing, the FDA had approved OxyContin as a 12-hour drug, and 12-hour dosing was more convenient for patients. Their final reason: It was better for business. “The 12 dosing schedule represents a significant competitive advantage of OxyContin over other products,” the lawyers wrote. ‘Is it just me or does oxycontin not even last 8 hours’ In the years that followed, attacks on the 12-hour claim largely dropped from the agenda of Purdue’s critics. The federal investigation was over. Class-action attorneys moved on to other drugs. For many patients, the problem never went away.
A week later, Judge Stephens ordered one more document withdrawn from public view: His Nov. 5 ruling that there was enough evidence against Purdue to warrant a trial. The Times reviewed a copy of the ruling. The settlement did not require Purdue to admit any wrongdoing or change the way it told doctors to prescribe the drug. ‘A significant competitive advantage’ While Purdue’s litigators were working in courthouses around the country to fend off civil suits, its regulatory attorneys in Washington, D.C., made a blunt admission to the FDA: The 12-hour dosing schedule is, at least in part, about money. The issue arose in a regulatory dispute that attracted little attention. The Connecticut attorney general had complained to the FDA that doctors prescribing OxyContin every eight hours, rather than the recommended 12, were unintentionally fueling black market use of the drug. In a 2004 letter to the FDA, Purdue lawyers responded that the company had no evidence that prescribing contributed to abuse or was unsafe. They went on to make a case far different than the one Purdue sales reps were making to doctors. Eight-hour dosing, the attorneys wrote, could “optimize treatment” for some patients and should level out the narcotic roller coaster. Nonetheless, they said the company planned to continue telling doctors OxyContin was a 12-hour drug. The lawyers gave a list of reasons: Purdue hadn’t submitted studies to the FDA to support more frequent dosing, the FDA had approved OxyContin as a 12-hour drug, and 12-hour dosing was more convenient for patients. Their final reason: It was better for business. “The 12 hour dosing schedule represents a significant competitive advantage of OxyContin over other products,” the lawyers wrote. ‘Is it just me or does oxycontin not even last 8 hours’ In the years that followed, attacks on the 12-hour claim largely dropped from the agenda of Purdue’s critics. The federal investigation was over. Class-action attorneys moved on to other drugs. For many patients, the problem never went away.