Big Pharma in the Crosshairs: Senator Seeks Fed Investigation of OxyContin Long-Term Pain Relief Claims
A U.S. senator has called for a federal investigation of Purdue Pharma, the manufacturer of OxyContin, in the wake of reports that the money-making pain reliever wears off early in many patients, leaving them exposed to pain and increased risk of addiction.
Sen. Edward Markey (D-MA) Friday sent letters to the Justice Department, the Food and Drug Administration, and the Federal Trade Commission urging them to begin probes of the Connecticut-based drug maker.
The move comes in the wake of a Los Angeles Times investigation into Purdue Pharma's claim that OxyContin relieves pain for 12 hours, which was one of the drug's main selling points. But the Times found that the effects often wore off before that, leaving patients cycling between relief and intense pain and suffering from opiate withdrawals before their next scheduled pill.
The Times also found that Purdue knew about the problem since OxyContin first appeared in1996, but continued to claim that it worked for the full 12 hours in part to protect its revenues. The newspaper reported that when faced with the problem, Purdue instructed doctors to prescribe stronger doses, not more frequent ones. Stronger doses of opioid pain relievers are more likely to implicated in overdose deaths.
"These are serious allegations," Markey wrote in his letter to Attorney General Loretta Lynch. "They raise questions about ongoing deception by Purdue, harm to the public, continued costs to the United States, and the availability of further judicial recourse against Purdue. If upon investigation these allegations are substantiated, the Department should take legal action" against the drug company.
Purdue has rejected the Times’ findings, noting that the FDA had approved OxyContin as a 12-hour drug.
"We promote our medicines only within the parameters approved by FDA and, given FDA has not approved OxyContin for eight-hour use, we do not recommend that dosing to prescribers," the statement said.
That's not good enough for Markey, who represents a state hard-hit by problems with prescription opioids and heroin. More than 1,300 people died from opioid overdoses in the state last year, according to the state Department of Public Health.
In his letter to the FDA and FTC, Markey called Purdue "the leading culprit in the current opioid and heroin overdose epidemic" and accused it of making "false and misleading claims about the longevity of OxyContin's pain-relieving properties."
The FDA and FTC should "investigate these claims and take action to protect patients and consumers from the harm caused by Purdue Pharma's deceptive marketing materials."
Justice, FDA, and FTC all say they are studying Markey's letter.