A U.S. senator on Friday called for federal investigations of OxyContin's manufacturer in response to a Los Angeles Times report that found the bestselling painkiller wears off early in many patients, exposing them to increased risk of addiction.
Sen. Edward J. Markey, a Massachusetts Democrat whose state has been hit hard by prescription drug abuse, urged the Justice Department, the Food and Drug Administration and the Federal Trade Commission to launch probes of drugmaker Purdue Pharma.
OxyContin's main selling point is that it lasts 12 hours. The Times investigation published this month found that when the effects don't last, patients can suffer symptoms of narcotic withdrawal, including intense craving for the drug, and experience a cycle of agony and relief that experts say promotes addiction.
The newspaper found that Purdue had evidence of the problem for more than two decades, but continued to insist the drug lasted 12 hours, in part, to protect its revenue. OxyContin's market dominance and premium price hinge on its 12-hour duration. Purdue instructed doctors who complained about the drug's duration to prescribe stronger, but not more frequent, doses. Research shows that patients taking high doses of opioids are at greater risk of an overdose and death.
"These are serious allegations," Markey wrote of The Times' findings in a letter to Atty. Gen. 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…"
In a separate letter to the heads of the FDA and FTC, Markey called OxyContin "a leading culprit in the current opioid and heroin overdose epidemic." More than 194,000 people have died from overdoses involving opioid painkillers since 1999 and abuse of those drugs is blamed for the resurgence in heroin addiction in the U.S. Markey said the agencies should "proactively warn prescribers, patients, and the general public" about problems the newspaper identified with OxyContin.
Purdue, a family-owned Connecticut company that has collected more than $31 billion from OxyContin sales, rejected The Times' findings. In a statement, the company said Purdue shared Markey's concerns about the opioid epidemic, but noted that the FDA 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.
A Justice Department spokesman said the department was reviewing the letter and an FTC spokesman confirmed the agency had received the letter, but declined comment.
An FDA spokeswoman said the agency was reviewing the letter and would respond directly to Markey. Previously, the agency spokeswoman told The Times the FDA "will revise labeling as necessary to improve proper prescribing and treatment," but also placed responsibility with doctors.
"It should be well understood by physicians that there will be some individual variability in the length of time that patients respond to this drug," the spokeswoman said.
Dr. Lewis Nelson, a New York University professor of emergency medicine who has advised the FDA on risks of prescription opioids, said that in his experience teaching physicians around the nation, many doctors have forgotten their medical school training about how opioids work in individuals.
"I don't think the average doctor would recall the difference between changing a dose to q8," medical shorthand for every 8 hours, "or increasing the dose," Nelson said.
He said the Times findings were credible and the FDA "should change the label."
"It would seem like this is a very fixable problem," Nelson said.
OxyContin's history is inextricably linked with the prescription drug epidemic. Purdue launched the drug in 1996 with an aggressive marketing campaign to primary care doctors that presented the painkiller as appropriate treatment for back aches and knee pain. Purdue and three company executives pleaded guilty in 2007 to federal charges of drug misbranding for what the company acknowledged was an attempt to downplay OxyContin's risk of addiction. They were ordered to pay $635 million.
Markey has been an outspoken critic of the role of pharmaceutical companies and the FDA in the opioid crisis. In January, he temporarily blocked the nomination of Dr. Robert Califf as FDA commissioner to protest the agency's approval process for opioids, including its August decision to approve OxyContin for use in children as young as 11. Califf was later confirmed.
"OxyContin is the original sin of the current opioid epidemic," Markey said in a statement to The Times. "For years, Purdue Pharma lied to federal regulators and the public about the addictiveness of OxyContin and countless patients got hooked on this deadly painkiller. We need to know if Purdue once again lied about the longevity of OxyContin's pain-relieving properties and hold Purdue accountable."
Markey's focus on opioids reflects Massachusetts' severe problem with painkillers and heroin, which has been embraced by many prescription drug addicts as a cheaper alternative to pills. The death rate from opioid overdoses is more than twice the national average – and climbing. More than 1,300 people died from opioid-related causes last year, according to the Massachusetts Department of Public Health.
"Four people die every day and we haven't been able to bend the trend," said Marylou Sudders, the commonwealth's secretary of health and human services. "That's not a problem. That is a crisis."
Sudders attributed the problem, in part, to doctors over-prescribing opioids. A state law passed in March requires doctors to receive additional training and limits first-time opioid prescriptions to seven days.
The Times report concerned an issue that went largely unnoticed in the scrutiny of OxyContin: the drug's duration. Purdue's clinical trials demonstrated the problem. In the first test on patients, for example, OxyContin wore off early in about half of participants.
After the drug hit the market, the company was confronted with additional evidence, including complaints from doctors and research by outside scientists.
In his letter to Lynch, Markey wrote that "if warranted" the Justice Department should try to recoup "taxpayer dollars that federal healthcare programs may have needlessly and unnecessarily spent on OxyContin prescriptions."
12:52 p.m.: This post has been updated to include statements from the FTC and statistics about opioid deaths in the U.S.
10:33 a.m.: This post has been updated to include statements from Purdue.
9:46 a.m.: This post was updated to include responses from the Justice Department and the FDA.