Purdue Pharma rejects the claims made by The Los Angeles Times (LAT) in “OxyContin’s 12-Hour Problem.” In an attempt to resurrect a long-discredited theory, the paper ignores the clinical and regulatory data that directly contradicts their story.
Over the course of two years, Purdue Pharma provided the LAT with more than a dozen hours of briefings and discussions regarding the clinical evidence supporting OxyContin’s 12-hour dosing and the regulatory requirement that we promote the product as such. Unfortunately, the paper disregarded this information, instead publishing a story that’s long on anecdote and short on facts.
CLAIM: OxyContin has a 12-hour dosing “problem” that puts patients at risk.
FACT: Nearly a decade ago, the FDA cited a lack of clinical evidence when it formally rejected the “fundamental premise” that patients receiving OxyContin at intervals more frequent than twice-daily are at increased risk of “side effects and serious adverse reactions.” In doing so, the agency reinforced the twice-daily labeling for OxyContin. The LAT omitted the findings of this report from its story.
CLAIM: The clinical data shows OxyContin is “an 8-hour drug.”
FACT: Scientific evidence amassed over more than 20 years, including more than a dozen controlled clinical studies, supports the FDA’s approval of 12-hour dosing for OxyContin. The OxyContin label has been updated more than 30 times and at no point did FDA request a change to the dosing frequency. In fact, the FDA-approved label clearly states, “There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours.”
CLAIM: Purdue should tell physicians to prescribe OxyContin for eight-hour use.
FACT: The FDA prohibits pharmaceutical companies from promoting their products for uses, including dosing, not approved by the agency. Given FDA has not approved OxyContin for eight-hour use, we do not recommend that dosing to prescribers. In fact, a State Attorney General recently cited a peer company for falsely claiming that OxyContin was an eight-hour drug. The LAT omitted this piece of information from its story.
CLAIM: It’s rare for patients to take extended-release drugs at different intervals.
FACT: In a 2008 report on OxyContin dosing, the FDA recognized there may be significant “patient variability” when it comes to opioid-based treatment of pain. The agency also noted that “it is important that physicians individualize the treatment and dosing for each patient.” The LAT omits this finding specific to the use of OxyContin.
CLAIM: The Los Angeles Times has uncovered new information.
FACT: The LAT’s claims have not only been publicly voiced, they’ve been directly rejected by regulatory authorities. This story not only fails to provide the public with the facts about a complex topic, it risks creating more confusion around our national opioid epidemic. For more than a decade, Purdue Pharma has sought to play a constructive role in the fight against opioid abuse, including by reformulating OxyContin with abuse-deterrent properties and leading our industry in this area of innovation. That may be an inconvenient fact for the LAT, but it’s a fact nonetheless.