Editor-in-Chief and Publisher
The Los Angeles Times
202 West 1st Street
Los Angeles, CA 90012
I write to express my disappointment with your paper’s recent story, “OxyContin’s 12-Hour Problem.”
Far from being an “untold story,” the long-discredited theory rehashed by your paper substitutes anecdotes for facts and omits critical information that refutes the story’s central claims. Of what value is the extensive research your reporters claim to have undertaken if they ignore clinical and regulatory data?
- Nearly a decade ago, the FDA formally cited a lack of evidence when it rejected the claim that patients receiving OxyContin® (oxycodone HCI) extended-release tablets at intervals more frequent than 12-hour dosing are at increased risk of developing side effects and serious adverse reactions.
- The FDA-approved label for OxyContin has been updated more than 30 times, and at no point has the FDA requested a change from 12-hour dosing. In fact, the label clearly states that “There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours.”
- The FDA prohibits pharmaceutical companies from promoting their products for uses, including dosing, not approved by the agency. Given the 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.
This information was provided to the paper on multiple occasions, but it was not included in the story. As such, the Times violated its own “Ethics Guidelines” by failing to provide a balanced depiction of a complex issue.
The opioid epidemic is among the greatest challenges our nation faces, and unfortunately The Los Angeles Times has potentially worsened the problem by encouraging patients to take their medicines more frequently than their physician prescribed.
Dr. Gail Cawkwell
Chief Medical Officer
Purdue Pharma LP