A Times Investigation

Purdue Pharma issues statement on OxyContin report; L.A. Times responds


urdue Pharma issued a statement Friday defending its best-selling painkiller, OxyContin, and criticizing a Los Angeles Times report that the medication wears off early in many patients, exposing them to increased risk of addiction.

OxyContin’s main selling point is that it relieves pain for 12 hours. The Times investigation found that when the effects don’t last, patients can suffer excruciating symptoms of narcotic withdrawal, including intense craving for the drug.

The article said that Purdue had held fast to 12-hour dosing in part for financial reasons. OxyContin’s market dominance and premium price hinge on its 12-hour duration.

Purdue’s statement called the article “long on anecdotes and short on facts” and said it was based on a “long-discredited theory.”

Hillary Manning, a Times spokeswoman, said: “Our editors see nothing in Purdue’s statement that casts doubt on our reporting or our findings.” She said the statement criticized The Times for omitting or disregarding information that in fact was included in the article.

Here are Purdue’s complaints about what it called The Times’ “claims,” followed by the newspaper’s responses:

From Purdue’s statement

“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.”

Times response

The Food and Drug Administration decision cited by Purdue did not focus on whether OxyContin lasts 12 hours. But it is consistent with The Times’ findings.

The decision was the result of a regulatory dispute described in the article. The FDA had approved OxyContin as a 12-hour drug, although doctors can prescribe it for more frequent use to suit individual patients’ needs.

In a petition to the FDA, the Connecticut attorney general said that some doctors were prescribing OxyContin for use every 8 hours, and that this was unsafe and was fueling black-market sales of the drug. The state asked the FDA to add a warning to OxyContin’s product label prohibiting prescriptions for anything less than 12 hours.

Purdue opposed the warning. Company lawyers acknowledged in their response to the petition that 8-hour dosing could “optimize treatment” for some patients and should not be prohibited. Still, the lawyers said, the company planned to continue marketing the painkiller as a 12-hour drug. Among the reasons the company cited was the “competitive advantage” over painkillers that have to be taken more frequently.

As The Times’ article noted, Purdue’s position that 8-hour dosing was best for some patients stood in stark contrast to what its sales representatives had told doctors: that when patients complain about OxyContin wearing off early, physicians should strengthen the dose and stick to the 12-hour schedule.

The FDA rejected the Connecticut petition in 2008. It said physicians should retain the option to prescribe OxyContin at less-than-12-hour intervals to suit patients’ needs.

From Purdue’s statement

“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.’ ”

Times response

Purdue’s statement that scientific evidence and clinical studies support 12-hour dosing was included in the article. The Times report also describes clinical trials conducted by Purdue that found patients given OxyContin requested more pain medication in between 12-hour doses. In the first clinical trial, more than a third of patients who took OxyContin complained about pain within eight hours, and about half had asked for more medication by the 12-hour mark.

From Purdue’s statement

“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.”

Times response

The article does not say Purdue should tell physicians to prescribe OxyContin for 8-hour use. Rather, it details evidence that OxyContin does not last 12 hours in many patients, and it describes the potential consequences: withdrawal symptoms and an increased risk of addiction. The article makes clear that Purdue sought and received FDA approval of the painkiller as a 12-hour drug. It also notes that Purdue did not test OxyContin on other dosing schedules, although it could have.

From Purdue’s statement

“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.”

Times response

The article does not state that it is rare for patients to take extended-release drugs at different intervals. In fact, it makes the opposite point: Many physicians prescribe OxyContin for intervals shorter than 12 hours when patients complain that the effects wear off sooner. The article explained that narcotic painkillers work differently in different people. It included an FDA spokeswoman’s statement that 12-hour dosing of OxyContin “is a reasonable starting point” and that “physicians should carefully individualize their approach to patients based on how quickly they metabolize the drug.”

From Purdue’s statement

“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.”

Times response

Much of the information in the article had not previously been published. The article drew on thousands of pages of internal Purdue records, many of which had been sealed by courts at Purdue’s request. The article acknowledges instances in which scientists or litigants raised questions about whether OxyContin lasts 12 hours.

Regarding Purdue’s efforts to deter abuse of OxyContin by reformulating the pill and funding anti-theft programs, they are described in the article.

From Purdue’s statement

Purdue said The Times disregarded information that the company provided during “more than a dozen hours of briefings and discussions.”

Times response

Purdue executives declined to speak to The Times on the record. The company arranged two phone briefings on 12-hour dosing with a Purdue executive, on condition the executive not be quoted and the information not be attributed to Purdue. The Times fully considered that information and included in its article the parts that were relevant and could be verified independently. Purdue provided a one-page, on-the-record statement, portions of which are quoted in the story.