There’s never been a secret about the addictive properties of opioid painkillers. But a new investigation by the Los Angeles Times revealed something that wasn’t so widely known: The maker of one of the most popular opioid painkillers pushed doctors to adhere to a regimen that, as it turned out, made it more likely for patients to become addicts. And by the way, it was the regimen approved by federal regulators — one with unanticipated consequences regulators and doctors have been too slow to address.
There’s never been a secret about the addictive properties of opioid painkillers. But a new investigation by the Los Angeles Times revealed something that wasn’t so widely known: The maker of one of the most popular opioid painkillers pushed doctors to adhere to a regimen that, as it turned out, made it more likely for patients to become addicts. And by the way, it was the regimen approved by federal regulators — one with unanticipated consequences regulators and doctors have been too slow to address.
The drug in question is OxyContin, a version of the generic opioid painkiller oxycodone Purdue Pharma introduced 20 years ago as a 12-hour alternative to cheaper, shorter-lived oxycodone products.
The Food and Drug Administration approved OxyContin based on evidence that the two-pills-per-day regimen worked for half or more of the patients in a test group. But sealed court records and internal company documents reviewed by The Times showed the company knew the relief wore off for many patients well before 12 hours.
Such results shouldn’t come as a surprise. After all, the FDA doesn’t require drugs to work as promised for all patients. What was eye-popping about The Times’ findings was how Purdue responded when doctors told them their patients weren’t getting the full 12 hours of relief promised. Instead of recommending such patients take OxyContin more than twice per day — which might make it less appealing than cheaper generic opioids with short durations — Purdue’s sales reps told doctors to stick to the 12-hour regimen and prescribe higher-strength pills.
As several medical experts explained to The Times, the change accentuated the most addictive properties of oxycodone. When the effects of OxyContin wear off well before 12 hours, a patient’s pain returns along with symptoms of opioid withdrawal, increasing the craving for another pill.
Purdue insists research supports the FDA’s approval of the 12-hour regimen, and that it is dedicated to fighting the opioid epidemic. Yet, like every other drug manufacturer, its profits depend on maximizing sales. Documents show the sale of higher-dose pills resulted in bigger profits for Purdue and higher paydays for its sales representatives.
Given those incentives, it’s essential the health care industry respond quickly when doctors and patients find prescription drugs aren’t working as expected. The opioid epidemic resulted in part because regulators and prescribers didn’t realize just how powerfully addictive those substances were. And part of the solution might be prodding the FDA to monitor dangerous prescription drugs more closely and update their usage limits and warning labels more rapidly once problems become clear.
The more immediate step is for doctors to prescribe opioids less frequently.
To their credit, doctors already reduced the number of opioids they prescribe. Yet, physicians’ groups have pushed back against these proposals, citing potential technical problems or the risk that patients who really do need the drugs won’t be able to obtain them. It’s certainly true opioids have an important role to play in pain relief. But given the steady rise in overdoses and addictions from coast to coast, it’s inarguable that the use of these drugs has gotten wildly out of hand. Just as regulators and drugmakers have to step up their efforts, so too do those who prescribe opioids.
— Los Angeles Times