A bombshell investigation by the LA Times accuses Purdue Pharma of lying about the effectiveness of OxyContin to promote it as superior to other painkillers. When it wore off early, patients took more OxyContin and became addicted.
Opiate painkillers were nothing new when OxyContin hit the market in 1996. The difference was a bold marketing claim: One dose provided 12 hours of pain relief, more than twice as long as generic painkillers. Over the next two decades, OxyContin became the best-selling painkiller in America.
The drug — which is essentially heroin — has raked in an estimated $31 billion for Purdue, a privately-owned company. The success propelled the Sackler family into the top-20 richest families in America, the 1-percenter’s 1%, with Forbes conservatively estimating their wealth at $14 billion.
But did Purdue pad their pocketbook by creating an epidemic of abuse?
According to the Times, executives at Purdue knew that OxyContin acted more like an “8-hour drug” in many patients based on its own studies.
In the first clinical trial, more than a third of patients who took OxyContin complained about pain within eight hours, and half asked for more medication within 12 hours. In another clinical trial in cancer patients, 95% needed “rescue” painkillers to get them through to the next dose.
Purdue stuck to 12-hour marketing claims anyway. They needed a reason to justify the cost — up to hundreds of dollars per bottle — and they didn’t want doctors prescribing more-frequent doses, which would make OxyContin less appealing than cheaper generic opioids.
When doctors began prescribing OxyContin at shorter intervals in the 1990s, executives at Purdue told sales representatives to “refocus” physicians on 12-hour dosing and prescribe higher-strength pills, not more frequent doses.
The problem is that higher-strength pills do not necessarily prolong the effects. Like heroin, patients will experience a higher “high.” But when the effects wear off, pain returns along with more serious withdrawal symptoms — especially cravings for another pill. Higher doses also increase the chance of an overdose and death.
The investigation suggests that Purdue Pharma’s dosing claims were motivated by profit, not evidence. The consequences for public health have been disastrous.
Statistics clearly show a parallel between OxyContin’s popularity and overdoses deaths. In the last 15 years, opioid painkiller prescriptions quadrupled and the rate of overdose deaths increased by 200%, according to a report by the CDC.
Big Pharma may be partly responsible, but the FDA shares some of the blame.
The FDA approved OxyContin’s twice-daily dosing based on only one study in which less than half of the patients made it all 12 hours without needing more painkillers. The official who led the review left the FDA soon afterward, and within two years was employed by Purdue in new product development.
In 2007, three top executives at Purdue pled guilty to fraud for downplaying the risk of addition from OxyContin. The Justice Department ordered them to pay $635 million, but the dosing problem was never addressed.
Today, twice-daily doses of OxyContin are still marketed for “smooth and sustained pain control all day and all night.” What do you think? Is it time for the FDA to take a second look?
Source: Los Angeles Times