Purdue Pharmaceuticals Misled Doctors about Its Bestselling Painkiller
The Los Angeles Times report found that not only did Purdue Pharma, the makers of OxyContin, provide incomplete information to the FDA, they also falsely marketed the drug as having much longer lasting effects than were demonstrated during clinical trials.
Many believe that OxyContin, a powerful, bestselling painkiller, is partially responsible for America’s prescription opioid epidemic. Purdue insisted that the drug relieved pain for 12 hours — twice as long as generic medications — despite the fact that clinical trials proved otherwise .
According to The Los Angeles Times article, in the late 1980s, Purdue Pharmaceuticals found itself in a financial bind. The patent on its long-lasting morphine pill, MS Contin, was almost up, and the drug company needed a new source of revenue to make up for losses they’d incur when generic versions of the drug became available. That’s when they pushed their researchers to develop a new painkiller.
Purdue used a technique it developed to extend the release time of oxycodone, a cheap narcotic found in prescription drugs such as Percocet and Roxicodone that only lasts up to six hours. The drug company spent $40 million to develop OxyContin, and it resolved to bring the pharmaceutical to market as 12-hour treatment option.
Here’s the problem: Purdue’s own clinical trials raised doubts about the drug’s effectiveness.
Purdue sought a patent through the Food and Drug Administration in 1992, claiming that OxyContin helped 90 percent of patients manage their pain for the full 12 hours. But in clinical trial after clinical trial, patients reported that the drug wasn’t doing its job. They needed higher doses, or supplemental painkillers called “rescue medication.”
“[I]n one study of 164 cancer patients, one third of those given OxyContin dropped out because they found the treatment ‘ineffective,’ according to an FDA analysis of the study,” The Los Angeles Times reports. “In another study of 87 cancer patients, ‘rescue was used frequently in most of the patients,’ and 95 percent resorted to it at some point in the study, according to a journal article detailing the clinical trial.”
But in order to obtain FDA approval for OxyContin, Purdue only disclosed the results of a less damning 1989 study of 90 women in Puerto Rico. While a third of the women who received the drug complained of pain less than eight hours after administration. the study reasonably established that OxyContin was “safe, relieved pain and lasted longer than the short-acting painkillers.” The FDA approved OxyContin in 1995.
When doctors and researchers called attention to OxyContin’s reported shortcomings, Purdue executives pushed back.
OxyContin’s market value largely depended upon the company’s claim that it lasted twice as long as generic options. When that claim was challenged by physicians who took part in the clinical trials, Purdue executives instructed them to increase the dosage strength — not to adjust the frequency of its dosage — which put patients at greater risk of developing an addiction to the drug.
OxyContin’s Role in the Opioid Epidemic.
More than 7 million Americans have abused OxyContin since it hit the market more than 20 years ago, according to the National Survey on Drug Use and Health. The drug, in additional to other prescription painkillers, has contributed to a public health crisis in the U.S. — the opioid epidemic — which has claimed the lives of approximately 190,000 Americans since 1999.
Opioid-based painkillers such as OxyContin are highly addictive. OxyContin is so addictive, in fact, that the U.S. Department of Justice sued Purdue for $635 million in 2007 because the drug company misled doctors about the risk of abuse, The New York Times reports .
If a doctor stops writing prescriptions for OxyContin, patients can experience serious withdrawal symptoms, including intense cravings for the drug. When users can’t access (or afford) the medicine any longer, they’ll sometimes turn to harder, more potent drugs such as heroin. People who are addicted to painkillers are also 40 times more likely to abuse heroin, the Centers for Disease Control and Prevention reports .
The prescription painkiller is still widely popular in the U.S.
In 2014, doctors wrote more than 5 million prescriptions for OxyContin. 80 percent of which were prescribed for 12-hour dosing. Purdue has reaped billions from OxyContin sales since 1996, and the drug’s profitability has been consistent.
“After years of the company telling doctors to answer complaints about duration with greater strengths of OxyContin, many patients are taking the drug at doses that public health officials now consider dangerously high,” The Los Angeles Times reports. “To this day, physicians frequently contact Purdue with questions about dosing. Only 12-hour dosing has been proved safe, the company tells them.”
The spokesperson wrote:
“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.”
Featured Image: AP/Toby Talbot