Revealing the Bad Science behind OxyContin
As Americans continue to struggle with opioid addiction, many blame the pharmaceutical industry for driving the problem through the extensive marketing of pain medicine and promoting prescribing practices that many regard as reckless. A recent Los Angeles Times investigation focused on the pharmaceutical company Purdue and their opioid pain medication OxyContin. They found that Purdue pushed OxyContin on patients and physicians in ways many would find unethical, if not illegal. Additionally, the company helped convince Americans that opioid medications weren’t just for those in agony from cancer or major surgery – but that drugs like OxyContin could be used for much more manageable forms of short-term as well as chronic pain.
Still, Purdue needed to show that its drug was the best. While short-acting opioid medications like Vicodin and Percocet lessen pain for four to five hours, OxyContin was marketed as longer-lasting, with doses required only once every 12 hours. Hence, it was touted as a miracle pill, supposedly allowing those suffering from chronic pain to function without paying constant attention to taking medication. It was even advertised as being less addictive than other opioids, a claim that was later shown to be false.
While the U.S. Food and Drug Administration (FDA) did approve OxyContin for 12 hour daily use, new information has surfaced that makes it clear Purdue knew there were issues with the dosing, and that their marketing strategy didn’t conform to safe practices for pain medication.
The history behind OxyContin’s creation
In 1990, Purdue’s drug MS Contin – a powerful opioid primarily used for cancer patients – was about to lose its patent (and millions of dollars of business with it). In turn, the company devised a plan to create a new medication from similar chemical compounds. Though this is not an unheard of practice in the industry, Purdue wasn’t satisfied with a superficial change to their medication. Instead, they were determined to create a new blockbuster – a revolutionary long-lasting pain medication, one that could be utilized with a wide range of patients, and not only those suffering from cancer. OxyContin was born.
Initial signs of the drug’s potential were positive. Purdue’s first study, conducted in Puerto Rico, showed that the medication lasted around 12 hours; however, this research was later revealed to have had flaws. In follow-up studies, many patients needed “rescue medication” between doses. In other words, additional opioid pain medication was needed in-between patients’ 12-hour doses of OxyContin. In fact, up to 95 percent of all patients on OxyContin didn’t regularly achieve pain relief for the full 12 hours the drug promised.
Purdue submitted an application for approval to the FDA without including the research that showed the drug did not last for 12 hours for most patients. Yet the FDA approved OxyContin for 12 hour use in 1995, based on the data that was submitted – the first study Purdue conducted. Soon, OxyContin was on the market – brandished as the new miracle pain relief, one that was less likely to cause addiction than short-acting opioids. A few months later, the head of the FDA was on the market, too – and he began working in new product development at Purdue.
But doctors didn’t believe the hype
Briefly after OxyContin prescriptions began, doctors faced complaints from their patients about the hours between doses. For many patients, the medication wore off in as few as six hours, leaving them in more agony than before. In turn, physicians began prescribing the medication every six to eight hours, against the FDA-approved dosing instructions. That, coincidentally, was the same length of time many other opioids were prescribed, defeating OxyContin’s intended purpose, as well as threatening its market power.
When Purdue became aware that doctors were prescribing for every six to eight hours, the company’s representatives demanded this practice end. Instead of prescribing OxyContin for a short duration, Purdue began pressuring doctors into increasing doses. The theory was that if patients could not take the medication more than once every 12 hours, they could at least achieve pain relief by taking a more potent prescription.
There was a major problem with this reasoning: A dose increase doesn’t necessarily provide longer relief. It’s merely more powerful over the same (short) period of time. And because the effect of the drug is stronger, it creates a greater risk of dependency and even greater discomfort from withdrawal. Unfortunately, many physicians followed Purdue’s directions.
For the many patients who were prescribed OxyContin in the hopes of alleviating excruciating pain, relief from their suffering was complicated by the consequences of being given too-high doses. Some became addicted. We now know that the over prescription of OxyContin and other pain pills has played a significant role in the current opioid epidemic in America.
Though lawsuits have been filed against Purdue in regard to its marketing of OxyContin, none have been able to stop OxyContin sales, much less change the labeling to reflect the drug’s actual duration. In 2004, the West Virginia Attorney General did accuse Purdue of “deceptive marketing” – i.e. lying about the 12 hour pain relief. Yet Purdue’s legal team, led by future U.S. Attorney General Eric Holder, managed to settle with the state for $10 million in funding for drug prevention programs, offering little consolation to the many who had become addicted to OxyContin or families who had lost loved ones due to the drug.
In 2007, the federal government made some headway against Purdue’s false advertising, forcing the pharmaceutical company to settle for around $600 million regarding their claims that OxyContin was less addictive. These claims were made to physicians, based on the theory that the long-lasting pain relief meant the medication was less likely to be misused – a theory that was never verified and proved to be tragically wrong for many families who lost loved ones to overdose on these and other medications. Three of Purdue’s executives were charged with felonies in the case as well, resulting in individual fines of up to $19 million.
There have been some positive developments from this newfound vigilance. In 2012, soon after Center on Addiction made recommendations to the federal government concerning opioid medication regulations, the FDA adopted a new risk evaluation and mitigation strategy for long-acting opioid medications. This included new, more stringent ways of evaluating opioid medications – and the dubious claims once made by Purdue.
Yet for all the fines and regulations, OxyContin continues to generate revenue of about $3 billion a year. And it is still marketed as long-lasting pain relief and remains an important driver of the opioid epidemic.
Max Dorfman, MA
Max is a Science Writer at Center on Addiction