The opioid crisis is a hot topic in today’s news. As prescribers, nurse practitioners find themselves at the center of the crisis. We’re the access point between patients and these medications. Part of our job (and a frustrating part at that!) is to determine who legitimately needs opioids and who might be drug-seeking. It often seems unfair that this burden and part of the responsibility for the crisis is put on us. Recently, however, the manufacturer of OxyContin has also been called to take responsibility for some of the crisis and found itself in serious legal trouble.
Over the last two decades, the opioid crisis has continued to worsen throughout the country, claiming the lives of hundreds of thousands of Americans from all walks of life. While street drugs like heroin are a problem, they’re not the only opioid to blame. As a matter of fact, from 1999 to 2016, more than 200,000 people in the United States died from overdoses related to prescription opioids. In 2016, the CDC estimated that forty-six people died every day from overdoses involving such pharmaceuticals, a statistic that’s five times higher than it was just seventeen years ago. Among the most common prescription opioid at the center of these deaths – OxyContin.
Released on the market in 1996 by Purdue Pharma, OxyContin was aggressively pitched to providers as being a pain killer unlike any other of its kind. The company made bold claims that it would simplify and improve the lives of patients by providing “smooth and sustained pain control all day and all night” because just one dose could relieve pain for 12 hours, twice as long as the generic painkillers. Furthermore, Purdue Pharma claimed that because of it’s extended release, it’d was less addictive and thus likely to be abused.
Today, the medication that was once touted as America’s bestselling painkiller, bringing in $31 billion in revenue for Purdue Pharma, is at the center of blame for the rising opioid crisis and is now known as the most abused pharmaceutical in U.S. history. The question is, did Purdue Pharma knowingly mislead prescribers and consumers about OxyContin?
Making the Case
According to thousands of pages of confidential documents and other records from Purdue Pharma, the company did in fact know long before OxyContin went on the market that the medication was not living up to what the company had intended it to and there might be issues down the line. During clinical trials in the 1980s, many participants claimed that not only would the drug wear off hours beforehand but they were also experiencing the agony of opioid withdrawals. Despite these results, the company never once tested OxyContin at more frequent intervals and pressed onward in seeking the FDA’s approval for a 12-hour drug. All Purdue had to do to establish duration to the FDA was demonstrate that the drug was as safe and effective as others like it on the market and that it lasted 12 hours for at least half of the patients in one trial. The company was able to do just that in a Puerto Rico study it conducted.
Soon after the product hit the market in 1996 though, as with the clinical trials, patients prescribed OxyContin began complaining to their physicians that the medication was wearing off at least four hours early, at which time they found themselves waiting in sheer misery until they could take their second dose and again, all the while also struggling with withdrawal like symptoms. When doctors discussed these issues with Purdue representatives, rather than advising doctors to prescribe the medication at shorter intervals to patients or working to correct the issues at hand, company executives advised its reps to continue to push 12-hour doses by recommending that the doctor prescribe stronger doses of the drug instead, which was an extremely dangerous piece of advice for multiple reasons. Not only had research shown that the more potent the dose of an opioid, the greater the risk for overdose and death, but many doctors began either prescribing patients other painkillers to take intermittently between OxyContin to alleviate pain or otherwise prescribed OxyContin for every eight hours anyway. Even in cases wherein the doctors didn’t take either of these actions, patients began taking matters into their own hands by consuming more than two pills per day in order to cope with the existing pain and now with their opioid withdrawal.
Why was Purdue Pharma so adamant about pushing 12-hour dosages at higher potencies nor unwilling to address a better solution to the drugs’ issues? Documents discovered in an investigation revealed that Purdue executives ultimately were fearful about the financial impact of departing from 12-hour dosing; the higher the potency, the more the company could rake in. For example, the company charged wholesalers roughly $97 per bottle of 10 milligrams of OxyContin whereas it charged an upwards of $630 or more for a bottle of 80 milligrams of OxyContin. Countless evidence found in the investigation showed emails and memos from Purdue executives and representatives discussing how much money they could make by talking up stronger doses of OxyContin in conversations with providers. Furthermore, moving away from a 12-hour dosage would mean insurance companies might not cover as much of the cost of the non-generic medication, as well as that there would be more DEA oversight.
Not only does the evidence show that Purdue Pharma knew early on that the powerful opioid was being abused by patients who were actually prescribed the drug, but a copy of a confidential Justice Department report showed that during a four year investigation by federal prosecutors, Purdue Pharma executives and the Sakler family (which owns the company) had received numerous reports that OxyContin was being stolen from pharmacies, as well as that some doctors were being charged with selling prescriptions of the drug. Pills were being crushed and snorted, and extracted with syringes by addicts on the streets. Company officials were beyond well aware that its product was known on the streets as the hottest thing since Vicodin, even being up to speed with what the going cost was for one pill. Yet in spite of it all the information given to them about the drug being abused, the company concealed and denied such knowledge and continued to market OxyContin as less prone to abuse and addiction than other prescription opioids (according to prosecutors in 2006).
Ten years after OxyContin was released on the market, federal prosecutors recommended that based on its findings, three of the top Purdue Pharma executives be indicted on felony charges, including conspiracy to defraud the United States. Unfortunately, top Justice Department officials did not support the move, which would have sent the executives to prison if convicted. Instead, the government settled the case in 2007. The three executives pled guilty to misbranding the product while also marketing the drug in a way that misrepresented its risk of addiction and the potential to be abused. The executives were ordered to perform community service and, along with the company itself, had to pay a combined $634.5 million in fines.
The 2007 case was by no means a victory for families who have lost loved ones nor for the federal prosecutors who worked tirelessly on gathering evidence in the hopes that Purdue Pharma would finally be held accountable for its part in the opioid epidemic, thus slowing the number of opioid related deaths. Despite all of the findings against them, the company has, to this day, continually stood firm that it did not know of OxyContin’s growing abuse until the early 2000s and that it is in now way responsible for any part in the opioid crisis.
The Legal Battle
Fortunately, hope for justice may be on the horizon and Purdue Pharma, as well as the Sackler family, may be finally held accountable for all of its wrongdoings once and for all. As recently as August 2018, as many as 27 states have brought forth hundreds of lawsuits against the company, accusing them of misleading marketing tactics including targeting nurse practitioners and physician assistants, deceiving physicians, violating Deceptive Trade Practice Acts and consumer protection laws, and fueling the nation’s opioid epidemic. The state of Massachusetts has even taken the initiative in suing the Sackler family outright, directly naming members of the family in their suit. In addition, the company is also facing hundreds of other charges from individual, cities, counties and Native American tribes.
Although two states have already settled with the company, given the number of current legal cases that have been brought forth, many are hopeful that it will prove difficult for Purdue Pharma to continue to hide behind the curtain as its done for the last thirty years.Time will tell what will become of it all and if Purdue Pharma and the Sackler family will every confess to its role in the opioid epidemic.