When a patient isn’t allowed relief from pain sooner than prescribed, they can suffer debilitating withdrawal symptoms — body aches, nausea, anxiety, and more — similar to that of heroin. And according to experts, the euphoria of relief heightened when the next dose is finally administered creates a cycle of addiction — the same cycle that causes patients held to such dosing to seek relief in more illicit substances. That narcotic-fueled cycle, Washington University neuropharmacologist Theodore J. Cicero told the Times, could be “the perfect recipe for addiction.” In fact, the return of pain coupled with “the beginning stages of acute withdrawal,” can easily become “a very powerful motivator for people to take more drugs.”Daily Beast:
New research by the University of Pennsylvania’s Wharton School and the RAND Corporation has found OxyContin users made the jump to heroin and thousands didn’t survive.
“Our results, imply that a substantial share of the dramatic increase in heroin deaths since 2010 can be attributed to the reformulation of OxyContin,” the study’s authors wrote.
In 2010, OxyContin’s manufacturer, Purdue Pharma, changed the opioid painkiller to supposedly stem the abuse epidemic it ignited. When new “abuse-deterrent” OxyContin was crushed, it would turn to jelly, Novascone said. As much as 80 percent of the three-fold increase in heroin mortality since 2010 can be attributed to OxyContin’s reformulation, the study concluded.
As dangerous as Oxy can be, it is at least regulated by federal government and produced uniformly by a pharmaceutical company. Heroin, on the other hand, is is increasingly cut with fentanyl, an opioid as much as 80 times stronger than morphine.
Using the study’s estimate, that means the reformulation likely caused more than 7,500 additional heroin deaths.
In 2010, the year Purdue rolled out the new formula, there were 3,038 heroin deaths in the United States, according to the Centers for Disease Control and Prevention. By 2013, the death toll jumped to 8,260. Since then heroin deaths have continued to climb, hitting a record high of 12,989 in 2015, the latest year for which there is data.
“The reformulation totally screwed up our game,” said Kevin Joyce, 53, who started out using OxyContin before 2010. “We eventually moved to heroin and our addiction’s got worse.”
“In the past two years 7 of my friends have died,” Joyce said.
“The White House, FDA, and DEA consider abuse-deterrent technology to be an important part of a comprehensive approach toward combating prescription drug abuse,” Purdue said, adding drug treatment and prevention should be part of that approach.
Despite previous studies that link OxyContin’s reformulation to increased heroin use, the CDC maintains that there is no causal link between supply reductions in prescription painkillers and the rise in heroin deaths.
It’s the second time in as many decades that Purdue Pharma tried to make its drug safer.
OxyContin was rolled out in 1996 and aggressively marketed by Purdue and pharmaceutical-giant Abbott Laboratories as a wonder drug for pain that only needed to be taken twice a day. Other painkillers like Vicodin would wear off after 4 to 6 hours, requiring several daily doses to relieve pain. Oxycontin, on the other hand, supposedly lasted 12 hours, requiring only two doses.
In advertisements for OxyContin, doctors paid by Purdue misrepresented the risk of the drug’s addiction potential.
“The rate of addiction amongst pain patients who are treated by doctors is much less than one percent,” a doctor said in this video advertisement made by Purdue. Though the risk of addiction in the chronic pain population is debatable, the problem is OxyContin was over prescribed and massively diverted from the medical system.
A Los Angeles Times investigation revealed that Purdue knew their blockbuster drug’s effects didn’t last that long. So they told doctors to prescribe stronger and stronger doses, increasing the risk of overdose for thousands of patients. The “extended-release formula” that supposedly made OxyContin safe was a total sham.
The marketing scheme was brought to light in 2007 when Purdue pleaded guilty to misleading doctors and regulators. The company paid out $600 million in fines and to this day is still fending off lawsuits by states that see the Purdue’s marketing campaign responsible for killing hundreds of its residents.
The grim irony is OxyContin was supposed to be safer than other opioids but instead turned out to be deadly. So Purdue tried making it safer with a reformulated version and the outcome was even more deaths, according to Wharton and RAND.
“They call these heroin deaths unintended consequences. If they had any understanding of opioid addiction they would’ve known that these consequences were inevitable,” said Sam Snodgrass, a former opioid user who holds a PhD in biopsychology, and works at a buprenorphine clinic that treats patients with opioid use disorder in Arkansas.
“I truly believe that if the CDC, FDA, HHS, and other organizations that put their time, effort, and money into restricting access to pain pills and reformulations, had instead put resources into education, harm reduction, and treatment, so many of the dead would be alive. And that’s on them,” said Snodgrass, who is also a board member of Grief Recovery After Substance Passing (GRASP), a resource for families who have lost a loved one to addiction. Snodgrass’s work puts him on the frontlines of the epidemic’s tragic toll.
Leo Beletsky, an associate professor of law and health sciences at Northeastern School of Law, who also holds a post at University of California San Diego, said that the story behind Purdue’s abuse-deterrent formulation is more “sinister” than it appears.
“A lot of the motivation behind the reformulation was arguably not about public health,” said Beletsky. “It was driven by the dynamics of one of Purdue’s patents expiring.”
In 2013, the exact day Purdue’s patent on OxyContin expired, the FDA made the decision that it would not approve any generic versions of OxyContin’s old formula because it was too dangerous.
That was after OxyContin’s sales increased from $45 million in 1996 to more than $3 billion in 2010.
The FDA’s decision was another win for Purdue, as the company was able to retain its share of the painkiller market without cheap, generic competitors—a practice in the pharmaceutical industry called “evergreening.”
“It was a brilliant strategy by Purdue,” said Beletesky. “But devastating from a public health standpoint.”
Beletesky sees policies that make painkillers more difficult to access too limited in scope. “I’m not arguing that the misuse of a medication should continue unabated,” he said. “As with any intervention, you need to be mindful to do more good than harm and balance various considerations.”
That didn’t happen with OxyContin’s reformulation, said Beletsky.
One of the study’s co-authors, David Powell, an economist at RAND, told The Daily Beast that instead of only focusing on the supply side of the equation, perhaps policy that emphasizes “demand-side interventions like harm reduction might be more effective.”
“Most drug policy tends to be supply side,” said Powell. But he noted that the heavily lobbied 21st Century Cures Act earmarked $1 billion to treat opioid addiction. This could mean the United States is moving away from strictly supply side interventions, said Powell.
For Snodgrass, who treats opioid addiction with medication, harm reduction policies and interventions include expanding access to naloxone, the lifesaving antidote for opioid overdoses, as well as providing medication-assisted treatment like methadone and buprenorphine on-demand.
» Los Angeles Times: Investigation into OxyContin's reformulation and Purdue Pharma