The original version of OxyContin contained highly concentrated levels of the opioid oxycodone, which was designed so small amounts of the drug were released over a long period. A person who wanted to abuse the drug could crush and then snort it, or dissolve it in liquid and inject it. It turns into a gooey gel if it is crushed, making it almost impossible to snort or inject, the article notes. The new study included 11, people being treated at drug treatment facilities in 48 states.
Two years later, 26 percent said they got high using the abuse-deterrent formulation of the drug in the month before entering treatment. Mitchell Katz, then head of the San Francisco public health department, said in an interview. One of the plaintiffs was a retired Alabama businessman named H. Jerry Bodie. His doctor had Bodie on 30 milligrams of OxyContin every eight hours for chronic back pain.
A Purdue sales rep persuaded him to switch Bodie to a higher dose every 12 hours, according to a judge's summary of the evidence. The doctor kept raising the dose, eventually putting Bodie on milligrams a day.
Purdue got suits dismissed by asserting, among other defenses, a legal doctrine which shields drug companies from liability when their products are prescribed by trained physicians. Purdue settled other lawsuits on confidential terms. In a federal suit, Alabama businessman H. Jerry Bodie accused Purdue of overstating the duration of OxyContin, among other complaints. The lawsuit was dismissed. In these legal battles, the company successfully petitioned courts to have evidence sealed, citing the need to protect trade secrets.
In the fall of , in a remote courthouse in Appalachia, the hour dosing issue came close to a public airing. In describing problems with OxyContin, many said the drug wore off hours early. All these efforts failed. Purdue had one final shot at avoiding trial: A motion for summary judgment. Stephens, son of a local coal miner and the first African American elected to the West Virginia circuit court.
To make this critical argument, the company tapped Eric Holder Jr. On Oct. Stephens disagreed. He ruled that there was enough evidence that a jury could find Purdue had made deceptive claims about OxyContin, including how long it lasted. His decision meant that for the first time, questions about OxyContin's duration would be aired at a trial. Sealed evidence would be laid out in public for class-action attorneys, government investigators, doctors and journalists to see.
All the evidence under seal would remain confidential. A week later, Judge Stephens ordered one more document withdrawn from public view: His Nov. The Times reviewed a copy of the ruling. The settlement did not require Purdue to admit any wrongdoing or change the way it told doctors to prescribe the drug. The issue arose in a regulatory dispute that attracted little attention.
The Connecticut attorney general had complained to the FDA that doctors prescribing OxyContin every eight hours, rather than the recommended 12, were unintentionally fueling black market use of the drug. They went on to make a case far different than the one Purdue sales reps were making to doctors. Nonetheless, they said the company planned to continue telling doctors OxyContin was a hour drug. In a letter to the FDA, Purdue lawyers said the company planned to continue promoting OxyContin to doctors as a hour drug for several reasons, including "competitive advantage.
The federal investigation was over. Class-action attorneys moved on to other drugs. Earlier this year, a man posting to a chat board for pain patients said he got six to eight hours of relief from OxyContin, but hadn't been able to convince his doctor to prescribe it more frequently. For a brief moment three years ago, it seemed the problems with hour dosing might get wider attention.
The FDA had called for public input on how to make painkiller labels safer. Egilman, an expert in warning labels, had worked on hundreds of product liability cases ranging from asbestos to microwave popcorn.
Some judges said he went too far. In a case against the drugmaker Eli Lilly, for example, a judge found that Egilman leaked confidential documents about the controversial antipsychotic medication Zyprexa to a New York Times reporter. In the OxyContin cases, Purdue had attacked his ethics and qualifications. He submitted a PowerPoint presentation to be played in his absence. Egilman noted that he had reviewed confidential Purdue documents and sealed testimony of company executives through his work as an expert witness.
He also declined to share the records with The Times. A snowstorm was bearing down on the East Coast that day, and the hearing room was nearly deserted. When the presentation concluded, there was a brief pause, and then the FDA moderator moved on to the next speaker. OxyContin is still hugely popular. Doctors wrote 5.
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. Told of the Arkansas analysis, Dr.
To this day, physicians frequently contact Purdue with questions about dosing. Only hour dosing has been proved safe, the company tells them. Design and development by Lily Mihalik and Evan Wagstaff. Stephanie Ferrell also contributed to this project. Read the Stories. Your Story. Full Coverage. Times responds. Video The cycle of addiction.
But the new research suggests that when it comes to tackling the opioid crisis, simply cutting back on the misuse of opioid painkillers is not enough. The study, which has not been peer reviewed yet, used economic models to measure trends in opioid overdose deaths — breaking them down to focus on heroin — to see what happened after the OxyContin reformulation was introduced in The paper concluded that there was a break in the trends starting on August , when the reformulation was introduced.
Most importantly, heroin overdose deaths began to rise more quickly after that month. It found that the states with large OxyContin and heroin markets saw the biggest rise in heroin deaths. In contrast, states with the small OxyContin and heroin markets saw the smallest increases. So when heroin was widely available, people were generally quicker to shift from OxyContin to the illicit opioid. The researchers looked at other potential explanations for these breaks in previous trends: if there was a sudden drop in the heroin price that may have led to more heroin use, whether new prescription drug monitoring databases may have cut off access to OxyContin and pushed people to heroin more so than the reformulation, and if the crackdown on Florida pill mills — which unscrupulously gave out opioid prescriptions — pushed people to heroin more than the reformulation.
What about fentanyl? This category of drugs has recently appeared in the black market, where fentanyl and its analogs are often laced into other drugs or misleadingly sold as heroin. Since fentanyl is more potent than heroin, this creates a higher risk of overdose, which could explain an increase in deaths. But fentanyl is believed to have taken off in the black market around — three years after the OxyContin reformulation, so long after the time period that the study looked at.
One caveat is a lot of the people that did shift to heroin from OxyContin likely would have done so anyway. That could have led people to abandon OxyContin for heroin regardless of the reformulation. This is also just one study; future research could produce different findings.
But for now, the paper suggests that the reformulation of OxyContin may have at least sped up the increase in heroin overdose deaths — perhaps enough to, in the short term, outweigh the lives saved by preventing more OxyContin overdoses.
Humphreys does not doubt that some people really did move on to heroin because of the OxyContin reformulation. He said he personally knows people who did this. But he cautioned that this does not mean the reformulation of OxyContin was a bad idea. Keep writing million scrips a year without any protections whatsoever? At some point you have to think about the future. To Humphreys, the key point in favor of the reformulation — and other interventions that make opioid painkillers harder to misuse — is that they prevent more people from getting addicted to the drugs.
After all, if the problem was that painkillers were so accessible that they made it easy for people to start on a path that ends with misusing and overdosing on heroin, then the inverse is true as well: Making opioid painkillers hard to obtain and misuse will stop people from going down a path of addiction. On one hand, you have the current stock of opioid users who are addicted; the people in this population need treatment or they will simply find other, potentially deadlier opioids to use if they lose access to painkillers or the ability to misuse painkillers.
On the other hand, you have to stop new generations of people from accessing and misusing opioids — or they will get addicted to the drugs and potentially overdose and die.
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