Kentucky at the time chose not to participate in a settlement Purdue reached with many states. A Kentucky appellate court said late last year that the deposition and other documents related to the case should be unsealed, in response to a legal challenge from health-care publication STAT.
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Purdue said the leak of the deposition is regrettable and violates a court order since the appeal is pending. Sackler with concerns that the drug could get pigeonholed into the cancer market. When probed by an attorney during the deposition, Mr. Kentucky is one of some 37 states and more than 1, cities and counties currently pressing lawsuits against the makers and distributors of prescription painkillers.
The lawsuits claim the companies played down the addictive risks of the drugs and helped contribute to the opioid crisis. Kentucky is among the states with the highest opioid-related overdose deaths, according to the federal government. In , there were opioid-related overdose deaths, a rate of During the deposition, Mr. Sackler said during the deposition that he first became aware OxyContin was being abused in Sackler served as a longtime Purdue board member and as president from to Purdue has denied wrongdoing and said it is committed to being part of the solution to the opioid epidemic.
Write to Sara Randazzo at sara. All Rights Reserved. Before OxyContin, doctors had viewed narcotic painkillers as dangerously addictive and primarily reserved their long-term use for cancer patients and the terminally ill. Purdue envisioned a bigger market. Sales reps pitched the drug to family doctors and general practitioners to treat common conditions such as back aches and knee pain.
With Percocet and other short-acting drugs, patients have to remember to take a pill up to six times a day, Purdue told doctors. The marketing succeeded in ways that astonished even Purdue executives. It dwarfed them. The success of OxyContin brought a whole new level of wealth. Other drug companies began marketing their own narcotic painkillers for routine injuries.
A push to make prescription opioids more difficult to abuse touched off a surge of heroin deaths.
OxyContin accounted for a third of all sales revenue from painkillers that year, according to industry data. Rates of addiction and overdose have soared alongside the rise in prescriptions. News coverage of these problems in Appalachia and New England in the late s made OxyContin notorious. Purdue dispatched representatives to Virginia, Maine and elsewhere to defend its drug.
They blamed misuse of OxyContin and insisted their pill was a godsend for pain sufferers when taken as directed. David Haddox, told a reporter in The U. Justice Dept. The company eventually rolled out a tamper-resistant version of the painkiller that was harder to crush and snort. Subscribe today for unlimited access to exclusive investigations, breaking news, features and more. But in all the scrutiny of Purdue and OxyContin, the problem of the drug wearing off early was not addressed.
Purdue Family Member Sought to Avoid Comparison of OxyContin to Morphine, Documents Show
In reports to headquarters, they wrote that many physicians were prescribing it for three or even four doses a day. Lawrence Robbins started prescribing OxyContin at his Chicago migraine clinic shortly after it hit the market. But insurance carriers often refused to cover the pharmacy bill for more than two pills a day, he said. Over the years, he wrote insurance companies more than 25 times on behalf of patients who he believed needed OxyContin more frequently than every 12 hours, he said.
In some cases, the insurers relented. When others did not, Robbins switched the patients to another drug. In this letter, a Purdue regional manager writes that he is concerned about doctors prescribing OxyContin at 8-hour intervals. Sales reps should visit those physicians and convince them to go back to hour dosing, he writes. Data analyzed by company employees showed that one in five OxyContin prescriptions was for use every eight hours, or even more frequently. Purdue held closed-door meetings to retrain its sales force on the importance of hour dosing, according to training documents, some included in sealed court files and others described in FDA files.
In a petition to the FDA, attorneys for the state of Connecticut described the alarm inside Purdue when some doctors began prescribing OxyContin at more frequent intervals. There is no ceiling on the amount of OxyContin a patient can be prescribed, sales reps were to remind doctors, according to the presentation and other training materials. After some physicians began prescribing OxyContin more frequently than every 12 hours, Purdue summoned its sales force to special seminars. As this presentation shows, company officials were concerned more frequent dosing would hurt business.
Higher doses did mean more money for Purdue and its sales reps. Commissions and performance evaluations for the sales force were based in part on the proportion of sales from high-dose pills. In this memo entitled "It's Bonus Time in the Neighborhood," a Purdue sales manager told her staff to talk up stronger doses of OxyContin in conversations with doctors.
In the training materials reviewed by The Times, little was said about the effect of higher doses on patient health. Those on higher doses of opioids are more likely to overdose, according to numerous research studies. An analysis of the medical records of more than 32, patients on OxyContin and other painkillers in Ontario, Canada, found that one in 32 patients on high doses fatally overdosed. As a varsity athlete at the University of Central Florida and later a public school teacher, Burgess MacNamara was used to following rules. That changed in when he had knee surgery and his doctor put him on OxyContin.
Your whole day revolves around that. Within a month, he was crushing and snorting the pills. Within a year, he was forging prescriptions.
He eventually tried heroin, which was cheaper, and other drugs. MacNamara was arrested for forging prescriptions, possession of controlled substances, stealing pills from a school clinic and other drug-fueled crimes. He lost his teaching career and spent 19 months behind bars.
A separate study underwritten by a Purdue competitor, Janssen Pharmaceutica, reached a similar conclusion. In the real world practice of medicine, some doctors turned away from OxyContin entirely. San Francisco public health clinics stopped dispensing the painkiller in , based in part on feedback from patients who said it wore off after eight hours. The clinics switched to generic morphine, which has a similar duration and costs a lot less. 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.
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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.
Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse | FDA
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.
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