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T he drugmaker Purdue Pharma launched OxyContin two decades ago with a bold marketing claim: One dose relieves pain for 12 hours, more than twice as long as generic medications. Patients would no longer have to wake up in the middle of the night to take their pills, Purdue told doctors.

The problem offers new insight into why so many people have become addicted to OxyContin, one of the most abused pharmaceuticals in U. I have had an experience with OxyContin.

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I know someone who has had an experience with OxyContin. The internal Purdue documents reviewed by The Times come from court cases and government investigations and include many records sealed by the courts. They span three decades, from the conception of OxyContin in the mids toand include s, memos, meeting minutes and sales reports, as well as sworn testimony by executives, sales reps and other employees.

The documents provide a detailed picture of the development and marketing of OxyContin, how Purdue executives responded to complaints that its effects wear off early, and their fears about the financial impact of any departure from hour dosing.

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Reporters also examined Food and Drug Administration records, Patent Office files and medical journal articles, and interviewed experts in pain treatment, addiction medicine and pharmacology. Experts said that when there are gaps in the effect of a narcotic like OxyContin, patients can suffer body aches, nausea, anxiety and other symptoms of withdrawal.

When the agony is relieved by the next dose, it creates a cycle of pain and euphoria that fosters addiction, they said. Louis and a leading researcher on how opioids affect the brain. Gail Cawkwell, said. He broke up bar fights and street brawls. During a torrential rainstorm inhe waded into a flooded intersection to rescue two motorists. He had several surgeries and tried various pain medications over the next two decades. Byhe was on OxyContin. His parents and siblings watched and worried as the strong, fastidiously neat man they knew became wobbly on Oxy looking for my girl date feet and unkempt.

He spent much of his day sleeping. He never awoke. He was A toxicology test showed lethal levels of oxycodone in his blood. Based on the date Gallego filled the prescription, there should have been 44 pills left. There were 7. By the late s, the patent on its main source of revenue, a morphine pill for cancer patients called MS Contin, was running out.

Executives anticipated a massive loss of revenue as generic versions drove down the price of MS Contin, according to internal company correspondence from the period. The company was focused on finding a new moneymaker. In a memo, Robert F. Kaiko, vice president for clinical research, laid out why it was important to develop a second painkiller. In this memo, Robert Kaiko, the scientist who would go on to help invent OxyContin, explains why Purdue needs another painkiller. In MS Contin, the technique made morphine last eight to 12 hours.

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Kaiko and his colleagues decided to use it on an old, cheap narcotic, oxycodone. Sold under several names and formulations, including Percocet and Roxicodone, oxycodone controls pain for up to six hours. Goldenheim,then-vice president of scientific and medical affairs, wrote in a court declaration. At a meeting, Purdue executives described how OxyContin could "cure" the "vulnerability" of generic competition and laid out how they planned to market the drug.

The first patients to use OxyContin were women recuperating from abdominal and gynecological surgery at two hospitals in Puerto Rico in In the clinical study, deed and overseen by Purdue scientists and paid for by the company, 90 women were given a single dose of the drug while other patients were given short-acting painkillers or placebos. None of the women were regular users of painkillers, so they were more susceptible to the effects of narcotics.

Even so, more than a third of the women given OxyContin started complaining about pain in the first eight hours and about half required more medication before the hour mark, according to an FDA analysis of the study. The study found that OxyContin was safe, relieved pain and lasted longer than the short-acting painkillers. Purdue moved ahead on two paths: seeking patents for its new drug and running additional clinical trials to secure FDA approval.

In study after study, many patients given OxyContin every 12 hours would ask for more medication before their next scheduled dose. A Tennessee pain specialist whom Purdue selected to field-test the drug in as part of the FDA approval process eventually moved 8 of 15 chronic pain patients to 8-hour dosing because they were not getting adequate relief taking the drug twice a day.

Robert Reder wrote to the Memphis physician, using medical shorthand for hour dosing. Narcotic painkillers work differently in different people. Some drug companies discuss that variability on their product labels and recommend that doctors adjust the frequency with which patients take the drugs, depending on their individual response. The morphine tablet, Kadian, manufactured by Actavis, is deed to be taken once a day, but the label states that some patients may need a dose every 12 hours.

It did not test OxyContin at more frequent intervals. To obtain FDA approval, Purdue had to demonstrate that OxyContin was safe and as effective as other pain drugs on the market. Under agency guidelines for establishing duration, the company had to show that OxyContin lasted 12 hours for at least half of patients.

Purdue submitted the Puerto Rico study, which showed that. Officials at the agency declined to be interviewed. After OxyContin hit the market inin medical journals left no ambiguity about how long it lasted. A spotlight illuminated two dosage cups, one marked 8 AM and the other 8 PM. She had struggled with back pain since age 14, when she was thrown from a horse while practicing for an equestrian competition.

On that day inher physician said he had something new for Oxy looking for my girl date to try. He told her to take OxyContin every 12 hours. Only the next pill would relieve her suffering. The change had little effect. For a year and a half, she spent each day cycling through misery and relief. Sometimes, she said, she contemplated suicide. 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. OxyContin ed 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. 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 Oxy looking for my girl date 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 Oxy looking for my girl date. 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 inbased 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. 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.

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