Two patients had withdrawal problems, but one was at the end of the study, and the other had simply run out of the medication.
“Withdrawal syndrome was not reported as an adverse event for any patient during the scheduled respites,” the authors reported.
The trial also showed that the drug was effective and was embraced by the Purdue marketing team, which ordered 10,000 reprints to distribute to its sales staff, with instructions to highlight the finding on withdrawal.
But according to company documents disclosed in a court case, the paper left out several cases of withdrawal.
Inside Purdue, supervisors and employees reviewed a more complex set of data, according to a document signed by company attorneys and prosecutors, which accompanied a 2007 settlement in which federal prosecutors charged Purdue with misbranding the drug.
The document has not previously been linked to the Archives article.
“Multiple” patients, a company review said, “directly stated or implied that an adverse experience was due to possible withdrawal symptoms.”
Eleven study patients “reported adverse experience due to possible withdrawal symptoms during these periods,” according to the court document.
How did this discrepancy arise?
One of the authors of the Archives article, Roy Fleischmann, a clinical professor of medicine at the University of Texas Southwestern Medical Center at Dallas, said the authors were given the data by Purdue.
“We reported on the data which was provided to us,” he wrote.
He said the discrepancy may have arisen because some of the side effects — such as insomnia, nausea and anxiety — were not characterized by Purdue “as withdrawal symptoms, although, in retrospect, they probably were,” he said in an e-mail.
Doctors who have treated OxyContin addicts, and some former addicts, moreover, say that considering the doses given to the patients in the trial and its duration, even the internal document undercounted patients reporting withdrawal symptoms. They say the majority of patients were likely to have suffered withdrawal symptoms when the drug was cut off.
At the doses given in the trial, most patients are “pretty consistently” going to have withdrawal symptoms, said Phillip Prior, a board-certified addictionologist in the Portsmouth area who has treated thousands of patients addicted to opioids.
He said the lower estimates are “flawed conclusions from a very flawed study.”
“I’ve never seen anyone come off of them and not get withdrawal,” said Billie Taylor, 42, a former addict who works at a treatment center in Portsmouth. “I would have quit a lot earlier if it had not been for the withdrawal. You feel like you want to die. Even if you take them at prescribed levels, you get withdrawal.”
“You could say these marketing tactics are merely concerning,” Prior said. “But I think of them as satanic. What the data are telling us is that these drugs are ruining people’s lives.”