"I gave so many lectures to primary-care audiences . . . and would cite six, seven, maybe 10 different avenues of thought or avenues of evidence, none of which represented real evidence. And yet, what I was trying to do was to create a narrative so that the primary-care audience would look at this information in toto in a way they hadn't before and feel more comfortable prescribing opioids," Portenoy said in the video. "In essence, this was education to de-stigmatize. And because the primary goal was to de-stigmatize, we often left evidence behind."
The deceptions worked. Ballantyne admits she was swayed. Asked if Purdue's marketing of Oxy changed the way she thought about the drug when she first prescribed it, she said, "Absolutely."
HOOKED
Within just a few years after its release on the market, it was becoming increasingly clear that Oxy was not the pain panacea Purdue claimed it was. Rather than getting better, Ballantyne said her patients were largely getting worse.
"I began seeing patients, and I had been taught that they would do better [with opioids], and they were doing really badly," Ballantyne said. "They weren't getting good pain relief, and there were a lot of behavioral problems."
OxyContin was initially approved only for relatively low doses of 10, 20, and 40 milligrams a pop, but a year after Purdue won its initial approval, the FDA approved an 80-milligram dose. Four years later in 2000, the FDA approved a whopping 160-milligram pill for "opioid-tolerant patients."
Part of Purdue's pitch for Oxy was that the pill would release little doses of the medication over time, blunting the full effect of the drug. But the medication's own label offered a handy guide to getting around that: "OxyContin tablets are to be swallowed whole, and are not to be broken, chewed, or crushed. Swallowing broken, chewed, or crushed OxyContin tablets could lead to the rapid release and absorption of a potentially toxic dose of oxycodone."
The FDA would comment later that the warning label may have "alerted abusers to a method for misuse."
By this time, reports were beginning to come in from Maine, Kentucky, Virginia, West Virginia, Pennsylvania, and Ohio that people were doing just as the label suggested: crushing the drug, swallowing, snorting, and injecting it for a quick, powerful high. Law-enforcement agencies, public-health departments, and physicians were also beginning to see addicts who had not been prescribed the drug — but had become addicted after first receiving a pill through a friend, parent, or relative. Pill addicts were flooding treatment centers, ERs, and morgues.
By March 2001, the FDA formed a response team and compelled Purdue to make minor changes to their warning label. But less than a year after the FDA began studying the growing epidemic, the agency concluded that "opioid analgesics are an essential component of pain management," and "any [risk-management program] that restricts opioid treatment may prevent their appropriate utilization."
Yet some doctors, like Ballantyne, began to worry about how Oxy was affecting their patients. She wrote a paper in 2003, arguing for limits on dosages and encouraging doctors to prescribe responsibly.
In Ballantyne's study, which appeared in the New England Journal of Medicine, Ballantyne and her colleagues exhaustively reviewed the results from Oxy's clinical trials. They didn't find any evidence to support Purdue's claim that Oxy is not addictive.
