Dopesick - Beth Macy Page 0,25
Portenoy, Van Zee asked Portenoy to describe what he believed to be an acceptable level of addiction risk from OxyContin. Given that the “less than 1 percent” figure, trotted out repeatedly from the 1980 medical-journal letter, was out of date and applied only to a hospital setting—rather than in the context of chronic pain treated at home—Van Zee asked Portenoy: Hadn’t that been a meaningless calculator of long-term risk?
He showed Portenoy an OxyContin distribution map, highlighting the overlap between heightened crime and drug abuse in regions like Lee County, where OxyContin was prescribed at a rate 300 to 600 percent above the national average.
“That’s good,” Portenoy responded. The more opioids that were out there, the better to meet the needs of chronic-pain patients.
But what if the risk of addiction is 5 or 6 percent? Van Zee persisted. “What do you consider acceptable collateral damage? If you create fifty thousand patients that are opioid addicts?”
The country doctor’s single-mindedness exasperated Portenoy, who walked away.
Although a decade later Portenoy conceded to Wall Street Journal reporters that he and other pain doctors had mistakenly overstated the benefits of opioids while discounting their risks, back then Van Zee was the doctor whose judgment was questioned and even mocked. “A lot of people discounted Art as a rabble-rouser and a kook,” a prominent Virginia health care administrator explained. Another parent activist suggested that Van Zee’s uncomfortable and slightly disheveled appearance helped Purdue cast him as a kook rather than the groundbreaking physician he was. “He should’ve gotten the Nobel Peace Prize,” she said.
Van Zee pressed on, raising similar concerns at the end of the 2002 hearing with the FDA committee’s chairman, Dr. Nathaniel Katz. He told Katz he’d spent months looking for studies that addressed the long-term-abuse risks to patients who used painkillers.
“There’s a reason you didn’t find any,” Katz, also a prominent pain doctor, explained. “They don’t exist.”
This time it was Van Zee’s turn to walk away. It dawned on him then that the only detailed study about potential abuse was the one that Purdue itself had undertaken in 1995 for its NDA—the one he’d read about in the gift from his wife. The one that noted that 68 percent of the drug could be extracted from a crushed tablet.
The FDA forum ended with experts urging the agency to closely monitor abuse and addiction as soon as new drugs went to market. But for Van Rooyan’s son Patrick, the efforts were way too little, way too late. A year before his death, the FDA had missed another opportunity to help her son when it chose not to restrict the use of OxyContin to severe pain, a move that might have reduced addiction without compromising terminally ill or dying patients’ access to the drug. Van Rooyan was never against the use of OxyContin for terminal pain but argued that it should not be used for chronic, noncancer pain unless all other treatments have first been explored. “To this day, I believe OxyContin has a place for terminal, end-of-life care, and for acute pain when other, lesser opioids haven’t worked,” she told me. But it was clear as early as 2004 to Van Rooyan, then a researcher, professor, and college counselor, that the FDA failed to protect the public, her son included, not only when it approved the drug but also multiple times thereafter.
It would not come to light for nine more years that FDA regulators and Big Pharma executives had been quietly holding private meetings at expensive hotels at least annually since 2002, through a drug-industry-funded nonprofit, an ethical quandary a Milwaukee Journal Sentinel reporter shone the light on in 2013. The meetings led to the development of “enriched enrollment,” an aptly named practice that allowed drug companies to weed out people from their studies who didn’t respond well to their drugs, therefore tipping the balance toward FDA approval of new drugs—and away from science.
“Pay-for-play is just not the way the FDA operates,” an FDA regulatory official claimed when the investigation broke. “That’s not part of the culture of the FDA.”
The same Journal Sentinel reporter, John Fauber, would also uncover how the American Pain Society and the American Academy of Pain Medicine pushed for expanded use of opioids for long-term chronic pain while taking in millions from the companies that made them. His articles prompted a 2012 Senate investigation, led by Senators Chuck Grassley and Max Baucus, that targeted both the American Pain Foundation and Purdue, among other nonprofits and pharmaceutical companies.
But the results of that