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 investigation would end up sealed in the Senate Finance Committee’s office, where they remain buried, despite periodic calls for their disclosure.
“A lot of us were very happy when they started the investigation, but nothing’s come of it; it was never followed up on,” said Dr. Steve Gelfand, a South Carolina addiction specialist and activist who helped Van Rooyan file a recall petition with the FDA.
“To me, it’s all been just another political power play,” he said.
*
Staffers at the FDA got used to hearing the name Barbara Van Rooyan. (“We all know who you are,” an ombudsman told her.) She was burning up their phone lines, demanding a temporary recall of OxyContin until it could be reformulated in abuse-resistant form and relabeled for severe pain only. “The FDA’s recall form is long and involved, designed to make you not want to do it,” Van Rooyan remembered. A similar FDA petition to force Purdue to put stronger warning labels on OxyContin, detailing the risks of frequent prescribing, had been filed by the Connecticut attorney general in 2004—and was stalled in bureaucratic purgatory. (That initial application would be rejected four years later, in 2008.)
“But I’m a stubborn Dutchwoman with my degree from Berkeley, and I was used to doing research.” And the words of the friend who’d given Patrick the OxyContin pill haunted her as she typed: “It’s kind of like a muscle relaxant, and it’s FDA-approved, so it’s safe,” he had told him.
If Van Zee’s decade-long quest had begun to feel quixotic—now in his sixties, he wondered how much longer he could keep up the pace of thirteen-hour workdays, much of them spent treating addicted patients—Van Rooyan’s focus was a balm. Whereas Van Zee’s earlier recall petition with its ten thousand signatures was never formally submitted to the FDA—“we simply didn’t have the time, energy, staff to do that,” he said—Van Rooyan was unfazed by the paperwork, happily folding Van Zee’s data into hers with her physician husband’s help and filing it on February 1, 2005.
She testified alongside Van Zee at FDA hearings and organized a protest in her Northern California hometown outside a Purdue-funded continuing medical-education seminar taught by a well-known pain-clinic doctor.
She waited for an answer on her FDA recall petition. And she waited.
Following in her artist son’s footsteps, she painted portraits of herself holding Patrick shortly after his birth, then another of his brother, Andrew, as she saw him in his grief at his brother’s death: raw and naked, curled up in a fetal ball.
“I had a feeling that things would get a lot worse before they got better,” she told me. “I knew that I might not see change in my lifetime, but I was going ahead with this battle anyway.”
If the federal regulators weren’t moved by memorials to dead Americans from their grieving mothers and fathers, maybe the country doctor and the nun and their growing team of mourning parents would finally get justice from the courts. At minimum, they hoped to amplify Purdue Pharma’s negative press and raise awareness about the heroinlike drug.
*
Among RAPP’s first courtroom targets was the 2003 civil lawsuit against Purdue brought by former Florida Purdue sales rep Karen White. She’d been fired in 2002 for allegedly having paperwork irregularities, poor communication skills, and declining sales, the company said. But White claimed in her legal filing that she was actually fired for refusing to sell to doctors who were illegally overprescribing OxyContin to their patients.
In the winter of 2003, the company bragged in a press release about all the civil suits it had won against people blaming their addictions on OxyContin under a headline that read like a football blowout: “65–0.” “These dismissals strengthen our resolve to defend these cases vigorously and to the hilt,” said general counsel Howard Udell. “We have not settled one of these cases—not one. Personal injury lawyers who bring them in the hopes of a quick payday will continue to be disappointed.”