Dopesick - Beth Macy Page 0,26
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.
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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.
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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.”
But the firm’s legal bills were mounting—to the tune of $3 million a month—and Purdue still had 285 lawsuits pending against it, including another whistle-blower suit, filed by Marek Zakrzewski, an assistant research director who described raising safety concerns with seventeen different higher-ups about the “serious negative implications” of the drug, according to his complaint. His bosses banned him from undertaking additional research into the problems and even from informing the company’s regulatory department about his concerns, his suit claimed. Fired in May 2003 after complaining to the FDA, Zakrzewski eventually dropped his lawsuit, citing illness, the