Barbara Van Rooyan

Barbara Van Rooyan became an advocate against the broad use of OxyContin after her twenty-four-year-old son, Patrick, died in 2004 after taking his first and only pill at a Fourth of July party. Her campaign joined a family’s bereavement to a close examination of drug-approval evidence: working with Art Van Zee, she challenged how OxyContin had been approved, sought its temporary recall and reformulation, and pressed the FDA to restrict its use for chronic pain. The partial, delayed response she received underscored the distance between a regulatory decision and the people living with its consequences.

Loss and the Question of Approval

Patrick’s death led Van Rooyan, who lived in Folsom, California, to contact Ed Bisch, who connected her with Art Van Zee. At first, she knew little about OxyContin beyond the fact that Rush Limbaugh had been addicted to it. Her central concern was how a drug so powerful had been permitted onto the market. The question was not abstract: she was trying to understand the circumstances around her son’s death and the decisions that had made the medication available.

Art Van Zee explained the FDA’s 1995 approval process, overseen by examiner Curtis Wright, and shared Purdue Pharma’s New Drug Application. Sue Ella Kobak had given him a copy as a Christmas present in 2000. The application offered Van Rooyan a documentary basis for asking whether the risks of OxyContin had been visible before its approval, rather than discovered only after widespread use. It also connected her inquiry to the years of work Art Van Zee had already devoted to the drug and its consequences.

Evidence in the Application

The application’s review described risks that, in Van Rooyan’s view, demanded more caution than the drug’s later promotion displayed. It noted that crushing the tablets could release the medication immediately rather than in a controlled fashion, that withdrawal symptoms had been observed in several clinical-trial patients, and that 68 percent of the oxycodone in a crushed pill could be recovered when it was liquefied and injected. The document therefore became more than background on the approval: it supplied specific evidence against the claim that the dangers of manipulating the drug had been unknowable.

Wright’s approval summary had also urged care in OxyContin’s promotional materials, including restraint in competitive promotion. Purdue Pharma’s marketing did not, in Art Van Zee’s assessment, reflect that caution. Wright later worked as a consultant for Purdue Pharma. The sequence sharpened Van Rooyan’s concern about how the drug had moved from review to promotion, while the application’s details gave her campaign a concrete evidentiary foundation.

Petition and Public Advocacy

Van Rooyan sought a temporary recall until OxyContin could be reformulated to resist abuse and relabeled for severe pain only. She also wanted it limited to severe, acute, or terminal pain, with chronic use deferred until other treatments had been explored. The FDA’s recall paperwork was lengthy, and a similar petition from the Connecticut attorney general, seeking stronger warnings about frequent prescribing, had remained stalled after it was filed in 2004. Those obstacles did not stop her from assembling her own case.

Art Van Zee had gathered ten thousand signatures for an earlier recall petition, but that effort was never formally submitted because his group lacked the time, energy, and staff. Van Rooyan took up the filing work, combined Art Van Zee’s data with her research, and received help from her physician husband. She submitted her petition on February 1, 2005. She later testified alongside Art Van Zee at FDA hearings and organized a protest outside a Purdue-funded continuing-medical-education seminar in her Northern California hometown. Her advocacy thus moved between written evidence, regulatory hearings, and public protest.

Van Rooyan’s campaign also carried the strain of a loss that did not end with the filing. She painted a portrait of herself holding Patrick shortly after his birth, and another depicting his brother Andrew in grief after Patrick’s death. The paintings gave form to the family’s aftermath while her petition made a public case about drug policy. She expected change to take time and continued the campaign despite believing she might not live to see it.

Reformulation and a Delayed Decision

After Purdue Pharma reformulated OxyContin in 2010, Victoria, a former user interviewed in the book, recalled that attempts to crush the abuse-resistant pills caused them to gel. They could no longer readily be snorted or injected, and, according to her account, pills either became unavailable or too expensive; people who had dealt pills began dealing heroin instead. This account illustrates both the practical effect Van Rooyan had sought from an opioid antagonist and the limits of treating one formulation change as a resolution to the broader problem.

Two weeks before Jesse Bolstridge died, the FDA notified Van Rooyan that it had approved one part of her petition: withdrawing approval of the original OxyContin formulation. By then, Purdue Pharma had already withdrawn that version voluntarily, three years after the reformulated drug reached the market. Van Rooyan believed her petition may have helped prompt the reformulation, but she later questioned whether Purdue Pharma had acted for safety reasons, noting that the company was losing its patent on the original formulation. The agency’s decision therefore arrived after the practical change it addressed and did not establish why the company had made that change.

The FDA denied the other part of her petition: limiting OxyContin to severe, acute, or terminal pain and requiring other treatments to be explored before chronic use. Patrick had been dead for nine years when the letter arrived. The decision angered Van Rooyan and renewed her grief, not only for her son but for the many lives lost while the petition awaited action. Three years would pass before another federal agency put her suggestions into practice.

Significance

Van Rooyan’s role in the account is that of a bereaved parent who turned a question about her son’s death into sustained regulatory scrutiny. The approval application, the petition, the public testimony, and the protest each offered a different way to challenge the handling of OxyContin. Her arguments did not reject the drug in every circumstance: she supported its use for terminal, end-of-life care and for acute pain when less powerful opioids had failed, while opposing routine chronic use before other treatments were tried.

The contrast between the specificity of the evidence and the slowness and narrowness of the official response defines the outcome of her campaign. The FDA eventually acted on the original formulation after it was already off the market, while refusing the prescribing limits she had also requested. Van Rooyan’s work could not undo Patrick’s death, and the record does not make her solely responsible for the reformulation. It does show how she helped keep the questions of approval, risk, and access before regulators, and how a mother’s demand for an explanation became an argument about public protection.