Art Van Zee challenges OxyContin addiction-risk evidence at an FDA advisory hearing

Art Van Zee challenges OxyContin addiction-risk evidence at an FDA advisory hearing, carrying questions about addiction, prescribing, and public responsibility into a forum where he was sharply outnumbered. His intervention joined concrete details about the drug’s abuse potential to a larger argument: decisions made in the name of treating pain had to account for the risks borne by patients and communities, not just the benefits claimed for the medicine.

Background and stakes

The hearing took place against a widening disagreement over OxyContin and opioid prescribing. Purdue Pharma’s position, represented at the meeting by executives and pain-management experts, emphasized the need to make opioids available to people living with chronic pain. Van Zee challenged the evidentiary assumptions used to support that position. The often-repeated estimate that addiction occurred in fewer than one percent of patients came from a 1980 medical-journal letter, and, as Van Zee pointed out, applied to a hospital setting rather than people taking medication at home for chronic pain. In his view, a figure detached from the circumstances of long-term treatment could not settle the question of risk.

The dispute was not abstract for Van Zee. He showed Russell Portenoy an OxyContin distribution map and drew attention to the overlap between heightened crime and drug abuse in places including Lee County, where the drug was prescribed at 300 to 600 percent above the national average. Portenoy’s answer, as the account relates it, was that wider opioid availability helped meet the needs of people with chronic pain. Van Zee’s map made the opposing concern visible: increasing supply also meant confronting what could happen where prescribing was especially high.

Testimony and confrontation

In January 2002, Van Zee drove eight hours to Maryland to testify before a U.S. Food and Drug Administration advisory committee convened to consider the agency’s role in approving and overseeing narcotics. He wore his only suit and a Jerry Garcia necktie his mother had given him. The details set him apart from the institutional scale of the meeting: a rural doctor arriving with limited resources to address a room filled with Purdue representatives and recognized experts, many of whom acknowledged that they were or had been paid speakers for the company.

Van Zee was outnumbered nineteen to one. He was not accustomed to public speaking and found the encounter intimidating, particularly because the other participants were his professional peers and had established reputations in pain management. Yet he considered the testimony his responsibility. Sue Ella Kobak, who accompanied him, recalled that he practiced repeatedly and spoke carefully, limiting himself to what he knew. His manner of preparation became part of the contrast at the hearing: the company-backed case for broad opioid use carried considerable institutional authority, while Van Zee’s challenge depended on close scrutiny of what the available evidence could actually establish.

The morning after his testimony, Van Zee spoke with Portenoy and asked what level of addiction risk would be acceptable. He pressed the weakness of the under-one-percent estimate and asked Portenoy to consider a possible risk of five or six percent. He then put the consequence in human terms, asking what level of collateral harm could be accepted if opioid prescribing created fifty thousand patients with addiction. Portenoy became exasperated and walked away. The exchange exposed the disagreement more clearly than a general debate over access: the question was not simply whether opioids could relieve pain, but how much foreseeable addiction could be treated as an acceptable cost of doing so.

The evidence and its limits

Van Zee returned to the issue in a further exchange with the committee’s chairman, pain specialist Nathaniel Katz. He explained that he had spent months searching for studies addressing the long-term abuse risks for patients using painkillers. Katz told him that such studies did not exist. Van Zee left the exchange with a sharper understanding of the evidentiary gap: the detailed study he had found was Purdue’s own 1995 review for the drug’s new-drug application.

That review had described hazards relevant to the question before the committee. It noted that crushing the tablets could release the drug immediately rather than in a controlled manner, that withdrawal symptoms had been observed in clinical-trial patients, and that 68 percent of the oxycodone in a single crushed pill could be recovered after liquefaction and injection. Although Purdue claimed it had not known about OxyContin’s abuse problems until February 2000, the review Van Zee had located showed that information about these risks had been documented years earlier. The significance of the hearing, therefore, was not merely that a critic raised doubts. It was that the public debate over addiction risk was taking place alongside evidence that had already been available in the company’s regulatory materials.

Aftermath and significance

The FDA forum ended with experts urging close monitoring of abuse and addiction as new drugs entered the market. That call did not resolve Van Zee’s central objection: monitoring after approval was not the same as establishing the long-term risks before widespread prescribing. For Barbara Van Rooyan, whose son Patrick died after struggling with OxyContin, later attention came too late. She supported the drug’s use for terminal and acute pain when other treatments had failed, but argued against its use for chronic, noncancer pain before other treatments had been explored. The committee’s recommendation and her experience thus marked different measures of the same question: whether oversight could protect people while preserving appropriate pain care.

The book places Van Zee’s challenge within a crisis shaped not only by prescribing but also by stigma and unequal institutional responses. In the early years of reporting on heroin in Roanoke, many suburban families were too ashamed to speak publicly. Families affected by addiction later encountered gaps between health care and criminal justice, while treatment itself could carry its own stigma: Tess Henry, for example, felt shunned at Narcotics Anonymous meetings because she took buprenorphine. These accounts do not arise from the advisory hearing, but they illuminate what was at stake in its language about risk and responsibility. When addiction is treated as a rare or marginal concern, the burden of that judgment falls on patients and families after the medical and regulatory decisions have been made.

The racial contrast in the wider account further complicates any simple division between medical access and drug enforcement. Doctors prescribed painkillers to people of color at substantially lower rates than to white patients, in part because of distrust and assumptions about misuse; meanwhile, drug enforcement and incarceration fell disproportionately on Black and Hispanic people. Van Zee’s challenge focused on the consequences of opioid supply and the inadequacy of the evidence used to justify it. Read alongside these disparities, the hearing also reveals how institutions distribute both access to pain treatment and exposure to the consequences of drug policy. Its enduring importance lies in the question Van Zee insisted should not be avoided: what risks were being accepted, on whose behalf, and with what evidence?