A drug research program at Denver Health has landed in the center of a national controversy, with supporters saying it does vital work to understand the landscape of addiction and opponents accusing the program’s staff of helping opioid makers shift blame from their products.
In October, the U.S. Food and Drug Administration posted an announcement and solicited public feedback for its plans to study whether a survey of people in drug treatment programs produced useful data, and how much of a burden it is for treatment centers to administer the survey.
The agency was referring to data collected by the Researched Abuse, Diversion and Addiction-Related Surveillance program, which is known as RADARS and is based at Denver Health.
The notice touched off a backlash, with advocacy groups including Public Citizen and Physicians for Responsible Opioid Prescribing, as well as some individuals who lost family members to overdoses, urging the FDA not to work with RADARS.
They alleged the organization is too close to Purdue Pharma, which experts widely blame for sparking the opioid crisis through its misleading marketing of OxyContin as an almost risk-free solution for people in pain.
Purdue created RADARS in 2001 to satisfy the FDA and U.S. Drug Enforcement Agency that it was tracking misuse of its products and cases where people in health care diverted the pills for their own use or to sell on the illicit market. The company sold the system to Denver Health four years later for $100 upfront and $10 million in subscriptions to its data reports. Other companies that make opioids and drugs that people can misuse also subscribe to the RADARS reports.
Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, said that, even after the move to Denver Health, RADARS staff argued against stricter limitations on prescription opioids before multiple state legislatures and the FDA, and lent their names to articles authored by employees of Purdue and other opioid makers.
Much of the information that concerns advocates came from a 2019 lawsuit by Colorado Attorney General Phil Weiser alleging Purdue used RADARS to advance its own interests, he said.
“Its primary role was helping the opioid industry,” Kolodny said of RADARS.
But RADARS executive director Dr. Richard Dart said the criticism is off-base. The FDA requires companies that make controlled substances to provide information about how their products are used and misused, and the companies pay RADARS to gather the data and package it for them. But the organization is independent and has an important role in protecting public safety, he said.
Dart said RADARS didn’t hesitate to sound the alarm when deaths from prescription opioids rose during the first decade of the millennium. Drugmakers don’t have access to the raw data, so they can’t manipulate it to make their products look safer, and their contract forbids them from using RADARS data in advertising, he said.
“We have to be squeaky clean” or the FDA would refuse to accept the data, he said.
The FDA released a statement Friday saying it was considering all comments on its announcement about studying the RADARS survey data. Agencies periodically assess surveys they use to ensure that respondents understand the questions and give similar answers even if asked in a slightly different way.
“We will continue to advance solutions that encourage appropriate prescribing, promote innovation in pain management, prioritize overdose prevention, reduce opioid and other substance use disorders and champion effective treatment and support for those with substance use disorder,” the statement said.
The Colorado attorney general’s lawsuit against Purdue seeks compensation for the damage done by its OxyContin marketing. The AG’s team alleges RADARS and its staff assisted Purdue and other opioid makers in lobbying against restrictions and in pushing for states to prioritize versions of painkillers that are harder to crush and snort.
Evidence is mixed on whether so-called abuse-deterrent formulations work, with some studies finding lower risk of overdose, while others suggested people found other ways to misuse the pills or switched to other products.
“After its transfer to the Denver Health and Hospital Authority, Purdue and the individual defendants continued through at least 2018 to use RADARS to lobby for legislation and other policies supporting Purdue’s abuse-deterrent opioids in Colorado and around the country,” the lawsuit said.
The attorney general’s office declined to comment on the allegations, because the lawsuit against Purdue is still pending.
RADARS’ reports include information collected from calls to poison centers; law enforcement data on drug diversion arrests; a national survey of about 60,000 members of the general public; a website that collects information on the cost and availability of different drugs from street dealers; and the survey of people seeking drug treatment about their history with substances.
RADARS was a leader in identifying the prescription drug overdose crisis and spotting that heroin was beginning to displace pills as the top killer around 2011, before being displaced itself by fentanyl, said Dart, the program’s director.
The data suggests that the drug misuse problem goes deeper than any particular product, as many people answering the surveys admit they know they’re risking their lives with fentanyl, but are willing to do so as a way of coping with emotional struggles, he said.
“It’s unfathomable why our society has this need to misuse and abuse drugs,” Dart said. “I don’t think it’s party-time stuff.”
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