The U.S. Food and Drug Administration’s campus in Silver Spring, Maryland, on October 14, 2015. The agency plans to conduct a survey of people seeking drug treatment, sparking controversy surrounding Denver Health’s drug research program. (AP Photo/Andrew Harnick, File)
A Denver Health drug research program is at the center of a national controversy, with supporters saying the program has played an important role in understanding addiction and opponents accusing its workers of helping opioid manufacturers shift blame .
In October, the U.S. Food and Drug Administration issued an announcement and sought public feedback on its research plan to study whether surveys of people in drug treatment programs and treatment centers administering the surveys yielded useful data. How big of a burden it is.
The agency was referring to data collected by the Abuse, Diversion and Addiction-Related Surveillance Research Program, known as RADARS, based at Denver Health.
The notice sparked a backlash, with advocacy groups including Public Citizen and physicians responsible for prescribing opioids, as well as some individuals who have lost family members to overdoses, urging the FDA not to cooperate with RADARS.
They claim the group is too closely aligned with Purdue Pharma, which experts widely blame for sparking the opioid crisis by misleadingly promoting OxyContin as a nearly risk-free pain solution.
Purdue University created RADARS in 2001 to meet requirements from the FDA and the U.S. Drug Enforcement Administration that the company was tracking abuse of its products and cases of health care providers diverting the drugs for their own use or selling them on the illicit market. Four years later, the company sold the system to Denver Health for an upfront payment of $100 and a $10 million subscription fee for data reporting. Other companies that make opioids and drugs that people may abuse also subscribe to RADARS reporting.
Dr. Andrew Kolodny, president of the Association of Physicians for Responsible Opioid Prescribers, said that even after moving to Denver Health, RADARS staff went before multiple state legislatures and the FDA to oppose regulation of prescription opioids. Tighter restrictions and lending their names to employee-written articles about Purdue University and other opioid manufacturers.
He said much of the information that supporters are focused on comes from a 2019 lawsuit filed by Colorado Attorney General Phil Weiser, accusing Purdue of using RADARS to advance its own interests.
“Its main role is to help the opioid industry,” Kolodny said of RADARS.
But RADARS executive director Dr. Richard Dart said the criticism was unfounded. The FDA requires companies that make controlled substances to provide information about how their products are used and abused, and the companies pay RADARS to collect the data and package it for them. But he said the organization is independent and plays an important role in protecting public safety.
When deaths from prescription opioids rose in the 2000s, RADARS didn’t hesitate to sound the alarm, Dart said. Drugmakers don’t have access to the raw data so they can’t manipulate it to make their products appear safer, and their contracts prohibit them from using radar data in advertising, he said.
“We have to be completely clean” or the FDA will reject the data, he said.
The FDA issued a statement on Friday saying it was considering all comments in the statement regarding data from the study’s RADARS investigation. Agencies regularly evaluate the surveys they use to ensure respondents understand the questions and give similar answers, even if they are asked in slightly different ways.
“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 provide effective treatments and supports for people living with substance use disorders,” the statement said. .”
Colorado’s attorney general has filed a lawsuit against Purdue University, seeking damages for the marketing of OxyContin. The AG team alleges that RADARS and its staff helped Purdue and other opioid manufacturers lobby against restrictions and pushed states to prioritize versions of the painkiller that were harder to crush and smoke.
Evidence is mixed on whether so-called abuse-deterrent preparations work, with some studies finding a lower risk of overdose and others suggesting people find other ways to abuse the drugs or switch to other products.
“After being turned over to the Denver Health and Hospitals Authority, Purdue and the individual defendants continued to use RADARS through at least 2018 to lobby in support of Purdue’s opioid abuse prevention legislation and other legislation in Colorado and across the country,” the lawsuit states. policy.”
The attorney general’s office declined to comment on the allegations because the lawsuit against Purdue remains pending.
RADARS reports include information collected through calls to poison centers; law enforcement data on drug diversion arrests; a national survey of approximately 60,000 members of the public; a website that collects information from street dealers on the cost and availability of different drugs; People in treatment undergo surveys about their drug use history.
Dart, the program director, said RADARS was a leader in identifying the prescription drug overdose crisis and found that heroin began to overtake the drug as the top killer around 2011, before being replaced by fentanyl.
He said the data showed the drug abuse problem was bigger than any specific product, as many people surveyed admitted they knew they were risking their lives by using fentanyl but were willing to do so as a way to cope with emotional struggles. Way. .
“It’s puzzling why our society needs drug abuse and abuse,” Dart said. “I don’t think it’s a party time thing.”
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