The U.S. Food and Drug Administration campus in Silver Spring, Maryland, on October 14, 2015. The agency's plan to study studies of people seeking drug treatment has sparked controversy over the Denver Health-based drug research program. (AP Photo/Andrew Harnik, File)
Denver Health's drug research program has emerged at the center of a national controversy, with supporters saying it does important work in understanding the current state of addiction and opponents saying the program's They accuse staff of helping opioid manufacturers shift the blame.
In October, the U.S. Food and Drug Administration determined whether surveys of people in drug treatment programs would produce useful data and how burdensome it would be for treatment centers to conduct the surveys. presented plans to investigate the issue and asked for public feedback.
The agency was referring to data collected by the Abuse, Diversion, and Addiction Research Program, known as RADARS and based at the Denver Health Department.
The notice sparked a backlash, with advocacy groups including citizens and doctors seeking responsible opioid prescribing, as well as some individuals who lost family members to overdoses, asking the FDA not to cooperate with Radar.
They claim the organization is too close to Purdue Pharma, which experts have widely accused of causing the opioid crisis through misleading marketing of OxyContin as a near-risk-free solution for people in pain. There is.
Purdue University launched RADARS in 2001 to convince the FDA and the U.S. Drug Enforcement Agency that it was tracking cases of misuse of its products and cases in which medical personnel diverted the pills for personal use or for sale on the illicit market. was founded. The company sold the system to Denver Health four years later for an upfront payment of $100 and a $10 million subscription fee for data reports. Other companies that manufacture opioids and drugs that people can abuse also subscribe to RADARS reports.
Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, said that even after the move to Denver Health, RADARS staff continued to oppose stricter restrictions on prescription opioids before multiple state legislatures and the FDA. They said they lent their names to articles written by employees. Purdue and other opioid manufacturers.
He said much of the information advocates are concerned about came from a 2019 lawsuit by Colorado Attorney General Phil Weiser that claimed Purdue used the radar to advance its own interests. That's what it means.
“Its main role was to support the opioid industry,” Kolodny said of Radar.
But Radars executive director Dr Richard Dart said this criticism was misplaced. The FDA requires companies that make controlled substances to provide information about how their products are used and misused, and companies pay RADARS to collect and package the data. are paying. But he said the organization is independent and has an important role in protecting public safety.
Dart said Radar didn't hesitate to sound the alarm when prescription opioid deaths rose in the first decade of the 2000s. Because drug companies don't have access to the raw data, they can't manipulate it to make their products appear safer, and they're contractually prohibited from using radar data in advertising, he said.
“We have to be completely clean,” or the FDA will refuse to accept the data, he said.
The FDA issued a statement Friday saying it is reviewing all comments on its announcement about the study of RADARS survey data. Agencies regularly evaluate the surveys they use to ensure that respondents understand the questions and give similar answers even when asked in slightly different ways.
“We encourage appropriate prescribing, promote innovation in pain management, prioritize overdose prevention, reduce opioid and other substance use disorders, and promote effective treatment and support for people with substance use disorders. We will continue to promote solutions that will
The Colorado attorney general's lawsuit against the city of Purdue seeks damages caused by the marketing of OxyContin. The AG's team helped RADARS and its staff lobby Purdue and other opioid manufacturers against regulation and in states to prioritize versions of painkillers that are less crushable and easier to snort. claims.
The evidence is mixed on whether so-called abuse-deterrent formulations work, with some studies finding a low risk of overdose and others finding other ways to misuse the tablets or switching to other products. Some studies suggest that.
“Following the transfer to the Denver Health and Hospitals Authority, the City of Purdue and each Defendant will continue to be on the radar until at least 2018, lobbying for laws and other policies supporting Purdue’s Abuse Deterrent Opioid in Colorado and across the country. and continued,” the complaint states.
The attorney general's office declined to comment on the allegations because the lawsuit against the city of Purdue is still pending.
RADARS reports contain information collected from poison center calls. Law enforcement data on drug trafficking arrests. A nationwide survey targeting approximately 60,000 members of the general public. A website that collects information about the prices and availability of various drugs from street dealers. Surveys on drug use history for people seeking drug treatment.
Raders was a leader in identifying the prescription drug overdose crisis and discovering that heroin began displacing pills as the number one cause of death starting around 2011, before being replaced by fentanyl, said Program Director. Dart said.
This data suggests that the drug abuse problem runs deeper than a specific product, with many survey respondents saying they know they are risking their lives with fentanyl, but they are emotionally He said he admits he does it happily as a way to deal with conflict. .
“I don't understand why our society would have to misuse and abuse drugs,” Dart says. “I don't think it's a party time thing.”
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