From The Trussville Tribune staff reports
WASHINGTON (AP) — Dr. Raeford Brown was uniquely positioned to help the U.S. government answer a critical question: Is a new version of the painkiller OxyContin helping fight the national opioid epidemic?
An expert in pain treatment at the University of Kentucky, Brown led a panel of outside experts advising the Food and Drug Administration on opioids that have been reformulated to deter snorting and injecting.
There’s just one problem: Neither the company that makes OxyContin nor the FDA has allowed the experts to see data on whether it reduces abuse.
“We asked for that data probably 40 or 50 times in last four or five years and were denied every time,” said Brown, whose term as an FDA adviser ended in March.
Nearly a decade ago, the FDA approved reformulated OxyContin and told the company, Purdue Pharma, that it would be evaluated on whether the new version decreased cases of addiction, overdose and death. The data submitted by Purdue to answer that question remains secret.
“It’s in the public interest that we all know what these drugs are doing and yet none of us can see it, which is really terrifying when you think about it,” Brown told The Associated Press.
In 2015, Brown and his colleagues were supposed to review follow-up data on OxyContin at a meeting in Washington, but the FDA canceled it only days before. Purdue had pulled its application to update OxyContin’s label with new information on abuse, saying it wanted more time to analyze the data. Such meetings are typically planned months in advance and are almost never canceled.
A Purdue spokesman said the Stamford, Connecticut-based company has been working to complete four updated study requirements assigned by the FDA in 2016. The company said it has submitted three of the FDA-mandated studies and expects to submit the final one by October.
“Once all of the studies are completed and FDA has had the opportunity to review the results, we will evaluate options to disseminate this important data to the scientific community,” said Bob Josephson, in a statement.
But the FDA’s top staffer for opioids said at a public meeting last year that the agency expected the information to become available “years ago.”
“They have it, but it’s hard for us to force them to submit it,” said Sharon Hertz, FDA’s division director for pain medications.
The unreleased OxyContin data highlights the FDA’s precarious role as both a public health agency and close confidante of industry. While the agency can order a drugmaker to research important questions, the information itself still belongs to the company and is deemed “confidential commercial information.”
An FDA spokeswoman said in an email that it would be “premature” to comment on Purdue’s results before they have been fully submitted and reviewed. The agency noted that the company’s final OxyContin study has been delayed. FDA staffers expect the studies “will help us understand the real-world impact of OxyContin’s reformulation on abuse,” said Lyndsay Meyer.