OxyContin Study Recruits Children
A clinical trial would test the powerful painkiller on children ages six to 16—and possibly grant its manufacturer a patent extension.
Purdue Pharma is recruiting more than 150 children, ages six to 16, to participate in a study to see what happens when kids are given its highly addictive painkiller OxyContin. Nevertheless, Purdue spokesman James Heins tells The Fix, "We are not seeking FDA approval for the use of OxyContin to treat children nor are we making a children’s version of the medication. Purdue does not promote OxyContin for use in children or adolescents." Rather, the spokesman said, "The studies are evaluating the safety of OxyContin tablets in these young patients and the way the drug is absorbed, broken down and eliminated to see if there are any significant differences from the way the drug is handled by adults." He added, "Secondarily, we will be studying if the drug works as well for pain relief as it does in adults."
What is the opinion of the medical community regarding this study? Andrew Kolodny, MD, chair of psychiatry at New York City's Maimonides Medical Center and president of Physicians for Responsible Opioid Prescribing, offers his view to The Fix: "If they are testing Oxy on children with a diagnosis of cancer and they are at the end of their life, I don't really have a problem with their study. If on the other hand they are testing Oxy on children with chronic pain, I think that's unethical. We don't have good evidence that putting people with chronic pain on opioids is effective. And with a higher-risk populace like children—if you get addicted to opioids, that could affect the rest of your life."
The driving factor behind Purdue’s pursuit of this Oxy-for-kids test is a potential six-month patent extension on the drug from the FDA, which in recent years has begun offering such extensions as incentive for drug manufacturers to conduct clinical trials on children, a previously neglected area of study. (At present, Purdue’s patent on Oxy is set to expire in April 2013, after which generic versions of the drug would proliferate, undercutting profits on what is the drug company’s top seller, raking in $2.8 billion in revenue last year.) But Dr. Kolodny isn't wholly inclined to believe that Purdue is not also interested in getting permission to market Oxy to children. "They are not the most trustworthy of companies," he says.