The pharmaceutical company behind OxyContin is paying dozens of clinical sites to document the effects of the highly addictive painkiller on children as part of an effort to secure a Food and Drug Administration approval to label the drug for use by kids ages six and up, according to a report published by The Daily.
Though Purdue Pharma insists it is conducting the trials to ensure the safety of children currently being prescribed OxyContin "off-label" by doctors, some, including three physicians involved in the trials, said the company is more concerned about the impending expiration of the drug's patent, and is hoping to receive a six-month extension from the FDA.
To combat the rampant prescription of adult drugs to children by pediatricians, the FDA has incentivized pediatric trials by offering pharmaceutical companies six-month patent extensions in return.
"[Purdue is] doing [the pediatric trial] for patent exclusivity, there's no doubt about it in my mind - not out of largesse," Dr. Elliot Krane of Stanford University's Lucile Packard Children's Hospital told The Daily. "That's important for their bottom line." (The company made some $2.8 billion in revenue from the sale of OxyContin last year.)
Another criticism of the Purdue trial comes from doctors worried that if children are allowed to take OxyContin, pill abuse rates could skyrocket.
"There's good medical evidence that suggests a brain that's not fully mature is at greater risk at developing the disease of addiction," Physicians for Responsible Opioid Prescribing president Andrew Kolodny said, adding that Purdue has spread a lot of misinformation about the drug's dangers.
In May 2007, Purdue paid millions in fines for its off-label marketing of OxyContin. Later that same month, Purdue and its executives were ordered to pay hundreds of millions for misbranding and misrepresenting OxyContin and its abuse potential.
Purdue says it is not looking to market OxyContin to pediatricians, but Krane believes the company is being "disingenuous."
Still, he isn't too concerned. "I think they've learned from that experience," he said, "and they can't get away with that again."
[photo via AP]