The maker of OxyContin is seeking Food and Drug Administration approval to label the controversial painkiller for use by children as young as 6 in a move that could serve to extend the company’s expiring patent on the lucrative drug, The Daily has learned.
Purdue Pharma has paid dozens of clinical sites around the country to document what happens when OxyContin, an addictive pharmaceutical widely abused by recreational users, is given to children.
The company says that its motivation is to help doctors who currently prescribe the drug off-label to children, a common practice in the treatment of pediatric conditions that involve moderate or severe pain.
But three physicians working with Purdue on the trials said the Stamford, Conn.-based company appears to be doing the research to get a six-month extension on their patent for the original formulation of OxyContin, which expires next year.
“They are doing (the pediatric trial) for patent exclusivity, there’s no doubt about it in my mind — not out of largesse,” said Dr. Elliot Krane, director of pain management at Lucile Packard Children’s Hospital at Stanford University in Palo Alto, Calif. “That’s important for their bottom line.”
The family-owned pharmaceutical company earned an estimated $2.8 billion in revenue last year from sales of the powerful opioid, part of the same drug family as morphine and heroin. Purdue is fiercely guarding its exclusivity in the market through ongoing legal battles, and now, it appears, through a pediatric trial that could stave off competitors for another six months.
The Purdue trial involves 154 children ages 6 to 16 and is slated for completion in August of next year, according to a filing submitted to the FDA. The document says that the study is currently recruiting participants.
Many of the nation’s top pediatric pain experts say Purdue’s children’s trial is, all in all, a good thing. But critics, citing Purdue’s history of criminal marketing practices, worry that use of the drug by children could expand and lead to greater addiction and abuse woes.
“There’s good medical evidence that suggests a brain that’s not fully mature is at greater risk at developing the disease of addiction,” said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing and the head of psychiatry at Maimonides Medical Center in New York City. The pediatric community underestimates those risks, he said, because they have given too much credence to drugmakers, who have systematically downplayed the dangers.
“Much of that misinformation (came from a) campaign funded by Purdue.”
In a landmark case for the pharmaceutical industry, Purdue in 2007 admitted in court that it misled doctors and the public about OxyContin’s risk of addiction. The company and three top company executives, each charged with a felony, paid $635 million in fines.
Purdue confirmed it is seeking permission to label the drug for pediatric use and pointed to a need to better understand how opioids affect children.
“We feel it is beneficial for clinicians who are treating pediatric patients with chronic, moderate-to-severe pain to have access to this information in scientific publications and in the product’s label, whether the results are positive or negative, so they can make better decisions about the care of their patients,” company spokesman James Heins wrote in an e-mail to The Daily.
Last year, 0.3 percent of OxyContin prescriptions were written for patients 19 and under, according to Purdue.
Numerous pediatric pain experts consulted by The Daily supported the company’s rationale, saying the trial will yield valuable data about a drug that children are already being prescribed.
“It’s clear in children certain drugs are definitely metabolized differently,” said Dr. Jeffrey Galinkin, a member of the American Academy of Pediatrics’ committee on drugs and research director of anesthesiology at Children’s Hospital of Colorado.
Purdue’s pediatric trial will help clarify how best to use the drug, he said. “It’s information we really do need to have.”
Purdue spokesman Heins told The Daily that the company does not plan to seek the right to market OxyContin to pediatricians — a separate category of FDA approval above and beyond labeling permission that would likely bring additional scrutiny of the company’s motives. A federal green light to market OxyContin for use in children, some worry, could lead to a higher rate of prescribing the drugs for kids and an army of Purdue sales representatives pressuring doctors to prescribe the drug more.
Krane, the physician involved with the study, doubted the company’s disavowal of any desire to market the drug to pediatricians.
“That’s probably disingenuous,” he said. “I believe (an FDA approval for marketing to pediatricians) is where they’re going.”
The question of patent rights looms equally large over the pediatric drug trial.
Purdue has been aggressively seeking to protect its original patent for OxyContin, which is scheduled to expire next year. The company has filed a raft of lawsuits against generic drug makers and is trying to get the FDA to ban generics of the original, easy-to-abuse formulation outright. Purdue released a new tamper-proof version of the drug in 2010 and that patent expires in 2025.
But the clinical trial for children offers another way to extend the life of the original patent.
In recent years the FDA has been encouraging pharmaceutical makers to test drugs for pediatric use and offering six-month patent extensions as a reward. Historically testing drugs for use in children is not something the pharmaceutical industry does, because the pediatric market is much smaller than the adult market.
As a consequence, pediatricians and family doctors simply use adult drugs on kids, making educated guesses about dosage amounts and side effects, several pediatricians said. Today more than 60 percent of drugs prescribed for children are not FDA-approved for pediatric use.
But in the case of Oxycontin, Kolodny and others worry that children are especially vulnerable to addiction. He also points to a 2005 study from the University of Michigan finding that children who are prescribed opioids are more likely to abuse painkillers in later life.
Teen abuse of OxyContin has already taken an epic toll on communities across the country.
“We’ve had 10 people die since May. Constant funerals lately,” said Joanne Peterson, founder of Learn to Cope, a Massachusetts-based group that helps parents of pill-addicted youth. All of the young people died from heroin overdoses, but their addiction started with OxyContin, she said. They moved to heroin because it provides a similar high but is cheaper. “I’m not going to ever trust anybody who mismarketed that drug on purpose.”
OxyContin's track record for abuse so far is stark. Last year painkillers - mainly oxycodone (OxyContin) and hydrocodone - caused more deaths than cocaine and heroin combined. The opioid epidemic has killed more than 100,000 people since 1999, more than U.S. military deaths during the Vietnam war.
Yet a broader view among pediatricians is that addiction risks for children properly prescribed the drug are manageable.
“We’ve been using (OxyContin) for over 10 years,” said Dr. Steven Weisman, pain management director of the Children’s Hospital of Wisconsin. “And we haven’t had any problems with addiction or diversion” of the prescriptions to addicted family members or to the street for resale, he said.
Weisman, along with Krane and Galinkin, received consulting fees from Purdue in recent years. Their hospitals get paid by Purdue to do the trial but there is no direct personal financial benefit to doctors, they said. Purdue is working with many of the nation’s top pediatric pain experts for the trial.
Krane said he’s not worried that Purdue will aggressively push OxyContin on pediatricians. The bad press, fines and criminal convictions in 2007 have changed the game for Purdue, he said.
“From top to bottom, I think they’ve learned from that experience and … they can’t get away with that again,” he said.
He told The Daily he would be “astounded” if OxyContin prescriptions for children rose by more than “1 or 2 percent” if the drug were to get FDA approval.
However, he conceded, it’s possible that even a tiny increase in the rate of prescriptions could do harm.
“We are possibly opening the door to (OxyContin) being abused by a younger, more vulnerable population,” Krane said.