Government

Drug Manufacturer to Research Addictive Painkiller OxyContin for Children as Young as Six

OxyContin is infamous as an effective — but additive — narcotic that can easily be considered one of the most abused of prescription painkillers. Now, The Daily reports, the manufacturer is looking into studying the drug’s affect on children as young as six with the potential for the Federal Drug Administration to someday approve it for younger patients. Still, some believe there is more to the company wanting to conduct the trial than just researching the affect on children.

The Daily says the reasoning behind trying to extend the label to include younger children could be its method to “extend the company’s expiring patent.” Although, the manufacturer that makes the drug — Purdue Pharma — says it is moving forward down this road as some doctors are already prescribing OxyContin to children without tests of its influence or proper dosage guidelines.

According to the Department of Justice’s National Drug Intelligence Center, nearly 1 million Americans 12 and older have used OxyContin recreationally at least once. It notes abuse in high school age students is a particular problem with 4 percent of high school seniors in the U.S. taking the drug non-medically at least once, according to the University of Michigan’s Monitoring the Future Survey.

OxyContin is also a considered a gateway drug to other harder substances such as heroin.

“We’ve had 10 people die since May. Constant funerals lately,” Joanne Peterson, founder of Learn to Cope, a Massachusetts-based group that helps parents of pill-addicted youth, said to The Daily. 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.

The trial Purdue will conduct, according to The Daily, involving minors age 6 t0 16 is expected to be complete by August 2013. Some pediatricians are on board with testing the drug on younger patients, but others worry about the manufacturer’s practices as a whole after a 2007 court case where the company admitted to misleading professionals and patients on the addictive nature of the drug:

“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.”

Still, the company and other medical professionals believe there is much to be learned about a developing mind and how it would metabolize this sort of drug:

“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.

[...]

“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.”

The Daily notes that 60 percent of drugs prescribed to children are not FDA approved for their use. This means doctors could be guessing dosages.

Still others think the true motivation behind Purdue’s study is to protect its sole patent rights for the drug that will expire next year. Dr. Elliot Krane, director of pain management at Lucile Packard Children’s Hospital at Stanford University in Palo Alto, Calif., told The Daily that he believes “patent exclusivity” is the reason Purdue wants to research the drug on children and teens.

How would a trial such as this actually extend patent rights? The Daily reports that the FDA has been wanting drug companies to conduct tests for children’s use — something rarely done because of the smaller market size — with the incentive of six months patent extension.

Read more details from both sides in The Daily here.

Comments (26)

  • BaltimoreJoe
    Posted on July 3, 2012 at 11:41am

    Severe burns, excruciating bone cancer pain, and many other cases make this drug one of the handful that will work. Any one of you parents of a child suffering this way would not hesitate a second to use it if it was necessary and of last resort. They should not go forward with the test/trials but leave it to doctors and parents to make these decisions. What test result would cause you to not use it if your child was screaming at the top of their lungs from pain? Don‘t make it easier for doctors to use and don’t limit it.

    You know what… Just be glad you are not a parent in that situation and keep the snide comments about Rush and the water-supply to yourselves. This is a serious subject. I pray you never find out for yourself just how much.

    Report Post »  
  • Leader1776
    Posted on July 3, 2012 at 10:03am

    The FDA may soon require drug companies to include children in the testing of most medications. For obvious reasons it hasn’t been a requirement in the past. Over the years and as drugs have generally become safer than the ones they replaced it has become apparent that children, when the need arises, can benefit from these medications as well. To encourage companies to seek a pediatric indication for medications they would grant a 6 month extension to the drug patent if the company successfully completed a program seeking that pediatric indication. Of course, this has been met with moral outrage from the general public.

    No one wants to test medication in children. That‘s why companies haven’t. That doesn’t help the children. Yes, children don’t have the disease prevalence as do adults. But many do have issues that need treatment. Health care professionals have gotten by by using medications approved for adults and guessing at what the children’s dose/effect might be. Trial and error. Many times it works, sometimes it delays real treatment.

    This oxycontin case is a bit unique. Oftentimes children are in extreme pain situations …….. pain that is excruciating. It may or may not be transitory, but certainly can be terrible to endure. I’m not a fan of government, but in this case systematic testing to get closer to a safe, effective dose in children is good for the kids.

    Report Post » Leader1776  
  • MRMANN
    Posted on July 3, 2012 at 5:56am

    And where will they find the children who will be the test subjects? This article detailing the drug study using children seems cynical, & struck me as being disturbing. There’s only one thing that bothers me more than Big Government & that is Big Pharma.

    Report Post »  
    • Leader1776
      Posted on July 3, 2012 at 10:11am

      I’m with you. Let’s close down all Big Pharma. No, let’s let big Government take over big Pharma. That way we’ll get free drugs in the glove compartments of the free government cars. No, better yet …….. let’s go live in a cave.

      What bothers me is people in one sentence arguing against government and the free market.

      Report Post » Leader1776  
  • trueamerican40
    Posted on July 3, 2012 at 3:46am

    And just WHO will be leading this ‘experiment’? Could it be Dr. Mengele or Dr. Green known by his patients? Yikes!!!

    Report Post » trueamerican40  
  • gurlpleeze
    Posted on July 2, 2012 at 6:50pm

    “I’d peddle narcotics to those I could……..”, “I’d come up with drugs to sedate and target the young….., If I were the devil” hmmm

    Report Post »  
    • jzs
      Posted on July 2, 2012 at 11:35pm

      Isn’t that the drug Rush Limbaugh is addicted to?

      Report Post » jzs  
    • The-Monk
      Posted on July 3, 2012 at 12:49am

      Hey jzs,

      Don’t you mean “was”? Or don’t you know the difference between “is” and “was”?

      Bill Clinton didn‘t so I guess you don’t either. Was it true that Anthony Weiner was sending his “pics” to you? I heard it “is” true on the Internet so it “must” be true. Right? Your definition of “is” is past.

      Report Post » The-Monk  
    • jzs
      Posted on July 3, 2012 at 10:51am

      No Monk, the correct word is “is.” Not sure if he’s still taking the drug or not. But he’s still addicted.

      Report Post » jzs  
  • bethsioux
    Posted on July 2, 2012 at 6:04pm

    Dear God, why the h-e-double hockey sticks would we let the GOVERNMENT determine how much PAIN we are to withstand?
    ..the Supreme Court w/Roe v Wade said we can do with our bodies as we like, if a person cannot handle the drugs, we have plenty of drug rehabs..why must the patients in pain suffer because of a drug addict getting their hands on their meds These are adults (or adults acting on a child’s behalf) to decide whether to RISK becoming dependant on a med or suffer the pain..we sign medical releases ALL the time with meds that can have a number of BAD side effects, including death. The majority of studies show less than 10 percent of pain pts become addicted. Isn’t that a risk an adult may want to make for themselves? An addict will find ANYTHING to abuse so now we have rules on how many cans of whipped cream we can buy at one time
    Ask ANY pain specialist how many patients have killed themselves because they couldn’t have their pain controlled, and then ask them how scared they are of having the same gov’t take their license away for overprescribing narcotics. I do know more than 1 pain pt who killed themselves b/c doc said they didn’t want to risk their license I know of ALOT more pain pts who actually can have a NORMAL life–working, taking care of the family, because of intellegent opiod prescibing. It’s called the free market system in some parts–if everyone ends up addicts or dead, people will no longer use that treatment, and the company will no longer o

    Report Post »  
    • HorseCrazy
      Posted on July 2, 2012 at 6:46pm

      I am a lifelong pain patient since the age of 10 for a non cureable disease. these pain meds have kept me working on not on the government dime disability. the cost I incur due to the regulation of these drugs is ridiculous. I take other opiods not oxycontin but they are classified the same. I have to see my dr every 3 months for my pills. he and I both know it is a waste of time and money because there is no curing this disease there will be no change just more pain. I am tired of people fearing these drugs and the hype surrounding them. If I drink I can kill myself it says so on the bottle so I don‘t I wouldn’t drink anyways I don’t care for it. if people want the truth about pain meication death stats less than 1% of overdose deaths are caused solely by the pain meds it is all a combo of alcohol or other unprescribed pills people take with them. they are safer than tylenol or many other otc drugs period.

      Report Post »  
    • sawbuck
      Posted on July 2, 2012 at 8:27pm

      HorseCrazy
      I agree with you ..my wife also suffers from sever pain ,
      due to an accident that left her with permanent inoperable
      severe nerve damage to her spine.. I can attest to the fact
      that a person having to have pain medicine for “daily living”
      is no different than a person taking any other medicine …
      The person looses that euphoria and the medicine does what
      it suppose to do.. It gives the patient relief from severe pain…

      They are not getting high or stoned.

      I hate the stigma that goes with pain medicine
      and the people that need it to have any kind of a life.

      Report Post » sawbuck  
  • 1forthegoodguy
    Posted on July 2, 2012 at 5:52pm

    Well, it worked for your hero, Rush so well and he’s acts like a 6 year-old so…..

    Report Post »  
    • Git-R-Done
      Posted on July 2, 2012 at 6:41pm

      And you Marxists act like newborn babies who can’t take care of yourselves.

      Report Post »  
  • Elena2010
    Posted on July 2, 2012 at 5:51pm

    Unless the child is dying, train them in biofeedback. Avoid introducing drugs that are easily addictive. I saw more than one fine man destroy a Navy career because of addiction that began before puberty.

    Report Post » Elena2010  
    • sawbuck
      Posted on July 2, 2012 at 6:36pm

      Biofeedback…? Only if a kid is dying….?
      Wow…
      You ever hear the term… their things worse than death..?

      How about burn victims ..or any other medical problem
      that produce high levels of pain..?

      And you want them to use some form of yoga…?

      Are you going to be one of the new representatives ,
      for the new TAXMECARE coming our way….?

      Report Post » sawbuck  
    • HorseCrazy
      Posted on July 2, 2012 at 6:50pm

      I have been taking these type of drugs since I was 10 to control a lifelong incurable disease. they have kept me off of disability and given me a somewhat normal life. there is a huge difference between dependance which long term pain patients develop and addiction. addiction happens in a small percentage of patients usually predictable if they have relatives with history of alcohol problems. my parents are doctors one specializes in pain and these drugs do far much greater good than harm. I back the use of these in appropriate candidates for treatment 100%

      Report Post »  
  • JACKTHETOAD
    Posted on July 2, 2012 at 5:42pm

    Perdue Pharma? Is it just me that thinks they‘re ’chicken hawks’? God help us.

    Report Post » JACKTHETOAD  
  • soybomb315
    Posted on July 2, 2012 at 5:38pm

    FDA is another one of those organizations that has completely failed their mission. Need to abolish it or overhaul it

    Report Post » soybomb315  
    • HorseCrazy
      Posted on July 2, 2012 at 6:54pm

      yes it needs to go. these idiots are a clown show and like with any regulation people find ways around it to manipulate it and corner the market. the rebranding of compounded drugs is a perfect example. drugs used for a 100 years made in compouning pharmacies are now being patented and therefore forcing the compounding pharmacies to stop providing if they don’t want to be sued. it happened to me with a drug that saved my childs life in utero which cost me $15 at a compouning pharmacy and it happened with a relatives seizure meds as well. http://www.cleveland.com/healthfit/index.ssf/2011/04/the_high_price_of_preventing_p.html

      Report Post »  
  • Xavier_Holden
    Posted on July 2, 2012 at 5:16pm

    There would be no other reason to give a child OxyContin unless for pain management. So I don’t really see why children should suffer from pain, if a drug like Oxy exists.

    Chances are, if Oxy is used in children, they are terminal. So basically, the drug would give them pain relief instead of suffering otherwise.

    Report Post »  
  • Get off your butt and join the Marines
    Posted on July 2, 2012 at 5:02pm

    As a guy with several spinal surgeries and subsequent nerve damage and chronic pain I think that this study is a good idea. Obviously the study will use small doses for children, but the research will be good in the long-term. There are many children with various diseases such as cancer and/or problems from fires or car accidents and the like, and there is no need for the kids to suffer in moderate to sever pain once they leave the hospital. I realize that narcotics are physically addictive, but they don’t damage the liver or kidneys or the gastro-intestinal system, like tylenol or ibuprofen does. I have been on various doses of opioids for several years now and if used correctly and if they are rotated to avoid tolerance problems, they are a godsend. To be able to move and do simple things that without the medication would be very painful, and lead to sleep deprivation and depression is a beautiful thing. If people abuse them, so be it. These Darwin award winners will eventually OD, but for people who really need them and don’t abuse them, they can give you a life once again…. And children deserve that chance even more so than an old geezzer like myself….

    Report Post » Get off your butt and join the Marines  
  • Tri-ox
    Posted on July 2, 2012 at 4:42pm

    Christ, Marx, Wood and Wei, led us to this perfect day … ‘This Perfect Day’ – Ira Levin

    Report Post » Tri-ox  
  • The_Jerk
    Posted on July 2, 2012 at 4:40pm

    Hospitals have been pushing doctors to push narcotics to their patients for years. Patient satisfaction, not healthcare, has been the goal since the ‘80’s. Nothing makes addicts more ‘satisfied’ than having a legitimate pusher called doctor.

    Report Post »  
  • TSUNAMI-22
    Posted on July 2, 2012 at 4:08pm

    Why don’t they just continue to trickle it into the public water supply. OOOps, did I say that out loud?

    Report Post »  
    • Unbelievable
      Posted on July 2, 2012 at 4:24pm

      The younger they can get them hooked the sooner they can control every aspect of their lives.

      Report Post »  

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