The news that Purdue Pharma, the pharmaceutical company behind OxyContin, is paying dozens of clinical sites to document the effects of the highly addictive painkiller hit the Internet hard this week.
The first report was published by The Daily, and cited the company is seeking Food and Drug Administration approval to label the controversial, highly addictive painkiller for use by children as young as six.
Proponents, and the company, insist that the trials are a good thing because its intent 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.” Apparently, this is a huge problem, and one the FDA wants nipped in the bud. So much so, it’s offering an extension to the company’s patent by six months if it conducts the trials. Which is what several doctors involved in the trial explain is the real reason for the trials in the first place. The patent on OxyContin is set to expire in April of next year and this would add another half year of protection to the company.
For opponents, like me, the revulsion to this is obvious. If OxyContin is to be tested for children it has to be tested on children. If you have ever known anyone who has had to overcome addiction to OxyContin–as I have–then it should scare the bejesus out of you.
I did some research into what exactly clinical trials entail, because the thought of giving kids doses of a strong painkiller is really frightening to me. There are many definitions and protocols for clinical trials, depending on who’s doing them and their intent and purpose. According to Purdue Pharma, the trials will involve 150, six to 16-year olds who will be given two daily doses, and recruitment has commenced. This means children will indeed be tested with the drug. The trials will conclude in August of next year.
Fear and greed aside, the question that remains in my mind is: Is there a need for a potent, addictive painkiller–remember, OxyContin is a opioid like morphine–for children who suffer with constant, crippling pain? One would have to assume there is if so many doctors are prescribing it off label. But the company insists that the reason for the study isn’t to increase its pediatric consumer base but to ensure there are competent studies behind the drug’s use to help children.