Tuesday, July 3, 2012

Purdue Crosses the Line: Leave the Kids Alone

Front page of the Wall Street Journal this morning: "Purdue Pharma hopes to gain six months of extra patent protection for OxyContin by testing whether the pain killer is safe for children."

As I flipped to the article, I thought "this must be for terminally ill kids... because as sad as that would be, there's no way, in good conscience, they could test this stuff on kids otherwise."

I was wrong. The study will include subjects ages 6 to 16 in "moderate to severe pain." Purdue is attempting to take advantage of an FDA rule that allows for the extension of patent exclusivity merely for conducting studies in pediatric populations. The goal of the incentive is to help pediatric specialists understand the effect of a wide range of medications on children (which sounds like a good idea). In this case, Purdue is exploiting the FDA reg in order to rack up another $1 billion before OxyContin goes generic. It's despicable.

The very nature of FDA trials are short-term. The real danger here is the long term effects on the children that participate in the study (about 150 children will be included). What impact might this have on the future risk of addiction to opioids or other addictive substances? How will Purdue know? Are there requirements to track these kids as they grow into adulthood? Is the risk here really worth the "benefit," which will largely accrue to a pharmaceutical company in the form of additional revenues?

True, pediatric specialists will have more data on the drug's safety and efficacy profile in children... but so what? While we grapple, as a society, with the unintended consequences of opioid misuse - a problem the CDC has rightly labeled an "epidemic" - let's leave the kids out of it. Please.

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1 comment:

  1. Michael. Thanks for posting this article. The behavior of bi Pharma never fails to amaze me but this one makes me lose my appetite! There is clear data that exposing young brains to drugs (under early 20's since the brain is still evolving/growing) is a major CAUSE of addiction. The development of addictive disease could take years or decades long after this 6 month trial was over So even doing the trial is putting kids at risk, let alone considering what might happen should they get the indication approved. Furthermore it boggles the mind to think that a young person with pain would benefit from a lifetime of the inevitable downwardcspiral for most with opioids for chronic pain.
    And I'd it's for acute pain, OxyContin wouldn't be in the running.
    I am a member of PROP, Physians for responsible opiate prescribing and I'm sure the organization will weigh in on this newest crazy development.
    Thanks for the post