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.
Michael
On Twitter @PRIUM1
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.
ReplyDeleteAnd 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
Mel
Mpohl@centralrecovery.com