Senators criticize FDA's OxyContin for Children policy and sounding the alarm on it's increasing addiction
Janice Reynolds
An another issue you should be aware of is “U.S. Senator Angus King (I-Maine) and a bipartisan group of his colleagues called for an investigation into the Food and Drug Administration’s (FDA) decision in August to approve OxyContin for use by children as young as 11-years-old as well as an examination of the rise in the opioid misuse, abuse, and consequent overdose deaths.”
Information on this can be found at http://www.king.senate.gov/newsroom/press-releases/king-colleagues-call-for-investigation-into-fda-decision-on-oxycontin. Another article was in the paper yesterday; http://www.pressherald.com/2015/09/21/king-among-8-senators-to-criticize-fdas-oxycontin-policy/comments/. While taking the FDA to task for its approval of OxyContin for children it continues to make the link between medication prescribed for pain and the so called epidemic of prescription drug addiction which is myth (addiction is found in those taking opiates (because they are throwing heroin in the mix now as well). As we all know, rarely does someone become addicted taking opioids for pain-they become physically dependent (as with other meds such as steroids, benzodiazepines, etc.) but addiction is more psychological (otherwise how could you have addiction to gambling, etc.). Yes a few do become addicted but that is even preferable to pain (and close monitoring by the prescriber can nip that in the bud. The FDA should not be involved in the issue of addiction prevention. Its job is the evaluate research, approve or not approve medication based on that, be concerned adverse effects and deal with via black boxing, stronger warnings and maybe occasionally removal as something weighing in harm vs. benefits. Some years back a new drug was being presented to the FDA for advanced Prostate cancer-Provenge. When it was not approved because it lacked sufficient research the two physicians on the approval committee actually received death threats. Many wanted Congress to intervene (similar to what we are seeing here except some not wanting the approval). Provenge was eventually approved and didn’t turn out to be the wonder drug the public wanted it to be.
I wrote my letter to Senator King (one of my senators). Saturday I got a call from his aide about the letter-I am afraid he was not very happy with me (of course he did call when I was fixing dinner so I wasn’t too pleased with him either).
Him: He wanted to clarify what their reason for doing this was. The FDA did not get advice or approval from a couple of entities as well as FDA decision was made without the advice of an independent advisory committees which was what they were supposed to do when there significant public interest, highly controversial, or in need of a specific type of expertise.
Me: “Why?” Oxycodone has already been approved for children, OxyContin is already being used for children off label, and the FDA relies on the research and expertise. I don’t agree there should be significant public interest, it should be highly controversial, or they are in need in need of a specific type of expertise. Those only apply if you are buying into the opioid for pain causes addiction myth. I believe he was quite taken back.
Some more discussion including my “you don’t believe children should have their pain relieved?”
The kicker though;
Him: “We believe there are way too many drugs out there for pain.” That got him a little lesson on how not ever medication works for everybody; hydromorphone may work best for me where as morphine works better for you (I didn’t go into genetics and the Cytocine P450 pathway). I ask him if they were concerned about too many types of blood pressure medication or medication for diabetics.
He finished with: the senator is going to issue another press release shortly (another letter for me and I hope you). This was the one which came yesterday.
I am a little slow on the uptake, but I realized this was Zohydro once again-although the hysteria hasn’t reached that level yet (and yet none of their predictions became true). “We recognize that, in serious cases, children may need appropriately approved and prescribed narcotics. But an increase in the availability of opioids like OxyContin to children — and the potential for abuse — poses a serious U.S. public-health issue.” I don’t understand how-there will likely be no increase in the amount of OxyContin available (by the way abuse deterrent) as children have already been using it for years. This just takes it off of off label as well as increasing safety with dosage suggestions, etc. It is based entirely on the myth of taking medication for pain frequently leads to addiction.” Opioid overdoses, once almost always due to heroin use, are now increasingly due to abuse of prescription painkillers like OxyContin.” That train has left the station; because of the abuse deterrent formulas, availability, and cost, most are changing to heroin (remember when OxyContin was called Hillbilly Heroin?)
I don’t believe there is ever a time for legislators to get involved with involved with undermining the FDA. It will protect no one and cause more suffering in the long run.
Janice
Janice Reynolds RN, BC, CHPN
Retired
Brunswick, ME