Late last Friday, an advisory panel to the US Food and Drug Administration voted – far from unanimously – to toughen restrictions on painkillers such as Vicodin, which contain the opioid hydrocodone. Typically, the FDA takes the advice of such advisory committees.
Bad, bad, bad move.
As always seems to happen in the tortuous world of pain and painkilling drugs, the loudest voices came from those concerned about prescription painkiller abuse, with the voices of legitimate pain patients relatively silenced. To wit: The committee voted 19 to 10 to tighten restrictions in the belief – mistaken, I believe – that such tightening would help combat abuse.
In reality, it might not help combat abuse much, if at all, and would certainly mean that legitimate pain patients will have a tougher time getting the opioids (formerly called narcotics) that they need to function.
For one thing, it should be clear by now that the much-touted war on drugs has failed. Indeed, recent evidence shows that the more the government tries to combat abuse, the more street addicts and abusers find ways around the restrictions. In a July, 2012 letter to the New England Journal of Medicine, for instance, researchers from Washington University reported that after OxyContin was made more tamper-resistant, abusers simply began turning to heroin instead.(1)
More to the point, if the FDA goes ahead and tightens restrictions, chronic pain patients – who number 100 million, according to the Institute of Medicine – will suffer. In testimony to the panel on Friday, Massachusetts pain patient Cindy Steinberg, Policy Chair for the Massachusetts Pain Initiative and New England Director for the American Chronic Pain Association, explained the toll chronic pain takes on sufferers and argued that hydrocodone medications, which she herself takes, should not, as proposed be moved from their current less restrictive status (so-called Schedule III drugs) into the more restrictive catgory (Schedule II).
Among other things, if the FDA accepts the advisory panel’s recommendation, it will no longer be possible for pain patients to get refills via called-in or faxed prescriptions from doctors. This means patients will have to go physically to the doctor every time they need a refill, a major obstacle for people in severe pain with mobility problems.
If you are a pain patient concerned about access to opioids, it is not too late to make your voice heard. Since June, 2012, the FDA has maintained a docket on which you can voice your opinion, but that docket will close on Friday, Feb. 1. The docket number is FDA-2012-N-0548. The link to submit electronic comments is http://www.regulations.gov/#!
(1) Cicero, T.J., Ellis, M.S., &Surratt, H.L. (2012). Effect of abuse-deterrent formulation of OxyContin [Letter to the editor]. New England Journal of Medicine, 367, 187-198.
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