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Nothing New Under The Opiate Sun

April 23, 2014

The “War against prescription drug abuse” (don’t you really hate that phrase ‘war against’?) is alive and well, focusing as always on the wrong issues.  The latest salvo comes from a California company called Zogenix.  It has come out with a “new” drug called Zohydro, a long-acting version of hydrocodone  (Zogenix plus Hydrocodone.  Get it?  Drug companies are super clever!).  Here’s what the Zogenix website says their company’s goal is:

“We are developing and commercializing products for the treatment of central nervous system disorders and pain by leveraging technology to provide innovative solutions for unmet medical needs.”

OK, so first of all, a long-acting opioid is not an unmet medical need.  There are plenty of long-acting opioids out there that come in pill form, patch form, IV form, epidural form, and any other form you can think of.  Second, a new formulation of an old drug is not really “leveraging technology”.  It’s more like leveraging shareholder value. Why is this one better?  Since it does not contain acetaminophen, the new drug will provide steady relief without the risk of liver damage, according to officials at Zogenix.  Once again, we have other pills that don’t contain Tylenol.  Like, oh, say, morphine.  Oral morphine, in it’s various forms, costs $12.99 retail.  Zohydro costs $375.

But, the FDA has approved Zohydro.  So you can buy it, if you want.  It’s great for snorting.  Those awesome little capsules are full of pure hydrocodone powder.  The FDA advisory committee, which is supposed to be a panel of experts, strongly discouraged the FDA from approving it.  The NYT article has the following two paragraphs that say it all in response to this advice:

“F.D.A. officials say they have an obligation to approve new treatment options for the more than 100 million americans who live with chronic pain, which can be debilitating and can prevent them from working and living productive lives, though that figure has been questioned.”

“To say to people with chronic pain who are taking opiates around the clock that we shouldn’t offer them an extended-release option is unnecessarily penalizing the patient,” Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said in an interview. “We need to balance the medical needs of people in severe pain with the risks of these medications, including the risk of abuse and addiction.”

But since Zohydro is not a new treatment option and since there are extended-release options that cost far less, the above statements are ludicrous at worst, disingenuous at best.  The FDA has tried to curb prescription drug abuse by targeting all but the actual person putting the pills in their mouth.  It has required stronger language on labeling, restrictions on refills, and lots of post-marketing studies.  It has made doctors take special classes and register with various governmental agencies.  The Times article says the FDA has also approved a drug that can be injected to reverse the effects of narcotics.  You mean Naloxone, which has been available since the 1960’s?

Please don’t prescribe or take this drug.  Stop the madness.

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