Wednesday, December 18, 2013

Just What We Need: Another Long-Acting, Highly Addictive Narcotic!

Peter R. Coleman, M.D. 

The FDA has recently approved Zohydro®, a brand new opiate painkiller, to be used for pain management.  It will most likely be highly addictive and it will most likely be fatal for a large number of people.  Actually, it is not a new opiate - just a new and more abusable form of the current drug Hydrocodone.  That's right - the pharmaceutical company Zogenix has reformulated the highly addictive drug Hydrocodone into a long-acting version, just like Oxycontin®.  They have not even put any tamper resistant mechanisms into the new formulation.  It will be very easy to crush it, snort it, and inject it.  It is hard to imagine what the FDA is thinking.  The last thing we need is another highly abusable opiate.  In fact, the FDA has an advisory panel that reseaches new drugs very thoroughly - and the advisory panel voted 11-2 not to approve the drug but the new drug got approved anyway.  

This new drug is coming out right at a time when we are seeing an epidemic of opiate abuse. Opiate abuse has been a serious problem for many years, but it has now become a full-fledged epidemic!  The statistics are frightening.  Consider these facts:
  • Americans make up 5% of the world population, but we use 99% of the world’s Hydrocodone®.
  • About 8% of high school seniors tried Hydrocodone® last year.
  • Since 1990, the death rate from drug overdoses has tripled.
  • There are now 100 people in the US who die every day from drug overdose.
  • The CDC has determined that each year there are 2 million Americans who use opiate drugs recreationally for the first time.
  • Many people who try these drugs will become addicted.
  • Once addicted, long-term success rates are very poor.
  • Most addicted people will end up in jails, institutions or dead.
  • Many addicted people will end up standing in lines every day at a methadone clinic or becoming addicted to Suboxone®.
Sometimes, from the outside looking in, it is hard to understand what is going on at the FDA when certain decisions, such as this one, are made. It seems totally irresponsible for the FDA to approve a drug like this when it is not needed. We already have plenty of options to treat pain with very strong narcotic medicines.

Fortunately, in the last week or so, some pressure has been exerted by members of A.S.A.M. (American Society of Addiction Medicine) and others to have the FDA reconsider. In addition, the Attorney General offices from a number of states have started proceedings to try to get the FDA to reconsider. I have joined with a number of physicians from the American Society of Addiction Medicine to lobby senators to try to stop this new drug from hitting the market. Hopefully, these combined efforts will have some effect!

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