Plans for the manufacture and sale of hydrocodone pills five to 10 times more potent than is now available and sold under the brand name Vicodin and others is a warning sign of an escalation of what we might call the "prescription opiate arms race" among pharmaceutical companies. They are competing in a race to develop a stronger super-potent narcotic drug.
Reports surfaced last month that four pharmaceutical companies are attempting to develop a drug containing pure hydrocodone in high dosages per tablet. More troubling is that one company, Zogenix, is a year away from applying for approval for its product, Zohydro.
If the Food & Drug Administration (FDA) approves Zohydro, it could hit the market in two years and elevate the prescription opiate arms race to a new, heightened level.
Hydrocodone, currently the second most abused opiate drug, is available for prescription with other components in 5, 7.5 or 10 mg tablets. The rationale for vastly increasing the dosage of hyrodocodone tablets up to 50 mg, argue the manufacturers, is that there are clinical indications for higher doses.
Unstated are the anticipated high profits from sales of this very potent opiate narcotic product, which of course would not be a generic. Brand drugs sell for far more than generics.
History has a well-known habit of repeating itself. In 1995, Purdue Pharma introduced Oxycontin, produced in doses per tablet substantially larger in its oxycodone component than what was then on the market. At the time oxycodone was prescribed in 5, 7.5 or 10 mg tablets and sold under the brand names Percocet and/or Percodan.
Oxycontin was an instant market success. Purdue earned billions of dollars in the first few years of its release.
Today, oxycodone is one of the most commonly abused narcotic medications in this country. It's no coincidence that the drug's branded version, Oxycontin, currently can be prescribed in pills that deliver enormous dosages, up to 40 mg or 80 mg tablets (or even 160 mg manufactured outside the U.S.).
The unfortunate reality was that its introduction led to a rapid escalation in overdoses, emergency room visits and drug addiction as a result of the inevitable misuse of this super-potent prescription narcotic.
Nonetheless, or maybe for the same reasons, the prescription opiate arms race among drug manufacturers shows no signs of abating.
Oxycodone and hydrocodone are two drugs prescribed as opiate narcotic painkillers. They are chemically similar. Both are classified as synthetic opiates and in the same class of drugs as heroin, morphine and opium.
Opiate narcotic analgesics typically sell on the street for a dollar a milligram, making them attractive for drug dealers to obtain from those prescribed the drugs, which they resale on the black market. Consider too how desirable another super-potent opiate tablet would be. And consider the extent to which some people would go to obtain a new, pure, highly-addictive drug on the market.
Abuse of new, super-potent opiate pills on the market will surely lead to severe opiate addiction for many. What follows are all the medical, family, social and economic consequences of addiction. Some opiate addicts will resort to violent crime to obtain the drug. You may recall last June when four people were gunned down in a Long Island pharmacy by a man motivated to steal thousands of hydrocodone pills for profit as well as to feed his wife's addiction to the narcotic drug. We have not seen the end of this type of violent tragedy in our nation.
According to recent and alarming statistics, and correlated with the availability of super-potent prescription opiates, the CDC has estimated that the number of prescription painkiller overdoses more than tripled between 1999 and 2008.
Government studies also show more than 37,000 people died as a result of a drug overdose in 2009. And for the first time in our nation's history, drug overdoses outnumbered motor vehicle accidents as a cause of death.
We cannot ignore the current epidemic of prescription opiate abuse in this country today, largely as a result of over-prescription (unnecessary medical prescribing). And with no reliable national database to monitor the legal sale of prescription drugs, "pill mills," doctor-shopping and unregulated foreign internet pharmacies will continue to thrive.
The adverse consequences of misuse of currently available -- and potentially future new -- super-potent narcotic drugs should not be underestimated. Solutions exist to reducing the current tsunami of prescription opiate abuse and addiction in our country. Pharmaceutical companies and government officials in every state must launch campaigns of prevention, early intervention and treatment of drug addiction. This will be the best antidote to the for-profit competition we witness in the form of the "prescription opiate arms race."
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