Herald-Leader Editorial

FDA's Oxy action has side effects; costs stay high for those in true need

April 19, 2013 

A subsidiary of Purdue Pharma paid $600 million in fines in 2007, and three of the company's executives paid a total of $34.5 million after they pleaded guilty to misleading doctors and the public about OxyContin's addictiveness.

The company had sold over $1 billion of the painkiller, targeting areas like rural Kentucky where salespeople offered doctors bonuses for prescribing it and downplayed the likelihood that patients could become addicted.

Abusers had been crushing the time-release painkiller so they could snort or inject it and get a quick high. The company developed a formula that made it difficult to abuse the drug, was awarded a patent for it by the Food and Drug Administration and began shipping it in 2010. That patent expires in 2025.

This year the patent for the original version of OxyContin was due to expire. Generally, that would mean a generic, and much cheaper, version would soon be produced by other pharmaceutical companies.

But the FDA said Tuesday that it will block production of any version of the original, easily abusable drug.

That action was hailed by agencies and individuals who fight drug abuse, relieved that a lower-cost version won't be available on the market.

The action also means Purdue Pharma retains its monopoly on any version of OxyContin and can, therefore, maintain higher prices.

We don't argue with people, including U.S. Rep. Hal Rogers, R-Somerset, and Sen, Mitch McConnell, R-Kentucky, who praise the FDA's action. No one wants that dangerous drug back in the marketplace.

But we wonder why Rogers and McConnell aren't calling for Purdue to voluntarily share its new formulation.

As it now stands, Purdue continues to make lots of money with its OxyContin monopoly. At $6.80 a tablet, the new OxyContin is a big moneymaker, with estimated $2.8 billion in sales last year.

Cancer patients and others with extreme pain will continue to pay what Purdue, not the market, determines for another dozen years.

Meanwhile, evidence indicates that those who had abused OxyContin have already moved on to a cheaper substitute.

In a letter to the New England Journal of Medicine last year, three researchers who studied what OxyContin users did after reformulation, quoted one of their subjects: "'Most people that I know don't use OxyContin to get high anymore. They have moved on to heroin [because] it is easier to use, much cheaper, and easily available."

The researchers wrote, "It is important to note that there was no evidence that OxyContin abusers ceased their drug abuse as a result of the abuse-deterrent formulation. Rather, it appears that they simply shifted their drug of choice."

So, here's the summary:

Purdue Pharma's OxyContin profits are going gangbusters, thanks to the latest patent and the FDA's decision Tuesday; people who truly need the painkiller continue to pay a premium for it; those who abused it have moved on to cheaper drugs.

It's really not much to celebrate.

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