December 21, 2013

OUR OPINION: Approval of new pain medication a bad deal for Maine

The FDA shows it has not learned the lessons of Oxycontin.

When Oxycontin was introduced in 1995, it was a boon to sufferers of chronic pain. The powerful, extended-release pills could provide relief for hours, in a way that other painkillers available at the time could not.

But the same features that made Oxycontin attractive to patients also opened the way for abuse. In the decade after its introduction, painkiller abuse went from negligible to epidemic across the country. In Maine, substance abuse treatment because of synthetic opiates increased by more than 500 percent between 1998 and 2001, according to the Maine Office of Substance Abuse. A 2008 report put Maine at the top of the list for prescription drug abuse.

Now the Food and Drug Administration is poised to make the same mistake again. Despite the objections of an advisory board, the FDA has approved Zohydro, a painkiller whose power and potential for abuse is on par with Oxycontin. Unbelievably, at a time when substance abuse treatment and law enforcement resources are overwhelmed dealing with the many adverse effects of opiate abuse, the agency feels it is prudent to approve a drug that necessarily will make it easier to obtain high-powered opiates.

The approval is enough to get the attention of 28 attorneys general, including Janet Mills of Maine, who earlier this month sent a letter to FDA officials asking them to reconsider the approval and force the makers of Zohydro to at least incorporate abuse-deterrent features in the drug. The makers of the drug, Zogenix, are working on a deterrent, but it’s unclear whether it will be ready when the drug becomes available, and it certainly isn’t required by the FDA.

Abuse deterrents are now used in Oxycontin. Originally, when the pills were crushed, the medication designed to be absorbed over 12 hours could be snorted and taken all at once in seconds, producing a euphoric high. Under pressure, the makers of Oxycontin added to the drug a gel that prevents the pill from being crushed but keeps it just as effective at alleviating pain.

Unfortunately, it was too late. A study of more than 2,500 people addicted to opiates, completed by researchers at Washington University in St. Louis, showed abuse of Oxycontin dropped from 35 percent to 12.8 percent in the 21 months after the formula was changed. However, the addicts hadn’t beaten their addictions — they’d simply moved on to other opiates.

In Maine, that has largely meant heroin, whose popularity has increased as prescription opiates have become harder to obtain and abuse. Medications often have side effects, and with Oxycontin that side effect is a legion of Mainers now and forever addicted to opiates, in whatever form they are available.

Even though it has helped many patients deal with debilitating pain, Oxycontin’s legacy will be pharmacy robberies and opiate abuse. That could very well be the future for Zohydro as well, unless the FDA shows it has learned the lessons of the past decade.

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