PharmaView: What's the Prescription for Painkiller Nation?

With FDA and the Obama administration on alert, it is drug manufacturers' turn to address a crisis.

By Paul Thomas, Senior Editor

Data is neither good nor evil. What matters is how it is used. Consider drug prescriptions. When a patient takes antidepressants, that information becomes critical to how he or she is treated in the future, but can also be used to, for example, bias potential employers. With the HIPAA legislation of 1996, patients in the U.S. gained control over their own health records, including information about what they’ve been prescribed.

Doctors do not have similar protections. When a doctor writes a script, the information is recorded at the pharmacy and becomes part of the physician’s overall behavioral profile. This information is available (for a fee) and of keen interest to drug marketers. If Dr. Jones readily doles out Wellbutrin, he becomes a target for sales reps peddling any drug in that class.

Physician groups have begun to fight back, asserting their right to have their prescribing habits protected. The vortex of the fight is a Supreme Court case, Sorrell vs. IMS Health, that will decide whether the state of Vermont has the right to keep prescribing data confidential.

Interestingly enough, it is this same company, IMS—a pharmaceutical “intelligence” and consulting firm—that caused a stir in April when it released a wide-ranging report about what medicines U.S. doctors prescribe most. At the top of the list—at a whopping 131.2 million prescriptions last year—was the generic form of Vicodin.

When I was in the hospital last fall for a surgical procedure, Vicodin (acetaminophen/hydrocodone) was my best friend. When you’re in pain, your sole desire is relief, so the potent painkiller was a godsend.

But, as the IMS numbers suggest, not everyone taking Vicodin should be. There’s a lot of abuse going on. Some critics say that doctors and dentists tend to prescribe the drug because it is not as tightly regulated as other painkillers (incorrectly scheduled by DEA as a class III rather than a II, says one). Regardless, it’s not the only opioid that’s being misused—Percocet and OxyContin also head the list.

America, the press has begun to report, has become a “nation of painkillers.” The U.S., it is estimated, consumes 80 percent of the opioids prescribed worldwide, and 99 percent of the world's hydrocodone.

A lot of the abuse taking place is by teens and others who get the drugs secondhand. The anecdotal information coming forth is startling. In Ohio, prescription drug overdoses have supplanted car crashes as the leading cause of accidental death. In the town of Portsmouth, Ohio, the New York Times relates, there’s a makeshift display in the window of a department store that memorializes the dozens of teenagers that have died of painkiller overdose. “We’re raising third and fourth generations of prescription drug abusers now,” said the local police chief. In one instance, a grandmother was arrested for reselling her prescribed pain meds to local teens.

As these stories come to light, the rhetoric has ramped up. Painkiller popping is a growing health crisis that is “suffocating our society,” says HHS Secretary Howard Koh.

“There’s an epidemic of prescription drug abuse that is beginning to rival that of illegal drug abuse,” said FDA CDER director Janet Woodcock recently, speaking to Bloomberg News. “It’s either the kids who get it out of their medicine cabinet or someone who gets multiple prescriptions.”

FDA has been focusing on painkillers since it was given the teeth it needed in 2007, when it received the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug outweigh its risks. FDA sent a clear message in 2008 when it rejected Abbott’s application for an extended-release version of Vicodin. (Abusers seek out extended-release pills due to their higher opioid content.) In 2009, a committee of experts recommended to the Agency that painkillers be severely restricted, and drugs like Vicodin and Percocet even perhaps being removed from the market.

It hasn’t come to that, yet, but in April, the Obama administration announced a Prescription Drug Abuse Prevention Plan with a special emphasis on painkillers. As part of the plan, FDA has informed opioid manufacturers that they must develop training materials to help physicians manage patients’ use of the drugs. (Will this help? Do physicians really not know the dangers of what they’re prescribing?) Within 120 days (i.e., by August), these drugmakers must also lay out plans on how they’ll train doctors and screen patients who are potential abusers.

Manufacturers of pain medications are under siege. That’s a good thing. Education—of physicians and patients—is essential. And abuse-resistant versions of some of these most dangerous drugs (including OxyContin) have been in development for years. Pfizer and Pain Therapeutics, for instance, are partnering on the investigational drug Remoxy, which is water-insoluble, carries a smaller dosage, and is designed to limit “dose-dumping.” Part of the trick is making it unappealing—in taste and texture, for example—to abusers who would chew it to get immediate release of the stronger dosage.

But these are small steps. We’re just beginning to realize the punishing impact that painkillers may have on society. Manufacturers are one of many parties that must work together for a solution. One pill or policy won’t ease the pain.

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