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FDA Proposal To Curb Painkiller Overdose Deaths Would Add Burdens For Pain Patients

10/26/2013 09:40 am ET | Updated Jan 23, 2014

The Food and Drug Administration on Thursday recommended new restrictions on the use of some prescription painkillers. Citing a reported dramatic increase in the number of overdose deaths related to opioid-based painkillers over the last decade, the agency recommended switching drugs like Vicodin, which contain less than 15 milligrams of the opioid hydrocodone, from Schedule III to Schedule II. Doing so would restrict the number of medical personnel authorized to prescribe the drugs, require patients to bring physical prescriptions to a pharmacy (as opposed to having a doctor call in a prescription), and allow patients fewer refills before requiring another prescription.

The move is the latest in a decade-long debate over narcotic painkillers. Public health advocates and anti-drug organizations point to the sharp increase in prescriptions for drugs like OxyContin, the spike in overdose deaths, and reports of accidental addiction in people with no prior drug-abuse history as indications of a dire need for stricter regulation. Pain patients, pain specialists, and their advocates say more restrictive federal policies and the high-profile prosecutions of doctors accused of over-prescribing the drugs have left people in pain to needlessly suffer -- particularly poorer patients and those with chronic pain. The FDA has long sided with the latter, but this week's announcement is a clear sign that the agency has changed its mind.

As HuffPost reported in a series of articles last year, the problem may not be that the government is failing to regulate prescription pain medication, but that it's going about it in the wrong way.

Today, the prescription painkillers are primarily controlled not by medical specialists, but through criminal law -- restrictions and resulting investigations by the Drug Enforcement Administration, and subsequent prosecutions by federal prosecutors. (Several states regulate the drugs this way, too.) That has scared careful, conscientious doctors out of pain management.

But because pain patients still suffer and find themselves desperate for relief, they turn to less scrupulous doctors and "pill mills" willing to offset the risk of prosecution by churning out scripts without the oversight and individual attention required of effective pain management.

Dr. Albert Ray, president of the Florida Academy of Pain Medicine, told HuffPost last year: "All legitimate doctors want to stop drug diversion and abuse and to close down the pill mills that are violating good medical practice principles for the sake of their greed. But these restrictions are costing the majority of legitimate patients and doctors much frustration, fear, time, energy, and discomfort." He added: "We need to view this through the lens that the patient comes first -- what they need, and what the best ways are to get it to them. How to get the system to respond in that way remains a frustrating problem."

In the United States, the government often gives a higher priority to fighting addiction than it does to medical care. That's why a law enforcement agency like the DEA -- as opposed to a science-based agency like the FDA -- has final say over whether a restricted drug has medicinal value. Which means that ultimately, a doctor-patient decision on whether to pursue a course of treatment with a particular drug isn't strictly a doctor-patient decision, but is also affected by whether other people abuse that drug. The DEA has the power to restrict not only opioid painkillers, but medical marijuana, attention-deficit drugs like Adderall, and of course other narcotics like morphine and cocaine. Even pharmacies, warehouses, and wholesalers have added extra layers of restrictions on some of these drugs out of fear of DEA retribution.

Despite assurances from federal officials that opioid restrictions in no way restrict pain patients' ability to find treatment -- including from outgoing Obama Drug Czar Gil Kerlikowske -- hundreds of patients contacted HuffPost last year to report exactly that predicament. Some suffered from painful maladies and were desperate for relief, but couldn't find a competent doctor willing to treat them.

The restrictions that have so far been put into place also may not have achieved what proponents intended. According to drug monitoring reports from Ohio and elsewhere, recent diversion controls put on prescription opioids have simply pushed drug abusers to switch to street heroin.

Worse, cognizant of DEA targeting for over-prescribing opioids, but still wanting to give their patients relief, some doctors have been prescribing methadone instead. (Methadone is cheaper as well.) Because the body takes longer to metabolize methadone than brand-name opioids like OxyContin, the drug can be more dangerous for pain patients. That means that methadone overdoses are on the rise, too. Non-opioid painkillers, including over-the-counter acetaminophen, carry risks of their own.

This week's FDA recommendation must still be approved by the DEA and the Department of Health and Human Services. Both are expected to sign off, meaning the new policy could be in effect by next year.

One certainty is that the new rules will make life more difficult for people in pain, particularly those with chronic pain. Whether it will have a significant effect on overdose deaths or accidental addiction remains to be seen. But if the results of prior efforts to restrict the drugs are any indicator, that's far from a sure thing, and the unintended consequences may cause more harm than good.