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Health Care Workers Petition Fda To Change Opioid Labeling

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July 26, 2012


Thirty-seven health care workers signed and submitted a petition to the Food and Drug Administration Wednesday, urging officials to change labels on prescription opioids, such as OxyContin, morphine or Vicodin, all part of an effort to curb prescription drug abuse.


"If the requested changes were adopted, drug companies would not be able to claim that the pain medications are safe and effective for long-term use by noncancer patients," read a statement from Public Citizen, the nonprofit advocacy group spearheading the petition.


The petition follows a wave of reports of increased addiction to opioid pain drugs. Although pain management and addiction specialists agreed with the sentiment behind the petition, several doctors told ABC News it takes a step too far by limiting opioid access to noncancer patients with chronic pain.


"I believe this is not an appropriate way to address the disease of addiction," said Pam Kedziera, the clinical director of Fox Chase Cancer Center's pain program. "Pain is a significant problem in the United States, and those who suffer deserve treatment."


The proposal suggests striking the word "moderate" from opioid labels to reserve it only for patients with severe pain; limiting the maximum daily dose to the equivalent of 100 milligrams of morphine; and limiting the maximum prescription duration to 90 days.


Dr. Joshua Prager, who directs the Center for Rehabilitation of Pain Syndromes at the University of California at Los Angeles, told ABC News he's treated chronic pain patients for nearly 30 years and believes a regulation that would make it harder for doctors to treat these "legitimate patients" would be "extremely regressive."


Prager's patients have included people who've had a failed back surgery or severe osteoarthritis.


Other chronic pain patients could have shingles, multiple sclerosis or pain from a nerve injury.


"We've seen the pendulum go from it being extremely difficult for physicians to prescribe opioids to patients who didn't have cancer… to where it was clearly being overprescribed," Prager said. "What I would argue for is that there really has to be balance that doesn't have the pendulum swing back too fast and too far beyond what is reasonable."


Prager called the 90-day limit "draconian," and Kedziera called it "unbelievable." After all, the definition of chronic is that it is long-lasting, and Kedziera said she's worried about arbitrarily taking chronic pain patients off medication just because time runs out.


Regardless of whether doctors said they believed the petition went too far, they agreed on the need to rethink opioid prescriptions based on firsthand knowledge and the data presented in the petition.


Opioids are the second-most-addictive drug, right behind tobacco, said Dr. Stephen Ross, who holds a slew of addiction and psychiatry titles at New York University hospitals and said he is in favor of the petition. He said about one-quarter of all patients who try heroine, an illegal opioid, become addicted.


Ross said about 75 percent of all opioid users get it from a friend or a parent's medicine cabinet, and because doctors prescribe it, they think it's safe. However, opioids can suppress breathing and become lethal.


However, even addiction specialists like Ross said they were worried about curbing opioid addiction at the expense of pain patients.


Dr. Gregory Collins, who heads the Cleveland Clinic's Alcohol and Drug Recovery Center, said he believes there are other, better ways to combat prescription drug abuse than what the 37 doctors have outlined in their petition.


"While I share the grave concerns about the epidemic of opiate medication abuse and its associated mortality," he said. "I believe that the proposed measure unduly restricts doctors' access to opiate medication in the treatment of numerous noncancer but painful conditions."


Many doctors who spoke to ABC News said insurance companies should provide coverage for alternative therapies for chronic pain regardless of whether they agreed or disagreed with the overall petition.


An FDA spokesperson said the agency would respond to Public Citizen. In the meantime, it will allow interested parties to provide input on the issue before it is approved or denied.


The Drug Enforcement Agency declined to comment.

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To hell with this!!!


There are a lot of people who need opioids long term for pain, including myself - I have nerve damage from shingles and it can be more painful than you can even imagine, unless you've experienced it yourself. Worse than a broken bone.


I am so sick of people trying to deny access to opioids... they are already too difficult to get, at least for young people... I have suffered tremendously and lost almost everything I cared about as a result of shingles and the excruciating nerve pain/damage... I haven't been given a prescription for opioids in over 8 months... if it weren't for kratom, I don't know if I would even still be here. Sadly MJ helps, but it is not enough, I have to combine it with opioids and lidocaine patches to get relief.

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