Doctors Petition FDA to Change Labeling of Painkillers
Doctors Petition FDA to Change Labeling of Painkillers [Milwaukee Journal Sentinel]
From Milwaukee Journal Sentinel (WI) (July 26, 2012)
July 26--Nearly 40 doctors, researchers and public health officials Wednesday asked the Food and Drug Administration to change the labeling used on narcotic painkillers, a move that, if approved, would make it more difficult for drug companies to market the medications for chronic, non-cancer pain.
Although many of the 37 who signed the petition are associated with the reform group known as Physicians for Responsible Opioid Prescribing, most are from other institutions, including the Cleveland Clinic, the Mayo Clinic, several universities and the watchdog group Public Citizen.
The move comes amid concerns that prescribing practices of doctors have contributed to an opioid epidemic in America.
"By implementing the label changes proposed in this petition, FDA has an opportunity reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed opioids," the petition says.
Controversy has grown over the practice of prescribing powerful painkillers such as Oxycontin or fentanyl to treat long-term, non-cancer pain. Prescriptions for opioids have increased four times over what they were a de cade ago, leading to big increases in opioid-related overdose deaths as well as people seeking treatment for addiction.
Before the late 1990s, opioids had been used primarily to treat short-term pain, such as pain after surgery, as well as pain associated with cancer and end-of-life disease.
Morgan Liscinsky, an FDA spokesperson, said the agency will review the petition and provide a response directly to Public Citizen.
The issue involves labels on most opioid analgesics. Public Citizen says most of the labels are overly broad and only state that the drugs are approved for moderate to severe pain without any limit on the amount of time a patient should be taking the products.
The petition calls for changing the labels to eliminate "moderate" and to include a maximum of the equivalent of 100 milligrams a day of morphine and a time period of no more than 90 days when used to treat non-cancer pain.
Uses beyond that then would become off-label. That in turn would prevent drug companies from promoting the drugs for off-label uses through methods such as advertisements, dinner talks to other doctors and medical meetings. It also would affect continuing medical education courses for doctors.
The changes would not affect a doctor’s ability to prescribe off-label, just such promotion by drug companies, said Sidney Wolfe, director of the health research group at Public Citizen.
The petition notes that many doctors are under the false impression that opioids have been proven safe and effective for long-term non-cancer pain.
Typically, studies of opioids for treating non-cancer pain last fewer than 12 weeks.
"In the absence of long-term studies demonstrating safety and effectiveness, we need limits on what drug companies can claim about opioids," Ed Covington, director of the Neurological Center for Pain at the Cleveland Clinic, said in a statement.
Lewis Nelson, an emergency physician and medical toxicologist at NYU Langone Medical Center, said doctors are wrong in assuming that the current "on-label" use of opioids is based on good scientific evidence.
"It’s time to close the loophole on opioid labels," he said in a statement.
Both Covington and Nelson signed the petition.
Beginning in the late 1990s, Purdue Pharma and several other companies that market opioids funded activities that promoted use of the drugs for long-term, non-cancer pain such as low-back pain and fibromyalgia.
"Over-prescribing of opioids is harming many chronic pain patients," Covington added. "The label change is a way for the FDA to let the medical community know that risks may outweigh benefits when used long-term."
That is not to say that opioids don’t help some chronic pain patients.
Doctors estimate that about 30% of such patients may benefit. Typically they get about a 30% reduction in pain.
The uncertainty over who might benefit has to be weighed against serious risks such as addiction, overdosing, respiratory suppression, falls and fractures in the elderly, sleep apnea and cognitive impairment.
The label change setting the maximum dose at the equivalent of 100 milligrams of morphine means that it would apply mainly to higher doses of the drugs, which also are the most dangerous, said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing.
That’s about equal to 14 tablets of Vicodin or 13 tablets of Percocet a day, said Kolodny, chairman of psychiatry at Maimonides Medical Center in Brooklyn. Someone taking twice-a-day, 80 mg of Oxycontin, which is made by Purdue, also would be over that limit, he said.
James Heins, a spokesman for Purdue Pharma, said the FDA and numerous medical experts think current labeling for long-acting opioids, such as Oxycontin, is appropriate.
"We agree with the FDA that prescribing information for any medication should be subject to ongoing review and modification to the extent that compelling medical evidence emerges," he said in an email.
Wolfe of Public Citizen said the next step is for the FDA to take action on the petition. He said the agency could simply grant the labeling changes or hold an advisory panel hearing on the issue.
"They can’t just write this off," he said.
If the agency does not take action in a reasonable amount of time, Public Citizen could take it to court to force a response, he said.
A look at past reporting
Last year, the Journal Sentinel began investigating the growing use of opioids to treat chronic pain and the pharmaceutical industry’s financial influence in that trend.
In April 2011, the Journal Sentinel found the University of Wisconsin Pain & Policy Studies Group had taken $2.5 million from opioid companies over a decade while advocating for liberalized use of the drugs.
In February, the Journal Sentinel reported that a network of pain organizations, doctors and researchers pushed for expanded use of opioids while taking in millions of dollars from companies that make the drugs.
The stories were among those that have prompted a U.S. Senate investigation into financial ties between drug makers, doctors and the groups.
This story was reported as a joint project of the Journal Sentinel and MedPage Today. MedPage Today provides a clinical perspective for physicians on breaking medical news at medpagetoday.com.
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Posted: July 2012