An April 2011 paper in the Archives of Internal Medicine found that as dose escalated the risk of opioid-related death increased. For high-dose patients the risk of death was three times greater than in lower-dose patients.
The "no ceiling" dose statement appears in the Pain Foundation's "guide for people living in pain," a publication that received funding from three drug companies.
Two of the companies, Purdue Pharma and Cephalon, were the subject of U.S. Justice Department investigations involving their opioid products.
In 2007, Purdue was accused of misleading doctors by claiming, with no proof, that its narcotic painkiller OxyContin was less addictive, less likely to cause withdrawal and less subject to abuse than other pain medications.
At the time, scores of deaths and an even greater number of addictions were attributed to OxyContin. The company and three of its executives pleaded guilty to various charges. A court imposed fines and restitution payments totaling $635 million.
In 2008, Cephalon settled an investigation of off-label marketing of three of its drugs, including Actiq, a powerful painkilling product manufactured as a lollipop with the drug fentanyl. The drug was approved for use only by cancer patients who no longer were getting pain relief from morphine based drugs. Cephalon allegedly promoted the drug for non-cancer patients with conditions ranging from migraines to injuries. It also promoted Actiq for use in patients who were not opioid-tolerant and for whom it could have been life-threatening.
Cephalon agreed to pay a $425 million penalty.
In recent years the American Pain Foundation has received millions of dollars from industry, including companies that market opioids.They include Purdue, Cephalon and several other opioid companies.
Foundation officials declined to be interviewed for this story.
In an email statement Micke Brown, a registered nurse and spokesperson for the foundation, said it stands by the statements in its pain guide, which was developed by leading pain experts.
"APF along with many from the pain community is concerned (about) the misuse and abuse of these valued medications. Unfortunately, the weight of this complex problem has been placed on the backs of people living with pain."
Addiction Risk
In 1996, the American Academy of Pain Medicine and the American Pain Society, organizations that get substantial funding from drug companies, issued a joint statement endorsing the use of opioids to treat chronic pain and claiming the risk of addiction was low.
The chairman of the group that issued the statement was J. David Haddox, DDS, MD, a physician and paid speaker for Purdue Pharma, maker of the highly-prescribed opioid, OxyContin.
Three years after the chronic pain statement, Haddox became an executive at Purdue.
Doctors on both sides of the debate agree most people who are put on opioids long-term will become physically dependent. The risk of addiction, which is more severe than physical dependence, is significant, they say.
One of the problems in assessing addiction risk is that many of the clinical trials that involved opioids excluded people with mental illness or who had a family history of substance abuse, groups that are more likely to develop addiction.
But many of those people are put on opioid therapy for chronic pain.
Some people are able to come off opioids without much trouble while others will be addicted, said Jane Ballantyne, MD, a professor of anesthesiology and pain medicine at the University of Washington.
"The vast majority of people are somewhere in between," she said.
Part of the problem is that addiction has become more of a lay term defined by differently by different groups. Addiction rates have varied widely in studies.
The National Institute on Drug Abuse says addiction rates among chronic pain patients have ranged from 3% to 40%.
A 2011 study looking at different data also found a substantial problem.
The research involved 705 people on long-term opioid therapy for non cancer pain. It used a new definition known as opioid-use disorder. Thedisorder is similar to addiction, said Joseph Boscarino, PhD, the study's lead author and senior investigator at the Geisinger Clinic in Danville, Pa.
Nearly 35% of those in the study had either moderate or severe opioid-use disorder at some point during their lives.
"It (addiction) is not low," said Boscarino, a professor of psychiatry at Temple University. "It's pretty high."
The 1996 consensus statement was taken down from the web site of the American Academy of Pain Medicine last fall after a doctor complained about it. It should have been reviewed years earlier, said Philip Saigh, executive director of the academy.
Last year, the academy received $1.3 million from the pharmaceutical industry, including unrestricted grants, according information supplied to the Journal Sentinel/MedPage Today.
In addition, the AAPM's "corporate relations council" allows companies that pay up to $25,000 each to gain access to physician leaders associated with the academy. Last year, that program took in $170,000.
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