Doctors at top health centers including the Cleveland Clinic and University Hospitals want the U.S. Food and Drug Administration to toughen rules for prescribing powerful painkillers like OxyContin and similar opioids, saying this could curb addiction and drug abuse.
Yet there is pushback -- from, among others, medical professionals at some of the same hospitals, including the Cleveland Clinic, public records and interviews show.
These doctors and clinicians say they, too, want to halt addiction and deaths from the over-consumption and abuse of opioid painkillers, which the U.S. Centers for Disease Control calls an epidemic. The CDC lists Ohio as among the states with the highest rate of overdose deaths from OxyContin and similar drugs that use synthetic or natural versions of the opium poppy to suppress pain -- and can create a sense of euphoria and addiction in some people. Included in this drug class is not only OxyContin but also Vicodin, Percocet, methadone and codeine, the CDC says.
But some medical specialists worry that more harm than good could come if patients with long-term pain from injuries or medical conditions cannot get relief, especially if opioids are only recommended for patients in severe rather than moderate pain -- a personal and subjective call, some say. Doctors might be able to prescribe "off-label" uses for select patients, depending on what the FDA decides, but this would restrict how drug companies market the painkillers and could make insurers reluctant to pay.
It could lead to patients lying to their physicians about their pain in order to meet higher thresholds, and to increased illegal street sales -- or even to suicide if untreated pain becomes unbearable, according a letter submitted to the FDA by one Cleveland Clinic pain-management nurse and researcher.
Nonsense, responds Dr. Andrew Kolodny, a Brooklyn, New York psychiatrist who treats addiction and is president of a group lobbying for more restrictive opioid prescribing. He says the painkillers are over-prescribed and used for purposes far beyond what research supports.
He called the suicide claim "totally bogus," saying suicide can result from the severe anxiety and panic attacks associated with drug withdrawal -- a problem that stems from addiction to painkillers, he said, not failure to treat pain appropriately.
"We're not trying to take these people's opioids away from them, we're trying to prevent new starts," he told The Plain Dealer.
The director of the Cleveland Clinic's Neurological Center for Pain, Dr. Edward Covington, is among those backing the petition submitted by Kolodny and the group, Physicians for Responsible Opioid Prescribing, or PROP, last July. The group says that "an increasing body of medical literature suggests that long-term use of opioids may be neither safe nor effective for many patients, especially when prescribed in high doses."
The group says that misperceptions among clinicians "lead to over-prescribing and high-dose prescribing." It wants the FDA to strike the term "moderate" from prescribing indications for non-cancer pain. It also wants the drug regulatory agency to recommend a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain, and to limit patients' continuous use to 90 days maximum.
Other doctors who signed the PROP letter to the FDA include Kurt C. Stange, a medical professor at Case Western Reserve University, and Sidney Wolfe, director of Public Citizen's Health Research Group, a national public interest group. Writing to the FDA separately in support was Dr. Salim Michel Hayek, an anesthesiologist and pain specialist at University Hospitals.
"The major question is, are we helping the patients with these medications?" Hayek said in an interview last week. Evidence suggests that for patients recovering from surgery or with painful end-of-life illnesses, opioids can be effective, even a godsend, he said. But they are questionable in other uses, such as regular treatment of chronic back pain, and the tolerance buildup requires higher doses and increases risks, Hayek said.
Yet Dr. Riad Laham, an anesthesiologist and pain management specialist at the Cleveland Clinic's Hillcrest Hospital, wrote to the FDA in late September in apparent support of a group of pain doctors who disagreed with PROP. Laham's correspondence, like other documents cited in this article, was obtained from electronic FDA public records, and he and others at the Clinic did not respond to requests for interviews.
He told the FDA, according to its electronic records, that PROP's petition was "short sighted and plain deleterious. Opiates have given some chronic pain sufferers their life back. It is a part of a multimodal approach to treat this population."
Dr. Constantino Benedetti, a professor in the clinical department of anesthesiology at Ohio State University, signed a similar letter to the FDA as a member of the American Pain Society. The society said the PROP proposals "will not accomplish the intended goals, but instead have unintended negative consequences for patients including but not limited to untreated pain and loss of access to individualized care." The letter also said that "opioids achieve good pain control with minimal adverse effects for some patients but not others. At present, we lack adequate evidence to predict which patients are which."
Holding a similar view was Esther Bernhofer, a registered nurse who specializes in pain management and conducts pain-management research at the Clinic. She warned the FDA of poor consequences if opioids are only considered appropriate for severe pain but not moderate pain -- words that "may have little meaning."
"If the intent with this legislation is to decrease the amount of abuse, then it will surely backfire and only harm the people who really need professional help," she said in a letter to the agency. "It will encourage hoarding of medication, lying to a practitioner regarding the severity of pain, and perhaps even leading to further misuse of opioids by persons whose pain is not adequately controlled through legitimate routes."
She added that Washington state, which has adopted stringent standards, "has seen an upsurge in patients who can find no relief and suicides. We are literally trying to solve a societal problem on the backs of legitimate patients."
Even the American Cancer Society's Cancer Action Network cautioned against over-regulating, despite language in PROP's proposal showing it does not want to restrict opioids for cancer patients. The action network, an advocacy arm of the cancer society, said it is concerned about cancer survivors who may require painkillers for subsequent conditions.
"We don't tend to focus on cancer pain versus non-cancer pain," Keysha Brooks-Coley, the organization's director of federal relations, said in an interview last week. "We focus on the issue of pain in general and access to pain medications."
This split among medical professionals underlies how difficult the issue is for patients, whose treatment can depend on which side of the divide a physician falls.
"Not having access to it would put me in a lot of pain," said Paula Chamot, a Cincinnati resident who has asked the FDA to reject PROP's request. Operations to treat a nerve injury left her with complex regional pain syndrome in her right arm, she told The Plain Dealer. Under a doctor's care, she supplements pain patches with Percocet. Although she must deal with the effects of detoxification including anxiety when she eases off the medication, the pain would be a much worse alternative, she said.
Yet in early February, a former teacher from Ontario, Canada, Ada Giudice-Tompson, told an FDA hearing about her son, Michael, who went to sleep one night in 2004 while on prescription painkillers and never woke up. Her testimony was part of a two-day informational hearing.
"We are legally providing heroin-like drugs, and should expect nothing less than an epidemic of addiction and death along with poor pain management," she said.
The FDA has not decided what to do about opioids. In a letter Jan. 22, it told PROP that is "has been unable to reach a decision on your petition because it raises significant issues requiring extensive review and analysis by agency officials." The agency did not say when it expects to reach a decision.
Meantime state officials in Ohio, where OxyContin addiction has plagued several rural communities, are considering measures independent of the FDA. No date has been announced. But the state standards would be voluntary rather than mandatory, said Dr. Theodore Wymyslo, director of the Ohio Department of Health.
They would include a recommendation that doctors or nurses closely monitor anyone for whom they prescribe a painkiller equivalent to 80 milligrams or more of morphine, and for more than 90 days. There would also be a recommendation that these patients see a pain-management specialist. The 80-milligram threshold is lower than the proposed federal 100-milligram prohibition for certain patients, and the 120 milligram standard mandated in Washington state, Wymyslo said.
"Our group thought 120 milligrams was too high," he said. "We thought that 120 milligrams is a lethal dose for some people."
Even groups that oppose the PROP proposal have agreed to Ohio's standards, the health director said, although the state's medical licensing boards still must approve. "The fact that we came to consensus is a modern-day miracle," he said.
But he acknowledged a key reason for this consensus: Ohio's standards would be voluntary.