An issue near to my own heart

Washington -- 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.

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.

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.

as a chronic pain sufferer, and pain management patient, this issue evokes strong emotions for me. I have the exact same "moderate" long- term pain - not severe (usually) or accute - just constant aching sore muscles all throughout my body, and there is nothing, NOTHING, that improves my standard of living up to just bareable, more than opiate medication. Just hydrocodone, basically the weak stuff compared to oxy.

Basically what these narrowminded medical academiacs are saying to people with long term moderate pain, is to just suffer, RATHER THAN approaching the issue from a more practical stance, and break down on those dr.s and patients who are breaking current laws rather than some arbitrary bureaucratic blanket policy that doesnt cover evrryone.

I mean granted, moderate pain is acceptable when overcoming an injury, or strained back, whatever, over the short term. But as i can attest, when it never goes away and is always present, even with meds, it really does begin to effect your psyche, and leads to a great amount of depression, so the stories of suicide, i dont believe, are an exaggeration. What would happen would be more people seeking out illegal drugs, or alcohol in attempt to find relief.

F drugs. I got cronic back pain. I refuse pain management. As time goes by, I find that my body gets used to the pain. It becomes "normal". When it gets too bad, a few sessions of physical therapy do the trick. While my solution is not the best for all, I know too many people who abuse the pain management system. I also know too mamy people at the methadone clinic. This was supposed to be a step down medicine. Years later, the same people are still hooked on methadone.

Well ive been off of them for long enough periods as to eliminate the simple yearning of withdrawals as my motivating factor. Dont get me wrong, im not saying popping a pill solves everything, or even that it should be a first option, or evn that there are no negative side-effects, and it is a complex issue because of the abuse and fraud, but usually at the hands of a few sleezy crooked doctors, or med seeking patients who bounce from doc to doc often obtaining meds from multiple drs and filling them at differnt pharma. Regardless, you of all ppl should recognize a government intrusion like this. But im skeptical such radical measures will pass.

Because for me, the only alternative would be massage treatments, mass trigger point injections, and osteopathic adjustments. Something i can neither afford or have time for as i cant drag my daughter along to all that shit all the time, and the beneficial effect of such treatments in the past has ranged from 1-3 days depending on which one were talking about. But basically everyones situation is different when it comes to stuff like this

Been on patches, but not only was their effect negligible, they left rectangular rashes on my skin. Done physical therapy and honestly, because of my condition, thats counterproductive because my muscles dont rebuild like normal ppl's do, and thats mainly their goal is to strengthen the muscles around the injury. So its always just resulted in me hurting more as a result. Same even with pool therapy. Only thing i can really do thats beneficial like that is stretch.

Pun wrote:Well ive been off of them for long enough periods as to eliminate the simple yearning of withdrawals as my motivating factor. Dont get me wrong, im not saying popping a pill solves everything, or even that it should be a first option, or evn that there are no negative side-effects, and it is a complex issue because of the abuse and fraud, but usually at the hands of a few sleezy crooked doctors, or med seeking patients who bounce from doc to doc often obtaining meds from multiple drs and filling them at differnt pharma. Regardless, you of all ppl should recognize a government intrusion like this. But im skeptical such radical measures will pass.

Trust me, my feelings about pain meds and pain management clinics do not affect my decision on this. I don't like the government getting involved in what people can and cannot put into their bodies. This is not what the FDA and governmental oversight was created for anyway. I guess once all the snake oil salesmen were taken care of they had to expand their sphere of influence.

BTW-you do know that for every perscription given, doctors get a kickback from pharma??? Yeah, that's like saying "write as many scripts as you can for these certain meds. That ensures us of an ever growing client base and we can use our stroke with the Feds to ensure that we are the only approved drug dealers on the block."

Well yeah thats why you always have the pharma reps in there

Pun wrote: as a chronic pain sufferer, and pain management patient, this issue evokes strong emotions for me. I have the exact same "moderate" long- term pain - not severe (usually) or accute - just constant aching sore muscles all throughout my body, and there is nothing, NOTHING, that improves my standard of living up to just bareable, more than opiate medication. Just hydrocodone, basically the weak stuff compared to oxy.

Basically what these narrowminded medical academiacs are saying to people with long term moderate pain, is to just suffer, RATHER THAN approaching the issue from a more practical stance, and break down on those dr.s and patients who are breaking current laws rather than some arbitrary bureaucratic blanket policy that doesnt cover evrryone.

I mean granted, moderate pain is acceptable when overcoming an injury, or strained back, whatever, over the short term. But as i can attest, when it never goes away and is always present, even with meds, it really does begin to effect your psyche, and leads to a great amount of depression, so the stories of suicide, i dont believe, are an exaggeration. What would happen would be more people seeking out illegal drugs, or alcohol in attempt to find relief.

My mom is in a similar situation. Shes confined to a wheelchair and uses these pain patches (fenyl...something). They are high powered suped up painkillers that allow her to exist and without them she told me she'd had thoughts of suicide. They are prescribed by a doctor and I have to jump through hoops to get them filled for her at the pharmacy. (ie...the Drs wont just call the Rx in, I have to go to the officve for her, sit and wait sometimes all day to pick up the Rx, then take it to to Pharmacy to get filled, then listen to alecture EVERtime on the dangers of that patch, etc).

A few months ago, Medicare in their infinite wisdom decided it was too expensive for them to pay for these patches, so they said they werent gonna pay anymore. So mom goes to the Dr and they say ok, we'll try you on Oxycontin if Medicare wont pay for the patches. Ok...so mom gets on this highly addictive medicine...which turns out not only to NOT work for her, but makes her extremely sick. So we go through weeks of trying one drug after another until FINALLY, a couple of days ago they agree to let her go back on the patches that the Dr had prescribed for her in the 1st place!
This, my friends, is what happens when the govt gets involved in the medical field. No longer are you or your Dr deciding what you can take...the govt wants to decide based solely on money.