Doctors Petition FDA to Limit Painkillers

Saying it was time to “close the loophole” on narcotic painkillers, a coalition of doctors and public health officials is petitioning the Food and Drug Administration to change the prescription guidelines for opioid medicines.  The move comes amid growing concern that the overprescribing and misuse of narcotic pain relievers has contributed to an epidemic of prescription painkiller abuse.

The FDA currently approves most opioid analgesics for “moderate to severe pain,” but the petitioners say that is an overly broad definition that has encouraged physicians to prescribe powerful narcotics for long periods to patients who don’t really need them.

“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 petition states.  It calls on the FDA to change the guidelines so that opioids are only indicated for severe pain.

The petition is signed by 37 physicians, scientists, researchers and public health officials, including Dr. Andrew Kolodny, co-founder of Physicians for Responsible Opioid Prescribing, which lobbies against opioid abuse and overprescribing. Others who signed the petition are the New York City Health Commissioner and the New York state Commissioner of Health, as well as doctors associated with medical schools and prominent institutions such as the Mayo Clinic and the Cleveland Clinic. The lead petitioner is the watchdog group Public Citizen.

The petitioners say the prescribing of opioids has increased over the past 15 years, in response to a campaign by Purdue Pharma and other pharmaceutical companies that exaggerated the benefits of painkillers, while minimizing the risk of their long term use.

“Unfortunately, many clinicians are under the false impression that chronic opioid therapy is an evidence-based treatment for chronic non-cancer pain,” the petition says. “These misperceptions lead to over-prescribing and high dose prescribing. By implementing the label changes proposed in this petition, FDA has an opportunity to reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed opioids.”

The petition calls for changing the labels on narcotic painkillers to eliminate the word “moderate,” and to include a maximum daily equivalent of 100 milligrams of morphine for a period of no more than 90 days to treat non-cancer pain. It does not request changes for treatment of pain in cancer patients.

Doctors would still be able to prescribe the drugs for “off-label” use, but drug makers would no longer be able to promote them for anything other than cancer pain or severe, non-cancer pain. Many chronic pain patients say it is already difficult to get prescriptions written or filled because recent crackdowns against pill mills and pharmacies have created a climate of fear among pain care providers.

“In the absence of long-term studies demonstrating safety and effectiveness, we need limits on what drug companies can claim about opioids,” petitioner Ed Covington, director of the Neurological Center for Pain at the Cleveland Clinic, said in a statement.

“It’s time to close the loophole on opioid labels,” said petitioner Lewis Nelson, MD, an emergency physician and medical toxicologist at NYU’s Langone Medical Center, who claims the current FDA  guidelines create “a mechanism that allows drug companies to promote opioids for unproven uses.”

Purdue Pharma released a statement a statement calling the current guidelines “appropriate.”

“The FDA, its advisory committees, and numerous medical experts maintain that the current indications for long-acting opioids are appropriate,” the company said. “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.”

Public Citizen said it would go to court if the FDA denies the petition or doesn’t hold an advisory panel hearing on the issue. The FDA has 180 days to approve, deny or provide a tentative response to the petition.

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7 Responses

  1. C.C says:

    I think its rediculous that a small group of people who don’t have a clue what severe chronic pain is, can try to change the laws for everyone. and that a few drug addicts can cause such paranoia in this society. Its gotten to the point that doctors are totally paranoid over precribing pain meds period! for fear of losing their licence. This law would guarantee a slew of people will be commiting suicide, due to the stupidity of a few people! If someone wants to abuse drugs they will find a way to do it, illegally or not. Where are the rights of the patient anymore? This is getting totally out of control!

  2. Trudy Duffy says:

    I applaud this petition to re-label this highly addictive drug, fraudulently marketed by Purdue Pharma. The harm to the public and lack of corrective action by the FDA is unconscionable. Patients as well as physicians have been misled, production quotas increased despite mounting evidence of great harm. If the US accounts for 85% of world consumption what do other nations medical practices use to control chronic non-cancer pain in a compassionate way? This petition would help cautiously approach responsible prescribing not eliminate it and is a positive step towards reform. R

    Thank you doctors and Public Citizen and PROP for initiating this action.

  3. Paula says:

    I have severe chronic pain from a car accident where I was ejected from a car after being hit by a drunk driver. Now I have nerve damage and arthritis in my back. I follow all the rules and regulations that my pain doctor has put in place (use the same pharmacy, agree to random urine drug screens to check to make sure I’m taking my dosage, not get any opioids from another doc, etc). Now because a minority has decided to abuse these drugs I’m going to be told I can no longer be treated for pain because t doesn’t fit into their draconian guidelines. I read an article from the DEA and even they stated that only 2% of chronic pain patients become addicts or misuse their medications. This guideline is going to cause more suffering to the already suffering chronic pain community. For what reason? An addict will find a way to get a fix whether or not it’s from a pain pill, heroin, etc. this will not deter them, only cause unnecessary suffering. These people have obviously never suffered from serious pain but I wish they did walk a mile in our shoes before judging us.

  4. Sally says:

    It is INSANE to set a “dose maximum” for opioids. How is that evidence based? People don’t ALL metabolize medication the same way! There’s this thing called GENETICS…..HELLO?????? Anybody out there????? To set dose and time limits for people who live with severe intractable pain? Is that a joke? I have a rare, genetic, connective tissue disorder called Ehlers-Danlos Syndrome. I have frequent, excruciating joint and spine dislocations. I’ve had too many surgeries to count, There is no cure for what I have. I have to manage symptoms to survive, sleep, walk, bathe, function…. Without the use of daily opioids I would KILL myself from the unrelenting pain & repeated injury. NO ONE should be expected to live with excruciating pain when there are medications that help relieve it. It is TORTURE, plain and simple. Anyone who says otherwise doesn’t have a clue or a conscience. When legit pain patients are taking and storing their medications responsibly, don’t mix them with substances that will cause DEATH, use one pharmacy, one provider for prescribing, and have their pain significantly reduced ….. LEAVE THEM ALONE! Or, how about trade places with them for ONE day? Then there would be NO foolish discussions about dose and time limits. How about we educate the public about the dangers of these medications when they are NOT taken as directed, or taken by people who aren’t opioid tolerant, and what will happen to them if they mix them with alcohol or other contraindicated substances? How
    about we treat addiction as a disease, instead of criminalizing it. People who are addicted to drugs, will continue to abuse whatever substances they can. Until they DIE or get HELP. Taking opioids away from patients who benefit from them is NOT the answer. I had to laugh when I read part of this article in the Globe today….. SERIOUS risks for longterm opioid therapy….including hormone imbalances (hello? Those can be replaced), & increased falls in the elderly!! So…. Those things are WORSE than living in debilitating, severe, disabling PAIN everyday? I don’t think so! Some of these “doctors” want to be relieved of prescribing responsibilities. Period. They don’t make enough money off of patients who manage their pain with opioids & don’t need to spend all their time and money hanging around ERs, endless appointments, having dangerous interventional procedures, rounds of PT & cognitive behavioral therapy (ya know…. To just LEARN how to just IGNORE that feeling of having a knife sticking in their neck). How about common sense, compassion for those that suffer tremendously, safety measures & guidelines that make sense (like locking up prescriptions & having an honest
    relationship with your doctor). Here’s an even better idea! How about we start treating people in pain with respect, compassion & dignity, and stop trying to deny them treatment that helps relieve their suffering? How about we start taking medical decisions AWAY from insurance companies & politicians, and put it into the hands of capable, educated doctors, who aren’t black & white thinkers? There are plenty of pain conditions that are MORE painful, or AS painful as cancer pain. To say otherwise is simply NOT true! How about we stop listening to doctors who don’t understand pain, are desperate to hang onto their “15 minutes” in the spotlight… screaming about epidemics & body counts. Yes, stories about lives that have been destroyed by addiction, overdose and death are devastating. SO are the stories of countless pain sufferers who resort to suicide after years of living with severe untreated or under treated pain. Or the patients who are told their pain isn’t real, who are accused of being liars, fakers, scammers, and “drug seekers”. UNDER TREATED & UNTREATED PAIN is the EPIDEMIC we should be talking about & changing…..

  5. Jeanne Hyatt says:

    When people can’t get relief from their pain, they will resort to doing the only thing they can and kill themselves to find some, any relief. Is this what “responsible” physicians want?

  6. Elsie says:

    So, 30-some doctors intend to leave an aging population to deal with chronic pain without options. They sound like sado-masochists to me, probably all surgeons that fail to provide humane levels of surgical and post-surgical pain relief also.

    Humanity no longer dies at age 60 avoiding the pain of destroyed bodies from years of hard work in industrialized society. Cancer is not the only thing that causes intractable pain. People suffer from traumatic injury regularly (think of all of those returning soldiers with traumatic injury – these new rules would deny them treatment – would cause a replay of the Vietnam veteran heroin addict crisis from the 70s and the 80s in modern society). Workplace accidents, auto accidents, sports accidents. Other disease causes intractable pain and sometimes modern medicine has no other answer but to mask that pain with pain killers-opiods. Some people simply cannot find relief with the other options available (notice i said SOME people, not all). a 90 day limit isn’t going to prevent addiction, a person can becomes addicted in a week to these medications at the right dosage or with the right biological make-up.

    What these 30-some doctors are proposing would result in massive increases in disability rolls. Would result in people seeking relief in illicit drugs (heroin is an opioid too). Do they really want to see millions of heroin ODs. Most people on Rx opioids DO NOT abuse them (heroin on the other hand does not come in standard, clean, doses, rather it comes in nasty, cut with who knows what, in who know what amount doses). Most doctors prescribing them follow the law. The whole of society shouldn’t be punished because a few knowitall fradicats think that by outlawing these MEDICATIONS that society will be better. It wont. More people will be in pain, more people will turn to street drugs, more crime, more violence, more suffering, more disease (and you thought HIV and AIDS was bad – wait until a million current chronic pain suffers are getting their pain relief on the street…and sharing needles…and passing who knows what next killer disease around).

    The oath is “First do no harm” not “First make them suffer” Fear is NOT how modern medicine is supposed to be practiced. Fear is how dark-ages medicine was practiced. Doctors who break the rules should be punished. Patients who no longer need opiods should not be granted the medications. Patients who have become addicted should be TREATED. Making everyone in the world suffer isnt the solution because a few doctors break the rules or because a few patients cannot control themselves…and that IS the outcome of this “solution”…suffering…on massive scale

  7. HS says:

    What a joke. 37 doctors? Out of all the doctors and officials nation wide? Can this even be accepted? It represents such a small portion of the population. Why doesn’t someone report on the myriad of petitions online from pain patients with 100-1000′s of signatures. What happened to government for the people by the people, instead of government for the people by the rich and powerful. So tired of an America without democracy, freedom, and rights. Good-bye America, I’ll miss you!

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