Opioid Risk Evaluation Mitigation Strategy

Opioid Risk Evaluation Mitigation Strategy

Along with a dozen other members of our national coalition, Advocates For Prescription Opioid Drug Reform (“APODR”), Larry Golbom, host of the Prescription Addiction Radio Show, and I attended a meeting on February 10, 2009 that was convened by the Food and Drug Administration (“FDA”). This was an “invitation only” meeting to discuss possible actions that the federal government could take to address the misuse of prescription opioids.

Unfortunately, many of our APODR members have lost children or loved ones because of these narcotic prescription drugs that are interchangeable with heroin. Almost all of our younger patients at Novus Medical Detox Center tell us that they have numerous friends that have died from opioid overdoses. When I speak to high school classes about the dangers of prescription drugs, I often am approached by a student who tells me of a friend who died from taking one of these dangerous narcotics.

Medical doctors who are members of APODR are outraged and embarrassed by rogue medical doctors who run coupons in the paper offering to do an exam and provide a prescription for OxyContin and Xanax, all for the price of only $150.00. Our member doctors are outraged and embarrassed by doctors who don't try to address the actual cause of a patient's pain but instead make them dependent on narcotics that treat nothing but only mask the symptoms.

Most of us believe that the inaction of the FDA has created the environment in which the manufacturers of these opioids and certain medical doctors have created this deadly epidemic. Needless to say, when we arrived at the February 10th meeting we were prepared for a combative meeting with our demanding action and the FDA officials being evasive.


We were pleasantly surprised. Both Deputy Director Douglas Throckmorton and Dr. Bob Rappaport, the director of the group overseeing the opioid class of drug, were friendly and interested in listening to our views. Doug Throckmorton very proudly explained to me that the announcement on February 9, 2009 that they were going to require Risk Evaluation Mitigation Strategies (“REMS”) for the most common and deadly narcotic drugs.

The affected opioid drugs include brand name and generic products that are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. Doctors wrote over 21 million prescriptions for these dangerous drugs in 2007. The FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) which became law in September of 2007.

REMS can be required when the FDA is concerned that the risks of a drug may outweigh the benefits of the drug. Dr. Dal Pan, the Director of the Office of Surveillance & Epidemiology Center for Drug Evaluation and Research, gave a presentation at the meeting and explained some of the elements that the FDA may require.

Here are some of the choices:

  • Revised patient and/or professional labeling;

  • Healthcare providers who prescribe the drug have particular training or experience or special certificates;

  • Pharmacies, practitioners or healthcare settings that dispense the drug are specially certified;

  • The drugs may only be dispensed in certain healthcare settings, i.e., in a hospital;

  • Requiring that the drug may only be dispensed after receiving written consent from the patient, a pregnancy test and a liver enzyme test;

  • Patients receiving the drug to be included on a patient registry.


In an article entitled F.D.A. to Place New Limits on Prescriptions of Narcotics written by Gardiner Harris and published February 10, 2009 in the NEW YORK TIMES, Dr. John K. Jenkins, director of the F.D.A.’s new drug center, was quoted as saying that the current restrictions have failed to “fully meet the goals we want to achieve...What we’re talking about is putting in place a program to try to ensure that physicians prescribing these products are properly trained in their safe use, and that only those physicians are prescribing those products.“This is going to be a massive program.”

The article continues, “Doctors are also to blame. A common reason for disciplinary actions at state medical boards is the use of narcotics in patients who show clear signs of addiction or for whom the drugs are obviously inappropriate. The F.D.A. generally avoids interfering with the practice of medicine because doctor behavior is governed by state medical boards. Instead, the agency usually tries to provide doctors with the best and most current information, and then allows them to decide how to use it.”


After listening to the presentations by the FDA and other federal regulatory agencies about what they feel the opioid REMS will accomplish, it seems that a key issue is going to be the definition of treatment.

Palliative Treatment

The paid representatives of the drug companies who run the various pain associations argued that people in pain need to be “treated” with these narcotics. No one wants people to suffer, but it seems that the treatment advocated by the drug companies and their paid advocates is palliative treatment, not real treatment.

Palliative comes from the Latin word pallium. A pallium was a cloak. Therefore, palliative treatment would be any treatment that “cloaked” or covered up the actual problem. An example of a palliative treatment for a car engine that was making grinding noises would be to not find out why and repair it but simply turn up the volume of the radio so you cannot hear it. Pretty soon you would be stopped at the side of the road with an expensive problem.

In addition, unbiased medical studies are showing that this palliative treatment with narcotic opioids actually creates more pain—opioid-induced hyperalgesia. For many, after six months the pain actually increases and is not alleviated regardless of the amount of opioids a person takes. The pain increases to a point where the person cannot safely take larger doses of opioids to control it.

Real Medical Treatment

While it is not always possible because our knowledge of genetics is so limited, we should always seek to cure any medical illness or problem, not mask the symptoms. This is particularly true when dealing with pain. Except for people who only have months to live, isn't it better to treat the cause of the suffering than to have people dependent/addicted to these dangerous narcotics that only mask the pain? If you can't feel any pain, are you not likely to further harm the source of the pain by different movements or things that you do like lifting too much weight?

At the FDA meeting, we met Dr. Saper, who runs an institute in Michigan that treats headaches. He requires anyone coming to his institute to be off all opioids because they have found the opioids just make the headaches worse.

The Rosomoff Institute in Miami regularly helps people handle the cause of their pain and, in many cases, be off all medication. They will not treat patients who are on opioids. As their website explains, “Our philosophy is to treat the cause of pain and not teach people to 'live with pain'. Your pain is real. Our decades of research and experience indicate that chronic pain has a physical cause; often with unavoidable behavior consequences.”


At Novus Medical Detox Center, we regularly have people arrive on a high daily dose of opioids and a pain level of eight (on a scale of one to ten with ten being the highest level of pain), who detox off the opioids and find that they have a pain level of two. One of our patient's success stories is in this newsletter. Other patients have come to Novus on high doses of opioids, received treatment from a physical therapist and left Novus off of all drugs and also with little or no pain.

Opioids are not the answer for almost all non-terminal patients. They have a role to control the pain until the necessary tests and treatment can be done to locate and treat the cause.

We have been assured that APODR will be invited to a meeting after the drug manufacturers meet with the FDA on March 3, 2009. We expect to be able to review the restrictions proposed by the drug companies. It is almost certain that they are going to propose some restrictions but it is doubtful that they will address the real issue—the type of treatment for which these dangerous narcotics are used.

Since the FDA and the drug companies apparently read this newsletter, here is what we believe the REMS for the opioids should require:

  • These dangerous drugs are used only as part of the medical treatment for non-terminal patients;

  • Any doctor who prescribes more than twenty opioids to a non-terminal patient has to have specialized training in how to recognize and address the actual cause of a patient's pain;

  • Opioids can only used for limited amounts of time for non-terminal patients unless it can be established that all attempts at handling the cause of the pain have failed.

At Novus Medical Detox Center we daily help people escape the trap of OxyContin addiction, Vicodin addiction, heroin addiction, high dose methadone addiction and addictions to other opioids. We also help people detox from alcohol and other drugs—like antidepressants and benzodiazepines on which they have become dependent. Please call us if we can help.

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