Addiction/Abuse Risk
15,000 Americans die every year from pain killer overdoses–that's 40 per day. And, the death rate continues to worsen, it has increased three fold over the last 25 years. Considering that opioid-based like OxyContin, fentanyl, Percocet, Darvocet, Roxicodone,
15,000 Americans die every year from pain killer overdoses
Firstly, consider in 2010 nearly 3,000 young people (aged 18-25) died of prescription drug overdoses. The expense of those drugs leads many to heroin, and about half of young IV heroin
users report that they got addicted by abusing opioids first.
Secondly, consider who the typical new “junkie” is: white, under age 30 (many are teenagers), from middle-class, educated suburban families–that have lectured their children about street drugs like crack, but never mentioned the pain killers in their medicine chest.
Learn about this growing crisis among average, middle- and upper-class people in Erin Marie Daly's 2014 book Generation Rx: A Story of Dope, Death, and America's Opiate Crisis, summarized here.
So What Happened?
For centuries, opium-based compounds have been used to treat pain. In the US for many years traumatic injuries, postoperative pain, and pain associated with terminal illnesses such as cancer were treated with opioid analgesics with little controversy. In the 1980’s the intersection of the growth of medicine-as-business (think about those drug and lawyer ads that suddenly appeared on TV) along with more patient-centered treatment (patient satisfaction measures drove hospital–insurer negotiations) caused an expansion of opioid use in noncancer pain treatment. Also, this was happening in the context of increasing recreational drug abuse in the “self-medication” era. Between 1999 and 2010 sales of opioid-based painkillers increased 4-fold. Of course, drug companies met the increasing demand by manufacturing more and newer formulations, but all were still based on opiates or it’s synthetic variations (like morphine).
Drug companies were sensitive to the addiction risk and overdose issues, so they developed extended-release (ER) products to lessen dosing frequency which was believed to play a role in the addiction process, as well as reduce patient suffering between doses. However, abusers discovered that crushing ER pills allowed a “high” upon inhaling or injecting a solution of the pill’s contents all at once.
In addition to the above factors, expressed in a 2012 JAMA viewpoint, there may be hidden forces driving the increased use of pain medications. Doctors who have prescribed more pain killers to meet Joint Commission analgesia standards and/or to protect patient satisfaction scores “have become the primary supplier of the drugs fueling this epidemic.” Of course, another big factor is marketing:
Secondly, consider who the typical new “junkie” is: white, under age 30 (many are teenagers), from middle-class, educated suburban families–that have lectured their children about street drugs like crack, but never mentioned the pain killers in their medicine chest.
Learn about this growing crisis among average, middle- and upper-class people in Erin Marie Daly's 2014 book Generation Rx: A Story of Dope, Death, and America's Opiate Crisis, summarized here.
So What Happened?
For centuries, opium-based compounds have been used to treat pain. In the US for many years traumatic injuries, postoperative pain, and pain associated with terminal illnesses such as cancer were treated with opioid analgesics with little controversy. In the 1980’s the intersection of the growth of medicine-as-business (think about those drug and lawyer ads that suddenly appeared on TV) along with more patient-centered treatment (patient satisfaction measures drove hospital–insurer negotiations) caused an expansion of opioid use in noncancer pain treatment. Also, this was happening in the context of increasing recreational drug abuse in the “self-medication” era. Between 1999 and 2010 sales of opioid-based painkillers increased 4-fold. Of course, drug companies met the increasing demand by manufacturing more and newer formulations, but all were still based on opiates or it’s synthetic variations (like morphine).
Drug companies were sensitive to the addiction risk and overdose issues, so they developed extended-release (ER) products to lessen dosing frequency which was believed to play a role in the addiction process, as well as reduce patient suffering between doses. However, abusers discovered that crushing ER pills allowed a “high” upon inhaling or injecting a solution of the pill’s contents all at once.
In addition to the above factors, expressed in a 2012 JAMA viewpoint, there may be hidden forces driving the increased use of pain medications. Doctors who have prescribed more pain killers to meet Joint Commission analgesia standards and/or to protect patient satisfaction scores “have become the primary supplier of the drugs fueling this epidemic.” Of course, another big factor is marketing:
The US Food and Drug Administration (FDA) is tasked with ensuring that medications are effective and safe. However, the FDA is prevented from interfering with the “practice of medicine.” At the crossroads of these requirements is postmarketing, off-label prescribing, over which the FDA historically had limited direct influence.
LS Nelson, J Perrone. JAMA 2012; 308.
What Has Been Done About It?
There has been much attention to the growing problem of prescribed pain killer abuse/addiction and conversion to heroin use, which is the subject matter covered on this website. The following sections will show odd-ball attempts to address this, like making pain pills rubbery to make it harder to crush them. The conflict between treating drug addiction as a medical problem vs. a crime will be addressed. The DEA’s involvement needs to be understood as it continues to play a role in doctors’ “fears” of using pain killers, even when warranted. Various attempts at legislation and addiction treatment will be covered. The “drug-free” residential treatment programs favored in the US (based on Alcoholics Anonymous 12-step programs) don’t work over 90% of the time for opioid addiction treatment will be discussed. Ultimately, we will offer methods to determine who is at most at risk for abuse/addiction to opioids, and whole-patient approaches to pain management that can complement the use of medications.
We first turn to the FDA for guidance on medications. The Food and Drug Administration Amendments Act (FDAAA) of 2007 empowered the FDA to require “postmarketing” studies of a drug’s safety after it has been released. This is part of the new science of pharmacovigilance, according to Wikipedia at least, that involves postmarketing surveillance (PMS). The idea is that just because a drug showed no harmful effects in a small, short-term clinical trial before its release for sale, does not mean it is safe for long-term use in large populations. This is exactly the problem that evolved when opioid use was expanded to the noncancer, larger population in the US.
Another result of the FDAAA was the FDA was empowered to mandate that a drug manufacturer produce a Risk Evaluation and Mitigation Strategy (REMS) for any drug that was shown useful, but also had potential to cause harm. So far two types of opioid-based pain killers are included in this class. We will have much to say about the REMS process later on this website.
There has been much attention to the growing problem of prescribed pain killer abuse/addiction and conversion to heroin use, which is the subject matter covered on this website. The following sections will show odd-ball attempts to address this, like making pain pills rubbery to make it harder to crush them. The conflict between treating drug addiction as a medical problem vs. a crime will be addressed. The DEA’s involvement needs to be understood as it continues to play a role in doctors’ “fears” of using pain killers, even when warranted. Various attempts at legislation and addiction treatment will be covered. The “drug-free” residential treatment programs favored in the US (based on Alcoholics Anonymous 12-step programs) don’t work over 90% of the time for opioid addiction treatment will be discussed. Ultimately, we will offer methods to determine who is at most at risk for abuse/addiction to opioids, and whole-patient approaches to pain management that can complement the use of medications.
We first turn to the FDA for guidance on medications. The Food and Drug Administration Amendments Act (FDAAA) of 2007 empowered the FDA to require “postmarketing” studies of a drug’s safety after it has been released. This is part of the new science of pharmacovigilance, according to Wikipedia at least, that involves postmarketing surveillance (PMS). The idea is that just because a drug showed no harmful effects in a small, short-term clinical trial before its release for sale, does not mean it is safe for long-term use in large populations. This is exactly the problem that evolved when opioid use was expanded to the noncancer, larger population in the US.
Another result of the FDAAA was the FDA was empowered to mandate that a drug manufacturer produce a Risk Evaluation and Mitigation Strategy (REMS) for any drug that was shown useful, but also had potential to cause harm. So far two types of opioid-based pain killers are included in this class. We will have much to say about the REMS process later on this website.
The Dilemma: Untreated Pain
This writer recalls reading, 25 years ago, the game-changing article The Tragedy of Needless Pain by Dr. Ronald Melzack published in Scientific American. That article helped define the national debate on the dilemma of risking addiction to treat pain. No one seemed to argue with use of the morphine-type drugs in treating terminal cancer pain; however Dr. Melzack pointed out:
Sadly, there are some kinds of pain that existing treatments cannot ease. That care givers can do little in these cases is terribly distressing for everyone involved but is certainly understandable. What seems less understandable is that many people suffer not because their discomfort is untreatable but because physicians are often reluctant to prescribe morphine. Morphine is the safest, most effective analgesic (painkiller) known for constant, severe pain, but it is also addictive for some people. Consequently, it is typically meted out sparingly, if it is given at all.
Dr. Melzack argued that the studies up to 1990 showed that avoiding pain medication in psychologically sound pain patients without history of substance abuse due to fear of addiction made little sense. He believed that addiction was most likely in people who take morphine for its mood-altering properties (e.g., its ability to produce euphoria and relieve tension), because they require increasing doses to achieve these feelings. He suggested a need to distinguish between the addict who craves morphine for its mood-altering effect from the “psychologically healthy patient who takes the drug only to relieve pain.” While this is true, we now know that people without prior substance abuse issues are also susceptible to addiction, and thus there is a need to assess all potential patient for abuse risk.
Dr. Melzack also argued against the PRN, or as needed, approach to pain medication use. Rather than wait for a patient to plead for an injection, he advocated for an approach where “doses are given regularly, according to a schedule that has been actually tailored to prevent recurrence of the individual’s pain. Thus, pain is controlled continuously; a patient does not wait for discomfort to return before receiving the next dose.” This pain prevention approach was particularly successful in controlling cancer-related pain.
Based on studies at the time it was widely believed that so-to-speak “genuine” pain patients did not develop high tolerance to morphine and thus were not at significant addiction risk. So the professional mood shifted to trying to determine who had real pain vs. imagined or fake pain, in order to prevent abuse/addiction. We now know the borderline between mental and physical pain is blurred, and the DSM-5 does not make this distinction. Dr. Melzack did help loosen the restraints on the use of pain medication which helped many patients. It also helped jump-started a pharmaceutical industry and given the shear volume of patients who were treated, with a resulting increase in prescription drug abuse.
As a psychologist, Dr. Melzack never suggested that a drug prescription should replace a multidisciplinary approach to pain management; in fact, he believed both approaches to be compatible and complementary with each other. TestSTAT’s philosophy is based on the goal of reducing addiction risk to allow considering pain medication as an option for any patient. We also believe in bringing in alternative and complementary treatments to supplement medications, and replace them where possible. “The goal is nothing short of rescuing people whose lives are now being ruined by pain” as Dr. Melzack put it in the concluding statement of his seminal Scientific American article.
Read on for a Patient’s Viewpoint of pain in the next section.
Dr. Melzack also argued against the PRN, or as needed, approach to pain medication use. Rather than wait for a patient to plead for an injection, he advocated for an approach where “doses are given regularly, according to a schedule that has been actually tailored to prevent recurrence of the individual’s pain. Thus, pain is controlled continuously; a patient does not wait for discomfort to return before receiving the next dose.” This pain prevention approach was particularly successful in controlling cancer-related pain.
Based on studies at the time it was widely believed that so-to-speak “genuine” pain patients did not develop high tolerance to morphine and thus were not at significant addiction risk. So the professional mood shifted to trying to determine who had real pain vs. imagined or fake pain, in order to prevent abuse/addiction. We now know the borderline between mental and physical pain is blurred, and the DSM-5 does not make this distinction. Dr. Melzack did help loosen the restraints on the use of pain medication which helped many patients. It also helped jump-started a pharmaceutical industry and given the shear volume of patients who were treated, with a resulting increase in prescription drug abuse.
As a psychologist, Dr. Melzack never suggested that a drug prescription should replace a multidisciplinary approach to pain management; in fact, he believed both approaches to be compatible and complementary with each other. TestSTAT’s philosophy is based on the goal of reducing addiction risk to allow considering pain medication as an option for any patient. We also believe in bringing in alternative and complementary treatments to supplement medications, and replace them where possible. “The goal is nothing short of rescuing people whose lives are now being ruined by pain” as Dr. Melzack put it in the concluding statement of his seminal Scientific American article.
Read on for a Patient’s Viewpoint of pain in the next section.