10/3/17

Feuding Ideologies, Part 1

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In August of 2017, the now former Health and Human Services Secretary, Tom Price, said he didn’t think it was necessary to declare the opioid epidemic to be a national emergency. This was despite the president’s own opioid commission recommending it as the “first and most urgent recommendation.” Two days later, the President reversed Price’s statement, saying: “The opioid crisis is an emergency, and I’m saying officially right now it is an emergency.” The response was mixed. While President Trump’s announcement could be used to help free up federal resources and help to prioritize responses to the disaster, it could also permit the administration to push for new sentencing legislation in order to get “tough on crime” related to drug use.

What isn’t disputed is that the U.S. does have a serious opioid problem and something needs to be done about it. Drug overdose is the leading cause of death in Americans under the age of fifty. Forecasts by STAT News are the annual death rate will increase by at least 35 percent by 2027. The CDC reported that from 2002 to 2015 there was a 5.9-fold increase in the overdose deaths from heroin and non-methadone synthetic opioids.

The latest statistics for the U.S. opioid epidemic is now available in the 2016 National Survey on Drug Use and Health (NSDUH). Among the myriad of statistics reported there was news that heroin users increased 230% from 2002 to 2016, while heroin deaths increased 630%. An estimated 948,000 people aged 12 or over reported they used heroin in the past year. That translates to .4% of the country’s population. There were also an estimated 11.5 million people who misused pain relievers in the past year, 4.3% of the population aged 12 or over. Combined, there are 11.8 million people who misused opioids, 4.4% of the population, in 2016.

The 2016 NSDUH Report can be accessed here. A shorter, graphic-based report of key findings, including those noted above, is here.

One of the treatment approaches often touted to address the opioid crisis is medication-assisted treatment (MAT) with Suboxone. In January of 2015, Jason Cherkis wrote “Dying To Be Free.” His subtitle asked why we weren’t using a treatment for heroin addiction—Suboxone—that actually worked. The opioid problem in Kentucky was the focus of his article, which I found to be rhetorically persuasive and well written. You are introduced to individual after individual who wouldn’t or couldn’t use Suboxone and ended up dead from an eventual overdose.

“Dying To Be Free” was a finalist for a Pulitzer in 2016 for its “deeply researched reporting on opioid addiction” that showed how many drug overdoes deaths could have been prevented. The cover letter submitted for its entry for the Pulitzer by The Huffington Post said it triggered a series of state and federal policy changes that rejected abstinence for opioid misuse and embraced medication-assisted treatment. “‘Dying To Be Free’ offered readers an immersive experience that included audio and video documentaries and photo and data displays.”

This was not fake news. “Dying to Be Free” captured the agony of individuals and families who struggle with opioid misuse. But it also made abstinence-based approaches to treatment and recovery a bogeyman responsible for many of the unnecessary deaths from opioid overdoses. The rhetoric of the article was a straw man attack on abstinent-based treatment while it extolled MAT. Its biomedical treatment bias seemed to dismiss or ignore many of the problems with Suboxone as a MAT for opioid addiction. Nor did it tell the whole story behind Suboxone. It also misrepresented the recovery philosophy of self-help groups like Alcoholics Anonymous. Here’s what I mean.

In the last paragraph of his second chapter, Cherkis said: “There’s no single explanation for why addiction treatment is mired in a kind of scientific dark age, why addicts are denied the help that modern medicine can offer.” This succinctly captures the problem as he sees it with existing treatment approaches to the opioid crisis. Heroin addiction is a medical disease and should be treated as a medical disease. Modern medicine has a scientific treatment for heroin addiction that is resisted because of stigma, a deep-rooted adherence to self-help, and the criminalization of heroin addiction. If you question or oppose MAT, you are apparently mired in a kind of scientific dark age.

To enter the drug treatment system, such as it is, requires a leap of faith. The system operates largely unmoved by the findings of medical science. Peer-reviewed data and evidence-based practices do not govern how rehabilitation facilities work. There are very few reassuring medical degrees adorning their walls.

Dr. Mary Kreeft, one of the pioneers of methadone maintenance, was liberally quoted to support the medical model of addiction. She noted how opioid addiction alters multiple regions in the brain, including those that regulate reward, memory, learning, stress, hormonal response and stress sensitivity. According to Dr. Kreeft, after a long cycle of opiate addiction, a person needs specific medical treatment. Some people may be OK in time. But “the brain changes, and it doesn’t recover when you just stop the drug because the brain has been actually changed.”

An abstinence-only treatment that may have a higher success rate for alcoholics simply fails opiate addicts. “It’s time for everyone to wake up and accept that abstinence-based treatment only works in under 10 percent of opiate addicts,” Kreek said. “All proper prospective studies have shown that more than 90 percent of opiate addicts in abstinence-based treatment return to opiate abuse within one year.” In her ideal world, doctors would consult with patients and monitor progress to determine whether Suboxone, methadone or some other medical approach stood the best chance of success.

This is a rigid, strict medical model of opioid addiction. And it gives a mixed message regarding whether or not the individual will ever be able to stop taking Suboxone or methadone. Neither drug, said Cherkis, is a miracle cure. But they buy addicts time to fix their lives, seek counseling and allow their brains to heal. So far, so good. But here comes the caution: Doctors recommend tapering off the medication cautiously. The process could take years, as addiction is a chronic disease and effective therapy takes time. Then comes the typical analogy of the pure medical model of addiction:

Doctors and researchers often compare addiction from a medical perspective to diabetes. The medication that addicts are prescribed is comparable to the insulin a diabetic needs to live.

There is no mention of neuroplasticity—the brain’s ability to reorganize itself by forming new neural connections. “Neuroplasticity allows the neurons (nerve cells) in the brain to compensate for injury and disease and to adjust their activities in response to new situations or to changes in their environment.”

Jeffrey Schwartz and Rebecca Gladding use an almost identical description of neurological action to that given above by Dr. Kreeft to describe how to change the brain; to modify bad habits (including addiction) and unhealthy thinking. In You Are Not Your Brain, they describe how we teach our brains to act in unhealthy ways. The brain does not distinguish between beneficial and destructive habits, “it just responds to how you behave and then generates strong impulses, thoughts, desires, cravings, and urges that compel you to perpetuate your habit, whatever it may be.”

Clearly, the brain can exert a powerful grip on one’s life—but only if you let it. The good news is that you can overcome the brain’s control and rewire your brain to work for you by learning to debunk the myths it has been so successfully selling you and by choosing to act in healthy, adaptive ways.

Neuroplasticity, as described by Schwartz and Gladding, does not reject Kreeft’s neurological description of addiction.  But it does say it isn’t the whole story. An ideology of addiction as a purely biomedical condition seems to permeate “Dying To Be Free.” Addiction, when conceived strictly as a brain disease, rejects or ignores the non-scientific construct of mind. If we are conceived as only biological beings, then addiction is explained and treated within a biomedical worldview. Any treatment approach to addiction not based on this premise is therefore faulty.

Drug treatment facilities were said in “Dying To Be Free” to “generally” fail to distinguish between addictions. They have a one-size-fits-all approach.  Addicts in residential treatment experience a “hodgepodge” of drill-instructor tough love and self-help lectures. Programs appear simultaneously excessively rigid and wildly disorganized. “And with roughly 90 percent of facilities grounded in the principle of abstinence, that means heroin addicts are systematically denied access to Suboxone and other synthetic opioids.”

After describing two older, drug treatment programs with a therapeutic community model of care that used coercive techniques—Synanon and Daytop (Drug Addicts Yield TO Persuasion)— he said:

The number of drug treatment facilities boomed with federal funding and the steady expansion of private insurance coverage for addiction, going from a mere handful in the 1950s to thousands a few decades later. The new facilities modeled themselves after the ones that had long been treating alcoholics, which were generally based on the 12-step methodology. Recovering addicts provided the cheap labor to staff them and the evangelism to shape curricula. Residential drug treatment co-opted the language of Alcoholics Anonymous, using the Big Book not as a spiritual guide but as a mandatory text — contradicting AA’s voluntary essence. AA’s meetings, with their folding chairs and donated coffee, were intended as a judgment-free space for addicts to talk about their problems. Treatment facilities were designed for discipline.

In support of this claim, Cherkis referred to a 2012 study conducted by the National Center on Addiction and Substance Abuse at Columbia University. It apparently was a reference to “Addiction Medicine: Closing the Gap between Science and Practice.” He said the study concluded the U.S. treatment system was in need of a “significant overhaul” and questioned whether the low levels of care received by addiction patients constituted a from of medical malpractice.

While medical schools in the U.S. mostly ignore addictive diseases, the majority of front-line treatment workers, the study found, are low-skilled and poorly trained, incapable of providing the bare minimum of medical care. These same workers also tend to be opposed to overhauling the system. As the study pointed out, they remain loyal to “intervention techniques that employ confrontation and coercion — techniques that contradict evidence-based practice.” Those with “a strong 12-step orientation” tended to hold research-supported approaches in low regard.

The Columbia University study did state a significant overhaul was needed in current treatment approaches; and it raised the question if the insufficient care received by addiction patients constituted “a form of medical malpractice.” It also pointed to the need for medical schools to “educate and train physicians to address risky substance use and addiction.” Unsurprisingly, it went on to say that all aspects of stabilization and treatment with addictions should be managed by a physician “as is the case with other medical diseases.” Remember that the Columbia study and Cherkis were both advocating for a physician-centered, medical model approach to addiction treatment.

However, I couldn’t find where it was supposed to have said the majority of front-line treatment workers were low-skilled and poorly trained. There was a section stating that physicians and other health professionals should be on the front line addressing addiction. Then it said: “Paraprofessionals and non-clinically trained and credentialed counselors can provide auxiliary services as part of a comprehensive treatment and disease management plan.”

It did not say the majority of front-line treatment workers were low-skilled and poorly trained “incapable of providing the bare minimum of medical care.” Yet in the case study examples found in “Dying To Be Free,” that is what Cherkis presented. The Columbia study did cite another study, which found that recovering support staff had little enthusiasm for evidence-based practices. “They also were more likely to support intervention techniques that employ confrontation and coercion–techniques that contradict evidence-based practices.” But these paraprofessionals only made up “24 percent of the treatment provider workforce.”

Cherkis seems to have mis-remembered what the Columbia study actually claimed in this matter. I wonder if, because of his commitment to a strictly medical model ideology for opiate treatment, he was reading into the study. His quote above supported the description of the treatment facilities he highlighted in his article, but wasn’t found by me in the article he cited on the Columbia study.

Another example of how his treatment ideology distorted his portrayal of Suboxone treatment was with how he described Hazelden’s Suboxone treatment program. “Dying To Be Free” mentioned that Hazelden, now the Hazelden Betty Ford Foundation, developed its own Suboxone treatment program for opioid addicts. But it failed to note this wasn’t accompanied by a rejection of “Twelve Step practices.” Within “The History of Hazelden,” on the Hazelden Betty Ford Foundation website, was the statement of how it “integrates the cornerstone Twelve Step practices of mutual support along with multidisciplinary clinical care, evidence-based therapies and the latest research in brain science.” Why weren’t there some case study examples from Hazelden in “Dying To Be Free”?

The facilities Cherkis highlighted in Kentucky were not representative of abstinent-based addiction treatment centers in the U.S.; ones that use the 12 Steps to structure their treatment program. In reading “Dying To Be Free” I see an underlying ideology of conceiving and treating addiction, specifically opiate addiction, through a strict biomedical lens. That is not the whole story of addiction. As a result, the rhetoric of the article constituted a straw man attack on abstinent-based treatment while it extolled MAT. This bias presents readers with an implied choice, a dichotomy, between Suboxone as an MAT for addiction and 12 Step, abstinent-based treatment. Ironically, Hazelden, an historically important treatment center that pioneered 12 Step, abstinence-based treatment, did not choose MAT over the 12 Step-based treatment, but combined the two. But you don’t get that information in “Dying To Be Free.”

Parts 2 and 3 of this article will look at how “Dying To Be Free” misrepresented the recovery philosophy of self-help groups like Alcoholics Anonymous; and skimmed over the problems with MAT, specifically Suboxone.

04/5/16

I Smell a RAT

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© antonihalim | Stockfresh.com

Medication Assisted Treatment (MAT) for addiction comes in various forms that are often (unhelpfully) lumped together into one category. Replacement or substitution methods, like methadone or Suboxone maintenance are radically different from using naltrexone to treat alcohol or opioid use disorders. Yet they are combined into the single category of MAT. While naltrexone is not a cure for addiction, it has been shown to help minimize cravings for urges for both alcohol and opioids. And there is some evidence emerging that it could be useful to blunt cravings for methamphetamine.

In 2010 Karlia et al. did a literature review on pharmacological approaches to treat methamphetamine use disorders. They concluded there was no substantial evidence for effective treatment at the time. “Clinical trials using aripiprazole [Abilify], GABA agents (gabapentin [Neurontin], baclofen, vigabatrin), SSRIs, ondansetron and mirtazapine [Remeron] have failed to show efficacy.” They noted where there was some indication where “agonist replacement medications” like d-amphetamine and modafinil may hold some promise.

The unavoidable problem with “treating” methamphetamine addiction with d-amphetamine is you are using a similarly addictive substance to “treat” methamphetamine addiction. Again, it repeats the error of opioid substitution/replacement therapy. While methamphetamine and amphetamine are Schedule II controlled substances, Modafinil still has an addictive potential as a Schedule IV. It is used to treat narcolepsy and shift work disorder, and it is touted as a “life hack” on Wall Street or “smart pill”—until you decide to stop taking it.

They also pointed to the work of Swedish researcher, Nitya Jayaram-Lindström, who showed in a 2005 study where naltrexone significantly reduced the subjective effects of dexamphetamine and blocked cravings in dependent patients. Additionally, the frequency and amount of amphetamine use was significantly reduced. A double blind study by Jayaram-Lindström in 2008 again showed the efficacy of naltrexone in reducing cravings and self-reported use of amphetamine. A further double-blind, placebo-controlled study by Jayaram-Lindström again demonstrated a significant reduction in cravings and self-reported use of amphetamine. “Naltrexone therefore appears to be a highly promising medication for amphetamine dependence.”

Now there is a study by UCLA researchers on naltrexone as a treatment for methamphetamine addiction. Here is a link to a pre-publication manuscript of the study by Ray et al. Again it was found that naltrexone blunted cravings for methamphetamine and lowered self-reports of subjective effects. Lara Ray, a UCLA psychology professor said: “The results were about as good as you could hope for.” The UCLA press release on the study and an article on The Fix by Zachary Siegel noted where clinical trials into the efficacy of naltrexone to treat methamphetamine addiction have already begun.

One clinical trial with naltrexone was completed and last updated in May of 2013 but no results are posted yet; and another study is ongoing. Although results for the complete trail by California Pacific Medical Center Research Institute were not posted on Clinicaltrails.gov, it does seem to be reported in a 2015 study by Pal et al. reported in the Journal of Addictive Medicine. There was not an improved treatment response found in this study. The Pal et al. study was quite small and does not really argue against further clinical trials into the potential use of naltrexone to treat methamphetamine addiction. The replication of Jayaram-Lindström’s results by Ray et al. are sufficient to see further research into this potential treatment.

The side effects from naltrexone are minimal, making it a viable medication to assist addicts trying to establish and maintain abstinence from dependence upon alcohol, opioids, and now—apparently—methamphetamine. Substitution or replacement medications for addiction need to be distinguished from other medications such as naltrexone within the catchall category of MAT. Perhaps they would be better labeled as SAT—Substitute Addiction Treatment—or RAT—Replacement Addiction Treatment—instead of MAT, Medication Assisted Treatment. Personally, I’m partial to RAT.

11/30/15

The Seduction of Opioid Substitution

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© Everett Collection Inc. | Dreamstime.con

Heroin and prescription opioid abuse is a widely recognized public health crisis in the United States. In 2014, Attorney General Eric Holder referred to overdose deaths from heroin and other prescription pain-killers as an “urgent public health crisis.” The CDC reported that heroin use more than doubled among young adults between 18 and 25 over the past ten years. Forty-five percent of the people who use heroin are also addicted to prescription opioids.

A July 2015 “Morbidity and Mortality Weekly Report” report by the CDC recommended a comprehensive response to this public health crisis. The recommendations included: reducing inappropriate prescribing and use of opioids, stronger prescription drug monitoring programs, improved access to evidence-based substance abuse treatment—including medication-assisted treatment for opioid use disorders and greater access and training in the use of naloxone to treat overdoses. There have been several steps taken towards making these recommendations a reality. For example, on November 18, 2015, the FDA approved the first nasal spray version of naloxone hydrocloride: Narcan nasal spray. But not all of the proposals have the same potential to free the individuals caught up in the opioid health crisis.

And legislation has been introduced in the Senate to “combat the opioid crisis.” “The Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act” would dedicate $600 million to this crisis. About $250 million would support programs related to prevention, treatment and recovery. Another $200 million would fund local and state law enforcement programs. Fifty million would go toward the CDC; and $35 million would go to NIDA to monitor prescription drug programs and do targeted research on drug addiction. “We are losing lives daily and our first responders, healthcare providers and criminal justice system are overwhelmed.”

I’m not a fan of increasing the use of opioid maintenance medications such as methadone and buprenorphine because they’re “treating” an opioid addiction with addictive opioids. And I’m concerned that in the midst of the existing health crisis, increased access to such treatment seems to be indiscriminately promoted as the most effective “treatment” approach. Sometimes the studies of medication-assisted treatment fail to consider the negative consequences to individuals when promoting opioid substitution treatment. And sometimes studies that suggest the “effectiveness” of opioid maintenance have a biased interpretation of their results. Often what emerges is a program for the social control of addicts rather than one that helps them establish and maintain a recovery-oriented lifestyle. Here is an example of one such study.

The National Institute on Drug Abuse (NIDA) turned a “Science Spotlight” on a new study that looked at intervention approaches for opioid dependent patients in emergency departments (ED). The idea is a good one—developing an intervention for ED medical personnel to help opioid-dependent patients get into treatment. But what it doesn’t make clear is that the “treatment” is primarily ongoing participation in opioid substitution treatment.

This study showed that patients who received buprenorphine, along with a brief intervention to discuss opioid use, and up to 12 weeks of buprenorphine maintenance, were more likely to get follow-up addiction treatment and had reduced self-reported illicit opioid use. In addition, they were also less likely to need inpatient addiction treatment services, saving treatment costs. This adds to the growing body of literature suggesting that opioid-dependent patients may benefit from immediate initiation of medication while awaiting more comprehensive substance use disorder treatment.

Let’s take a closer look at the study by D’Onofrio et al. to see if it truly lives up to the endorsement it received from NIDA.

The primary outcome was what the researchers called “engagement in treatment.” This was defined as being enrolled in and receiving formal addiction treatment on the 30th day following randomization. “Formal addiction treatment” could include a range of clinical settings such as an opioid treatment program, such as a methadone clinic, inpatient or residential treatment and outpatient services. The outpatient services could be intensive outpatient programs and “office-based physicians who prescribe buprenorphine or other forms of medication-assisted treatment.”

The patients in the buprenorphine group of the study received buprenorphine in the hospital and take-home doses of buprenorphine to last until a scheduled appointment in the hospital’s primary care center, which was within 72 hours of their placement in the group. The buprenorphine patients continued to receive office-based burprenorphine treatment for 10 weeks. At that time they were transferred to a maintenance treatment program or a clinician for ongoing treatment. If they preferred, they were offered a 2-week detoxification.

In the buprenorphine group, 78% of the patients were still engaged in treatment at the thirty-day follow-up. Only 37% of the referral only group and 45% of the brief intervention and referral group were engaged in treatment. But remember what the study considered as “treatment.” Any patient in the buprenorphine group who was still active in the free, office-based treatment after 30 days would have been counted as “still engaged in treatment.”  And they would have had another 40 days of free buprenorphine coming.

There was no information or data available on any of the groups beyond the thirty-day follow-up. So there was no clear indication if the patients in the buprenorphine group remained in treatment beyond the 10 weeks of the study’s subsidy of their substitution treatment. If the goal was to eventually engage individuals in more comprehensive treatment services, this “interim opioid agonist treatment,” should not have been lumped in with others as the outcome measure of “formal addiction treatment.” The failure of the researchers to distinguish this level of care from the others confounds the findings within the study’s primary outcome measure.

These patients had buprenorphine treatment initiated before they left the hospital. They also had an appointment scheduled within 3 days of their initial dose, with sufficient take-home medication to prevent any withdrawal until that appointment time. The other two groups did not receive any medication and so were on their own medically until they made an appointment and became engaged in treatment. They were sitting ducks for resuming the illicit opioid use that initially brought them to the ED. So the deck was staked in favor of the primary outcome measure.

Additionally, the buprenorphine care in the study was provided at no cost to the patients. The researchers dismissed this as a potential bias in their study, saying that 80% of the study’s patients had health insurance. However there are potential cost issues in health insurance despite the authors’ dismissal. Buprenorphine maintenance treatment is not always covered by insurance, as it is considered a “niche” medicine by insurance plans, as it is approved solely for the treatment of opioid dependence. Insurance companies predict that a limited number of their covered clients will need or use it. When there is coverage, there can be high co-pays. Insurance may pay for the prescription but not the office visits. Some Suboxone doctors don’t take insurance.

A secondary outcome measure for the study was self-reported use of illicit opioids. The buprenorphine group reported greater reductions in the mean number of days of illicit opioid use, from 5.4 days per week to .9 days per week. Patients in the referral group decreased from 5.4 days per week to 2.3 days; and the brief intervention group went from 5.6 days to 2.4 days. Remember that the buprenorphine group was treated with medication (buprenorphine) that forestalled withdrawal symptoms from the time they were placed in that treatment group while still in the hospital ED. Also, all three groups reduced their illicit opioid use over time. Comparing the buprenorphine treatment group to the others indicated that even with the medication, there were only 1.4 or 1.5 days less per week of illicit opioid use in the buprenorphine group.

Finally, the decreased use of inpatient treatment by the buprenorphine group was to be expected. The withdrawal symptoms that often precipitate detoxification or residential treatment were being addressed by the buprenorphine.

It has long seemed to me that the so-called harm reduction approach of opioid substitution treatment is more social control than actual treatment aimed at helping the individual addict to establish and then maintain sobriety. The positive outcomes and effects that are highlighted are typically things like lowered costs for residential treatment; lowered ED visits and costs; decreased drug-related crime.

There is proposed legislation, the Recovery Enhancement for Addiction Treatment Act, which would broaden the definition of a qualifying practitioner to include certain nurse practitioners or physician assistants and doctors with a board certification from the American Board of Addiction Medicine. The number of patients that a qualifying practitioner could dispense buprenorphine to within their first year would increase from 30 to 100. After one year, qualifying physicians could request approval to treat an unlimited number of patients under specified conditions. Writing about this proposed bill for the Huffington Post, James Charkis said:

The consensus among the medical establishment is that medically assisted treatments such as buprenorphine (and methadone), along with counseling, represent the best chance for addicts to gain a foothold on sobriety. Both medications can make withdrawal less painful and can significantly diminish further cravings for opioids — greatly reducing the chance of relapse.

One of the problems as I see it is that this “best chance” description is often mostly rhetoric. The “along with counseling” add-on becomes more window dressing than reality. Even where there is a tighter requirement for Suboxone patients to be active in some kind of counseling, individuals either fall through the cracks with counseling or just take up space because their presence in counseling is required for them to get what they really think will “treat” them—their Suboxone. Some individuals merely want Suboxone handy in case they can’t get any heroin or their opioid of choice to get high. Others want it to sell on the street to make some cash.

There is a place for opioid substitution treatment as we attempt to address the opioid health crisis. But the potential adverse consequences to the individual receiving the treatment need to be more clearly communicated. And studies of its “effectiveness” need to look beyond just the social benefits and the ability of opioid substitution treatment to seduce addicts into a more socially controlled form of opioid use.