America’s Current Guidelines For Fixing The Opioid Crisis Will Increase Suffering And Death, Not Reduce It.

Yesterday afternoon, President Trump declared America’s opioid crisis a public health emergency, and for good reason: the American Society of Addiction Medicine estimates that there’s nearly 2.6 million Americans with an opioid addiction, and the communities affected include some of our poorest and most vulnerable. The problem is becoming critical, and solving it goes beyond politics to become one of basic human compassion.

The only problem: current guidelines by the FDA and CDC are ineffective, based on a factually‐faulty premise unsupported by evidence, and will almost certainly increase suffering and death without significantly improving the numbers for opioid addiction.

Let’s focus on “ineffective” first.

Current Guidelines

FDA Commissioner Scott Gottlieb has put out a statement affirming that they “have an important role to play in addressing the crisis, particularly when it comes to reducing the number of new cases of addiction”:

Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don’t expose them unnecessarily to prolonged use, which increases the risk of opioid addiction. Moreover, as FDA does in other contexts in our regulatory portfolio, we need to consider the broader public health implications of opioid use. We need to consider both the individual and the societal consequences.

(For this, and all future quotes, all bolding is my own emphasis.)

The CDC goes further with its current guidelines, including a clinical “reminder” that “opioids are not first-line or routine therapy for chronic pain”. It recommends to use as low of a dose as possible for as short of a time as possible, frequently reconsider its upkeep, and to only start them as a last resort.

Almost any statement made by public officials relating to the crisis is based on the same two premises: reducing the number of patients receiving long‐term opioid prescriptions is the most effective way to curtail the opioid epidemic, and most opioid addictions start as a result of use that began as legitimate.

Unfortunately, nearly all the evidence we currently have contradicts these foundations. If you’re interested in a detailed, academic look at the topic, there’s a fantastic article written by three doctors — including an Associate Professor at the University of Massachusetts Medical School — appropriately titled “Neat, Plausible, And Generally Wrong”:

Recommendations from the Centers for Disease Control and Prevention (CDC) for chronic opioid use, however, move away from evidence, describing widespread hazards that are not supported by current literature. This description, and its accompanying public commentary, are being used to create guidelines and state-wide policies.
These recommendations are in conflict with other independent appraisals of the evidence — or lack thereof — and conflate public health goals with individual medical care. The CDC frames the recommendations as being for primary care clinicians and their individual patients. Yet the threat of addiction largely comes from diverted prescription opioids, not from long-term use with a skilled prescriber in a longitudinal clinical relationship. By not acknowledging the role of diversion — and instead focusing on individuals who report functional and pain benefit for their severe chronic pain — the CDC misses the target.

We need to break some statistics down. According to the 2014 National Survey on Drug Use and Health, 74.9% of nonmedical opioid use happens as a result of people taking medication they were not prescribed, such as those obtained or stolen from a friend or drug dealer. A further 3.1% fraudulently obtained prescriptions from multiple doctors, a practice called “doctor‐hopping”. That’s a total of 78% of sources other than a relationship with a single doctor. That leaves 22% of those who were addicted who do receive their pills from a doctor, but that number must be put into perspective.

A Cochrane review of opioid use in chronic non‐cancer pain found that fewer than one percent of people who were responsibly prescribed opioids developed an addiction.

The findings of this systematic review suggest that proper management of a type of strong painkiller (opioids) in well-selected patients with no history of substance addiction or abuse can lead to long-term pain relief for some patients with a very small (though not zero) risk of developing addiction, abuse, or other serious side effects.
[…]
Signs of opioid addiction were reported in 0.27% of participants in the studies that reported that outcome.

A scant 0.27% of patients prescribed long‐term opioids for chronic pain showed signs of becoming addicted. The doctors above found similarly‐low rates of addiction with other sources of data.

Image sourced from “Neat, Plausible, And Generally Wrong”, reproduced under fair use.

Part of responsible prescribing involves screening patients for their addiction risk. Though physicians tend to report a low confidence in this field, a pilot study in the Journal of Pain and Symptom Management found that it’s far easier than one would expect to find which patients are genuine, and the results have been repeated since.

Responses of addicted patients significantly differed from those of nonaddicted patients on multiple screening items, with the two groups easily differentiated by total questionnaire score. Further, three key screening indicators were identified as excellent predictors for the presence of addictive disease in this sample of chronic pain patients.

It’s important to recognize that scripts written properly aren’t the cause of the epidemic, because — beyond being ineffective — this mindset can actually lead to reduced access to treatment for those with addictions.

Buprenorphine is an opioid that’s used as maintenance therapy, as it has a far lower risk of causing respiratory depression, the primary killer in opioid overdose. Its use as a maintenance therapy is associated with a significantly lower chance of death than leaving addiction untreated; inexplicably, however, the use of buprenorphine was stifled by a 2000 law stating that only 30 patients could be treated at any one time per physician to begin with, and only after jumping through numerous bureaucratic hoops that made it more difficult to prescribe treatment for opioid addiction than the opioids themselves.

[As of June 2017,] only 35,894 providers are currently eligible to prescribe buprenorphine for addiction. Of those 35,894 only about 1/3 actively prescribe the treatment; and these few are further limited by the patient caps.
Photo from freestocks.orgCC0

Prescriptions, given to patients adequately screened by and in possession of a good relationship with the physician, and used by the patient for which they were prescribed, simply are not the cause of the majority of opioid use disorders — diverted prescriptions and irresponsible mass scripts from so‐called “pill mills” are. You may have heard the small West Virginian town of Kermit mentioned in the news recently due to one of their drugstores: “In just two years, drug wholesalers shipped 9 million opioid pills to a pharmacy in Kermit, WV, a town of just 400 people.

Researchers logged nearly 1,000 cases of doctors being either charged or administratively reviewed for the inappropriate prescription of opioid drugs over an eight year period, and specific high‐profile cases have been the subject of numerous documentaries. Pill mills prey on those susceptible to addiction, and prescribe indiscriminately:

Like the other pain clinics in Portsmouth where Volkman had worked, the clinic only accepted cash — no insurance, no Medicaid. In exchange for $150, patients could expect to receive high doses of pain medications, anti-anxiety agents, and muscle relaxers. In September 2005, according to a search warrant, one Portsmouth Police informant stopped in to see Volkman and received prescriptions for 180 oxycodone pills, 180 Lorcet (a hydrocodone-based painkiller) pills, 120 Soma (a muscle relaxer) pills, and 90 Xanax. Two days later, another informant received a prescription for 270 oxycodone pills, 270 Percocet, 120 Somas, and 60 Xanax. Volkman’s clinics brought in thousands of dollars in cash and pumped out thousands of pills in a region that was already being described in the Portsmouth Daily Times as “The OxyContin Capital of the World.”

Pill mills have become as much an epidemic as the problem they have, in large part, caused, and their existence is supported by the for‐profit pharmaceutical companies that manufacture the opioids; in 2016, the pharmaceutical industry spent over $246M dollars lobbying lawmakers to, among other things, enfeeble the DEA’s ability to go after improper drug distributors, and it’s not slowing down. At the time of this article’s publication, over $208M has been spent by the industry thus far in 2017.

It’s an operation driven by profit from the top down, and it’s easy to see how backing the CDC’s position of cracking down on opioids entirely becomes tempting, but there are ways to curtail excessive prescriptions without creating a devastating case of throwing the baby out with the bathwater.

According to the American Pain Society, there are over 25 million Americans who experience daily chronic pain — pain that affects quality of life every single day. Conditions like lupus, fibromyalgia, Ehlers‐Danlos syndrome, various forms of arthritis, and many more cause pain that is not only severe, but unending. That’s an important number, because it’s just about ten times the number of patients with an opioid addiction.

I’ve made two separate claims: increased suffering, and increased deaths. I’ll start with suffering.

Photo by Dominik Wycislo | Unsplash License

“But Have You Tried Yoga?”

Invariably, you’ll find guidelines instructing doctors to tell patients to pursue “alternative” painkilling strategies first, as if there are myriad wells of untapped relief that chronic pain patients simply ignore.

There aren’t.

We can save time and start with the easy ones: acupuncture doesn’t work. There’s some evidence for massage being somewhat effective for some conditions, but the fact that it’s rarely covered by insurance and the need for ongoing treatment renders the cost/benefit ratio bad. Marijuana is still federally illegal, unavailable in many states, and its presence on a drug test still precludes many employment opportunities for pain sufferers who are able to work. Chiropractic is ineffective pseudoscience that hurts more than it helps. Supplements can cause harm, interact with real medicine, and extraordinarily few have any high‐quality evidence for any condition, including almost none for chronic pain.

That leaves the big one: exercise. “Exercise helps reduce chronic pain!” is repeated often and adamantly, as if it is long‐accepted fact that has a long, positive background in research. Does it?

As recently as April of this year, Cochrane looked over twenty‐one of their reviews of studies regarding exercise for chronic pain, and found that the evidence was generally insufficient:

The quality of the evidence examining physical activity and exercise for chronic pain is low. This is largely due to small sample sizes and potentially underpowered studies. A number of studies had adequately long interventions, but planned follow-up was limited to less than one year in all but six reviews.
There were some favourable effects in reduction in pain severity and improved physical function, though these were mostly of small-to-moderate effect, and were not consistent across the reviews. There were variable effects for psychological function and quality of life.
[…]
Additionally, participants had predominantly mild-to-moderate pain, not moderate-to-severe pain.

Beyond that, the correlation between chronic pain and chronic fatigue is massive, with everything from lupus and fibromyalgia to EDS, rheumatoid arthitis, and Raynaud syndrome causing heavy fatigue, and that in no way comprises a complete list. Despite what the CDC incorrectly insisted for years past being proven inaccurate, exercise invariably makes chronic fatigue, such as found in CFS, worse.

So strike all the chronic pain patients suffering from chronic fatigue. Of the remainder, what about the ones with a strong medical reason not to exercise? Chronic pain caused by physical damage, Ehlers‐Danlos patients unable to exercise or maintain yoga‐esque positions due to frequent joint dislocations, inflammatory conditions that forbid normal ranges of movement, those with heart conditions exacerbated by activity…

We’re left with a small slice of the pie chart for which exercise gets the chance to be effectively used at all, and I would posit that even if there was evidence for it, calling it a replacement for pain management and not something to do alongside it is an act of cruelty. This was stated earlier, but it necessitates repeating: chronic pain is daily. Chronic pain causes real suffering every day, and frequently every hour.

There are no “good days” where you don’t have pain, just days that are “somewhat better than usual”. Imagine this: every day, anywhere from “many parts” to “every part” of your body hurts; unrelenting, bone‐deep aching, nerves that light themselves on fire, jabbing pain coursing through your muscles upon the slightest activity.

If your pain levels average out to 7/10 on a daily basis, would you intentionally up the pain to 9/10 numerous days a week just to — after weeks and months of agony — potentially bring that daily average down to 6/10? Would you feel like you got good value on that proposition? Would you consider it worth it? Would you have the will to keep it up every week until your death, forever? It doesn’t matter if we assume the unsubstantiated claims of notable improvement are true; would you not want pain relief for the days in which your suffering was greatly increased?

Pain needs to be managed, and there are, unfortunately, limited ways to effectively do so. The single most efficacious non-pharmaceutical treatments involve mental mechanisms, such as mindfulness meditation and CBT, which do nothing to reduce the pain itself — merely one’s perception of it. They help, but they can take months to see improvement, and will always leave you with a certain baseline of pain that needs to be treated through some other avenue.

Photo by Jay MantriCC0

The End Of The Road

Depression affects up to half of all chronic pain patients. According to studies, risk of suicide is at least double that of controls, with up to 14% of CPP attempting suicide and around 20% of them experiencing suicidal ideation. Causes and levels of chronic pain can be disabling and prevent patients from maintaining gainful employment, or from participating in the hobbies and activities that were once important to them.

Chinese water torture is a process in which water is slowly dripped onto a person’s forehead, allegedly making the restrained victim insane.

The comparison might seem trite, but it’s apropos: the worst part of chronic pain is not the “pain” — it’s the “chronic”. Relentless pain dominates your life in a way few healthy people appreciate. It demands schedules to be built around it; it demands plans to be canceled en masse when it unexpectedly flares; it holds you as a hostage in your own body and taunts you with its permanency. Make no mistake that even with opioids, it makes it more manageable, not absent; completely eliminating pervasive pain is nearly impossible.

If relief is taken away from chronic pain sufferers indiscriminately and under faulty pretenses, the question is not whether it will result in increased disability and suicide — the question is only by how much.

The opioid crisis needs solutions, and quickly, but it also needs those solutions to be factual, effective, and compassionate, and our current theories for how opioid addiction starts and how it needs to end are none of the above.

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