The pharmaceutical industry created 3 myths around opioids: “Pain as the fifth vital sign,” the less-than-1% rate of addiction, and the diagnosis of pseudoaddiction. Inside, we look at what is true and what is exaggeration in these claims.
Published On: 02/07/2022
Duration: 17 minutes, 07 seconds
Related Article: “When Further Medication Trials Seem Futile,” The Carlat Psychiatry Report, June/July 2020
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Chris Aiken, MD, and Kellie Newsome, PMHNP, have disclosed no relevant financial or other interests in any commercial companies pertaining to this educational activity.
Doctors are bound to do no harm, so to get them to prescribe more opioids they had to be convinced that these drugs were safe. Today, we look at 3 of the myths that blinded physicians to the dangers of opioid drugs.
Welcome to the Carlat Psychiatry Podcast, keeping psychiatry honest since 2003. I’m Chris Aiken, the reports editor and the coauthor of the new textbook Prescribing Psychotropics. And I’m Kellie Newsome, a psychiatric NP and a dedicated reader of every issue.
KELLIE NEWSOME: Last week we fact-checked the new Hulu series Dopesick, which traces the opioid crisis from the boardrooms of Purdue Pharma to the devastated towns of Appalachia. Purdue was not the only pharmaceutical company that benefited from the prodigious sales of opioid medications, but they created the most widely abused drug of the epidemic – Oxycontin – and they developed many of the tactics that mislead physicians about the safety of these drugs.
Today we’re going to unpack 3 of those myths, and it’s not exactly fair to call them myths, as all half-truths have a ring of truth about them. But first, a preview of the CME questions for this episode.
What percentage of patients who are prescribed opioids for non-cancerous pain go on to develop addictive behaviors or full DSM-based substance use disorders on them?
A. Less than 1%
KELLIE NEWSOME: Now, let’s walk through those 3 myths. To increase opioid prescriptions, the pharmaceutical industry first had to get doctors to regularly screen for pain. Pain is difficult to treat, but doctors tended to reserve opioids for severe acute or end-of-life pain. To get them more comfortable with opioids, they would have to be convinced that these medications are not addictive. And when their opioid-treated patients did show signs of addiction, big pharma had a mythical diagnosis to white wash the whole problem: pseudoaddiction. Let’s start with the first step. To increase recognition of pain, they adopted a catchy tool: The fifth vital sign.
The fifth vital sign
CHRIS AIKEN: In Dopesick, we see nurses and physicians check blood pressure, pulse, respiration, temperature, and then move on to the fifth vital sign. They hold up a visual scale with smiley faces and frowns and ask the patient to rate their pain from 0 to 10. It’s implied that Purdue Pharma propagated this concept to sell more opioids, and that is partly true.
The idea of pain as 5th vital sign was first proposed by neurosurgeon James Campbell in his presidential address to the American Pain Society in 1996. The idea had some merit to it. 1 in 3 Americans suffer from acute or chronic pain, and studies consistently find that physicians underestimate the pain levels of their patients.
The idea spread quickly. The VA Health System adopted it, and it really took off when Medicare started reimbursing hospitals based on patient satisfaction scores, and satisfaction with pain was a big part of that score. The Joint Commission on Hospital Accreditation – JCAHO - also got on board in 2001, when they started requiring accredited organizations to assess pain in all patients. I was working at the outpatient psychiatry clinic at Duke in 2001, and I remember the day I was told to assess pain on a 0-10 scale for every psychiatric patient – including those in weekly psychotherapy. No one thought this made any sense since we don’t treat pain.
All of those ratings added up to an opioid epidemic, and as the overdose crisis overshadowed concerns about the-undertreatment of pain, organizations moved away from the 5th vital sign. JCAHO relaxed their pain-rating requirement in 2009, with one notable exception: Psychiatry. They still require mental health facilities to assess pain because – in the words of JCAHO - “these patients are less able to bring up the fact that they are in pain and, therefore, require a more aggressive approach.”
As the opioid crisis evolved, organizations like JCAHO tried to distance themselves from the 5th vital sign fiasco. JCAHO even published a pamphlet claiming that they never endorsed pain as the 5th vital sign. It’s a wonderful work of doublespeak, because while denying it they go on to admit that they required a pain assessment at all patient visits. But, in JCAHO’s view, they were innocent because they never used the phrase “5th vital sign.” And these are the people who are auditing our charts.
The final blow came in 2016 when the American Medical Association voted to remove pain as the 5th vital sign and Medicare stopped reimbursing hospitals based on how much they reduced pain scores. This was mainly a response to the opioid crisis, but it’s also recognition of a surprising finding. Issues of addiction aside, pain rating scales actually don’t work. Let’s look at that evidence.
Several studies have found that collecting routine pain ratings from 0-10 actually don’t improve pain outcomes. The reason seems to be that they shift the clinical focus from the big picture to a one-dimensional rating, and we don’t have good medications to directly target that rating. Opioids seem like they could do the job, but long-term studies find they don’t improve outcomes in chronic pain. After a few months, tolerance develops to both the analgesic and pleasurable/rewarding properties of opioids, prompting the urge for higher doses. For some patients, pain actually worsens with long-term opioid use, a condition known as opioid-induced hyperalgesia. Unfortunately, it takes longer for tolerance to develop to their respiratory effects, which is why the rates of accidental overdose are so high.
Instead of focusing directly on pain, treatment works better when we come at it from the side, focusing on factors that influence pain, like stress, social supports, sleep, and depression. Sounds like things that psychiatrists are well-equipped to address.
New guidelines recommend pain assessments that focus on quality of life – on how the patient is functioning with their pain, rather than on reducing that pain to zero.
KELLIE NEWSOME: We face a similar dilemma when working with chronic, treatment-resistant depression. After depression fails to respond to psychotherapy, antidepressants, ECT, and augmentation agents like lithium, antipsychotics, thyroid, and esketamine, we don’t have many options with a good track record of bringing relief. At that point, we’d do better to focus on functioning than subjective ratings of depression, and on the indirect factors that relieve depression instead of endless medication trials. And those indirect factors are fairly similar to the ones we listed for chronic pain. Stress reduction, social supports, sleep, as well as diet and exercise. In our June 2020 issue, Joe Goldberg talks more about this chronic illness approach to depression.
CHRIS AIKEN: Back to pain. There are many ways to treat chronic pain without opioids, and evidence supports mindfulness, CBT, exercise, yoga, acupuncture, antidepressants, the gabapentin and pregabalin, acetaminophen NSAIDs, epidural injections, nerve stimulators like the TENS unit, and biofeedback. But 20 years ago physicians turned to opioids, and they did so in part because of a second myth – that opioids do not lead to abuse when used for pain.
The 1% Doctrine
KELLIE NEWSOME: In Dopesick, we see drug reps reassuring physicians that fewer than 1% of patients who are prescribed opioids become addicted to them, and the same low-ball figure is quoted by journalists and academic physicians throughout the series. It was cited in over 600 journal articles. Scientific American called it an “extensive study” and Time magazine called it a “landmark study.”
This landmark study came from a prestigious source: The New England Journal of Medicine. But in Dopesick the article takes a strange turn, as the team of US attorneys are somehow unable to find it in the medical library. They search all night in databases, until finally the tension breaks as they realize it’s not an actual paper but a letter to the editor. Dopesick is mostly accurate, but take issue with that plot twist. Letters to the editor have always been indexed in the pubmed and the national library of medicine. It took us 5 seconds to find the article, and it’s worth reading the paper in its brief entirety:
“Recently, we examined our current files to determine the incidence of narcotic addiction in 39,946 hospitalized medical patients who were monitored consecutively. Although there were 11,882 patients who received at least one narcotic preparation, there were only four cases of reasonably well documented addiction in patients who had no history of addiction. The addiction was considered major in only one instance. The drugs implicated were meperidine in two patients, Percodan in one, and hydromorphone in one. We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction.”
Notice, the actual rate of addiction there was 0.03%, but the flaws in this analysis were many. The patients were only assessed in a controlled hospital setting; the author did not follow them after discharge. They were treated with low doses for a short time. But it’s not the only study showing low rates. Other studies found rates under 4%, but they had similar flaws, including the exclusion of patients with a history of psychiatric or substance use disorders.
It’s hard to get a precise number on the risk of addictive behaviors after prescription of an opioid, because the rates vary so much depending on the setting and the definitions of addiction. When a strict, DSM definition of addiction is used, the rate is about 8%, but when the full range of problems are added together - misuse, abuse, diversion, and other addiction-related behaviors, the rates range from 15 to 26%.
CHRIS AIKEN: However you categorize it, this means that your average primary care physician who started patients with non-cancer pain on Oxycontin in the 1990’s would soon see a range of suspicious problems. Addiction, misuse, diversion, as well as tolerance to the analgesic effects. And as their concerns rise in Dopesick, Purdue Pharma comes back with an answer. These patients do not have addiction. They are in pain. Pain makes people desperate for relief. And desperation looks like addiction. The word for this, according to Purdue’s hired physician David Haddox, is pseudoaddiction.
CHRIS AIKEN: Pseudoaddiction is a term to describe patients who act like drug addicts when their pain is undertreated. These patients ask for higher and more frequent doses, request specific drugs by name, act desperate and angry, and give the health care team the impression that they are manipulative. But the behavior is driven by pain, not by addiction.
The idea was introduced through a case report in a 1989 issue of the journal Pain. The series gets that right, but they introduce Dr. Haddox as a dentist who somehow rose to become the director of the Pain Rehabilitation Program at Emory Medical School. Dr. Haddox did graduate from dental school, but he quickly went on to medical school and completed residencies and fellowships in pain and psychiatry.
Haddox’s message was one of compassion, and it was not without a basis in reality. Studies in the 1980’s and 90’s had found that doctors underestimated the degree of pain that their patients were experiencing. But the problem with pseudoaddiction is that no one has figured out how to accurately separate it from real addiction, since the diagnosis hinges on the patient’s internal motivation for requesting pain medication
Since 1989, over 200 articles have been written about pseudoaddiction, and none of them confirmed or even tested the concept. In some ways, it’s become a mute point, as addictive medications are no longer considered effective for the long-term treatment of pain.
CHRIS AIKEN: And now for the word of the day, the 5-HT2A receptor
KELLIE NEWSOME: 5HT means serotonin, and the 5-HT2A is one of many serotonin receptors. So what do you need to know about it. Well, basically, psychedelics like LSD and psilocybin activate it, and some of our atypical antipsychotics block it, including clozapine, olanzapine, quetiapine, risperidone, asenapine, and the med for parkinsonian psychosis, pimavanserin, as well as a new antipsychotic, lumateperone, brand name Caplyta. And lumateperone is in the news now because it just gained FDA approval in bipolar depression. If you missed it, we have full coverage in our January 21st podcast.
KELLIE NEWSOME: You can earn CME credits for these episodes. Here’s how it works. Click on the link in the show notes or login to your Carlat account and click Store. For a flat rate (currently it’s on sale for $99) you get 30-40 CME credits for the year by answering 1-2 questions for each podcast. Right now we have 20 episodes in the list and it gets longer each week. You can whip through the tests pretty quickly, and it’s quite a dopamine rush to see those credits stack up.