Patients Vulnerable to Limits on Opioid Rx

Limits on Opioid Prescribing Leave Patients With Chronic Pain Vulnerable – from Jama – Rita Rubin, MAApril 29, 2019

Thomas Kline, MD, PhD, refers to 22 of his patients as “pain refugees.”

Stable for years taking opioid therapy for chronic pain, these patients sought out Kline—well-known for his advocacy on their behalf on Twitter and elsewhere—because their physicians had abruptly cut their dose or refused to refill a prescription.

They had appealed to multiple physicians for treatment with no success before contacting him, said Kline.

Kline accepts these patients that no one wants because he’s trying to keep them off another list, one he has helped compile: a list of US residents believed to have committed suicide because their physicians would no longer prescribe adequate doses of opioids to treat their chronic pain.  

As of late April, the list was 40 people long, but it is not inclusive, Kline said. “The problem is a lot of families don’t want this public. I have to respect that.”

“Chaotic and Brutal”

The CDC guideline recommends that physicians carefully reassess potential benefits and risks when considering whether to increase a patient’s dose to 50 or more morphine milligram equivalents (MMEs) per day (MMEs are used to compare doses of different opioids)

Although that recommendation relates to patients who have not yet started taking opioids for chronic pain, it has also been widely interpreted as a target for the millions of users who long ago surpassed 90 MMEs a day

editorial, titled “We Cannot Treat the Dead,” questioned whether the marked increase in US suicide rates might be related to inadequate pain treatment, as a CDC study noted that 22% of suicides in 2015 reportedly occurred among people with documented physical health problems.

In April, CDC Director Robert Redfield, MD, responded to the letter Kertesz coauthored, noting that “[t]he Guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm.”

Two weeks later, the authors of the 2016 guideline echoed Redfield’s letter in a Perspective piece published in the New England Journal of Medicine.

Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations,” the authors wrote.

This disaster is far more than merely “unfortunate” when it’s actually killing people. While these high level “leaders” muck around with layers upon layers of rules about access to medically necessary medications, patients in intractable pain are left with only one way out of their suffering, suicide.

Noncancer vs Cancer Pain

While the CDC’s opioid-prescribing guidelines were intended for noncancer chronic pain, physicians report that it has been used to block treatment of patients with cancer pain.

In a February letter, a CDC official responded to 3 medical organizations that had expressed concern over how misinterpretation of the agency’s guideline was affecting patients undergoing cancer treatment, cancer survivors with chronic pain, and people with sickle cell disease.

This distinction is simply not valid, no matter how many still believe it or continue to cite it: NO DIFFERENCE between cancer and non-cancer pain

The CDC guideline notes that “there is now an established body of scientific evidence showing that overdose risk is increased” at higher opioid dosages, but the guideline doesn’t cite evidence specifically supporting the 90-MMEs cutoff.

That’s because there is no such evidence. The 90MME cutoff was essentially arbitrary.

A previous post, Impact of High-Dose Opioid Analgesics on Overdose
shows that the CDC’s 90mg “threshold” is merely one of convenience and does not exist in “real life”.

some North Carolina patients with chronic pain have said their physicians stopped prescribing opioids and, by way of explanation, handed them a copy of the state’s 2017 Strengthen Opioid Misuse Prevention (STOP) Act, which limits initial prescriptions for acute pain to 5 or 7 days. The STOP Act specifically states that the limits do not apply to chronic pain

I find it impossible to believe that doctors are so ignorant, that they

  1. can’t tell the difference between guidelines for acute pain versus guidelines for chronic pain,
  2. don’t know that only acute pain is limited while chronic pain is lifelong,
  3. don’t understand that patients with long-term make pain will need long-term opioid prescriptions as well.

And yet, a quarter (663) of the 2661 physicians who responded last fall to a survey by the North Carolina Medical Board said they had stopped prescribing opioids for chronic pain.

The Pendulum Swings

Prescribing increased in the first decade of the 21st century for 2 main reasons:

  1. the concern that chronic, noncancer pain was not being adequately treated and
  2. the downplaying of opioids’ risks and overstating of their benefits by manufacturers

Management of pain became a quality measure, incentivizing physicians to prescribe large doses to stomp it out.

As if this were possible!

Those of us with disabling high impact chronic pain know that “stomping out” our pain 100% is impossible unless we’re unconscious. I would be ecstatic to get 90% pain relief, thrilled to achieve 80%, pleased at 70%, and glad for even a 60% reduction in my pain.

Anyone expecting 100% relief seems completely unrealistic and just plain greedy.

“Legacy Patients”

Multiple factors account for why patients with chronic pain have ended up taking high doses of opioids.

Tolerance is certainly one of them,” said Joanna Starrels, MD, MS, an internist and addiction medicine specialist

Patients’ pathology might have changed over time, and they might have new pain sites, she added.

They’ve missed the most pertinent and more obvious reason: Aging.

With a chronic condition, our body’s breakdown is accelerated because it doesn’t hold up as well against the normal deteriorations that accumulate over the years.

“In addition, we’re learning about opioid-induced hyperalgesia,” Starrels said, referring to a little-understood phenomenon in which long-term opioid exposure is thought to increase pain sensitivity, possibly leading to higher doses.

How can intelligent people keep repeating this nonsense? Hyperalgesia has only been confirmed in rodent experimental conditions, never in humans or in clinical conditions.

Here are several posts showing that hyperalgesia is NOT a known issue for patients taking opioids as directed:

  • The Truth About Hyperalgesia
    Demystifying Opioid-Induced Hyperalgesia – By Jennifer P. Schneider, MD, PhD – Feb 2019 Some insurance companies have declined to continue paying for opioid medications, citing OIH. Here’s why. In cases like these, many insurance companies state that patients should have their doses tapered in order to decrease their pain. Now, we’re really living in a fun-house…
  • High Quality Study Shows NO Hyperalgesia
    Analgesic tolerance without demonstrable opioid-induced hyperalgesia: a double-blinded, randomized, placebo-controlled trial of sustained-release morphine. – PubMed – NCBI – Pain. 2012 Aug This is the highest quality of research design: double-blinded, randomized, and placebo-controlled – you can ask for nothing more – and it showed NO hyperalgesia. Although often successful in acute settings, long-term use of opioid…
  • Inflammation → Hyperalgesia → Chronic Pain
    C-reactive protein and cold-pressor tolerance in the general population: PAIN – July 2017 I’m reposting this study because it explains that hyperalgesia, which is blamed on opioids, arises from chronic inflammation and the numerous chemical changes this causes in the body over time…
  • Diagnosing Hyperalgesia to Limit Care

The CDC guideline is reasonable for patients who are just starting opioid therapy for chronic pain, but it’s not meant to be retroactive, noted internist Margaret Lowenstein, MD,

I don’t think the CDC guideline is unreasonable – if it’s simply read as very general guidance for non-experts. If our pain medications were of any other class of drugs, like blood thinners or cholesterol-lowering drugs, there would be little controversy.

However, the guideline was written from an addiction specialist’s viewpoint and barely mentions the indispensable function of these medications to relieve debilitating pain. Instead, it exclusively advises on how to avoid a rare side-effect (addiction can occur in less than 5% of cases) with a relentless focus on milligrams prescribed.

Tapering as Opposed to Chopping

The CDC is supporting 4 extramural research projects examining the unintended consequences of tapering and discontinuation, according to an enclosure accompanying Redfield’s letter to Kertesz and colleagues.

Even though I scan much of the medical literature on pain and opioids, I have not seen a single mention of such studies until now.

I’ve also never heard of “extramural” research projects, which would seem to describe projects taken on by other agencies/groups, not the CDC itself, despite their promises to do so in the guideline itself.

To verify my suspicions, I looked it up:

Extramural Research has been defined 2 different ways in documents like Glossary of NIH Terms, National Institute of Food and Agriculture Glossary.

  1. as defined in Glossary of NIH Terms by U.S. Department of Health and Human ServicesU.S. National Institutes of HealthU.S. National Institutes of Health, Office of Extramural Research: Research supported by NIH through a grant, contract, or cooperative agreement.
  2. as defined in National Institute of Food and Agriculture Glossary by U.S. Department of Agriculture, National Institute of Food and AgricultureGrants and contracts to outside institutions or schools to help pay for research projects and resources.

So it seems the CDC is going against its own guideline, which committed it to study the outcomes of these guidelines and is letting other groups follow up instead.

As far as I know, no such study on outcomes has been initiated by the CDC.

Spurred by reports of serious withdrawal symptoms, uncontrolled pain, and suicide in patients whose opioid doses were abruptly stopped or cut, the FDA announced new opioid labeling changes in April to better inform physicians how to properly taper patients

Reduce Doses, Reduce Overdoses?

Intuitively, it makes sense that limiting opioid prescriptions would help reduce overdose deaths, Lowenstein said. However, she said, “the evidence is mixed at best.”

Sure, this would be true if overdoses were caused by pain patients taking their medication, but the deaths are caused by cocktails of various street drugs, not prescribed medication taken as directed.

While studies show that state prescription monitoring programs appear to have reduced potentially inappropriate opioid prescribing, that hasn’t necessarily translated into fewer overdose deaths, in part because most opioid overdoses are due to illicit fentanyl or heroin, not prescription opioids.

12 thoughts on “Patients Vulnerable to Limits on Opioid Rx

  1. Kathy C

    Thanks Zyp,

    There is a reason for the false narrative protecting the profiteers, and the industry. None of this has anything to do with public health, or common sense. There is a reason they ignored the rising deaths from illegal drugs, and conflated pain treatment and addiction. Bet Darnell, look to be the go to “expert” for all of these newsrooms, due to her social media persona. They did not get her to speak at Davos, the World Economic Forum, about mindset, because of her scientific background, they just like what she has to say. Years of these articles that steer people away from empathy, science and facts, to positive thoughts. The industries love her, she makes the pain go away. She makes it a good idea to deny healthcare to millions of Americans.

    NPR is at it again, our mass media is protecting the industry. https://www.npr.org/sections/health-shots/2019/05/20/724136568/how-the-brain-shapes-pain-and-links-ouch-with-emotion
    Another article about how pain is not really pain, and it can be wished away with an art project. The industry had to come up with a counter narrative, they did not want to treat all of those retiring baby boomers, and a population under so much stress they are turning to drugs, suicide and addiction.

    Here is an article from Kaiser Health News, Talk about burying the lead! https://khn.org/news/walmart-charts-new-course-by-steering-workers-to-high-quality-imaging-centers/

    “The issue crystallized for Walmart officials when they discovered about half of the company’s workers who went to the Mayo Clinic and other specialized hospitals for back surgery in the past few years turned out not to need those operations. They were either misdiagnosed by their doctor or needed only non-surgical treatment.”

    The Mayo Clinic is one of the most prestigious in the nation, yet 50% of their spine surgeries were “unnecessary.” Of course we really don’t know what they mean by that, it is very likely a percentage of these patients were left with intractable chronic pain, but they won’t mention that. They chose to blame the imaging. Walmart is one of the largest employers in the nation, so they are merely trying to cut costs. No other media outlets covered this story, to reflect the facts. That must be why they call it corporate media.

    The big story was that at the most prestigious surgical institution in the nation, the surgeons did “unnecessary” surgeries. That means that the other backwater hospitals had even worse rates. We can only assume there were less that ideal outcomes. A lot of other highly advertised spine surgery clinics have been closed. At least 20% of all of those surgery patients are left with intractable chronic pain, but they chose not to research any of that. The FDA buried reports of device failures for years too. That included pain pumps, and spinal implants which were sold to desperate people in pain with no other options. It is all about the money and profits. They have to protect the industries, that are profiting.

    Thanks to people like Beth Darnell we can ignore the people with pain and the human costs of our broken healthcare system. She re-framed it for America, and the corporations. Every day there is another article about the Opioid Lawsuit, and they continue to point the blame at patients and doctors. Americans are dying from despair, pain, and addiction and they needed a scapegoat. not one article on the opioids, describes how the industry is still cashing in. They do not describe how they diverted millions of doses to the black market. The rates of other drug abuse are going up, but that won’t be covered either. They sued the opioid companies before, and gave them a slap on the wrist, the price of doing business for big pharma.

    Thus is all marketing and propaganda, to ensure corporate profits, now any patient can be denied pain care for their own good. Al long as they have someone like Beth Darnell as their spokesperson, expert, we can pretend pain does not exist. The insurance companies can claim whatever they like, pharma will turn out even more expensive alternatives, and the medical industry can ignore their mistakes. They will continue to arrest compassionate doctors, who are not protected by corporations, and deny care to the patients they carefully trimmed out of any discussion of this topic.

    Liked by 2 people

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    1. Zyp Czyk Post author

      For several years I ranted and railed against Darnall’s trendy concept of pain being aided and abetted by “catastrophizing”, which was lapped up eagerly by pain deniers. You can see those numerous posts using the tag https://edsinfo.wordpress.com/tag/catastrophizing/, as I rebutted this “philosophy” of pain being a “psychosocial” disorder with only a hint of a biological component.

      But recently, she has “seen the light” (or rather the horrors of what’s being done to pain patients when opioid pain relief is denied) and is now advocating for us to be prescribed opioids when necessary (as had finally been done for barely a couple of decades, the 90s and 2000’s). https://edsinfo.wordpress.com/2018/12/23/dr-darnall-now-supports-necessary-use-of-opioids/

      We can only hope that other well-known anti-opioid activists also start understanding whatever it was that changed Dr. Darnall’s mind.

      Liked by 2 people

      Reply
      1. Kathy C

        Due to her comments on that pediatric pain article, there is no reason to think she has really changed. She seems to be more than willing to tailor her comments to the audience. There are marketing seminars for psychologists that recommend this kind of promotion. She presents herself as the go to expert, and used her position with Stanford to sell books and speaking engagements. She has to walk a tightrope in order to please her corporate sponsors.

        Here she goes again, https://www.npr.org/sections/health-shots/2019/05/20/724136568/how-the-brain-shapes-pain-and-links-ouch-with-emotion?utm_campaign=storyshare&utm_source=twitter.com&utm_medium=social We have had years of this pain denial narrative. Typically they use the one example of a person who “overcame” their pain with something, in this case his art. There is no doubt that distraction and having ones basic needs met, can help to alleviate the overall experience of pain. This has little to do with reality, though.

        They mention some more of that research, on animals, Squids and octopuses. They react to harmful stimuli, there is nothing new here. Once again she repeats
        “”Mental health disorders amplify pain,” she says. “They engage regions of the brain that associate with pain processing. And they can also facilitate rumination and fearful focus on the pain.”
        She never did any research, on how these findings were applied in actual practice. It is like a big elephant in the room. Questions like, what are the long term outcomes. How many people with chronic pain, had treatment for the pain postponed, because, the physician decided that the pain was of psychological origin, or referred them to a psychological intervention instead of treating the pain.

        “In dogs, for example, pain appears to cause emotional distress much the same way it does in people. And there must be a reason for that, Crook says.” Dogs were extensively tortured and researched, by Martin Seligman. https://www.newyorker.com/science/maria-konnikova/theory-psychology-justified-torture Pain does cause emotional distress in dogs, but not exactly the same as humans. Dogs tend to function, and go on, with horrible injuries. They seem to be better able to ignore horrible injuries, and brutal treatment. Dogs with horrible injuries, like a mangled leg, will still chase a ball, or lick the hand of the person that tormented them. Perhaps that is why they chose to “research” dogs.

        The article sounds really sciency, but there is nothing really new here. They always bring up animal studies, yet they have little to do with humans. They mix a little factual science with wishful thinking and anecdotal stories. These articles are designed to mislead. Firstly they misrepresent the level of medical and psychological care available. They often use studies form countries with good healthcare systems, and then apply them to American problems. The very same way they use the animal studies. These articles are designed to misinform the general public, and they seem innocuous, but they are not.

        Darnell states, “That’s what happened to Witt in his teens and 20s. His pain led to negative thoughts and depression, which made the pain even worse.” This is one of the few articles where the order is reversed.” Suddenly Darnell is explaining that the pain made the psychological distress worse. This is groundbreaking, the order is usually reversed. It looks like she is finally coming around, but she did make millions and get a lot of funding for Stanford based on her social media persona. She repeated crafty misinformation about opioid use disorder, Catastrophization and Hyperlagia. She helped confuse the issues, around pain, addiction, psychological interventions, and added to the culture of misinformation, and devious marketers using pain or opiophobia as a marketing hook.

        Instead of looking at how chronic pain and pain are being treated or not treated in the US, she re-framed the problem. One of the direct consequences is the refusal now to treat pain, and the stigmatizing of anyone reporting pain. The industries had to come up with a false narrative about thousands of Americans in distress, working long hours, driving and sitting at computers, bad nutrition, the condition the mass media had to create culture of denial about. There were also all of those surgical mistakes, expensive useless treatments, and the ghouls that cashed in on it. Psychologists saw a niche for their marketing. Most Americans do not have the best medical care, if any at all. So their pain conditions were misdiagnosed countless times, and treatments were postponed. Blaming patients became and easy and profitable narrative.

        Liked by 2 people

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        1. Zyp Czyk Post author

          Re: “They always bring up animal studies, yet they have little to do with humans. They mix a little factual science with wishful thinking and anecdotal stories.”

          You are so right! A convoluted mish-mash of science, often inconclusive, and assumptions, often wrong, with wishful thinking has ruined pain research for many years.

          Liked by 1 person

          Reply
  2. GZB

    I had spinal surgery two years in a row and I was told by some experts that the second had been unnecessary and botched. So, I’m left with stainless steel screwed into my spine and nerve damage. You might remember a media outcry thirty or so years ago about surgery being performed that used devices banned for use in the spine. Of course, all the hoopla blows over and you’re still left with the time bomb in your back. The point made by Walmart that pain that was caused by failed surgeries was not relevant enough to warrant medication because it was caused by failed surgeries! Good lord! That’s some quick and slick b.s.!
    Everyday I wonder how do you get through to these people? How much longer do we have to endure this? I hear the words “castrophizing(sp?) and hyperalgesia(? who makes up these words?) only do exactly what you say. They convolute the issue and condemn us to more suffering.

    Liked by 1 person

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    1. Kathy C

      GZB,

      We thought that the FDA or those health quality agencies were protecting us, but it was all a lie. Those so called Health Quality Agencies were set up to protect the industries. The media won’t report on these topics either. They even have a name for it, Regulatory Capture. The FDA appeared to be collecting data, and incident reports, https://healthimpactnews.com/2019/kaiser-health-blows-the-whistle-on-fda-and-medical-device-fraud/ One would think that all of these reports were important, yet the FDA hid them to protect the device manufacturers, hospitals and surgeons, who made money using these in patients. Some of these people died, were maimed or left with intractable pain, yet it was all kept from the public. Even Medicare, who paid out billions, as the national largest insurer was unable to get the factual information.

      The so called opioid epidemic, was used to push these dangerous devices on people in pain. As they took away opioid pain medications from patients, these devices, and surgeries, were the alternative for many. In desperation, people in serious pain, turned to these devices. In some pain clinics the devices were presented as the only choice for pain patients. https://www.painnewsnetwork.org/stories/2018/11/26/faulty-medical-devices-blamed-for-thousands-of-deaths Many of the sites online that appear to be informational were funded by the pharma and device industries.

      People who were the victims of these unscrupulous surgeons, often have multiple surgeries. These implants and devices caused numerous deaths, lifelong intractable pain, and multiple expensive and painful surgeries, but the industry is still silencing patients. They are still framing healthcare as a choice, yet most people are not aware of the dangers of these devices. Patients are denied this information. Patients that report pain afterwards are told they are opioid seekers or addicts. Even worse they got some unscrupulous psychologists to claim that these devices failed, due to the patients mindset. They are Gas Lighting us all.

      The agencies that were supposed to protect us, are now run by the corporations they were supposed to be regulating. Industry insiders also paid our politicians to look the other way, they spend billions on lobbying. The industries decided what data can be collected, or find ways to suppress it, like they did at the FDA. https://khn.org/news/fda-to-end-program-that-hid-millions-of-reports-on-faulty-medical-devices/ It is no accident they did not put this data to use or regulate the industry, the industry is in control. The same thing with pharmaceuticals, whether it was the opioid industry, or the generics industry. The manufacturers of the generic drugs, in India and China decided they did not need regulation either.

      People really should be scared, the infant and maternal death rate is rising, and it is very possible all of those deaths have not been counted either. Our corporate media does a really good jobs hiding the issues, while keeping us misinformed. It is highly doubtful the FDA is going to stop protecting the industry. The surgeons chose to blame the patients for these failed back surgeries, or ignore the patients and Gas Light them. The Lazer Spine Institute, which ran a major advertising campaign, directed at desperate patients who were refused pain medications recently shut down. https://heavy.com/news/2019/03/laser-spine-institute-closes/

      Spine surgery is big business so of course they have to protect their bottom line at the expense of patients. https://www.beckersspine.com/ The research is not for patients in fact there is virtually no research on long term outcomes, or the people left with intractable chronic pain. The industries have covered it up, and blamed patients. It looks like the only research being done is to increase profits, or on how to Gas Light patients.

      in my case the hospital altered the records and redacted the portion about the spinal implant. Years later in a follow up with a neurosurgeon, the hospital claimed they had lost my imaging.

      Liked by 1 person

      Reply
  3. Kathy C

    This is an example of the deceptive content marketing that used to be against the law. These informational sites are really just cover, targeting desperate people with pain. This site is owned by a physician with no ethical boundaries. The FTC as failed to keep up with any of this kind of deceptive targeted marketing. There is nothing “new” here at all, and these patient testimonials are a sign of deceptive advertising. In this kind of content marketing none of the adverse events or side effects have to be disclosed.

    Liked by 1 person

    Reply
  4. Kathy C

    Check this out, https://khn.org/news/hidden-reports-masked-the-scope-of-widespread-harm-from-faulty-heart-device/
    These were heart devices, a little easier to validate than pain devices.
    “What Sicklick and thousands of others in his position have not known is that the Food and Drug Administration quietly took steps to keep critical information out of the public light. Shortly after the recall, the FDA and Medtronic made a deal to keep reports about the widely used device’s malfunction incidents — now totaling 50,000 — shielded from public scrutiny.”

    Not much coverage in any of the mass media outlets. Pain is a bit harder to quantify, it is no wonder they had to smear people with pain repeatedly in the media.

    Liked by 1 person

    Reply
    1. Zyp Czyk Post author

      I saw a KHNews article about hidden reports on all kinds of medical devices, not just the heart device. We should think long and hard before allowing doctors to start cutting into us or do any “hardware installations” because we can end up forever damaged, even more than we are already, and then not be given pain relievers for it.

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