Truth About the Consequences of Opiophobia

A Dose of Truth about the Consequences of Opiophobia | HCPLive – 2010Joel S. Hochman, MD – Jan 2010

In this old article, the author picks apart a study from 2003 which became the backbone of the claims about hyperalgesia. It’s outrageous that a study from 17 years ago is determining our pain care (or lack thereof) today.

As this decade has progressed, some legal experts assumed that as a consequence of certain tort actions (cf. Bergman v. Chin), physicians would be compelled to treat pain effectively in compliance with the community standard of care.

The “community standard of care” no longer exists for pain control because opiophobia is preventing the use of the most effective medication just because some “street drugs” of the same chemical class, like heroin or illicit fentanyl, are being abused by people who then overdose. 

In this civil lawsuit filed in San Francisco, CA, a jury found Dr. Wing Chin to be negligent in failing to adequately treat and relieve the suffering of his cancer patient, Mr. Bergman, and awarded Bergman’s family $2.5 million (reduced subsequently by the court to $1.5 million).

In fact, Bergman v. Chin had little impact on the medical community. Not only has there been no subsequent case of its sort, there has been only a single instance in the US of a physician being disciplined by a state medical board for inadequately treating pain.

In contrast, “unnecessary prescription of opioids” continues to be one of the most common causes of action taken against physicians who provide treatment for chronic pain unrelated to cancer.

Indeed, the case against pain management has been intensified in recent years.

An additional strategy in the campaign to save “opiophobia” from extinction has been a movement to establish arbitrary ceiling doses for opioid usage.

One of the most egregious examples of this was the drafting of an arbitrary daily limit of 120mg of morphine, or its equivalent, in the State of Washington, which resulted in a federal lawsuit.

In my opinion, the justifications for limiting the use of opioid medications are exemplified in, and in many ways can be traced to, this article:

“Opioid Therapy for Chronic Pain,” by Jane C. Ballantyne, MD, and Jianren Mao, MD, PhD, published in the New England Journal of Medicine in 2003.

The article referenced above is listed in PubMed without even an abstract: 
Opioid therapy for chronic pain. N Engl J Med. 2003 Nov 13. Ballantyne JC, Mao J.

However, I did find this blurb on the full article on the NEJM website

“A difficult decision for physicians who treat patients with chronic pain not associated with terminal disease is whether and how to prescribe opioid therapy, which can relieve pain and improve mood and level of functioning in many such patients
This review considers current guidelines for opioid therapy in patients with chronic pain unrelated to malignant conditions and outlines caveats, areas of uncertainty, and management strategies.

There is no other peer-reviewed article in the medical literature promoting absolute or arbitrary limits on the use of opioids.

As with so many other anti-opioid biased studies and surveys, they seem to have decided what the study will “find” first and then comb through and/or manipulate any data that supports their desired outcomes.

To this day, they’re using old and corrupted CDC data even after the CDC admitted to overcounting overdoses:

Then they use convoluted language or strangely complicated study design to make their anti-opioid “conclusions” (often only conjectures) sound like facts while rejecting any positives as “unclear” or “incidental findings” or simply don’t mention them at all.

The article has been frequently cited by anti-opioid activists.

Current Practice, a Disconnect

In the article, Ballantyne and Mao noted that although many experts on pain recommend that patients suffering from chronic pain not be denied opioids, many physicians “remain uncertain about prescribing opioids to treat chronic pain and do not prescribe them.”

This is exactly what I pointed out above: they are stating a pure conjecture as a finding of the study when there are no data to support it.

The authors write their impression of the interview as though it were hard data related to the outcome of their study, which it most certainly wasn’t.

The authors also noted that some (perhaps a minority) of pain practitioners think that “opioids are only marginally useful in the treatment of chronic pain, have a minimal effect on functioning, and may even worsen the outcome.”

In their review of current clinical studies, Ballantyne and Mao stated that the opioid treatment literature was based mainly on “reports of surveys and uncontrolled case series,” and supported the view that patients with chronic pain can “achieve satisfactory analgesia by using a stable (nonescalating) dose of opioids, with a minimal risk of addiction.”

Ballantyne and Mao went on to cite evidence showing

  • that various pain syndromes, including neuropathic pain, are responsive to opioid therapy;
  • that opioids are effective in the treatment of neuropathic pain; that long-term oral opioid therapy is useful for treating chronic pain; and
  • that opioids can relieve pain even without functional improvement.

The authors stated that

  • “pain relief is the expected end point of opioid therapy,” and
  • that one of the “fundamental principles of pain management is that the dose of an opioid should be increased until maximal analgesia is achieved with minimal side effects.”

Ballantyne and Mao claim that long-term use of opioids may be associated with the development of abnormal sensitivity to pain (hyperalgesia).

Interestingly, they point out that it is unclear whether “opioid-induced abnormal pain sensitivity” is related to the dose, the particular opioid, the route of administration, the duration of use, or other factors.

From these perceived dangers and limitations, the authors conclude that it may be proper to limit the dose of opioid medications in patients with complex problems.

Thus, the concept of a “ceiling dose,” the acceptance of which is growing in clinical practice, say the authors, despite the fact that it is “difficult to define a dose that could be recommended as a ceiling.”

Certainty and Pain from Conjecture

The Ballantyne and Mao article is now used by both individual practitioners and government authorities as a basis for attempting to set arbitrary and absolute limits on the dosage of opioids in managing intractable pain.

However, in my opinion, a careful reading of their article reveals it to be largely conjectural, though subtly so.

Initially, they establish that the treatment of intractable pain is supported by the contemporary standard of medical practice. They then review the accepted approach to pain management through careful titration.

The authors conclude their article by stating that

“Whereas it was previously thought that unlimited dose escalation was at least safe, evidence now suggests that prolonged, high-dose opioid therapy may be neither safe nor effective.

It is therefore important that physicians make every effort to control indiscriminate prescribing, even when they are under pressure by patients to increase the dose of opioids.”

I know of no publication, article, or practitioner that has ever called for the indiscriminate prescription of opioids.

But, most importantly, the hypotheses of adverse consequences—initially qualified and hedged through thethe hypotheses of adverse consequences.

use of terms such as “may,” “can,” and “could”—are thereby reified, giving the perception that opioids are over-prescribed, and that high doses are dangerous and must be limited, as they are neither safe nor effective.

The Ballantyne and Mao article does not establish that substantial evidence exists that high-dose opioid therapy is neither safe nor effective.

In fact, there is no such evidence.

Indeed, extensive clinical experience demonstrates that, in the treatment of chronic pain, opioids do not impair cognitive and personal function or the immune system (except in a limited number of instances of suppressed testosterone levels in males; opioids do not otherwise cause serious hormonal problems).

Everyone seems to forget that all the other “pain medications”, like NSAIDs or cortisone shots or daily Tylenol, can cause tremendous damage to our bodies.

It’s easier on your body to take opioids every day than taking all the other non-opioid drugs, like antidepressants, antispasmodics, and NSAIDs that are recommended (by people who should know better).

High-dose opioids do not induce tolerance in intractable pain patients, nor do they induce hypothetical allodynia or other pain hypersensitivities to any significant extent.

Opioids are effective in controlling pain and dramatically improving the quality of life in patients who experience chronic pain.

Opioid overdoses are nearly always due to addictive misuse or unauthorized polypharmacy, frequently including alcohol, and are statistically insignificant among pain patients when the medication is used as prescribed.

Caution vs. Ideology

While it is judicious to exercise caution and continuing evaluation of the effects of long-term treatment of pain with opioids, the speculation that one may encounter adverse long-term effects is not a defensible basis for assuming that they do.

Sadly, the information and opinions in this article have been widely circulated and repeated, with many physicians uncritically quoting the hypothesis of hyperalgesia as an accepted fact.

Author: Joel S. Hochman, MD, is the executive director of the National Foundation for the Treatment of Pain.

Hyperalgesia… is used in two different contexts in pain medicine.

  1. In one context, hyperalgesia refers to the excessive pain often induced by neuropathies or certain chemicals…
  2. Another context is the unfounded assertion that some patients who chronically take high-dose opioids develop increased pain with increased doses, or increased sensitivity to noxious stimuli.

This is based on studies of laboratory animals, and of people given intrathecal opioids or studied under other unusual conditions. I am unaware of any studies supporting the existence of this phenomenon in clinical practice with respect to patients chronically on oral or transdermal opioids.

The assertion of opioid-induced hyperalgesia has found its greatest usefulness by physicians and regulators looking for justification to limit opioid prescribing, and by some cost-conscious insurance companies seeking a medical reason to deny payment for high doses of opioids.”

Author: Jennifer Schneider, MD, PhD, from a guest editorial that appeared in the Jan/Feb 2009 issue of Practical Pain Management.

 

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