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How Expert Testimony Distorts the Standard of Care

During regulatory assaults, a disturbing pattern of conflict exists between expert testimony offered against pain-treating physicians employing opioid analgesics and the scientific evidence and medical principles upon which a rational standard of care for pain management is based.
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Editor’s note: The recent national media reporting, involving the investigation and prosecution of physicians for treating pain, highlights one inescapable fact. Too many doctors throughout the country fail to adequately prescribe opioids for chronic and intractable pain for fear of investigation and prosecution. One of the tragedies of this obvious, under-treatment epidemic, is that some physicians—either due to ignorance, greed, or religious belief—are providing expert testimony that can only, in some instances, be described as preposterous and unbelievable. Dr. Frank Fisher has studied contemporary, expert testimony involving the prosecution of doctors and came to the conclusions he describes in his article.

PPM was not in a position to validate all of Dr. Fisher’s observations and conclusions; hence his article stands on its own. Nevertheless, PPM continually receives communications about physicians who are hired for pay by government agencies and who express “expert” opinion which cannot be validated by any scientific evidence.

PPM desires to champion some basic scientific facts concerning opioids and pain control. First, opioids are not known to cause tissue toxicity as may alcohol or anti-inflammatory agents, and there is no upper or maximal ceiling to opioid prescribing. Pain control is dependent upon adequate opioid blood or intrathecal levels. The nervous system has multiple opioid receptors and each individual will require a different regimen based on their genetic, receptor make-up. Opioids are properly administered at low dose and titrated upward to relieve pain and produce a physical status which allows the patient to escape a bed or house-bound state. Opioids should be prescribed according to the National Federation of Medical Board standards. Addiction and pain relief are not the same. Simply put, addicts compulsively take opioids for non-pain purposes. Chronic and intractable pain are not psychologic conditions but a result of some nervous system damage. Also, bonafide pain causes multiple complications involving the cardiovascular, immune, and endocrine systems which can easily be assessed at the bedside, office, or laboratory to help validate the bonafide presence of severe pain which will likely require opioids. Unless the nervous system damage can be permanently repaired, pain will last a lifetime and likely require lifetime opioid treatment. Over-medication and over-prescribing is easily diagnosed by a physical assessment of basic bodily functions such as blood pressure, pulse rate, reflexes, and pupil size. Pill counts cannot determine over-prescribing.

PPM calls on any physician who reads Dr. Fisher’s article and disagrees with his observations and conclusions to write us since we plan to liberally publish dissent. At this time, we believe there is a desire on the part of all concerned parties to resolve the under-treatment problem to the satisfaction of physicians, regulatory agencies, and patients. Within every community of about 100,000 persons, an experienced physician is needed who will accept and adequately treat—with opioids—severe chronic and intractable pain cases without fear of investigation and prosecution. PPM will support whatever regulations, standards, and systems that permit a decent, humanitarian, and scientific approach to the thousands of patients who are suffering and sustaining medical complications caused by intractable pain.

In the pathogenesis of chronic pain, ongoing pain is the single condition prerequisite to the development of this disease state. In this context, the term “pain” identifies the disease vector as well as the illness. Chronic pain is a malignant disease in the sense that when it goes untreated, or under treated, it tends to metastasize to areas of the nervous system it did not previously affect. Thus, the obligation to control pain lies at the core of the physician’s ethical commitment to his patients. A government witness testifying against a pain-treating physician appears unconcerned by this imperative:

“Well, it’s hard to make a judgment how much pain a person is having unless you wait while they’re off pain medication for a year or so. And that’s — and we as doctors are being told these days that you should never allow a patient to have any pain and so you get into a catch-22. We’re not supposed to allow them to have pain, and yet you can’t make a good judgment of whether they really have excessive pain or not.”1

The prospect of this sort of attack, occurring in a court of law, represents a menace to every physician who attempts to treat chronic pain in good faith.

Standard of Care for Pain Management

The standard of care for pain management consists, in its broadest outlines, of 1) medical indications for treatment, 2) clinical practices, and 3) therapeutic goals.

Indications and Therapeutic Trials

No tools exist that allow a physician to predict which individual pain sufferers might benefit from treatment with opioid analgesics, or to predict which specific medications might be of benefit. Consequently, these questions must be resolved empirically, on a patient-by-patient basis. This is accomplished through the implementation of a therapeutic trial.

This clinical strategy is eminently reasonable because, in the vast majority of cases, if a beneficial response to treatment doesn’t occur, opioids may be safely and uneventfully withdrawn.2 Consequently, a diagnosis of incurable pain is an absolute indication for a therapeutic trial of opioid analgesics.

In the following testimony, a government witness rejects this wisdom, and instead accuses a well-intentioned physician of recklessly exposing patients—carrying histories of substance abuse—to unacceptable risks of addiction:

“It’s clear that a number of his patients were drug use potential. Potential candidates. Particularly, patients addicted to cigarettes or who had habits of alcoholism. These are already abusive individuals and they are more likely than someone else to have an abuse problem with a — with a powerful analgesic medication.”1

“This is why in the American Society of Addiction Medicine, as part of my training and to be qualified as an Addictive Medicine Specialist, and as part of the American Society of Addiction Medicine, there’s a whole section on management of pain and patients with addictive disease because patients with addictive disease that have pain are at particularly high risk when you use opiates.”1

A review of the medical literature reveals that a history of substance abuse does not, in fact, reliably predict a poor therapeutic outcome, when chronic pain in this population is treated with opioids.3,4

Titration to Optimal Therapeutic Effect

Titration to optimal therapeutic effect is the central practice element within the standard of care for pain management. Its implementation is required in order to effectively execute a therapeutic trial of opioids.

Titration is accomplished by incrementally raising the dose of an opioid analgesic to one of two possible end points. These are: 1) optimal therapeutic response occurs, or 2) intolerable side effects intervene, preventing further dosage increases. If the latter occurs, the physician should then employ clinical practices such as combination treatment, or opioid rotation.

A ground rule for titration allows for a doubling of opioid dosages from one interval to the next.5 This represents a geometric progression, and allows for an 800 percent increase within a time frame of three dosage intervals. Below, a government witness expresses misgivings over a far slower rate of titration:

“In April of one year she was on 400 milligrams of OxyContin. It — it doubled in May, a month later. I don’t know if that was 30 days. I don’t have the — it went from 400 to 960. That’s more than doubled. I’m talking about milligrams a day. The numbers themselves don’t mean much to me, but the rate of getting to a total number means something. Then the very next month, June, it went up to 2400 hundred. So from April to May to June, say two months, 60 days, it went up 6-fold or six hundred percent. That’s an exceedingly high rate of titration, in my experience.”1

According to accepted guidelines, the above titration could have been accomplished within 2 1/2 dosage intervals. This would have required a maximum of 36 hours. Instead, the patient, whose care was in dispute, experienced this dosage increase over 60 days, or 1440 hours.

During the proceedings in which the above testimony was offered, it represented the high water mark for understanding by government experts of the subject of titration. Testimony offered by a second government witness demonstrated an even more profound ignorance of this essential clinical practice:

“ Titrated appropriately is a little strong because titrate appropriately means come down. There was more of a pattern of up.”1

One might note that if a physician failed to titrate to therapeutic effect when employing insulin in the treatment of diabetes, or when treating hypertension with blood pressure medications, this professional misconduct would be characterized as reckless negligence.

Finally, because there is no arbitrary upper limit to dosage at which opioid analgesics become toxic, titration is an open-ended practice. This phenomenon is placed into clinical context by the fact that dosages as high as 35 grams (35,000 mg) of morphine per day have been safely administered.6 In spite of this, a former president of the American Pain Society offered the following testimony against a colleague in federal court:

“…morphine at a dose of 195 mg/day constitutes a high dose.”7

Before the trial ended, six former presidents of the American Pain Society publicly rejected the witness’ testimony. In a letter to the court, they made the following remarks addressing the statement about opioid dosages:

“This statement is without foundation in the medical literature and we believe that it is, on its face, absurd.”8

The jury was not provided with this evidence, and the doctor was convicted.

Last updated on: May 16, 2011
First published on: September 1, 2005