How Expert Testimony Distorts the Standard of Care

PREEMPTIVE ANALGESIA
ETHICS AND AN UNDERLYING PRINCIPLE

Frank Fisher, M.D.;
Practical Pain Management.,
5(6), 33-41; 2005; (Sept.-Oct. issue)

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.

THE 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 & 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 imminently 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the vast majority of cases, if a beneficial response to treatment doesn't occur, opioids may be safely and uneventfully withdrawn.[2] Consequently, a diagnosis of incurable pain is an absolute indication for a therapeutic trial of opioid analgesics.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 3 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, Dr. Michael Ashburn, a former president of the American Pain Society offered the following testimony against his colleague, Dr. William Hurwitz, in federal court.

� morphine at a dose of 195 mg/day constitutes a high dose.[7]

Before Dr. Hurwitz's trial ended, six former presidents of the American Pain Society publicly rejected Dr. Ashburn's testimony. In a letter to the court, they made the following remarks addressing Dr. Ashburn's 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 Dr. Hurwitz was convicted. In early 2005, he was sentenced to 25 years in federal prison.

Patient-Controlled Analgesia

Because the experience of pain is a subjective phenomenon, only the patient can accurately assess his own pain levels, and responses to treatment. Consequently, for effective pain management to occur, patients must be empowered to participate both in the selection of their medications, and in the titration of their dosages. The practice of patient-controlled analgesia expresses the fundamental clinical principle of individualization of medical treatment. It also conforms to the bioethical pillars that form the basis of modern medical practice. These pillars include informed consent, patient autonomy, and the understanding that the existence of a partnership between the physician and the patient favors positive treatment outcomes.

For more than a decade, patient-controlled analgesia has been accepted as the standard in the management of acute post-surgical pain.[9] In this setting, the practice has proven to be safe and effective.[10,11,12] Patients treated with this approach are typically more satisfied with their pain control, use less medication, and leave the hospital sooner than patients treated with the conventional approach.[9]

Patient-controlled analgesia is also widely used in the management of chronic pain in outpatients. Immediate-release formulations of opioid analgesics are routinely prescribed to control breakthrough pain. These dosages are self-administered by patients on an as needed basis. Perusal of product literature reveals that this common clinical practice enjoys FDA approval.

All of the above conditions establish patient-controlled analgesia as an essential element of the standard of care in the management of chronic pain. However, an expert testifying against a pain treating physician rejects the practice as dangerous: So in essence, he was advancing, in my opinion, a self-medication regimen which is dangerous.[1]

This attack overlooks the significance of the physiological phenomenon of tolerance. In patients accustomed to opioids through regular exposure, tolerance effectively precludes the occurrence of significant respiratory depression.[13] A consensus statement from the American Academy of Pain Medicine and the American Pain Society confirms this.

It is now accepted by practitioners of the specialty of pain medicine that respiratory depression induced by opioids tends to be a short-lived phenomenon, generally occurs only in the opioid-naive patient, and is antagonized by pain.[14]

THERAPEUTIC GOALS

Therapeutic goals for the management of chronic pain are twotiered. 1) Pain relief is the first tier. (In the treatment of acute pain, achieving below 4 on a scale of 10 satisfies the standard of care.) 2) The second tier is the achievement by the patient of optimal functioning. When optimal therapeutic response has not occurred, the treating physician is obligated to titrate dosages of opioids upwards.

When a physician faces accusations based on his controlled substances prescribing, testimony by government experts typically promote rationales for why the targeted physician should have arbitrarily limited dosages. An exchange between a prosecutor and a government witness illustrates how these sorts of accusations conflict with the standard of care.

Q. There were many chart notes indicating that she was doing well on her current medication, so the whole course of the time in which these are being escalated, there not only is no justification for increasing it, there appears to be justification for leaving it exactly as it was; would you not agree, Doctor?

A. Not only do I agree with what you said, but I also noted it in a number of other patients whose charts I reviewed, that patients were doing fine. Medication was adequate. Painkillers were adequate. Whatever, those - these are in the typed notes. Yet at the same time the dosage was being escalated and escalated and escalated during the period of time when the statement made in the chart was pain coverage adequate.[1]

If the patient had achieved optimal functioning and dosages were titrated upwards anyway, the expert might have had grounds for dispute.

The sort of testimony excerpted above, raises the disturbing possibility that the discipline of pain management, as it currently exists, is only nominally engaged in pain control. This testimony raises instead the disturbing possibility that the overriding but unspoken agenda within the field is the accomplishment of drug control through the arbitrary limitation of opioid dosages.

THERAPEUTIC OPTIONS

Therapeutic options in the management of chronic non-malignant pain are distinguished from the previously discussed essential practices by the fact that their utility must be determined on a patient-by-patient basis. Evidence favoring one therapeutic option over another doesn't exist. A statement found in a position document posted on the American Pain Society Web site confirms this state of affairs.

APS acknowledges that there are currently no evidence-based guidelines, nor widely accepted consensus guidelines, for the management of chronic benign pain conditions.[15]

Controlled-Release vs. Immediate-Release Formulations

A controversy exists around the clinical issue of choosing between different formulations of a given opioid. Current dogma promises that controlled-release formulations offer superior pain control, and are less prone to abuse than their immediate-release counterparts. A government expert articulates these suppositions, as if they represented an element of the standard of care.

The standard of practice is to prescribe short acting opioids in limited amounts and then convert to a long acting opioid such a Methadone, Oxycontin, levorphanol or MS Contin to reduce the likelihood of euphoria/anxiolysis as inducements to develop addictive behaviors (running out early, multiple prescribers, losing prescriptions, etc.)[1]

There is in fact no evidence indicating that prescribing extended release formulations in the treatment of chronic non-malignant pain offers any advantages beyond convenience to the patient.[16] In the following testimony, a government witness speculates about the potential for misuse of immediate-release formulations.

The short-acting analgesics definitely promote pain behavior because they have this rebound phenomena where the blood level gets low and patients get irritable and they feel their pain and they want to take more. Patients start watching the clock. The whole pattern of pain behavior is increased when you deal or dish out these short-acting pain --pain killers.[1]

The above position is not supported by evidence. It is based instead on the misguided assumption that pain sufferers are at substantial risk to engage in substance abuse. They aren't, and the medical literature indicates that selected patients may in fact be effectively managed with immediate-release formulations of opioids.[17]

Gratuitous Abuse

The use by a government "expert" of expressions such as "deal" and "dish out" heaps gratuitous aspersions upon the physician against whom he is testifying. The potential effect on a jury is a lurid mischaracterization of well-intentioned medical practice. Any physician unfortunate enough to be prosecuted on this basis may anticipate this sort of character assassination, delivered in the courtroom by a rogue subset of his academic colleagues.

Previous Alcohol Abuse

Attacks by government experts against physicians, who prescribe immediate-release opioids, become more strident when these formulations are used in the management of pain in patients carrying histories of alcohol abuse.

�an extreme departure from the standard of care that represents a consistent ignorance of the usual practice of: avoiding highly addictive opioids (Norco, Vicodin ES, Demerol) in a patient with a history of alcoholism.[18]

This assertion is contradicted within the medical literature by evidence indicating that a remote history of alcohol abuse holds little or no predictive value for the success or failure of treatment.[3,4]

COMBINATION TREATMENT

Combination therapy, employing more than one medication, is a widely accepted clinical practice. It is applied in the treatment of a variety of medical conditions, ranging from high blood pressure to infections. In the context of pain treatment with opioid analgesics, this practice is a source of controversy. A government expert asserts that its use represents a deviation from the standard of care.

�a departure from the standard of care that represents an ignorance of the usual practice of: using more than one type of short acting opioid.[18]

The medical literature contains no clinically based evidence to either support or discourage the use of this approach to the management of chronic pain. Basic science has however established the existence of a heterogeneous array of opioid receptors, as well as the existence of a multitude of endogenous opioids, otherwise known as endorphins, which interact with these receptors. [19]

This evidence derived from basic science research, suggests that combination therapy with opioids will ultimately prove to be an effective pain treatment strategy. Until that occurs, the approach should be employed in the care of those individual pain sufferers who clearly benefit from it.

The Use Of Adjuvants

Adjuvants such as tricyclic antidepressants and anticonvulsants are commonly employed in the management of chronic pain. The stated intent of this approach is often to minimize opioid dosages. When employed for this purpose, the use of adjuvants is grounded neither in evidence, nor in principle. It is generally preferable to treat patients with the smallest number of medications possible, because when multiple medications are employed the odds favoring the occurrence of adverse drug interactions multiply.

Additionally, the use of adjuvant drugs is accompanied by an alarming array of adverse, and potentially lethal side effects. In contrast, opioids are relatively safe when used as directed by a physician. A government expert articulates a conflicting viewpoint.

I just happened to notice that in the 30 some odd cases I reviewed I didn't see much adjuvant or helping medications to help with the analgesic so that they act together on the pain.

But it's wise to titrate also by adding adjuvant drugs that would take the edge off pain as well rather than push up one drug solely.[1]

In addition to violating accepted medical principles, this testimony runs counter to academic wisdom, which states that employing opioids in combination with adjuvants is an option to be considered after titration with opioids has failed.[2]

Psychiatric Referrals & Behavior Modification

The importance of recognizing chronic pain as a disease cannot be overstated. Confusion often arises because the disease state typically expresses itself through an array of psychological symptoms including insomnia, anxiety, and depression. The following assertion, made by a government expert, assumes that psychological symptoms signify comorbid psychiatric diseases:

�a departure from the standard of care that represents a consistent ignorance of the usual practice of: in not referring the patient to a mental health practitioner when he recognized that the patient was suffering from anxiety/depression.[18]

This misconception is harmful because mistaking the symptoms of one disease as a diagnostic of another predictably leads to inappropriate treatment. Furthermore, insult is added to injury by the implication that rather than suffering from an illness with an organic basis the pain victim is psychiatrically deranged.

Multimodal Treatment

A government expert testifies that the treatment of chronic pain with opioids alone is not acceptable:

Chronic pain has to be managed by multiple modalities. Exercise, other devices. And, certainly, consultations with people who specialize in behavioral modification.[1]

This dogmatic one-size-fits-all approach is not supported by evidence. It overlooks the fact that many pain victims, treated exclusively with opioids, resume normal functioning. Through the accomplishment of treatment goals, this outcome, by definition, satisfies any rational standard of care. The expense and inconvenience accompanying the imposition of additional therapeutic modalities would represent only hardship to these patients.

Finally, for lack of funding sources, if not for lack of demonstrable cost-effectiveness, multidisciplinary treatment programs are headed for extinction. [20]

Behavioral Modification

The assertion that behavioral modification is a necessary element in the treatment of chronic pain suggests that this government "expert" regards chronic pain as a behavioral disorder, rather than as a disease with an organic basis. This is understandable in the following context.

Complaints of inadequate treatment represent a threat to the self interests of physicians who wish to avoid scrutiny by law enforcement. If these complaints are conceptualized as undesirable behavior, and then eliminated through a program of behavioral modification, the physician is freed to pursue, through the limitation of opioid dosages, a socially determined agenda of drug control. In this manner, a program of behavioral modification replaces the physician's obligation to titrate to optimal therapeutic effect.

CONCLUSION

Drug control is safer than pain control -- for physicians it is an unpleasant reality that unscrupulous physicians may offer corrupt testimony against their colleagues. It is also generally believed that physicians from highly regarded academic institutions can be counted upon to base their testimony on scientific evidence. Analysis of the testimony excerpted above reveals that within the field of pain management, this is not a given. In fact, the examples reveal an astonishing measure of scientific illiteracy on the part of otherwise reputable academic physicians. The common thread uniting their erroneous testimony is an apparent agenda to restrict the use of opioids in the treatment of chronic pain. This compulsion is held out in the courtroom as if it were a legitimate goal of treatment. It isn't. The benefits accrue only to the physician who endeavors to avoid regulatory scrutiny, not to the interests of his under treated patients. The preceding observations create a conundrum for the conscientious physician inclined to base his treatment of pain on scientific evidence and principle. Within the current regulatory environment, the physician who pursues a humanitarian, evidence-based approach to the management of chronic pain increases the risks that he might become the target of an unwarranted prosecution.

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7. United States v. William Hurwitz. December, 2004.

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