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  Methadone Cardiotoxicity
Methadone Cardiac Deaths Exceeded Respiratory Deaths

Mechanisms of Opioid Associated Death and the Apparent Cardiotoxity of Methadone at Low Dosages — An Examination of a Series of 18 Cases

Frank B. Fisher, M.D.


ABSTRACT


A series of 18 opioid associated deaths around which pain treating physicians were accused of murder, manslaughter, and wrongful death was analyzed with the purpose of evaluating the diagnostic accuracy with which medical examiners determined causes of death. Diagnostic accuracy was poor because apparent cardiac mechanisms were regularly overlooked. Unexpectedly, the data suggested a causal relationship between therapeutic Methadone use and sudden cardiac death. This resulted in the recognition that multiple lines of evidence exist in the literature supporting a causal relationship between Methadone and sudden cardiac death, and the ongoing epidemic of Methadone associated deaths. EMPHASIS ADDED 

HYPOTHESES


(1) Deaths occurring among patients suffering from chronic pain and attributed by medical examiners to opioid overdoses may in fact often result from other causes, particularly sudden cardiac death. (2) Methadone may be cardiotoxic, especially during the initial phase of treatment, and this may contribute substantially to the ongoing epidemic of Methadone related deaths among chronic pain sufferers treated with this medication.

OVERVIEW


Chronic pain has recently been identified as a disease in and of itself.  When it remains under treated, it produces or amplifies risk factors for cardiovascular disease. These include physical inactivity, and stress. Associated hormonal and inflammatory factors are recognized to play a role in the pathogenesis of cardiovascular disease caused by chronic pain.ii

The recent phenomenon of homicide accusations against pain treating physicians offers a unique opportunity to examine the subject of opioid associated death,iii and Methadone related deaths in particular. This opportunity exists because the government typically spends millions of dollars in the process of investigating and prosecuting individual pain treating physicians. As a result, a wealth of information surrounding each death becomes available for analysis.

Accused physicians are compelled to hire experts to examine this data to an extent unlikely to occur outside the context of adversarial proceedings. Such analysis was performed in all of the cases in this series of deaths.

MATERIALS & METHODS


Materials Examined
Data for analysis were extracted from the following sources.

1. Autopsy reports.
2. Toxicology reports.
3. Medical records.
4. Investigative reports containing statements by witnesses, as well as descriptions of death scenes by police, and by investigators associated with the offices of medical examiners.
5. Trial and deposition transcripts.

Selection Criteria


Cases meeting the following criteria were selected for analysis. A physician was accused of killing a patient through his prescription of opioid analgesics. Criminal accusations included murder and manslaughter charges. Malpractice accusations included wrongful death.

The one case in which a medical examiner attributed death entirely to cardiac causes met the selection criteria for inclusion in this series because it was an opioid associated death in which the physician was sued for wrongful death. The theory concocted by the plaintiff’s attorney was that treatment with opioids caused the patient to become addicted and consequently neglect his cardiac risk factors.

RESULTS


Respiratory vs. Cardiac Mechanisms of Death
Eight different medical examiners offered opinions concerning the deaths in this series of 18 cases. In 17 of the cases medical examiners attributed death to drug overdose.

In 2 deaths, a single medical examiner attributed death to cardiac mechanisms. In one of these, law enforcement prevailed upon him to attribute the patient’s cardiac death to an imagined toxic effect of his pain medications.

Opioid Levels Were Within Therapeutic Ranges


With only two exceptions, postmortem opioid levels fell within published therapeutic ranges for live patients suffering from chronic pain.iv v Analysis of circumstances surrounding these deaths excluded respiratory depression as a mechanism in each. EMPHASIS ADDED

One of the two exceptions was the death caused by massive trauma. The blood level of oxycodone of 21,900 ng/ml was drawn from the abdominal cavity after the heart had ruptured. The medical examiner testified that the patient would have died momentarily of a drug overdose, if a motor vehicle crash hadn’t intervened.vi

In the other exception with a postmortem Methadone level of 13,800 ng/ml the suddenness with which death occurred precluded opioid overdose. The patient had dropped off a prescription at his pharmacy minutes earlier and did not appear to be sedated. The elevated level of Methadone measured in his blood was most likely an error occurring in the laboratory, or in the transcription process.

Cardiac Deaths


11 of the 14 decedents were autopsied. Significant cardiac pathology was discovered in 10 of these 11. Autopsy findings included evidence of cardiac enlargement in the form of elevated cardiac weight and increased thickness of ventricular walls, acute inflammation of the epicardium, stenosis of the coronary arteries, perivascular fibrosis of the myocardium, and diffuse myocyte hypertrophy.  EMPHASIS ADDED



In 7 of the 11 autopsied cases, cardiac enlargement based on a weight of greater than 350 grams was found. Analysis of evidence indicated that 14 of the 18 deaths in the series were cardiac in nature. EMPHASIS ADDED

Non Cardiac & Respiratory Mechanisms of Death


Four of the 18 deaths in this series can reasonably be attributed to other than cardiac mechanisms.

One of these 4 was the previously mentioned trauma death.

Another was a death resulting from alcohol poisoning and aspiration of vomitus. Evidence of the possibility of foul play was present in the form of ligature marks on all four extremities. The medical examiner ignored this finding.

Evidence supported respiratory depression as the mechanism of death in two of the four non-cardiac deaths. In both suicides were likely on the basis of psychological autopsy.

Substances Potentially Precipitating Arrhythmia


In 7 of 14 cases where sudden cardiac death was likely, substances known to precipitate cardiac arrhythmia were determined through toxicological analysis to be present. The most common of these substances was cocaine, which was present in 5 of the 14. An excessive level of Reglan was present in the blood of one of the decedents. An excessive level of paroxetine was present in another.

Diagnostic Criteria Employed by Medical Examiners


In the majority of the cases reviewed, the presence in postmortem blood of an opioid at a concentration known to have been associated with any other deaths attributed to opioids was sufficient to provoke medical examiners to attribute death to overdose.

Pulmonary edema, which is an expected finding in deaths resulting from respiratory depression, as well as other mechanisms including cardiac death, was routinely regarded by medical examiners as evidence confirming that death was caused by overdose and consequent respiratory depression.

The Issue of Postmortem Redistribution of Opioids


Opioid levels were routinely accepted by medical examiners at face value. The phenomenon of postmortem redistribution of opioids was seldom considered. Even when defense attorneys brought it up medical examiners typically discounted it as insignificant.

Failure to Autopsy


Autopsies were performed on a total of 15 of the 18 decedents. In the 3 cases where autopsies weren’t performed, 2 different medical examiners each based their determinations that death was caused by opioids on postmortem blood levels alone.

Determining Tolerance


While medical examiners were usually aware that the decedent had been a chronic pain sufferer, no attempts were made to determine what sort of tolerance to opioid analgesics the decedent might have carried. Medical examiners routinely failed to review medical records and other documents, which contained evidence supporting the existence of opioid tolerance.

Circumstances Determined Through Police Investigation


In many cases, accounts of events surrounding the death were available in the form of police reports. These contained information such as when the decedent was last seen alive, details about timing and dosage of medications, and histories of alcohol and illicit substance abuse. Medical examiners routinely disregarded, or failed even to make themselves aware of this information.

Cardiac Risk Factors


Many decedents carried an array of cardiac risk factors. Some, such as obesity, should have been apparent at autopsy. Others, such as smoking, hypertension, or a previous myocardial infarction would have been apparent upon review of medical records, but medical examiners routinely failed to do this.

Methadone Associated Deaths


Seven of the 14 probable cardiac deaths were associated with Methadone. Medical examiners attributed all of these to drug overdose and consequent respiratory depression.

In 5 of these 7 cases, the timing of events surrounding these deaths excluded respiratory depression as a possibility. In the other two, there was compelling evidence that the deaths were most likely due to cardiac mechanisms as well. These issues are discussed in detail in the final section of this paper addressing a causal link between therapeutic Methadone use and sudden cardiac death.

6 of the 7 deaths occurred within 10 days of starting Methadone. In 3 cases, death occurred within 48 hours.   EMPHASIS ADDED

In 6 of the 7 Methadone associated cases, decedents carried multiple cardiac risk factors and autopsies revealed significant cardiac pathology.

Clusters, A Widespread Phenomenon


5 of the 6 accused physicians in the series were accused of causing between 2 and 5 patient deaths. The physicians who were accused of killing their pain patients practiced in 6 different states.

Tables
Data and observations about mechanism of death are summarized in the accompanying tables.

DISCUSSION OF MEDICAL EXAMINERS’ ERRORS, OMISSIONS, AND MISCONCEPTIONS

Problems with opinions and testimony offered by experts against physicians accused of misprescribing opioid analgesics are abundant.vii The conduct of medical examiners in the cases in this series fit this pattern.

Confusing Association with Causation, and Failure to Engage in the Process of Differential Diagnosis

The 8 medical examiners in this series routinely committed the classic error of confusing association with causation. They focused their attention on how opioids killed the decedent, rather than whether these medications were accountable.

The process of differential diagnosis is an essential element of medical thought. Its implementation is universally understood to be necessary in order to arrive at rational diagnostic conclusions. When opioids were found in the postmortem blood of patients whom a physician was suspected of killing, this process was abandoned.

Problems Associated with Thinking About the Role of Opioid Analgesics in Associated Deaths

Among the medical examiners contributing to this series, ignorance about opioid physiology and opioid pharmacology was abundant. As a result, their diagnostic framework for thinking about opioid associated deaths proved inadequate for the task in the majority of the cases reviewed.

Ignorance of the Phenomenon of Tolerance

Tolerance to opioid analgesics develops through ongoing exposure to these substances. It is also conferred by the presence of pain, which stimulates respiratory drive.viii This phenomenon accounts for the vast range of therapeutic levels of opioid analgesics known to exist for chronic pain patients.

By definition, the phenomenon of tolerance mitigates powerfully against the occurrence of respiratory depression in opioid tolerant individuals. Medical examiners were for the most part ignorant of the implications of this crucial aspect of opioid physiology.

Inappropriate Reliance on Postmortem Opioid Levels
 In order to achieve therapeutic goals in the treatment of opioid tolerant chronic pain sufferers, blood levels that would kill naïve individuals are often necessary. The phenomenon of tolerance allows these patients to consume dosages of opioids that would kill individuals not possessed of a tolerance.

For this reason the forensic pathology literature is replete with cautions that causality in opioid associated deaths cannot be determined through the measurement of postmortem levels alone.ix This however is exactly what most of the medical examiners in this series did.

Ignorance of Postmortem Redistribution

The phrase, postmortem redistribution, describes a process through which opioid levels in heart blood may change after death. This occurs when there was a difference between opioid levels in the blood and those in surrounding tissues of the myocardium and lungs. As a result of this process, opioid levels measured in postmortem heart blood may be as much as 4X as high as the as they were when the patient was alive. EMPHASIS ADDED

Medical examiners typically failed to reckon with this possibility. A consequence was that in a number of cases they based their theories about how death occurred on dramatically elevated blood levels of opioid analgesics that didn’t exist while the decedent was still alive.

Ignorance of the Physiology of Opioid Overdose

Testimony by the medical examiner in the above described trauma death, that the patient involved would have been dead within minutes anyway if the motor vehicle accident hadn’t interceded, reveals an astonishing ignorance of the manner in which death occurs in opioid overdose. Sedation is followed by somnolence, in a progressive manner, and finally gradual slowing of respirations occurs.viii

In contrast, the patient in question had been alert and shopping for furniture just minutes before the accident. These circumstances left no time for her to have passed through the expected stages. In other words, the mechanism of death proposed by the medical examiner was physiologically impossible.

Misinterpreting the Presence of Pulmonary Edema

When pressure relationships within the lungs are altered by cardiac or pulmonary events, fluid accumulates in the alveoli. When the dying process is protracted, more fluid accumulates. This produces higher post mortem lung weights.

Normal combined postmortem lung weights fall in the range from 700-800 grams. Weights of >1,700 grams occur when respiratory depression occurs gradually over a period of hours. Lung weights in deaths occurring through the mechanism of lethal ventricular arrhythmia fall into an intermediate range.
 Medical examiners routinely failed to consider lung weights as data useful in determining mechanism of death. Having concluded that a postmortem opioid level fell within the range that they believed was potentially lethal, they would simply point to the presence of pulmonary edema as if this confirmed their presumptive diagnosis of opioid overdose. Any elevation in lung weight would satisfy in this pursuit.

Only one combined lung weight in this series actually exceeded 1,700 grams. This death was likely the result of respiratory depression.

Deficient Autopsy Procedures, A Failure to Procure Important Evidence

Determining that a lethal ventricular arrhythmia may have caused an opioid associated death is impeded by the fact that ventricular arrhythmia doesn’t leave a distinct anatomical signature on which a medical examiner can rely. Only an EKG tracing documenting the event can do this. However, in 95% of deaths where the mechanism of death is cardiac, careful autopsy will disclose anatomical evidence to support this determination.x

In all decedents in this series, postmortem examinations of heart tissues were perfunctory. Thorough examinations of these hearts would have included intensive sectioning of the coronary arteries, detailed examination of the valves, and an examination of the conduction systems. The routine failure of medical examiners to seek this information in cases where their colleagues are accused of homicide is inexcusable.

Disregarding Important Evidence

When cardiovascular pathology such as atherosclerosis was revealed at autopsy, medical examiners invented ways to discount it. One referred to the finding of atherosclerosis as “normal” for age. Atherosclerosis is immutable evidence of cardiovascular disease. It is only normal in the sense that it is common.

Other positive findings were simply ignored. Notable among these were elevated heart weights indicative of significant ventricular hypertrophy, which is a risk factor for lethal arrhythmia,

Ignorance of Cardiac Medicine

When defense attorneys raised the concept of sudden cardiac death, medical examiners typically resisted this possibility. One testified that the decedent wasn’t known to suffer from cardiac disease. This contention reveals a startling ignorance of general medicine, as it is widely known among physicians that sudden death is the commonest presenting symptom of cardiovascular disease. xi

Ignorance of Benzodiazepine Tolerance
 

Chronic pain patients are often treated with benzodiazepines in combination with opioid analgesics. This is necessary because anxiety and insomnia are highly prevalent in this population as symptoms of the underlying disease. Additionally, benzodiazepines are neuromodulators. As such, they likely exert the beneficial effect of controlling neuropathic pain, which is ubiquitous in chronic pain syndromes.

Knowing that benzodiazepines can contribute to respiratory depression in opioid naïve individuals, medical examiners typically implicate them as contributing to presumed opioid induced respiratory depression and death. This approach ignores the (1) fact that with repeated exposure tolerance to benzodiazepines develops, just as it does with opioids.xii, and (2) respiration is not depressed in opioid tolerant patients to begin with.

Ignorance of the Pharmacology of Methadone

When a drug is administered repeatedly, it takes approximately 5 half lives for it to reach steady state blood levels. In the case of methadone, this process requires several days. During this time, Methadone levels rise to progressively higher peaks with each successive dose. This phenomenon, often referred to as “stacking up”, was repeatedly invoked by medical examiners in support of their presumption that patients died of overdoses.

However, medical examiners invoked this concept indiscriminately, failing to grasp that after Methadone levels peak, some 3-4 hours following administration, levels then fall until the time that the next dose is taken. While the level is falling, the patient will not experience respiratory depression if this didn’t occur at the time the level peaked. As a result of ignorance of this fact, medical examiners consistently committed the error of attributing death to overdoses occurring many hours after Methadone levels had already peaked.

The Apparent Role of Bias in Cases Involving Accusations Against Physicians

The diagnostic accuracy of the medical examiners examined in this series was abominable. Review of published series of opioid associated deaths, including those that will be cited later in this article, indicates that in cases where pain treating physicians aren’t accused, medical examiners attributed deaths to a variety of mechanisms.

By implication, the most likely explanation for why medical examiners in this series performed so badly is bias, introduced by the nature of the cases themselves. All of the medical examiners involved knew at the time they offered their opinions that the physician involved had been accused of wrongdoing.


DISCUSSION OF FACTORS THAT RULED OUT RESPIRATORY DEPRESSION AS A MECHANISM OF DEATH IN DECEDENTS IN THIS SERIES

Analysis of factors surrounding the Methadone associated deaths in this series excluded respiratory depression as the mechanism in 5 of the 7, and found it unlikely in the other 2. The following considerations operated during analysis:

- When death is known to have been sudden, this by definition excluded the mechanism of opioid induced respiratory depression, as these deaths are understood to occur gradually over a time span of hours.

- Combined postmortem lung weights found in this series in the range of 1,500 grams or less are inconsistent with gradual respiratory depression. These are intermediate lung weights that favor sudden cardiac death as a mechanism.

- Human physiology and opioid pharmacology don’t allow for the attribution of death to respiratory depression, under circumstances when death occurs long after opioid levels and corresponding physiologic effects have long since peaked.

- None of the Methadone using patients in this series were opioid naïve.

After a process of exclusion, ventricular arrhythmia remains as the most likely mechanism of death. This raises the specter of a previously unrecognized causal relationship between Methadone and lethal cardiac arrhythmia.

EVIDENCE SUPPORTING A CAUSAL RELATIONSHIP BETWEEN METHADONE AND LETHAL VENTRICULAR ARRHYTHMIA

A number of existing lines evidence converge to support a causal relationship between Methadone and lethal ventricular arrhythmia.

The Initiation of Methadone Treatment is Dangerous

The risk of sudden death is dramatically increased during the initiation of Methadone treatment. It may be as much as 7-fold higher than that of addicts remaining outside Methadone programs.viii

Dosages & Blood Levels in Methadone Associated Deaths

Patients have been noted to succumb to dosages of Methadone understood to be too low to provoke respiratory depression. Deaths have been noted at as little as 20 mg/day.xiii

Blood levels of Methadone lower than the expected lethal range are noted to occur in deaths attributed to Methadone. On this basis, a paper describing a series of Methadone associated deaths in Hennepin County, Minnesota, concluded that “no definable lethal level” for the medication could be established.xiv A similar series from Palm Beach County, Florida, concluded on the basis of deaths occurring at levels below the previously reported range that it may be impossible to define a lethal range for Methadone.xv  EMPHASIS ADDED

This data suggests that there may be no safe dosage of Methadone in patients initiating the use this substance.

Timing of Methadone Associated Deaths

A recent review of deaths occurring early in treatment with Methadone cited 5 studies in which deaths occurred many hours after the last dose of the medication had been ingested.xiii This occurred in a number of the deaths analyzed in present series as well.

A Potential Cardiac Mechanism

There exists electrocardiographic evidence associating Methadone with prolongation of QT intervals, even at low dosages.xvi It remains to be determined if this troubling observation has any bearing on the apparent phenomenon of sudden cardiac death associated with Methadone, occurring at low dosages and early in treatment.

DISCUSSION OF THE SCOPE AND NATURE OF THE EPIDEMIC OF METHADONE RELATED DEATHS

Methadone became widely prescribed in the treatment of chronic pain during the years between 1999 and 2004. This occurred as a result of law enforcement driven media hysteria over Oxycontin, making Methadone the pain medication of first choice for many pain treating physicians, who perceived this medication as posing less risk to themselves.

As a result, America now finds itself in the midst of an epidemic of Methadone associated deaths. Data from National Center for Health Statistics includes the following: xvii

- Nationwide, Methadone associated deaths increased 389.7% between 1999 and 2004. During this same time period, all poisoning deaths increased by only 54%.
EMPHASIS ADDED

Methadone associated deaths increased from 4% to 13% of the total of all poisoning deaths  EMPHASIS ADDED

- The statistics concerning Methadone associated deaths determined to be unintentional are even more dramatic. Between 1999 and 2004, more than 90% of Methadone related deaths were classified in this manner. There were 3,202 such deaths nationwide in 2004. This represents a 414% increase between 1999 and 2004.

- In some states, the increase in Methadone associated deaths observed between 1999-2004 was much larger than the nationwide average. The statistics include 2,500% in Virginia , 1,500% in Kentucky , 1,400% in Florida and Oregon , and 700% in North Carolina and Texas . This data is meaningful on the basis of sample size. In each state listed above, at least 50 of these deaths occurred during at least 3 of the six years that information was collected.
 What Population is at Risk?

It is widely believed that Methadone related deaths occur primarily among drug addicts. Evidence gathered in North Carolina refutes this supposition. xviii

- From 1997 to 2001 there were 198 deaths attributed by medical examiners primarily to Methadone. The number of such deaths increased from 12 in 1997 to 80 in 2001, a 666% increase.

- During this time period, there was a 400% increase in Methadone sold to pharmacies and hospitals. Retailing to addiction treatment programs increased by a factor of 2.6.

- In 75% of the 198 cases, medical examiners concluded that Methadone was the only drug that significantly contributed to death.

- Methadone associated deaths in pain patients outnumbered those of patients in addiction treatment by a factor of at least 9:1. This is apparent because a total of 8 (4%) decedents were enrolled in an addiction program at the time of their deaths, while at least 73 (37.5%) were determined to have been receiving Methadone through a prescription that could only have been intended for the treatment of pain.  EMPHASIS ADDED

The above data establishes that in North Carolina , Methadone is far more dangerous to patients treated for pain than it is to the population in which it is intended for the treatment of addiction. In fact, the disparity in risk between these two groups may be substantially larger than the data suggests, as many of the patients in addiction treatment programs are in reality chronic pain sufferers.

Often, pain patients, desperate to obtain relief unavailable from their intimidated physicians, pose as addicts and lie their way into addiction programs.xix In this manner pain sufferers, predisposed to sudden cardiac death through their underlying pain disease, are regularly forced to endure the additional risk of death that accompanies Methadone treatment.

The fact that 75% of the 198 Methadone associated deaths in North Carolina were attributed by medical examiners essentially to Methadone alone supports the hypothesis that Methadone is cardiotoxic. The following facts concerning pain treatment and opioid analgesics are worthy of consideration:

- When opioid associated death occurs through the mechanism of respiratory depression, it is commonplace for multiple drugs to be implicated as contributing to the overdose. With Methadone, one finds the opposite.

- Pain sufferers possess tolerance to opioid analgesics, which protects them against respiratory depression. This tolerance develops on the following bases:
(1) The presence of pain confers tolerance by stimulating breathing.
 (2) Ongoing use of opioid analgesics produces tolerance through continuing exposure of brain receptors, which become inured to the presence of these medications.

Consequently, if overdose causing respiratory depression were the underlying mechanism producing the current epidemic of Methadone associated deaths, pain sufferers should be the group most likely to survive. Instead, this group represent the lion’s share of the body count.

CONCLUSIONS


The Cardiotoxicity of Methadone

Compelling evidence indicates that Methadone provokes sudden cardiac death. This danger is so pronounced that it emerged in the form of clusters of deaths occurring within individual medical practices that contributed to this series of 18 opioid associated deaths. This apparent threat to public health demands that Methadone be immediately repositioned within the hierarchy of treatment choices both for chronic pain, and for addiction. An adjustment in the risk benefit analysis is required.   EMPHASIS ADDED

The recognized causal relationship between chronic pain and cardiac disease may render this group of patients particularly vulnerable to lethal ventricular arrhythmia triggered by Methadone. This circumstance is likely the basis of the almost 10:1 disparity in Methadone associated deaths observed between pain patients and addiction patients in North Carolina .

The Field of Forensic Pathology

The field of forensic pathology is in profound disarray around the subject of opioid associated death. Members of the discipline are ignorant of fundamental physiological and pharmacological principles at the interface between opioid analgesics and the management of chronic pain. As a result, they are bereft of the tools that would allow them to arrive at rational conclusions when determining causation in opioid associated deaths.

The apparent causal relationship between Methadone and sudden cardiac death urgently demands further investigation. This endeavor will likely be hampered by a dearth of accurate information concerning causes of death in opioid associated cases, as the results of this investigation raise troubling questions concerning the ability of the field of forensic pathology to produce meaningful data in this area.

Implications for Pain Treating Physicians

When a physician is accused of misprescribing opioid analgesics, the diagnostic performance of medical examiners further deteriorates. Medical examiners’ only apparent function within this context is to rubber stamp the accusations of prosecuting attorneys.
 As a consequence, if a patient dies and a prosecutor decides to file criminal charges, it is all too likely that the local county medical examiner will eagerly testify against his pain treating colleague. The risk that a pain patient will die during treatment is amplified by the selection of Methadone.

Implications for Patients

Assuming that Methadone is cardiotoxic, many of the thousands of associated deaths that occur each year among pain patients represent an ongoing and preventable public disaster. Preventable because there is no evidence to suggest that the increased prescribing of other opioid analgesics has resulted in anything resembling an epidemic of deaths among pain patients. Shameful because pain treating physicians have been bullied by zealous government drug warriors, and by their counterparts in the field of addictionology, into switching suffering patients from relatively safe analgesics such as oxycodone, to this deadly drug.

The Chilling Effect Exerted by Law Enforcement Drives the Epidemic

It is unlikely that chance accounts for the dramatic increases in Methadone associated deaths encountered in the particular states that registered 700% or greater increases in Methadone associated deaths between 1999 and 2004. In all of these states, brutal repression of pain treatment by law enforcement manifested itself in the form of high profile prosecutions of pain treating physicians.

- In Virginia , where an astonishing 2,500% increase in Methadone associated deaths occurred, law enforcement continues to conduct its highest profile persecution of a pain treating physician. This culminated in the 2004 witch trial and judicial lynching of Dr. William Hurwitz.

- In Kentucky , numerous pain treating physicians have been persecuted and imprisoned. At the same time, a prescription monitoring program, KASPER, was highly touted by law enforcement as serving public health interests.

- In Florida , Drs. Deonarine and Luyao were both accused of multiple murders, among other crimes. While the murder charges failed to stick, both physicians are serving very long prison terms. Also in Florida , Dr. James Graves is serving a prison term of 63 years because the government took exception to his treatment of chronic pain.

- In Oregon , the state medical board has relentlessly hounded Dr. Martin Klos.

- In North Carolina , Dr. Joe Talley was run out of practice by his state medical board. While never indicted Dr. Talley has been threatened with criminal prosecution for over 5 years.

- In Texas , following a media blowout around his arrest, Dr. Daniel Maynard continues to face criminal prosecution on multiple counts of manslaughter Physicians are well known to be averse to risk, and only a fool would suggest that these high profile politically motivated prosecutions don’t chill prescribing behavior, to the detriment of millions of patients.

Distorting Medical Decision Making Through Errors in Social Policy

The history of the 20th Century reminds us that when the executive branch of government has seized control of the physician/patient relationship, some of the worst things that happened during the 20th Century occurred. The ongoing epidemic of Methadone deaths among pain patients serves as an example of such a phenomenon. A social agenda, prohibition in the guise of the war on some drugs, has dangerously distorted medical decision making. The unforeseen and unintended consequences are horrific.



END NOTES:
iArgoff CE. Managing Neuropathic Pain: New Approaches for Today’s Clinical Practice. Medscape. Available at: http://www.medscape.com/viewarticle/453496_1

iiTennant F. Identification and Management of Cardiac-Adrenal-Pain Syndrome. Practical Pain Management. September 2006. P. 12-21.

iiiLibby R. Treating Doctors as Drug Dealers, The DEA’s War on Prescription painkillers. Policy Analysis, CATO Institute. 2005;545:1-26. Available at: http://www.cato.org/pubs/pas/pa545.pdf

ivJung BF, Reidenberg MM. Interpretation of opioid levels: comparison of levels during chronic pain therapy to levels from forensic autopsies. Clin Pharmacol Ther. 2005 Apr;77(4):324-34

vTennant F. Tennant Blood Study, Summary Report, Opioid Blood Levels in High Done, Chronic Pain Patients. Practical Pain Management. March 2006. 28-29

viState of California vs. Dr. Frank Fisher. Transcript of preliminary hearing. 1999. Available @ PRN Web site. http://www.painreliefnetwork.org/

viiFisher F. How Expert Testimony Distorts the Standard of Care. Practical Pain Management 2005; 5:33-41.

viiiBrookoff D. Chronic Pain: Part 2. The Case for Opioids. Hospital Practice. 2000

ixKarch SB, Stevens BG. Toxicology and pathology of deaths related to methadone: retrospective review. West J Med. 2000 Jan;172(1):15-6.
 xChugh SS et al. Sudden Cardiac Death With Apparently Normal Heart. Circulation. 2000;102:649. Available at: http://circ.ahajournals.org/cgi/content/abstract/102/6/649

xiZipes DP, Wellens HJJ. Sudden Cardiac Death. Circulation. 1998;98:2334-2351. Available at: http://circ.ahajournals.org/cgi/content/full/98/21/2334

xiiShader RI, Greenblatt DJ. Use of Benzodiazepines in Anxiety Disorders. NEJM. 1993;328:1398-1405.

xiiiProceedings of Expert Workshop on the Induction and Stabilisation of Patients Onto Methadone. January 28th and 29th 1999. Adelaide , South Australia . Available at: http://www.
health.gov.au/internet/wcms/publishing.nsf/Content/
87AFC56E26122571CA2570370007714F/$File/mono39.pdf

xivGagajewski A, Apple FS. Methadone-related deaths in Hennepin County , Minnesota : 1992-2002. J Forensic Sci. 2003 May;48(3):668-71.

xvWolf BC, Lavezzi WA , Sullivan LM, Flannagan LM. Methadone-related deaths in Palm Beach County . J Forensic Sci. 2004 Mar;49(2):375-8.

xviLeavitt SB, Krantz MD. Cardiac Considerations During MMT (Methadone Maintenance Treatment). Addiction Treatment Forum. October 2003. Available at: http://66.102.7.104/search?q=cache:gobcBLV77ZMJ:
www.atforum.com/SiteRoot/pages/addiction_resources/CardiacPaper.
pdf+Cardiac+Considerations+During+MMT&hl=en&gl=us&ct=clnk&cd=1

xviiFingerhut LA. Increases In Methadone-Related Deaths: 1999-2004. National Center For Health Statistics. Available at: http://www.cdc.gov/nchs/products/pubs/pubd/
hestats/methadone1999-04/methadone1999-04
.htm (last visited 02/18/2007)

xviiiBallesteros MF et al. Increase in Deaths Due to Methadone in North Carolina . JAMA. Vol. 290 No. 1, July 2, 2003

xixJoranson DE. Is Methadone Maintenance the Last Resort for Some Chronic Pain Patients? American Pain Society Bulletin. 1997;7(5)1,4-5.


About the Author

Dr. Fisher is a Harvard-trained general practitioner who has dedicated his career to caring for medically underserved populations. His appropriate treatment of patients suffering from chronic pain resulted in his 1999 arrest and prosecution on charges of multiple murders, drug dealing, fraud, and conspiracy. Following his exoneration, he has served as an expert witness in numerous cases brought against other similarly accused physicians.

Other Publications

Pain Killer. Harvard Medical Alumni Bulletin. Winter 2006;32-37.

How Expert Testimony Distorts The Standard Of Care For Pain Management With Opioid Analgesics Practical Pain Management. September/October 2005.

Evaluating The Risks Of Unwarranted Prosecution Part I: The Criminalization Of Pain Management. The Journal of American Physicians and Surgeons. Fall 2004.

The Role Of Controlled-Release Opioids In The Treatment Of Chronic Pain, The Journal of American Physicians and Surgeons. Summer 2004.

Interpretation of “Aberrant” Drug-Related Behaviors. The Journal of American Physicians and Surgeons. Spring 2004

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