Anesthesiology News - January 2011 - Digital Edition

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McMahon Publishing

The Independent Monthly Newspaper for Anesthesiologists AnesthesiologyNews.com • J a n u a r y 2 0 1 1 • Volume 37 Number 1

Plagiarism in Med Lit Frustrates Journals

Report: Hospital Mortality Falls 40 million records studied; GI surgery mortality up; Reliability of data questioned

T

he largest annual study of hospital quality in the United States found that unadjusted mortality rates improved considerably from 2007 to 2009 in almost all procedures measured, falling 7.98% over the three years. The greatest improvements in unadjusted mortality were observed in chronic obstructive pulmonary disease (18.73%), bowel obstruction (14.72%), heart attack (13.68%) and stroke (13.5%).

Gastroenterology and coronary interventional procedures, however, bucked the trend with unadjusted mortality rates increasing by 8.76% and 9.26%, respectively, according to the 13th Annual HealthGrades

I

f a plagiarist plagiarizes from an author who herself has plagiarized, do we call it a wash and go for a beer?

That scenario is precisely what Steven L. Shafer, MD, found himself facing recently. Dr. Shafer, editorin-chief of Anesthesia & Analgesia (A&A), learned that authors of a 2008 case report in his publication had lifted two-and-a-half paragraphs of text from a 2004 paper published in the Canadian Journal of Anesthesia.

A contrite retraction letter, which appears in the December issue of A&A, from the lead author, Sushma Bhatnagar, MD, of New Delhi, called the plagiarism “unintended” and apologized for the incident. Straightforward enough.

But then things get sticky. Amazingly, the

see hospital mortality page 16

Life in a Fix: Confessions Of an Addicted Physician

see word theft page 18

INside

T

he majority of my patients complained of low back pain, which is easy to fake and virtually impossible to disprove.

The differential diagnosis is broad, PART 2 Editor’s note: Joel Freedland, DO, is a self-described physician addict. and when combined with other Dr. Freedland recently was released from a Michigan prison, where he common complaints such as hypertension, served four years for defrauding Medicaid. Before serving his sentence, he chest pain and nausea, allowed me to break the spent 17 years as a fugitive, living in the Middle East, South America and bank at Medicaid. What did I care? I was rich elsewhere. The following article is the second in a three-part series written and stoned. There was no limit to my potential,

by Dr. Freedland about his experiences. Anesthesiology News is unable and I was eyeing an even larger clinic to take to verify most of me to 20 physician employees. the statements Meanwhile, my addiction was becoming more made in these and more out of hand. At one point, within a articles, as they year of starting at my new clinic, I overdosed and represent personal a medical assistant called for help. I was taken recollections with to an emergency room where the physician on no supporting call correctly assessed the problem. I signed out information beyond against medical advice as soon as he suggested a the author’s urine sample for drug screen. assertions.

06 | In Brief Anesthesia in images: Inside the hospital ship Mercy.

10 | technology Simulation exercises reveal hidden hazards.

28 | CLinical Anesthesiology Spiking ocular pressures during RALP raise concern.

32 | Pain Medicine Probing bupivacaine for hints at novel anesthetics.

McMahonMedicalBooks.com The Essence of Analgesia and Analgesics Edited by Raymond S. Sinatra; Jonathan S. Jahr; J. Michael Watkins-Pitchford

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Heard Here First: Is the

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The 10 most-viewed articles last year on AnesthesiologyNews.com

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1. Fraud Case Rocks Anesthesiology Community 2. Anesthesia Journal Retracts Fluid Paper Over Ethics Concerns, Possible Fraud

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exclusion from Medicare and

3. Propofol Abuse Growing Problem for Anesthesiologists

Medicaid question.

4. DEA: Propofol Headed for Controlled Substance Schedule 5. Teva Exits Propofol Market 6. Current Concepts in the Management of the Difficult Airway (Educational Review)

See article on page 12.

7. Anesthesiologist Reuben Charged With Research Fraud 8. California Anesthesiologists Buck Governor Over CRNA Role 9. Multiuse and Multidose Drug Vials: Where Is the Liability?

10. AIMS Error Snags Attending in Costly Med Mal Case

Register for free @ AnesthesiologyNews.com to read these and other articles.

Alan Kaye, PhD, MD, New Orleans, LA Robert S. Lagasse, MD, New Haven, CT Alex Macario, MD, MBA, Stanford, CA The Independent monthly Newspaper for Anesthesiologists

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Looking for a PreAnesthetic Assessment CME lesson?

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WHEN CHOOSING AN IV SEDATIVE

Different situations require different solutions

Precedex : A right fit ®

FOR TODAY’S SEDATION MANAGEMENT PRACTICES

FASTEST GROWING IV SEDATIVE1

DIFFERENT SITUATIONS REQUIRE DIFFERENT SEDATIVE SOLUTIONS The first and only alpha2 agonist indicated for sedation2,3 —Nonintubated patients prior to and during surgical and other procedures2 —Intubated and mechanically ventilated patients during treatment in an intensive care setting2 Can be used alone or in combination with other sedatives or opioid analgesics to provide sedation and added patient comfort.2 Should be administered by continuous infusion not to exceed 24 hours.2 Effective for intubated patients not just before—but also during—and after extubation.2 More than 4.5 million vials administered to millions of patients since launch.4

IMPORTANT PRECEDEX SAFETY INFORMATION Clinically significant episodes of bradycardia, sinus arrest and hypotension have been associated with Precedex infusion and may necessitate medical intervention.

Moderate blood pressure and heart rate reductions should be anticipated when initiating sedation with Precedex.

Please see the brief summary of Prescribing Information on adjacent page.

The right fit

FASTEST GROWING IV SEDATIVE1

FOR TODAY’S SEDATION MANAGEMENT PRACTICES

For step-by-step instructions on how to start using Precedex and what to expect, please visit us at www.Precedex.com.

Moderate blood pressure and heart rate reductions should be anticipated when initiating sedation with Precedex.2 Clinically significant episodes of bradycardia and sinus arrest have occurred in young, healthy volunteers with high vagal tone or with different routes of administration such as rapid intravenous or bolus administration.2 Transient hypertension has been observed primarily during the administration of the loading dose. Treatment has generally not been necessary, although a reduction in loading dose infusion rate may be desirable.2

Hypotension and bradycardia can occur and may necessitate medical intervention such as —Decreasing or stopping Precedex infusion —Increasing rate of IV fluid administration —Elevating lower extremities —Administering pressor agents such as atropine, ephedrine or glycopyrrolate2 Use with caution in patients with advanced heart block or severe ventricular dysfunction.2 The most common adverse effects (incidence >2%) are hypotension, bradycardia and dry mouth.2

Please see the brief summary of Prescribing Information on adjacent page.

References: 1. Based on increases in weight of active ingredient sold (either mcg or mg). IMS Health National Sales Perspective 2Q 2009. US nonretail market, all channels injectables.

2. Precedex [package insert]. Lake Forest, IL: Hospira, Inc; 2008. 3. Kamibayashi T, Maze M. Clinical uses of B2-adrenergic agonists. Anesthesiology. 2000;93:1345-1349.

4. Data on file. Hospira, Inc. Hospira, Inc. 275 North Field Drive, Lake Forest, IL 60045 P10-2830 Aug., 10. Printed in the USA.

Advancing Wellness™

For more information on Advancing WellnessTM, contact your Hospira representative at 1-877-9HOSPIRA (1-877-946-7747) or visit www.hospira.com.

Precedex

®

(dexmedetomidine hydrochloride injection) For Intravenous Use

� Only

mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2). The population was between 17 to 88 years of age, 43% ≥65 years of age, 77% male and 93% Caucasian. Treatmentemergent adverse reactions occurring at an incidence of >2% are provided in Table 2. The most frequent adverse reactions were hypotension, bradycardia and dry mouth [see Warnings and Precautions (5.2)].

1

2

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Table 2: Adverse Reactions With an Incidence >2%—Intensive Care Unit Sedation Population

3

1

INDICATIONS AND USAGE

5

1.1

Intensive Care Unit Sedation

Body System/ Adverse Event

Precedex® is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered by continuous infusion not to exceed 24 hours.

Precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex prior to extubation.

1.2

Procedural Sedation

Precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

4 CONTRAINDICATIONS None 5

WARNINGS AND PRECAUTIONS

5.1

Drug Administration

5.2

Hypotension, Bradycardia, and Sinus Arrest

Precedex should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of Precedex, patients should be continuously monitored while receiving Precedex.

Clinically significant episodes of bradycardia and sinus arrest have been reported with Precedex administration in young, healthy volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration.

Reports of hypotension and bradycardia have been associated with Precedex infusion. If medical intervention is required, treatment may include decreasing or stopping the infusion of Precedex, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents.

Because Precedex has the potential to augment bradycardia induced by vagal stimuli, clinicians should be prepared to intervene. The intravenous administration of anticholinergic agents (e.g., glycopyrrolate, atropine) should be considered to modify vagal tone. In clinical trials, glycopyrrolate or atropine were effective in the treatment of most episodes of Precedex-induced bradycardia. However, in some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required.

Caution should be exercised when administering Precedex to patients with advanced heart block and/or severe ventricular dysfunction. Because Precedex decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension and in elderly patients.

In situations where other vasodilators or negative chronotropic agents are administered, co-administration of Precedex could have an additive pharmacodynamic effect and should be administered with caution.

5.3

Transient Hypertension

5.4

Arousability

Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive effects of Precedex.

Treatment of the transient hypertension has generally not been necessary, although reduction of the loading infusion rate may be desirable.

Some patients receiving Precedex have been observed to be arousable and alert when stimulated. This alone should not be considered as evidence of lack of efficacy in the absence of other clinical signs and symptoms.

5.5

Withdrawal

Intensive Care Unit Sedation If Precedex were to be administered for more than 24 hours and stopped abruptly, withdrawal symptoms similar to those reported for another alpha-2-adrenergic agent, clonidine, may result. These symptoms include nervousness, agitation, and headaches, accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma.

Procedural Sedation Withdrawal symptoms were not seen after discontinuation of short term infusions of Precedex (<6 hours).

5.6

Hepatic Impairment

6

ADVERSE REACTIONS

6.1

Clinical Studies Experience

Since Precedex clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see Dosage and Administration (2.2)].

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.

Use of Precedex has been associated with the following serious adverse reactions: •

Hypotension, bradycardia and sinus arrest [see Warnings and Precautions (5.2)]

•

Transient hypertension [see Warnings and Precautions (5.3)]

Most common treatment-emergent adverse reactions, occurring in greater than 2% of patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth.

Intensive Care Unit Sedation Adverse reaction information is derived from the continuous infusion trials of Precedex for sedation in the Intensive Care Unit setting in which 1007 patients received Precedex. The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1),

Vascular Disorders Hypotension Hypertension Gastrointestinal Disorders Nausea Dry mouth Vomiting Cardiac Disorders Bradycardia Atrial fibrillation Tachycardia Sinus tachycardia Ventricular tachycardia General Disorders and Administration Site Conditions Pyrexia Hyperthermia Chills Edema peripheral Metabolism and Nutrition Disorders Hypovolemia Hyperglycemia Hypocalcemia Acidosis Respiratory, Thoracic and Mediastinal Disorders Atelectasis Pleural effusion Hypoxia Pulmonary edema Wheezing Psychiatric Disorders Agitation Blood and Lymphatic System Disorders Anemia Injury, Poisoning and Procedural Complications Post-procedural hemorrhage Investigations Urine output decreased

All Precedex N = 1007 n (%)

Randomized Precedex Placebo N = 798 N = 400 n (%) n (%)

Propofol N = 188 n (%)

4

6

Hypotension was defined in absolute and relative terms as Systolic blood pressure of <80 mmHg or ≤30% lower than pre-study drug infusion value, or diastolic blood pressure of <50 mmHg. Hypertension was defined in absolute and relative terms as Systolic blood pressure >180 mmHg or ≥30% higher than pre-study drug infusion value or diastolic blood pressure of >100 mmHg. Bradycardia was defined in absolute and relative terms as <40 beats per minute or ≤30% lower than pre-study drug infusion value.

Tachycardia was defined in absolute and relative terms as >120 beats per minute or ≥30% greater than pre-study drug infusion value.

Respiratory depression was defined in absolute and relative terms as respiratory rate (RR) <8 breaths or >25% decrease from baseline.

Hypoxia was defined in absolute and relative terms as SpO2 <90% or 10% decrease from baseline.

6.2 248 (25%) 123 (12%)

191 (24%) 101 (13%)

48 (12%) 76 (19%)

25 (13%) 7 (4%)

90 (9%) 35 (4%) 34 (3%)

73 (9%) 22 (3%) 26 (3%)

36 (9%) 4 (1%) 21 (5%)

20 (11%) 1 (1%) 6 (3%)

52 (5%) 44 (4%) 20 (2%) 6 (1%) 4 (0%)

36 (5%) 37 (5%) 15 (2%) 6 (1%) 4 (1%)

10 (3%) 13 (3%) 17 (4%) 2 (1%) 3 (1%)

0 14 (7%) 2 (1%) 4 (2%) 9 (5%)

35 (4%) 19 (2%) 17 (2%) 4 (0%)

31 (4%) 16 (2%) 14 (2%) 2 (0%)

15 (4%) 12 (3%) 13 (3%) 2 (1%)

8 (4%) 0 4 (2%) 4 (2%)

31 (3%) 17 (2%) 7 (1%) 6 (1%)

22 (3%) 15 (2%) 7 (1%) 5 (1%)

9 (2%) 7 (2%) 0 4 (1%)

9 (5%) 5 (3%) 4 (2%) 4 (2%)

29 (3%) 23 (2%) 16 (2%) 9 (1%) 4 (0%)

23 (3%) 16 (2%) 13 (2%) 9 (1%) 4 (1%)

13 (3%) 4 (1%) 8 (2%) 3 (1%) 1 (0%)

12 (6%) 12 (6%) 5 (3%) 5 (3%) 4 (2%)

20 (2%)

16 (2%)

11 (3%)

1 (1%)

19 (2%)

18 (2%)

7 (2%)

4 (2%)

15 (2%)

13 (2%)

10 (3%)

7 (4%)

6 (1%)

6 (1%)

0

4 (2%)

Procedural Sedation Adverse reaction information is derived from the two trials for procedural sedation in which 318 patients received Precedex. The mean total dose was 1.6 mcg/kg (range: 0.5 to 6.7), mean dose per hour was 1.3 mcg/kg/hr (range: 0.3 to 6.1) and the mean duration of infusion of 1.5 hours (range: 0.1 to 6.2). The population was between 18 to 93 years of age, 30% ≥65 years of age, 52% male and 61% Caucasian.

Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 3. The most frequent adverse reactions were hypotension, bradycardia, and dry mouth [see Warnings and Precautions (5.2)]. Pre-specified criteria for the vital signs to be reported as adverse reactions are footnoted below the table. The decrease in respiratory rate and hypoxia was similar between Precedex and comparator groups in both studies.

Table 3: Adverse Reactions With an Incidence >2%—Procedural Sedation Population Body System/ Precedex Placebo Adverse Event N = 318 N = 113 n (%) n (%) Vascular Disorders 173 (54%) 34 (30%) Hypotension1 Hypertension2 41 (13%) 27 (24%) Respiratory, Thoracic and Mediastinal Disorders 117 (37%) 36 (32%) Respiratory depression5 7 (2%) 3 (3%) Hypoxia6 Bradypnea 5 (2%) 5 (4%) Cardiac Disorders 45 (14%) 4 (4%) Bradycardia3 Tachycardia4 17 (5%) 19 (17%) Gastrointestinal Disorders Nausea 10 (3%) 2 (2%) Dry mouth 8 (3%) 1 (1%)

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Precedex. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypotension and bradycardia were the most common adverse reactions associated with the use of Precedex during post approval use of the drug.

Table 4: Adverse Reactions Experienced During Post-approval Use of Precedex Body System Preferred Term Body as a Whole Fever, hyperpyrexia, hypovolemia, light anesthesia, pain, rigors Cardiovascular Disorders, Blood pressure fluctuation, General heart disorder, hypertension, hypotension, myocardial infarction Central and Peripheral Dizziness, headache, neuralgia, Nervous System Disorders neuritis, speech disorder, convulsion Gastrointestinal System Abdominal pain, diarrhea, Disorders vomiting, nausea Heart Rate and Rhythm Arrhythmia, ventricular Disorders arrhythmia, bradycardia, hypoxia, atrioventricular block, cardiac arrest, extrasystoles, atrial fibrillation, heart block, t wave inversion, tachycardia, supraventricular tachycardia, ventricular tachycardia Liver and Biliary System Increased gamma-glutamyl Disorders transpepsidase, hepatic function abnormal, hyperbilirubinemia, alanine transaminase, aspartate aminotransferase Metabolic and Nutritional Acidosis, respiratory acidosis, Disorders hyperkalemia, increased alkaline phosphatase, thirst, hypoglycemia Psychiatric Disorders Agitation, confusion, delirium, hallucination, illusion Red Blood Cell Disorders Anemia Renal Disorders Blood urea nitrogen increased, oliguria Respiratory System Apnea, bronchospasm, dyspnea, Disorders hypercapnia, hypoventilation, hypoxia, pulmonary congestion Skin and Appendages Increased sweating Disorders Vascular Disorders Hemorrhage Vision Disorders Photopsia, abnormal vision 10 OVERDOSAGE The tolerability of Precedex was studied in one study in which healthy subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hr. The maximum blood concentration achieved in this study was approximately 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest doses were first degree atrioventricular block and second degree heart block. No hemodynamic compromise was noted with the atrioventricular block and the heart block resolved spontaneously within one minute.

Five patients received an overdose of Precedex in the intensive care unit sedation studies. Two of these patients had no symptoms reported; one patient received a 2 mcg/kg loading dose over 10 minutes (twice the recommended loading dose) and one patient received a maintenance infusion of 0.8 mcg/kg/hr.

Two other patients who received a 2 mcg/kg loading dose over 10 minutes, experienced bradycardia and/or hypotension. One patient who received a loading bolus dose of undiluted Precedex (19.4 mcg/kg), had cardiac arrest from which he was successfully resuscitated.

Manufactured and Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA Licensed from: Orion Corporation, Espoo, Finland Reference EN-1937 Printed in USA

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IN B R I EF

Anesthesia at Sea

L

t. Cmdr. Eugenio Lujan, MD, a Navy anesthesiologist, recently returned from a six-month tour on the hospital ship USNS Mercy. The San Diego-based vessel—a converted oil tanker with 12 operating rooms and beds for 1,000 patients—visited ports in four countries: Vietnam, Cambodia, Indonesia and Timor Leste. Dr. Lujan and his colleagues administered more than 850 anesthetics during the humanitarian mission, with cases ranging from cleft palate surgeries for Operation Smile to gynecologic and urologic procedures.

—Adam Marcus

ClipChart (Viva!) Las Vegas: A hat-tip and congratulations to anesthesiologist and Elvis fan Claudio Palma, MD. On Dec. 5, Dr. Palma was at the Burger Bar at Mandalay Place, having recently run a halfmarathon clad as the King, when another runner at the restaurant collapsed. Dr. Palma, 36, performed CPR to revive the woman. He told the Las Vegas Review-Journal that the woman “freaked out” when she came to and saw that her lips were touching Elvis’. The incident capped an eventful day for Dr. Palma, who picked up something more than just a few blisters during the race. He and his girlfriend, Rhanee, got married at a run-through chapel at Mile 2.

Seattle: The Washington State Hospital Association has created a Web-based tool that allows patients to look up rates of surgical infections at the state’s hospitals, broken out by type of surgery. The system covers infections associated with abdominal and vaginal hysterectomies; heart bypass and transplantation; heart valve and septum surgeries; and knee and hip replacements. It also lets patients see whether hospitals are following infection-control protocols, including the timely dosing of antibiotics.

Rockville, MD: The FDA is seeking guidance from academic anesthesiologists and others to improve the understanding of how sedatives work in patients. The agency said the initiative—which could drive the development of new drugs—was not a response to the ongoing shortage of propofol and other sedatives, but rather “was undertaken due to the poor quality of the studies we receive for sedative drug products” and a lack of internal expertise to conduct such research itself. The FDA said it will collect public comments on the sedation initiative through Jan. 28, 2011.

Lebanon, NH: Dartmouth anesthesiologists have found that giving ketamine to opioid-tolerant patients undergoing back surgery can significantly reduce the amount of opioids they require during recovery. The study, one of the first randomized, double-blind controlled trials to examine the therapy in such patients, found that total opioid consumption was 37% lower in the ketamine group 48 hours after surgery. The researchers published their findings in a recent issue of Anesthesiology (2010;113:639-646).

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AnesthesiologyNews.com I 7

IN BR IEF

Images courtesy of Eugenio Lujan, MD

Now Available on CMEZone.com Brain Monitoring of Anesthetic Effect

An Evidence-Based Assessment of Clinical Impact and Safe Use To participate in this FREE CME/CE activity, log on to www.CMEZone.com and enter keyword “SR1058” Release Dates: October 1, 2010 (physicians) November 1, 2010 (CRNAs)

Expiration Dates: April 1, 2012 (physicians) October 31, 2011 (CRNAs)

Learning Objectives

Goal

At the completion of this activity, participants should be better prepared to:

The goal of this educational activity is to provide physicians and nurse anesthetists with information on the clinical rationale and recent evidence supporting the use of brain monitoring during anesthesia.

1 2

Describe brain monitoring terminology, technology, and concepts.

Evaluate current research documenting the effects of brain monitoring on patient care during anesthesia.

3

Identify differences among available technologies and their effects in various clinical situations.

4

List the potential benefits of brain monitoring technology on emergence and recovery from general anesthesia.

5

Apply appropriate management strategies based on patients’ clinical profiles and brain monitoring information.

Faculty Marc J. Bloom, MD

Tong J. Gan, MD

Clinical Associate Professor Department of Anesthesiology New York University Langone Medical Center New York, New York

Professor Vice Chair for Clinical Research Department of Anesthesiology Duke University School of Medicine Durham, North Carolina

Medical Writer Oren Traub, PhD, MD

Accreditation Statements Physician: This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of AKH Inc., Advancing Knowledge in Healthcare, and Applied Clinical Education. AKH Inc. is accredited by the ACCME to provide continuing medical education for physicians. AKH Inc. designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Nurse Anesthetist: This program is approved by the American Association of Nurse Anesthetists for 1.0 CE credit. Code number 33406.

Expiration date October 31, 2011.

Jointly sponsored by AKH Inc. and Applied Clinical Education.

Distributed via: Supported by an educational grant from

To participate in this FREE CME/CE activity, log on to www.CMEZone.com and enter keyword “SR1058”

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TECHNOLOGY

Injection Visualization Improved With Ultrasound Algorithm San Diego—Improved ultrasound imaging of injected anesthetics and perineural distribution may be on the horizon as a result of research at Duke University Medical Center, in Durham, N.C. Using ultrasonic decorrelation algorithms, investigators have mapped the location of injected fluids to delineate areas of soft tissue infused with regional anesthetics.

Pre-injection

“Our clinical motivation for this work is that the distribution of regional anesthetic injection is sometimes difficult to visualize with ultrasound,” said Samantha L. Lipman, MS, a medical student at the institution who helped conduct the study. Despite an increased use of ultrasound in regional anesthesia, few efforts have been directed at improving the visualization of injected anesthetics.

The researchers administered saline injections to a 40-year-old man at the popliteal fossa, supraclavicular brachial plexus and interscalene brachial plexus.

Raw radiofrequency data were captured at a rate of 42 frames per second, before, during and after the injections (Figure).

Regions of decorrelation were identified as those with correlation coefficients less than 0.8 persisting for at least 20% of

elapsed imaging time. The injected anesthetic map was superimposed on traditional B-mode images. Ms. Lipman reported the team’s findings at the 2010 annual meeting of the American Society of Anesthesiologists (abstract A112).

“We believe that when the correlation values decrease, that’s when there’s fluid injection or tissue accommodation for the injected fluids,” she said.

INDICATION

0 Depth, mm

EXALGO® tablets are an extended release oral formulation of the opioid agonist hydromorphone hydrochloride that is indicated for once daily administration for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

IMPORTANT RISK INFORMATION WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE Needle

Nerve

40 -20

Lateral position, mm

20

Post–9 cc injection

Depth, mm

0

Proper Patient Selection EXALGO is an extended-release formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients when a continuous around-the-clock opioid analgesic is needed for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer.

EXALGO is for use in opioid tolerant patients only.

Fatal respiratory depression could occur in patients who are not opioid tolerant.

Accidental consumption of EXALGO, especially in children, can result in a fatal overdose of hydromorphone.

Needle Nerve

40 -20

Lateral position, mm

20

In vivo injection map

Depth, mm

0

40 -20

Lateral position, mm

Potential for Abuse EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. EXALGO can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing EXALGO in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.

20

Figure. B-mode images (pre- and post-injection) after 9 cc of saline was injected adjacent to the distal sciatic nerve in the popliteal fossa of a 40-year-old man. The decorrelation map superimposed in green on the B-mode image indicates the non-ideal deep distribution of the injection. This is an example of an injection that would benefit from needle reposition to achieve a more ideal distribution around the nerve.

Limitations of Use EXALGO is not indicated for the management of acute or postoperative pain.

EXALGO is not intended for use as an as-needed analgesic.

EXALGO tablets are to be swallowed whole and are not to be broken, chewed, dissolved, crushed or injected. Taking broken, chewed, dissolved or crushed EXALGO or its contents leads to rapid release and absorption of a potentially fatal dose of hydromorphone.

• EXALGO is also contraindicated in patients who: - need management of mild pain or pain not expected to persist - have significant impaired respiratory function including those with acute or severe bronchial asthma or hypercarbia.

- have or are suspected to have paralytic ileus - have narrowed or obstructed gastrointestinal tract including those from previous surgery or “blind loops” in the GI tract - have known hypersensitivity to any components including hydromorphone hydrochloride and sulfites.

• Avoid concurrent use of alcohol and EXALGO. Concurrent use of EXALGO with CNS depressants, including alcohol, increases risk of respiratory depression, hypotension, and profound sedation, potentially resulting in coma or death. EXALGO may impair the ability to drive a car or operate machinery.

• Not intended in patients who have received MAO inhibitors within 14 days of starting EXALGO. • Use with caution and in reduced doses in older or debilitated patients, as well as patients with renal or hepatic insufficiency, Addison’s disease, delirium tremens, myxedema or hypothyroidism, prosthetic hypertrophy or urethral stricture, toxic psychosis. May aggravate convulsions in patients with convulsive disorders; may induce or aggravate seizures in some clinical settings. Consider use of an alternate analgesic in patients with severe renal impairment.

• Respiratory depression, which occurs more frequently in elderly or debilitated patients, is the chief hazard with EXALGO. • Most common adverse events (>10%) seen in clinical studies (N=2474) were: constipation (31%), nausea (28%), vomiting, somnolence, headache, asthenia and dizziness. Serious adverse events could also include head injury, hypotensive effects, GI effects, cardiac arrest from overdose and precipitation of withdrawal.

• Use EXALGO with extreme caution in patients susceptible to intracranial effects of CO2 retention.

• Do not abruptly discontinue EXALGO Please see brief summary of Full Prescribing Information, including boxed warning on following pages.

COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and internationally registered trademarks of Covidien AG. EXALGO is a registered trademark of Mallinckrodt Inc. © 2010 Mallinckrodt Inc., a Covidien company. MK8976 September 2010 Printed in USA.

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TECHNOLOGY The researchers successfully generated injection maps for all three imaged anatomic locations. They also created videos of the injection, “to get a feel for how the whole thing progresses,” Ms. Lipman said.

Images and videos are not created in real time, but after a delay of several seconds.

The researchers believe that such images and videos may be an additional tool for the regional anesthesiologist to optimize the distribution of anesthetic around a nerve of interest and reduce the likelihood of nerve block failure; in addition, pain management

repositioned during the injection and a valid image will still be obtained.

“The equipment used for this project and the data acquired for analysis meant that —Craig T. Hartrick, MD the technique was not exactly real time,” said co-investigator Stuart Grant, MBChB, “Sometimes when you inject you get professor of anesthesiology at Duke. “Nevin patients will likely be improved.

“This seems like it will remove a lot of ‘spread’ in odd places,” he said. “Have you ertheless, when applied in a commercially the guesswork from the injection process,” tried chasing it down? Can you reposi- available ultrasound machine, this technolsaid Craig T. Hartrick, MD, director of tion the probe and actually see what it ogy will give real-time images of where the anesthesiology research at Beaumont did and where it went, and get an image local anesthetic [has] spread.”

Hospital in Royal Oak, Mich, who was of that?” he asked.

—Michael Vlessides not involved in the research.

Ms. Lipman said that the probe can be

‘This seems like it will remove a lot of the guesswork from the injection process.’

Keep pain waiting.

With once-daily EXALGO®, he’ll be here awhile.

With 24-hour extended-release hydromorphone, EXALGO helps you keep pain at bay. You can minimize peaks and troughs at steady state for your opioid tolerant patients with moderate to severe chronic pain, and they can reduce their pill burden. To find out more, visit www.keeppainwaiting.com. ®

10 I AnesthesiologyNews.com

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TECHNOLOGY

‘In Situ’ Simulation Uncovers Hidden Hospital Hazards Trial run reveals benefit of testing systems preparedness San Diego—Although simulation testing in actual patient care settings has been well documented as a way to improve clinical knowledge, a pilot study by San Francisco researchers has revealed a lesser-known benefit: Latent threats to patient safety were uncovered that were related to

missing, inappropriate or nonfunctioning equipment in the clinical care environment.

“Traditionally, simulation has been performed in a simulation center that’s removed from the hospital,” said Francis A. Wolf, MD, an anesthesia resident at the University

of California San Francisco Medical Center. “We do what we call ‘in situ’ simulation, in the actual place of patient care rather than in a simulation lab.”

An important feature of in situ simulation is that participants rely on the same resources they would use in

BRIEF SUMMARY - Consult full prescribing information before use.

EXALGO™ (hydromorphone HCl) Extended-Release Tablets WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE Potential for Abuse EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. EXALGO can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing EXALGO in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression [see Drug Abuse and Dependence (9)].

Proper Patient Selection EXALGO is an extended-release formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients when a continuous around-the-clock opioid analgesic is needed for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg of oral oxycodone/ day, 8 mg oral hydromorphone/day, 25 mg of oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer [see Indications and Usage (1) and Dosage and Administration (2)].

EXALGO is for use in opioid tolerant patients only [see Indications and Usage (1) and Dosage and Administration (2)].

Fatal respiratory depression could occur in patients who are not opioid tolerant.

Accidental consumption of EXALGO, especially in children, can result in a fatal overdose of hydromorphone [see Warnings and Precautions (5.1)].

Limitations of Use EXALGO is not indicated for the management of acute or postoperative pain [see Indications and Usage (1)].

EXALGO is not intended for use as an as-needed analgesic [see Indications and Usage (1)].

EXALGO tablets are to be swallowed whole and are not to be broken, chewed, dissolved, crushed or injected. Taking broken, chewed, dissolved or crushed EXALGO or its contents leads to rapid release and absorption of a potentially fatal dose of hydromorphone [see Warnings and Precautions (5)].

CONTRAINDICATIONS Opioid Non-Tolerant Patients EXALGO is contraindicated in opioid non-tolerant patients. Fatal respiratory depression could occur in patients who are not opioid tolerant.

Impaired Pulmonary Function EXALGO is contraindicated in patients with significant respiratory depression, especially in the absence of resuscitative equipment or in unmonitored settings and in patients with acute or severe bronchial asthma or hypercarbia.

Paralytic Ileus EXALGO is contraindicated in patients who have or are suspected of having a paralytic ileus.

Preexisting Gastrointestinal (GI) Surgery or Narrowing of GI Tract EXALGO is contraindicated in patients who have had surgical procedures and/or underlying disease that would result in narrowing of the gastrointestinal tract, or have “blind loops” of the gastrointestinal tract or gastrointestinal obstruction.

Allergy or Hypersensitivity EXALGO is contraindicated in patients with known hypersensitivity to any of its components including the active agent, hydromorphone hydrochloride or known allergy to sulfite-containing medications [see Warnings and Precautions (5.8)].

WARNINGS AND PRECAUTIONS Information Essential for Safe Administration EXALGO tablets are to be swallowed whole, and are not to be broken, chewed, crushed, dissolved or injected. Taking broken, chewed, crushed, dissolved EXALGO or its contents leads to the rapid release and absorption of a potentially fatal dose of hydromorphone [see Boxed Warning].

EXALGO is for use only in opioid tolerant patients. Ingestion of EXALGO may cause fatal respiratory depression when administered to patients who are not opioid tolerant [see Boxed Warning].

EXALGO tablets must be kept in a secure place out of the reach of children. Accidental consumption of EXALGO, especially in children, can result in a fatal overdose of hydromorphone.

Misuse and Abuse EXALGO contains hydromorphone, an opioid agonist, and is a Schedule II controlled substance. Opioid agonists have the potential for being abused and are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

EXALGO can be abused in a manner similar to other opioid agonists, legal or illicit.

This should be considered when prescribing or dispensing EXALGO in situations where the healthcare professional is concerned about an increased risk of misuse, abuse, or diversion.

Breaking, crushing, chewing, or dissolving the contents of an EXALGO tablet results in the uncontrolled delivery of the opioid and poses a significant risk of overdose and death [see Drug Abuse and Dependence (9)].

If attempts are made to extract the drug from the hard outer shell for purposes of parenteral abuse, the injection of tablet excipients may be toxic and may result in lethal complications.

Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. However, all patients treated with opioids, including EXALGO, require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Respiratory Depression Respiratory depression is the chief hazard of EXALGO. Respiratory depression occurs more frequently in elderly or debilitated patients as well as those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate therapeutic doses may dangerously decrease pulmonary ventilation, and when opioids are given in conjunction with other agents that depress respiration.

Use EXALGO with extreme caution in patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve such as asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea, myxedema, kyphoscoliosis or CNS depression. In these patients, even moderate therapeutic doses of hydromorphone may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. In these patients, consider alternative non-opioid analgesics, and use EXALGO only under careful medical supervision at the lowest effective dose.

Interactions with Alcohol and Other CNS Depressants The concurrent use of EXALGO with other central nervous system (CNS) depressants, including but not limited to other opioids, illicit drugs, sedatives, hypnotics, general anesthetics, phenothiazines, muscle relaxants, other tranquilizers, and alcohol, increases the risk of respiratory depression, hypotension, and profound sedation, potentially resulting in coma or death. Use with caution and in reduced dosages in patients taking CNS depressants. Avoid concurrent use of alcohol and EXALGO [see Clinical Pharmacology (12.3)].

Head Injury and Increased Intracranial Pressure In the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure, the respiratory depressant effects of EXALGO and its potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly exaggerated. Furthermore, EXALGO can produce effects on pupillary response and consciousness, which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries.

Hypotensive Effect EXALGO may cause severe hypotension. There is added risk to individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines, general anesthetics, or other agents that compromise vasomotor tone.

Administer EXALGO with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Gastrointestinal Effects Because the EXALGO tablet is nondeformable and does not appreciably change in shape in the GI tract, do not administer EXALGO to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic, for example: esophageal motility disorders small bowel inflammatory disease, “short gut” syndrome due to adhesions or decreased transit time, past history of peritonitis, cystic fibrosis, chronic intestinal pseudoobstruction, or Meckel’s diverticulum). There have been reports of obstructive symptoms in patients with known strictures or risk of strictures, such as previous GI surgery, in association with the ingestion of drugs in nondeformable extended-release formulations.

The administration of EXALGO may obscure the diagnosis or clinical course in patients with acute abdominal condition.

It is possible that EXALGO tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.

Sulfites EXALGO contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

MAO Inhibitors EXALGO is not recommended for use in patients who have received MAO inhibitors within 14 days, because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.

Special Risk Groups EXALGO should be administered with caution in elderly (≥ 65 years) and debilitated patients and in patients who are known to be sensitive to central nervous system depressants, such as those with cardiovascular, pulmonary, renal, or hepatic disease [see Use in Specific Populations (8)].

EXALGO should also be used with caution in the following conditions: adrenocortical insufficiency (e.g., Addison’s disease); delirium tremens; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and, toxic psychosis.

EXALGO may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

Use in Pancreatic/Biliary Tract Disease EXALGO can cause an increase in biliary tract pressure as a result of spasm in the sphincter of Oddi. Caution should be exercised in the administration of EXALGO to patients with inflammatory or obstructive bowel disorders, acute pancreatitis secondary to biliary tract disease and in patients about to undergo biliary surgery.

Driving and Operating Machinery EXALGO may impair the mental and/or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Caution patients accordingly. Also warn patients about the potential combined effects of EXALGO with other CNS depressants, including other opioids, phenothiazines, sedative/hypnotics, and alcohol [see Drug Interactions (7)].

Precipitation of Withdrawal Mixed agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) should not be administered to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesic, including EXALGO. In these patients, mixed agonists/antagonists analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms. Do not abruptly discontinue EXALGO. Clinical conditions or medicinal products that cause a sudden and significant shortening of gastrointestinal transit time may result in decreased hydromorphone absorption with EXALGO and may potentially lead to withdrawal symptoms in patients with a physical dependence on opioids.

ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Respiratory Depression [see Warnings and Precautions (5.3)] • Head Injury and Increased Intracranial Pressure [see Warnings and Precautions (5.5)] • Hypotensive Effect [see Warnings and Precautions (5.6)] • Gastrointestinal Effects [see Warnings and Precautions (5.7)] • Cardiac Arrest [see Overdosage (10)] • Precipitation of Withdrawal [see Warnings and Precautions (5.13)]

a true patient emergency. “There’s an increased sense of realism and engagement for the participants,” Dr. Wolf said. “Moreover, you have the ability to look at your system itself. You can look at how your providers interact with the environment and resources, and look for defects in systems and

Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

EXALGO was administered to a total of 2,524 patients in 15 controlled and uncontrolled clinical studies. Of these, 423 patients were exposed to EXALGO for greater than 6 months and 141 exposed for greater than one year.

The overall incidence of adverse reactions in patients greater than 65 years of age was higher, with a greater than 5% difference in rates for constipation and nausea when compared with younger patients. The overall incidence of adverse reactions in female patients was higher, with a greater than 5% difference in rates for nausea, vomiting, constipation and somnolence when compared with male patients.

A 12-week double-blind, placebo-controlled, randomized withdrawal study was conducted in opioid tolerant patients with moderate to severe low back pain [see Clinical Studies (14)]. A total of 447 patients were enrolled into the open-label titration phase with 268 patients randomized into the double-blind treatment phase. The adverse reactions that were reported in at least 2% of the patients are contained in Table 1.

Table 1.

Number (%) of Patients with Adverse Reactions Reported in ≥2% of Patients with Moderate to Severe Low Back Pain During the Open-Label Titration Phase or Double-Blind Treatment Phase by Preferred Term Preferred Term Open-Label Double-Blind Treatment Phase Titration Phase EXALGO (N=447) EXALGO (N=134) Placebo (N=134) Constipation 69 (15) 10 (7) 5 (4) Nausea 53 (12) 12 (9) 10 (7) Somnolence 39 (9) 1 (1) 0 (0) Headache 35 (8) 7 (5) 10 (7) Vomiting 29 (6) 8 (6) 6 (4) Drug Withdrawal Syndrome 22 (5) 13 (10) 16 (12) Pruritus 21 (5) 1 (1) 0 (0) Dizziness 17 (4) 3 (2) 2 (1) 16 (4) 2 (1) 6 (4) Asthenia a Insomnia 13 (3) 7 (5) 5 (4) Diarrhea 13 (3) 5 (4) 9 (7) Back Pain 13 (3) 6 (4) 8 (6) Dry Mouth 13 (3) 2 (1) 0 (0) Edema Peripheral 13 (3) 3 (2) 1 (1) Hyperhidrosis 13 (3) 2 (1) 2 (1) b 10 (2) 2 (1) 0 (0) Anorexia Arthralgia 9 (2) 8 (6) 3 (2) Anxiety 9 (2) 0 (0) 4 (3) 9 (2) 4 (3) 3 (2) Abdominal Pain c Muscle Spasms 5 (1) 3 (2) 1 (1) Weight Decreased 3 (1) 4 (3) 3 (2) a b c

Fatigue was grouped and reported with asthenia Decreased appetite was grouped and reported with anorexia Abdominal pain upper was grouped and reported with abdominal pain

The adverse reactions that were reported in at least 2% of the total treated patients (N=2,474) in the 14 chronic clinical trials are contained in Table 2.

Table 2.

Number (%) of Patients with Adverse Reactions Reported in ≥2% of Patients with Chronic Pain Receiving EXALGO in 14 Clinical Studies by Preferred Term Preferred Term All Patients (N=2,474) Constipation 765 (31) Nausea 684 (28) Vomiting 337 (14) Somnolence 367 (15) Headache 308 (12) 272 (11) Asthenia a Dizziness 262 (11) Diarrhea 201 (8) Pruritus 193 (8) Insomnia 161 (7) Hyperhidrosis 143 (6) Edema Peripheral 135 (5) b Anorexia 139 (6) Dry Mouth 121 (5) 115 (5) Abdominal Pain c Anxiety 95 (4) Back Pain 95 (4) 88 (4) Dyspepsia d Depression 81 (3) Dyspnea e 76 (3) Muscle Spasms 74 (3) Arthralgia 72 (3) Rash 64 (3) Pain in Extremity 63 (3) Pain 58 (2) Drug Withdrawal Syndrome 55 (2) Pyrexia 52 (2) Fall 51 (2) Chest Discomfort f 51 (2) a b c d e f

Fatigue was grouped and reported with asthenia Decreased appetite was grouped and reported with anorexia Abdominal pain upper was grouped and reported with abdominal pain Reflux esophagitis, gastroesophageal reflux disease and Barrett’s esophagus were grouped and reported with dyspepsia Dyspnea exacerbated and dyspnea exertional were grouped and reported with dyspnea Chest pain and non-cardiac chest pain were grouped and reported with chest discomfort

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TECHNOLOGY processes of care.”

Using a portable, life-sized computerized mannequin, Dr. Wolf and his colleagues, Richard Fidler, CRNA, and senior author, Brian Cason, MD, conducted 10 sessions of in situ simulation over six months. Scenarios involved either an acute change in patient condition (e.g., shortness of breath, chest pain, cardiac arrest or respiratory arrest) or evacuation of a patient via the stairwell. Scenarios were conducted in a number

The following Adverse Reactions occurred in patients with an overall frequency of <2% and are listed in descending order within each System Organ Class: Cardiac disorders: palpitations, tachycardia, bradycardia, extrasystoles Ear and labyrinth disorders: vertigo, tinnitus Endocrine disorders: hypogonadism Eye disorders: vision blurred, diplopia, dry eye, miosis Gastrointestinal disorders: flatulence, dysphagia, hematochezia, abdominal distension, hemorrhoids, abnormal feces, intestinal obstruction, eructation, diverticulum, gastrointestinal motility disorder, large intestine perforation, anal fissure, bezoar, duodenitis, ileus, impaired gastric emptying, painful defecation General disorders and administration site conditions: chills, malaise, feeling abnormal, feeling hot and cold, feeling jittery, hangover, difficulty in walking, feeling drunk, hypothermia Infections and infestations: gastroenteritis, diverticulitis Injury, poisoning and procedural complications: contusion, overdose Investigations: weight decreased, hepatic enzyme increased, blood potassium decreased, blood amylase increased, blood testosterone decreased, oxygen saturation decreased Metabolism and nutrition disorders: dehydration, fluid retention, increased appetite, hyperuricemia Musculoskeletal and connective tissue disorders: myalgia Nervous system disorders: tremor, sedation, hypoesthesia, paraesthesia, disturbance in attention, memory impairment, dysarthria, syncope, balance disorder, dysgeusia, depressed level of consciousness, coordination abnormal, hyperesthesia, myoclonus, dyskinesia, hyperreflexia, encephalopathy, cognitive disorder, convulsion, psychomotor hyperactivity Psychiatric disorders: confusional state, nervousness, restlessness, abnormal dreams, mood altered, hallucination, panic attack, euphoric mood, paranoia, dysphoria, listless, crying, suicide ideation, libido decreased, aggression Renal and urinary disorders: dysuria, urinary retention, urinary frequency, urinary hesitation, micturition disorder Reproductive system and breast disorders: erectile dysfunction, sexual dysfunction Respiratory, thoracic and mediastinal disorders: rhinorrhoea, respiratory distress, hypoxia, bronchospasm, sneezing, hyperventilation, respiratory depression Skin and subcutaneous tissue disorders: erythema Vascular disorders: flushing, hypertension, hypotension DRUG INTERACTIONS CNS Depressants The concomitant use of EXALGO with central nervous system depressants such as hypnotics, sedatives, general anesthetics, antipsychotics and alcohol may cause additive depressant effects and respiratory depression. Additionally, hypotension and profound sedation or coma could occur. When this combination is indicated, the dose of one or both agents should be reduced. The concomitant use of alcohol should be avoided [see Clinical Pharmacology (12.3)].

Monoamine Oxidase (MAO) Inhibitors MAO inhibitors may cause CNS excitation or depression, hypotension or hypertension if co-administered with opioids including EXALGO. EXALGO is not intended for patients taking MAO inhibitors or within 14 days of stopping such treatment.

Mixed Agonist/Antagonist Opioid Analgesics The concomitant use of EXALGO with morphine agonist/antagonists (buprenorphone, nalbuphine, pentazocine) could lead to a reduction of the analgesic effect by competitive blocking of receptors, thus leading to risk of withdrawal symptoms. Therefore, this combination is not recommended.

Anticholinergics Anticholinergics or other medications with anticholinergic activity when used concurrently with EXALGO may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

Cytochrome P450 Enzymes In vitro data suggest that hydromorphone in clinically relevant concentrations has minimal potential to inhibit the activity of human hepatic CYP450 enzymes including CYP1A2, 2C9, 2C19, 2D6, 3A4, and 4A11.

USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Hydromorphone crosses the placenta. EXALGO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations (8.2)].

Hydromorphone was not teratogenic in pregnant rats given oral doses up to 6.25 mg/kg/day or in pregnant rabbits administered oral doses up to 25 mg/kg/day during the period of organogenesis (~1.2 times the human exposure following 32 mg/day).

Hydromorphone administration to pregnant Syrian hamsters and CF-1 mice during major organ development revealed teratogenicity likely the result of maternal toxicity associated with sedation and hypoxia. In Syrian hamsters given single subcutaneous doses from 14 to 258 mg/kg during organogenesis (gestation days 8 to 10), doses ≥ 19 mg/kg hydromorphone produced skull malformations (exencephaly and cranioschisis). Continuous infusion of hydromorphone (5 mg/kg, s.c.) via implanted osmotic mini pumps during organogenesis (gestation days 7 to 10) produced soft tissue malformations (cryptorchidism, cleft palate, malformed ventricals and retina), and skeletal variations (supraoccipital, checkerboard and split sternebrae, delayed ossification of the paws and ectopic ossification sites). The malformations and variations observed in the hamsters and mice were at doses approximately three-fold higher and <one-fold lower, respectively, than a 32 mg human daily oral dose on a body surface area basis.

Nonteratogenic Effects In the pre- and post-natal effects study in rats, neonatal viability was reduced at 6.25 mg/kg/day (~1.2 times the human exposure following 32 mg/day).

Neonates born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal.

Approaches to the treatment of the syndrome have included supportive care and, if indicated, drugs such as paregoric or phenobarbital.

An important feature of in situ simulation is that participants rely on the same resources they would use in a true patient emergency. of locations throughout the hospital, including the intensive care unit, emergency department, operating room and acute care rooms. Equipment-related hazards were recorded by an experienced observer through

Labor and Delivery EXALGO is not recommended for use in women during and immediately prior to labor and delivery. Administration of EXALGO to the mother shortly before delivery may result in some degree of respiratory depression in the neonate.

However, neonates whose mothers received opioid analgesics during labor should be observed closely for signs of respiratory depression.

Nursing Mothers Low concentrations of hydromorphone have been detected in human milk in clinical trials. Withdrawal symptoms can occur in breastfeeding infants when maternal administration of an opioid analgesic is stopped. Nursing should not be undertaken while a patient is receiving EXALGO since hydromorphone is excreted in the milk.

Pediatric Use The safety and effectiveness of EXALGO in pediatric patients 17 years of age and younger have not been established.

Geriatric Use Elderly patients have been shown to be more sensitive to the adverse effects of EXALGO compared to the younger population. Therefore, use extra caution when prescribing EXALGO in elderly patients and reduce the initial dose.

Neonatal Withdrawal Syndrome Chronic maternal use of opiates or opioids during pregnancy coexposes the fetus. The newborn may experience subsequent neonatal withdrawal syndrome (NWS). Manifestations of NWS include irritability, hyperactivity, abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, weight loss, and failure to gain weight. The onset, duration, and severity of the disorder differ based on such factors as the addictive drug used, time and amount of mother’s last dose, and rate of elimination of the drug from the newborn. Approaches to the treatment of this syndrome have included supportive care and, when indicated, drugs such as paregoric or phenobarbital.

Hepatic Impairment In a study that used a single 4 mg oral dose of immediate-release hydromorphone tablets, four-fold increases in plasma levels of hydromorphone (Cmax and AUC0- ) were observed in patients with moderate hepatic impairment (Child-Pugh Group B). Start patients with moderate hepatic impairment on a reduced dose and closely monitored during dose titration.

The pharmacokinetics of hydromorphone in severe hepatic impairment patients have not been studied. Further increase in Cmax and AUC0- of hydromorphone in this group is expected, therefore, use an even more conservative starting dose [see Dosage and Administration (2.4)].

Renal Impairment Renal impairment affected the pharmacokinetics of hydromorphone and its metabolites following administration of a single 4 mg dose of immediate-release tablets. The effects of renal impairment on hydromorphone pharmacokinetics were two-fold and four-fold increases in plasma levels of hydromorphone (Cmax and AUC0-48h) in moderate (CLcr = 40 to 60 mL/min) and severe (CLcr < 30 mL/min) impairment, respectively. In addition, in patients with severe renal impairment hydromorphone appeared to be more slowly eliminated with longer terminal elimination half-life (40 hours) compared to subjects with normal renal function (15 hours). Start patients with moderate renal impairment on a reduced dose and closely monitored during dose titration. As EXALGO is only intended for once daily administration, consider use of an alternate analgesic that may permit more flexibility with the dosing interval in patients with severe renal impairment [see Dosage and Administration (2.4)].

DRUG ABUSE AND DEPENDENCE Controlled Substance EXALGO contains hydromorphone, a Schedule II controlled substance with a high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone. EXALGO can be abused and is subject to misuse, abuse, addiction, and criminal diversion [see Warnings and Precautions (5.2)]. The high drug content in the extended release formulation adds to the risk of adverse outcomes from abuse.

Abuse All patients treated with opioids, including EXALGO, require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving.

“Drug-seeking” behavior is very common to addicts and drug abusers. Drugseeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated claims of loss of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” (visiting multiple prescribers) to obtain additional prescriptions is common among drug abusers, people suffering from untreated addiction and criminals seeking drugs to sell.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts.

In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Since EXALGO may be diverted for non-medical use, careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

EXALGO is intended for oral use only. Misuse or abuse by breaking, crushing, chewing, or dissolving EXALGO poses a hazard of overdose and death. This risk is increased with concurrent abuse of EXALGO with alcohol and other substances.

With intravenous abuse, the tablet excipients, especially polyethylene oxide, can be expected to result in necrosis and inflammation of cardiac tissues. In addition, parenteral drug abuse is commonly associated with transmission of infectious disease such as hepatitis and HIV. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Dependence Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time.

live observation and debriefing interviews.

Dr. Wolf ’s team discovered five major equipment-related threats to patient safety as a result of their simulations: a missing mask on a bag

Tolerance could occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physical dependence is a state of adaptation that is manifested by an opioid specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, piloerection, myalgia, mydriasis, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, increased blood pressure, respiratory rate, or heart rate.

Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms [see Use in Specific Populations (8.1, 8.2)].

OVERDOSAGE Symptoms Acute overdosage with opioids can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and sometimes bradycardia, hypotension and death. The extended release characteristics of EXALGO should also be taken into account when treating the overdose. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects.

Deaths due to overdose could occur with abuse and misuse of EXALGO. Due to the delayed mean apparent peak plasma level of EXALGO occurring at 16 hours following administration as well as the 11 hour mean elimination half-life of EXALGO, patients who receive an overdose will require an extended period of monitoring and treatment that may go beyond 24 to 48 hours.

Treatment Give primary attention to the re-establishment of a patent airway and institution of assisted or controlled ventilation. Employ supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques.

The pure opioid antagonists, such as naloxone and naltrexone are specific antidotes to respiratory depression from opioid overdose. Since the duration of reversal would be expected to be less than the duration of action of hydromorphone in EXALGO, the patient must be carefully monitored until spontaneous respiration is reliably re-established. EXALGO will continue to release and add to the hydromorphone load for up to 24 hours after administration and the management of an overdose should be monitored accordingly, at least 24 to 48 hours beyond the overdose.

Only administer opioid antagonists in the presence of clinically significant respiratory or circulatory depression secondary to hydromorphone overdose. In patients who are physically dependent on any opioid agonist including EXALGO, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Please see the prescribing information for the specific opioid antagonist for details of their proper use.

OROS is a registered trademark of ALZA Corporation.

EXALGO is a trademark of Mallinckrodt Inc. COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and/or internationally registered trademarks of Covidien AG. © 2010 Mallinckrodt Inc., a Covidien company Distributed by: Mallinckrodt Brand Pharmaceuticals, Inc. Hazelwood, MO 63042 USA Issued 03/2010-B

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valve mask; missing suction components; nonfunctioning emergency power outlets in patient rooms; oversized evacuation stretchers that could not pass around stairwell corners; and the presence of obsolete cricothyrotomy supplies in surgical airway kits. Dr. Wolf presented the results at the 2010 annual meeting of the American Society of Anesthesiologists (abstract A383).

After identifying the hazards, the investigators conducted roomto-room and equipment inventory inspections to assess whether the problems were isolated or systemic. Their analysis revealed that each identified problem was a widespread, systemic deficiency and not isolated to one specific room, kit or stretcher.

The investigators reported their findings to appropriate department heads, which resulted in changes to equipment ordering, maintenance and testing. “The problems were all relatively easy to fix,” Dr. Wolf said.

“The point here is not to air our dirty laundry,” he said, “but rather to illustrate the concept that every hospital has hidden problems. None of these could have been discovered simply by doing simulation in a simulation lab; most would have remained hidden threats until intended use on an actual patient, which could have led to harm.”

Dr. Wolf said that his team realized from their study the importance of having good communication with those ordering equipment and to have scheduled inspections. “While these particular five problems are specific to our hospital, all hospitals will have hidden threats to patient safety, and it’s important to have a way of performing proactive risk assessment before an adverse event occurs,” he told Anesthesiology News.

Matthew B. Weinger, MD, professor of anesthesiology at Vanderbilt University School of Medicine in Nashville, Tenn., related his experience with a similar issue. “It’s interesting that these were processrelated problems and not peoplerelated problems,” Dr. Weinger said.

“Years ago, we did a mock code with a simulator in Physical Therapy [department] that was down in the basement, and we detected lots of problems. But the biggest issue was that it took 13 minutes for the entire code team to find the place.”

—Michael Vlessides

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P OLI CY & M ANAGE MENT

The Company Model: Is Taking Less Money To Work at a Surgicenter Worth Jail Time?

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hen asked why he robbed banks, Willie Sutton responded, “Because that’s where the money is.”

Owners of ambulatory surgery centers (ASCs), who often are surgeons, are seeking a share of anesthesia fees for the same reason. But instead of a gun, many are turning to a new model of money extraction: the company model.

Demanding a kickback—“Bob, if you want to provide anesthesia at Greenacres ASC, you’ve got to pay us 30 cents on the referred dollar”—is clearly illegal. But even if far more ASC owners are willing to try that approach than they likely would admit, some are choosing a slightly softer tactic—forcing anesthesiologists to work for an entity affiliated with the surgicenter. That entity distributes a share of the anesthesia fees back to the ASC owners.

In these cases, the conversation might go like this: “Bob, if you want to provide anesthesia at Greenacres ASC, you’ve got to become an employee of our entity, Greenacres Anesthesia Services. We’ll even pay you commensurately with your production. In fact, we’ll pay you the lion’s share, 70 cents on the dollar!”

These entities become the “companies” of the company model. Of course, demanding 30% as a direct kickback has the same economic effect as forcing the anesthesiologists into an entity that rewards them with a 70% share.

But is the company model structure legal? That’s the $25,000 fine plus five years in jail plus exclusion from Medicare and Medicaid question. And don’t forget possible civil monetary penalties.

independent professional fees.

In many cases, the relationship between the anesthesiologists and the ASC takes on an additional dimension. The anesthesiologists might take on duties beyond providing care to patients, such as serving as the facility’s medical director. In compensation for those Mark F. Weiss, JD services, and to avoid a kickback (the provision of those services for free being an inducement to receive the referral of anesthesia cases), the ASC pays a stipend equal to the fair market value of the specific duty.

Sometimes the volume of cases or reimbursement earned from covering the ASC’s anesthesia needs is insufficient to attract or retain anesthesiologists. The ASC then must pay a stipend to the clinicians or their professional entity in order to supplement their billings.

Over time, some ASC owners began to question the conventional model of their facility’s relationship with anesthesiologists. For some, it was an issue of economics. Many ASCs were located in markets that already were saturated. Others were located in areas that became economically depressed, while some had cost structures that reduced or eliminated profitability.

For many, however, it was a question of greed.

Surgeon-owners saw that anesthesiologists were earning much more than they were taking home. They viewed anesthesia as a franchise that had value, and they wanted a share of it.

Over the past several years, the captive model has morphed into the company model. Some ASCs found that insurers rejected claims for reimbursement for anesthesia fees when billed under the facility’s name. In states such as California that prohibit the corporate practice of medicine, lay entity ASCs cannot provide medical services and therefore cannot employ anesthesiologists or even subcontract with them under a financial structure in which the ASC participates. Some ASCs had neither of these problems but simply wanted to separate out, perhaps for management purposes or perhaps to disguise their real intent, anesthesia coverage as a separate entity.

In some instances, it was not even the ASC itself that sought to change the relationship with their anesthesia providers by forming an anesthesia company owned by the ASC itself or by all of the ASC’s owners. Instead, it was a subset of the ASC’s owners, usually one or more surgeon-owners with referral clout, who sought to skim a bit of the profit cream off the top of anesthesia services.

Key Compliance Issues The federal anti-kickback statute (AKS) prohibits remuneration—that is, the transfer of anything of value—for referrals. State laws differ in their treatment, scope and interpretation, but generally contain similar provisions barring remuneration for referrals, sometimes expressed as anti-kickback or fee-splitting prohibitions. Because of the variations in state laws, this article focuses on the federal concepts applicable to patients covered under Medicare and Medicaid.

Business Models Courts have interpreted the AKS to apply even Captivity To better understand the issues of the company when an arrangement may have many legitimate purNo matter the motive, a second ASC–anesthe- poses; the fact that one of the purposes is to obtain model, it helps to consider the evolution of anesthesisia business model took form, one that I refer to as money for the referral of services or to induce further ologist–ASC business models.

The conventional, fee-for-service relationship the “captive model.” This model has the anesthesiol- referrals is sufficient to trigger a violation of the law. between anesthesiologists and ASCs mirrors the tra- ogists working for the ASC as employees or as indeCertain exceptions, known as safe harbors, define ditional relationship between anesthesiologists and pendent subcontractors—the defining characteristic permissible practices not subject to the anti-kickback hospitals: The anesthesiologists, directly or through being that the ASC pays anesthesiologists either a statute because regulators believe they are unlikely an anesthesiologist-owned entity, provide services to fixed amount or a fee based on productivity. The to result in fraud or abuse. The failure to fit within a the patients of the ASC for their own account, akin ASC may bill anesthesia fees under its own name, or safe harbor does not mean that an arrangement vioto surgeons performing their cases at the facility. The it may use the name of the anesthesiologists. In either lates the law; there’s just no free pass. facility charges a fee and the physicians, both sur- case, anesthesia fees eventually find their way into the The question, then, for the company model is geons and anesthesiologists alike, charge their own, ASC’s bank account. whether it runs afoul of federal anti-kickback law. To be sure, each deal must be analyzed carefully before it is structured. But it is possible to highlight the significant likelihood that many company model • The owner expands into a related • Absent participation in the joint ven• The owner and the manager/ deals are illegal.

The U.S. Department of Health and line of business that is dependent ture, the manager/supplier would supplier share in the economic Human Services Office of Inspector on direct or indirect referrals from, or be a competitor in the new line of benefit of the owner’s new General (OIG) has issued two fraud on other business generated by, the business, providing services, billing business. alerts applicable to the analysis of comowner’s existing business. and collecting in its own name. The • The aggregate payments to pany model deals: its 1989 Special anesthesiologists working for the the owner vary based on the • The owner does not operate the new Fraud Alert on Joint Venture Arrangecaptive entity would otherwise be owner’s referrals to the new business—the manager/supplier ments, which was republished in 1994, engaged in the business of providing business. does—and does not commit substanand a 2003 Special Advisory Bulletin —M.W. anesthesia for their own account. tial funds or human resources to it. on Contractual Joint Ventures.

The OIG considers a joint venture to

Features of an ASC That Might Run Afoul of Federal Rules

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AnesthesiologyNews.com I 13

POL ICY & M ANAGEMENT mean any arrangement, whether contractual or involving a new legal entity, between parties in a position to refer business and those providing items or services for which Medicare or Medicaid pays.

The OIG has made clear in its safe harbor regulations and other documents that compliance with both the form and the substance of a safe harbor is required in order for it to provide protection. In other words, even if planners generally work to fit a company model deal into the confines of a safe harbor, the OIG demands that if an underlying intent is to obtain a benefit for the referral of patients, the safe harbor would be unavailable and the AKS would be violated.

Fraud Alert and Advisory Bulletin The fraud alert states: “Under these suspect joint ventures, physicians may become investors in a newly formed joint venture entity. The investors refer their patients to this new entity, and are paid by the entity in the form of ‘profit distributions.’ These subject joint ventures may be intended not so much to raise investment capital legitimately to start a business, but to lock up a stream of referrals from the physician investors and to compensate them indirectly for these referrals. Because physician investors can benefit financially from their referrals, unnecessary procedures and tests may be ordered or performed, resulting in unnecessary program expenditures.”

In describing questionable features of suspect joint ventures, the fraud alert provides several examples, including: • Investors are chosen because they are in a position to make referrals (e.g., the surgeon-owners of the ASC who become the owners of the company model entity); • One of the parties may be an ongoing entity already engaged in a particular line of business (e.g., the anesthesiologists); and • The referring physician’s investment may be disproportionately small and the returns on investment may be disproportionately large compared with a typical investment in a new business enterprise (e.g., the company model, which requires only nominal start-up capital).

Notice that the features of the company model include many of those stated by the OIG in the alert to be questionable.

The 2003 advisory bulletin sheds even more light on the analysis of

company-model structures. It focuses on questionable contractual arrangements in which a health care provider in an initial line of business, termed the “owner,” expands into a related health care business by contracting with an existing provider of the related item or service, the “manager/supplier,” to provide the new item or service to the owner’s existing patient population.

Note that the term “existing provider” is not limited to situations in which anesthesiologists have an existing

relationship with the ASC at the time the company model joint venture is formed.

The advisory bulletin lists some of the common elements of these problematic structures (sidebar). They appear to hint at a company model structure in which an ASC (or some or all of its surgeon-owners) forms solely for the purpose of providing anesthesia services to itself. Little capital is required. The anesthesiologists, not the owners, provide the services. But

for their engagement by the company, they would be providing anesthesia services for their own account. The company’s owners capture a share of the anesthesia revenue. And, importantly, the more cases the ASC or its surgeons refer to the company, the more money those company owners make.

The bulletin states that despite attempting to fit the contracts creating these joint venture relationships into one or more safe harbors, such see company page 14

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P OLI CY & M ANAGE MENT Company continued from page 13

payments from the owner to the manager/supplier for actual services rendered, protection might not be available. The not the “payment” from the manager/ OIG views the discount given within the supplier back to the owner in the form of joint venture’s common business enter- its agreement to provide services to the prise (e.g., the anesthesiologists agree to joint venture for less than the available be paid less by the company than they reimbursement—that is, the “discount” would receive if they billed independently given within the joint venture. of the joint venture) as not qualifying for Again, the failure to qualify for safe the safe harbor applicable to discounts. harbor protection does not mean that Even if the contracts could fit within a venture is illegal; it does mean that it one or more safe harbors, the bulletin might receive additional scrutiny that states that they would protect only the could lead to prosecution.

In 2009, the American Society of Anesthesiologists (ASA) requested that the OIG issue a special advisory bulletin on the company model. The ASA renewed that request in June 2010.

Although the OIG acknowledged the initial request, at the time of this writing it had yet to act.

The Bottom Line …

The bottom line is that company model ventures are fraught with kickback danger for all parties involved. Although

it may be possible that a particular instance qualifies for safe harbor protection, the OIG’s position as expressed in both the fraud alert and the advisory bulletin demonstrates that these arrangements are subject to special scrutiny.

As the government’s focus on weeding out health care fraud intensifies, the need to fully understand the risks grows. Each situation must be analyzed carefully as there is a high chance of an AKS violation leading to criminal fines, civil penalties, exclusion as a provider and even imprisonment. … and an Important Postscript The fraud alert and the advisory bulletin clearly indicate that there is no requirement that a fraudulent joint venture be operated through a new legal entity. Captive model structures in which anesthesiologists work directly for the ASC itself, whether as employees or as independent subcontractors, are joint ventures.

The financial relationships within those captive model joint ventures is as equally suspect as those within company model joint ventures, a fact most often glossed over. In fact, the company model format may simply be a slightly slicker variation of the captive model—slicker because it provides the ASC with an alternative way to bill for anesthesia professional fees, and in states with a strong prohibition on the corporate practice of medicine, creates a medical entity to hold the anesthesia business.

In other instances, the company model is simply a captive model with stickier fingers; instead of the ASC or its owners sharing in the anesthesiologists’ pie, a subset of the surgeon-owners takes that slice for itself.

Viewed in the light, the captive model and the company model are two sides of the same coin, one that the surgeon-owners of ASCs are attempting to put into their pocket. Both models pose significant dangers of falling on the wrong side of anti-kickback rules.

—Mark F. Weiss, JD Mark F. Weiss, JD, is an attorney who specializes in the business and legal issues affecting anesthesia and other physician groups on a national basis. He holds an appointment as clinical assistant professor of anesthesiology at University of Southern California’s Keck School of Medicine and practices with the Advisory Law Group, a firm with offices in Los Angeles and Santa Barbara, Calif., representing clients across the country. He can be reached by e-mail at ­markweiss@advisorylawgroup.com.

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AnesthesiologyNews.com I 15

POL ICY & M ANAGEMENT

Random Drug Screens Enhance Opioid Compliance

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benefit from the pain clinic.”

Although random urine drug screening is an important component of Dr. Schneider’s practice, it’s not the only way to improve compliance among patients. The signed opioid agreement and the relationship between the provider and the patient also are key factors, she said.

“I have a small practice where patients see only me every time,” Dr. Schneider

said. “They know that they have to face me if they screwed up, and not just some resident they won’t see again. It’s the whole attitude that we’re going to be keeping track of what’s going on and not just give you early refills. If you have an attitude of accountability, you’ll get rid of bad apples and end up with compliant patients.”

The opioid contract that Dr. Anitescu gives to patients stipulates that they

receive opioid prescriptions from only one physician. “Not all communities have a pain clinic,” Dr. Anitescu said. “But, random urine drug screening is not only useful in testing for opioids, it can also be applied for antidepressants and a number of other medications. It has proved to be a very important tool.”

—Lynne Peeples

In P-

HI AC

I SC

E

EV

FORCED-AIR WARMING REINVENTED.

0 f-1

S AL GO

ith approximately 50 million Americans experiencing chronic pain and an increasing number of prescriptions written for potent analgesics, drug misuse and abuse has become a widespread concern. Pain clinicians may find some relief of their own by using extensive “opioid contracts” with patients that include random urine testing, new research shows.

“Twenty-five years ago, only if you were in pain with terminal cancer could you get a prescription for opioids,” said Magdalena Anitescu, MD, PhD, assistant professor of anesthesia and critical care at the University of Chicago Medical Center, who presented the findings at the 2010 annual meeting of the American Society of Anesthesiologists (abstract 1531). “More doctors are willing to prescribe controlled substances today. Yet a large number of patients are noncompliant.”

Patients may take more than the prescribed amount of an opioid or add to it an illegal drug. They may ration their pills to pad their wallets, selling into the illicit drug market for recreational users.

“As more drugs are going to be prescribed, even the same percentage of drugs diverted becomes a larger quantity,” said Jennifer Schneider, MD, a pain and addiction management specialist in Tucson, Ariz., who was not involved in the research.

Dr. Anitescu first tallied how often her pain patients intentionally or unintentionally misused prescribed opioids over a three-month period in 2008. She then monitored how patient compliance changed after stringent new policies were implemented, the centerpiece of which was random urine screening for controlled substances.

In the year after the program began, compliance rose from 48% to 74%, as measured by discrepancies between drug dosages prescribed and urine test results.

The proportion of positive urine samples declined from 12% in the baseline period to 9% in 2009. Furthermore, whereas 7% and 5% of urine samples showed results that were above or below the expected range, respectively, for the prescribed drug, just 0.7% of samples were above or below the expected range in 2009.

“We were not only looking for people who were abusing, but also for people who didn’t understand how to take the medication,” Dr. Anitescu said.

A few patients refused to sign the contract and left the clinic. “People who want to divert the medicine and don’t want to follow the contract no longer come,” she said. “You can focus on people who

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P RN Hospital Mortality continued from page 1 Hospital Quality in America report.

“The study shows that efforts at overall quality improvement may be generating the desired effects, but there are still plenty of opportunities for improvement, especially in gastrointestinal surgery,” said Gregory Ginsberg, MD, president-elect of the American Society for Gastrointestinal Endoscopy and professor of medicine at University of Pennsylvania School of Medicine in Philadelphia, who was not involved in the study.

The authors could not identify any factors driving the increase in gastrointestinal (GI)-related mortalities. “There are many possibilities,” said Kristin Reed, MPH, a study co-author and a HealthGrades vice president. “One is that there is no strong national movement focused on improving outcomes in gastrointestinal surgery like there has been for acute myocardial infarction and pneumonia, for example.”

In the report, the researchers analyzed mortality and complication rates for 26 diagnoses and procedures carried out at 5,000 nonfederal hospitals, using 40 million hospital records obtained from the Centers for Medicare & Medicaid Services. They evaluated in-hospital unadjusted mortality rates as well as the impact of in-hospital performance on all-cause mortality at 30 and 180 days following hospitalization for 17 procedures and diagnoses. Another nine procedures were evaluated for in-hospital complications.

HealthGrades researchers also rated hospitals as one-, three- or five-star centers based on how well each performed compared with predicted rates of outcomes, including risk-adjusted

mortality and in-hospital complications. The study, however, did not account for things like socioeconomic demographics and hospital characteristics, nor did it break down the types of GI procedures and operations analyzed.

Overall, 70% to 80% of hospitals were classified as three-star, defined as having outcomes not statistically different from the predicted results. The remaining hospitals fell equally into the one- and five-star categories.

The analysis revealed that although mortality rates improved overall, the gap between the topand bottom-performing hospitals across the country continued to be substantial. Patients treated at five-star hospitals had a 72% lower risk for dying compared with patients at one-star hospitals.

“We are encouraged by the steady improvement in mortality rates across America’s hospitals, but there’s an unacceptably wide gap that has persisted between the top-performing hospitals and all others in terms of patient outcomes,” said Rick May, MD, a study author and vice president with HealthGrades, in a statement.

The investigators estimated that if all hospitals performed at the level of five-star hospitals over the three years studied, they could have saved the lives of 232,422 patients on Medicare. They found that approximately 55.91% (129,949) of the potentially preventable deaths were associated with the following diagnoses: sepsis (48,809), pneumonia (29,017), respiratory failure (26,361) and heart failure (25,762).

Although the study offers a glimpse at mortality and complication rates in U.S. hospitals, it lacks information on how to enhance hospital quality.

“The authors have done as well as they can with this sort of data, but I wouldn’t base decisions of care on this analysis,”

‘The authors have done as well as they can with this sort of data, but I wouldn’t base decisions of care on this analysis.’

—Lawrence R. Schiller, MD

said Lawrence R. Schiller, MD, a gastroenterologist at Baylor University Medical Center in Dallas.

Dr. Schiller added that he is skeptical of ratings reports based on coding data. For instance, mortality rates can be affected by transferring moribund patients to hospice care or nursing homes before they die in the hospital. Some institutions may “game” the system by coding for a diagnosisrelated group that is better reimbursed, making their results look better, Dr. Schiller said.

“I’m not sure that gastroenterologists and surgeons can learn much from this sort of study without understanding why the higher performing hospitals had better outcomes,” Dr. Schiller said. “What did they do differently? Is it really the care provided or some other issues, such as type of patient referred, the way diagnoses are coded, the person who writes orders or the amount the hospital is paid?”

Dr. May said that “for hospital leaders as well as potential patients, it is essential that they understand—and act on—these findings.”

Among the study’s other findings: • The highest unadjusted mortality rates were for sepsis (20.59%), respiratory failure (19.45%) and GI operations and procedures (10.29%).

• On average, mortality associated with GI bleeds improved 6.7%, with a relative risk reduction of 79.77% when patients were treated at five-star hospitals compared with one-star. (GI bleeding was assessed separately from GI procedures and operations.)

• On average, one in nine patients developed a hospital-acquired complication for the nine procedures studied.

• Rates of complications varied between the “best” and the “worst” hospitals for the nine procedures studied. Five-star–rated hospitals had significantly lower unadjusted complication rates across all three years studied. The highest unadjusted in-hospital complication rates were for cholecystectomy (17.97%), spinal fusion (17.15%) and hip fracture repair (16.09%).

• Closing the performance gap on just three cohorts could potentially prevent the greatest number of complications: hip fracture repair (42,312), total knee replacement (35,466) and cholecystectomy (28,502).

• On average, patients treated at hospitals with statistically lower risk-adjusted mortality rates were less likely to die of all causes up to six months following hospitalization.

• Variation exists at the national and state levels.

The states with the lowest overall risk-adjusted mortality were Arizona, Ohio, Maryland, Michigan and Utah. The states with the lowest overall rates of risk-adjusted in-hospital complications were Hawaii, Delaware, Idaho, Arkansas and Mississippi.

—Christina Frangou

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Anesthesiology News. “However, Dr. Bhatnagar’s paper in the Journal of Palliative Medicine is one of the source journals for the plagiarism by Dr. Memiş. To give you an idea how widespread this is, we recently rejected a paper that copied large blocks of text from a paper by Dr. Memiş.”

December issue of A&A also retracts a 2010 manuscript by Turkish researchers who, according to Dr. Shafer, plagiarized from at least five other published papers—one of which happens to have been a 2008 article by Dr. Bhatnagar in the Journal of Palliative Medicine.

Plagiarism’s No Joke “Dr. Bhatnagar’s paper in AnesAs farcical as the case of merry-gothesia & Analgesia was retracted because it contained text taken from round cheating might be at first blush, a paper by Dr. Munir,” Dr. Shafer told journal editors are far from amused by

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More on the Boldt Affair—From Study Troubles to Allegations of Patient Death

I

n late October, Anesthesia & Analgesia (A&A) announced that it was retracting a 2009 article by Joachim Boldt, MD, PhD, and colleagues. The journal accused Dr. Boldt, a prominent scientist with more than 200 publications to his name, of “very serious misrepresentations” in his article, titled “Cardiopulmonary Bypass Priming Using a High Dose of a Balanced Hydroxyethyl Starch Versus an Albumin-based Priming System.”

According to the retraction notice, Dr. Boldt failed to obtain approval from an institutional review board (IRB) or informed consent from patients in the study. The journal also suggested that he may have fabricated his data—providing results that, on reflection, seemed impossibly good—but said any conclusions about fraud would have to wait until the results of an ongoing investigation by German health officials.

At the time Dr. Boldt, an expert in colloids with an international reputation, was head of anesthesia at the Klinikum Ludwigshafen, a private hospital. That has changed.

Less than a month after Anesthesia & Analgesia issued its retraction notice, Klinikum Ludwigshafen released Dr. Boldt. The researcher may have bigger concerns: He reportedly may soon face criminal charges in the matter.

As a press release from the German

Society for Anesthesiology and Intensive Care Medicine stated: “In his work, Boldt had pretended to have compared two drugs, known as plasma expanders. This should have involved two different patient groups connected to a heart-lung machine during heart surgery. A scientific commission has concluded that there was no convincing evidence that study was conducted.

One indication of this is that, for example, no laboratory and patient data of the study are available.”

German authorities also are investigating Dr. Boldt for his role in a drug trial several years ago that resulted in the death of a patient, the Weinheimer Nachrichten has reported. That incident occurred when Dr. Boldt was at the University Hospital Giessen. Officials there acknowledged an investigation into the matter but declined to comment further.

Dr. Boldt initially replied to a request from Anesthesiology News for comment but said “as this is an ongoing process with a lot of people involved, I am not able to talk about this issue at this moment.” He did not reply to a subsequent e-mail.

If Dr. Boldt is indeed guilty of research fraud, the magnitude of his curriculum vitae leaves journals with the daunting task of trying to determine how far the misdeeds extend.

Steven L. Shafer, MD, editor-in-chief of A&A, is the unofficial head of a group of editors who will be working with Klinikum Ludwigshafen to delve into Dr. Boldt’s bibliography.

They will review the German scientist’s publications in their respective journals, sorting the papers into three categories: “Highly Suspect,” “Possibly Suspect” and “Not Suspect.”

Dr. Shafer said he expects the review to take from six to 12 months. Other publications involved include Anesthesiology,

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AnesthesiologyNews.com I 19

PRN the episode and similar incidents. Dr. Shafer, for example, estimates that he spends up to one-third of his time dealing with lifted text or, less commonly, fraudulent presentations of data in manuscripts. He still devotes several hours each week to sorting out the aftermath of the Scott Reuben fiasco—a sweeping case of data fabrication that led to the retraction of 21 papers, 11 of which appeared in A&A. He expects the fallout to linger for years.

Dr. Shafer said his journal is now

Anaesthesia, the British Journal of Anaesthesia, the European Journal of Anaesthesiology and Anaesthesia and Intensive Care. Recent articles from Dr. Boldt’s group have appeared in these and other titles, including Cardiovascular Research, the Journal of Cardiothoracic and Vascular Anesthesia and Critical Care Medicine.

In addition to the retracted article in A&A, journal editors have identified other papers for which Dr. Boldt may not have obtained proper approval from an IRB or written informed consent from patients, said Massimo Antonelli, MD, editor in chief of Intensive Care Medicine.

Although lack of IRB approval certainly is a serious issue, questions also have been raised about the validity of Dr. Boldt’s findings. Dr. Antonelli, professor of intensive care and anesthesiology at Catholic University in Rome, said the investigation was triggered by suspicions about unrealistic standard deviations in data for levels of pH and interleukin-6 in blood.

Dr. Antonelli said his journal has identified four papers by Dr. Boldt that require investigation. Published between 2002 and 2009, the manuscripts all deal with hemodynamics, a field to which Dr. Boldt has contributed substantially, Dr. Antonelli said.

“He was always considered a distinguished investigator. His transparency and reputation was really clean. Up to now.”

Dr. Antonelli said it’s too soon to know the impact of Dr. Boldt’s apparent misdeeds, and whether current practice must be modified to accommodate any additional retractions of his research papers. “We should avoid any immediate conclusions without solid investigation. The biggest mistake we may commit is to throw away the baby with the bath water.”

Another question is how much, if at all, Dr. Boldt’s numerous co-authors were aware of his actions. “We have no clear clue” that they did know, Dr. Antonelli said.

—A.M.

running every submitted manuscript through CrossCheck, a copy-checking system that allows editors and publishers to screen papers for signs of plagiarism.

A&A, through its publisher Lippincott, Williams & Wilkins, belongs to a consortium called CrossRef, one of whose goals is to prevent misuse of previously published material using CrossCheck, which screens manuscripts against a database of articles in order to detect possible plagiarism.

Robert Creutz, general manager of

iThenticate, which makes the software that powers CrossCheck, said the plagiarism catcher now has access to some 50,000 titles and 28 million published articles. “We can generally evaluate a manuscript in anywhere from 45 seconds to three minutes,” Mr. Creutz said.

Individual customers pay $1,000 per year for 500 pages of checking. Members of the CrossRef consortium have a different arrangement. They pay 75 cents per manuscript (under 25,000 words) but earned the discount by agreeing to

Please visit the Edwards booth #1218 at SCCM for more information.

provide iThenticate with access to thousands of papers upfront as seed for the database.

“I’m seeing a lot of journals overseas that are taking advantage of the technology,” Mr. Creutz said. The motivation appears to be competing with established journals and improving impact factor, he added.

Dr. Shafer said that since his journal began screening manuscripts routinely for signs of plagiarism, he has identified see word theft page 20

20 I AnesthesiologyNews.com

jan u a r y 2 0 1 1

P RN Word Theft continued from page 19 about a dozen papers with unacceptable amounts of verbatim text from other sources. That’s a rate of approximately one in 10 submissions to A&A, he said.

Authors for whom English is not their native language may inadvertently commit plagiarism, Dr. Shafer observed.

“I am very sympathetic to the challenges faced by investigators struggling to write a scientific paper in an unfamiliar language. However, I have no choice but to retract papers that contain plagiarized text, even if it is only a single paragraph, and even if the intent was simply to express an idea in proper scientific English,” he said.

The U.K. journal Anaesthesia has been using CrossCheck to screen every manuscript it receives, according to Steven M. Yentis, MD, editor-in-chief of the publication. In a recent editorial, Dr. Yentis said his journal publication rejected 4% of submitted manuscripts in 2010 because the software turned up evidence of plagiarism.

So how common are retractions from the anesthesia literature in particular?

Dr. Yentis looked at this question last June, and came up with the following numbers: 26 from the eight leading titles in the specialty dating back to 1993. Of those, 16 (62%) involved papers on which Dr. Reuben was a co-author.

The tally does not include the retraction in the December issue of A&A of an article by German researcher Joachim Boldt, MD, PhD, and colleagues (sidebar). It does, however, include a retraction in Anaesthesia—evidently the first yet by the title—of a paper on the safety of cardiac surgery without transfusions in Jehovah’s Witnesses.

According to the retraction notice, “the study did not have ethical approval as claimed. In addition, the article was written and submitted without the knowledge or consent” of three of the four authors, who agreed to the retraction. “It has not been possible,” the notice concludes, “to obtain a response from the corresponding author”—who, to add insult to the injury of forgery, evidently misspelled the surname of one of his unwitting collaborators.

Recently, an Internet forum for medical editors was buzzing with complaints about author misconduct.

“The kinds of crimes I have seen over the years are at best belief defying,” wrote Udo Schuklenk, PhD, professor of philosophy at Queen’s University in Kingston, Ontario, and co-editorin-chief of the journals Bioethics and Developing World Bioethics. “My all-time favorite, by a long stretch, was the medical journal deputy editor who plagiarized

‘The kinds of crimes I have seen over the years are at best belief defying.’

—Udo Schuklenk, PhD a whole piece we had published in his medical journal (a paper on medical ethics, appreciate the irony of it all). We duly contacted his editor-in-chief as well as the journal’s editorial board. After extended umming and aahhing we were told that

By the way, A&A retracted another article in the December issue, but it doesn’t involve plagiarism, at least not from someone else’s text. In this case, the authors republished a paper they had previously published in German.

a correction (!) would be published, and that—given the deputy editor’s seniority, —Adam Marcus experience and professional standing— they had accepted the ‘honest mistake’ Editor’s note: A version of this article explanation of their plagiarizing medical previously appeared on AnesthesiologyNews.com. ethics expert.”

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JED™ works on a wide range of patient types, from obese to normal adult and pediatric patients.

jan u a r y 2 0 1 1

AnesthesiologyNews.com I 21

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Neuromuscular Blockers May Boost Survival in ARDS Pts

U

sing a neuromuscular blocking agent to induce muscle paralysis in patients with early, severe acute respiratory distress syndrome (ARDS) helps improve their odds of survival without causing muscle weakness, according to a recent French study.

In the double-blind ACURASYS trial, study authors at 20 hospitals

randomly assigned 340 patients with severe ARDS—a life-threatening lung condition marked by inflammation, excess fluid in the pulmonary alveoli, low blood oxygen and respiratory distress—to receive either cisatracurium besylate (Nimbex, Abbott) or placebo.

Results, published in September in The New England Journal of

Medicine, showed that 178 patients in the cisatracurium group had a lower risk for death (hazard ratio, 0.68) compared with 162 patients in the placebo group (P=0.04). The crude 90-day mortality rate was 31.6% in the cisatracurium group and 40.7% in the placebo group (P=0.08), and the 28-day mortality was 9.6 percentage points lower

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among patients in the cisatracurium group versus the placebo group (23.7% vs. 33.3%; P=0.05). The beneficial effect of cisatracurium was confined to the two-thirds of patients presenting with the most severe form of ARDS, based on arterial blood oxygen values.

Patients who received cisatracurium (150 mg ) also had significantly more ventilator-free days than the placebo group during the first 28 and 90 days, had more days free of organ failure (other than the lungs) during the first 28 days, and spent significantly more days outside the intensive care unit (ICU) between day 1 and day 90. The rate of muscle weakness did not differ significantly between the groups.

Based on these findings, lead author Laurent Papazian, MD, PhD, of the Université de la Méditerranée in Marseille, said that he recommends neuromuscular blocking agents for ARDS at all hospitals, but only for patients with severe hypoxemia. He added that the drug must be administered early in the course of ARDS (the first day or two) and for a short duration (48 hours or less).

Dr. Papazian said further study could help determine whether the use of neuromuscular blocking agents for only 24 hours would be beneficial, and how the drug helps, although he believes it decreases ventilator-associated lung injuries.

John W. Devlin, PharmD, associate professor and director of the critical care pharmacy fellowship program at Northeastern University and Tufts Medical Center in Boston, said he thought the study was “particularly noteworthy,” given that most ICUs over the past decade have moved away from routine administration of continuous infusions of a neuromuscular blocker in ARDS patients because of their see ARDS page 25

22 I AnesthesiologyNews.com

jan u a r y 2 0 1 1

P RN Juggernaut continued from page 1 About six months later, an investigator for the state professional board came to see me at my clinic. He asked me about the incident. I admitted to having had personal problems at the time but that I’d been working them out. He responded that I was telling him more than he wanted to know, then led me through an affirmation that I’d suffered an adverse reaction to antihistamines. I was much better now. The incident would not be repeated.

I was rather stoned during this meeting but the investigator either didn’t know or didn’t care. He held hands with me while we meditated about the problem. He also apologized for the delay in reviewing the situation, saying that he was the only investigator for the lower half of the state.

The three licensed physicians (there was also one physician changing residency programs) that I hired were a curious lot. One was writing his own narcotic prescriptions in his grandmother’s name.

The second was bounced out of a residency program for her own addiction problem. The third was a chronic alcoholic who had trouble maintaining her medical license.

Perhaps it was the proximity to these people and their problems, but not long after we began working together I admitted to myself that I, too, needed help. I checked myself into a nearby hospital seeking treatment for “depression.” I stayed a week or two but reestablished my drug habit within days of coming home. A second hospitalization ensued, with the same results.

‘Gone Overnight’ All bubbles eventually burst, and within two years of opening my new clinic it was gone virtually overnight. A newly enacted provision allowed the state to summarily suspend Medicaid privileges of practitioners who performed a pattern of procedures that was inappropriate, unnecessary or “dangerous.” State officials claimed that my orders for complete spinal x-rays, including thoracic and cervical scans, for patients with low back pain were potentially harmful.

Medicaid billing represented 95% of my revenue.

Apparently, I was big news. The day after the state suspended me, the Egyptians buried their slain leader, Anwar Sadat. But the banner headline on the front page of one local paper read: “Medicaid Clinic Closed.”

President Sadat’s funeral was below the fold. In the story about my case, the Michigan Medicaid director declared that the new law, “with teeth,” was intended to stop abuse of the program and prevent abusers from financing their lawyers with government money.

That night, a close relative invited me to her home

T

and told me that she had received word that if I left Michigan, the state would not attempt to bring any further proceedings against me. The arrangement sounded like a good one. I knew I had a drug problem and that I needed therapy. It also was apparent to me that my professional and personal lives were out of control and that I might do well to start over again in another state. I floated this past my wife who responded, “All my friends are here, you have to stay and fight this.”

Well, I had lived in the state all but two years of my life and she had lived there for only four years. But I listened to her and stayed.

Meanwhile, the primary source of money for the clinic was immediately cut off, and the state was holding against future claims more than $300,000 in payments that had been approved but not disbursed.

I had no choice but to reduce my staff. I had 33 employees, including the physicians. I let all but one doctor go and laid off most of the other employees.

Of course, this did nothing but create a singleness of purpose with my former employees to consider their own best interests. Which were not mine. Three of the doctors eventually either testified against me or were slated to be rebuttal witnesses against my testimony in the criminal trial.

With a small cash reserve, I could not finance legal help for long. The lawyers went through $66,000 in less than two weeks, and I had to fall back on another attorney who had less ability but whose fees were more in line with my shrinking bank balance.

My attorney decided that there was no way to establish the necessity for the procedures. We attacked only the “danger” aspect of the allegation.

Oddly enough, the state never contested the diagnoses of low back pain at the time, and my lawyer never realized that every diagnosis was matched for consistency with the procedure by something called the procedure, diagnosis and formulary file. It would not have made any difference how right we technically would have been in these circumstances.

At a Glance: Health Care Fraud

he federal government has cracked down on Medicare and Medicaid fraud with increasing vigilance—and IS reaping increasing returns. The government received more than $2.5 billion in fiscal 2010 payments stemming from allegations of health are fraud. That number, a record high, marked

a 48% increase over the fiscal 2009 figure of $1.68 billion.

In fiscal 2009, the feds reclaimed more than $441 million in Medicaid funds, an increase of 28% over the previous year, officials said.

—AN Staff

Foregone Conclusion An administrative tribunal in Michigan is led by an employee of the department bringing the allegation and is held in the building that houses the department bringing the charges. The director of the department reviews the administrative law judge’s findings. In other words, it’s their backyard, their bat, their ball, their umpire, their rule book. From my perspective, the decision was a foregone conclusion.

After five months or so of driving to the state capital to submit to the administrative tribunal process, the inevitable happened. The panel ruled that the two additional x-rays my patients had received raised their risk for cancer by as much as if they’d smoked two cigarettes in a lifetime. However, even this was sufficient for their purposes. They also established a “pattern of practice” against me, although only two charts out of 20 originally cited suggested “excess” x-rays.

Two of the four physicians (myself included) had their suspensions confirmed. No funds were returned to the clinic from the billings paid to the two doctors whose suspensions were not upheld. The decision to uphold the director’s decision further alienated me from my physician colleagues.

A few weeks later I was served with 80-count criminal information alleging that I submitted false claims to Medicaid, as well as one broader count of Medicaid fraud. The false claims were punishable by a maximum of four years in prison and the fraud count, by up to 10 years.

Rehab I’d had a nervous breakdown while the administrative tribunal was in progress, but the criminal information snapped me out of the deep depression. This may sound strange—it certainly seemed bizarre to me—but my mood improved and my life took on greater purpose.

The court convened a prolonged preliminary hearing in which my three former physician employees

jan u a r y 2 0 1 1

AnesthesiologyNews.com I 23

PRN testified against me. At some point during the proceedings I injected Demerol into my anterior thigh. Several hours later, every muscle in my upper leg went into contraction and caused a comminuted fracture of the proximal portion of the femur.

I was taken to a nearby clinic, where the physician responsible for drug rehabilitation questioned me at length.

Oddly enough, no one diagnosed the fracture! As it happened, the break wasn’t found for at least two weeks, during which time I was in excruciating pain and Demerol withdrawal.

After a few days at the clinic, the drug rehabilitation physician announced that she couldn’t do anything for me and referred me to an out-of-state treatment center that specialized in rehabilitating physicians.

(Before I left, the rehab physician told me that she had received several calls from state police and the professional board asking whether I’d received treatment there at any time. She had declined to comment.)

I went home briefly, then flew off for my stay at the treatment facility. My fractured femur was still undiagnosed.

The philosophy of treatment centers is to confront patients with their addiction and denial. My physical complaints were considered the whining of an addict seeking compassion rather than a legitimate physical complaint, and accordingly were largely ignored.

But after a week or so, I finally underwent x-rays. The staff was a bit nonplussed when the films revealed the comminuted fracture. They became very apologetic.

I needed surgery for the break but couldn’t afford the procedure (the rehab facility would not cover it). My surgeon was rightfully irritated at the thought of operating on credit and was scorchingly abusive. I managed to come up with the money, whereupon he performed an internal fixation of my hip that left my foot pointing east when I faced north. I had always been a bit splayfooted but this was a gross exaggeration.

At this point, they began criticizing even the low doses of anti-inflammatory drugs that, as a Crohn’s disease patient, I was taking to control my bowel symptoms. I took this behavior as collective undoing: They had treated my hip pain as if it were merely the malingering of an addict seeking more drugs and were transferring their shame at their ineptitude into apology.

A few days later, word reached me that my last physician employee had quit and agreed to testify against me.

I decided to drop out of the treatment program and return to Michigan to salvage what was left of my clinic. As I was leaving, several of the clinic doctors confronted me and tried to convince me to remain. I ignored them.

Arriving at the Detroit airport, I was met by my father and attorney, both of whom urged me to return to rehab. I wasn’t listening. I took a cab home. On the way home, I asked the cab driver to stop at my clinic. I wanted some Demerol.

The taxi was waiting when I left and drove me home, but I passed out in the back seat before he reached the address, and when I awoke he had driven several miles past my house. I had vomited in the back seat, which didn’t really disturb him since the meter was in the stratosphere.

I returned to practicing from a wheelchair. But unknown to me, someone claiming to be a physician at the rehabilitation facility called the state osteopathic board. It turned

out that the caller wasn’t on staff after all. I later learned that he was another addicted physician in early recovery.

The clinic had a four-month program, the first month of which is pretty much the standard fare for rehab facilities. The next three months of the program consist of counseling and analyzing fellow addicts. The judge reviewing my case gave the professional see juggernaut page 24

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jan u a r y 2 0 1 1

P RN Juggernaut continued from page 23 board the chart numbers of hospitals where I had sought help for depression on previous occasions.

That was all the board needed. Within days, the state police showed up and presented me with a notice of suspension of my license.

Recovery One good thing had happened while I was in rehab: an introduction to 12-step self-help recovery programs. Back in Michigan, I started attending these meetings nightly and occasionally more often.

After a few months, I became drug-free and the situation became scarier. The 12-step program helped immensely. Recovering addicts are the least judgmental people on earth, and you can’t shock them.

My story, which seemed pretty wild to my ears, was unremarkable to them—possibly a bit mundane.

And everyone else’s addiction story seemed mundane to me. So I was a qualified member of a recovery fellowship.

After 48 hours without drugs, it is pretty hard to distinguish an addict while walking down the street.

Although I needed a walker to get around, I began to Advertisement

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look relatively normal.

By this time I was driving a taxi to support myself.

Driving a cab is a rather enjoyable way to make a living. It is not the profession for which I had trained.

My identity as a physician was ebbing painfully. I continued to go to professional meetings for continuing education credits and I exceeded the requirements, but I was unable to regain my license.

Meanwhile, my attorney was able to negotiate a plea deal for me—I wouldn’t contest the charges and I’d be on probation, but I’d receive no jail time and would settle any financial restitution in a collateral civil suit. I balked. In my mind, I had a constitutional right to a $90,000-per-week clinic and no one was going to take it from me.

One of the basic premises of recovery is to not make any major changes in your lifestyle in the first year of recovery, and none was made. After a year, however, I filed for divorce. Or rather, I spoke to my wife and asked her if she wanted to file first. She did.

My gesture proved to be a tactical error, however, as it prevented me from filing in a county more hospitable to the visitation rights of fathers. Although I had been clean for more than a year, my wife obtained very restrictive terms regarding my visitation rights. The arrangement pained me greatly. My marriage may have been over but I loved my children, and they enjoyed our time together as much as I did.

We found activities they liked. We went camping on one occasion, something my father never did with me. All I knew was that Ward, Wally and the Beav went camping, and so did Ozzie, Ricky and Davy. It was a great experience.

I found a job as medical director of a plasmapheresis center in a neighboring state. The money was nothing special, but at least I had my identity as a physician back. I started dropping urines three times a week with a pathologist who randomly selected one for drug analysis. I was demonstrably and objectively clean. Soon, I could present this fact to the professional board. Life was beginning to brighten slowly.

My legal troubles appeared to be improving, too, or at least changing in a way that wasn’t necessarily bad. A judge had dismissed my case on a technicality, quashing a subpoena from the grand jury after learning that prosecutors had not provided the jurors with certain documents, and for two and a half years I no longer had criminal charges hanging over my head. I didn’t have a license, either, however, which prevented me from enjoying the situation more. Nor could I shed the nagging feeling that the winds would shift again—and they did.

On Trial On one of my trips back to Michigan to see my sons, I received a letter: It stated that the court had reversed my dismissal. By this time, I was out of money. I contacted Legal Aid and a public defender.

Again I was offered probation. Again I refused.

The trial was a bloodbath. Two of my former physician employees testified against me, as did many other former employees. I received a desultory character defense from the few loyal remaining former employees that didn’t help matters.

I had tried to contact former classmates from medical school to appear as expert witnesses on my behalf.

MD Misdeeds: Inside the Numbers A 2004 survey by the American College of Physician Executives (ACPE) found that many doctors consider drug or alcohol abuse to be a problem in the workplace.

Here’s a closer look at the results:

What percentage of physician behavior problems at your organization are linked to alcohol or substance abuse?

Response Percent

Response Total

None

42.9%

653

1%-10%

51.9%

791

11%-25%

4.1%

62

26%-50%

0.9%

13

51%-75%

0.3%

4

76%-100%

0%

0

Total respondents

1,523

(skipped this question)

112

The ACPE also reported data from the North Carolina Physician Health Program (NCPHP). At the NCPHP—which assesses physicians and, if necessary, refers them to appropriate treatment programs—the number of assessments each year has climbed steadily over the last two decades, from 26 in 1988 to 138 in 2003.

Source: The American College of Physician Executives. Reprinted with permssion.

Breakdown by Diagnosis

2003

Total in Program

Aging

0

3

Alcohol

25

368

Amphetamine/ stimulant

0

8

Barbiturate

1

9

Benzodiazepine

0

7

Cocaine

2

19

10

63

Marijuana

1

10

Opioids/analgesics

11

152

Polydrug

5

143

Psychiatric disorder

24

178

Sexual misconduct

7

102

Other

26

211

Unsubstantiated

26

116

138

1,389

Dual diagnosis

Totals

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AnesthesiologyNews.com I 25

PRN They had similar patterns of practice and were afraid to testify under the circumstances. After all, if they testified that my pattern of practice was solid and theirs was similar, they might find themselves accused of Medicaid fraud, as well.

In the end, I couldn’t afford to hire an expert witness to counter the state’s claims. Although the prosecution’s Medicaid expert testified that my claims were consistent with Michigan’s standard, my attorney neglected this bit of information. He had never won a case and never tried a fraud case. His summation to the jury lasted less than five minutes.

I reported to a state sentencing agency. They recommended incarceration. The judge said that although I posed no threat to the community and

was incapable of committing the crime again, he wanted to set an example to other would-be Medicaid abusers.

The maximum sentence for the false claim was four years, but since this was my first violation the judge could give me no more than half the maximum. On the conspiracy count, I received the maximum for a first conviction—another five years—for a total of seven years.

I returned to driving a cab in the area, as I was on appeal bond and could not leave the state. My child support

payments were set at a rate that would have been appropriate for a physician but were much higher than any cab driver could pay. Twice, I was jailed for contempt of court for not paying child support.

The judge for the child support hearings asked if I could get my medical license back, or whether I could sell any jewelry to raise the money. The answer to both of these questions was no.

Finally, I completed six months of urine screens with a pathologist and

applied for reinstatement of my license, which had been suspended specifically for impairment from my use of narcotics. The professional board found that I was no longer impaired by addiction, but they revoked my license anyway because of my conviction.

My appeals were rejected, as was my option and leave to appeal to the Michigan Supreme Court, and the U.S. Supreme Court declined to hear the case. I was told to surrender myself for incarceration.

ARDS continued from page 21 association with prolonged muscle weakness. That trend can also be due, he said, to the availability of newer ventilator and sedation strategies that counteract the ventilator-associated dysynchrony that frequently occurs in ARDS patients managed with a low tidal volume strategy.

However, he said, “It remains unclear in the study whether the rapid administration of cisatracurium after intubation truly allowed ICU clinicians adequate time to try the many non-paralytic strategies that have been shown to reduce ventilator-associated dysynchrony in this population, such as aggressive sedation and opioid administration, and various ventilator adjustments.”

Dr. Devlin also noted that study patients had their sedation monitored with a sedation scale instead of bispectral index monitoring, and did not receive train-of-four monitoring.

“Pharmacists in the ICU should evaluate this study in the context of current ventilation and sedation/analgesia strategies for ARDS management at their institution before adopting continuous neuromuscular [blocking] therapy in this population on a widespread basis,” Dr. Devlin said. He further cautioned that the results of this study may not be reproducible with other paralytic agents, or when paralytics are either not started soon after intubation or continued for prolonged periods.

—Karen Blum

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26 I AnesthesiologyNews.com

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P RN

FDA Grants Appeal To Reconsider Automated Propofol Sedation System

I

n early November, the manufacturer of an auto- moderate sedation and yet the device is mated propofol sedation system, which the FDA designed to administer propofol in doses known previously had declined to approve, announced to produce general anesthesia,” Dr. Martin that the agency had granted the company’s appeal to said. He added that studies to date have shown reconsider approval of the device. As a result, the FDA that patients administered propofol using Sedawill appoint a new independent advisory panel to sys have experienced unconsciousness or respirareevaluate the safety and efficacy of the Sedasys System, tory depression (Digestion 2010;82:127-129). For a computer-assisted personalized sedation system from example, in the largest prospective, randomized trial evaluating the safety of the device compared with Ethicon Endo-Surgery.

“This is big news,” said Lawrence Cohen, MD, a gas- the current standard of care, five patients (1%) experitroenterologist and associate clinical professor of med- enced general anesthesia with Sedasys (submitted for icine at Mount Sinai School of Medicine in New York publication).

But Daniel Pambianco, MD, medical director of City. “The decision shows that the FDA is trying to be fair-minded and evenhanded in its assessment of the Charlottesville Medical Research, in Charlottesville, Va., and lead author on the major study, disagreed device’s safety and effectiveness.”

The FDA has granted such an appeal only once with Dr. Martin’s assessment. Dr. Pambianco maintained that the five patients in this study experienced before, more than 20 years ago.

“It is uncommon for a company to use the appeals no serious or device-related adverse events, and did not process [to contest the FDA’s decision], but it’s even require rescue interventions.

“I don’t think the ASA’s concerns make sense,” Dr. more uncommon for them to be successful,” said Frederick A. Stearns, JD, a partner at the law firm Keller Pambianco said. “These patients were only transient and Heckman LLP, who specializes in legal issues for about 20 seconds and experienced no physiologic consequences from the sedation. The concerns appear involving the regulation of drugs and medical devices. to be based on ‘what ifs,’ not The decision essentially means data.” that the commissioner’s office ‘This is big news. The The ASA also voiced con“acknowledged the [FDA’s] Cencern that Ethicon is attempting ter for Devices did not review the decision shows the FDA is to market Sedasys for clinidata correctly,” added Mr. Stearns, cians under conditions that do who was not involved directly in trying to be fair-minded not comply with the current this case. “It would be surprisblack box warning in the propoing if, on the second time around, and evenhanded in its fol label, namely that propothe company still does not get assessment of the device’s fol “should be administered approved.” only by persons trained in the The Sedasys System is being safety and effectiveness.’ administration of general anesdeveloped by Ethicon, a division thesia and not involved in the of Johnson & Johnson Company, —Lawrence Cohen, MD conduct of the surgical/diagnosto provide automated, minimal tic procedure.” to moderate propofol sedation Dr. Martin pointed to the for patients undergoing colonoscopy and upper gastrointestinal procedures. The FDA’s Aug. 11 decision, which strongly supported device would permit gastroenterologists and nurses retaining the black box warning on the grounds that to administer propofol without the presence of an “the warning is warranted and appropriate in light of the risks associated with the use of propofol as a sedaanesthesiologist. tion agent for endoscopic procedures.”

Safety a Matter of Opinion “We [the ASA] share [the FDA’s] concerns and feel The safety and utility of the Sedasys System has been that extensive training in deep sedation and general the subject of debate for several years. Steven L. Sha- anesthesia is required to provide the knowledge, attifer, MD, editor-in-chief of Anesthesia & Analgesia and tudes, skills and practices needed to safely administer professor of anesthesiology at Columbia University in propofol to patients by any physician, be they a gastroenterologist, anesthesiologist or other physician,” New York City, supports the system.

“The Sedasys provides an opportunity for anesthesi- Dr. Martin said.

Dr. Shafer, however, dismissed concerns about ologists to set up ultra-high throughput gastrointestinal endoscopy services, improve patient safety, patient propofol.

“Many anesthesiologists carry the erroneous persatisfaction, endoscopist satisfaction and reduce the ception that propofol is intrinsically more dangercost per procedure,” Dr. Shafer said.

However, Donald E. Martin, MD, associate dean for ous to patients,” he said. “This perception, however, administration at Pennsylvania State Hershey College of is not supported by data.” The available data sugMedicine and chair of the Section on Clinical Care at gest that the safety profile of propofol is the same as the American Society of Anesthesiologists (ASA), has midazolam (Gastrointest Endosc Clin N Am 2008; expressed concerns about the safety of the device.

18:717-725).

“Sedasys is requested to provide minimal to Dr. Shafer highlighted the system’s built-in

safeguards, explaining that Sedasys is designed to monitor and record a patient’s vital signs, including oxygen saturation, respiratory rate, heart rate, blood pressure and patient responsiveness. The device automatically detects and responds to signs of oversedation—its yellow alarm interrupts propofol delivery and its red alarm stops delivery.

“All physicians who would use the device would need to have the appropriate credentials and be certified,” Dr. Pambianco added. In his study, gastroenterologists and nurses who used the device required six to eight hours of training to become competent to use the Sedasys System.

Proponents Hold Out Hope According to Ethicon, widespread use of Sedasys would save money. The company estimated a cost savings for a single health plan in 2015 would total approximately $163 million for colonoscopy and $131 million for esophagogastroduodenoscopy if Sedasys were used in 80% of procedures that would have otherwise required an anesthesiologist.

Based on the data supporting the safety and efficacy of Sedasys, Dr. Cohen believes that “there was some other issue or bias, or perhaps a misunderstanding” that caused the FDA to reject the device initially.

He pointed to Michael Jackson’s death from an overdose of propofol as a possible reason.

“After Mr. Jackson’s death, propofol suddenly became a household name,” he said. “People began asking how a drug like propofol fell into the hands of non-anesthesiologists. It’s my personal opinion that these queries may have influenced the FDA’s initial decision to not approve the device.”

Dr. Cohen added that the drug is becoming the anesthesia of choice.

“Propofol is now being used in about half of all procedures done in the United States, and its use may double over the next five to seven years. There simply isn’t the anesthesiology manpower to do all of this,” he said.

The FDA declined to comment on the specifics of the case.

—Victoria Stern

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AnesthesiologyNews.com I 27

CLIN ICAL ANESTHES IOLOGY

Trendelenburg Position Plays Role in Post-op Corneal Abrasion San Diego—Corneal abrasions, although rare, can occur after almost any type of surgery requiring anesthesia. Now, a review of more than 78,000 procedures has shed more light on the risk factors for the adverse event.

Researchers at New York-Presbyterian Hospital/Weill Cornell Medical Center, in New York City, confirmed that factors that contribute to the development of corneal abrasions postoperatively include patient age, same-day admission and general anesthesia (P<0.001, respectively). In addition, they newly identified the Trendelenburg position as a significant risk factor for corneal abrasion (P<0.001).

“We’ve been collecting data on corneal injury since the early 1990s,” said Susan L. Faggiani, RN, regulatory administrator for the Department of Anesthesiology at New YorkPresbyterian Hospital. “Periodically, we review the data and we recently examined a series of patients from January 2007 to December 2008.”

The investigators reviewed 78,542 procedures requiring anesthesia, identifying 86 corneal abrasions (0.11%).

Perioperative patient records were evaluated for a host of possible risk factors, including patient demographics, preoperative and intraoperative parameters, and postoperative management.

In addition to several contributing factors uncovered by the study, the researchers also identified other risks, including taping of eyes for protection (P<0.001), large blood loss (P<0.001), recovery in the main postanesthesia care unit (PACU; P=0.0044) and oxygen administration in the PACU (P<0.001).

The complication was treated most commonly with antibiotic ophthalmic ointment combined with artificial tears (37.6%). “The other interesting thing was that there were no long-term sequelae whatsoever in any of these cases after we followed up with their surgeons and ophthalmologists,” said co-investigator Farida Gadalla, MD, professor of clinical anesthesiology and obstetrics and gynecology at Weill Cornell.

The analysis has led to the development of an algorithm to expedite the care of patients with corneal abrasions, according to principal investigator Peter M. Fleischut, MD, assistant professor of anesthesiology at Weill Cornell. “We haven’t studied the algorithm, but we use it in our clinical practice so patients who need treatment receive

the appropriate treatment and get a consultation with an ophthalmologist.”

He reported the study findings at the 2010 annual meeting of the American Society of Anesthesiologists (abstract A971).

Although the researchers were quick to point out that they have not studied methods to prevent corneal abrasions, they offered a few suggestions. “I think

we need to be careful when we tape the eyes shut to ensure they are completely closed,” Dr. Gadalla said. “As prior research has shown, we should not be regularly lubricating the eyes of all our patients, because of the adverse effects of the lubricant.

“I also think a lot of it has to do with the nasal cannula and oxygen flow rates,” she said. “We should consider

avoiding supplemental oxygen in the PACU if the oxygen saturation is above 94% or 95%, because it may dry the eye and perhaps increase the patient’s urge to rub their eyes.”

Karl Zheng, MD, clinical instructor in anesthesia at Stanford School of Medicine in Stanford, Calif., called the study a good reminder that corneal see corneal page 33

28 I AnesthesiologyNews.com

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CL IN I CAL ANESTHESIOLOGY

Ocular Pressures Spike During Robotic Prostate Surgery, Raising Risk for Eye Damage San Diego—Patients who undergo robot-assisted laparoscopy in the steep Trendelenburg position for radical prostatectomy experience significant increases in intraocular pressures throughout the majority of operative time, placing them at greater risk for visual disturbances and even visual loss,

researchers have found.

As a result, patients with pre-existing eye disease should be counseled about the potential risks of such procedures and ophthalmic consultation should be considered, according to the investigators.

“Our initial concern was there wasn’t

Closed.

much research into robot-assisted laparoscopic procedures, even though the urology community has found a couple of patients who had visual disturbances after being in the steep Trendelenburg position,” said Lt. Cmdr. Eugenio Lujan, MD, assistant professor of anesthesiology and residency director at

Open.

Naval Medical Center San Diego, who led the study. “What’s more, the patient population for this procedure has some definite co-morbidities associated with visual loss to begin with.”

The pilot study included 33 patients, of whom 17 (mean age, 56.7±11.9 years) underwent surgery in the steep Trendelenburg position on a da Vinci robot (Intuitive Surgical). The remaining patients underwent open and laparoscopic procedures and served as controls (mean age, 54.4±15.5 years).

Each patient had an ophthalmologic examination before surgery and one month after the procedure. Anesthetic technique was controlled for all patients, as was intra-abdominal pressure during surgery.

‘The big thing we should consider is screening.

If you have patients with glaucoma or other significant risk factors, they should be referred to ophthalmology prior to surgery.’

—Eugenio Lujan, MD

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As Dr. Lujan reported at the 2010 annual meeting of the American Society of Anesthesiologists (abstract A195), baseline intraocular pressures were similar in patients undergoing robotic or conventional surgery (14.6±3.4 vs. 15.2±5.3 mm Hg, respectively). After one hour, however, patients in the steep Trendelenburg position experienced a doubling of their mean intraocular pressure, which remained at or above that level for the rest of the case. This increase corresponded to a significant rise in intraocular pressure compared with controls at all time points from the 60-minute mark through the end of the case (P<0.017).

The investigators also found significant increases in intraocular pressures during the steep Trendelenburg position compared with either the open or the laparoscopic surgery controls

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AnesthesiologyNews.com I 29

CLIN ICAL ANESTHES IOLOGY considered separately. An hour after the conclusion of the procedure, pressures remained slightly elevated but not significantly different between the two groups of patients (19.9±6.3 mm Hg in the robot-assisted group vs. 18.6±4.2 mm Hg in controls; P=0.320), the researchers said.

“As you might expect, these results were concerning,” Dr. Lujan said.

“These are patients at high risk for visual disturbances; now their intraoperative intraocular pressures are increasing to the point where we run the risk of injuring the optic nerve or even the retina.”

Six patients in the group undergoing robot-assisted laparoscopy experienced an increase in intraocular pressure of more than 45 mm Hg ; one patient had an optic hemorrhage with significant visual loss.

Two questions remaining to be answered, Dr. Lujan said, are which groups of patients are at greater risk for developing increased intraocular pressure during these procedures, and what—if anything—can be done to prevent its occurrence.

“I think it’s too soon to tell if people should change their practice at this point,” he said. “I think the big thing we should consider is screening. If you have patients with glaucoma or other significant risk factors, they should be referred to ophthalmology prior to surgery.”

The results are similar to those reported in a 2009 study published in Anesthesia & Analgesia, by Ohio researchers who looked at intraocular pressure in 33 patients undergoing robot-assisted prostatectomy (2009;109:473-478). According to the authors, the length of surgery and endtidal carbon dioxide “were the only significant variables predicting changes in [intraocular pressure] during stable and prolonged Trendelenburg positioning.”

After adjusting for end-tidal carbon

dioxide, the researchers observed an increase in intraocular pressure of 0.05 mm Hg for every minute of surgery.

Charles Watson, MD, chairman of anesthesia at Bridgeport Hospital in Bridgeport, Conn., said the new findings contradict the long-held belief that ophthalmic circulation autoregulates perfusion in the Trendelenburg position. But they fit with data from his own institution, dating from 2004, showing that intraocular

pressures in patients who spend one to two hours in the steep Trendelenburg position during laparoscopic surgery may increase more than fourfold, with subsequent, potentially dangerous decreases of ophthalmic perfusion pressure and a potential risk for ischemic optic neuropathy, unless pharmacologic and other interventions are performed.

“It is my impression that awareness of this risk in the United States has increased to the extent that

several groups are measuring intraocular pressure during these procedures,” added Dr. Watson, a member of the editorial board of Anesthesiology News. “The specific risk of eye injury during such procedures is discussed preoperatively with all patients scheduled for robot-assisted laparoscopic prostatectomy and other lengthy laparoscopic procedures performed in steep Trendelenburg position.”

—Michael Vlessides

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PAI N MED I CI NE

Morphine/Oxycodone Combination Superior To Separate Components Montreal—MoxDuo, a fixed-dose The study, presented in two poster combination of morphine sulfate and sessions, compared the analgesic effects oxycodone hydrochloride, helped relieve and side effects of MoxDuo with patients’ acute moderate to severe pain its individual components adminisfollowing bunionectomy surgery and tered at equianalgesic doses to patients led to fewer side effects compared with who experienced moderate to severe equivalent analgesic doses of morphine pain following a unilateral bunionecand oxycodone alone, according to a tomy. Patients were included if they Phase II clinical trial presented at the had baseline pain intensity of at least 2 International Association for the Study on a Likert scale and at least 4 on the of Pain meeting in Montreal (posters 10-point Numerical Pain Rating Scale PH326 and PH328).

(NPRS) within six hours after the surgery. Patients were excluded if they were receiving nonopioid analgesics at doses ‘This two-part study shows high enough to interfere with the study medications. that treatment with the Dr. Stern and his colleagues randomized 196 patients, from six sites across combination regimen the United States, to receive oral treatis more effective than ments of MoxDuo morphine 12 mg/ oxycodone 8 mg (12/8 mg), morphine with its components.’

12 mg, oxycodone 8 mg, MoxDuo 6/4 mg, morphine 6 mg or oxycodone 4 mg —Warren Stern, PhD every six hours over a 48-hour period (PH326). Of the patients in the study, “To obtain market approval for com- 83.8% were women. Study participants bination analgesics, the FDA requires had a mean age of 46 years and a mean the combination be better than its indi- baseline PI score of 6.6 on the NPRS. vidual components,” explained lead The primary measure was time-weighted author Warren Stern, PhD, executive sum of pain intensity differences zero to vice president of drug development at 24 hours postsurgery (SPID24).

The investigators found that, comQRxPharma, the study’s sponsor. “This two-part study shows that treatment pared with its individual milligram with the combination regimen is more components, the dual-opioid MoxDuo produced better pain relief with the effective than with its components.”

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AnesthesiologyNews.com I 31

PA IN MED IC INE ago that it was easier to control pain said that QRxPharma, which has locaintraoperatively and postoperatively by tions in Bedminster, N.J., and Sydney, using a combination of analgesics,” said Australia, will seek approval for four how it pans out when the drug is approved.’

Lynn Webster, MD, medical director fixed-dose combinations of MoxDuo: of Lifetree Clinical Research and Pain 12/8, 9/6, 6/4 and 3/2 mg.

—Lynn Webster, MD Clinic in Salt Lake City.

“The concept is sound, but we will Dr. Webster added that this con- have to see how it pans out when the 12/8-mg and 6/4-mg doses. The tolerability and low rate of discontin- cept is now used to combine opioids drug is approved,” said Dr. Webster. “I higher-dose combination regimen uation of patients in the dose-combi- because each opioid has a different believe it will be more effective at lower (MoxDuo 12/8 mg) was significantly nation regimens might lead to greater chemical and unique effect and some opioid doses than using one opioid at more effective than either component acceptance for using combination doses patients have more relief with one type higher doses.” administered separately (P<0.05). The of opioids. of opioid than another.

—Alice Goodman 12/8-mg combination also had the “Anesthesiologists discovered years Based on the study results, Dr. Stern highest number of responders at 24 (76.5%) and 48 hours (94.1%), and was superior at reducing pain compared with the morphine 12-mg and oxycodone 8-mg groups. Results were comparable for the MoxDuo 6/4-mg group compared with its components.

Despite having twice the analgesic power, the higher-dose combination showed similar treatment-emergent adverse events compared with the other doses. The number of patients who had at least one adverse event was similar in the 12/8-mg group (91.2%) compared with the morphine 12-mg group (96.6%) and the oxycodone 8-mg group (70.6%). The incidence of Since 1987, Preferred Physicians Medical (PPM) has opioid-related events in the MoxDuo exclusively insured anesthesiologists and their practices.

FREE, No-Obligation Evaluation of 6/4-mg group also was lower than that Our policyholders also own PPM, so it’s no surprise that Your Informed Consent Process in the morphine- or oxycodone-alone protecting our physician owners’ professional reputation is group. at the core of everything we do.

Our experience has shown plaintiff The most common moderate to attorneys often focus on a practice’s There is no substitute for experience. With over 23 years of severe adverse events in the 12/8-mg informed consent process to underexperience exclusively defending anesthesiologists, PPM mine a jury’s confidence in the quality group compared with the morphine draws upon that extensive knowledge to arm our physician of anesthesia care delivered. and oxycodone groups, respectively, owners with practical, anesthesia-specific strategies to were nausea, 35% vs. 28% and 26%; Every new PPM policyholder receives effectively identify and manage risk, including: vomiting, 35% vs. 21% and 21%; and this evaluation as part of our extensive dizziness, 12% vs. 7% and 12%. Overall, audit of current practice protocols. Call On-site, anesthesia-specific risk management seminars both dose levels provided substantial us today at 800.562.5589 to arrange Exclusive online access to timely and useful risk your free, no-obligation evaluation. pain control and were well tolerated by management resources patients.

Take ownership of your own reputation In the second part of the study A subscription to Anesthesia & the Law, our industryand advantage of this free review. Call respected risk management newsletter (PH328), the investigators found that PPM today. three morphine-equivalent dose treatIn-house Claims Attorneys and Claims Specialists ments (MoxDuo 6/4 mg, morphine 12 skilled in developing defense strategies to effectively mg and oxycodone 8 mg) had comparesolve claims rable analgesic effects as measured by SPID24 (least squares mean, 30, 28.5 and 35.7, respectively).

The percentage of patients reporting common opioid adverse events, however, was markedly reduced in the 6/4 mg group compared with the morphine 12-mg or oxycodone 8-mg groups. The patients indicated lower rates of moderate to severe nausea (9.4% vs. 27.6% and 26.4%, respectively), emesis (6.3% vs. 20.7% and 20.5%), dizziness (3.1% vs. 6.9% and 11.7%) and treatmentemergent constipation (3.1% vs. 10.3% and 5.9%). The percentage of dropouts also was lowest in the 6/4-mg group Add your good name to our growing list of ASA “standard of care” clinicians. Call us toll free today at 800.562.5589 (3.1% vs. 6.9% and 11.8%). and join other select anesthesiologists who have already secured ownership in their professional reputations.

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32 I AnesthesiologyNews.com

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P A IN M ED I C I NE

Unexpected Bupivacaine Finding May Lead to Novel Analgesics

Better understanding from animal data of multiple mechanisms of action

T

he painkilling action of bupivacaine appears to work through more than just voltage-dependent sodium channels, thus opening up possibilities for the development of new analgesic compounds, according to Swiss researchers. The bupivacaine molecule also binds and inhibits neuronal nicotinic acetylcholine channels with an even higher affinity. The investigators presented this unexpected finding at the 2010 annual meeting of the American Society of Anesthesiologists (abstract A1501).

“Bupivacaine has been around for quite some time,” said Daniel Bertrand, PhD, professor of neuroscience at the University of Geneva, and co-author of the study. “But, we’re just now getting a better understanding of the mechanisms of action for the local anesthetic.”

The molecule has long been known to bind to the intracellular portion of

sodium channels, blocking sodium influx and therefore the generation and conduction of nerve impulses. More recently, researchers identified other potent analgesics—epibatidine, for example—that act at nicotinic acetylcholine receptors.

However, concerns about toxicity halted progress with those investigations.

Another concern is the possibility of addiction to some agonists. “Nicotine is one of the molecules in cigarettes that gives pleasure to smoking,” said Patrick Mantyh, PhD, professor of pharmacology at the University of Arizona, in Tucson. “So, there’s been a concern that if you give agonists to a patient, [over] time nicotine-like properties will push the patient to seek it out.”

Researchers now believe that bupivicaine, by targeting nicotinic channels as an antagonist rather than an agonist, can skirt that issue, while still inhibiting the associated

ICIC mcM 50 26 50 26 µM

Bupivacaine

IC 1 mcM IC50 50 1 µM nAChR

NaV Outside

Outside Inside

Dorsal Root Ganglion

Inside

Figure. Bupivacaine inhibits nicotinic receptors at low micromole doses.

Spinal Cord

IC50, inhibitory concentration of 50%; mcM, micromole; nAChR, nicotinic acetylcholine receptor; NaV, voltage-dependent sodium channel

Managing CSF Leaks During Spinal Cord Stimulation Trial

A

cerebrospinal fluid leak can be a headache for anesthesiologists performing a spinal cord stimulator trial, not to mention a trigger for an excruciating post-meningeal puncture headache for the patient.

Securing the leads and completing the programming a couple of days later might be a reasonable management option, according to a team of Washington anesthesiologists who shared an

experience with the challenging complication at the 2010 annual fall meeting of the American Society of Regional Anesthesia and Pain Medicine, in Phoenix (abstract 117).

“We were able to get stimulation without having to redo the entire procedure,” said Russell Kinder, MD, of Virginia Mason Medical Center, in Seattle, and lead author of the case report.

Spinal cord stimulation is often considered for patients who have refractory pain after less invasive treatments, such as injection therapy and medication management, have failed.

Leaks of cerebrospinal fluid (CSF) during spinal cord stimulation trials—the test run before permanent implantation of the stimulator to drown out the pain—are relatively rare. Dr. Kinder estimated an incidence of approximately one per 100 procedures.

Lead migration is a much more common complication, occurring in up to one in

five trials.

The patient was a 60-year-old woman with pain in her right leg. After ruling out other sources, Dr. Kinder and his colleagues decided that an old fusion in the woman’s cervical spine was causing the discomfort. After exhausting other treatment options, they turned to spinal cord stimulation.

“We decided to apply it just as if the lower extremity pain was caused by some form of lumbar pathology,” said Dr. Kinder, noting that his team successfully used electrical stimulation to confirm the proper location.

They uneventfully set the first lead.

But on accessing the epidural space to place the second lead, the 14-gauge epidural needle punctured the meninges.

The team then successfully placed the needle up a level, but with decreased impedances that likely were resulting from the leaked fluid. They secured the leads and postponed the procedure until the CSF drained from the epidural space.

On completion of the trial run, the stimulation failed to adequately control the patient’s pain and no permanent device was placed.

John Dombrowski, MD, director of the Washington Pain Center, in Washington, D.C., and clinical associate professor at Georgetown University,

expressed concern that the patient still had a mild post-meningeal puncture headache at the return visit, which may have led to difficulty in judging the potential benefit of the stimulator.

“If a complication occurs, you really might want to consider just starting over another day after the headache has gone away,” Dr. Dombrowski said.

“Since resources are so expensive and you’ll likely only do one trial, you want to make sure that a patient has the best chance possible to respond to the therapy and know for certain if it works.”

But because of the separation between the two areas of the body, Dr. Kinder noted that his team was not concerned that the headache had obscured the leg pain. “We were, however, concerned that the patient would have a pretty severe headache that would need to be treated,” he said. Fortunately, the resulting headache was not severe enough to require placement of an epidural blood patch.

“Our treatment is a good management option if you run into this complication,” Dr. Kinder told Anesthesiology News. “If you do have an inadvertent leak and have leads in place, then even though you can’t program at the time, you can secure the leads and tell the patient to come back in about 48 hours.”

—Lynne Peeples

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AnesthesiologyNews.com I 33

PA IN MED IC INE transmission of noxious stimuli and central sensitization.

Dr. Bertrand and his colleagues Horace F. Massa, MD, and Francois Clergue, MD, tested bupivacaine in an animal model (Xenopus) on the main nicotinic acetylcholine receptors (nAChRs) implicated in noxious stimuli in humans. They were surprised to find that the receptors were inhibited by much lower concentrations of bupivacaine than are needed for voltage-dependent sodium channels. The concentrations that inhibited half of the nAChR function ranged from 0.85 to 2.33 mcM. In contrast, 26 mcM of bupivacaine is needed to inhibit half of the sodium-channel receptors (Figure).

Furthermore, the blockade could not be removed by increasing concentrations of acetylcholine, suggesting that bupivacaine acts as a noncompetitive inhibitor.

“This finding indicates that new nonmorphinic compounds can be developed to relieve pain,” Dr. Bertrand said.

“Alternatively, it suggests that the addition of another molecule to bupivacaine might help in reducing the active dose.

“This is extremely important for clinicians,” he said. “Now, they can adjust the dose while knowing how it works.”

Dr. Mantyh was impressed with the findings. “It’s a very interesting, unexpected result,” he said. “And it probably does explain in part how bupivacaine

‘This finding indicates that new non-morphinic compounds can be developed to relieve pain. Alternatively, it suggests that the addition of another molecule to bupivacaine might help in reducing the active dose.’

—Daniel Bertrand, PhD Dr. Mantyh said that whereas he works. It clearly binds to both receptors, which may serve as a lead to pur- does not think the discovery of the new sue this nicotinic antagonist idea as a mode of action will change the way clinicians use bupivacaine, he believes that pain reliever.”

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Corneal continued from page 27 abrasions still occur, even though taping the eyes shut is regarded as standard practice. “The identification of large blood loss and Trendelenburg position as risk factors is consistent with the fact that the majority of corneal abrasions result from exposure and drying out,” Dr. Zheng said. “As far as preventing corneal abrasions is concerned, previous research has shown that proper taping [of ] the eyes shut remains the most protective maneuver, while avoiding the high incidence of blurry vision and irritated eyes associated with lubricants and ointments.”

Dr. Zheng said it would be of interest if the study distinguished between corneal abrasions due to trauma and those due to exposure or drying out, to elucidate the more prevalent etiology. He said that, for example, if traumatic corneal abrasions were found to be more prevalent, “this would allow [the investigators] to definitively advocate increasing PACU vigilance.”

—Michael Vlessides

over time, this finding may translate into novel clinical applications. “We will need to go through various compounds and really see what the benefits and side effects are,” he said.

Research and clinical trials on nAChRs are currently under way at many pharmaceutical companies, Dr. Bertrand noted. He suggested that anesthesiologists might expect a new product within five years.

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CAREER O P P ORTU NITIES

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AnesthesiologyNews.com I 35

CAREER O PPORT U N IT IES

NAPA is seeking a Pediatric Anesthesiologist at Cohen Children’s Medical Center, part of the NSLIJ Health System.

North American Partners in Anesthesia not only offers great benefits, but also a rewarding career path. Some advantages of a position with NAPA are: • Physician-owned and led • Advancement opportunities • Innovative and highly competitive compensation package

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Benefits of the NSLIJ Health System:

• Integral Faculty of the new NSLIJ Hofstra University School of Medicine • Cohen Children’s Medical Center provides a full range of pediatric services including a pediatric Level I Trauma Center program, and busy, high risk OB and neonatal services.

• Flexibility to participate in adult anesthesia services Please submit your CV to: Jeanne Wagner, Director of Clinical Recruitment jwagner@NAPAanesthesia.com Ph: 516-945-3096 • Fax: 516-626-6446

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36 I AnesthesiologyNews.com

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CAREER O P P ORTU NITIES

Position Available:

Director of Pediatric Anesthesia The North Shore-LIJ Health System is currently seeking a Director of Pediatric Anesthesiology for The Cohen Children’s Medical Center. The Medical Center is undergoing significant expansion with 50 new patient care beds and eight new pediatric ORs. The Director of Pediatric Anesthesiology will lead a division responsible for a busy clinical service, research, resident education and medical student education as part of the new NSLIJ-Hofstra University School of Medicine. The candidate should be fellowship trained or equivalent, BC in Anesthesia with a minimum of 5-10 years experience in clinical research, education or pediatric anesthesia.

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Biomarkers Predict Response to Steroid Injections in Radiculopathy Patients

Orlando, Fla.—The presence of a novel complex of fibronectin and aggrecan predicted whether patients with lumbar radiculopathy responded to an epidural steroid injection (ESI), according to a prospective study presented at the 25th annual meeting of the North American Spine Society.

The investigators found that assaying the epidural space lavage for the biomarkers prior to receiving an ESI lowered patients’ risks for infection, postprocedure dural puncture headache and epidural hematoma.

According to Sukdeb Datta, MD, this test may become useful in optimizing ESI therapy. “With the widespread availability of ELISA [enzyme-linked immunosorbent assay] techniques, such a test may become routine and help in ‘staging’ patients in terms of different mediators present in the epidural fluid,” said Dr. Datta, chief of the Pain Medicine Division and associate professor in the Department of Anesthesiology at Vanderbilt University Medical Center in Nashville, Tenn., who was

not involved in the research. “Perhaps this test may also allow physicians to quantify the natural milieu of the intervertebral disc in a patient undergoing ESI. This is important because we know very well that if such a milieu is not addressed or optimized, interventions such as ESIs will be suboptimal.”

This study follows on the heels of previous research conducted by Gaetano Scuderi, MD, clinical assistant professor of Spine Service in the Department of Orthopaedics at Stanford University in Palo Alto, Calif., who examined the diagnostic value of immunoreactive epidural interferon-γ in patients with radiculopathy (Spine 2009;34:2311-2317).

In the current investigation, Dr. Scuderi’s team prospectively examined epidural lavage samples from 26 patients with radiculopathic pain and herniated nucleus pulposus. Patients were a mean age of 46 years and 19 were male. The subjects had symptoms consistent with dermatomal radiculopathy in one or more lumbar

nerves. Twenty-four patients had one vertebral level affected, whereas two patients had two symptomatic levels.

Herniation was present in the L3-L4 disc in four patients, the L4-L5 disc in 15 patients and the L5-S1 disc in seven patients. In most cases, pain was unilateral. Seventeen of the 26 patients had private insurance and nine were receiving workers compensation.

Using an ELISA, Dr. Scuderi and his colleagues assayed the lavage fluid for the fibronectin–aggrecan complexes. They then administered an ESI and measured symptoms both prior to and following the procedure using the short-form 36 (SF-36), specifically comparing the 35-item physical component summary (PCS) of the SF-36.

The researchers found that the two biomarkers were present in 14 patients.

Twelve of those 14 responded to ESI treatment, reporting statistically significant improvements in the PCS component of the SF-36. Specifically, the mean improvement from baseline PCS in patients with the fibronectin– aggrecan complex was 22.9 compared

with 0.64 for those without the complex (P<0.001). Among the 12 patients who did not have the fibronectin–aggrecan complex, one responded to the ESI. An area under the curve (AUC) analysis revealed that biomarker complex predicted whether patients would respond to an ESI (AUC=0.97; P=0.001). There was no significant difference in age (P=0.25), gender (P=0.84), laterality (P=0.06), lumbar spinal level (P=0.75) or payer type (workers compensation vs. private insurance, P=0.90) between groups with and without the biomarker.

“Our results show the subset of patients with this biomarker complex are more likely to respond vigorously and have improved functional outcome after ESI,” Dr. Scuderi told meeting attendees. “Our investigation is one step toward establishing a set of tools that can be used to predict and potentially improve response to ESI for patients with radiculopathy.”

—David Wild

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Learn the fundamentals of anesthesiology in the context of real patients.

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Current Topics in Anesthesia for Head and Neck Surgery, An Issue of Anesthesiology Clinics

Joshua H. Atkins; Jeff E. Mandel This issue brings the anesthesiologist up to date on current essential topics in anesthesia for otolaryngologic surgery, covering the newest cutting-edge procedures. Topics covered include functional vocal cord surgery; functional endoscopic sinus surgery and skull base surgery; pediatric and adult laryngeal/tracheal surgery; jet ventilation; middle ear; neuromonitoring; transoral robotic surgery; and more.

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The Tension Myoneural Syndrome Hypothesis Explained: Q&A With John Sarno, MD Musculoskeletal pain syndromes are commonplace, from bad backs to carpal tunnel. These syndromes often are intractable, leaving patients in pain for years. John Sarno, MD, professor of rehabilitation medicine at New York University School of Medicine, in New York City, believes these ailments are psychogenic and can be grouped into one syndrome, which he calls tension myoneural syndrome (TMS). If patients understand this, he believes, their symptoms will simply dissipate.

Dr. Sarno has seen more than 10,000 such patients over 30 years, and says roughly three-quarters of them have gotten better. Anesthesiology News recently interviewed Dr. Sarno to discuss his theory.

educated them about TMS, 96 (88%) sized portion of your arm of oxygen.

I developed this TMS hypothesis either became completely pain free or very close, reporting being free of phys- because conventional physical therapy for musculoskeletal manifestations— ical restrictions and fear of pain. which gives most patients at least AN: Why do people develop this psy- temporary relief—consisted of deep heat in the form of high-frequency chogenic pain in the first place?

Dr. Sarno: The physical pain serves sound waves, deep massage and active to distract the patient’s attention from exercise of the muscles involved. All emotional pain or rage, which often of these treatments boost circuladerives from the pressure people put tion. It seemed logical that the brain on themselves to be good or perfect. was causing all this through the autoIt’s amazing how often this is a prime nomic nervous system, which confactor driving a person’s psychologi- trols blood flow.

Migraines provide an excellent cal state. What happens is this: In an attempt to live up to these high stan- example of this process. The migraine dards, something in the unconscious— is a condition of spasmodic narrowan inner child—is made very, very ing of the blood vessels. The narrowangry. I think that’s probably the major ing usually takes place in one large blood vessel, such as the carotid. First dynamic I deal with.

AN: How did you come up with this Patients often ask me, “Do you want you experience pain, and if it persists diagnosis and treatment? me to start being nasty?” and I say, long enough, you may have a stroke.

Dr. Sarno: I have always been aware “No.” I simply want them to understand Several studies support this oxygenof the importance of emotional phe- that the drive to be perfect angers the deprivation hypothesis. nomena. Years ago, before I established unconscious. Once the person recogI believe that unconscious rage my practice, I developed symptoms of nizes that this is what is happening, is extremely common and leads the hay fever at the appropriate time dur- they no longer automatically react to brain to produce distracting symping the spring. Yet, I remember asking pressure with anger and rage. They no toms. It’s a scary thing that your myself, “Wait: what’s going on with longer need the distraction of physical unconscious rage can lead to serious you psychologically?” physical symptoms. I honestly believe pain.

For a number of years, in my work I that people can die of anger without was preoccupied with the problems of AN: What illnesses are caused by their doctors ever knowing the true rehabilitating people with stroke, spinal TMS? cause. cord injuries and other ailments. Little Dr. Sarno: Besides musculoskeletal by little, I began seeing patients with maladies, the most common illnesses AN: To paraphrase a quote about cigars intractable pain, which I had always are gastrointestinal. Migraines and attributed to Sigmund Freud, is a bad attributed to some structural abnor- other headaches are classic problems back sometimes just a bad back? mality. I discovered, however, that in as well. Other ailments include recur- Dr. Sarno: That’s very rare. In other the case of back pain, and in other pain rent sinus infections and “globus hys- words, you could have bone dissyndromes as well, structural abnor- tericus,” the feeling you have a lump in ease, which would produce pain, but malities often do not correspond to your throat despite having no pathol- that’s easily recognized with approprithe pain. For example, a study by Mau- ogy. People also report a broad range ate imaging. The vast majority of bad reen Jensen et al. published in The New of allergic reactions as well as genito- backs involve minor abnormalities, England Journal of Medicine concluded urinary problems, particularly involv- which I find are completely benign, but are often blamed for the pain. That that “The discovery by MRI [magnetic ing frequent urination. diagnosis immediately gets the docresonance imaging] of bulges or protrusions [in discs] in people with low AN: How does the brain produce all of tor off the hook. He can prescribe conservative measures or surgery. I would back pain frequently may be coinci- these symptoms? dental.” [Editor’s note: N Engl J Med Dr. Sarno: The brain probably pro- judge that 90% of back, neck and duces these symptoms by slightly shoulder surgery is unnecessary.

1994;331:69-73].

When this is the case, patients who reducing the amount of oxygen availlearn about TMS usually can get bet- able to circulate in the body. Your AN: Do other bodily systems cause ter. In 1987, I surveyed 109 patients brain has exquisite control of your similar syndromes? who complained of back pain that they entire circulatory system. If it wants, Dr. Sarno: Some mind–body attributed to a herniated disc. After I your brain can deprive a pinhead- disorders appear to be mediated by the neuroendocrine-peptide system. These include bulimia, anorexia nervosa ‘I discovered, however, that in the case of back and chronic fatigue, which in Freud’s time was known as neurasthenia. In pain, and in other pain syndromes as well, structural the case of chronic fatigue, physicians abnormalities often do not correspond to the pain.’ from three of the United Kingdom’s

‘The physical pain serves to distract the patient’s attention from emotional pain or rage, which often derives from the pressure people put on themselves to be good or perfect.’ royal colleges issued a report in 1996, which suggested that psychological factors were primary causes of pain syndromes, and that therapy consisting of psychotherapy and physical activity was most effective (Chronic Fatigue Syndrome, Council Report CR54.

London: Royal Colleges of Physicians, General Practitioners & Psychiatrists).

A 1993 paper on neuroendocrineimmune interactions in The New England Journal of Medicine (N Engl J Med 1993; 329:1246-1253) concluded that “central nervous system influences on the immune system are well-documented and provide a mechanism by which emotional states could influence the course of diseases involving immune function.”

AN: What are the most compelling criticisms of your theory?

Dr. Sarno: I’ve never seen any compelling criticisms. If my ideas represented a threat to the usual practice of medicine you can be sure many people would be criticizing them. But I don’t think most doctors take it seriously enough to feel they have to do something. Most doctors are like automobile mechanics. Very few are willing to say that the symptoms are the results of a psychosomatic process.

AN: Is it possible that some alleged “treatments” for some of these diseases are actually distractions in the same manner as the illness? I’m thinking of colonic irrigation, for example.

Dr. Sarno: Colonic irrigation is a placebo. If the person continues to use it, in two, three or four months it won’t work anymore and he [or she] will have to find another placebo. The placebo phenomenon is enormous in medicine.

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Echocardiography for the Anesthesiologist SCOTT R. STEWART, MD Fellow in cardiothoracic anesthesiology Medical University of South Carolina Charleston, South Carolina CAROLINE C. MCKILLOP, MD Fellow in cardiothoracic anesthesiology Medical University of South Carolina Charleston, South Carolina JAMES H. ABERNATHY III, MD, MPH Associate Professor of Anesthesiology and Perioperative Medicine Medical University of South Carolina Charleston, South Carolina

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