A review of the federal guidelines that inform and influence relationships between physicians and industry.

The effective delivery and continued advancement of health care is critically dependent on the relationship between physicians and industry. The private sector accounts for 60% of the funding for clinical research and more than 50% of the funding sources for physician education. The nature of the physician-industry relationship and the role of the physician as a gatekeeper for health care make this association vulnerable to abuse if certain safeguards are not observed. This article will review the current federal guidelines that affect the physician-industry relationship and highlight several illustrative cases to show how the potential for abuse can subvert this relationship. The recommendations and "safe harbors" that have been designed to guide business relationships in health care are discussed.

One-year medical outcomes and emergency department recidivism after emergency department observation for cocaine-associated chest pain.

STUDY OBJECTIVE: Chest pain is the most common complaint among cocaine users who present to the emergency department (ED) seeking care, and many hospital resources are applied to stratify cocaine users in regard to future cardiac morbidity and mortality. Little is known about the longitudinal cardiac and noncardiac medical outcomes of cocaine users who have been stratified to an ED observation period after their ED visit. We examine 1-year cardiac outcomes in a low- to intermediate-risk sample of patients with cocaine-associated chest pain in an urban ED, as well as examine ED recidivism at 1 year for cardiac and noncardiac complaints. METHODS: Prospective consecutive cohort study of patients (18 to 60 years) who presented to an urban Level I ED with cocaine-associated chest pain and were risk stratified to low to intermediate cardiac risk. Exclusion criteria were ECG suggestive of acute myocardial infarction, increased serum cardiac markers, history of acute myocardial infarction or coronary artery bypass graft, hemodynamic instability, or unstable angina. Baseline interviews using validated measures of health functioning and substance use were conducted during chest pain observation unit stay and at 3, 6, and 12 months. ED utilization during the study year was abstracted from the medical chart. Zero-inflated Poisson regression analyses were conducted to predict recurrent ED visits. RESULTS: Two hundred nineteen participants (73%) were enrolled, 65% returned to the ED post-index visit, and 23% returned for chest pain; of these, 66% had a positive cocaine urine screening result. No patient had an acute myocardial infarction within the 1-year follow-up period. Patients with continued cocaine use were more likely to have a recurrent ED visit (P<.001), but these repeated visits were most often related to musculoskeletal pain (21%) and injury (30%), rather than potential cardiac complaints. CONCLUSION: Patients with cocaine-associated chest pain who have low to intermediate cardiac risk and complete a chest pain observation unit protocol have a less than 1% rate of myocardial infarction in the subsequent 12 months.

Illicit stimulant use in a United States heart failure population presenting to the emergency department (from the Acute Decompensated Heart Failure National Registry Emergency Module).

Illicit stimulant drug use may have a profound clinical impact in acute decompensated heart failure (ADHF). The chronic use of cocaine and methamphetamine may lead to overt cardiomyopathy and ADHF. The Acute Decompensated Heart Failure National Registry Emergency Module (ADHERE-EM) collected data on patients presenting to emergency departments with ADHF at 83 geographically dispersed hospitals in the United States. This registry was queried to determine the rate of self-reported illicit drug use in emergency department patients presenting with ADHF and compare these patients with those without illicit drug use. The registry enrolled 11,258 patients with ADHF with drug use data from January 2004 to March 2006. Of these patients, 594 (5.3%) self-reported current or past stimulant drug use. Compared with nonusers, these patients were more likely to be younger (median age 49.7 vs 76.1 years), to be African American (odds ratio 11.9, 95% confidence interval 9.8 to 14.4), and to have left ventricular ejection fractions <40% (odds ratio 3.4, 95% confidence interval 2.8 to 4.2). Admitted users had no difference in mortality (adjusted odds ratio 0.83, 95% confidence interval 0.25 to 2.72) compared with nonusers. In conclusion, data from ADHERE-EM suggest that a clinically important percentage of patients with ADHF report the use of illicit stimulant drugs. Although these patients are younger with a greater degree of LV dysfunction, they did not have greater risk-adjusted mortality.

Risk stratification in women enrolled in the Acute Decompensated Heart Failure National Registry Emergency Module (ADHERE-EM).

OBJECTIVES: It has been reported that the mortality risk for heart failure differs between men and women. It has been postulated that this is due to differences in comorbid features. Variation in risk profiles by gender may limit the performance of stratification algorithms available for heart failure in women. This analysis examined the ability of a published risk stratification model to predict outcomes in women. METHODS: The Acute Decompensated Heart Failure National Registry Emergency Module (ADHERE-EM) database was used. Characteristics, treatments, and outcomes for men and women were compared. The ADHERE registry classification and regression tree (CART) analysis was used for the risk stratification evaluation. RESULTS: Of 10,984 ADHERE-EM patients, 5,736 (52.2%) were women. In-hospital mortality was similar between men and women (p = 0.727). Significant differences (p < 0.0002) were noted by gender in all three variables in the CART model (blood urea nitrogen [BUN] > or = 43 mg/dL, systolic blood pressure < 115 mm Hg, and serum creatinine > or = 2.75 mg/dL). However, the CART model effectively stratified both genders into distinct risk groups with no significant difference in mortality by gender within stratified groups. CONCLUSIONS: The ADHERE Registry CART tool is effective at predicting risk in ED patients, regardless of gender.

Past-year violence typologies among patients with cocaine-related chest pain.

This study examines a consecutive cohort of patients (n = 219) presenting to an urban Emergency Department (ED) for cocaine-related chest pain (June 2002 to February 2005). Patients were interviewed regarding violence, substance use, and psychosocial factors. Significant markers of violence were increases in: past-year medical service use, binge drinking, marijuana use, cocaine diagnosis, but not cocaine use days. Rates and correlates of violence differed by relationship type (intimate partner, nonpartner) and role context (victimization, perpetration). Understanding these correlates has public health implications, both for preventing future violence and its associated ED service utilization, and for future interventions in cocaine users presenting to the ED.

Characteristics of cocaine users presenting to an emergency department chest pain observation unit.

OBJECTIVES: This report examines the sociodemographic and substance use characteristics, co-occurring psychological status, substance abuse consequences, and prior experiences with substance abuse treatment among patients with cocaine-associated chest pain presenting to an emergency department chest pain observation unit. METHODS: This was a consecutive cohort of patients in the emergency department chest pain observation unit aged 18-60 years with low to moderate risk for acute coronary syndrome and recent cocaine use. Responses on standardized and validated instruments were used to examine demographic and clinical characteristics of the sample and to compare patients who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for past three-month substance abuse or substance dependence with patients who did not. RESULTS: Of 145 eligible patients identified between June 1, 2002, and February 29, 2004, 86% met criteria for a lifetime DSM-IV substance use disorder and 50% met past three-month criteria. Approximately one half of the total sample reported substantial symptoms of depression. Substance use frequency and consequences, depression, and psychological distress were significantly more severe among those with past three-month substance use diagnoses; however, most sociodemographic characteristics were not associated with substance use diagnoses. Interest in treatment services and treatment history was also significantly associated with the presence of a substance use disorder diagnosis. CONCLUSIONS: Findings regarding diversity in alcohol and drug involvement, current level of psychological functioning, depressive symptomatology, and interest in treatment services provide useful information for designing emergency department-based interventions for this population.

Effect of cocaine use on bone marrow-mediated erythropoiesis.

OBJECTIVES: Cocaine-mediated erythrocytosis is one of several effects that cocaine may have on hematologic indices; however, the precise mechanism by which cocaine induces peripheral erythrocytosis is not fully understood. The objective of this study was to examine the contribution of the bone marrow to cocaine-mediated erythrocytosis. METHODS: Differences in mean hemoglobin concentration, hematocrit, and reticulocyte counts were measured in consecutive cocaine-exposed and cocaine-unexposed patients who presented to the emergency department (ED) with chest pain. Acute cocaine exposure (<3 hours) was confirmed by history and toxicologic analysis of the urine on all patients. Means were compared using independent-samples t-test and covariates were examined using multiple regression. RESULTS: Seventy-nine patients met enrollment criteria. Hemoglobin and hematocrit levels were significantly elevated in the cocaine-using subjects (13.5/39.8) compared with controls (12.6/37.7; p < 0.02). However, no corresponding elevation in reticulocyte count (p = 0.2) was observed. Multivariate logistic regression revealed that male chest pain patients were significantly more likely to be exposed to cocaine (OR 5.15 [95% CI = 1.77 to 15.3]) than females (p = 0.001), and all relative increases in hemoglobin concentration in the cocaine-exposed group were attributable to gender. Cocaine exposure was not significantly associated with reticulocyte count. Multivariate linear regression revealed that of demographic, medical, and substance use covariates, only a history of diabetes mellitus was significantly associated with an elevated reticulocyte count (p = 0.009). CONCLUSIONS: Acute cocaine exposure is not associated with erythrocytosis in younger ED patients with chest pain. The lack of an elevated reticulocyte count suggests that bone marrow does not contribute to any transient erythrocytosis that may occur.

Validation of a brief observation period for patients with cocaine-associated chest pain.

BACKGROUND: Retrospective studies of patients with cocaine-associated chest pain suggest that a strategy of discharging patients from the emergency department after a 12-hour observation period if they do not have evidence of ischemia should be associated with a very low rate of complications. METHODS: We prospectively evaluated the safety of a 9-to-12-hour observation period in patients with cocaine-associated chest pain who were at low-to-intermediate risk of cardiovascular events. Consecutive patients who reported or tested positive for cocaine use and who received protocol-driven care in a chest-pain observation unit were included. Patients who had normal levels of troponin I, without new ischemic changes on electrocardiography, and who had no cardiovascular complications (dysrhythmias, acute myocardial infarction, or recurrent symptoms) during the 9-to-12-hour observation period were discharged from the unit. The main outcome was death from cardiovascular causes at 30 days. RESULTS: Three hundred forty-four patients with cocaine-associated chest pain were evaluated. Forty-two of these patients (12 percent) were directly admitted to the hospital. The study cohort comprised the remaining 302 patients. During the 30-day follow-up period, none of the patients died of a cardiovascular event (0 percent; 95 percent confidence interval, 0 to 0.99), and only 4 of the 256 patients for whom detailed follow-up data were available had a nonfatal myocardial infarction (1.6 percent; 95 percent confidence interval, 0.1 to 3.1). All four nonfatal myocardial infarctions occurred in patients who continued to use cocaine. CONCLUSIONS: Patients with cocaine-associated chest pain who do not have evidence of ischemia or cardiovascular complications over a 9-to-12-hour period in a chest-pain observation unit have a very low risk of death or myocardial infarction during the 30 days after discharge.

Alcohol and/or other drug use among adult non-occupant motor vehicle crash victims.

AIMS: To identify the frequency of current or lifetime history of alcohol and/or other drug (AOD) use among the full range (admitted and discharged) of injured bicyclists and pedestrians involved in motor vehicle crashes. METHODS: In a prospective study of non-occupant motor vehicle crash (NOMVC) victims >or=18 years over a 29-month period, blood was obtained for alcohol and drug testing. Current alcohol abuse/alcohol dependence (AA/AD) or drug abuse/drug dependence (DA/DD) was based on the Diagnostic Interview Survey. RESULTS: In all, there were 108 NOMVC victims. Eleven per cent were alcohol (+), 7% drug (+), and 3% both. Sixteen per cent were AA/AD (+), 2.7% DA/DD (+), and 1.4% both. CONCLUSIONS: A substantial portion of patients with NOMVC injuries tested AOD (+) and had a current or lifetime substance abuse (AA/AD; DA/DD) diagnosis.

Quantitative comparison of coronary artery flow and myocardial perfusion in patients with acute myocardial infarction in the presence and absence of recent cocaine use.

BACKGROUND: Numerous factors have been implicated in the pathogenesis of cocaine associated myocardial infarction (CAMI). However, the relative contributions each of these mechanisms provide to the pathogenesis of CAMI have not been well defined. We hypothesized that significant angiographic differences exist between CAMI patients vs thrombotic AMI patients (TAMI) and normal controls. METHODS: The TIMI Flow Grade, corrected TIMI Frame Count (CTFC), TIMI Myocardial Perfusion Grade (TMPG), presence of triple-vessel disease, stenosis severity, and presence of angiographically apparent thrombus were compared in patients who sustained CAMI to TAMI patients and normal controls. RESULTS: 2495 angiograms were analyzed (CAMI = 57, TAMI = 2403, Controls = 35). Impairment in both epicardial and microvascular flow in patients with CAMI was intermediate between TAMI and controls. Compared to TAMI patients, CAMI patients were less likely to have 3 vessel disease (8.9% vs. 19.1%; p < 0.05), epicardial stenosis was less severe (14.9+/-30.2 vs. 72.6+/-18.6; p < 0.0001), less thrombus was present (6.5% vs. 33.1%; p < 0.001) and TIMI grade 3 flow was observed more frequently (76% vs. 59%). Normal TMPG 3 perfusion was significantly impaired in both CAMI and TAMI patients when compared to controls without AMI (TMPG 3 was 40% and 26.6% vs. 100% respectively; p < 0.001 for both). The majority of patients in both AMI groups had diminished or absent tissue level perfusion (TMPG 0 flow, CAMI 53.9 vs. TAMI 56.8%). CONCLUSIONS: Both epicardial and microvascular flow is impaired in CAMI. While epicardial flow among CAMI patients is slightly better than TAMI patients, the incidence of little or severely impaired tissue level perfusion is nearly identical.