Strange bedfellows: The ethics and politics of medical futility in Texas

Background: Futile medical treatments are interventions that are not associated with a benefit to the patient. The definition and concept of medical futility are controversial. The Texas Advance Directives Act (TADA) was passed in 1999 to address medically inappropriate interventions by allowing providers to withdraw inappropriate interventions against a surrogate decision maker's wishes following a review, attempt to transfer the patient, and 10-day waiting period. The original legislation was a negotiated compromise by players across the political spectrum. However, in recent years there has been increasing controversy regarding TADA and attempts to alter its applicability in Texas. ^ Purpose: The purpose of this project was to apply Paul Sabatier's advocacy coalition framework (ACF) to gain understanding into the historical, ethical, and political basis of the initial compromise, and determine the sources of conflict that have led to increased opposition to TADA. ^ Methods: Using the ACF model, key actors within the medical futility policy debate in Texas were aggregated into coalitions based on shared beliefs. A narrative summary based analysis identified the core elements of the policy subsystem, as well as the constraints and resources of the subsystem actors. Externalities that promoted adjustments to coalition beliefs and tactics used by coalition participants were analyzed. Data sources included review of the published literature regarding medical futility, as well as analysis of published newspaper accounts and editorials regarding the medical futility issue in Texas, legislative testimony, and review of weblogs and online commentaries dealing with the issue. ^ Results: Primary coalition participants in developing compromise legislation in 1999 were the Providers and Vitalists, with Autonomists gaining a prominent role starting in 2006. Internal factors associated with the breakdown of consensus included changes to the makeup of the governing coalition and changes in individual case information available to the Vitalist coalition. Externalities related to the intertwining of the Sun Hudson case and the Terri Schiavo case generated negative publicity for the TADA from progressive and conservative viewpoints. Dissemination of information in various venues regarding contentious cases was associated with more polarization of viewpoints, and realignment of coalition alliances. ^ Conclusions: The ACF provided an outline for the initial compromise over the creation of the Texas Advance Directives Act as well as the eventual loss of consensus. The debate between the Provider, Vitalist, and Autonomist coalitions has been affected by internal policy evolution, changes in the governing coalition, and important externalities. The debate over medical futility in Texas has had much broader implications in the dispute over Health Care Reform.^

PANEL DISCUSSION: "Medical Ethics, Eugenics, and the Holocaust"

A panel discussion moderated by Dr. Thomas R. Cole, McGovern Chair in Medical Humanities and Director of the John P. McGovern Center for Humanities and Ethics at the University of Texas Health Science Center in Houston. Panelists include: Rabbi Samuel E. Karff, Rabbi Emeritus of Congregation Beth Israel and Associate Director of the John P. McGovern Center for Humanities and Ethics and Visiting Professor in the Department of Family Medicine at the University of Texas Health Science Center at the Texas Medical Center. Cardinal DiNardo, the second Archbishop of the Archdiocese of Galveston-Houston and the first cardinal archbishop from a diocese in the Southern United States. Dr. Sheldon Rubenfeld, Clinical Professor of Medicine at Baylor College of Medicine. He is Board Certified in Internal Medicine and in Endocrinology, Diabetes, and Metabolism, and is a Fellow in both the American College of Physicians and the American College of Endocrinology. Dr. Rubenfeld has taught "Healing by Killing: Medicine During the Third Reich" for three years and "Jewish Medical Ethics" for seven years at Baylor College of Medicine. He created a six-month program about Medicine and the Holocaust at Holocaust Museum Houston, including an exhibit entitled How Healing Becomes Killing: Eugenics, Euthanasia, Extermination and a series of lectures by distinguished speakers entitled "The Michael E. DeBakey Medical Ethics Lecture Series".

Implications of Health Care Reform (Medical Ethics Series, 2011)

A video of a panel discussion on how Obama's Health Care Reform would affect Texas Medical Center institutions and health care in general.Speakers include Tom Cole (moderator), Roberta Schwartz (Methodist Hospital), Pauline Rosenau (UT-Houston School of Public Health), and Laurence McCullough (Baylor College of Medicine).

A simulation study using the hybrid statistic and the meta-analysis t-test for data with matched and unmatched subjects in the interim analysis of clinical trials

An interim analysis is usually applied in later phase II or phase III trials to find convincing evidence of a significant treatment difference that may lead to trial termination at an earlier point than planned at the beginning. This can result in the saving of patient resources and shortening of drug development and approval time. In addition, ethics and economics are also the reasons to stop a trial earlier. In clinical trials of eyes, ears, knees, arms, kidneys, lungs, and other clustered treatments, data may include distribution-free random variables with matched and unmatched subjects in one study. It is important to properly include both subjects in the interim and the final analyses so that the maximum efficiency of statistical and clinical inferences can be obtained at different stages of the trials. So far, no publication has applied a statistical method for distribution-free data with matched and unmatched subjects in the interim analysis of clinical trials. In this simulation study, the hybrid statistic was used to estimate the empirical powers and the empirical type I errors among the simulated datasets with different sample sizes, different effect sizes, different correlation coefficients for matched pairs, and different data distributions, respectively, in the interim and final analysis with 4 different group sequential methods. Empirical powers and empirical type I errors were also compared to those estimated by using the meta-analysis t-test among the same simulated datasets. Results from this simulation study show that, compared to the meta-analysis t-test commonly used for data with normally distributed observations, the hybrid statistic has a greater power for data observed from normally, log-normally, and multinomially distributed random variables with matched and unmatched subjects and with outliers. Powers rose with the increase in sample size, effect size, and correlation coefficient for the matched pairs. In addition, lower type I errors were observed estimated by using the hybrid statistic, which indicates that this test is also conservative for data with outliers in the interim analysis of clinical trials.^