Harriet A. Washington - Carte Blanche: The Erosion of Medical Consent

Carte Blanche

The Erosion
of Medical Consent

Carte Blanche

The Erosion of
Medical Consent

Harriet A. Washington

COLUMBIA GLOBAL REPORTS
NEW YORK

For Ron DeBose

Support for this book was provided in part by the Robert Wood Johnson Foundation. The views expressed here do not necessarily reflect the views of the Foundation.

Carte Blanche:

The Erosion of Medical Consent

Copyright 2021 by Harriet A. Washington

All rights reserved

Published by Columbia Global Reports

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New York, NY 10027

globalreports.columbia.edu

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@columbiaGR

Library of Congress Cataloging-in-Publication Data

Names: Washington, Harriet A., author.

Title: Carte Blanche: The Erosion of Medical Consent / Harriet A. Washington.

Description: New York, NY : Columbia Global Reports, [2021] | Includes bibliographical references. |

Identifiers: LCCN 2020040295 (print) | LCCN 2020040296 (ebook) | ISBN 9781734420722 (paperback) | ISBN 9781734420739 (ebook)

Subjects: MESH: Informed Consent--ethics | Human Experimentation--ethics | Researcher-Subject Relations--ethics | United States

Classification: LCC R853.H8 (print) | LCC R853.H8 (ebook) | NLM W 20.55.H9 | DDC 174.2/8--dc23

LC record available at https://lccn.loc.gov/2020040295

LC ebook record available at https://lccn.loc.gov/2020040296

Book design by Strick&Williams

Map design by Jeffrey L. Ward

Author photograph by Aaron Mayes, University of Nevada at Las Vegas (UNLV)

Printed in the United States of America

CONTENTS

Preface
Informed Consent in the Time of Infection

Chapter One
Exigencies of War

Chapter Two
The Legacy of Nuremberg

Chapter Three
False Blood

Chapter Four
The Other

Chapter Five
Cold-Blooded Killer

Chapter Six
PushingSpecial K

Chapter Seven
Erasing Consent

Conclusion
Reclaiming Choice

Informed Consent in the Time of Infection

It was mid-May in 2020 when Robin Armstrong declared victory over the coronavirus.

Armstrong, a doctor at a nursing home called The Resort in Texas City, described giving the anti-malarial drug hydroxychloroquine to dozens of nursing home employees and patients in his care who suffered from COVID-19. Armstrong told reporters that hydroxychloroquine demonstrated its safety and effectiveness when thirty-five of his patients recovered and only three died. However, he produced no documentation to support this claim, and the Galveston County Health District has not verified it. In fact, county health officials say retesting of forty infected patients at The Resort found that nineteen still tested positive, and that there were five new cases.

Armstrong admitted having given the drug to scores of elderly patients, some of whom suffered from dementia, making them unable to offer informed consent. Armstrong also failed to elicit consent from the designated family members who could give consent in their stead.

Two months previously, U.S. president Donald Trump had begun touting hydroxychloroquine on Twitter. By April, vice president Mike Pence announced that hydroxychloroquine was to be used in several drug trials covering, for example, three thousand patients at a hospital in Detroit. Pence told a White House briefing that they were more than prepared to make hydroxychloroquine available to doctors offices and pharmacies in the Detroit area.

Without evidence, President Trump insisted that hydroxychloroquine be pressed into service as a treatment for coronavirus. In addition to the paucity of supporting data and Trumps lack of scientific acumen, his championing of the drug was marred by conflicts of interest, including his interest in European stock-market index funds and in French drugmaker Sanofi, which manufactures the medication.

From March 9 to 19, prescriptions for hydroxychloroquine spiked by 367 percent. The medication is approved for use against malaria and it is legal for U.S. physicians to prescribe FDA-approved medications for other, off-label, uses. Moreover, the FDA specifically issued hydroxychloroquine an Emergency Use Authorization against COVID-19 in March. Still, prescribing must adhere to ethical requirements that include informing a patient or the patients representative, in cases where the patient is incapable of giving or withholding consent. But were patients being informed of hydroxychloroquines experimental nature and its risks? Did they have a chance to say yes or no to this experimental medication?

On April 23, Helen Edrozo died at the age of eighty-seven after Armstrong gave her hydroxychloroquine and her condition rapidly worsened. Edrozos dementia precluded informed consent and her son says he was not consulted. Larry Edrozo questions whether the drug might have hastened his mothers decline. Across the nation, nursing homes had barred family members to discourage the spread of infection, and The Resort was no exception, but Armstrong could have explained the medication regimen and arranged to obtain consent by telephone.

Armstrong was unapologetic about not having done so, telling Houston Chronicle reporters Nick Powell and Taylor Goldenstein, If I had to call all the families for every medicine that I started on a patient, I wouldnt be treating any patients at all. I would just be talking to families all the time.

Armstrongs defense evokes the pressures of clinical urgency, a common plea for dispensing with consent that will be revisited often in this book. The staggeringly high rates of coronavirus infection in nursing homes filled with susceptible elderly certainly constitutes an emergency, but it does not present an excuse for abandoning ethical behavior, especially when caring for the powerless who cannot effectively express their own opinions about their medical fate nor advocate for themselves.

Although Trumps fondness for and financial interest in the drug led to its endorsement by many of his political followers, most medical experts soon took a much dimmer view of its appropriateness for coronavirus treatment. By mid-April, an effectiveness study of hydroxychloroquines analogue chlo-roquine in Brazil was cut short when subjects developed irregular heartbeats and eleven people died within six days. The FDA revoked authorization for hydroxychloroquine coronavirus treatment on June 15, noting in part that recent data from a large randomized controlled trial showed no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation of HCQ treatment in hospitalized patients with COVID-19.

Armstrong serves as a Texas Republican national party committee member and even nominated Trump for president at the 2016 Republican National Convention. Conflicts of interest entail social, professional, and political benefits as well as financial ones, and it is reasonable to ask whether Armstrongs political fealty influenced his medical judgment in this case.

Withholding Care

What precisely is informed consent? Most of us have a notion, however vague, that in twenty-first-century America, patients cant be coerced into medical research without their permission, and that this permission must be not only voluntary but also informed by a useful knowledge of what the research entails. Many people, and even some healthcare workers, consider informed consent a piece of paper, a document signed by the subject to indicate her understanding of the studys purpose, requirements, and other pertinent details, including known risks.