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Malignant: How Bad Policy and Bad Evidence Harm People with Cancer

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How hype, money, and bias can mislead the public into thinking that many worthless or unproven treatments are effective.

Each week, people read about new and exciting cancer drugs. Some of these drugs are truly transformative, offering major improvements in how long patients live or how they feel—but what is often missing from the popular narrative is that, far too often, these new drugs have marginal or minimal benefits. Some are even harmful. In Malignant, hematologist-oncologist Dr. Vinayak K. Prasad writes about the many sobering examples of how patients are too often failed by cancer policy and by how oncology is practiced. Throughout this work, Prasad illuminates deceptive practices which

• promote novel cancer therapies long before credible data are available to support such treatment; and
• exaggerate the potential benefits of new therapies, many of which cost thousands and in some cases hundreds of thousands of dollars.

Prasad then critiques the financial conflicts of interest that pervade the oncology field, the pharmaceutical industry, and the US Food and Drug administration.

This is a book about how the actions of human beings—our policies, our standards of evidence, and our drug regulation—incentivize the pursuit of marginal or unproven therapies at lofty and unsustainable prices. Prasad takes us through how cancer trials are conducted, how drugs come to market, and how pricing decisions are made, asking how we can ensure that more cancer drugs deliver both greater benefit and a lower price. Ultimately, Prasad says,

• more cancer clinical trials should measure outcomes that actually matter to people with cancer;
• patients on those trials should look more like actual global citizens;
• we need drug regulators to raise, not perpetually lower, the bar for approval; and
• we need unbiased patient advocates and experts.

This well-written, opinionated, and engaging book explains what we can do differently to make serious and sustained progress against cancer—and how we can avoid repeating the policy and practice mistakes of the past.

ISBN-13: 9781421437637

Media Type: Hardcover

Publisher: Johns Hopkins University Press

Publication Date: 04-21-2020

Pages: 304

Product Dimensions: 6.10(w) x 9.10(h) x 1.20(d)

Age Range: 18 Years

Vinayak K. Prasad, MD, MPH is a practicing hematologist-oncologist and internal medicine physician. An associate professor of medicine and public health at Oregon Health & Science University, he is the coauthor of Ending Medical Reversal: Improving Outcomes, Saving Lives.

What People are Saying About This

Kenneth W. Lin

Prasad does a commendable job demonstrating how lax standards of evidence and regulations, coupled with the profit-driven pharmaceutical industry, result in a lot of poorly effective or ineffective (but very expensive) drugs being used on cancer patients in the United States and worldwide. There isn't anything quite like this book out there.

David P. Steensma

Oncology drug development is full of hype and spin, which raises false hopes, confuses patients, and wastes money. Prasad incisively dissects crummy evidence and systematic abuses, including the pernicious effects of financial conflicts and academic self-promotion, and proposes sensible steps to improve development of new therapies for cancer.

Ameet Sarpatwari

Prasad outlines a plan that will educate consumers about how we ended up in our current predicament and explain what we can do to extricate ourselves from it. I highly recommend this book to patients, patient advocates, and all physicians—not just oncologists.

Richard Lehman

Malignant confirms Vinayak Prasad's status as one of the most cogent critical voices in oncology today. This is a book that needs to be read by everyone involved or interested in the care of people with cancer as a comprehensive overview of a dire situation and a call to action.

Christopher Booth

An insightful, well-written, and important book. Prasad has a masterful understanding of the issues he presents, weaving them into a compelling story.

John A. Hickman

This important book tackles a very topical and controversial subject in a scholarly, original, and skeptical (but not too cynical) way. Prasad's iconoclastic position will hopefully contribute to reflections on how to change some paradigms in cancer medicine. An essential read for oncologists in training, people in the drug industry, and health care policymakers.

From the Publisher

Prasad does a commendable job demonstrating how lax standards of evidence and regulations, coupled with the profit-driven pharmaceutical industry, result in a lot of poorly effective or ineffective (but very expensive) drugs being used on cancer patients in the United States and worldwide. There isn't anything quite like this book out there.
—Kenneth W. Lin, MD, MPH, Georgetown University

This important book tackles a very topical and controversial subject in a scholarly, original, and skeptical (but not too cynical) way. Prasad's iconoclastic position will hopefully contribute to reflections on how to change some paradigms in cancer medicine. An essential read for oncologists in training, people in the drug industry, and health care policymakers.
—John A. Hickman, health care consultant

Prasad outlines a plan that will educate consumers about how we ended up in our current predicament and explain what we can do to extricate ourselves from it. I highly recommend this book to patients, patient advocates, and all physicians—not just oncologists.
—Ameet Sarpatwari, Harvard Medical School / Brigham and Women's Hospital

An insightful, well-written, and important book. Prasad has a masterful understanding of the issues he presents, weaving them into a compelling story.
—Christopher Booth, MD, Queen's University at Kingston Cancer Research Institute

Oncology drug development is full of hype and spin, which raises false hopes, confuses patients, and wastes money. Prasad incisively dissects crummy evidence and systematic abuses, including the pernicious effects of financial conflicts and academic self-promotion, and proposes sensible steps to improve development of new therapies for cancer.
—David P. Steensma, MD, Dana-Farber Cancer Institute / Harvard Medical School

Malignant confirms Vinayak Prasad's status as one of the most cogent critical voices in oncology today. This is a book that needs to be read by everyone involved or interested in the care of people with cancer as a comprehensive overview of a dire situation and a call to action.
—Richard Lehman, University of Birmingham

A must-read! Prasad masterfully dissects problems in policy and evidence that have led to a surfeit of high-cost/low-value cancer drugs. With powerful examples he shows why this cannot continue if the best interests of patients are to be served and offers solutions ready for implementation.
—Elizabeth Eisenhauer, OC, MD, FRCPC, Queen's University

Elizabeth Eisenhauer

A must-read! Prasad masterfully dissects problems in policy and evidence that have led to a surfeit of high-cost/low-value cancer drugs. With powerful examples he shows why this cannot continue if the best interests of patients are to be served and offers solutions ready for implementation.

Table of Contents

Acknowledgments
Introduction

Part I. Cancer Drugs: The Outcomes They Improve and at What Price
Chapter 1. The Basics of Cancer Drugs: Cost, Benefit, Value
Chapter 2. Surrogate Endpoints in Cancer: What Are They and Where Are They Used?
Chapter 3. The Use and Misuse of Surrogate Endpoints for Drug Approvals
Chapter 4. How High Prices Harm Patients and Society

Part II. Societal Forces That Distort Cancer Medicine
Chapter 5. Hype, Spin, and the Unbridled Enthusiasm That Distorts Cancer Medicine
Chapter 6. Financial Conflict of Interest
Chapter 7. The Harms of Financial Conflicts and How to Rehabilitate Medicine
Chapter 8. Will Precision Oncology Save Us?

Part III. How to Interpret Cancer Evidence and Trials
Chapter 9. Study Design 201
Chapter 10. Principles of Oncology Practice
Chapter 11. Important Trials in Oncology
Chapter 12. Global Oncology

Part IV. Solutions
Chapter 13. How Should Cancer Drug Development Proceed?
Chapter 14. What Can Three Federal Agencies Do Tomorrow?
Chapter 15. What Can People with Cancer Do?
Chapter 16. What Can Students, Residents, and Fellows Do?

Epilogue: The Hallmarks of Successful Cancer Policy
Glossary
References
Index