Main description:

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.

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