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 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.
Part I. Cancer Drugs: The Outcomes They Improve and at What PriceChapter 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 MedicineChapter 5. Hype, Spin, and the Unbridled Enthusiasm That Distorts Cancer MedicineChapter 6. Financial Conflict of InterestChapter 7. The Harms of Financial Conflicts and How to Rehabilitate MedicineChapter 8. Will Precision Oncology Save Us?
Part III. How to Interpret Cancer Evidence and TrialsChapter 9. Study Design 201Chapter 10. Principles of Oncology PracticeChapter 11. Important Trials in OncologyChapter 12. Global Oncology
Part IV. SolutionsChapter 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 PolicyGlossary ReferencesIndex