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Malignant: How Bad Policy and Bad Evidence Harm People with Cancer, by Prasad Vinay., Baltimore, Maryland, Johns Hopkins University Press, 2020.
In 2018, my father’s cousin Paul called to tell me that he was diagnosed with a subcutaneous melanoma. Paul was charismatic and smart, he had had an adventurous life, working for the Foreign Service and the United Nations, first in London, and then spending 20 years in Haiti. He was a devout environmentalist, and fought passionately for the creation of a national park in Haiti. What I most cherished in Paul personally, however, was that he always encouraged me to speak out about what mattered to me—even when what I was saying was controversial, or likely to be unpopular. Paul’s cancer was stage IV—this meant that his time was short. What was devastating for me, however, was witnessing his struggle over the next year and a half. Despite the fact that he was not initially identified as a good candidate, he fought to enter into a clinical trial for a new cancer drug after first line therapies failed. He was convinced that this drug would save him. Although the new drug did help him at first, allowing him to return to activities he loved, his last months were especially difficult, and he ultimately died from toxic side effects. He pinned so much hope on this new therapy, but like many new cancer drugs, this drug too did not live up to the hype. Paul’s story is—sadly—not uncommon, and Prasad’s book explains why.
Vinayak Prasad’s new book, Malignant: How Bad Policy and Bad Evidence Harm People with Cancer is courageous and devastating. All future clinical oncologists should read this book, as should everyone involved in testing and regulation of approval of new cancer drugs, and last but not least: cancer patients, and their families, especially those patients considering whether to participate in a clinical trial. Prasad documents why many new cancer treatments are not living up to their often overhyped promise. There are several reasons: surrogate endpoints fail to predict which drugs improve overall survival; accelerated approval is granted for drugs that do not meet the criterion of serving an “unmet” need; United States Food and Drug Administration (FDA) approval is granted for drugs...