Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer’s drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate United States authority on a drug’s safety and efficacy? In Drugs and the FDA, Mikkael Sekeres-a leading oncologist and former chair of the FDA’s cancer drug advisory committee-tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices.

Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member.

When you are told that you have leukemia, your world stops. Your brain can’t function. You are asked to make decisions about treatment almost immediately, when you are not in your right mind. And yet you pull yourself together and start asking questions. Beside you is your doctor, whose job it is to solve the awful puzzle of bone marrow gone wrong. The two of you are in it together. In When Blood Breaks Down, Mikkael Sekeres, a leading cancer specialist, takes listeners on the journey that patient and doctor travel together.
Sekeres tells the compelling stories of three people who receive diagnoses of adult leukemia within hours of each other: Joan, a forty-eight-year-old surgical nurse, a caregiver who becomes a patient; David, a sixty-eight-year-old former factory worker who bows to his family’s wishes and pursues the most aggressive treatment; and Sarah, a thirty-six-year-old pregnant woman who must decide whether to undergo chemotherapy and put her fetus at risk. We join the intimacy of the conversations Sekeres has with his patients, and watch as he teaches trainees. Along the way, Sekeres also explores leukemia in its different forms and the development of drugs to treat it-describing, among many other fascinating details, the invention of the bone marrow transplant and a treatment that targets the genetics of leukemia.