Books
How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin.
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 US authority on a drug's safety and efficacy? In Drugs and the FDA, I tell 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, throughout the twentieth century, the government was forced to take increasing 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. I describe 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. The Avastin hearings put to the test a century of the FDA's evolution, demonstrating how its system of checks and balances works—or doesn't work.
Reviews, excerpts, or mentions in The Washington Post, The New York Times, National Public Radio, Slate.com, StatNews, Harvard Law Petrie Flom Center, LawBusiness Insider, LuckBox Magazine, Next Bright Idea Club, AACR Cancer Today, Medscape/WebMD, Oncology Business Review (OBR), The Pink Sheet, The Miami Book Fair, Demystifying Science, Healthcare Unfiltered, KevinMD, NewBooksNetwork, Holodoxa, Living Legacy Leadership, Seize the Moment, Book Society, This is Democracy
Drugs
And
The
FDA
The compelling stories of three adult leukemia patients and their treatments, the disease itself, and the drugs developed to treat it.
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, I take readers on the journey that patient and doctor travel together.
Hear about the compelling stories of three people who receive diagnoses of adult leukemia within hours of each other: Joan, a 48-year-old surgical nurse, a caregiver who becomes a patient; David, a 68-year-old former factory worker who bows to his family's wishes and pursues the most aggressive treatment; and Sarah, a 36-year-old pregnant woman who must decide whether to undergo chemotherapy and put her fetus at risk. Join the intimacy of the conversations I have with my patients, and watch as I teach trainees. Along the way, I also explore 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 (first performed experimentally on beagles) and a treatment that targets the genetics of leukemia.
The lessons to be learned from leukemia are not merely medical; they teach us about courage and grace and defying the odds.
Reviews, excerpts, or mentions in The Washington Post, National Public Radio Medical Mondays, Talk Radio Europe, Salon.com, Outspoken Oncology, CHOICE (American Association of College and Research Libraries), Utne Reader, Kirkus Reviews, Publishers Weekly, The MIT Reader, Popular Science, The Daily Beast, the Miami Book Fair, ASH Clinical News, ASCO Post, AACR Cancer Today, Lancet Haematology.
When
Blood
Breaks
Down
On
The
Edge
Of
Life
An extraordinary tale, told by the freshly-minted doctors rotating through the Medical Intensive Care Unit of one of the world’s greatest hospitals,
These stories are collected and placed into context by me and my co-author Theodore Stern, M.D., the Chief of the Psychiatric Consultation Service at the Massachusetts General Hospital and a Harvard Medical School professor of Psychiatry. The entries recorded in the seven-volume “Medical Intensive Care Unit (MICU) Journal” cover a twenty-year period, beginning in January, 1980, and reflect the unguarded reflections of these interns and residents as they are thrown into the chaos of the Massachusetts General Hospital intensive care unit, the last resort of medical care for much of New England, where only the sickest of the sickest patients are referred. Join these young doctors as they struggle with extremes of medical care, the outrageousness of humor in the midst of such despair, their first encounters with death, and ultimately take a step back to appreciate the miracle of survival as the human spirit triumphs over medical calamity. It is remarkable that, even as these interns and residents themselves toil through 36-hour, sleepless shifts, they steal away for a few minutes to write an entry in this diary, to place their experience in a greater context. It is even more incredible that their words, recorded at the peak of vulnerability, have survived.
Facing
Cancer
THE BEST INFORMATION SOURCE IN THE BATTLE AGAINST CANCER
Uniquely supportive of the emotional, social, and familial aspects of living with cancer, Facing Cancer is for anyone whose life is affected by this diagnosis—yourself, a family member or friend, or even a health care professional. Written by the leading physicians in their respective fields—psychiatry and oncology— Facing Cancer is the only reference that combines top-tier medical information and compassionate counsel on cancer, its causes, and treatments with a caring approach to the emotional aspects of living with this diagnosis. This book gives you solid, trustworthy information in distinctive chapters that answer the most pertinent questions about cancer. It features integrative and complementary therapies, including faith and prayer, and the best medical advice on nutritional and other health-building lifestyle changes.
Facing Cancer provides the best information on cancer and its treatment, guidance to the finest outside information sources, and advice on tried and true coping strategies for everyone involved. This book is vital to ease the loneliness, fear, and pain of facing this diagnosis.
Clinical
Malignant
Hematology
The only comprehensive guide to the clinical management of hematologic and lymphatic cancers
Filling an unmet need in the clinical literature, this commanding, just-in-time reference sheds light on the full spectrum of cancers in the blood, bone marrow, and lymphatic system (leukemia, lymphoma, myeloma). Clinical Malignant Hematology includes a consistent, unified patient management strategy in each chapter, as well as a streamlined three-section format that expertly examines ontogeny and physiology of blood cells, myeloid neoplasia, and lymphoid neoplasia. You'll also find never-before-published perspectives and precise recommendations for dosing and other critical areas that reflect the latest scholarship of this increasingly vital field.