Mikkael A. Sekeres's Books

Drugs and the FDA

Safety, Efficacy, and the Public's Trust

By: Mikkael A. Sekeres

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Drugs and the FDA

Safety, Efficacy, and the Public's Trust

By: Mikkael A. Sekeres

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, 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. The Avastin hearings, he says, put to the test a century of the FDA’s evolution, demonstrating how its system of checks and balances works—or doesn’t work.

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Page Count

319

Publisher

MIT Press

Published Date

ISBN 10

0262548399

ISBN 13

9780262548397

When Blood Breaks Down

Life Lessons from Leukemia

By: Mikkael A. Sekeres

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When Blood Breaks Down

Life Lessons from Leukemia

By: Mikkael A. Sekeres

A leading cancer specialist tells the powerful stories of 3 adult leukemia patients—shining new light on the hidden history of the disease and the drugs developed to treat it. “A look at leukemia patients’ fear, survival and grace while fighting the disease . . . a quiet chronicle of life with and beyond leukemia, and sometimes life’s end.” —The Washington Post 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 readers on the journey that patient and doctor travel together. Sekeres, who writes regularly for the “Well” section of The New York Times, tells 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. We join the intimate conversations between Sekeres and his patients, and we 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 (first performed experimentally on beagles) and a treatment that targets the genetics of leukemia. The lessons to be learned from leukemia, Sekeres shows, are not merely medical; they teach us about courage and grace and defying the odds.

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Page Count

325

Publisher

MIT Press

Published Date

ISBN 10

0262542250

ISBN 13

9780262542258

Facing Cancer

A Complete Guide for People with Cancer, Their Families, and Caregivers

By: Theodore A. Stern,Mikkael A. Sekeres

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Facing Cancer

A Complete Guide for People with Cancer, Their Families, and Caregivers

By: Theodore A. Stern,Mikkael A. Sekeres

Cancer is the second leading cause of death worldwide, accounting for nearly 600,000 deaths annually in the United States alone.

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Page Count

488

Publisher

McGraw Hill Professional

Published Date

ISBN 10

0071414916

ISBN 13

9780071414913

Clinical Malignant Hematology

By: Mikkael A. Sekeres,Matt Kalacyio,Brian Bolwell

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Clinical Malignant Hematology

By: Mikkael A. Sekeres,Matt Kalacyio,Brian Bolwell

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 is edited by staff members from the renowned Taussig Cancer Center at the Cleveland Clinic, which has pioneered some of the most important clinical discoveries and treatment trends in recent years. Look inside and you'll see 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. Features Full coverage of all treatment modalities-chemotherapy, monoclonal antibodies, and hematopoietic stem cell transplantation Strong background chapters that offer guidance on how to address treatment complications and other supportive care issues A detailed, regimen-based orientation in each chapter Abundance of clinical pictures and photomicrographs displaying examples of peripheral blood smears and bone marrow aspirates Uniform headings and tables in each chapter, which convey specific recommendations on the work-up, staging, diagnosis, differential diagnosis, and treatment of hematologic malignancies Nearly 200 illustrations

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Page Count

1240

Publisher

McGraw Hill Professional

Published Date

ISBN 10

0071509747

ISBN 13

9780071509749

When Blood Breaks Down

Life Lessons from Leukemia

By: Mikkael A. Sekeres

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When Blood Breaks Down

Life Lessons from Leukemia

By: Mikkael A. Sekeres

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Page Count

325

Publisher

MIT Press

Published Date

ISBN 10

0262542250

ISBN 13

9780262542258

Drugs and the FDA

Safety, Efficacy, and the Public's Trust

By: Mikkael A. Sekeres

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Drugs and the FDA

Safety, Efficacy, and the Public's Trust

By: Mikkael A. Sekeres

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N/A

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Solve jigsaw puzzle

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Page Count

319

Publisher

MIT Press

Published Date

ISBN 10

0262548399

ISBN 13

9780262548397

Book's by Mikkael A. Sekeres

Drugs and the FDA

Drugs and the FDA

When Blood Breaks Down

When Blood Breaks Down

Facing Cancer

Facing Cancer

Clinical Malignant Hematology

Clinical Malignant Hematology

When Blood Breaks Down

When Blood Breaks Down

Drugs and the FDA

Drugs and the FDA

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