Experimental Cancer Therapy Holds Great Promise — But at Great Cost
By Meghana Keshavan,
STAT
| 08. 23. 2016
Soon after she received the treatment, Karen Koehler’s brain swelled. Her blood pressure plummeted. As she fell into a coma, her husband and sister sat at her bedside — urging the doctors to keep pushing her farther along the razor’s edge between life and death.
Koehler was undergoing a promising — and terrifying — experimental therapy that her oncologists hoped could rid her body of cancer entirely. It’s called CAR-T therapy, and it works by engineering the patient’s own immune cells to attack cancer.
One of the hallmarks of CAR-T: It has to nearly kill you if it’s going to save you.
The treatment induces such sudden and severe side effects that it can take a small army of top specialists to keep patients alive while their newly engineered immune systems attack their cancer cells. The result: CAR-T remains so risky, so complex, and so difficult to manage that experts warn it’ll be years before it’s available to most patients who would stand to benefit — even though two drug makers, startup Kite Pharma and pharmaceutical giant Novartis...
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It’s been a busy couple of months in biopolitics, with developments in the US, UK, China, Japan, and implicitly on Mars. Time for a brief roundup.
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Bioethics needs an update
The National Research Act is now 50 years old. It was signed into law on July 12, 1974, as a direct response to publicity about the 1932 “Tuskegee Study of Untreated Syphilis in the Negro Male.” The Hastings Bioethics Forum celebrated its anniversary with an...
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Image courtesy National Human Genome Research Institute
The U.S. Food and Drug Administration (FDA) is supposed to encourage effective medical advances while also ensuring that patients and research subjects are protected. This dual mandate demands tricky judgment calls that are made more difficult by outside pressures of several kinds, political, judicial, and especially commercial. This April story at Bloomberg examines one deeply troubling pattern of regulatory capture:
Americans Are Paying Billions to Take Drugs That Don’t Work
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