Jyoti Madhusoodanan

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How a controversial

How a controversial US drug policy could be harming cancer patients worldwide

Illustration by Karol Banach In August 2021, Amol Akhade, an oncologist at Nair Medical Hospital in Mumbai, India, received an e-mail from the Swiss drug manufacturer Roche recommending the use of a drug named atezolizumab to treat a specific kind of breast cancer. Akhade was surprised. That month, Roche had withdrawn the drug for this purpose in the United States (although it is still approved to treat other kinds of cancer). For the type of breast cancer in question — known as triple-negative because it lacks three key protein markers — atezolizumab was made available in 2019 through the US Food and Drug Administration’s (FDA’s) Accelerated Approval Program. Accelerated approval is a fast-track process designed to place desperately needed drugs in the hands of patients quicker than is possible with conventional drug approval. But a follow-up study found that atezolizumab made little difference to tumour growth, and that people who received it were less likely to survive up to two years after treatment than were those not taking it 1 . When the FDA received

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