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Bloomberg analysis finds half of approved cancer drugs lack proof of longer survival

Bloomberg analysis finds half of approved cancer drugs lack proof of longer survival

A Bloomberg investigation reports that fully half of approved cancer drugs do not have proof they extend survival for any of their approved uses. The reporting traces the FDA's accelerated approval process, which often clears drugs on tumor shrinkage or progression-free survival, a measure critics say does not reliably predict how long patients actually live.

A Bloomberg investigation has raised pointed questions about how well many widely used cancer drugs actually work. According to the reporting, fully half of approved cancer drugs do not have proof that they extend survival for any of their approved uses. The finding goes to the heart of whether patients are gaining real benefit or are simply being exposed to treatments that may not help them live longer.

The report describes a growing recognition within parts of the medical community that some treatments may not be as helpful as patients hope or deserve. One concern is whether certain drugs could be taking away quality of life and making people feel sick without actually extending it. That doubt, the reporting says, has begun to drive a movement among clinicians who want clearer evidence of benefit.

At the centre of that effort is a coalition described as common sense oncology, presented as a global grassroots group. Its stated aim is to raise the bar in cancer care and to be very clear about identifying treatments that make a real difference in the lives of patients, rather than ones that deliver only marginal or unproven gains.

To explain how the situation developed, the reporting traces the history of how the United States regulates cancer drugs. In the 1980s and 1990s, the Food and Drug Administration faced heavy criticism from HIV activists who argued it was not moving quickly enough to bring potentially life-saving drugs to market at a time when HIV was widely seen as a death sentence.

That pressure led to a new pathway known as accelerated approval, under which the agency could clear drugs based on preliminary data that had not yet been fully proven. Over the past two decades, regulators have leaned heavily on this process to approve many cancer drugs, often on the basis of tumour shrinkage alone or a measure called progression-free survival.

Critics quoted in the reporting say that measure can be misleading, because progression-free survival is not the same as survival. It mainly reflects whether a drug delays the growth of a tumour on a scan, and it has turned out not to be as predictive of how long patients actually live. Drug companies and many patient advocates allied with them counter that the medicines are needed quickly and that patients cannot afford to wait.

The stakes are also financial. The reporting notes that enormous sums are being spent on these treatments without clear knowledge of how much they truly help. In the United States, private insurance and programmes such as Medicare often cover most cancer treatment costs, while in countries like India, where many patients cannot afford therapies that can run into the high tens of thousands of dollars a year, doctors are experimenting with lower doses that could mean less time in treatment and greater savings.

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