P

atient advocates have long complained that drug and device makers do not make enough experimental medicines available, but a new study finds that the industry funds most trials that aim to get such products to patients.

Specifically, companies funded 61 percent of nearly 400 studies that make drugs or devices available to patients prior to regulatory approval, according to the analysis in BMS Research Notes. And the researchers suggest that, even without federal intervention, industry is “establishing programs to make experimental therapies available to terminally ill patients.”

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  • Most of these are what we call “Investigator Initiated Studies”. The playbook is to throw a small pile of money a doc to run a compassionate use small “trial”, get it published and use this as support. Most of these are not large hypothesis driven studies but a rationale for lining the pockets of the KOLs to keep them in the pharma stable. You can run 100 of these little studies for the price of one pivotal trial, and as Trump says the PR value is “UUGE”.

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