FDA: Some Cancer Patients Shouldn’t Be Forced to Take Placebos in Drug Trials: Brainstorm Health
Hello and happy hump day, readers!
The Food and Drug Administration (FDA) is taking a remarkable step regarding the use of placebos in clinical drug trials.
In new guidance set to be published in the Federal Register on Thursday, the agency proposes that certain patients with serious medical conditions—including some forms of cancer—shouldn’t have to take placebos if there’s a therapy on the market that already works.
“Placebos are often used in clinical trials. However, patients fighting life-threatening diseases, like certain cancers, shouldn’t be given a placebo when there is a known effective therapy,” wrote Acting FDA Commissioner Ned Sharpless in a tweet on Wednesday. (Relatedly, Sharpless was the director of the National Cancer Institute prior to his selection as the acting FDA chief.)
“Today’s guidance provides clarity to industry regarding our recommendations regarding the use of placebos and advises that they should only be used in select circumstances or in certain trial design features for patients with cancer,” he added.
Under the guidance, the FDA states that cancer clinical trials which use a placebo should largely be limited to those that involve follow-on, “adjuvant” therapies (i.e. additional treatments used to support a primary drug regimen), add-on trials, or studies for cancer types which have no currently approved therapies.
One key detail to keep an eye on as the public comment period on the guidance commences: Will patients with rare disorders with no approved treatments insist the same guidance applies to them?
Read on for the day’s news.
Sy Mukherjee, @the_sy_guy, sayak.mukherjee@fortune.com