I like Dr. Shirvalkar’s decision process quoted below. He says that a patient should be allowed to take a therapy without proof of efficacy, if the costs and risks are low.
This decision process is consistent with my suggestion that the F.D.A. should stop mandating efficacy, and limit itself to only mandating safety, thus greatly reducing the costs of drug development.
(p. D7) Acetaminophen. Acupuncture. Massage. Muscle relaxants. Cannabinoids. Opioids. The list of available treatments for low back pain goes on and on. But there’s not good evidence that these treatments actually reduce the pain, according to a new study that summarized the results of hundreds of randomized trials.
. . .
Aidan Cashin, the paper’s first author and deputy director of the research group Center for Pain IMPACT at Neuroscience Research Australia, said the aim of the study was to identify which first-line treatments for low back pain had any specific effects beyond a placebo, which might merit further study and which may not be worth pursuing.
. . .
One limitation of the type of analysis that Dr. Cashin conducted was that it aggregated data from different studies and different populations in order to emulate one large trial. But in the process, a strong signal from one study that a treatment worked could be diluted amid noise from other studies that may not have been designed as well, he said.
. . .
The evidence for something like heat might be inconclusive, doctors said, but they would still recommend that patients try it. “It’s cheap, it’s accessible, it almost causes no harm,” Dr. Shirvalkar said.
For the full story see:
(Note: ellipses added.)
(Note: the online version of the story was updated March 24, 2025, and has the title “What Works for Low Back Pain? Not Much, a New Study Says.” Where the versions differ, in the passages quoted above, I follow the online version.)