4 ms·
The FDA approved propranolol in 1973, but not for treatment of hypertension or angina. It wasn't until 1978 that they allowed beta blockers to treat those disea
by ggreer 6y ago
The FDA approved propranolol in 1973, but not for treatment of hypertension or angina. It wasn't until 1978 that they allowed beta blockers to treat those diseases (which are the bulk of lives saved by beta blockers).
The WaPo article does talk about a study that had just concluded, but Timolol had been studied for over a decade previously, and had been used in Europe for years. I didn't have to look hard to find a US study done in 1976 that praised Timolol's effectiveness in protecting cardiac muscle after a heart attack.[1]
If you doubt that Timolol is far more effective at preventing heart attacks than propranolol, then why believe the rest of the WaPo article? It references a study that you can't find on the Internet because it was published over 40 years ago.
The bottom line is this: Despite the drug being considered safe by the relevant European authorities, the FDA forbade US doctors from prescribing it. Had the FDA simply allowed doctors to prescribe compounds approved by their European counterparts, they would have avoided tens of thousands of deaths.
1. https://www.sciencedirect.com/science/article/abs/pii/0014299977902588 https://www.sciencedirect.com/science/article/abs/pii/001429...
- refurb 6y agoBut the FDA does not dictate how drugs can be used, only whether they can be marketed and sold. There is nothing stopping a physician in the US from using propranolol for preventing heart attacks before the FDA gives its blessing for that use. If you look at cancer treatments today most uses (not drugs, uses) are not formally approved by the FDA. It all based on research, publications and guidelines.
- ggreer 6y agoIf a doctor prescribes a drug for a condition not approved by the FDA, they open themselves to legal liability.
- Vecr 6y agoSure, but that kind of makes sense for why the FDA acts like they do, if you want more risky off-label treatments without the large studies the FDA requires, your doctor (and you) can take the risk at your (and their) option.
- refurb 6y agoYes, but published data, other physician usage and guidelines are defenses for liability. As I said, in oncology the vast majority of treatments are off-label.