Thread by @sam_baker

Today: FDA panel recommends pulling from the market a drug to prevent preterm births. It was approved through a fast-track process before all the clinical trials were complete, and those trials ended up showing that the drug doesn't work, after all.

2019: The FDA pulled from the market a cancer drug that was approved through the same fast-track process, before clinical trials were completed. The trials ended up showing that the drug didn’t work, after all.

2021: The FDA approved an Alzheimer’s drug, using the same fast-track process, even though the clinical trials *never* suggested it works. It wasn’t pulled from the market, but Medicare refused to cover it, so very few patients will ever take it outside of ongoing clinical trials

These about-faces have literal costs — the cancer drug did $500 million in sales before the FDA pulled the plug; the Alzheimer’s drug would have cost about $56,000 per year. You don't get your money back when the drug goes bust.
axios.com/2019/04/26/eli…

There’s also a cost in false hope: Someone caring for an Alzheimer’s patient could be forgiven for reading the headline “FDA approves Alzheimer’s drug” and celebrating that there’s finally an effective Alzheimer’s treatment. But there isn’t.
axios.com/2021/06/28/alz…

And if the FDA does pull the drug for preterm birth, there will be zero drugs to prevent preterm birth — but maybe there’s never actually been an effective one.