Right, that's the opinion that supports the FDA here, that probably most readers are used to hearing. It is, however, decreasingly the universal consensus amon

Right, that's the opinion that supports the FDA here, that probably most readers are used to hearing. It is, however, decreasingly the universal consensus among doctors, scientists, and others, there is much more dissent these days, opinion that the FDA is approving drugs they shouldn't be -- as demonstrated by the very unusual resignations from the FDA committee. Those scientists thought it was more questionable than your story. As far as patient advocates, as many pieces point out, one of the historical things was AIDS activism for availability of drugs. I was struck by this from a recent piece about ACT UP, from one of the activists at that time: «Today, Franke-Ruta is a journalist, and she spoke to Schulman about the wider implications of some of act up’s success. “I don’t think that we realized at the time that this was part of the broader gutting of the FDA that we’ve seen since; that there was a lot of political agendas that we just happened to be in sync,” she said. After President Donald Trump touted the promise of hydroxychloroquine as a treatment for covid-19, the F.D.A. issued an emergency-use authorization for the drug, which was shown to be useless for the purpose. (The agency withdrew the authorization three months later.) “Sometimes it seems like it’s gone too far in the other direction,” Franke-Ruta went on. “But there’s a really strong pharmaceutical lobby against the FDA as well that I don’t think we were aware of.”» And from the article's author, editorializing a bit: «In retrospect, one can ask whether act up’s victories on the research front pushed the F.D.A. too far. The drugs-into-bodies approach to fast-tracking—the use of “surrogate endpoints” (like T-cell counts or viral load), for example, rather than clinical benefits in actual people—can be valuable, especially for patients who are facing death and have no good alternatives. This approach at least offers desperate patients a chance, while allowing scientists to gather meaningful data. But, today, a number of drugs, for everything from asthma to periodontitis, have won approval before benefits in human patients were established, and critics argue that drug approval is too often based solely on benefits shown in biomarkers rather than in bodies. “Right to try” legislation, meanwhile, enables the sale of drug candidates without even involving the F.D.A. When restrictions are weakened, experimental drugs—many of which end up proving useless or worse—become harder to distinguish from effective medicine.» https://www.newyorker.com/magazine/2021/06/14/how-act-up-changed-america https://www.newyorker.com/magazine/2021/06/14/how-act-up-cha...