FDA versus Patients, Part II

Amid all the drugs available to us, antibiotics are remarkable in that, when they work, they cure. Because of them, we have forgotten about the era when microbes won the battle most of the time and a fever could be a death sentence. Yet not long from now, that scenario may recur on a worryingly frequent basis. Some serious infections involve bacteria that are resistant to most, if not all, antibiotics, so doctors are running out of options….

Unfortunately, the FDA has been moving at glacial speed in providing industry with that clear set of rules — known in medical parlance as “guidance” — as to the proper design of clinical trials for testing antibiotics.

Read more by Sylvia Pagan Westphal writing in the Boston Globe.

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