The U.S. is in the midst of an opioid epidemic and investigators suggest that the U.S. Food and Drug Administration itself aided and abetted such a thing to happen from the start.
Looking at clinical data from 1997 to 2018, researchers found that, of 48 proposed pain products, none had trials that lasted more than three months. “These trials often excluded patients who could not tolerate the drugs and failed to systematically assess some important and well known opioid-related adverse events,” according to a Johns Hopkins news release.
Not only did the “short and small-scale” trials stack the deck in favor of “finding a medicine safe and effective,” but the use of patients’ “spontaneous” reports on safety issues virtually closed the door on learning whether tolerance levels could occur that would lead to non-medical use of the drugs.
In other words, the FDA didn’t do its oversight job of asking for longer trial periods with more participants and actual trial data on addictive features of the drugs — thus sending them to market and setting the stage for the epidemic that it is today.
SOURCE: Johns Hopkins September 29, 2020