We are watching an almost total collapse of a whole generation of people who trusted their doctors and the FDA for safe, tested and effective medicine in the opioid crisis but let’s just trust them and all there “consensus” until their “consensus” changes and people start dying, and getting addicted, and their lives ruined. Whoops
Pharma has long marketed opioids in ways that contribute to opioid use disorder and deaths by overdose. Regulatory mistakes in approving and labeling new analgesics by the FDA didn’t make us safer.
journalofethics.ama-assn.org
“FDA failure to obtain adequate evidence of effectiveness was not limited to oxycodone. Over the past 25 years, despite mounting evidence that a surge in opioid consumption was resulting in adverse public health consequences, the FDA continued to approve new opioid formulations for chronic pain based on efficacy trials utilizing a controversial methodology called enriched enrollment randomized withdrawal (EERW).26 Since its 2006 approval of oxymorphone, the FDA has relied on EERW as evidence of opioid efficacy for chronic pain.27”