The FDA has at this time received 79 comments for its "Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions; Public Workshop."
Here is the 80th.
FDA
There has been a lot of ink spilled, and bytes spent this week discussing the FDA’s approval of aducanumab, brand-name Aduhelm, for the treatment of Alzheimer’s Disease. I have mixed feelings; there are advantages to a Phase 4 study, but how do you say no to hope?
The Vaccine Adverse Event Reporting System (VAERS) is a favorite tool of skeptics aiming to spread immunization fears. As it turns out, VAERS has actually helped ensure the safety of FDA-approved shots.
The first customers have lined up for AquaBounty's genetically engineered (GE) salmon, committing to purchase five metric tons of the fish that will be harvested at the end of May. After 30 years of regulatory roadblocks, lawsuits, and activist opposition, AquAdvantage salmon may finally be heading to US restaurants and grocery stores.
The recent excellent article by Josh Bloom, “NYC Pol Uses Phony Cancer Scare & ‘Children’ to Ban Glyphosate in Parks,” talks about the scare tactics used by a council member in New York to ban glyphosate (Roundup) from city parks. I’m taking a deeper dive looking at how the WHO’s International Agency for Research on Cancer (IARC) and our EPA determine whether or not glyphosate causes cancer. A flawed process leads to flawed science, which like radioactivity – stays around forever!
Back in August, the FDA issued an Emergency Use Authorization for convalescent plasma for treating those with COVID-19. With more data in hand, the agency has now limited its use to a subset of hospitalized patients.
From vaping to cutting-edge biotechnology, UK health regulators do a far better job than their American counterparts. This was proven yet again when the UK beat the U.S. FDA at approving a coronavirus vaccine produced by Pfizer, an American company.
The false narrative that prescription drugs caused the opioid crisis has been relentlessly undermined by evidence to the contrary, yet it remains. It may have suffered a ding here and there, but it's still mostly intact. But if evidence really matters, Dr. Jeffrey Singer just gave it another ding. Maybe even a dent. From 2019.
FDA Commissioner Stephen Hahn indicated that his agency would be willing to grant emergency authorization to a coronavirus vaccine, even before it completes Phase 3 clinical trials. This is a reckless gamble and could cause an unmitigated public health disaster.
The FDA’s rigorous oversight – rather than a race to satisfy an aggressive agenda – is imperative during this pandemic.
Perhaps someday a ballad will be written about the tragic tale of hydroxychloroquine (HCQ) and its ugly cousin chloroquine (CQ). HCQ, a potential (and controversial) therapy for COVID-19 at one time, is no more. The FDA revoked the emergency authorization of both HCQ and CQ. This was an example of how NOT to develop a drug. A lesson learned -- or not.
As new breeding techniques create new ethical debates over food, we think the ethical toolbox needs updating. Talking about crossing species lines simply isn’t enough. If Darwin had known about gene editing, we think he would have agreed.