
Making medicines safer for all of us
Adverse drug events are now the fourth leading cause of death in hospitals.
It’s a reasonable bet they are an even greater cause of death in non-hospital settings where there is no one to monitor things going wrong and no one to intervene to save a life. In mental health, for instance, drug-induced problems are the leading cause of death — and these deaths happen in community rather than hospital settings.
There is also another drug crisis — we are failing to discover new drugs. [Read more…]
From the blog…
The Miracle of Artificial Intelligence
The recent FDA Panel on SSRIs and Pregnancy attracted a scathing Media Response. See Unsafe Safety Systems for 25 responses including the American Psychiatric Association and Britain’s College of Psychiatrists. For the most part the responses were remarkably similar, displayed complete amnesia for previously accepted facts, and downplayed any risks with phrases like earlier smaller…
There’s Something About Pregnant Mary
A recording of the full FDA Panel on SSRIs and Pregnancy is linked to the last post here. There has been extensive media coverage of this event – and 18 takes on what reporters heard can be found linked to Unsafe Safety Systems on RxISK. Roger McFillin was on thin ice, at the recent FDA…
FDA Panel: SSRIs and Pregnancy
On behalf of FDA Commissioner Marty Makary, M.D., M.P.H., the FDA is holding a series of roundtable discussions with independent panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and may offer recommendations for regulatory action. This initiative is part of the FDA’s broader efforts to…
Bauer Power and Informed Consent
In Epidemiology of Autism Spectrum Disorder on RxISK, I mention that for me a key paper in a reference list of 27 references was one by Ann Bauer and colleagues, who recognized limitations to the epidemiological data but nailed their colours to the mast in saying that there was sufficient evidence here that pregnant women…
Secret Moderna Trial Documents
This post by Peter Selley details yet another Selley triumph. It’s extraordinary what focus and persistence can achieve. I am dedicating this post to Nikki Rutman, twenty years an analyst with the FBI, who currently heads up Moderna’s Global Intelligence Division. Moderna’s shares have plummeted since its 2021 Covid heyday. This appears unrelated to my…