Following a media feeding frenzy in the wake of an FDA Panel on SSRIs in Pregnancy - see Unsafe Safety Systems - another feeding frenzy erupted with an HHS (Health and Human Services ) statement that it was reviewing the use of Tylenol in Pregnancy and possible links to Autism. This post engages with both of these frenzies. It is partnered with an ideally read first post … [Read more...] about Partnerships in Healthcare
Politics of Care
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 … [Read more...] about The Miracle of Artificial Intelligence
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 Panel on SSRIs and pregnancy, when he told us that women have emotions and maybe … [Read more...] about There’s Something About Pregnant Mary
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 … [Read more...] about FDA Panel: SSRIs and Pregnancy
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 should be warned of a possible link between … [Read more...] about Bauer Power and Informed Consent
Unsafe Safety
On March 20th, Senators Tina Smith and Ben Lujan, and Representatives Andrea Salinas and Becca Balint, sent a letter to the Secretary of the US Department of Health and Human Services, Robert F Kennedy, expressing concern about his promotion of disproven and outright false theories about mental health medications. In separate comments, Senator Smith indicated she had been … [Read more...] about Unsafe Safety
Tangled up in Bureaucracy
In response to Thomas Kingston’s death, Katy Skerrett, the coroner at his inquest, wrote to the MHRA (Britain’s medicines regulator) and to NICE (Britain’s guideline body) suggesting that their communications around antidepressant hazards appeared to downplay the risks of suicidal reactions to SSRI antidepressants, perhaps contributing to his death. See Aunts, Ants and … [Read more...] about Tangled up in Bureaucracy
The Respiratory Syncytial Virus Challenge
This post by Peter Selley centres on a Moderna RSV vaccine trial, the Rhyme trial, in young babies that was stopped last year when 7 out of 40 babies between 5 and 8 months of age developed severe lung disease, compared to 1 in 20 controls. Moderna had good reason to think its vaccine could cause this, as you will see, but the company appears to have opted to overlook the … [Read more...] about The Respiratory Syncytial Virus Challenge
Kingston’s Rule
This post is written by Dr Pedro who is watching events unfold from 10,000 miles away - with some extras added at the end. The UK Royal College of General Practitioners (RCGP) has been asked by Katy Skerrett, Senior Coroner for Gloucestershire, to respond to her Regulation 28 report to Prevent Future Deaths, after the inquest of Thomas Kingston (above). His death seemed to … [Read more...] about Kingston’s Rule
A Turning Point in History
That time of year thou mayst in me behold When yellow leaves, or none, or few do hang Upon those boughs which shake against the cold Bare ruined choirs where late the sweet birds sang. Shakespeare Sonnet 73 These lines came to mind recently when walking by a school playground crowded with young children on lunch-break. Like birds chirping in a tree or bush, they were … [Read more...] about A Turning Point in History