When Clinical Trials began in the 1950s, investigators knew the patients and because of this could spot changes in them for the better or the worse. The expectation was that they would make a judgement call about things happening in a trial and, in many cases, would link the drug to an event – good or bad. Company Strategy 101 Starting in 1990 with Prozac, and becoming ever … [Read more...] about Mike Dever and Vaccines
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Shipwreck and Salvage
Shipwreck of the Singular was written before before Covid landed and published just as the vaccines began to roll out. It's central messages are that Life expectancy is now falling and this is linked to polypharmacy People injured by treatment are the crack through which the science gets in The use of antidepressants for children and teens illustrates just how far … [Read more...] about Shipwreck and Salvage
Miracles in Buenos Aires: Water and Wine
This post is by our South American correspondent. A Water into Wine miracle occurred in Buenos Aires in October 2020. A 66 year old volunteer, number 12315632 in Pfizer’s Comirnaty vaccine trial, had received his second vaccination of BNT162b2 (30 μg) on the nineteenth of September in the city’s Hospital Militar. Twenty-nine days later he was admitted to hospital with … [Read more...] about Miracles in Buenos Aires: Water and Wine
Yellow and Other Virus and Vaccine Perils
Big Friendly Gates On 28 April the NEJM published the interim results of a trial of Prefusion F Protein–Based Respiratory Syncytial Virus Immunization in Pregnancy. This paper contains evidence of a neonatal jaundice hazard in the babies whose mothers had been immunised - but you'd never guess it from the way the paper is written. Prizer's RSVpreF Trial Pfizer’s phase 2 … [Read more...] about Yellow and Other Virus and Vaccine Perils
Military Maneuvers in the Dark
This post follows on from If You Wake at Midnight. Military Medicine When the history of modern medicine is laid out - See Shipwreck of the Singular - it is clear that, from Napoleon onwards, the military have been the greatest influence on its development. In Wars before 1900, more soldiers died from disease than from enemy efforts. There was a pressing need to change this. … [Read more...] about Military Maneuvers in the Dark
If You Wake at Midnight
Andrew Marriott's recently published If You Wake at Midnight is a compelling read. It would have been a great candidate for inclusion on the recent list of Books on Medical Treatments Gone Wrong. It tells the story of Lariam – mefloquine – a treatment to ward off malaria. A drug that for over 40 years has been causing suicides, homicides, depression, and a wide range of … [Read more...] about If You Wake at Midnight
Forked Tongues. Adverse Event or Adverse Reaction?
Linguas Bifidas © Nina Otulakowski July 2022 An Adverse Event is anything that happens while a trial is happening - even a nuclear war. There were lots of traffic accidents and broken bones in Buenos Aires during the Pfizer trial - mostly on placebo. Maybe Covid vaccines prevent fractures or accidents. Not impossible if you are too sick to get out and about. An Adverse … [Read more...] about Forked Tongues. Adverse Event or Adverse Reaction?
The Best Books on What Medicine Should Be
Two months ago I had an email from Ben Fox of forauthors@shepherd.com – a new venture looking to promote books in a new way. See Shepherd.com. The idea is to feature a book by an author and then get her or him to list five books that have particularly influenced them – centered on a topic of their choosing and linked into their work. Newspapers have been doing this for … [Read more...] about The Best Books on What Medicine Should Be
Harmatology: a New Science
In 2008-2009, 7 young women died in a HPV vaccine trial in India. There was a backlash against the clinical trial industry. Quite apart from Pharma trials, the National Institutes of Health (NIH) had 70 ongoing trials that were abandoned. It was clear, Indian investigators had to be taught how to assess awkward events properly. Barbara Bierer, a Haematologist, and … [Read more...] about Harmatology: a New Science
Mark and Barb and Eric and Carole
If North Americans don't know much about Asterix cartoons - see The Harmed, Europeans don't know about MAD. This image was adapted by Nina Otulakowski from a front cover image in Mad, see below, featuring the 1969 Bob, and Carol, and Ted and Alice movie. Born in the USA Multi-Regional Clinical Trials (MRCT) was born in the USA in 2009. Pfizer had just resolved a case with the … [Read more...] about Mark and Barb and Eric and Carole