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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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
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?
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
Fishy Business in the Rio de la Plata
From our South American Correspondent... The Argentine national flag is from a design by General Belgrano who died on June 20 1820 - 200 years almost to the day before Fernando Polack's strange plasma trial began. Fernando Pedro Polack MD in the spotlight Strange things have been going on in the murky world of clinical trials in the democratic nation of Argentina. … [Read more...] about Fishy Business in the Rio de la Plata
Karunya Come Home
Case 3 Karunya Venugopalan This is the third case in the Cause and Effect Forum that looks at how we establish if a vaccine or a drug has caused a harm. On January 7, 2022, there was an extraordinary article in the BMJ by Priyanka Pulla - How Covid-19 vaccines exposed India's adverse event reporting systems. This outlined a series of injuries and deaths on Covid vaccines … [Read more...] about Karunya Come Home
Injuries in Vaccine Trials
A Fine Balance © Nina Otulakowski February 2022 Brianne Dressen's case below is the first of 10 clinical scenarios which will be laid out on Cause and Effect over the next few weeks. The credentials of those interviewing Bri and others can also be found there, along this week with Maddie De Garay's case. The publication of these cases challenges anyone who thinks the … [Read more...] about Injuries in Vaccine Trials
Cause and Effect
Ring the bells that still can ring, Forget your perfect offering... © Billiam James 2022 THE CRACK THROUGH WHICH THE SCIENCE GETS IN The Covid Vaccines have introduced us to an issue that everyone on a medical treatment faces – how do we tell when a drug, device, or vaccine has caused a problem? For harms related to other drugs or devices, most of us could ignore the … [Read more...] about Cause and Effect
Who’s Afraid of Science?
I was invited by Yulia Mikhailova to deliver a Guest Lecture to the New Mexico Technical Institute on Wednesday February 2. The talk began and appeared to be going smoothly, when halfway through the Zoom room was hacked with the hackers saying and writing a lot divisive and hateful things. A later post will say more. The talk has been re-recorded and hopefully a recorded Q and … [Read more...] about Who’s Afraid of Science?