Post by Admin on Jun 8, 2022 16:09:46 GMT
Harmatology: a New Science
davidhealy.org/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 founder of MRCT travelled to India in 2014 to help the new Indian Society for Clinical Research (ISCR) with causality assessment. ISCR had been set up by Pfizer in 2010 and company support made the ISCR journal open access.
Causality assessment refers to the ways to assess possible links between a drug or vaccine and harms happening in company trials or other studies, or just clinical practice.
At this MRCT workshop investigators were encouraged to distinguish between adverse events and adverse reactions and to establish if:
there were similar reports previously linking the drug or vaccine to an event
there were similar reports in the label of related drugs or vaccines
the event appeared in the investigator brochure
the event was consistent with the pharmacological mode of action of the drug
the event was consistent with the pharmacokinetic profile of the drug
the event was consistent with peak plasma or overall concentration of the drug
the event might be consistent with the first sign of a latent illness
whether there were concomitant drugs
whether there were concomitant conditions
whether anything else was happening at the time of the event
if none of the above consider that the event might have happened but be unrelated to the drug.
In the world of company trials, nothing ever steers an investigator toward linking a harm with a treatment. The entire trial process hinges on a mantra that trials rather than an assessment of individual cases by a clinician offer true cause and effect information. Unless an event has been demonstrated to happen to a statistically significant extent in a controlled trial there is no good evidence that the drug or vaccine has caused it.
davidhealy.org/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 founder of MRCT travelled to India in 2014 to help the new Indian Society for Clinical Research (ISCR) with causality assessment. ISCR had been set up by Pfizer in 2010 and company support made the ISCR journal open access.
Causality assessment refers to the ways to assess possible links between a drug or vaccine and harms happening in company trials or other studies, or just clinical practice.
At this MRCT workshop investigators were encouraged to distinguish between adverse events and adverse reactions and to establish if:
there were similar reports previously linking the drug or vaccine to an event
there were similar reports in the label of related drugs or vaccines
the event appeared in the investigator brochure
the event was consistent with the pharmacological mode of action of the drug
the event was consistent with the pharmacokinetic profile of the drug
the event was consistent with peak plasma or overall concentration of the drug
the event might be consistent with the first sign of a latent illness
whether there were concomitant drugs
whether there were concomitant conditions
whether anything else was happening at the time of the event
if none of the above consider that the event might have happened but be unrelated to the drug.
In the world of company trials, nothing ever steers an investigator toward linking a harm with a treatment. The entire trial process hinges on a mantra that trials rather than an assessment of individual cases by a clinician offer true cause and effect information. Unless an event has been demonstrated to happen to a statistically significant extent in a controlled trial there is no good evidence that the drug or vaccine has caused it.