Press Release - Adverse Events, 7th May 2019

Did you know that it is estimated only 2% to 10% of adverse events are reported?  For example:
 
Australia specific:
  • Quote from Therapeutic Goods Administration (TGA), a regulatory body and division of Australia's Department of Health. "It is generally acknowledged that adverse events are under-reported around the world, with estimates that 90-95% of adverse events are not reported to regulators." Ref 1
  • On its website the TGA acknowledges that the reporting of adverse events related to all medications is only voluntary and under-reported. Ref 2
  • In 2010, Peter Collignon, Professor of Infectious Diseases from the Australian National University, felt the number of adverse reactions was probably under estimated given the authorities don’t have a congruent and approachable system to monitor people’s reactions. Ref 3
  • In 2003, there were more than an estimated 680,000 severe adverse drug events. An estimated less than 2% of severe adverse drug events (ADEs) from primary care are reported to the Adverse Drug Reactions Advisory Committee. In 2013 only 5% of the reports of ADEs came from GPs. The percentage of GP’s that report ADEs is only 9%. Ref 4
  • Passive post-marketing surveillance of adverse events, as used in Australia, results in significant under-reporting. Ref 5
  • Although an active surveillance system (AusVaxSafety) for selected vaccines has been implemented in Australia in last 5 years, it would appear that the surveillance stops a mere three days post-vaccination, making it unsuitable for detecting adverse events with a delayed onset. Ref 6
Around the World:
  • Quote from Harvard Medical school, USA.... "fewer than 1% of adverse events are reported". Ref 7
  • Vaccine Adverse Events Reporting System (VAERS) in USA showed that in 2018, there were 412 deaths associated with vaccines.  Ref 8. "VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA". Ref 10. Could we assume the number to be higher if only 10% were reported?
  • Similar limitations are found in vaccine science purporting to show that vaccines are safe. Pre-licensure clinical trials of vaccines lack the sensitivity to detect the less common adverse events, or those with a delayed onset. Ref 9

If elected, IMOParty will address the urgency of a more accurate adverse events reporting system.

REFERENCES:
1. https://www.tga.gov.au/media-release/new-web-service-helps-consumer-reporting-side-effects
2. https://www.tga.gov.au/about-daen-medicines
3. http://www.onlineopinion.com.au/view.asp?article=16055
4. http://archive.i2p.com.au/?page=site/article&id=999; http://www.hconc.org.au/wp-content/uploads/2015/06/HCC-submission-on-Therapeutic-Goods-Amendment-Bill-2016.pdf
5. https://academic.oup.com/inthealth/article/9/3/164/3861041
6. http://www.ncirs.org.au/our-work/ausvaxsafety
7. https://web.archive.org/web/20190813160009/https://paleofam.com/wp-content/uploads/2019/02/r18hs017045-lazarus-final-report-2011.pdf
8. https://vaers.hhs.gov/data.html
9. https://vaccine-safety-training.org/pre-licensure-vaccine-safety.html
10. https://vaers.hhs.gov/about.html
 
 
 
 
 
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