by Arjun Walia, The Pulse:
The HPV vaccine is one of Merck’s highest-grossing products, bringing in annual global revenues of billions. But new information sheds light on some shady practices.
I’ve seen some people scoff at the word “Big Pharma.” To someone like me, it refers to the documented criminal activities we’ve seen take place for decades by large pharmaceutical companies.
For example, from 2002 to 2010 Pfizer was assessed $3 billion in criminal convictions, civil penalties and jury awards and set records for both criminal fines and total penalties. This type of thing is disturbingly common, yet it was only during the COVID era that more people came to be aware of such facts.
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“A corporation may treat both criminal and civil penalties as simply business expenses, to be weighed against the revenues earned from illegal behaviour. But human beings can be put in jail, and that is a whole other matter. Conceivably, convicting corporate executives of criminal behaviour and sentencing them to terms of imprisonment might be a more effective deterrent to the “repeat offender” behaviour demonstrated by Pfizer.”
– Robert G. Evans, PhD, Emeritus Professor, Vancouver School of Economics (PMID: 21532766)
The story below isn’t quite ‘criminal’ per se, because Merck and federal health regulatory agencies believe aluminum adjuvants in vaccines are completely safe, but we’ll get to that later.
What Happened?
A new study published in the International Journal of Risk & Safety in Medicine, explains how Merck significantly misled the clinical trial participants for its Human Papilloma Virus (HPV) vaccine.
Participants in Merck’s Gardasil FUTURE II study were led to believe that the study’s placebo was saline, which is harmless. But instead of injecting saline, the placebo in this trial contained an adjuvant called amorphous aluminium hydroxyphosphate sulphate (AAHS).
AAHS is more potent than traditional aluminum vaccine adjuvants.
As you can see in the image below, the trial consent form stated that “One half of the participants will receive the active vaccine, while the other half will get the placebo vaccine (meaning a vaccine without active substance)” leading the participants to falsely believe the placebo was inactive.
The next image shows Merck’s advertisement informing potential participants that they would be receiving a saline placebo.
A number of trial participants experienced chronic disabling symptoms, including some randomized to the adjuvant “placebo” group.
“We examined the informed consent form and the recruitment brochure for the FUTURE II Gardasil vaccine trial conducted in Denmark; and we interviewed several FUTURE II trial participants and their treating physicians. We also reviewed regulatory documentation related to Gardasil vaccine approval process and the guidelines on evaluation of adjuvants used in human vaccines.
It was found that the vaccine manufacturer Merck made several inaccurate statements to trial participants that compromised their right to informed consent. First, even though the study protocol listed safety testing as one of the study’s primary objectives, the recruitment brochure emphasized that FUTURE II was not a safety study, and that the vaccine had already been proven safe. Second, the advertising material for the trial and the informed consent forms stated that the placebo was saline or an inactive substance, when, in fact, it contained Merck’s proprietary highly reactogenic aluminum adjuvant which does not appear to have been properly evaluated for safety. Several trial participants experienced chronic disabling symptoms, including some randomized to the adjuvant “placebo” group.
– A reactogenic “placebo” and the ethics of informed consent in Gardasil HPV vaccine clinical trials: A case study from Denmark
Senior editor at the British Medical Journal, Dr. Peter Doshi et al found similar evidence after analyzing clinical study reports from the European Medicines Agency dealing with five randomized controlled trials of the HPV vaccine.
