In 1956 German pharmaceutical company Chemie Grünenthal GmbH, licensed a new experimental drug designed to treat colds, flu, nausea and morning sickness. Known as Distaval in the UK, Distillers Biochemicals Ltd declared the drug could ‘be given with complete safety to pregnant women and nursing mothers without adverse effect on mother or child’ – a basic pre-requisite for licensing a drug. While forty-nine countries licensed the drug under multiple different names, the then head of the FDA Dr. Frances Kelsey, a physician-pharmacologist with a profound interest in fetal development, refused authorization for use in the US market due to her concerns about the lack of evidence regarding the drug’s safety. The drug was also known as Thalidomide. Sixty-five years on and the stringent safety measures brought in to avoid another scandal on the scale of Thalidomide have been swept aside in order to fast track the approval of experimental mRNA vaccines. This is in spite of concerns voiced by (among others) Dr Wolfgang Wodarg and Dr Michael Yeadon who petitioned the European Medical Agency (EMA) with a Administrative/Regulatory Stay Of Action in regard to the BioNtech/Pfizer study on BNT162b – not just in regard to concerns about pregnant women, the foetus and infertility – but also in regard to the effect of the mRNA vaccines on those with prior immunity, for whom immunization could lead to a hyperinflammatory response, a cytokine storm, and a generally dysregulation of the immune system that allows the virus to cause more damage to their lungs and other organs of their body. It took five years after the initial licensing of Thalidomide before anyone realised Thalidomide crossed the placental barrier and caused serious birth defects, a discovery hampered by the fact the drug had been marketed under multiple different names across 49 countries. It took a further five years to mount a legal challenge. Nobody was found guilty. Not until the mid-seventies following a fierce moral crusade by the late, great investigative journalist and editor Harold Evans (who referred to investigative journalism as ‘attacking the devil’) did the families of those children who died or who were born with limb, eye and heart problems receive commensurate compensation. Fifty years later, Chemie Grünenthal GmbH apologised. Evans believed the Thalidomide scandal was a lesson in how a government can betray its duty. They’re still doing it. Chief Executive of the MHRA Dr. June Raine was ‘delighted’ to approve the AstraZeneca vaccine for use on the citizens of the UK. ‘No stone is left unturned when it comes to our assessments’ she said. That there had been ‘a robust and thorough assessment of all the available data’ and that her staff had ‘worked tirelessly to ensure we continue to make safe vaccines available to people across the UK’. I doubt Dr. Frances Kelsey would see it that way. Or Harold Evans.
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