Any student of pharmacy should be familiar with the thalidomide tragedy and most of the public are at least vaguely aware of this disaster. Thalidomide was a sedative that was found to be useful in preventing morning sickness in pregnant women. It was developed by the German company Chemie Grunenthal in 1954 and was introduced onto the market in the U.K. in 1958. However, doctors started to notice an increase in the number of babies being born with birth defects and, in December 1961, the Australian gynaecologist, Dr. William McBride published a short letter in the medical journal the Lancet highlighting his concerns that thalidomide might be responsible for these birth defects. At the same time, the German doctor, Dr. Widukind Lenz noted similar concerns and, in November 1961, warned Chemie Gruenenthal of his fears. The drug was withdrawn from the market at the end of 1961 but disputes over the question of whether thalidomide did or did not cause malformations went on for months. Chemie Gruenenthal continued to deny the teratogenic effects of thalidomide for years, but there was suspicion that this was not due to honest ignorance but in order to weaken the accusations against the company (see this extract from a lecture given by Dr. Lenz for details).
Why is this relevant to the withdrawal of the AstraZeneca Covid Vaccine? Well, as any good pharmacy student will also know, the thalidomide tragedy led to the formation of the Committee on Safety of Drugs (1963) which was set up by Sir Derrick Dunlop. This became the Committee on Safety of Medicines (1968) then the Medicines Control Agency (1989) and finally the Medicines and Healthcare products Regulatory Agency (MHRA) in 2003. The MHRA is the U.K. agency that monitors the safety of drugs and approves them for use on the U.K. market. It also monitors safety of medicines available to the public through the Yellow Card Scheme.
Prior to the set-up of the Commission on Safety of Drugs, companies could make drugs and sell them to the public without undertaking testing and without the drug formally being approved for use in patients. In 1968, with the introduction of the Medicines Act, medicines needed to be licensed before being introduced onto the U.K. market. Companies needed to show that they were safe for use in patients through proper testing (pre-clinical testing and clinical trials), quality testing and pharmacovigilance (post-marketing safety monitoring). The AstraZeneca Covid Vaccine, Vaxzevria, went through an accelerated version of this process and was deemed safe for use in patients on an emergency basis, with the first patient injected in January 2021.
Problems with any drug should be picked up through the Yellow Card reporting scheme. This scheme was introduced into the U.K. in 1964 in response to the thalidomide tragedy. The Yellow Card scheme allows healthcare professionals and the public to report suspected side-effects or adverse reactions associated with medicines, vaccines, herbal remedies and medical devices. The information gathered through the Yellow Card Scheme helps regulatory authorities, such as the MHRA to monitor the safety of medicines and to take appropriate regulatory actions (e.g. withdrawal of the medicine) to protect the public.
For vaccines, the number of reported side-effects tends to be fairly low (in the hundreds) and the number of deaths reported tends to be in single figures. These vaccines tend to mainly be given to babies and children as part of the standard vaccination protocol. The estimated reporting rate of side effects per 100,000 doses is around 10 for such vaccines (for example, see the 2009 report from MHRA).
With the outbreak of Swine Flu, a mass vaccination programme was introduced in the USA in 1976, but with severe consequences. Approximately 1 in 100,000 vaccinated individuals developed Guillain-Barré syndrome according to CDC figures, and several deaths were also reported; the vaccine was withdrawn from the market when these concerns became too obvious to ignore.
There are lessons we should have learnt from this incident and, as Richard Fisher pointed out in his BBC article in September 2020, we really should have looked at this past mass vaccination programme and been forewarned. If you rush out a vaccine for a mass vaccination programme, as a Government you are under a lot of pressure to fulfil your promise of vaccinating the population and people dropping dead is really quite inconvenient.
In the U.K., approximately 50 million doses of the AstraZeneca Covid vaccine were given to approximately 25 million people. The vaccine was mainly used between January 2021 and July 2021, with the Pfizer vaccine becoming the primary vaccine of choice from the summer of 2021. Up until the end of September 2022, the MHRA Yellow Card Scheme received 246,393 reports of adverse reactions to AstraZeneca vaccine, with a total of 873,051 reactions and a massive 1,314 suspected fatalities related to the vaccine (the data were nicely summarised on the U.K. column website). Approximately 1% of patients who received the vaccine reported side-effects and five suspected patient deaths were reported per 100,000 patients injected.
If we compare that to the Swine Flu fiasco, where the vaccine was withdrawn when 1 in 100,000 patients developed the serious side-effect of Guillain Barre syndrome, it might reasonably have been expected that, with five suspected deaths per 100,000 patients injected, either MHRA or AstraZeneca might have considered withdrawing the product.
Should AstraZeneca vaccine have been withdrawn sooner? The company voluntarily withdrew the product from the market this week (May 7th 2024). It cites commercial reasons for withdrawing the product – which is fair since it has hardly been used in earnest in the U.K. since the summer of 2021 – and the fact that it is probably not effective against any current strain of COVID-19, also fair. However, this still raises the question as to why, with unprecedented safety concerns relating to this medicine, was it not withdrawn earlier? The Yellow Card Scheme highlighted these concerns. I fear that Sir Derrick Dunlop would have been very disappointed that we still haven’t fully learnt the lessons from thalidomide. Like Chemie Gruenenthal, will AstraZeneca continue to deny the side-effects of its vaccine, or will it continue to plead ignorance in order to weaken the accusations against the company?
Dr. Maggie Cooper is a pharmacist and research scientist.
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The side effects of thalidomide were extremely obvious and presented in very specific, narrow cases.
Yet it still took three years to cancel the whole thing and even longer for the involved parties to admit it.
And the victims still have to live with the results. They were teenagers when I was training at Roehampton Hospital, and used to meet some of them.
My late father once worked with a man whose son had been born with physical abnormalities as a result of his wife taking Thalidomide. Abnormalities so severe that he told my father that he was glad for his son’s sake that the child died after a few days.
I think the drug’s still in use but they’re waaay more careful now.
Isn’t one the major differences the fact the manufacturer has been granted financial immunity by the Government? If they had not been, it might not have happened, if they were not prepared to take the risk of shortening the assessment procedure for a novel product.
Immunity was granted because the government and pharma companies knew they were pushing dangerous products. There was even a “consultation” prior to this racket being finalised and to which I responded – for all the good my comments and those of thousands of others made. As I have repeatedly stated on DS the injections were brewed to a recipe and the harms were baked in.
What a splendid fellow Sir Derrick Dunlop seems to have been.
‘Democracy is, however, a very difficult form of government’
‘The drawbacks of the FDA are that it is entirely composed of civil servants and it is questionable whether a professional bureaucracy, not always attracting the best talent, should dogmatize…..’
‘It is, doubtless, salutary that our profession should always regard ministers with a healthy degree of suspicion….’
‘….medical establishments……..have not always been in the van of progress’
‘I sometimes envy these people with strong principles and convictions who, confronted by any controversial problem, immediately seem to know what is right and what is wrong. They are the people who do the most good in the world – and the most harm.’
‘….a proper understanding of the problems involved is the first stage to their intelligent solution’
D. Dunlop, The control of drugs and therapeutic freedom, 24 May 1968
After his sterling efforts, he would, without doubt, have been horrified that: ‘Approximately 1% of patients who received the vaccine reported side-effects and five suspected patient deaths were reported per 100,000 patients injected.’ and that ‘Up until the end of September 2022, the MHRA Yellow Card Scheme received 246,393 reports of adverse reactions to AstraZeneca vaccine, with a total of 873,051 reactions and a massive 1,314 suspected fatalities related to the vaccine.’
How right he was that ministers should be regarded with a healthy degree of suspicion and that the medical profession has not always been in the van of progress.
It is hard not to think that certain representatives of the political and medical professions should, rather, be in the Police van making progress to one of His Majesty’s Institutions of Correction……
The AstraZeneca debacle shows that the lessons from Thalidomide have been learnt very well by the pharmaceutical industry.
I was just typing that thought.
I take 5 portion of COVID vaxx a day.
No mention of the fact that only 10% of deaths and 1% of adverse reactions are ever reported. So that’s potentially 13,140 deaths, 24,639,300 adverse reports and 87,305,100 reactions.
Move along now please nothing to see here.
I worked with the FDA in the USA in the noughties on a medical device. Their timeline for approval was a minimum of 10 years following safety and efficacy clinical trials. This is why I have never and will never take this experimental jab.
The effects of Thalidomide should be well-known to anyone born in the 1950/60s. It raises the question as to why any MP born in that era could be so unwary of pharmaceutical risks associated with inadequately tested experimental medicines?
It defies belief that they were prepared to take these risks and provide immunity from prosecution to the pharmaceutical companies who developed and manufactured these novel mRNA gene therapies. No matter what the disease or pandemic threat, governments are responsible for taking decisions that do not undermine human health and well-being. In this instance they have succeeded in destroying the education of a whole generation and the very fabric of a stable and prosperous society.
A Mid Western Doctor Substack investigates the forgotten side of vaccine harms. There is a long list, a list that Public Health authorities would do well to make themselves aware of before rushing once more to approve experimental, novel medicines based on mRNA technology. They should also read Sir Graham Wilson’s 1967 published expose cautioning against the risks associated with vaccine side-effects. (Link in article. wilson_vac.haz.pdf).
This is a long Substack but the more one reads about the history, safety and effectiveness of vaccines, or the lack thereof, the more convinced I am that I was right to never have had one.
https://open.substack.com/pub/amidwesterndoctor/p/the-forgotten-science-of-vaccine?r=egcno&utm_campaign=post&utm_medium=web&comments=true