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Wednesday 21 July 2021

Pharmaceutical Drug Regulation. It's primary task is to protect patients. Yet drug regulators do not do so. Why?

How do we know if pharmaceutical drugs and vaccines are safe?

How can patients protect themselves from the harm caused by adverse drug reaction?

Ever since the Thalidomide tragedy in the 1970's every nation now has a drug regulator. Their primary task is to protect patients - you are me. Yet they don't. The last 50 years has seen a huge number of pharmaceutical drug and vaccines - approved by regulators - often used for decades - only to be belatedly withdrawn or banned because of unacceptable levels of patient harm.

Even the pharmaceutical drugs and vaccines we are prescribed today have very serious adverse reactions. How do we know this? They are listed in the patient information leaflet that comes with each pack of pills, and each vaccine. They make is clear that today's drugs are no safer than yesterday's banned drugs.

One problem is that the reporting of drug/vaccine side effects is known to be a small fraction of the total number of people who have been harmed - estimated to be about 1%. I have written about this before, many times, see for instance The Under-Reporting of Adverse Drug/Vaccine Reactions.

What this means is that pharmaceutical drug side effects are under-reported - to the extent that the harm they cause is under-estimated by anything up to 100 times. 

Yet the under-reporting reporting systems (the 'Yellow Card' system in Britain) is not the only problem with drug regulators and their regulatory activity (or lack of it). What is becoming increasingly clear is that when large numbers of serious, life threatening, life altering adverse drug/vaccine reactions are reported - no action is taken by the UK's drug regulator, the MHRA. 

The MHRA, and drug regulators around the world are content to explain away patient harm; they discount adverse reactions; they seek to justify side effects. They do not warn the public that the drug can cause them harm. And they do so even when a drug or vaccine is know to be killing people.

Never has this been clearer than during the past 8 months, and the introduction of the various Covid-19 vaccines. To demonstrate my point I will highlight the weekly reports of MHRA (British Drug Regulator) on serious adverse reactions to the Covid-19 vaccines that it has received. The latest data can be found on the UK's government website. Between 9th December 2020 and 7th July 2021 the MHRA states that it has received reports of 1,470 deaths, as well as severe allergic reactions (Anaphylaxis), blood clotting, Bell's Palsy, Thrombo-Embolic events with concurrent low platelets, capillary leak syndrome, menstrual disorders and vaginal bleeding, inflammation of the heart, delayed hypersensitivity reactions, Guillain-Barre syndrome, and "events with a fatal outcome".

It is important to remember that whilst this information is published on a relatively obscure government website, the full enormity of the patient harm these vaccines are causing has not been relaid to the general public - either by the government, by the medical authorities, or by the mainstream media (MSM). They continue to urge us to take the vaccine, threaten us with 'vaccine passports' and mandatory vaccination if we don't comply. The vaccines, we are told, are safe. 

So people who are being vaccinated do not know about this information; they are told for over 8 months, that the vaccines are safe. They are, therefore, unable to make an informed decision based on all the evidence.

So it is instructive to see how the MHRA presents this patient harm, and what action it is proposing to take to prevent this harm. Each week the number of reported serious adverse reactions, including "events with a fatal outcome", increases. So how is this drug regulator protecting us?

I will take you through the lengthy document in order to highlight this.


This starts with a reminder that over 128,000 have died of Covid-19. Bear in mind this figure includes anyone who died within 28 days of being tested positive with Covid; so it includes those who died "with it", and those who died "of it". This should be borne in mind. It goes on to describe the 3 vaccines that have been used in the UK, leaving us in no doubt that "vaccination is the single most effective way to reduce deaths and severe illness from Covid-19"

Not much room for doubt there! Yet this is actually one of the more surprising statements. I am not sure that a drug regulator, when reviewing a drug, should tell us it is the best treatment. Their concern should be whether it causes patient harm; but for some reason this is what the MHRA wants to tell us

The MHRA goes on to state that all three vaccines have all been tested by the drug companies, and authorised by the MHRA, following "thorough review(s) of safety, quality and efficacy" - but failing to mention that these vaccines did not go through the full testing and review procedures, and have only been given 'emergency' approval.

However, the MHRA then says its role was to "continually monitor safety", and that they had "a proactive strategy" to do so. It introduces the Yellow Card process for the first time, before making the first attempt to discount the importance of reported side effects they will outline later in the document.

        "The nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated, and especially when most vaccines are being given to the most elderly people and people who have underlying illness."

Then it outlines the number of Yellow Cards it has received emphasising that the "data cannot be used to derive side effect rates or compare the safety profile of Covid-19 vaccines", and that most side effects "relate to injection site reactions (sore arm, for example) and generalised symptoms such as flu-like illness". Nothing too serious to worry about, then. We are further reassured. "These type of reactions reflect the normal immune response triggered by the body to the vaccines".

Severe Allergy

The MHRA informs us there were "early reports of anaphylaxis" so it has "amended its advice". They are "very rare" reports, and all of them are generally "associated with other vaccines". Nothing to worry about here either, then.

Blood Clots

These are "extremely rare" and the MHRA has undertaken "a thorough review". MHRA singled out the AstraZenica vaccine, stating that if a patient had 'difficulties' after the first vaccine the second should not be taken. There is no mention that other drug regulators have 'suspended' the use of this vaccine for this very reasons


This section just repeats that "the vaccines are the best way to protect people from Covid-19 and have already saved  thousands of lives". No problem there, then. The MHRA will review the vaccines; but they have already decided they are the best thing on offer!


Another description of the Yellow Card scheme, this time stating that the MHRA plays "an active role" in responding to the Covid-19 pandemic.

What is Yellow Card?

Yes, the Yellow Card scheme is introduced - yet again - this time followed by a long message, discounting the importance of the reports that are received from doctors and patients.

        "We ask for any suspicions to be reported, even if the reporter isn’t sure if it was caused by the vaccine. Reports to the scheme are known as suspected adverse reactions (ADRs). Many suspected ADRs reported on a Yellow Card do not have any relation to the vaccine or medicine and it is often coincidental that they both occurred around the same time. The reports are continually reviewed to detect possible new side effects that may require regulatory action, and to differentiate these from things that would have happened regardless of the vaccine or medicine being administered, for instance due to underlying or undiagnosed illness. It is therefore important that the suspected ADRs described in this report are not interpreted as being proven side effects of COVID-19 vaccines.

So they may be reported, but the MHRA is already set to discount and dismiss them.


Vaccine doses administered

This section stresses how many vaccine doses have been administered in England, Wales, Scotland and Ireland. It presumably sets us up to see how 'uncommon' and 'rare' the reported adverse reactions are, but nowhere mentions that usually only 1% of side effects are ever reported.

Yellow Card Reporting Trends

Again, this section begins by discounting the trends, even before we know what the trends are! Recall, the primary task of drug regulators is to protect the patient from adverse drug reactions (ADR's) not to support the drug or vaccine. 

        "A report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports."

This section provides us with the total numbers of reported ADR's in England, Wales, Scotland and Northern Ireland.


In this section MHRA outlines the enormity of their task, "given the huge scale of the Covid-19 immunisation programme" and outlines what that task is. The first, it says, is "to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. We then can take any necessary action to minimise risks to individuals."

Absolutely right, except that the second task goes some way to undermining the first task, yet more discounting - even before we have any details of the ADR's. The MHRA is clearly preparing us for the worst!

        "... we need to very quickly establish if any serious medical events which are temporally-related to vaccination are merely a coincidental association. These associations are likely while we are still in the midst of a national epidemic, and because many of the millions of people offered the vaccine in the early phase of a vaccination campaign are elderly and/or have underlying medical conditions, which increases the likelihood of unrelated illnesses occurring soon after vaccination. As mentioned above, the nature of Yellow Card reporting means that reported events are not always proven adverse reactions, and some may have happened regardless of vaccination."

Overall Safety

This section begins with yet more prevarication, more discounting of the reports of patient harm it has received, more implicit support of the vaccines.

        "As with any vaccine, the COVID-19 vaccines will cause side effects in some people. The total number and the nature of Yellow Cards reported so far is not unusual for a new vaccine for which members of the public and healthcare professionals are encouraged to report any suspected adverse reaction."

And the majority of side effects are (of course) minor, "a sudden feeling of cold with shivering/shaking accompanied by a rise in temperature, often with sweating, headache (including migraine-like headaches), nausea, muscle aches and feeling unwell, starting within a day of having the vaccine".

Really? Nothing to worry about then. And we are now half way through the paper.......

Comments on Specific Reports

Only now does the MHRA move to more serious ADR's. But in doing so they make comments that undermine and underplay the seriousness of the reports.

Anaphylaxis. "The nature and frequency of these reports is in line with that reported in previous updates, and severe allergic reactions to the Pfizer/BioNTech vaccine remain very rare. The MHRA’s guidance remains that those with a previous history of allergic reactions to the ingredients of the vaccine should not receive it."

And what have the MHRA done? They have recommended that some people do not get the vaccine. They continue to monitor the situation. And the product information leaflet has been updated. Heavy stuff!

Bell's Palsy. "The number of reports of facial paralysis received so far is similar to the expected natural rate and does not currently suggest an increased risk following the vaccines. We will continue to monitor these events...." Heavy discounting here then, accompanied with minimal response! 

Thrombo-embolic events with concurrent low platelets. The MHRA discusses this in relation to young people, and with females. So there are concerns, but no concerns that require action because "on the basis of this ongoing review, the advice remains that the benefits of the vaccine outweigh the risks in the majority of people" (my emphasis). So some harm to some people is acceptable, as long as most people are not harmed. The "risk-benefit" analysis is just a statement, of course, no published calculation! In several other countries it is these 'thrombo-embolic events' that has led to the ongoing suspension of one or more of the vaccines by some drug regulators.

Capillary Leak Syndrome. Only 8 cases have been reported; but remember that with 1% of side effects are ever being reported, this could mean 800 cases. As usual we are reassured, and minimal actions has been taken. "... 2 people had a history of capillary leak syndrome. This is an extremely rare relapsing-remitting condition and triggers for relapses are not well understood. As a precautionary measure, the MHRA is advising that COVID-19 vaccine AstraZeneca is not used in people who have previously experienced episodes of capillary leak syndrome. The product information will be updated to reflect this advice." 

Menstrual disorders (period problems) and unexpected vaginal bleeding. There have apparently been 22,981 reports received about this; so this is heavily discounted on the basis that this number "is low in relation to both the number of females who have received COVID-19 vaccines to date and how common menstrual disorders are generally". It would appear that the MHRA is taking no action at all about this. So, you women, just get on with it, suffer - there's a lot of it around! A little more will make little difference.

Inflammation of the Heart. Both Myocarditis and Pericarditis have been reported, and the MRNA admits that the numbers of reports is many more than the annual rate for this disease. It says that similar reports are coming from other countries following the vaccines. But we are not to worry! Of course not! "These reports are extremely rare, and the events are typically mild with individuals usually recovering within a short time with standard treatment and rest." And we are assured that the MHRA will continue to monitor the situation.

Delayed Hypersensitivity Reactions. If anyone gets this, they are advised to get medical advice, presumably from the same doctor who recommended the vaccine! Otherwise the MHRA is taking no action.

Guillain-Barre Syndrome. This syndrome, which is linked to many other vaccines, is being monitored but at this time, "based on the available evidence .... (the MHRA) are not able to confirm or rule out a causal relationship with the vaccine". And, needless to say, it is taking no action.

Events with a Fatal Outcome. Death is, of course, the ultimate "side effect" of every pharmaceutical drugs and vaccines. This is the MHRA's first response - before it even tells us how many deaths have been reported following Covid-19 vaccines.

        "Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination. A high proportion of people vaccinated early in the vaccination campaign were very elderly, and/or had pre-existing medical conditions. Older age and chronic underlying illnesses make it more likely that coincidental adverse events will occur, especially given the millions of people vaccinated."

 So death is an understandable result of medical treatment. The UK's drug regulator seeks to explain away vaccine-caused death before it does anything else. It goes on to defend the harm caused by medical treatment by comparing the Covid-19 vaccine death rates with 'natural' death rates. It comes to an inevitably conclusion. These people would have died anyway!

        "Based on age-stratified all-cause mortality in England and Wales taken from the Office for National Statistics death registrations, several thousand deaths are expected to have occurred, naturally, within 7 days of the many millions of doses of vaccines administered so far, mostly in the elderly."

Well, that's alright then. The MHRA finally tells us that there have been 1,470 reported deaths. And it leaves it there. No further explanation. No effort to discover a link between the vaccines and these deaths. 

This is literally an unbelievable response from the drug regulator whose primary task is to protect patients from harmful (not to say lethal) adverse reactions.


Just as it started, just as it did consistently throughout, the conclusions drawn by the MHRA, the agency whose primary role is to protect patients from dangerous pharmaceutical drugs and vaccines, defends the Covid-19 vaccines, regardless of the harm they are doing.  

        ".... over 128,382 people across the UK have died within 28 days of a positive test for coronavirus. Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. A national immunisation campaign has been underway since early December 2020."

The MHRA, alongside other national drug regulators, has long been accused of being an arm of the pharmaceutical industry, and nowhere can this be seen more clearly than in this document.

It repeats that the vaccines have been tested; and states that "data is now available on the impact of the vaccination campaign in reducing infections and illness in the UK".

Most trains running from any two cities get most of their customers there safely. Most restaurants feed their diners safely. Most industries have a workforce that survive their working conditions. But none of them are allowed to kill 1,470 people - and do little or nothing about it! 

        "... all vaccines and medicines have side effects", they tell us.

Ask a train company, a restaurant, and all other industries, how much harm, injury and death they can cause before serious questions are asked, and decisive action taken. It would seem that the same rules do not apply to the pharmaceutical industry.

        "Following widespread use of these vaccines across the UK, the vast majority of suspected adverse reaction reports so far confirm the safety profile seen in clinical trials. Most reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as a ‘flu-like’ illness, headache, chills, fatigue, nausea, fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these reactions are not associated with more serious illness and likely reflect an expected, normal immune response to the vaccines."

So all is well with the Covid-19 vaccines. There is nothing for us to worry about it. And the government agrees - because this is published on the government website. And as the mainstream media agrees because they have not told us about any of this. Everyone agrees.

So the message from the MHRA is implicitly clear. "We have a duty to announce these reported side effects, so here they are. But rather than do our duty and take effective action to protect patients, we will defend the drug companies, and the drugs and vaccine they market and profit from. Patient harm is an acceptable side effect". And perhaps they can do this because they know government, and the MSM, will not disagree with this assessment.

        "We take every report of a suspected ADR seriously and encourage everyone to report through the Yellow Card scheme."