An Asthma Drug Kills: so the Drug Regulator does another "Review". Is this enough?

Montelukast is an asthma drug, better known as Singulair. It has caused the death of patients who have taken it. This Guardian headline (3 March 2024) says that "a healthy kid dies and there has been no change": parents’ anger over lack of warnings for blockbuster asthma drug. Teenager Harry Miller took his own life two years after being prescribed montelukast. His family say they were not made aware of the reported psychiatric side-effects of the drug".

The parents were not told about the "side effects" of the drug? (And is death really a "side effect"). I am surprised that anyone should be surprised at this statement! Too many people trust their doctors, implicitly, and put their complete faith entirely and completely into the hands of a medical system that has always peddled dangerous drugs and vaccines. 

I checked to see what the NHS website now says about the "side effects" of this drug - 4 years after Harry's death. It highlights Diarrhoea, High Temperature, Headaches, stomach pain, feeling or being sick, and a mild rash. Then it goes on to mention, under 'serious side effects', that a doctor should be called if "you notice changes and you become depressed, aggressive or you're thinking of harming yourself".

This is presumably the doctor who prescribed the drug and omitted to tell the parents about the 'side effects' of aggression and self-harm (suicide) that it was known to cause. 

Yet what does my go-to website for pharmaceutical harm, Drug.com, say about Montelukask? It's all there, within a black box warning.

        "Warning: Serious Neuropsychiatric Events. Serious neuropsychiatric (NP) events have been reported in patients taking montelukast. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with montelukast use are currently not well understood. Because of the risk of NP events, the benefits of montelukast may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies."

So the problems of this asthma drug are known by conventional medical authorities. Yet the drug has been prescribed in most countries since 1998, over 25 years! And as the Guardian article intimated, until recently it was a 'blockbuster' drug. In 2020, two years after Harry's death, Montelukask-Singulaire was still the 14th most commonly prescribed drug, and therefore, highly profitable for the drug company.

Montelukask-Singulaire is yet another example of the dishonesty of the pharmaceutical industry, another medical tragedy waiting to be made public. Informing patients about serious adverse drug reactions means that they will be more cautious about taking it, thus harming the attractiveness and profitability of the drug. Yet Merck, the drug company, knew that its asthma drug could lead to suicide. Indeed, a group of parents have been trying to sue the company for many years, but as this Children's Health Defense link said, in June 2023, the legal action was unsuccessful, “stymied by an effective corporate liability shield: the doctrine of federal pre-emption”

What this means is that drug companies are prepared to harm us for profit! They have, after all, been doing so for many decades, with many other pharmaceutical drugs, and if you believe this is an over-statement of the situation I have listed some of the more serious medical scandals that demonstrate the assertion at this link. And, of course, there have been literally hundreds of pharmaceutical drugs that have been banned or withdrawn over the last 70 years, and more; I have listed many of these at this link.

Yet such is the parlous state of drug regulation now it would seem that pharmaceutical drugs that harm patients are no longer banned or withdrawn. As with Montelukask-Singulaire they are "placed under review", and doctors are restricted to when, and to whom, they can be prescribed! But what this means is that highly profitable drugs continue to be prescribed. This asthma drug was highly profitable: which, of course, is probably the main reason for it not being banned, or withdrawn. And why people like Harry are dying.

Drug Regulation around the world is now dominated, under the firm control, of pharmaceutical interests. Originally, the main purpose of drug regulators like the MHRA in the UK, the FDA in the USA, and the EMA in Europe, was to protect patients. They now fail to do so. In the UK this possibility has, at last, been recognised by a small group of MP's in the UK Parliament, where an all-party group have stated that the MHRA were aware of heart and clotting issues arising from the Covid-19 vaccines were known about as early as February 2021, but did not highlight the problems for several months. 

The result of this concern, perhaps coincidentally, has been that the Chief Executive of the MHRA has suddenly announced her resignation from the post! This was reported in the Telegraph 0n 27 February 2024. The MP's have also warned that the MHRA's Yellow Card reporting system, which encourages patients and doctors to report their concerns about adverse drug reaction, "grossly underestimates" the size of the problem of patient harm by pharmaceutical drugs, in some instances picking up just 1 in 180 cases of the harm drugs have caused.

I have been writing about the problem of pharmaceutical drug regulation, and the patient harm caused by these drugs, for many years. Perhaps, now, at long last, something will be done, although this issue too will probably have to be 'reviewed' many times before any effective action is taken! Perhaps it will make parents, like Harry's, more aware that pharmaceutical drugs are dangerous, and that no-one within the NHS will protect them. 

And during these interminable drug reviews there will undoubtedly be many more "Harry's", people who pay the ultimate price for the mayhem being caused by pharmaceutical medicine.

 

Pharmaceutical Medicine: Outcomes, and the importance of Empiricism

Observing the outcomes of taking pharmaceutical medicine is important. Such observations are an important element of science - examining the world, investigating what is happening around us. It is called empirical science.

        "Empirical evidence is information acquired by observation or experimentation. Scientists record and analyze this data. The process is a central part of the scientific method." 

"I'm ill again, I've been diagnosed with (illness3) now!"

"Oh! What bad luck. That's a nasty illness, I am so sorry."

"You know I have never been well since I got (illness1) and was given that (drug) to treat it."

"Yes, I remember. You went down with (illness2) soon after; and now you have (illness3)."

"I'm just unlucky; or perhaps I am just getting old".

So what has caused these illnesses? Is it a matter of luck? Can it be put down to ageing? Or are other factors involved - like the 'side effects' from the medication we have taken for previous illnesses?

Since early 2021 many people have been having similar conversations regarding the Covid-19 pandemic, and the vaccines used to prevent and treat it. It is time for us all to start asking the same questions. Anyone who actually observes, and considers what they are seeing, cannot help but conclude that the world is witnessing dreadful adverse vaccine reactions, including heart disease and death. Millions of people, particularly in the most vaccinated countries, are reporting these 'side effects' to national drug regulators. One Covid-19 vaccine (AstraZeneca) has already been quietly withdrawn from the market, and described as "defective".

Conventional, or pharmaceutical medicine, have always (and are clearly doing so now) routinely dismissed such observations and reports as ‘anecdotal’ and ‘unscientific’. The problem is that medical science does not usually look at vaccine or drug harm without being paid; and drug companies won’t pay for them to do so if the outcome is likely to produce bad publicity! So such conversations pass by, never examined, never investigated.

Yet these observation are the basis of science - empirical science. If something is observed it should trigger more science, more investigation either to confirm or deny the observation. Britannica describes empirical evidence as "information gathered directly or indirectly through observation or experimentation that may be used to confirm or disconfirm a scientific theory or to help justify, or establish as reasonable, a person’s belief in a given proposition. A belief may be said to be justified if there is sufficient evidence to make holding the belief reasonable."

So medical science usually ignores our observations about health, preferring not to investigate in case what they find is not appreciated by their drug company paymasters.

Yet our observations are important for another, more practical reason: what we witness going on around us is a clinical outcome - they are the outcome of an illness, and/or the outcome of medical treatment. It is a truism that patients are only interested in medical treatment only when they are sick. They then want treatments that make them better, treatments that are both effective (an outcome) and safe (another outcome).

Most patients are not interested in what has once took place in a scientific laboratory!

Yet this is why pharmaceutical medicine have never been interested in treatment outcomes. Drug companies invest in ‘medical science’ for one reason - to produce positive evidence of the safety and effectiveness of a treatment. This evidence forms the basis of their advertising and promotion; it is used to encourage people to take the treatment; it ensures that profits are made - this is their primary purpose. 

Any outcome of a treatment, after this, might prove that the treatment is less safe, and less effective than patients have been told. This is not wanted. It’s bad advertising. It's not what pharmaceutical medicine wants us to know!

In the 1960's and 1970's conventional medicine clearly recognised the need for empiricism in medicine, and the importance of outcomes. Around the world, National Drug Regulators were created in order to ensure there was no further drug scandals, like Thalidomide disaster. Each new drug had to go through a process of scientific tests; and in addition reporting systems were established. 

These reporting system were based almost entirely on patient observations about the outcomes of medical treatment.

The result was that many new drugs and vaccines were tested, approved by the regulator, came to the market, and given to patients. Then patients reported on adverse drug reactions; the drug regulator investigated the reports, and then took appropriate action. The result was that many pharmaceutical drugs were eventually banned, withdrawn, or 'discontinued' because they were were found to be either ineffective, or unsafe for patients. I have listed many of these banned drugs here. It is a very long list. But what is becoming clearer, as the years have passed, is that drug regulation is no longer as effective as it was during the latter decades of the 20th century.

The reason for this is also becoming clearer. Drug Regulation is now effectively controlled by the Pharmaceutical Industry. I first wrote about this situation over 10 years ago now. The situation has become progressively much worse. The Regulator is now controlling the Regulated. Even the unprecedented number of patient reports about the harm caused by the Covid-19 vaccines, based on patient observation, have been largely ignored. It is not that the reports have been investigated, and found to be unreliable. They have not been properly investigated!

We are sicker now than we have ever been. Name any chronic disease that has not reached epidemic proportions during the last 70-100 years - the years when pharmaceutical medicine has gradually taken over health provision, and now control it entirely.

Many people are beginning to ask important questions about the outcomes of conventional medicine:

• is what I am being told about pharmaceutical treatments honest and true?
• what are the health outcomes of taking pharmaceutical drugs and vaccines?
  
• could my illness be an adverse drug or vaccine reaction?
• when will medical science be expected to focus on adverse drug outcomes?
  
• how many people will drug regulators allow to contract a serious disease, how many people allowed to die, before they take action to protect patients?
• why is it that politicians, governments, and the mainstream media do not tell us about what is going on?
• how much more money will we have to spend on pharmaceutical medicine before we reach the conclusion that it is ineffective, and unsafe for patients.
  

Who Protects Patients from Pharmaceutical Drugs and Vaccines?

We have a fairly uniform system of pharmaceutical drug regulation, in force in most countries of the world. The current system was brought in after the Thalidomide tragedy of the 1970’s. Its primary purpose, really its sole purpose, was to protect patients from being harmed by dangerous pharmaceutical drugs and vaccines. It has two main components.

• First, new drugs are tested by medical science.
• Then, national drug regulators examines the scientific evidence that has been found for the efficacy, and the safety, of the new drug. It is the drug regulator that determines whether the new drug should be approved for public use.

Unfortunately the system does not work (A List of Banned and Withdrawn Drugs).

This is evidenced by the large, and ever growing number of new drugs, brought to the market over the years, having been tested by medical science, and approved as ‘safe’ by the drug regulators, then sold to patients for many years, often decades, only to be withdrawn and banned - because ultimately they have proven to be dangerous, and to have caused serious patient harm.

The main problem with the drug regulation is that during the last 50 years the pharmaceutical industry has taken over control of the entire regulatory process.

• Medical science makes its living testing drugs. The pharmaceutical industry pays them to do so. Yet if any scientist, or any science company, puts up too many obstacles to new drugs entering the market, they know that they will not used any more. So they go either go out of business; or they comply with the interests of the drug companies. So most ‘medical science’ has been bought and paid for - it is controlled by the drug industry.
  

• The Drug Regulatory Process is also largely funded by the pharmaceutical industry; but the pharmaceutical industry has another weapon to ensure that it controls the process. It has created a 'revolving door' which ensures that drug industry personnel move into the regulatory agencies, and that agency personnel in the other direction to lucrative posts in the industry. Drug regulation has one of the most effective ‘revolving door’ policies in operation anywhere.
  

• The government is largely complicit with the process. This has been demonstrated most recently by allowing the approval of the Covid-19 vaccines in double-quick time, and promoting the vaccines for the drug companies. Why? Politicians, and political campaigns, are funded by Big Pharma; and governments want to attract pharmaceutical investments in their country. Most governments now award drug companies with indemnity against any harm pharmaceutical drugs cause - including the harm caused by Covid-19 vaccines. Certainly, governments around the world have shown little interest in making sure that drug regulation protects patients.

• The mainstream media is now also largely funded by large corporate industries, through advertising and mutual directorships of companies - not least the pharmaceutical industry. The Covid-19 pandemic has demonstrated how the mainstream media sings along with the drug companies, and is prepared to censor and exclude any, and all opposition to the pharmaceutical narrative. The mainstream media has still failed to tell the public about the harm that is being caused by the Covid-19 vaccines.
  

This leaves the patient entirely unprotected.

Patients are now at the mercy of pharmaceutical profiteering, supported by governments and the mainstream media who tell us that the pharmaceutical drugs and vaccines are we are being given are entirely safe, and amazingly effective. 

It is usually only when the levels of patient harm being caused by drugs and vaccines become undeniable that any action is taken.

So what we have now is an industry, a powerful industry, whose products are (i) not properly tested or (ii) regulated, with drugs and vaccines regularly entering the market, causing serious patient harm, without the public being told.

The entire pharmaceutical industry is dishonest, corrupt and fraudulent; and it is supported in this by medical science, national governments, and the mainstream media. The court cases listed here demonstrate that the primary purpose of the drug companies is to make profits. Public safety has never been a major concern for them.

Postscript. What happens when a drug company is faced with an independent safety study?

• Pfizer applied for an Emergency Use Application for its Covid-19 vaccine in India. 
• The regulator asked the company to undertake an independent safety study, to determine if the vaccine was safe, and generated an adequate immune response.
• Pfizer refused to conduct a local safety trial, and instead withdrew its application!

This is how drug regulation should work. India is prepared to protect its citizens, at least in this instance. Why are our governments failing to do so?

 

The Demise of Pharmaceutical Drug Regulation: there is no effective system for protecting patients from drug/vaccine harm

Pharmaceutical Drug Regulation has only one purpose - safeguarding patients from drugs and vaccines that can cause serious harm.

The main problem with drug regulation, around the world, is that it no longer protects patients. The process has been taken over by the pharmaceutical industry.

The origins of the existing system of drug regulation goes back to the Thalidomide tragedy of the 1960's, after which most countries adopted a formal process of drug regulation along similar lines. It was a good, logical process. But 'the regulated' is now in control of 'the regulated' - so the system no longer works.

In the first stage of drug regulation, any new drug and vaccine have to be tested by medical science, and as I have written elsewhere, medical science is funded largely by the drug industry, so is under the financial control of the pharmaceutical industry.  

What this has meant, increasingly, is that new drugs have been approved for use that have caused serious patient harm. 

So there have been a plethora of pharmaceutical drugs, all fully tested by medical science, and approved by drug regulators, that have had to be banned or withdrawn over the years - although only after many years, and following considerable patient harm. Worse, pharmaceutical companies have created new drugs, and marketed them to patients in the full knowledge that they can cause serious patient harm. This is all a matter of record, not debate - follow the blue links to read more.

The pharmaceutical industry, in close alliance with medical science, has a long, largely hidden history of dishonesty, corruption and fraud.

Hence, the importance of the second stage of drug regulation - the reporting system. Many of the drugs and vaccines that are being prescribed to patients today will be harming patients, and so will ultimately be banned or withdrawn. Albeit in hindsight, the reporting system should be protecting patients - but it isn't. The reporting process is, or rather should be, a simple one.

1. A drug or vaccine is prescribed a drug, and it is taken by a patient.
2. The patient experiences a side effect, or adverse drug reaction.
3. The patient should be routinely asked to report “any suspected side effect”. The patient does not have to prove a link between the side effect and the drug - it is sufficient to suspect a link.
4. When informed, the doctor is then legally obliged to report the side effect, or the adverse reaction, to the national drug regulator.
   
5. The drug regulator is then obliged to (i) record all reported side effects and adverse reactions, and (ii) to intervene in the interests of patient safety when they believe that a drug is causing serious harm to patients.

The ignorance and non-compliance surrounding this process is much in evidence. The system breaks down at each and every stage. The result is that several studies have shown that only about 1% of serious adverse drug reactions are ever reported to drug regulators. This is how drug reporting is subverted - in the interests of conventional medicine and the pharmaceutical industry.

• The patient takes the drug, having been told (invariably) that it is both safe and effective. Most patients are not aware of the reporting system, nor are they told about it.
  
• The patient, who does not expect to experience a side effect from a drug that has been declared as being "safe", will often assume that an adverse drug reaction is part of the illness, or even part of the healing process. So for a variety of reasons they do not report it. The doctor is, after all, very busy!
  
• When a patient does report an adverse drug reaction they often face a 'defensive' doctor; it is, after all, the doctor who has prescribed the drug, usually after telling the patient it was entirely safe. And in any case the doctor is busy, and reporting to the drug regulator takes time. So, too often, the patient is often told that it is NOT a drug side effect - and the matter is left unreported.
  
• The non-reporting of adverse drug reactions was recognised to be a problem in or around 2008, and consequently patients were given a direct route to the reporting system that does not involve the doctor. However, very few patients know about this, or how and where to do this. When was the last time you remember being told about reporting adverse drug reactions? And so, yet again, it is not done.
• So drug regulators receive reports of only 1% (and probably far less) of adverse drug or vaccine reactions. In other words, the harm that is being caused by pharmaceutical drugs and vaccines is discounted by at least a factor of 100. This enables the drug regulator to tell doctors, and for doctors to tell their patients, that adverse drug reactions are "rare" or "uncommon".
  
• Yet even when a drug or vaccine is known to cause serious adverse reactions, drug regulators rarely intervene quickly. The data is supposed to be evaluated "by a team of medical safety experts", made up of "doctors, pharmaceutics and medical scientists" to identify "previously unknown" safety issues. Yet too regularly, national drug regulators prefer to allow patient harm to happen over a period of several years; until such time, that is, that the issue can no longer be kept from the public view. 
• So reports of adverse drug reactions are always counted, and then published. They have to be, by law. So they appear on obscure government websites; but, too often, little else is done, and the general public is not informed.

One of the most serious problems is that the entire reporting process is conducted by senior members of the conventional medical establishment, who usually have strong links to the pharmaceutical companies. So drug regulators usually have strong vested interests in the success, and the profitability, of drugs and vaccines they are supposed to be regulating.

I wrote a blog in July 2021 that linked this flawed process to the reports of serious adverse reactions to the Covid-19 vaccines. It outlined the large and growing numbers of patients reporting serious adverse vaccine reactions to the vaccines, and looked in detail at how the UK's drug regulator were discounting the patient harm being caused by the vaccines. No action was being taken to protect patients. Six months on there is still no action. In the UK, 2,000 people have reported to the MHRA that a patient has died shortly after taking one of the vaccines. There is still no action being taken to protect patients. Indeed, the general public is still unaware that this is happening. The government continues to insist that the Covid-19 vaccines are safe. Conventional medicine continues to inject these vaccines into people's arms, into their bloodstream. The mainstream media goes along with this misinformation.

This is a description of a failed system, a system designed to protect patients from harm that does not work. National drug regulators are aware of the data, it is their data; but for some reason the general public is not being informed.

My July 2021 blog has produced considerable criticism from supporters of pharmaceutical medicine, most of whom are disparaging about the drug reporting scheme, even question the veracity and validity of the huge numbers of reported adverse reactions to Covid-19 vaccines. They say....

• reports to not prove prove a link between the adverse reactions and the drug, 
• the reports are fabricated by 'anti-vaxxers' who do not like pharmaceutical medicine,
• the number of reported adverse reactions is small in comparison to the number of people who have been vaccinated,
• that even those who died "would have died anyway",
• or even that reports cannot be true as the 'scientific' testing of the vaccines did not suggest that the vaccines caused this kind of reaction.
  

Such criticism appears to be entirely ignorant of the purpose of drug regulatory agencies. It accepts that reports can be dismissed or discounted without any action being taken to investigate.

Even national drug regulators themselves state on their websites how important it is for patients to report adverse reactions - this taken from the UK's MHRA.

            “Data we gather from the Yellow Card Scheme are vital in our work to protect the public, by ensuring that drugs are used safely.  We need the data in order to continue identifying new side effects and ways in which the risks of recognised side effects can be minimised.  Every report we receive contains potentially useful information - without the reports, we simply would not be able to continue this important work."

        “Side effects reported on Yellow Cards are evaluated, together with additional sources of information such as clinical trial data, medical literature or data from international medicines regulators, to identify previously unknown safety issues. These reports are assessed by a team of medicine safety experts made up of doctors, pharmacists and scientists who study the benefits and risks of medicines. If a new side effect is identified, the safety profile of the medicine in question is carefully looked at, as well as the side effects of other medicines used to treat the same condition. The MHRA assesses the balance of risks and benefits of all medicines at the time of initial licensing and throughout their use in clinical practice..... The MHRA takes action, whenever necessary, to ensure that medicines are used in a way that minimises risk, while maximising patient benefit.”

Yet here we have supporters of pharmaceutical drugs and vaccines stating that reports of side effects are questionable, that it is okay for thousands of people to be killed by a vaccine, that there is no need to take action to protect patients.

So, not only have the pharmaceutical establishment taken control of national drug regulators, the whole purpose of drug regulation is being trashed by people who do not support the idea that patient should be safeguarded again drug and vaccine harm. 

And this is why reports of adverse reactions can be ignored, dismissed, discounted. There is no effective system for protecting patients who are harmed by pharmaceutical drugs and vaccines.

Pregabalin has killed at least 131 patients in the last two years in the UK alone. But Britain's drug regulator states it will take no action. So who is protecting us?

The Conventional Medical Establishment (CME) routinely prescribes dangerous drugs to its patients. They cause illness, disease, and death - but little or nothing is ever done to protect us from them.

Pregabalin is an anti-epileptic or anti-convulsant drug which has recently returned to my attention in two Pulse articles. The first article, published on 20th August 2021, was entitled "Northern Ireland GP's told to stop initiating pregablin for neuropathic pain amid deaths rise".

        "According to the Northern Ireland Statistics and Research Agency, there were 77 drug-related deaths involving pregabalin in 2019 - appearing in 40% of all drug-related deaths recorded that year - rising from 54 in 2018."

A routine report? Surely, this was the CME doing what it should be always do, something most people assume it usual does - to protect patients from pharmaceutical drugs that cause them harm.

The second article, published on 27th September 2021, was entitled "MHRA (the UK's drug regulator) has no plans to curb pregabalin prescribing by GP's".

    "The drug was removed from the country’s formulary as the preferred option for the treatment of neuropathic pain but GPs will still be able to prescribe pregabalin where they deem it to be ‘clinically appropriate’. Now the MHRA has confirmed to Pulse that it has no plans to limit prescribing of gabapentinoids, including pregabalin and gabapentin."

So this was the CME doing what it normally does: very little, or nothing at all, to protect patients from pharmaceutical drugs, even though the CME admits that the drug killed 77 patients last year, and 54 patients the year before.

This is not a unique situation. It has happened to all pharmaceutical drugs over the years, dangerous, but banned only after years, sometimes decades, of patient harm. This is why we cannot, and should not, ever be assured that the drugs doctors prescribe today are safe.

I have written about Pregabalin before. In April 2020 I wrote an article that reported a similar situation,  "Health, Safety & Pharmaceutical Drugs. Pregabalin/Lyrica causes death each and every year - but doctors can continue prescribing it! So this is not a new problem that the CME does not know about!

Further back, in June 1917, I wrote "The NHS, Pfizer and Lyrica. Corporate Profit and Patient Harm", in which I described pregabalin (or Lyrica as it was then known) as "a nasty little drug, with lots of nasty side effects", including infection, ataxia, blurred vision, constipation, diplopia, dizziness, drowsiness, fatigue, headache, peripheral edema, tremor, weight gain, visual field loss, accidental injury, xerostomia, abnormal gait, abnormality in thinking, amnesia, arthralgia, asthenia, cognitive dysfunction, confusion (dementia), edema, neuropathy, sinusitis, speech disturbance, vertigo, visual disturbance, myasthenia, and amblyopia.  

At this time, death was not listed amongst its "side effects". Nor is it still! Note that "death" is still not listed as a "side effect" on the Drugs.com website, a website that is supposed to provide doctors and patients with a complete list of side effects for every pharmaceutical drug.

The simple moral we can take from this simple tale is simply this.....

• ANY PATIENT WHO AGREES TO TAKE A DOCTOR-PRESCRIBED DRUG SHOULD NOT ASSUME THAT THE DRUG WILL BE SAFE, THAT IT WILL NOT CAUSE THEM HARM!

• NONE OF US CAN BE ASSURED THAT OUR DOCTORS ARE SUPPORTED BY A STRUCTURE THAT PROTECTS PATIENTS FROM HARMFUL PHARMACEUTICAL DRUGS AND VACCINES!
  

So we all need to be aware of how the CME operates, and avoid all of them.

 

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.

SUMMARY

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

Conclusion

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!

1. INTRODUCTION

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.

2. YELLOW CARD REPORTS

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.

3. ANALYSIS OF DATA

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.

4. CONCLUSION

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."

REALLY?