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Wednesday, 2 February 2022

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drugs, all fully tested by medical science, and approved by drug regulators, that have had to be banned or withdrawn over the years - although only after many years, and following considerable patient harm.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and vaccines that are being prescribed to patients today will be harming patients, and so will ultimately be banned or withdrawn.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.