So if we are ever to have access to a medical system that is genuinely “safe and effective” we need to be able to identify the strategies the CME uses to make their judgement that they are “doing no harm”.
Drug Regulation is central to CME’s claim to be based on the Hippocratic principle of “doing no harm”. The establishment of most drug regulators around the world was triggered by the Thalidomide scandal of the 1960’s (a pharmaceutical drug that undeniably, and very visibly harmed patients. So it came up with a regulatory system that was based on the following principles.
First, all pharmaceutical drugs and vaccines should be proven to be both safe and effective by medical science through adequate, well-controlled clinical trials. Prior to this no drug or vaccine should be prescribed to patients.
Second, once a drug is approved by the drug regulator it can be prescribed to patients, but there should then be a reporting system that enables both doctors and patients to report drug ‘side effects’. This was thought necessary in order to ensure that medical science had not ‘missed’ any adverse reactions caused by the drug.
Third, when serious side effects were reported the Drug Regulator would take quick and effective action to protect patients from harm, reviewing the evidence of harm, and if necessary withdrawing approval of the drug.
All Drug Regulation is still supposed to be based on these three simple premises. It really is as simple as that! And these principles follow the important premise, “do no harm”. The primary objective of drug regulation, before everything else, was to protect patients.
However, Drug Regulation no longer does this. Over the years/decades it has become a sham. Pharmaceutical interests have taken control of the system, in a variety of ways, and at different levels within the system. For instance,
Drug testing has been paid for by the drug companies who have a vested interest in ensuring that new drugs are quickly approved.
Medical ‘science’ soon realised that if they failed to come up with the ‘right’ results they could expect little or no further work from their paymasters, the drug companies.
So medical science became dishonest. They either designed inadequate, poorly designed drug testing trials, which were unable to pick up serious ‘side effects’, or the trial data was manipulated/corrupted to produce the required answer, and various other strategies in order to conclude that the drug was “safe and effective”.
Drug Regulators should then have reviewed/uncovered this flawed science, and exposed it to be either inadequate, dishonest, or both. Approval for the drug should not have been given. However, this did not happen, as evidenced by the huge number of pharmaceutical drugs that have been ‘approved’, but subsequently withdrawn or banned, over the last 70+ years.
The main reason for this was that the Drug Regulatory Agencies were soon ‘captured’ by the Pharmaceutical Industry. A “revolving door” staff recruitment policy was established that ensured regulatory staff were ‘pharma’ people, or who were enticed to become pharma people with the promise of lucrative contracts with drug companies after they retired from the agency.
The capture of Drug Regulatory Agencies was allowed by politicians, and never questioned by the mainstream media. The pharmaceutical industry used its massive wealth to capture and control the mainstream media (advertising revenues), governments (commercial investment), and politicians (campaign donations).
The result has been that CME doctors have been prescribing dangerous drugs that have caused serious harm to their patients.
At the time of writing (November 2025) there are serious attempts in the USA to return the Drug Regulatory System closer to its one, simple objective - to protect patients from medical harm. How successful this will be, and whether the objective is achieved, remains to be seen.
However, the room for scepticism is strong. As long as pharmaceutical medicine is dominant within health service provision I remain doubtful whether drug regulation will ever be allowed protect patients from harm! Before this can happen there are several fundamental issues that will need to be addressed, assumptions made by CME that, one way or another, will mean that no pharmaceutical drug can ever be genuinely safe. The fundamental question is simple.
Should National Drug Regulators consider pharmaceutical drugs to be safe until proven harmful?
Or should they be considered harmful until they are proven (by the proper application of honest medical science) to be safe?
Clearly, for medicine to be safe it has to be the latter. But the CME continues to support a number of ideas that run counter to this
No Gain without Pain. Conventional medicine too often accepts that there can be no ‘medicine’ without the medicine causing harm. It is the “no gain without pain” argument. We are told, routinely, that all drugs cause side effects, and this is the price patients have to pay for effective medicine. However, most natural medical therapies refute this, not least homeopathy, yet these therapies are routinely dismissed by the CME for this very reason!
The Advantages outweigh the Disadvantages. This leads to the CME’s oft-used position that the advantages of a drug or treatment outweigh the disadvantages, that the gains outweigh the pains. Whilst often stated this calculation is rarely justified beyond the bare assertion. And when examined the equation is usually found to (i) exaggerate the gain, and (ii) underestimate the pain. It is a fundamentally dishonest calculation which at some time has invariably been used to support drugs that eventually had to be banned.
Tolerance of Toxicity. Conventional medicine also states that toxic substances have certain ‘tolerance’ levels, so can be used ‘safely’ in medicines without causing harm. This stance is usually further justified with (largely unsupported) assertions that adults can take more than children and/or pregnant women. To demonstrate this I recently read this Substact article on the ‘safe’ limits for the aluminium content in vaccines. It amply demonstrates the point - that it is a means of justifying harmful medical treatments.
Built-in Delay. The Regulatory Reporting system has an inbuilt delay. This means that patient harm has first to be reported before any action can be taken to protect them. Usually before action is taken the horse has already bolted, indeed many thousand ‘horses’ - all of which may have been seriously harmed.
How much reported harm is necessary before action is taken? In recent years it has become clear that the number of reports considered ‘normal’ or ‘acceptable’ has been greatly expanded. For example, since 2021 there have been many thousands of reports that the Covid-19 vaccines have caused death. Previous vaccines have been withdrawn on the basis of just a handful of reported deaths. Yet the CME is still promoting the Covid-19 vaccines. Reports of drug/vaccine harm can go through many years, often many decades of pharmaceutical inaction, obfuscation, and denial before any action is taken to protect patients.
Medical Justifications and Excuses. Where there are significant numbers of patient harm reports these are to often, almost routinely now, dismissed as “not proven”; or “no conclusive evidence” - so nothing is done. Excuses, like “correlation is not necessarily proof of causation” are trotted out as an excuse for inaction, for not looking further into the correlation between treatment and patient harm. One of these situations, recently reported, can be seen in this Medscape article on Acetamorphen and Autism.
Patient Redress. So patients who have been harmed by pharmaceutical drugs/vaccines find it difficult/impossible to hold the drug companies to task. They have to prove that the harm was caused by the drug/vaccine, with drug companies obstinently denying responsibility. With vaccines the government has given drug companies protection against liability, and this usually makes the task much more difficult.
Why were harmful drug side effects not discovered earlier? Often, when reports of serious patient harm have been reported, it has been found that drug testing should have identified the harm, or had actually identified the harm. But this somehow went unnoticed in the original clinical trials, or was never reported. However, when this happens, medical science and/or the drug companies, are rarely called to task for the failure.
The full seriousness of drug side effects are not recognised. When the cause of any disease is discussed a wide variety of causes are usually mentioned, whether environmental, dietary, stress, genetic, et al. But there is usually one cause that is routinely/usually ignored. This is highly dubious as any pharmaceutical drug/vaccine/treatment with known side effects (which means most conventional drugs/vaccines/treatments!) have had them published, openly within conventional medical literature. They are not hidden, although rarely highlighted. So why do they continue to be ignored when considering the cause of disease?
The CME, dominated as it is by the pharmaceutical industry, faces considerable opposition at the moment, particularly since the Covid-19 debacle. Even so politicians, governments, and the mainstream media (certainly outside the USA) continue to ignore, discount and dismiss the culpability of pharmaceutical treatments. There appears to be two schools of thought.
One, by far the largest, arises from more thoughtful and critical critical members of the CME, who believe that the main problem with pharmaceutical medicine is (i) the corruption of the industry, and (ii) the failure/capture of the regulatory system. Their position seems to be that if medical science can be returned to honesty; if the regulatory system is made truly independent of commercial, then all will be well. Safe and effective treatments will gradually emerge and come to the fore which will not harm patients. The old promise of medical science will be reborn.
The second school of thought is more dubious about this happy re-emergence of so-called ‘scientific’ medicine. The history of conventional medicine, over the last 800 years should warn us about this: conventional medicine does not have a good track record, even before the failure of drug regulation. Historically it has used ‘heroic medicines’, usually drugs based on mercury (Calomel) or opium (Laudemum) - and continues to do so. Conventional medicine may believe itself to be more sophisticated now - and it probably is! But if it was able to produce successful/safe drugs/vaccines it would surely have done so by now! Yet the ‘scientific’ development of medicine through the 20th century, right up to today, continues to use treatments that promise much, but deliver little.
And many more people, who question the safety and effectiveness of conventional medicine, are now realising that there are safer and effective medical therapies - natural medical therapies. And they see these as part of the necessary future of medicine.
