DRUG REGULATION. Reporting Pharmaceutical Drug Side Effects. Do doctors take their responsibility seriously?

Conventional medicine admits that pharmaceutical drugs can produce serious adverse reactions to our health; in other words, that they can do harm to patients. However, as this blog will demonstrate, doctors usually fail to report serious drug side affects do so with their patients.

After the Thalidomide tragedy of the 1960's, a comprehensive system of drug regulation was introduced, designed to stop patients being harmed by drugs. It is still in operation today; or at least it should be. (To read a critique of drug regulation, as it exists throughout the world, click here). An important part of the regulatory process was the reporting of side effects to the drug regulator.

In addition, this blog has regularly referred to several studies that have demonstrated that only between 1% and 10% of drug side effects (at best) are ever properly reported.

My recent experience of two NHS patients, both of whom I know well, have demonstrated that the process of drug regulation, and in particular the reporting of drug side effects, is not working. And it is not working because conventional doctors are not using the reporting system, but actively ignoring it.

This situation raises serious questions about whether patients can make an informed choice, about health freedom and patient choice, and the honesty of conventional medicine.

• All adverse drug reactions, or 'side effects' as they are euphemistically called, are supposed to be reported by doctors, not as a matter of personal judgement, but as a matter of routine.
• And doctors are supposed, if not obliged, to tell their patients of the known and suspected side effects of the drugs they prescribe.
  

TP. The first patient is a woman in her late 80's. Only a year ago I commented on her health; that she was so well for her age, fit and fully active, and on no medication (except for eye drops taken for her long-term glaucoma). I linked these two facts together, as I always do; people who do not take pharmaceutical drugs remain healthier for longer. 

Then TP went to see her doctor as she was worried (she is an inveterate worrier) about her high blood pressure. She was given drugs, and her health has deteriorated seriously since that time.

Her doctor gave her Amlodipine for the high blood pressure. This drug has a long list of side effects; but her doctor did not tell her about these; and TP did not read the Patient Information Leaflet (PIL). So few people ever do - they assume that their doctor will not give them drugs that will do harm. So when, over the next few months, TP began to complain of slow and irregular heartbeat, fatigue, joint and muscle pain, loss of appetite, nausea, swelling of ankles and feet, difficult urination, dizziness, anxiety, depression, and loss of memory, I suggested that these were not the result of old age, or high blood pressure (as she assumed, and other people told her) but were adverse drug reactions to Amlodipine.

This is not a popular diagnosis! Certainly, when this possibility was mentioned her doctor did nothing; even though she is supposed to know about adverse reactions, and to report them when potential side effects are reported by a patient. And TP herself did nothing; on the basis that her doctor would not give her anything that would cause such problems.

So the situation continued. TP's health declined until she was admitted to hospital, where she stayed for 3 days. When she was discharged the drug regime had changed. She had been taken off Amlodipine, but now she was taking 3 drugs, Bisoprolol, Losartan, and Eliquis. Again, hospital staff did not tell her about the side effects of the new drugs, and she did not did bother to read the PILs which came with them. For 2-3 weeks she seemed to be much better; relief was expressed that the hospital had sorted out her medication, which was now working properly. 

But gradually she became unwell again, with many of the old side effects returning, and a few new ones. The worst of these was increasing short-term memory loss and confusion. Her friends were now worried that she was suffering from dementia, after all, she was in her late 80's now.

I pointed out, in vain, that all the 3 drugs she was now taking were known to cause 'confusion'. It was a 'side effect' clearly stated on each of the PILs. 

But obviously (sic) a hospital specialist would surely not put her on drugs that might harm her. So she continued taking them, and her confusion got worse, quite quickly. TP's doctor was informed, and also asked whether the 3 drugs might be the cause of her confusion. This suggestion seemed to make little difference; the drugs were not stopped, even temporarily. Yet if her drugs were causing confusion the problem could be treated simply, and probably resolved, by taking her off the drugs!

But conventional medicine is loathe to admit that pharmaceutical drugs can cause serious illness and disease, even when their literature tells them that it does. So instead she was sent for a blood test. And her doctor informed her that she would be given a dementia test. 

"First, do no harm" does not appear to be something that is alive and well within conventional medical practice.

SL. The second patient is a man in his late 40's. SL is not someone who supports conventional medicine, he has been a user of homeopathy for most of his life. However, following an sport-related accident, which led to headaches, and difficulty finding words, he was given an MRI scan which, to everyone's surprise, discovered a sizeable tumour on his brain. He was sent for another, more detailed MRI scan; but this time he was to have an injection - to improve the quality of the scanned image. SL told me that he asked the doctors what the injection was, but they were reluctant to tell him. Eventually, at his insistence, he was told it was Gadobutrol (Gadovist). He insisted on having the box, and the PIL that came with the drug, so that his homeopath could have a look at it. This is how the PIL describes the side effects of Gadivist - click here to read the PIL for yourself.

"The most serious side effects (which have been fatal or life-threatening in some cases) are:

• heart stops beating (cardiac arrest) and severe allergy-like (anaphylactoid) reactions (including stop of breathing and shock).

 

In addition for the following side effects life-threatening or fatal outcomes have been observed in some cases:

• shortness of breath (dyspnoea), loss of consciousness, severe allergy-like reaction, severe decrease of blood pressure may lead to collapse, stop of breathing, fluid in the lungs, swelling of mouth and throat and low blood pressure."

Thousands of people, throughout the world, have MRI scans, every day; and it seems likely that most of them, the vast majority, either do not bother to ask about either the side effects of the scan, or this drug; do not read the PIL; and are not told about its dangers by doctors.

The Gadovist PIL went on to describe a multitude of other known (and officially accepted) adverse reactions caused by the drug, although as usual they are always heavily discounted.

• "Like all medicines, this medicine can cause side effects, although not everybody gets them".
• "In rare cases".
• "Uncommon".

Yes, they many indeed be uncommon and rare....

• if very few side effects are reported by doctors; 
• if known side effects are routinely kept from patients by their doctors; 
• if , when side effects are mentioned, they are accepted or properly reported by doctors; 
• if patients are not told, and discouraged from finding out about drug side effects;
  
• and not encouraged to report them when they experience them.

Both these cases demonstrates that all is not well with drug regulation, the system designed to keep patients safe, and free from the harm pharmaceutical drugs are known to cause. Moreover, they suggest that it is the doctors, the people who are supposed to administer the system, who are largely to blame.

If these two cases are typical of what is going on within conventional medicine, and my experience is they are, then drug regulation is not happening, it is being circumvented and ignored. 

This means that patients are routinely at risk of harm. Informed patient choice and health freedom cannot exist without full and freely available information. And it would appear that this is not provided - unless patients (like SL) actually demand it.

 

Doctors under-report side effects of drugs and vaccines, which makes them 10 times more dangerous than they tell us

A study, reported in the Journal of the American Medical Association, (2006; 296: 1086-93) found that whilst prescribing doctors should be reporting side effects and adverse reactions in his patients many do not do so. In fact, the actual rate of reporting was found to be alarmingly low - about 10 times below the optimum level set by the World Health Organization. The study report procedures amongst doctors in Portugal, where 26 adverse reactions were reported per 1 million population, whereas WHO say that this should be closer to 300 report per million people.

The researchers said that this under-reporting was not restricted to Portugal, and that the USA, Canada, Italy, Sweden and the UK also have very low reporting rates

Commenting on this study WDDTY said that if the WHO targets were reached, the whole drug industry would 'grind to a halt', and of course, that would never do!

In the Guardian, on 12th May 2006, Sarah Bosely wrote that the BMA had said the Yellow Card scheme was not being used enough. The article quoted BMA figures that at least 250,000 people went to hospital each year because of the damaging side-effects of medication, and that about 5,000 die. As a result the BMA was urging doctors to be more vigilant, and to report any suspected side-effects their patients might experience. They said that only an estimated 10% of adverse drug reactions were currently reported through the "yellow card" scheme to the MHRA. A BMA spokesperson said

           "Doctors have a professional duty to report all adverse drug reactions, especially if children or the elderly are involved. Unfortunately too many health professionals are confused about reporting procedures. Doctors must make sure they report any suspected [adverse drug reactions] and at the same time increase awareness among their patients about the reporting process".

Another BMA spokesman said that not all side-effects could be picked up in clinical trials before the medicine is licensed, which meant that greater vigilance was needed on the part of doctors, pharmacists and nurses. In the same article the MHRA urged healthcare professionals to use the yellow card scheme. It said

          "There is no need to prove that the medicine caused the adverse reaction, just the suspicion is good enough" 

The article concludes by saying that it has long been known that doctors did not report all the suspected side-effects their patients tell them about, and that 10 years earlier the BMA had issued similar guidance to doctors - but with little effect. So what does this mean, in practical terms? 

It means that if only 10% of the known DIEs of a drug or vaccine are reported, these drugs and vaccines are 10 times more dangerous than the conventional medical establishment realises, or accepts.

Yet there is another issue, and that involves the honesty and transparency with which the conventional medical establishment deals with issues about the dangerousness of drugs. In an Observer article published on 20th January 2008, Dennis Campbell reported that Steve Walker, chief executive of the NHS Litigation Authority, said that doctors must own up to the mistakes they make in order to cut down on compensation claims that were totalling £613 million annually. He called for a new culture of honesty and openness.

Negligence lawyers say that the main reason a number of victims take legal action is to obtain more information. 'The message to doctors is: if you're aware of an error, or a shortfall in what's been delivered, you should feel free, indeed you should feel under an obligation, to tell your patients and to apologise and to explain, either verbally or in writing, even if the patient is likely to sue,' he told The Observer. 

           "The explanation bit is really important to many, many claimants. It doesn't matter if it heads off a claim or encourages a claim, people as human beings and patients are entitled to this and they should be getting it. Some patients are dissatisfied by not getting this information already. Some patients and patients' relatives feel short-changed by the system. They believe there's a lack of honesty, of frankness and of candour.'

The NHSLA handles some 5,400 claims every year for clinical negligence in England. Walker wants doctors to 'sympathise with the patient or the patient's relatives' where someone has died and to 'express sorrow or regret' at any death or injury which followed substandard care. He has put his advice in writing to every hospital in England and will do the same to doctors, midwives and nurses through their professional bodies.

          'I feel, and this authority feels, very strongly that people are entitled to know when something has gone wrong; entitled to an apology if something has gone wrong; entitled to an explanation of what went wrong and why, in words that they will understand; and entitled to the opportunity to ask questions about what happened and why,' Walker said. 'While some hospitals already do these things, I want to see the NHS adopt this as universal good practice.'

Whilst this kind of testimony is often made, it is usually done within the context of doctors, or some other medical staff. making a mistake or error. 

What this ignores is that the medicines conventional doctors use are inherently dangerous.

It is a matter of inadequate and dangerous tools being defended, whilst those who task is to use those tools are blamced for the problems that arise from using them!

Often the conventional medical establishment will be heard calling for more honesty and transparency, and the importance of admitting that mistakes have been made. Yet, as this book will show time and time again is that dangerous drugs and vaccines are being prescribed, and the DIEs they cause are either not known, they are denied, or or they are heavily discounted. 

There is little honesty or transparency within the conventional medical establishment about the dangerousness of pharmaceutical drugs and vaccines, either before, during and after their prescription. 

As a result, many people will read this book and find it hard to believe how common illness and diseases, many at epidemic proportions, some never known before the present era, are known to be caused by conventional drugs and vaccines. They will be surprised because their doctors have never told them!

This article was first published in the Ebook, "DIE's. Disease-Induced-Illness".

 

Postscript February 2022

A German health insurance company has recently discovered that the adverse reactions to the Covid-19 vaccines were seriously under-reported in official government data - an 'independent' corroboration of the above article.