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Monday, 12 October 2020

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.