Search This Blog

Friday 17 May 2024

Informed Consent to Pharmaceutical Medical Treatment. What information do patients' require?

Informed consent is important in medicine. It is especially important in Conventional (Pharmaceutical) medicine which has a long history of causing patient harm. (Click here for a list of withdrawn and banned medical drugs prescribed by doctors, especially over the last 70 years). Conventional medicine has always emphasised the importance of informed consent. For example, the UK's National Health Service (NHS) states that: 

            "For consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision. The meaning of these terms are:
    * voluntary – the decision to either consent or not to consent to treatment must be made by the person, and must not be influenced by pressure from medical staff, friends or family;
    * informed – the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead;
    * capacity – the person must be capable of giving consent, which means they understand the information given to them and can use it to make an informed decision.”

Yet conventional medicine has a poor record in assuring that the patients have given their "voluntary informed consent" when it comes to the prescription of pharmaceutical drugs and vaccines. Conventional medicine is adept at informing us of the 'benefits' of drugs/vaccines; but they have been less ready to admit to the serious adverse reactions they can cause.

Indeed, in many during the recent Covid-19 pandemic it was clear that conventional medicine was prepared to mandate (force) patients to be vaccinated, without their consent, with vaccines that were (are) by its own admission 'experimental'. Even by the rather 'carefree' standards of pharmaceutical drug testing, were not fully or properly tested.

In December 2023 the USA drug regulator, the FDA, appears to have ditched the concept of voluntary informed consent entirely when it issued a 'final rule' providing an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject, and includes appropriate safeguards to protect the rights, safety and welfare of human subjects. This is, perhaps, thin edge of a very hefty wedge? Or perhaps, for a fundamentally dishonest industry, it is now trying to find reasons to ignore this principle altogether. Remember, at the time conventional medicine told us that Thalidomide, Vioxx, Avandia, Acomplia, Opioid painkillers, Sodium Valproate, and many others, came with "appropriate safeguards to protect the rights, safety and welfare of human subjects"! And they killed patients!

Conventional medicine has always been highly secretive about its treatments. Electro-Convulsive Treatment continues to be used on mental health patients (perhaps less now than before) quite regardless of the lack of evidence for its efficacy. But it is the prescription of pharmaceutical drugs/vaccines, and their adverse effects on patients, that most secrecy exists. Remember, "the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead" (my emphasis). The reverse is usually true.

  • Often the patient will not be told about 'side effects' at all.
  • Or they are told only of minor 'side effects'.
  • Or the serious 'side effects' are minimised, discounted, described as "uncommon" or "rare".
  • Or, when the patient suffers a side effect, the doctor assures the patient the drug was not the cause.
  • Or a patient suffers serious harm, and conventional medicine completely denies any link.

I wrote about informed consent in May 2012. This blog was in response to a report that described, in some detail, the problem of medical paternalism (I am a medical professional - I know best - you should/must take this drug - it is "safe and effective" - and I don't expect to be questioned). The report said that:

            "Doctors are deliberately withholding information about the dangers of some routine screening and clinical procedures - often because they fear patients would then refuse treatment".

In other words, doctors were refusing to give patients information which might help them make an "informed choice", that is, a choice different to the decision of the doctor! The report suggested that patients should ask the following questions before agreeing to take any prescription drugs:

  1. How long has the drug been on the market (if less than 2 years ask for an 'older generation' drug)?
  2. Can you confirm I am not taking part in a drug trial?
  3. Is the drug suitable for my age/gender/condition?
  4. Are you using this drug 'off-label' or for the condition for which it was originally licensed?
  5. Are there any special warning or 'black-box' alerts for this drug?
  6. Can you explain to me the known side-effects and the likelihood of me suffering them?
  7. Has the drug been tested among people similar to my own age/gender?
  8. Do you know if the drug has been banned from use in other countries? (Note, many drugs which are banned in one country are still sold and prescribed in others).
  9. Have you given this drug to other patients? If so, have they reported any adverse reactions?
  10. Is the dose you are recommending within the guidelines of the manufacturer for my age/ gender/ condition?
  11. Do you know if the new drug will react with other drugs I am currently taking?
  12. If I start to suffer from health problems when I take the drug, I shall stop immediately, and come to see you again. Do you agree this is the best course of action?

However, the report went on to question whether the average doctor would be able to answer many of these questions. In other words, it questions how well informed doctors are about the drugs they prescribe, and how reliant they are on inadequate, and partial information from the pharmaceutical industry, and the medical 'science' that it controls.

And then there is the question about whether medical staff are allowed to provide patients with 'negative' information about conventional medical treatment. The Telegraph has recently published a series of articles entitled "The four-step 'playbook' the NHS uses to break whistleblowers" which discuses how  doctors, who raise patient safety concerns, are confronted with systemic bullying and harassment from their managers and colleagues. 

This raises the important question - can doctors who wish to tell patients the whole truth about medical treatment actually allowed to do so?

The Telegraph articles outline how NHS whistleblowers have had their careers ruined whilc trying to raise concern about patient safety. It outlines how over 50 doctors and nurses have raised concerns about patient death, and poor patient care, and how rather than dealing with the problems raised NHS executives seek to undermine them using 4 specific tactics.

  1. Investigating the whistleblowers rather than investigating the issues raised.
  2. Bullying and Intimidatory tactics against the whistleblowers.
  3. Weaponising General Medical Council referrals to silence whistleblowers.
  4. Demotion, Disciplinary Action, and Dismissal.

Few medical professionals would want to g through this type of persecution? So the assumption must be that most do not go public with the information? So the information that the NHS does not want patient to hear about does not reach the public. And the patient has to make his/her "voluntary informed choice" without this important information.

Does this sound like an open, honest, transparent medical system to you?

Are you undertaking conventional medical treatment, or taking pharmaceutical drugs or vaccines?

Are you being denied information that would help you make an informed choice?

Even patients who were determined to obtain information about the treatment recommended to them. This link describes one woman's battle for medical information. The response she received to her questions show how careful patients must be to protect themselves from pharmaceutical harm; and the extent to which conventional medical authorities will go to ignore, discount and deny important information required by patients who seek to know the full picture about proposed medical treatment.

So 'voluntary informed consent' is not an easy, perhaps closer to impossible for the sceptical patients to elicit - which is perhaps why so many patients are seriously harmed by drugs which were given to make them well. The patient instead suffers serious iatrogenic harm which is then denied or discounted. 

No government, no mainstream news media, will assist you, as they invariably appear to follow the pharmaceutical line. An internet search might provide important information that doctors will otherwise keep secret. But even this is often difficult to find for ordinary, non-medical people to find.

One piece of advice I received when learning to drive a car, many years ago, was to assume that everyone else on the road was an idiot. It was good advice! It has kept me safe.

Similarly, I would advice any patient to assume that any doctor, if not an idiot, will not be prepared, or will not able, or willing, to tell the truth about the medical treatment you are being offered. So scepticism might just help keep you safe from iatrogenic harm!

Post Script

If you agree that informed choice is important in medicine, please have a look at the 'Free Speech for Health' website, and sign their petition.