Who Protects Patients from Pharmaceutical Drugs and Vaccines?

We have a fairly uniform system of pharmaceutical drug regulation, in force in most countries of the world. The current system was brought in after the Thalidomide tragedy of the 1970’s. Its primary purpose, really its sole purpose, was to protect patients from being harmed by dangerous pharmaceutical drugs and vaccines. It has two main components.

• First, new drugs are tested by medical science.
• Then, national drug regulators examines the scientific evidence that has been found for the efficacy, and the safety, of the new drug. It is the drug regulator that determines whether the new drug should be approved for public use.

Unfortunately the system does not work (A List of Banned and Withdrawn Drugs).

This is evidenced by the large, and ever growing number of new drugs, brought to the market over the years, having been tested by medical science, and approved as ‘safe’ by the drug regulators, then sold to patients for many years, often decades, only to be withdrawn and banned - because ultimately they have proven to be dangerous, and to have caused serious patient harm.

The main problem with the drug regulation is that during the last 50 years the pharmaceutical industry has taken over control of the entire regulatory process.

• Medical science makes its living testing drugs. The pharmaceutical industry pays them to do so. Yet if any scientist, or any science company, puts up too many obstacles to new drugs entering the market, they know that they will not used any more. So they go either go out of business; or they comply with the interests of the drug companies. So most ‘medical science’ has been bought and paid for - it is controlled by the drug industry.
  

• The Drug Regulatory Process is also largely funded by the pharmaceutical industry; but the pharmaceutical industry has another weapon to ensure that it controls the process. It has created a 'revolving door' which ensures that drug industry personnel move into the regulatory agencies, and that agency personnel in the other direction to lucrative posts in the industry. Drug regulation has one of the most effective ‘revolving door’ policies in operation anywhere.
  

• The government is largely complicit with the process. This has been demonstrated most recently by allowing the approval of the Covid-19 vaccines in double-quick time, and promoting the vaccines for the drug companies. Why? Politicians, and political campaigns, are funded by Big Pharma; and governments want to attract pharmaceutical investments in their country. Most governments now award drug companies with indemnity against any harm pharmaceutical drugs cause - including the harm caused by Covid-19 vaccines. Certainly, governments around the world have shown little interest in making sure that drug regulation protects patients.

• The mainstream media is now also largely funded by large corporate industries, through advertising and mutual directorships of companies - not least the pharmaceutical industry. The Covid-19 pandemic has demonstrated how the mainstream media sings along with the drug companies, and is prepared to censor and exclude any, and all opposition to the pharmaceutical narrative. The mainstream media has still failed to tell the public about the harm that is being caused by the Covid-19 vaccines.
  

This leaves the patient entirely unprotected.

Patients are now at the mercy of pharmaceutical profiteering, supported by governments and the mainstream media who tell us that the pharmaceutical drugs and vaccines are we are being given are entirely safe, and amazingly effective. 

It is usually only when the levels of patient harm being caused by drugs and vaccines become undeniable that any action is taken.

So what we have now is an industry, a powerful industry, whose products are (i) not properly tested or (ii) regulated, with drugs and vaccines regularly entering the market, causing serious patient harm, without the public being told.

The entire pharmaceutical industry is dishonest, corrupt and fraudulent; and it is supported in this by medical science, national governments, and the mainstream media. The court cases listed here demonstrate that the primary purpose of the drug companies is to make profits. Public safety has never been a major concern for them.

Postscript. What happens when a drug company is faced with an independent safety study?

• Pfizer applied for an Emergency Use Application for its Covid-19 vaccine in India. 
• The regulator asked the company to undertake an independent safety study, to determine if the vaccine was safe, and generated an adequate immune response.
• Pfizer refused to conduct a local safety trial, and instead withdrew its application!

This is how drug regulation should work. India is prepared to protect its citizens, at least in this instance. Why are our governments failing to do so?

 

Social Prescribing. Is Conventional Medicine Losing Confidence in Pharmaceutical Medicine?

I have always equated 'Conventional Medicine' with 'Pharmaceutical Medicine' - for good reason. There has never been any good reason to do otherwise. The two are indistinguishable, certainly within most national health services around the world, and certainly within the British NHS. Go to see your doctor, or go to hospital, and the chances are you will be treated with a pharmaceutical drug, or vaccine. 

Yet are they now diverging? Just ever so slightly?

The reason for asking this question is an article published in the GP magazine, "Pulse" on 7th February 2022, "Will Covid signal the end of the road for over-medicalisation".

            "Social prescribing, also sometimes known as community referral, is a means of enabling health professionals to refer people to a range of local, non-clinical services. The referrals generally, but not exclusively, come from professionals working in primary care settings, for example, GPs or practice nurses."

Over medicalising? Does this mean that too many pharmaceutical drugs are being prescribed?

Social prescribing? Is the suggestion that doctors will actually prescribe "a range of local, non-clinical services" rather than the wonder pharmaceutical drugs they have been prescribing for decades?

The Pulse article continues....

        "Recognising that people’s health and wellbeing are determined mostly by a range of social, economic and environmental factors, social prescribing seeks to address people’s needs in a holistic way. It also aims to support individuals to take greater control of their own health."

No suggestion here that health can be found in a bottle of pharmaceutical pills! I wrote about social prescribing two years ago, in February 2020, when the UK's NHS were suggesting a greater use of "Talking Therapies" for depression and other mental health issues. More talking therapies, and less use of drugs? Was this, I asked, a tacit admission that pharmaceutical drugs were not the 'wonder drugs' we have been promised by conventional medicine for the last 100 years? Was this actually an admission that pharmaceutical drugs just do not work, that they caused more harm than good?

After all, if the drugs were really so wonderful, so effective, so safe, why would conventional medicine want to recommend using anything else?

The Pulse article recommended "a range of activities that are typically provided by voluntary and community sector organisations". Several examples were given, including volunteering, arts activities, group learning, gardening, befriending, cookery, healthy eating advice and a range of sports. 

Not a pharmaceutical drug anywhere to be seen!

Yet, social prescribing was described as capable of supporting many people "with a wide range of social, emotional or practical needs, and many schemes are focused on improving mental health and physical wellbeing". 

Support, without pharmaceutical drugs! An admission that would surely never have been made a few years ago - when the drug companies were busy telling us that medical science would in some future utopia be capable of transforming our lives, and our experience of illness!

        "Those who could benefit from social prescribing schemes include people with mild or long-term mental health problems, people with complex needs, people who are socially isolated and those with multiple long-term conditions who frequently attend either primary or secondary health care."

This is a large group of people. If they can be helped by social prescribing rather than taking prescription drugs it would mean much less use of pharmaceuticals. Do the drug companies approve of such a suggestion?

Social prescribing is certainly a less harmful, more positive alternative to pharmaceutical drugs, not least in that it recognises the importance to health of social and emotional interaction with other people. But coming from a journal, one of the pillars of conventional medicine, it is not a great endorsement of the treatment it has been handing out to us, in ever-increasing quantities, for the last 100 years.

It is very clearly an admission that the drug treatments conventional medicine has been using have not been successful, that the drugs have not delivered health in the way we have all been promised for so long.

So perhaps I am going to have to be more careful in future about the distinction between conventional and pharmaceutical medicine!

Postscript 29 April 2022

Conventional medicine continues to have a crisis of confidence is pharmaceutical drugs. This time it concerns painkilling drugs.

"GP's should prescribed tailored exercise and weight loss to relieve osteoarthritis" is an article in today's 'Pulse' magazine. It announcers new NICE guidelines for the treatment of osteoarthritis, thereby continuing the trend of conventional medicine moving away (slightly) from pharmaceutical medicine.

            "Updated NICE draft guidance has placed a greater emphasis on exercise and weight loss in patients with osteoarthritis, with use of strong painkillers not advised. GPs should offer tailored therapeutic exercise, such as aerobic activity or muscle strengthening, to all people with the condition as well as consider offering education or behaviour change programmes, NICE said."

It is more specific about the non-use of painkilling drugs.

            "Pharmacological treatments should be used at the lowest effective dose for the shortest possible time and topical NSAIDs should be the first choice for joint pain due to the condition. Paracetamol and glucosamine should not be routinely offered, strong opioids should not be used and weak opioids only used for short-term pain relief and when all other drug treatments are contraindicated, not tolerated or not effective."

Whether this will make any difference of how doctors treat osteoarthritis may be doubtful, but this constitutes yet another admission - that pharmaceutical drugs are not effective in the treatment of osteoarthritis.

"Save the NHS". Spend even more money - because we are now so very sick.

We need to look at why we have been asked to "Save the NHS" for the last two years.

When the NHS began, in 1948, its budget was £345.31 billion. This represented just 0.8% of the country's GDP (Gross Domestic Product) at the time. This allowed £5.24 to be spent on each person for the year.

In 2020, the NHS budget had risen to £1884.49 billion. This represented 7.36% of GDP. And £2,419.37 could be spent on each individual.

Every year, without fail, we are told that the NHS requires even more money, for more testing, more drugs and vaccines, more operations; indeed, for more of everything. And the NHS usually gets what it wants as spending on health care is popular with politicians and governments - largely because it is popular with voters.

• Yet, each and every year from 1948 to today we have got sicker!
• And it's because of this that the NHS needs more money, each and every year!

The incidence every chronic disease is now considerably higher than in 1948, most running at unpecedented epidemic levels, and still increasing. My 2021 blog, "CHRONIC DISEASE. The rise and rise of chronic diseases over the last 100 years; and the introduction of some new ones" outlined this as far as ADHD, Allergy, Alzhemier's Disease and Dementia, Arthritis, Asthma, and Autism were concerned. I outlined far more in "Epidemic of Chronic Disease: why we are sicker now than we ever have been", a chapter in my "The Failure of Conventional Medicine" e-book, including Autoimmune Disease, Birth Defects, Cancer, Cardiovascular Disease, Chronic Fatigue (ME), COPD, Diabetes, Irritable Bowel, Mental Health, MS, Osteoporosis - and many more.

• These two facts cannot be denied. 
• Health services ARE costing more, year by year. 
• And year by year we ARE getting sicker. 
• How is it possible to justify this - year by year? 
• Why is it that we fail to put these two facts together - year by year? 
• In what other sphere of life would we be prepared to pay more for less only to get more of what we don't want?

Nor is it just chronic disease that is the problem for the NHS. The Covid-19 debacle shows that it also has no answer for infections - to the extraordinary extent that government felt the need to impose social distancing, face masks, test and trace, and lockdowns on us for two years in order to "Save the NHS". The NHS could not save its patients. Its patients had to safe the NHS! And in order to do this we were prepared to seriously sacrifice our social lives, harm the economy, ruin our livelihoods, damage our children's development, put on hold their education, damage mental health, and much else.

Then, in December 2020, the Covid-19 vaccines were introduced. We were told that these vaccines would save us, and return life to normal, within just a few months. We will all be free by February! Do you remember this headline? Check it out here! And this, by the way, was February 2021.

Over one year later the Covid-19 crisis is still with us. Two dosess were insufficient; so a booster was offered; still people were going down with the virus; so perhaps a 2nd booster, perhaps an annual jab? And still people continue to catch the virus.

The vaccines are causing serious patient harm. So who is protecting the patients? Certainly not the drug regulators! Thousands of people have reported millions of serious adverse vaccine reactions, including death, following vaccination - but nothing is done - the general public is not even told.  

So why not mandate the vaccines! Let's force people who wish to remain vaccine free to get vaccinated. Let's threaten their social life, their employment, their everything. The vaccines are safe and effective.

Let everyone see just how autocratic a democratically elected government can become!

So what is happening to our health services? Why is the NHS unable to reduce the levels of illness and disease? Why is it unable to cope with infections? Why do patients need to save the NHS? Why can't the NHS save patients? Why have we got sicker, year by year? Why do we still  need to spend more and more on the NHS?

The answer is simple, but not self evident to anyone convinced about the integrity of medical science, and the power of drugs and vaccines. It is the failure to recognise several key facts, our refusal to look beyond the perceived wisdom of those pharmaceutical interests that who now dominate and control the NHS.

1. The refusal to recognise that the NHS has given a complete monopoly to pharmaceutical medicine; good health, we believe, comes out of a bottle of pills, or a vial of vaccine.
   
2. The refusal to recognise the ineffectiveness of treatment based on pharmaceutical drugs and vaccines, and their ongoing failure to reduce levels of sickness.
3. The refusal to recognise that drug/vaccine "side effects", "adverse reactions", and "DIEs", have on increasing levels of sickness, and how they have actually led to the creation of illness.

The NHS is making us sicker. And it will continue to do so until such time we are prepared to question the dominance of pharmaceutical medicine, and to critically examine its record rather than its propaganda.

In 1948, the new NHS committed to providing us with "the best medicine", and to do so "free, at the point of need". It never committed to become the slave of the rich and powerful pharmaceutical industry. The NHS has sold itself, heart and soul, and is now paying the price. 

Or rather patients are paying the price, funded by the tax payers.

 

Rehabilitating HRT. Pharmaceutical medicine continues the process.

Today, 2 February 2022, the UK's drug regulator, the MHRA, has suggested that Hormone Replacement Therapy (HRT) could become available over-the-counter without a doctor's prescription. The possibility was heralded by the BBC, always a great supporter of pharmaceutical drugs. The drug is Gina 10, or estadiol, and the BBC article goes to great lengths interviewing conventional medical practitioners, who provide reassurance about the safety of the drug. For example, they quote the NHS.

            "Some types of HRT slightly increase the risk of breast cancer and blood clots in some women, but the risks are small and usually outweighed by the benefits".

I have written before about the history of HRT drugs. In November 2015, for instance, I wrote an article entitled "Menopause Issues and NICE guidelines? HRT might cause cancer, heart problems and dementia, but what the hell, women should take it anyway! In this I quoted from the British Medical Journal in , 2007 (335: 239-44).

            "Eventually, several trials produced results that were so bad they had to be discontinued. In 2002, trials conducted by the Women’s Health Initiative in the USA, described as 'the largest and best designed federal studies of HRT'  was halted because women taking the hormones had a significantly increased risk of breast  and cervical cancer, heart attacks, stroke and blood clots. More trials were terminated in 2007, when a study of 5,692 women taking HRT raised similar concerns but added 'more definition to the health risks'.

At the time I suspected that this might prove to be the end of HRT, but I clearly underestimated the ability of the conventional medical establishment to promote and sell dangerous drugs.

My 2015 article now contains several subsequent postscripts about conventional medicine's attempts to 'rehabilitate' hormone replacement therapy. The BBC enumerates how successful this rehabilitation has been. From a complete ban on HRT drugs in 2007 it states that 150,000 women are now prescribed HRT.

 So perhaps Gina 10, or estadiol, is different, perhaps it is safer? The BBC certainly wants us to believe this. It quotes one doctor.

            "It's different to HRT and it doesn't reduce the health risks of the menopause, but it is very safe".

 Whenever I hear a conventional doctor saying that a pharmaceutical drug or vaccine is safe, I run for cover! So I went to the drugs.com website to check. It makes horrendous reading, and contains one of the longest "warning" boxes that I have ever seen. I will not reproduce it here, the above link can be easily accessed.

Yet any woman who is considering taking this drug, it is important to read this information before making their decision. An "informed decision" is only possible after reading it - as it is clear conventional medicine will never be honest about the safety of their medicines.

• The BBC, as usual, are willing to promote a pharmaceutical drug, regardless of how dangerous it might be. 
• Conventional medical doctors may be willing to toe the line, and call any pharmaceutical drug "safe".

But no patient should ever take any pharmaceutical drug without checking the known, or at least the admitted adverse reactions is can cause.

So what should a woman do, who is suffering from serious menopausal symptoms? Conventional medicine has nothing else to offer - which is one of the reasons HRT is being regularly rehabilitated by the NHS. Women should certainly not suffer in silence. There are alternative to conventional medical treatment, much safe, and more effective treatments offered by natural medical therapies.

Homeopathy is one of them, certainly the one that I would recommend.

Why Homeopathy? for Menopause.

If it does nothing else (and it will) it will protect you from the harm of pharmaceutical treatment.

 

See also my previous blogs on the dangers of Hormone Replacement Therapy.

August 2016.         HRT Treatment causes Cancer. Old News but New News.

October 2019.       BREAST CANCER. Why is it that conventional medicine does not understand that HRT is a significant cause of this? Who protects patients from harmful drugs?

November 2021.   The Menopause, HRT, and Breast Cancer.

 

 

 

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.