by Rhoda Wilson, Expose News:
In June 2023, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) announced it will be the first drug safety regulator in the world to pilot its own genetic “biobank,” to better understand how a patient’s genetic makeup can impact the safety of their medicines.
“The Yellow Card biobank, which will contain genetic data and patient samples … forms part of a long-term vision for more personalised medicine approaches … [to] enable doctors to target prescriptions using rapid screening tests, so patients … receive the safest medication for them, based on their genetic makeup,” a press release said.
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In February 2024, as a personalised medicine project, the MHRA began recruiting patients who have experienced excessive bleeding after taking blood thinners to establish whether they have any special genetic traits which predispose them to excessive bleeding.
It may sound exciting however, personalised genetic medicine is a step towards an era where drug use and experimentation on populations become the norm.
As Dr. Guy Hatchard notes, whilst most pharmaceutical drugs entail adverse reactions and unanticipated side effects, drugs that are tailored to genetic characteristics may potentially have even more serious consequences and long-term adverse outcomes. This is because genetic systems are involved in all the functions of the physiology, its organs, bio-molecular messaging and overall immunity.
The Hollow Heart of Personalised Genetic Medicine
A recent article entitled ‘Using ChatGPT to predict the future of personalised medicine’ in the prestigious journal Nature offers the following outlook:
Personalised medicine is a novel frontier in health care that is based on each person’s unique genetic makeup. It represents an exciting opportunity to improve the future of individualised health care for all individuals.
At the centre of the personalised medicine hype is a research field known as pharmacogenomics which aims to study the genetic makeup of people in order to optimise drug prescriptions. It is envisioned that future treatments will be algorithm-based instead of evidence-based that will consider a patient’s genetic, transcriptomic, proteomic, epigenetic and lifestyle factors resulting in individualised medication.
That is a big mouthful; what does it mean? Supposedly, artificial intelligence (“AI”) tools will analyse the results of various genetic tests, microbiology assays and patient questionnaires and then prescribe what drugs will suit an individual best. The falling cost of genetic testing will, according to enthusiastic advocates, enable this process to become the universal healthcare of the near future.
The article finishes with the caveat: personalised medicine still has several limitations that need to be solved. That is an understatement of gigantic proportions. To understand these limitations, we need to examine how or more correctly if people in medicine are currently using genetic tools to personalise drug prescriptions. In other words, what is really going on here?
A Project to Implement Personalised Medicine
The UK Medicines and Healthcare Products Regulatory Agency (“MHRA”) is currently undertaking an investigation into blood thinners known as direct oral anticoagulants (“DOACs”). According to the MHRA, these drugs, which include rivaroxaban, dabigatran, apixaban and edoxaban, have been found to cause serious bleeding in between 2 to 5% of patients. In some cases, this leads to hospitalisation and even death. 1.5 million patients take DOACs in the UK alone.
The MHRA has started genetic testing of patients affected with DOAC bleeding to discover whether they have any special genetic characteristics which predispose them to excessive bleeding. According to Dr. Alison Cave, the MHRA chief safety officer: “The ultimate long-term goal for us is to identify patients most at risk of harm from side-effects with a particular medicine due to their underlying genetic make-up, and avoid them suffering from that harm.”
As she announced MHRA’s move to personalised medicine, Dr. June Raine, the CEO of MHRA predicted: “Almost a third of adverse reactions to medicines could be prevented with the introduction of genetic testing.”
This All Sounds Very Exciting and Hopeful. So, What Could Possibly Go Wrong With Personalised Medicine?
Firstly, the scale of the problems associated with modern medical procedures is gargantuan. In 2016, a Johns Hopkins study published in the BMJ found that medical error is actually the third largest cause of death in the USA. Just reflect for a moment. It almost certainly became the leading cause of death during the pandemic.
One problem lies in underreporting of medical error and adverse effects of medicines. Even if medical error occurs, it is seldom listed as a cause of death on death certificates. A 2016 study also estimates that less than 5% of adverse drug reactions (“ADRs”) are reported to the relevant safety authorities.
A 2021 meta-analysis entitled ‘Prevalence of adverse drug reactions in the primary care setting: A systematic review and meta-analysis’ investigated the extent of the problem and found that reactions to cardiovascular system drugs were most commonly implicated. These usually involve excessive bleeding following the administration of blood thinners. According to the study, 23% of all adverse drug reactions are preventable. So, is this a powerful argument for personalised medicine? No, because the data, the science and the known risks do not square with the public relations hype.
The 2-5% of people thought to be affected with serious bleeding by DOACs is an underestimate, the likely percentage is much higher due to underreporting of ADRs. Crucially another very important factor to consider is non-adherence to the prescribed drug regime. Only around two-thirds of patients persist with DOAC use. Collectively, these factors mean that the real-world rate of serious bleeding from DOAC blood thinners possibly exceeds 10% of patients. A very high rate of adverse effects which is no doubt driving MHRA concerns.
The problem doesn’t stop there. Excessive bleeding is not the only adverse effect associated with DOACs. For example, the prestigious Mayo Clinic lists 17 common adverse effects of Rivaroxaban. Other than multiple different types of bleeding, these include paralysis, headache, back pain, bowel or bladder dysfunction, leg weakness and numbness.
Blood thinners aim to reduce blood platelet counts and aggregation because platelets are responsible for clotting and are therefore involved in various types of thrombosis and heart disease – but that is not all platelets do. They also play a vital role in maintaining immunity, preventing tumour growth, maintaining the composition and stability or haemostasis of blood, and preventing leakage from blood vessels which can be associated with the metastasis or spread of cancers. Therefore, blood thinners inevitably have a range of serious side effects irrespective of anyone’s genetic composition.
What is the Proposed Net Result of the Current MHRA Personalised Medicine Investigation of Blood Thinners?
In essence, if one type of blood thinner proves unsuitable, doctors will simply recommend another drug.
Patients having an adverse reaction to DOACs are often switched to antiplatelet medications such as Clopidogrol, Ticagrelor, Prasugrel, etc. However, these medications have a broad range of side effects very similar to DOACs. For example, the Mayo Clinic lists 25 common side effects of Ticagrelor antiplatelet medication. Aside from excessive bleeding, these include chest pain, confusion, blurred vision, loss of consciousness, irregular heartbeat, paralysis, nervousness, and weakness. Hardly a picture of heart health. These serious side effects are not usually mentioned by doctors. Millions of people are prescribed this class of drug without full disclosure of the serious risks they carry.
Instead, heart patients, those at risk of cardiac events due to age, and even the general population are routinely prescribed various types of blood thinners, anticoagulants, and cholesterol-reducing drugs. Their use is always presented as the gold standard with the best possible outcomes. Pressure and fear are exerted, including the threat of early mortality if you don’t comply.
The aim of personalised medicine is not to decrease drug use but rather to personalise drugs, even to increase the use of drugs. Whilst most pharmaceutical drugs entail adverse reactions and unanticipated side effects, drugs that are tailored to genetic characteristics may potentially have even more serious consequences and long-term adverse outcomes. This is because genetic systems are involved in all the functions of the physiology, its organs, bio-molecular messaging and overall immunity.
Are There Alternative Approaches to Cardiac Health That the MHRA Should Be Considering?
A meta-analysis published in the BMJ entitled ‘Comparative effectiveness of exercise and drug interventions on mortality outcomes: meta-epidemiological study’ gives an affirmative answer. It concludes:
Randomised trial evidence on exercise interventions suggests that exercise and many drug interventions are often potentially similar in terms of their mortality benefits in the secondary prevention of coronary heart disease, rehabilitation after stroke, treatment of heart failure, and prevention of diabetes … exercise interventions should therefore be considered as a viable alternative to, or alongside, drug therapy.
Regrettably, the study also concluded:
Our findings reflect the bias against testing exercise interventions and highlight the changing landscape of medical research, which seems to increasingly favour drug interventions over strategies to modify lifestyle. The current body of medical literature largely constricts clinicians to drug options.
While little research has been undertaken comparing the relative effects of exercise and drugs on cardiac illness, even less research has been conducted assessing and quantifying the effects of herbal remedies. This is a remarkable omission. Inappropriate diet and lifestyle are arguably the most significant factors contributing to the genesis of heart disease. The corollary of this is highly significant: corrections to diet and lifestyle are the most significant measures that can be taken to avoid and mitigate heart disease.
A paper published in 2019 entitled ‘Review of herbal medications with the potential to cause bleeding: dental implications, and risk prediction and prevention avenues’ describes 20 common herbs which are understood to have antiplatelet, anticoagulant or other relevant actions that could be beneficial for heart disease.
These are: Aloe, Cranberry, Feverfew, Garlic, Ginger, Ginkgo, Meadowsweet, Turmeric, White Willow, Chamomile, Fenugreek, Red Clover, Dong Quai, Evening Primrose, Ginseng, Flaxseed, Grapefruit, Green Tea, Oregano, and Saw Palmetto. The paper discusses their effects based on in vitro experiments, animal studies, individual case studies and theoretical grounds. Sadly, the main thrust of the paper is not to investigate their worth but to suggest grounds to prevent their use in conjunction with dental treatment.
