MHRA is harvesting genetic data—here’s why it’s a complete waste of time

The Genes-are-Destiny model is broken

MHRA sets up its very own Biobank

Yes, it’s true, UKs MHRA has set up a biobank and this is what it’s all about:

About Yellow Card biobank

Yellow Card biobank is a collaboration between the MHRA and Genomics England. Its goal is to improve understanding of how a patient’s genetic makeup may increase their risk of harm from side effects.

By collecting genetic samples from patients who have experienced suspected side effects, the Yellow Card biobank will create a repository of genetic information that can be used to help determine whether a suspected side effect was caused by a specific genetic trait.

It is hoped the research generated from this resource will enable development of interventions such as screening tests for patients that can be used by healthcare professionals to personalise medical treatment to individuals, according to their genetics. For example, more information about how people with a certain genetic make-up have responded to medicines in the past, will enable healthcare professionals to prescribe the most effective and lowest risk medication to patients with similar genetics, and will allow patients at a low risk of harm to maintain access to medicines they need.

The initial phase of the project will concentrate on a medicine called Allopurinol, used to treat gout, kidney stones and other types of kidney problems, and the related rare side effect of severe skin reactions, including Steven Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). More topics for the pilot phase will be confirmed soon.

Genomics England will work alongside the MHRA to sequence and store genetic material using their established infrastructure.

Time to burst their bubble

This may shock you, but believe me, it’s true. The REAL scientists know that there is much more to health and sickness than your genetic material. You are going to hear now from a REAL scientist, Dr Ray Perkins, speaking at a conference I hosted in Wales just before C19 struck. This is the conference headline video (c. 3 minutes):

MEDICINES FOR THE 21st CENTURY: Safe, Better, Cheaper

Ray speaks at c. 1.57 minutes in.

This is what Ray wrote subsequent to the conference, contained as an appendix to a summary white paper I compiled. This is what he wrote:

MEDICINES F OR THE 21ST CENTURY: SAFE, BETTER, CHEAPER
APPENDIX C, Contribution by Dr Ray Perkins, 8 July, 2019

Here at the end of the second decade of the 21st century, the word “broken” best
describes our ability to diagnose and treat disease. Our ability to select therapies
that work is broken. Our ability to diagnose, even define, disease is broken.
Our ability to perform research that is reproducible is broken. Our fundamental
hypothesis of biology is broken. The list goes on. This is certainly a depressing and,
to many, surprising state of affairs. Commercial and non-commercial media outlets
are crowded with excited faces assuring us that something akin to immortality is just
around the corner. Even old and once-respected science publications now are filled
with only “positive” findings, with headlines adjusted to secure maximum attention.
Institutions and universities employ public relations offices whose influence on
scientists’ careers equals that of their peers.

This segment of the larger document touches on the nature and extent of broken-
ness, holding a mirror up for a public viewing. In doing so it is hoped that those
in a position to foster change will recognize the analyses for what they truly are:
opportunities.

Now that it is known how not to proceed, the 21st century can still become the century of genuine progress in medicine. Topics will be briefly addressed proceeding from the clinic to the lab to the offices of decision makers.

The application of medicine is broken. Specifically, the ability to select medicines
for patients presenting with symptoms is worse than hit-or-miss. In 2018 in the
United Kingdom, some one billion prescriptions were written. Of that number, the
best that can be said is that 900 million of those did nothing, providing neither
benefit nor harm.

The reality is much worse. Nine of ten patients are exposed to side
effects, some worse than the disease itself. Misuse of antibiotics leads directly to
drug resistant strains of bacteria. Of course, cost is an issue given that the cost of a
successful treatment, on average, is ten times the cost of individual treatments.

The ability of any given medicine to “work” is expressed in a simple metric: the Number Needed to Treat or NNT. No medicine is universally effective, i.e. has an NNT of one. Indeed, NNTs range from a “miracle” treatment with an NNT of five, a “good” medicine that works for every tenth person, to common medicines with NNTs of 40-50. There are even NNTs of infinity for prescribed medicines that don’t work
at all. NNTs must become the lingua franca for patients, clinicians, scientists and
institutions.

Biological research is broken. In 2005 a seminal publication appeared, “Why Most
Published Research Findings Are False” by John P. A. Ioannidis. Viewed over three million times, this publication became the warning klaxon. It is now universally
recognized – by scientists and institutions alike – that a minimum of 50% of published
findings cannot be reproduced. Heavily publicized, this “Reproducibility Crisis”
has not been effectively addressed. With the crisis now dating back over decades,
scientific literature is corrupted, given that which half is good vs. bad cannot be
discerned.

Within the context of this document, it must be acknowledged that the
foundational “knowledge” for development of new medicines and diagnostics is
likewise corrupt. The same judgment also applies to selection of therapies and is,
therefore, a contributor to the high NNT values of the pharmacopeia.

The Genes-are-Destiny model is broken. Readily refuted by simple arguments,
genes-are-destiny persists as the century-long basis of biology. Gene mutations,
for example, have long defined “treatable targets” in drug and diagnostic discovery.
As such, it must be seen as a primary contributor to their failures. Even the recent
“breakthroughs” in cancer immunotherapy reinforce this conclusion, all exhibiting
NNTs comparable to chemotherapy.

The picture is understandably bleak. Enormous amounts of money are wasted on
therapies that don’t work, and development of new therapies and diagnostics are
hamstrung. However, there are findings that point the way forward. The impact of
microbiome findings has only scarcely been felt. Humans are composite creatures
and must be approached as such. Further, the failure of genes-are-destiny must be
seen in contrast to its inverse: biology must be approached at the functional level of
complex, interacting networks of molecules, cells, tissues, organs, organisms and the
environment. Within this new and bracing context, the activity of proteins becomes
paramount, as well as the relationship between that activity and biological function.
“Functional Proteomics” must occupy centre stage in the eyes of researcher and
decision maker alike.

Else a pig is simply a ham sandwich.

Recommended Reading:
Dance to the Tune of Life: Biological Relativity, Denis Noble, Cambridge University
Press, 2016
The Black Swan: The Impact of the Highly Improbable, Nassim Nicholas Taleb,
Random House, 2007
Functional Proteomics, Chapter One, “Making the Case for Functional Proteomics,”
Ray Perkins

Returning to ‘The Genes-are-Destiny model is broken.’

I’m no scientist, but I do listen to those who know. What Ray is saying below, in my simple mind, is that the genes you are born with contribute only a fraction of your likelihood of getting sick. Your environment, and the various interactions inside your body based other factors, has far more bearing on your health.

“Readily refuted by simple arguments, genes-are-destiny persists as the century-long basis of biology. Gene mutations, for example, have long defined “treatable targets” in drug and diagnostic discovery. As such, it must be seen as a primary contributor to their failures. Even the recent “breakthroughs” in cancer immunotherapy reinforce this conclusion, all exhibiting NNTs comparable to chemotherapy.”

So, what of ‘About Yellow Card biobank’

Well, they say it is to investigate side-effects of existing drugs, but knowing what we now know, it doesn’t make sense. The genes we were born with aren’t going to tell them anything about how a drug reacts in your body—a lot will have happened since you were born!

I’ll finished off with an article from one of the pioneers of genetic research, Sir John Bell:

Sir John Bell: ‘Most people who have had the Covid vaccine are completely safe’

This is an extract from his Wikipedia profile:

“His charity positions include chairing the board of trustees of the Oxford Health Alliance^[9] and the science committee of the UK Biobank.^[19] He chairs the Global Health Scientific advisory board of the Bill & Melinda Gates Foundation, he is a Trustee of the Rhodes Trust, he sits on the award jury of the Gairdner Foundation, he is a non-executive member of Genomics England, and he is a member of Cancer Research UK. He has advised governments and foundations in Singapore, France, Canada, Sweden, Finland, and Alberta on biomedical research. He is on the Jenner Institute Board and the Gray Institute Board. He is on the advisory Board for the McGill Genomics Institute and the Montreal Neurological Institute, and chairs the advisory board for the Oak Foundation and the Robertson Foundation. He attended the 2013 Bilderberg Conference.^[20]

A 2021 feature article by freelance journalist Paul D Thacker in the BMJ stated: “The government and Oxford University’s failure to be open about Bell’s financial ties make[s] it impossible for the public to know what, if any, interests the professor has when influencing key decisions about which of the many covid-19 tests the UK should purchase”

Nothing to see here then?