Prologue
section:
Introduction
to the GMA project, the company, and its strategies
Despite
the name, Global Medicines Agency (GMA) is not “Medicines only”.
The
GMA project target is to provide safe and objective healthcare information
services, neutral and unbiased, to the best of the patients - globally.
We
will secure conceptual independence by placing the services in a neutral operational
environment with more than an arm-length distance to direct individual,
institutional, political or industrial influence.
GMA is a
Patient-security initiative.
We
have created this project based on two fundamental criteria:
1.
Patient centricity
2.
International cooperation
Patient-centricity
Every
person has health to care for. We have designed technology that serves the
patient across national, international, technical, linguistic, and geographical
borders. The best treatment and care will always be at hand by making the
individual Healthcare package of information readable and processable for
digital systems and skilled human experts, independent of geographical or
political positioning.
One
project target is to clear the ground for introducing the safe and accurate use
of Artificial Intelligence in the daily healthcare environment. We have
designed methods and tools that bridge the structural information gaps hindering
AI’s secure application and usage.
By
thinking “Out of the box”, we created “Simlrs world of digital accuracy”
with methods and tools to eliminate the main AI-introduction obstacle. Information
accuracy, the base foundation for AI to work within the quality borders of the
project, is built by the many digital project components designed for this
purpose.
The
technical and operational footprint is hence not trivial with its global functional
scope.
Along
the route to high-quality healthcare information handling, GMA has divided the complex
and extensive target area into two separate but integrated projects under the
GMA umbrella.
a.
GMA has its focus on organising
and eliminating healthcare information chaos. The current lack of content
interoperability, laming domestic and international health information
exchange, will become history by adding methods developed for this purpose.
GMA
has developed methods to open the door for innovative development in several sectors.
b.
The eME™-project (electronic
ME™) has a distinct patient-centric focus. eME®, with its three-level personal
health information storage platform, is essential to GMA’s extensive
technical/conceptual platform development (*).
When
designing, describing, and developing the base technology solutions for eME®,
creating a model for the information logistics that a “Personal Health System”
entails became critical. The results from this work, which has been ongoing for
more than five years, disclosed why the currently ruling technology, Health-institution-centric
systems, fail to reach their functional targets, a contrast to the simplification-focused
methods used in the eME™ designs.
We
have described the eME™ part of this project in the eME®
descriptive script.
International Cooperation is the key
to project success.
The GMA project is, from day one, founded on cooperation!
The parties invited to the project will sit at the table in the same spirit of
collaboration, skills exchange and development.
One
crucial issue backing the GMA project is the need to stop the endless stream of
words from people telling tales about information handling in health care. Without
practical experience, skills or methods to support their views, they explain; “what
we have to do” by describing the situation and the results we aim for instead
of the approaches to get there.
Detailed
statements, proven methods, explanations, and guidance on “how to get there” are
required. There are hundreds of “what we have to do” people pr., each “how to
do it” person.
Invitation
With this document, GMA invites Governmental bodies,
Supernational organisations, dedicated partners, and public and private
investors to join in a process that will open routes to modern, up-to-date healthcare
information processing and correctly priced medicines.
Additionally, to ensure that medicine patents and
licenses are legally issued within the boundaries of international law, providing
access to medicines financed, developed, priced and sold in the global market
by public bodies/organisations to the best of the patients.
We invite High-tech companies to
participate.
Expectedly, the high-tech companies are also ready to confirm
that the “how to solve healthcare” hangs high.
Over time, even the major high-tech companies, the
IBMs, Googles’, and Apples of this world, have burned their fingers trying to conquer
this business arena. Some have retreated, and some are waiting for new
opportunities.
We would also like to see the players from the list above
as parties interested in participating in the GMA initiative. Based on a cooperative
scenario, there will be openings for all.
With a “limited in size” patient-centric scenario, the
functional and operational scope of the GMA platform may appear to be limited.
It is not!
Please be aware healthcare is always patient-centric.
Focus is always on one patient at a time.
The extent of this initiative is endless. It includes the
complexity and challenges of expanding the initial path plan to a global
network of healthcare nodes. They are all linked seamlessly to healthcare
institutions worldwide. Each node will have the power of content- and
linguistic interoperability, supported by the inbuilt Harmonizer™ technology.
The focus will, however, always be patient-centric!
The tech companies will find supplementary and bordering
services to boost their business potential and interest in health care.
Serious healthcare issues, well known but left unattended, kill patients
daily!
Influential people globally, health politicians, health
care managers, hospital board members and -medical experts believe in words.
They should not!
Words alone will not move the severe healthcare issues
nor solve the global digital information interoperability tangle!
Despite millions of words spoken in seminars,
conferences, and on the screens in webinars, fundamental healthcare issues,
often fatally dangerous, are left unsolved. Not only unsolved but unattended
for decades, as if they are unsolvable. In addition, healthcare worldwide is
struggling due to a lack of funding, plus computer systems insufficiencies.
Hospitals spend billions of healthcare-related funding
on mending errors and fatal incidents caused by the referenced flora of
technical insufficiencies and errors.
Some of the severe issues addressed and solved by GMA in
this project have been resting on various study tables within Academia
worldwide for 25 years or more, with no solutions presented.
GMA has observed and analysed these issues from a
technical/practical angle by applying skills, expertise, and experience from
problem management in other sectors. The result is three inventions: one
patent-pending, plus additional new methods. These extensions to our toolbox
offerings will enable solutions to tangles costing patients’ lives, every hour
of the day, worldwide for decades, to be developed and kick-started into
action.
Example issue 1.
In Norway and probably the rest of the world, there is
only limited awareness among laypeople, patients, and relatives that doctors
and pharmacists, despite best will, make errors. Every day, they unwillingly,
seriously hurt or take the life of patients with drugs prescribed wrongfully.
The reason why these accidents happen is evident to
anyone looking for it. Safe drug prescription has been beyond the scope of the Doctors’
and Pharmacists’ manual judgment for decades! The digital support tools
available in their jobs are far from sufficient!
Academic health professionals worldwide have left this
topic unattended, even in Norway, after a detailed presentation to the managing
team of one of the largest Norwegian Hospitals 25 years ago.
According to international EU statistics dated 2008,
prescription drugs wrongfully prescribed to individual patients by their doctors
take the lives of +200 000 individuals each year within the EU area alone. The figures
translate to more than five individuals killed by prescription drugs every day
in Norway in the same year, damaged organs not leading to immediate death, plus
the amount of suffering not counted in the figures. The report also states
significant under-reporting.
Academia has had the funding and the resources but has
done nothing! Today, 25 years later, with the increased complexity of Medicine,
the risk of severe or fatal organ damage from prescription drugs has grown.
Example issue 2.
Commercial interests are triumphing over medical
ethics. The drug manufacturing industry is not always documenting and
explaining medications to the best of the patients, what to be aware of and
when the actual drug may be a risk.
Patients and professionals must go to the digital
version of the medical package insert to disclose serious side effects and
interactions. Not only is the print on the box insert unreadable due to font
size. Potentially lethal side-effects are found hidden behind digital bars or
included randomly in the unreadable text, not easily found. On the last page,
the manufacturers also hide critical facts having a sales-dampening effect.
The GMA technology will hinder these tricks from
manufacturers and undress each drug to the minor ingredients.
Deaths by Adverse Drug Reactions and incorrect dosage
calculations are among many drug-related issues. These are well-known but not acted
on by Academia. The GMA project has reacted and solved this major issue.
Example issue 3.
We need drugs to get well! The problem is that the
more you need it, the more it costs. Rocketing drug prices are a severe concern
for patients and politicians worldwide. “Big Pharma has the world under its shoe
heel” is used frequently among politicians representing the public payors.
GMA brings to the table methods and technology that
enable public bodies to fight this development within the borders of Western
law, providing support for the initiative from the same payors. **
** This topic is more deeply enlightened
in the eME® descriptive
script.
-----------------------
These example issues are a few out of many addressed
by GMA in its development.
People without a skill-based history in this field,
politicians and loud-speaking technical “experts” worldwide trust in “Digitalization,
Artificial Intelligence, Cloud-based information storage and super quick
computers and -networks” to solve the Healthcare systems insufficiencies.
However, these descriptions often describe new wrapping covering old deficiencies.
Digitisation, as we know it, is not new and not spectacular.
It started in the 60’ties when the first commercial computers appeared, almost
300 years after Mr. Leibnitz invented the digital representation of letters and
numbers. Computers triggered industrial digitalisation and created the digital
information chaos we all struggle with today.
Already ten or more years ago, computers and networks
in fashion at the time had processing power and transfer speeds in abundance, and
even more than what is required to solve the healthcare information chaos we
suffer from today.
Lack of processor- and transmission speed was not the
issue then and is not today; accuracy and content exchangeability are!
To achieve global digital goals for healthcare content
interoperability in 2022 and beyond, we must better manage existing and future
amounts of information - differently and better!
Managing, processing, and distributing objectively
correct, non-biased, coordinated, and harmonised health-related information
that is readable, understandable, and valuable to humans and computers
in all languages and coding standards, without further ado, are the prime
targets for the GMA project!
It is all in the methods!
GMA started its project with method development.
The average Hitech digitalisation project is kicked
off based on a “This is what we shall make and achieve” statement, often with
little concern about the obstacles ahead. GMA started the project one step
further into the process.
Having identified the massive health information chaos
hampering many well-founded digitalisation initiatives, a solution to this problem
had to be designed and tested successfully before moving on. Without a solution,
the GMA and the eME® projects would not have seen the light of day.
The terms “Absolute digital accuracy” and “Similarity
by definition” were put on paper, and the technology to handle the two complex
scenarios was designed and tested.
GMA created a “Digital World
of Accuracy™” to enable the project to succeed.
Even though it is designed for healthcare, many
sectors across many industries will benefit from introducing this technology. GMA
will open to the introduction of eME® based on accurate content
exchangeability.
Drug
development and -distribution must be revised!
Governments
worldwide are worried and looking for means to get their taxpayers out of the
BIG PHARMA price trap.
Politicians
must seek alternatives to the ongoing drug development regime, serving only the
medical industry shareholders. A change will only happen if political power and
tactical and practical methods are applied, supplied by targeted international
diplomatic and public juridical fora.
Anyone
who cares about health politics, medicine prices, and -procurement should take
the time to watch the movie BIG PHARMA - GAMING THE SYSTEM.
English
language version here,
or using this link in your browser: https://tv.nrk.no/program/KOID28004020
Other
language versions are available on YouTube. Look for: “Big Pharma Gaming the
system.”
Also,
see this catching speech (12 mins) by the charming Priti Krishtel at TED about
the patent laws we all suffer under. It answers the question, “Why are our
medicines so expensive?” Click here or YouTube search:
https://www.youtube.com/watch?v=-3y6_7_5PcQ
With her book “The Truth about the drug companies”, Marcia Angell has for years been a
front runner in the fight against the ever-growing power of the pharmaceutical
industry and, in particular, the club called “Big Pharma”.
People
interested in this vital topic should set aside time to see and listen to her
in her famous speech in the President’s Lecture Series: https://www.youtube.com/watch?v=ZqKY6Gr6D3Q
Listen also to more of her experiences: https://www.youtube.com/watch?v=cyBVfC_aabQ
https://www.youtube.com/watch?v=ytbXDgU7pfM
The Pharma industry claims to
operate within the barriers of formal laws.
The statement above is itself unprecise. “Formal law” varies widely
between countries, and the US appears to be a free haven for this industry. With
tons of dollars, the US drug lobby is the ruling party, potentially negatively
influencing the rest of the world.
With the right tools, politicians worldwide can impose patient-friendliness
in this vital part of global healthcare.
International law must raise
the bar for drug patenting.
There is an urgent need
for changes in Drug-patenting rules worldwide.
New technologies make drug
development easy, quick and manageable compared to the case only a few years
ago. Labs develop new biological drugs cheaply and quickly. The risk is that
drugs, often invented by coincidence, are blocked with a patent, leaving patients
worldwide with no alternative to paying out of the white in their eyes for easy-to-make
drugs.
Setting new rules for what
is unique and patentable is crucial.
The effects of the US patent regime, characterised by Mrs Priti Krishtel in the TED video addressed above, must be neutralised and neglected in the
rest of the world to open the Medicines market for necessary real competition. Hopefully,
this will also benefit US patients in their struggle for adequate welfare
services.
In this document, the term “Health”
has an expanded meaning.
This
Prologue document describes the subject and the information areas included in
phase 1 of the GMA initiative. “Health” and “Healthcare” are associated with drugs, doctors, and hospitals. Additionally, phase one covers health
security related to diagnostics, medication security, Food content security, Nutrition
issues and allergy issues related to the content of drugs, food, and skin-applied
chemical products. The project plan is the detailed composition, the
interaction between chemical components, and its implication on human bodies.
Drug and food declaration
A detailed declaration of each Medicine decomposed into single
components must be the foundation of new patents. This move will hinder what is the case today. Manufacturers are flagging a change of composition to get
a new patent protection period, but the only difference is “the shape of the
pill”.
GMA secures global medication- and food products with the “ByTag™”
technology. ByTAG™ is a QR tag structure that can provide every product detail:
the build-up, its components, the build-up of chemical elements and more.
The first step towards
necessary digital healthcare accuracy is a clean-up process.
Organising
every legal Medicine under one independent umbrella, according to profile, declared
and disassembled into individual components, and across every legal drug.
A
QR-link reading must display objective drug user information and potential risk
factors to professionals and laypeople on the computer- or mobile phone screens
in their native common language.
The
extent of the process involves Medicines, Food, and Skin-applied chemical
products, all closely related to our health.
The
problems related to nutrition, allergies, allergens, chemicals, and natural
products, all for use in or on humans and animals, are within the GMA and eME®
project’s capacity. We need process improvements in medicine user guidance,
development and production. Additionally, in food production, food surplus and
food shortages administration.
Information
organised and presented to the user - at the point of action must be
objectively correct, complete, and not influenced by commercial propaganda, shown
in a language and a subject terminology that the recipient/user understands.
Example:
Today, 50 years after healthcare digitalisation started, medical information
related to symptoms, diagnoses, treatment plans, medication, and many medically
critical coding systems still need to be harmonised. Randomly exchange of digital health
care information results in blank stops! Every error and misunderstanding effectively
disrupts any professional collaboration between professionals and
computers!
eME®
will exchange information between medical devices worldwide via the eME.world® service and the DWoA(*).
eME®
will be a digital physician and pharmacist assistant in one handheld unit. It
will work directly on the globally harmonised and unique digital information
hierarchy of terms found in DWoA*.
The
DWoA service, including The Harmonizer™, will be accessible as a small tool for
EPJ systems, erasing differences in terminology, nomenclatures, and
classification standards. Local, domestic, or global healthcare information interchange
will be easily achievable across linguistic borders.
*)
The Digital World of Accuracy will be explained and discussed
later in the document.
Roughly
speaking, people, diseases, treatments, and the medicines required are the same
worldwide, even though there are differences at a detailed individual level.
The
handheld digital doctor, pharmacist, and nutrition specialist, eME®, can be
used in all countries without customisation except for language profiles.
Linguistic transparency
levels out Language variations and opens global insight.
Linguistic
transparency - free use of local language across global healthcare, will open
for global harmonised insight into healthcare issues. One example is users in
the five countries illustrated below describing symptoms of illness in their
language. eME™ will give the same answer: Whooping cough, tailored to
their language profile. The symptoms of the condition are the same, and the
wording is different, but the disease, the treatment, and the medication are
the same. eME® and the importance of international harmonisation of
health information are described later in the document.
Norwegian: Kikhoste English:
Whooping cough
Russian: захлебывающийся кашель Arabic: السعال الديكي
Chineese: 百日咳
The
international health information chaos is crippling random digital information
exchange.
It
does not help to stand up and declare, “Somebody must make the exchange of
information happen.” Process improvements based on new methods are the cure!
There are, however, no quick fixes.
The
GMA staff have had this on their program for over five years. As a result, we
are ready with methods and have developed the necessary insight to make
information exchange happen.
In this document, the term “Health”
has an expanded meaning.
The
Prologue document describes the subject and the information areas included in
phase 1 of the GMA initiative. Phase one covers Medication, Food / Nutrition,
skin-applied chemical products, the chemical components, and their implication
on human bodies.
The
digital medical information chaos in areas like medicines, prescriptions,
diagnosis, side-effects, interactions, and errors causes thousands of
prescription medicine accidents, injuries, and deaths daily. However, GMA has developed methods that will
significantly reduce or prevent this.
Every
person who works in or uses products from the mentioned consumer sectors,
experts and laypeople needs easy and quick access to correct information. Split-second
insight into properties, raw material content, harmful and positive effects,
user information, and more at the “point of action” may save lives in everyday healthcare
situations.
Doctors
and pharmacists are good examples of occupational groups in disciplines where they
will develop and introduce new products and methods “every day.”
Learning is not a product of
schooling but a lifelong attempt to acquire it.
Albert Einstein (1879 - 1955), Physicist & Nobel Laureate
Although
I am neither a doctor nor a pharmacist, I saw the need for a way around
Einstein’s words about lifelong learning five years ago.
In
today’s ever-changing world, medical- and pharmaceutical skills are dynamic. The
number of topics is endless and- ever-changing. In health- and pharmaceutical treatment,
professionals, while performing at the maximum in their jobs, cannot cope with ongoing
development and stay expert vice on top without digital aids. - Not today and
not in the future! More importantly, we cannot wait a lifetime for doctors and
pharmacists to be up to speed.
Consequently,
they need help! They require tailored support from digital tools that know and
can help with structured, updated and to-the-point information within their
separate fields of expertise!
The
development of methods, including creating the Digital World of Accuracy, was
kicked off within the GMA technical framework to equip professionals and
individual patients with compatible digital healthcare technology.
GMA
aims to solve a global problem and has its eyes fixed on a worldwide spread.
GMA
wants to contribute significantly to the world’s health methodology as a
driving force for introducing the “absolute digital accuracy” necessary to
apply digital care technology safely.
Imperative:
Some
of the healthcare system weaknesses addressed in this script were well-known
within Academia 25 years ago. In a meeting set at Norway’s largest hospital, I
described the effects of the related problems to Norwegian healthcare
executives for the first time.
High
on words, people from Academia were willing to and interested in solving these described
problems scientifically through research. Unfortunately, I let go of the case
as I trusted the research to happen.
Leaving
this case with Academia was a tragic and deadly wrong decision; the investigation
is ongoing!
Ill-treatment
and insufficient methods, identified and accepted as such at the time, have,
over the past 25 years, killed thousands of patients in Norway alone.
So
far, 25 years later, no improvement has taken place. The situation in 2021/22
is worse than ever. When I realised this five years ago, I highlighted my old
notes and designed a state-of-the-art digital platform incorporating Digital
Accuracy. This process became the conception of GMA and the development of a
flight of personal digitation tools.
The
abovementioned facts have been on the table for three decades or more. Medical
professionals are, even today, fighting significant but solvable problems caused
by inadequate healthcare information exchange and -processability.
History shows what method not to choose to solve this
problem.
Hiring
hundreds of high-cost consultants from Global Consulting companies does not
help.
The
proof is easy to find between hundreds of stranded, limping, or abandoned
healthcare initiatives worldwide. The common denominator is the
presence of one or more of the “Majors”.
The
most common is that the focus is on their business plan and driving the
customer projects into complexity. Ever-lasting projects serving their revenue
stream are the result.
Addendum to the Prologue:
GMA
explains in the following primary documents how the technology and new thinking
will reduce the cost of medication and raise the level of medication security
through:
- Public ownership of medicine patents and
-licenses developed for public money.
- New methods for drug manufacturing, pricing,
distribution, and supply are introduced.
- Better control and utilisation of the public benefit from the
massive amount of skills and knowledge created at a high cost for
taxpayers, universities, and officially supported research units.
4. Disloyal scientists regularly sell, leak, or even give
away vital research information to drug manufacturers in exchange for jobs and
money. The result is new effective medicines sold to people and governments,
the people that financed the development in their tax bills, at astronomic and rocketing
prices.
- There is a need on the Governmental/Super national level to
introduce measures to reduce or eliminate the effects of the legal but
morally reprehensible pricing of critical drugs. The film “Gaming the
System” illustrates the problem.
- Most drug manufacturer/public sector cooperation
projects are taxpayers’ nightmares. The drug manufacturers pay for one
slice but get the whole cake, including drug-product experts fully trained
and educated at the taxpayer’s expense. They secure the patents and sell
at the price they need to meet their shareholders’ expectations (*).
*) Extracts
from the YouTube publications mentioned under “Drugproces are rocketing” above.
Suggesting
the above-described measures, including the attached fulfilment methods, making
the moves doable may create objections from many sources, including drug
manufacturers. Taking the silver spoon out of someone’s mouth will always
result in a reaction.
Yet,
when holding these expected objections up against the ever-recurring line of
thought in which individuals, mothers, fathers, children, young and old,
grandparents, neighbours, and colleagues, end up dead or injured in drug
prescription accidents, taking on some objections is like a walk in the park! This
is especially true when knowing that most of these individuals would have
avoided their sad destiny if more accurate and up-to-date information tools had
been available at the point of action.
GMA comes with a recipe for success; It is built on cooperation.
The
project will call dedicated professionals to the table, experts in the various
sectors of “Health” in the scope used in this document. Sitting worldwide,
these expert groups will collectively build the project’s professional
foundation in multiple task groups.
With
positive and engaged cooperation between experts, financial resources, and
public sector executives interested in solving the global digital information
exchange tangle, GMA will meet the goals set for the project.
An
important acid test for the project is the delivery of eME®(*).
*) Described at eME® and detailed in the main document.
The author of this script,
the initiator of GMA with its technical solutions, is humble.
This
script has no “I have solved this problem!”. The sad fact that the discovery of
inadequate medication prescription methods was left to be solved by high-headed
Norwegian professors from Academia 25 years ago reminds him of the need to act.
Many thousand patients have paid for that mistake.
This
invitation heads the presentation of GMA: Let us do this coordinated and together!
GMA
presents a new and different approach to solving global healthcare problems. A
distinct and diverse tool saw the light of day by identifying the need for the “Digital
World of Accuracy” and developing the technology to create it. Compared to Academia’s
traditional, theoretical, science-based suggestions brought to the table over
time, a viable solution is born.
GMA
opens a practical and doable way to patient security and random digital health
information exchange.
Parties
interested in a more profound introduction into the depth of the concept,
please send an e-mail or
Welcome
to GMA and our “Digital World of Accuracy.”
Langhus,
Ski, Norway
August
14th 2023
Per A. Sørlie (sign.)
__________________
Per
A. Sørlie
Global
Medicines Agency AS
Founder
t. +47
90032133
per@GMA.healthcare
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