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When I did not know much about ALS, I was rather instinctively refusing those critical claims pointing at non-transparent financial interests standing behind the absence of effective treatments of this brutal syndrome. The disease is rare, it is not really an opportunity for making profits due to complex & expensive research and so on. It was a naive view.

👶 The Step Out Of Naivety

For us humans, it is typical to make opinions instinctively, intuitively, often based on shallow knowledge or based simply on our (good) belief. Most of the people are actually good people, regardless their knowledge, they believe others are mostly equally good and that´s why it is not easy for them to follow any theory which suspects our core systems (government/politics, medical science, healthcare) are compromised to such degree that it prevents good things to happen. This human nature significantly simplifies the manipulation of public opinion. People naturally believe more in the scientific complexity of given problem (e.g. what really causes ALS) than in pretty bad human factor, human mistakes, criminal acts (Yes!), side interests including mainly power and money, which are blocking the progress.

It definitely is not about disseminating primitive conspiracy theories, it is all much simpler. It is about all those small(er) sins the current society is aware of and tolerates them. This is the main problem, because these sins cumulate, amplify mutually themselves in many ways and create certain debt. One example out of all is the lack of collaboration. Such a simple thing, right? Scientific teams indeed do not collaborate well, they compete! Why? They are part of profit seeking companies, often stock traded which creates even bigger pressure to make profits. In many usual areas this competitive nature works well, it pushes people to deliver better results, better services, better products etc. However beating ALS requires collaboration, not competing. Humans still did not grasp that. I was born with this conviction, but millions still haven´t learned that even after decades of their lives.

Anyway in this post I wanted to touch only the financial interests and how unethicaly they are applied within ALS community.

💰 There Is Not Enough Money in ALS – Oh Really?

Historically ALS has been underfunded – there is no doubt. I recall how Nelda Buss wrote in her amazing book^​1​ that the government in late 1980s allocated only $3 million for ALS research.

For the year 1985, the government designated $108 million for AIDS research and barely $3 million for ALS research. I supposed someone like the President would have to be stricken with ALS before more attention would be given to such a cause. I came to the conclusion that research is based on numbers, and that the 5,000 a year that are victimized with ALS had to depend on a miracle from the few dedicated researchers who are working on the disease. My hope of that happening in my lifetime was barely a glimmer at this point. In order to vent my anger, I told Glenn I was going to write to the Today Show and to Hour Magazine^​1​

Even before I got to this book I did a very quick research, inspected CDC stats and summarized that in the post called ALS Mystery As Important As Sex?. Based on CDC figures it is already much better than in 1980s but the amount is roughly same as the research focused on sexual behavior of American adolescents – hence the odd title. More than $100 million every year is already decent amount – the question should now be What exactly is this money spent on? Also in my very descriptive and for many also controversial and lengthy summary of ALS I cited ALS Association which claims $1-2 billion are estimated to obtain effective therapy if not a real cure. In the same post I noted that US governments have spent (or thrown away) $2.3 trillion over their 20 years lasting Afghanistan project.

I am not sure about many things but I am very sure I would not want to be in the skin of US tax payer. If it was only about money (it´s not), then America and the world could already have ALS cure if it was exchanged for leaving Afghanistan at least 10 years earlier if not earlier. Everyone watching world news could see how Afghans valued those enormous funds – massive corruption, no interest to transform into modern society (while respecting religion), no respect to women, obscurantism, violance and return of 🩸bloody Taliban🩸, which is even supported by EU and thus this time european tax payers – where is some logic? 👀🧠

What is the point anyway? It already is not entirely true, that ALS is underfunded. In my post I was realizing the overal amount is much bigger than below graph is showing – there are different and related categories and altogether this all is pretty substantial amount of funds! If we add that there is lot of additional funds in ALS coming from donors, charity we could state that hundreds millions should yield something better than what ALS community is getting. The problems are already different and somewhere else.

🚩 Bad News – ALS Got Monetized Too

The terrible finding is that business found a way how to make profits even without providing the desired service. ALS was accepted as part of this world and thousands of sick people are converted into customers every year. Drugs that do not cure are called treatments and profits are collected. It is like if someone would be selling you something called food, but if you were eating it you would be still starving, and ultimately die of this starvation. The system is so compromised that it enables such weird thing to happen and nobody is wondering. This is the tolerance of evil and it is no secret. How does that work?

Unfortunately it all is about manipulation, I would tend to add word sophisticated, but honestly, I disagree. Instead it is rather infinite impudence. We all should agree that it is normal to pay for some real value or service. If we buy a product we usually demand & obtain some warranty. We also have some experience and simply know if it is good product/service, if it works or serves well. There are numerous rules and laws which protect us from being fooled, robbed or cheated. Now switch to the ALS world, all these principles are broken. People learned that they are unable to provide a good product/service easily, a medication/therapy which either cures/heals or at least significantly helps and resigned on those rules. This has always consequences but not many realize it. As a benchmark we could use diabetes and insulin. It is no cure, but given the situation it is acceptable solution and it enables people with diabetes to live quite a normal life.

This lack of good solutions for ALS patients made people to find other ways how to meet their typical objectives (get value of everything). There are two main objectives – first it is necessary to simply Deliver Something. The modern society demands activity, demands solutions, demands cure or medication, demands at least tangible progress – it is impossible to not deliver anything, this leads to problems and instability. Second key objective is also simple – make money. Why should anyone Deliver Something and Have Nothing from it? Whoa! What a creative approach, patients are not important but society tolerates that as it lives in illusion and money is made, perfect safe setup.

🖤 Delivery Of Something

Responsible people decided to deliver something, but wait, there is a problem. How could these people prove that Something is actually good and acceptable product people will be paying for? This requires some measurements, we live in the age of evidence based science, right? As Leonardo Da Vinci stated once, simplicity is the ultimate sophistication. So these people simply decided to measure differences. What differences? Differences between ALS patients – one is taking that Something and other one is given a Fake Something (which is called PLACEBO). The desperate ALS patient is basically abused and forced to accept the rules of this game – he has some chance he will actually get the medication, but he may not get it at all. Is that ethical game? It is how current science in 21st century works. Back to those differences. It is necessary to come up with some standardization, introduce scale, ALSFRS-R is born. This is not a bad thing, if used correctly and ethically (congrats, if you already suspect this is actually not happening).

Amyotrophic Lateral Sclerosis (ALS), is a neurodegenerative disease that typically affects adults around 54-67[1] years of age, although anyone can be diagnosed with the disease. People diagnosed with ALS live on average 2–4 years after diagnosis due to the quick progression of the disease.[2][3] The progression and severity of ALS is rated by doctors on the ALS Functional Rating Scale, which has been revised and is referred to as ALSFRS-R^​2​.

We all should know that the differences among ALS patients are so diverse, that it is practically impossible to predict how the disease will progress in individuals. Comparing one ALS patient with another one is like comparing apple to orange. From some reason people still decided it is good idea to try to predict – but what? Death. Yes, people are predicting death and announcing such terrible news to freightened ALS patients in physician offices. Forget ethics because it is believed it is ethical to sentence ALS patient to death while sentencing a mass murderer to death is considered unethical – did you hear about Mr. Breivik^​3​ and his complaints he has old Playstation and videogames?

This unethical death forecasting game is often not really successful and you can read many stories where 💪ALS warriors🖖 proudly report how they are fighting for six, nine, fourteen or even 20+ years while given some average life expectancy outlook. All these aspects help to paint the overall highly unethical ALS picture. The situation could still be saved if the delivery of Something really showed dramatic value. If the medication or therapy at least doubled the average life expectancy we could assess that as a minor tactical success. This would mean all patients would live at least 5-10 years. However this never happened. People are unable to deliver such drug and thus they had to really enter a thin ice.

They decided to make another highly unethical step, otherwise they would need to conclude absolute failure. Through manipulation they taughed the ALS community that even minimal and rather subjective improvement is actually the success for which the society will be willing to pay big money. But wait, word improvement does not mean ALS patient would actually improve, it means the state deteriorates slightly slower. The wall of ethics is falling apart.

We are not talking about great numbers but rather poor numbers which are not far from statistical error and which cannot persuade anyone who is aware how big differences among disease progression exists naturally, regardless any medication. Well, those people are indeed aware of this phenomenon and they leveraged that. This helps to get numbers which are still embarassing, but which already promise some benefit. Still it is on the edge of acceptance – regulators are hesitating. What can these people do now? Yes, another unethical step.

These people will get their poor results but still some results, where statistics as a mathematical tool was rather abused/bent than well used, and involve the desperate ALS community. They will literally request the community to create massive pressure on FDA. After all it is about having nothing or something. Desperate people have practically no choice and given the overall situation even FDA will eventually accept those poor products because politics will kick-in at some point too. Once this happens the door to safe profits finally open – there is no great service to suffering patients, it all is mainly a money game and abusing of the most hopeless community on this world …

⚙ Controversial Money Machine

I am almost sure some readers will still think the room for profit in rare ALS is minimal and I am a mad fool. So let´s respond with some numbers. It is known that only in United States there is roughly 5,000 new ALS patients diagnosed every year and those ALS campaigns state this also with more urgent message that every 90 minutes there is a new person receiving the diagnosis. Simple math reveals that both statements are not in a big contradiction (365 * 24 / 1.5 = 5840). Another known and official number says that only in United States there is approx. 30,000 ALS patients living. ALS obviously does not hit only Americans but also Europeans and also people from other continents. We can put together some rough estimates and summarize that in table below.

The red numbers are my wild estimations, we don´t need to be highly accurate due to later use of those numbers. However based on this work^​4​ it is not that inaccurate. Very roughly we could talk perhaps about 100,000 ALS patients globally at given point of time and nearly 20,000 newly diagnosed every year (and similar amount of died every year).

The absence of cure is very well known but as we already know there are still some highly unethical products being sold while called treatments. Obviously the community has no choice and many take these products, many fight for additional ones despite it is quite rare to announce another poor allegedly slowing-down product – why would you do that, if you already have that, right? Nobody needs 15 poor 2-6 months life prolonging drug. It all makes sense, but at the end, it all is ultra-controversial & highly unethical matter 🤷‍♂️ Below table lists the officially approved so called treatments.

The figures were taken from publicly available sources and present^​5,6​ the costs from the system point, insurance companies etc. It is not end price for patients.

😜 Bad Joke #1 – Rilutek et al

Above table deserves some further comments, just in case the reader has not recognized how the situation looks like. More than 25 years ago FDA approved the very first official drug for ALS (Rilutek), but it does not work at all. Under the huge diversity across ALS cases (apples to oranges 🍎🤷‍♂️🍊) this drug is believed (notice the non-scientific word) it prolongs life by approximately 2-3 months on average, which we can also express as 5% added life expectancy compared to situation when no medication is taken. These numbers are based on some early studies and while the expression “it is believed” sounds terribly non-scientificaly, it really depicts the reality. Scientists do believe. They don´t have evidence despite they call themselves evidence-based science followers.

What is interesting is that this absolute failure (Rilutek) was reincarnated and re-introduced few times later and not surprisingly with even higher price tag. Problem? ALS patient in advanced stage often has difficulties with swallowing/administering the tabletes but there are people who obviously need to make money as much as possible, ideally till the very last breath of the ALS patient. This is why a new liquid and soluble forms of the drug were introduced, obviously it will be camouflaged as an effort to help but with Rilutek, are you serious?

Patients can take them for a longer time and it still does not help much, the drug performance is simply very poor, statistical error close. But wait, we are not finished yet. What should such expensive drug actualy do in the organism of ALS patient? This is another strange thing – again it is ONLY BELIEVED the drug should help with regulating those higher glutamate levels (neurotoxic already) detected in people with ALS, but nobody knows how. Is this still science? This sounds more like quackery or not? Following is the very official information.

The active substance in Rilutek, riluzole, acts on the nervous system. The exact way in which it works in ALS is not known. It is thought that the destruction of nerve cells in motor neuron disease may be caused by too much of the neurotransmitter glutamate. Neurotransmitters are substances that nerve cells use to communicate with neighbouring cells. Riluzole stops the release of glutamate and this may help in preventing the nerve cells being damaged^​7​.

😜 Bad Joke #2 – Ederavone Radicava

What do we have next? Another so called ALS treatment called Ederavone Radicava. This again is nothing new, which would be a result of already better funded ALS research in the last 20 years. In reality there are people who again re-introduced an old drug devised in late 1980s for some experimental stroke treatment. Here again we can see the same obscurant expressions (it is believed, it is not known how it can work). Isn´t this a great result of hundreds of million dollars which the ALS community was able to gather? I am convinced my sarcasm is valid, but I really do regret all those sick people, I want something better for them, they deserve much more and this is the reason why I am writing this article. Everyone should learn that in order to improving the overall balance in oxidative/reduction processes one certainly does not need to pay $146,000 for poorly designed drug. Fruit, vegetables, specific natural herbs, mushrooms, A.C.E vitamin combo and minerals are often very potent antioxidants which outperform Radicava drug not just in costs associated but also in terms of side effects and therapeutic value (nobody does such clinical trials with ALS patients, guess why 🤑).

The exact way Radicava works in patients with ALS is not known but it is thought to neutralise oxygen-containing molecules known as ‘free radicals’, which have been linked to nerve damage in patients with ALS^​8​.

😜 Bad Joke #3 – Relyvrio, Albrioza, AMX0035

After two ancient drugs which both are priced & sold as if they were the extremely promising brand new & 🔥hot products🔥 coming from research labs, we have something which could be more compliant. In September 2022 FDA approved new drug labeled as AMX0035. It is sold under Relyvrio name (US) and Albrioza name (Canada). Please notice the price tag while considering those again poor results. The drug performs so poorly that FDA had real problems with approving it. As usually in ALS world, instead rock solid ethical science it were again emotions what stepped in. FDA was unable to resist the pressure and this allegedly few months (based on trials, 🍊🍎) life prolonging drug got approved. Did anything change regarding the drug function? Not really, we again see speculative and over priced drug with unknown function.

The medication’s exact mechanism of action is incompletely understood, but it’s broadly thought the two compounds work together to prevent nerve cell death by blocking stress signals within two cellular compartments, specifically mitochondria and the endoplasmic reticulum^​9​.

The medicine is made up of two substances: sodium phenylbutyrate and tauroursodeoxycholic acid. How the medicine works is not fully clear, but it is expected to reduce nerve cell stress and prevent nerve cells from dying. This is expected to improve symptoms of the disease^​10​.

🌈 New Hope? NurOwn Stem Cell Therapy

Stem cell therapy is nothing new in the ALS world and there are known issues with it. It does not work well, many ALS patients underwent the therapy, but still progressed and eventually died. It is not officially approved in most countries and has over-the-counter unregulated character, patients need to travel to exotic countries, spend fortune etc. Surprisingly ethics is being mentioned now (LOL!). False hope is also mentioned but we should suspect what is going on here. It is very expensive and it does not work against the ALS cause. This means it can only temporarilly help someone but someone may not register any improvement. It seems it is a real roulette. FDA reviewing NurOwn now is again in troubles^​11​.

Obviously the money factor steps in – who is going to fund that for thousands of patients, repeatedly? The real reason is not ethics (how could someone believe in this after all facts mentioned here 🙄) but the economical aspects. Simply compare the money chain in case of mass produced drugs with extremely expensive stem cell therapy business affordable for VIP customers only. This therapy can prove its value but rather in the second stage (convalescence) of real ALS treatment (once discovered) or for plateau cases. Brighter person could most likely realized that this type of business is a threat to those drug based money chains which generate revenue for 27 years.

🤑 The Revenue Table

Below table and figures are illustrative only – the green figures are real, others are deducted & estimated from other information available (see references). Prices of those drugs are also real and taken from public sources.
The idea is not to provide accurate estimation regarding the revenue from individual pseudotreatments. Instead the purpose is to illustrate there is big money even in rare ALS and that it is highly unethical to make such high revenues on speculative treatments which fail to provide any significant benefit (at least tens of % would be needed). It is highly recommended to make your own estimations, corrections, still big figures will eventually pop out …

Please recall, that ALS Association claims 1-2 billion USD is estimated to develop already decent ALS therapy which rapidly improves life of the patients …

Below notes further clarify the table data.

• The number of new ALS diagnosed per year are more or less accurate (see references)
• This data shows the figures for United States and Europe (at the end same numbers, despite Europe population is twice as big, is that real?)
• World data comprise all continents, including USA and Europe, it is estimated number.
• It was chosen that only some patients decide to take those drugs available (50% of patients) but AMX0035 and NurOwn are new products and thus some patients from those refusing old unhelpful medication could try these (15% could try AMX0035; only 5% could afford or get to expensive NurOwn therapy). Again this is illustrative setup, if you would think it is too unrealistic, let us know your own setup.
• With our setup it is estimated that soon global ALS revenue could reach $3 billion per annum.
• Obviously revenue does not mean profit – still these would be high amounts given the benefit for patients (they are still dying few months later, if we could trust the controversial stats from limited clinical trials)
• Rilutek/Riluzol certainly generated more money as the price was higher, before generic form Riluzole was introduced, we counted simply with current Riluzole price which makes our estimation rather modest, still it could be $6 billion since the drug introduction.
• Please don´t forget that humans in some countries monetize even death of terminally ill fellows- what? Who? For instance those in Switzerland. In past they got rich during the darkest chapter of human history (Nazi financial center) and now they help people to die in exchange for a fee of several thousands GBP.
• This all is a 🏴amoral exploitation🏴 of those weakest and most hopeless ones … And this has its consequences.

via GIPHY

📜 The Judgement

Completing the last piece of the ALS mosaic is the TOUGHEST ONE and this task has been assigned to public. The destiny of ALS patients including those future, lies in the hands of ordinary people,
ending the tolerancy of exploitation and bringing back humane science centered around patients will become a game changer … Time is running.

Mr Underhill From Shire

Please see About Author page.