Catch-22
PART 1
Everyone has heard of the phrase Catch-22.
But what does it really mean?
The Collins English Dictionary defines Catch-22 as
" If you describe a situation as a Catch-22 situation, you mean that it is an impossible situation because you cannot do one thing until you do another thing, but you cannot do the second thing until you do the first thing."
It is a dilemma or conflict of circumstances for which there is no easy solution due to mutually exclusive events occurring at the same time. It is also a reflection on current, inflexible bureaucratic rules.
What are the origins of the phrase Catch-22?
The phrase Catch-22 was first used in a satirical war novel written in 1961 by American author Joseph Heller. The novel describes absurd, bureaucratic constraints imposed on American soldiers who were stationed in an airforce base somewhere in Italy, during World War ll.
One particular soldier named Captain Yossarian, a bombardier in the Army Air Corps, had become despondent with the war effort and wanted to get out.
He is faced with a dilemma:
The only way that he can get out of the army is to claim that the war had made him insane.
But the camp's doctor tells Yossarian that if he claims that he is insane then that proves that he is sane, because only a sane
person would claim to be insane in order to get out of the army.
The logic behind all of this way of thinking was that a concern for one's own safety in the face of danger is the process of a rational mind. The end result of all of this was that Yossarian did not get out of the army and all that he was left with was just a paradoxical dilemma.
Yossarian's situation is very similar to the one that I find myself in where we both face a huge bureaucracy with nowhere to go and end up with a paradoxical dilemma.
PART 2
The Therapeutic Goods Administration of Australia:
The Therapeutic Goods Administration of Australia is the medicine and therapeutic regulatory agency of the Australian Government. The Therapeutic Goods Administration of Australia regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics.
Any medicine, or medical device, or medical procedure, or even any mathematical formula that claims to have a therapeutic effect, or is involved in the administration of medicine, or is covered by the Therapeutic Goods Act 1989, or the Therapeutic Goods Regulations 1990, must be approved by the Therapeutic Goods Administration of Australia and registered in the Australian Register of Therapeutic Goods.
In order for any new medicine to be registered in Australia, it must first be supported by extensive information about the synthesis of the medicine and the method of manufacture of the medicine. Studies of its pharmacology and toxicology in animals must also be carried out and clinical trials in human beings demonstrating the efficacy and safety of the medicine must also be carried out.
The clinical trials
What is a Clinical Trial?
A clinical trial is a scientific study, or an organised test of medicines and new treatment options involving patient and non-patient human volunteers. Clinical trials confirm whether medicines are safe and effective to introduce as new treatments for a particular disease or condition.
Clinical trials may also be used to determine whether an existing medicine can be safely and effectively used for other diseases and conditions.
Who runs a clinical trial?
Each clinical trial is led by a doctor. The clinical trial team includes doctors and nurses as well as pharmacists and other health care professionals. The clinical trial team is responsible for checking the health of the participants at the beginning of the trial, monitoring them during the trial, and staying in touch with them for a period of time after the clinical trial has been completed.
Are all clinical trials the same?
There are four different types of clinical trials, each one associated with a different phase in the development of a new medicine or treatment:
Phase I clinical trials involve the first administration of the medicine to humans, usually to small numbers of healthy volunteers. Phase I clinical trials determine the safety of the medicine, how it works and how well it is tolerated. These clinical trials also identify preferred routes of administration (eg. tablet, liquid or injection) and help determine the appropriate doses for later studies. Phase I clinical trials are usually undertaken in centres appropriately equipped for the specialised monitoring and the high degree of surveillance needed.
Phase II clinical trials are normally the first trials of the medicine in patients suffering from the condition for which the medicine is intended. The principal aim of these clinical trials is to determine effectiveness and safety. These clinical trials are undertaken in a small number of closely supervised patients and conducted by researchers regarded as specialists in the particular disease or condition and its treatment.
Phase III clinical trials involve greater numbers of patients and are undertaken for the purpose of determining whether the medicine confers clinical benefit in the disease for which effectiveness was demonstrated in Phase II clinical trials. They also determine the nature and likelihood of any side effects. Phase III clinical trials are undertaken if the Phase II clinical trials indicate the medicine has potential benefit that outweighs the hazards.
Phase IV clinical trials are those clinical trials undertaken after the medicine has been approved for the treatment of a particular disease. Phase IV clinical trials are undertaken to compare a new medicines to a wider range of existing medicines. Such clinical trials are used to establish where, in the range of treatment options, the new medicine is best used.
Phase IV clinical trials are also undertaken to further investigate the use of the medicine in the normal clinical setting of the disease, as this may differ quite markedly from the conditions under which the other clinical trials were conducted. This includes post marketing surveillance studies.
Do all participants receive the new trial medicine?
In order to objectively determine the benefits of a new medicine it is necessary to remove any subjective bias. This is particularly the case in Phase III and IV clinical trials where participants are normally divided into two or more groups. One group (the test group) is given the trial medicine while the other group (the control or reference group) is given the standard treatment for the disease or condition. Where there is no pre-existing standard treatment a placebo – a look-alike or dummy medicine containing no active ingredient – may be given to the control group instead. Participants are randomly assigned to either group.
Ideally, neither researchers nor participants should know which group a particular patient is in. Clinical trials where this occurs are referred to as double blind trials. However, safety does come first. Should a participant develop an unexpected or serious side effect the blinding of the trial can be broken so that appropriate action can be taken.
PART 3
What we can see from this system of trials is that it involves a highly complex system of events designed to ensure maximum safety for everyone participating in the trials.
It is a high end system specifically designed for large scale research work. I have nothing against large scale medical research work.
But there must be some room made available for small scale medical research work such as mine.
I have no need for a large-scale system of trials. All that I require is for a cataract operation to be carried out on my own eyes using an Istent to control my glaucoma and using my own true Keratoconus formula. If it works then others can try the formula. If it works for them then the formula can be spread to others and so on and on.
In a matter such as this there is no need for a vast array of costly clinical trials.
Unfortunately for me, the system does not cater for someone like me working on a small scale.
If you think that the system in the United States is any different then you are wrong because the Therapeutic Goods Administration Act is a direct copy of the system of law operating in the United States.
It would be highly illegal for me to use my own Keratoconus formula on my own eyes in the United States and I could just as easily end up in jail in the United States as I could in Australia merely for using my own true Keratoconus formula on my own eyes. That is the problem that I am faced with. When I made my discovery, little did I know it at the time, what huge legal problems that I would face and that my only reward would be for me to end up being branded as a criminal and what is my crime? My crime is to use my own Keratoconus formula on my own eyes.
The Therapeutic Goods Administration is a direct copy of The United States Food and Drug Administration.
The United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
The FDA is just as bureaucratic as the Therapeutic Goods Administration of Australia.
If I were to go to the United States in order to have my cataract surgery/Istent implantation, I would be faced with exactly the same problems that I face in Australia and I would be subject to the same punitive laws.
PART 4
Ideally, I would like the following to occur:
Ideally I would like to go to the United States in order to have my cataract surgery/ Istent implantation carried out there.
But I now know that this is highly unlikely to ever occur because of how the law is written. The law will never allow me to use my own Keratoconus formula on my own eyes. But the law will allow people (including myself) who are suffering from cataracts and who have keratoconus to go blind because ophthalmologists do not know what lenses to place in their eyes.
How can that be?
What will happen to my true Keratoconus formula ?
Will it be lost for all time, never to be heard from again or will someone else discover it again in some distant future?
Good luck to whoever that may be.
What will happen to my dry eye formula?
No one will ever know.
I now know how Yossarian felt when he was confronted with such a huge dilemma involving out-of-control bureaucracy.
What should I do? What should I do…………?
What would you do? What would you do…….?
The law is an ass.
And what does this statement, which has since joined the long list of English proverbs, mean?
The Cambridge Dictionary defines 'the law is an ass ' as being the legal system or a particular law is wrong or not good enough and should be changed.
And why is the law being compared to an ass?
A common English word for a donkey is an ass. It is a well known fact that donkeys can be obstinate and stupid creatures under certain circumstances and are regularly referred to as asinine. Hence when you refer to the law as being an ass all that you are saying is that the law can be obstinate and stupid under certain circumstances just like an ass.
Written by
the Eye Enigma
20 July 2022
Be sure to watch out for my next article featuring Charles Darwin's Theory of Evolution and the Evolution of the Human Eye.
Did the whole human race evolve from apes or were we created?
Did the human eye evolve or was it created?
What is the true pathway of all fluid within the human eye?
These and other important questions will all be answered in my next article.
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