Monday 7 December 2015

Unexplained Deaths, Pharmaceuticals&The Medical ProfessionPart I

Unexplained Deaths, Pharmaceuticals&The Medical ProfessionPart I

On occasions the great majority of us would have heard, and may have known someone who looked healthy, employed, and enjoying life and all of the sudden hear that he or she had passed away. Cause of death in such situations are often unknown, and if a cause is shown on the Death Certificate it would normally be attributable to the last known diagnosed condition or conditions for which he or she was receiving medical treatment in the form of prescribed Schedule 4 medications which can only be dispensed by prescription. My question is whether the deceased’ doctor prescribing the medications or the pharmaceutical company that manufacture the prescribed medication could be held liable for the supposedly and accepted unknown cause of death. Let me briefly explain exactly what l mean.

Pharmacology

The well known pharmaceutical conglomerates that manufacture the bulk of the Schedule 4, prescription only medications are in the main Swiss based. Great deal of laboratory research and testing takes place before the overseeing authorities approves the medication and that medication is listed as prescription only Schedule 4. The starting point of that medication is testing initially on mice, rats, guinea pigs, and dogs before clinical trial testing commences. Some of the testing experiments often involve what is referred to as ‘double blind study’. What that means is that a known number of the animals or human in question are given a known dose of the active test substance and a known number given placebo which is pharmaceutically inert substance such as glucose. For all intent and purposes all the tablets look the same. The results of these testing are expressed graphically and are statistically analyzed. To be statistically valid specified number of randomly select sample (animal or human) needs to be tested and are often referred to as ‘population’. Validity of the test result, that is observance of the desired effect, needs to be in the right range which could varies depending on the known pharmaceutical properties of the chemical composition of the substance subject to the test. More often than not the graphical representation of the result is ‘Bell Shaped’. What that normally means is that 75% plus of the test subjects gave positive signs, or the desired observable or measurable response to the substance tested. However, the often forgotten or statistically ignored aspects of the test results are the 25% which are more or less distributed equally on either side of the graph. On the left side of the graph are those test subjects that gave no response, or negligible response to the test substance. However, it is totally different story on the right side of the graph. These subjects gave highly sensitive reaction or what often referred to as ‘exaggerated response’ which includes death. In human trials the subject in question may had to be administered first aid and in some cases resuscitation and the odd death. Regardless, of the near ‘nil’ response and the ‘death’ response the substance tested is statistically valid and warrants mass manufacture. It is also highly likely that when the statistical data is presented to the ‘Approving Authority or Authorities’ that makes recommendations that the medication in question be placed on Schedule 4, prescription only, the subtleties of the statistical data on either side of the ‘Bell Shaped Graph’ are often overlooked. Why? Because more often than not, that data is lost in the haystack of other more interesting data, pharmaceutical jargons and references.

Medical Profession

In the pre clinical second and third years of a medical course students are thought and study the subject, pharmacology, over six or eight weeks period. What they are thought in this pre clinical subject is general knowledge about the so called ‘family of drugs’ prescribed for various clinical conditions. The subtleties of the so-called mode of action, reaction and contra indications are rarely thought, let alone stressed. In clinical practice as far as prescription is concerned a General Practitioner or a Specialist heavily relies on tried and tested medications for diagnosed conditions and it is often trial and error before specific drug becomes associated with specific patient. He or she gets the information about the prescribed medication from MIMS produced by MediMedia Australia Pty Limited. Besides giving advice about categorizations of drugs that pose risks and to be prescribed and used sparingly in pregnant patients, all of Schedule 4 drugs are indexed under proprietary and generic names. Needless to say clinical diagnostic subtleties are often missed during normal consultation especially in a busy practice. On average one in five patients exhibiting reaction to Schedule 4 medication fitting either sides of the ‘Bell Shaped’ graph will be seen in practice. Some years, or possible months later when that patient condition had improved all of the sudden that patient dies. Cause of death? Possibly that patient is a member of the sample population fitting right side of the graph? In situations where post mortem is or are performed it is highly unlikely that toxicity studies are included and the cause of death is attributable to the clinical condition suffered by that patient. Does the family of the deceased have any option other than believing the medical profession and in some cases the mortician?

Is there a role for a specialist clinical pharmacologist in this equation? If the answer is a resounding ‘YES’ the next question is the stage at which the pharmacologist role commence.


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MAGNA CARTA Myth & Law Part II

MAGNA CARTAMyth & LawPart II


I ended Part I of the first blog on this subject by saying that in the next blog I will examine in some details the surviving three Clauses of the original Magna Carta and the writ of Habeas Corpus which requires the jailer holding a person to bring that person before the court to show his authority for detaining the person.
I will start by asking this question: ‘In light of the 11th September 2001, attack on America that focused on New York Twin Towers, America’s response based on purported ‘Axis of Evil’ knee jerk reaction that saw invasion of Afghanistan, Second Iraq War that toppled Saddam Hussein and his government, policy of pre-emptive strikes, the resulting chaos in the Middle East, the rise of Islamic State (ISIS) in Iraq and Syria, terrorists threat and bombings in European capitals coupled with legislative responses aimed at dealing with the perceived threat does the principle of Human Rights the likes of that enshrined the writ of Habeas Corpus still carry any legal weight or meaning in a Court of Law?
In light of the more often than not ‘knee jerk’ rush for legislative enactments after terrorist attacks (the last tragically carried out in Paris on Friday 13th November 2015), that are meant to prevent further terrorist attacks the question of one’s liberties and freedom, the likes of those guaranteed and enshrined in the Constitution of most Western Countries, does a Writ of Habeas Corpus, or a Writ based on Bill of Rights, carry any legal weight and achieve its intended purpose of bringing an individual held in custody before the Court and for the holder of that individual to justify the reason for holding the said individual? Regrettably I think not. 
Before a Court of Law, if counsel representing the person in custody asks the magistrate to have the incarcerator state the reason for holding his client or the charges, if any, to be laid against his client’? A magistrate could well respond: ‘under the legislation which your client is held I do not have to give you any reason and do not ask this question again’! A Magistrate could also say he, or she will not be able to tell how long the client will be in custody before any charges, if any, will be laid! If Counsel were to respond by uttering the words: ‘Guantanamo Bay’ he or she will most likely be in contempt of Court!
It is understandable that a country can invoke or enact State of Emergency legislation's that temporarily sets aside the enforceability of enshrined legislative acts based on the principle of Habeas Corpus. An example of this was made by Britain at the outbreak of World War I in 1914, ‘The ‘Defence of the Realm Act’, entitling the Home Secretary to legally hold residents of German descent. This Act was reinstated in 1939 at the outbreak of World War II to detain descendants of German background and fascist (Italian sympathizers). Prior to the advent of the 21st century, more specifically 11th September 2001, neither the threat of terror, nor acts of terror, had ever been a reason for enactments having not only the potential, but the reality of depriving any individual’ personal freedom without excuse, legal or otherwise. Or has, or is, the 21st century world after the so called 9/11 attack
on America, is officially, or unofficially, in a state of perpetual war? More specifically, does America’ so-called ‘War on Terror’ and supporting enactments aimed at preventing terrorism equates to, or should be treated as, the equivalent of declaration of world war, World War III? If so, who is so called ‘friend’, ‘neutral’, or ‘enemy’ or may be everyone is to be treated as suspect? Is a pre-emptive strike that kills and maims countless number of civilian in a country like Afghanistan, Iraq, or Syria legal and could be legally justified on the grounds or reducing the likelihood of terror?
Should the passage of Bill allowing Britain to carry bombing raids in Iraq and Syria on so-called Islamic State equate to official reinstatement of ‘Defence of the Realm Act’ that Britain passed in 1914 and reinstated in 1939 after the outbreaks of World War I and World War II respectively? 
Is it possible that another barbaric terrorist attack could result in the mass arrest and internment of residents, and non residents, of Arabic background born in say USA, Britain, and France?
Just a thought, and a frightening thought, if I may say so!

Coming back to the Writ of Habeas Corpus, and its relevance, if any, in the 21st century, let us assume that an individual had been arrested and incarcerated say for a traffic offence, under the Motor Vehicles Act. That person officially pleads not guilty, wishes to defend the charges and wants to apply for bail till the authorities are ready to proceed with the hearing. Is that individual’s chance of being granted bail under Habeas Corpus, the Bails Act, or any other relevant legislation still the same or has the pendulum swung too far against the grant of bail or grant of bail on onerous and unreasonable terms? Regardless of any statistics that may exist to the contrary, one cannot help concluding that grant of bail for any accused in custody had become more difficult, and sentences dished out on findings of guilt had been in the upper range.

It is very hard to fathom this somewhat subtle degradation of respect for human rights. The fact, and reality that substantial numbers of Guantanamo Bay detainees that had been dehumanized and held in barbaric incarceration for some 15 years without any charge; and if any country, including Congo Brazzaville, is willing to accept all or some of them. If finally to be released without any charge to their identity, being, and whatever is left of their humanity, there will always be a scar on America’s scale of justice. The pertinent question that would be on everyone’s lips, including hardcore gun lovers in America, is whether America had been safer place as a result of Guantanamo Bay.

MAGNA CARTA Myth & Law Part I

MAGNA CARTAMyth & LawPart I


In the highly successful 1997 Australian movie, The Castle, Lawrence Hammill (Bud Tingwell) who revealed himself as a retired Queen’s Counsel (QC) and offered to argue the Kerrigan appeal, The thrust of Hammill’s argument was that under section 51(XXXi) of the Australian Constitution the Kerrigans should be paid fair price for their house and that the said house should not be seen just as bricks and mortar but it is a home built with love and full of the Kerrigan’ Family shared memories and precious moments. Needless to say the argument persuaded the Presiding Justice to set aside the Lower Court judgment and find in favour of the Kerrigans. It is worth mentioning that in arguing the case in the Lower Court the Kerrigan’s incompetent lawyer, Dennis Denuto (Tiriel Mora), made reference to the ‘vibes’ all members of the Kerrigan Family felt whilst at home and to Mabo, a decision under which the High Court recognized indigenous title as bestowing good title to ownership of land to no avail.

Section 51 of the Australian Constitution gives Parliament power to make laws for peace, order, and good government of the Commonwealth. Under subsection (xxxi) or (31) that power relates to acquisition of property on just terms from any State or person for any purpose in respect of which Parliament has power…
The purpose of this blog is just to highlight the genesis of power given to Parliaments to make laws in countries really has all stemmed from the works of the original Magna Carta, the Great Charter of the English liberties delivered 19 June 1215 by King John at Runnymede to placate the English Barons. This famous Charter had long been superseded by 20th and 21st century enactments such as Bill of Rights. The American Constitution did not come into official existence till 573 years later in 1787, and the Australian Constitution some 685 years later in July 1900.
The Fifth Amendment to the Constitution of the United States of America: “no person shall be deprived of life, liberty, or property without due process of law” is a phrase derived from the Magna Carta. Likewise the very same Supreme Court of the United States of America referenced direct quote from Sir Edward Coke analysis of the Magna Carta as the pillar of the Sixth Amendment to do with the right to speedy trial of accused persons. Needless to say that Francis Bacon argued that Clause 39 of the Magna Carta was the basis for the sixteenth century introduction of jury system and judicial process. 

Coke used the Magna Carta as political tool and Sir William Blackstone (name familiar to all lawyers) published critical three volume edition of the Magna Carta.
In my next blog I will examine in some details the surviving three Clauses of the original Magna Carta and the writ of Habeas Corpus.