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.

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.

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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