Incapacity

Serious adverse reaction means an adverse reaction, which resuits in death, is iife-threatening, requires inpatient hospitaiisation, or proiongation of existing hospitaiisation, resuits in persistent or significant disabiiity or incapacity, or is a congenitai anomaiy/birth defect. 

A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. 

The acquisition and assimilation of bioelements are the most fundamental processes in an organism s struggle for life. It is therefore obvious that in complex natural systems the competition between thousands of species for limited quantities of a small number of elements is a major evolutionary factor. However, the individual contributions of the physical and biochemical aspects of nutrition to the fitness of an organism are widely unknown. The frequent observation that biodegradation processes, e.g. in soil remediation, are limited by physical obstacles to substrate acquisition, rather than by biochemical incapacities, points at the importance of substrate mobilisation strategies. 

There are two different mechanisms behind ordinary causes of constipation, functional and outlet obstructions. Functional constipation is caused by the slower movement of the colon, peristalsis, which comes with old age, often in combination with less physical activity and less intake of fibre containing food. Outlet obstruction is a result of incapacity to empty the rectum from faeces often due to too large masses of stool blocking the anus. It can also be caused by anal stricture from haemorrhoids or scar tissue caused by fissures. 

Thus Daniel Ullman was in good company (or at least a lot of it). We speak of self-government as if it was. .. a grand triumph of political sagacity, cautioned the North American Review. We all admit, that particular races, the Asiatics for instance, are not yet fit for it. We interpret their incapacity by assuming that they are not sufficiently advanced on the road to perfection. Quite possibly these peoples may never advance along that road, and have no need to advance. 75 The democratic experiment may be forever closed, in other words, to certain peoples inherently unfit for the arduous demands of political self-possession. 

When it gets into the blood, lead passes into and begins to destroy the red blood cells. These cells are used for carrying oxygen to the tissues. As more and more cells are destroyed, the effects become manifest as anemia, which contributes to the general weakness and lassitude, and if allowed to continue will ultimately contribute to the resulting incapacity and even death. 

Potentially, individuals with low activities of the enzymes phenol sulfotransferase and glucuronyl-transferase may be more susceptible to phenol toxicity. Persons with ulcerative colitis may have an impaired capacity to sulfate phenol (Ramakrishna et al. 1991), which may increase the amount of unchanged phenol that is absorbed following oral exposure. Neonates may also be more susceptible to toxicity from dermally-applied phenol because of increased skin permeability and proportionately greater surface area. A study in which 10-day-old rats were more sensitive to lethality following oral exposure to phenol than 5-week-old or adult rats (Deichmann and Witherup 1944) further suggests that the young may be more sensitive to phenol. (For a more detailed discussion please see Section 2.6.) Because phenol is a vesicant, individuals with sensitive skin or pulmonary incapacity may be more sensitive to phenol. Individuals with kidney or liver diseases that impair metabolism or excretion of phenol and phenol metabolites may be more susceptible to phenol. 

Report on adverse events, incapacity, and death, if any, and investigation... 

Fox, A.J J. Industr. Med Report on an Enquiry into the Incidence of Incapacity for Work, Ministry of Pensions National Insurance, Part 2, 76-17-2, H.M.S.O., London, 1965. 

The intracellular deposition of ABP as the first pathogenic event prior to the appearance of tau pathology in AD (272) is an indirect evidence of ABP aggregation and incapacity of the ubiquitin-proteasome-chaperone system to repair the distorted metabolism of APP-ABP leading to neurodegeneration. A similar phenomenon with aggregation of conformation-abnormal peptides probably plays a key role in many other neurodegenerative disorders. 

Kurz R, Crawley FP. The Clinical Trial Directive s ethical impact on research into disease that cause incapacity and diseases of chUdren perspectives from non-commercially fimded research in hospitals. Int ] Pharm Med 2003 17 7-9. 

In the case of other persons incapable of giving informed legal consent, all relevant requirements listed for persons capable of giving such consent shall apply. In addition to these requirements, inclusion in clinical trials of incapacitated adults who have not given or not refused informed consent before the onset of their incapacity... 

In rabbits with undemutrition due to a shortage of calories there was a depressed agglutinin production against typhoid vaccine (C3, R4). A similar incapacity to produce antibodies to typhoid vaccine was reported in children with severe protein malnutrition (Bll). During treatment of 5 children, mean age 24 months, with chronic primary malnutrition, it was observed that their response to a single standard dose of 100 imits of purified diphtheroid toxoid was small and slow. Furthermore there was no correlation between specific antibody response and serum protein levels (02). 

The search for mitigating reasons that would allow the practitioner to view the adult s incapacity as a temporary problem to be resolved, and therefore not necessarily a decision about child safety, was also a feature of the drug workers response to the situation ... 

The adoption of a wait and see approach to avoid formalizing the problem means the immediate problem of the mother s incapacity has to be dealt with informally and within the resources of the staff present. In a busy clinic such resources might be thinly stretched which, as the following drug worker acknowledged, could mean it was not addressed ... 

Our incapacity to decompose does not necessarily imply an impossibility of decomposition. For if we should call every substance an ele-... 

Because of the problems that resulted from self-regulation, another law, the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, was approved in 2006. This law requires manufacturers, packers, or distributors of supplements to submit reports of serious adverse events to the FDA. Serious adverse events are defined as death, a life-threatening event, hospitalization, a persistent or significant disability or incapacity, congenital anomaly or birth defect, or an adverse event that requires medical or surgical intervention to prevent such outcomes based on reasonable medical judgment. If this requirement were enforced, and consumers cooperated, these reports would make it possible to identify trends in adverse effects and would help to alert the public to safety issues. 

Perhaps these worries can be met by suitable refinements. Another, even more obvious, concern comes to the fore in Glover s discussion to avoid conflating incapacity and incontinence. How is unalterability to be distinguished from weakness of will 18 Here is Glover s suggestion ... 

If, like the alcoholic or drug addict, he is not open to persuasion by himself or by other people, then he does have a psychological incapacity. 

Yet, if a reasonable amount of persuasion would alter his intentions, but he himself chooses to avert his attention from the reasons in question, his is then a case of moral weakness without psychological incapacity. (Glover 1970,100)... 

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