Ethical Dilema Drug Tesing in Nigeria Essay Example | Topics and Well Written Essays - 2500 words

Ethical Dilema Drug Tesing in Nigeria - Essay Example There was evidence that using Trovan could lead to problems with joints, tendons and bones, and even perhaps cause liver damage. Led by Scott Hopkins, the team developing Trovan were anxious to carry out controlled clinical trials of the drug on children, in order to conclude whether it could safely be marketed as a treatment for diseases in children. While they believed that further refinement of the drug would make it much safer for children, they would need firm evidence in order to obtain approval from the United States Food and Drug Administration (FDA) for it to be marketed. At around the same time, in February 1996, there was a serious outbreak of meningitis in the area around Kano, a major city in northern Nigeria. Soon, over a hundred children were being brought to the basic local hospitals every day, and by March 3, 1,273 deaths had been reported, with some accounts putting the total at closer to 10,000 (Spar and Day, 2006, p.11). As most of the children infected with menin gitis would certainly die if given no treatment, Hopkins looked upon the outbreak as ‘a unique opportunity to test Trovan pills on children’, and ‘since Nigeria had both a raging epidemic and a distinct absence of personal injury lawyers, a drug trial there would be far more efficient’ than in the United States (Spar and Day, 2006, p.2). Meningitis outbreaks are fairly common across a large area of sub Saharan Africa during the dry season, when cold weather, malnutrition, and urban overcrowding can lead to the disease spreading rapidly among children. Epidemics of meningitis are caused by a particular strain of the bacteria, and the Trovan researchers had reason to believe, after extensive testing, that their new drug would be effective against that strain. It is worth understanding the processes which a drugs company needs to complete if it intends to market a drug in the United States, because, as we will see, it is questionable whether the situation at K ano provided an opportunity to carry out a satisfactory trial of Trovan on children. When a new compound is being developed, the pharmaceutical company responsible for it lodges an investigational new drug application, or IND, with the FDA. Having obtained this, the company is authorised to begin conducting clinical tests, which may be rolled out to many scenarios and over thousands of patients before a drug seeks FDA approval to be marketed. While such approval is sought within the United States, or from the appropriate authorities in other countries, it does not preclude a pharmaceutical company from carrying out clinical trials overseas. Indeed, it is even possible for a drugs company to conduct all of their clinical testing overseas, and only when the research gathered has shown the drug to be both safe and effective, for it to be submitted to the FDA for approval. In the case of Trovan, the new drug already had an IND, had already been subject to extensive clinical trials withi n the US, and so the team developing it were perfectly entitled to add a trial in Kano to its IND, or, alternatively, to carry out the tests in Nigeria and, if the results were positive, submit this data to the FDA subsequently. Pfizer would also have to meet some conditions under Nigerian law

Standard Costing Essay Example | Topics and Well Written Essays - 2250 words

Standard Costing - Essay Example This paper considers the other side or the side in which standard costing has found its inappropriateness and unsuitability. Furthermore, the outcome of the critical analysis of how standard costing works is also evaluated in terms of its effectiveness as a means of control in the global industry and the increase in consumer wealth. As a general idea, standard costing is a system of cost ascertainment and control in which predetermined and preset standard costs and income for products and operations are set. This standard costs and income for products and operations are periodically and from time to time compared with the actual costs incurred and income generated for the purpose of establishing any variances. Standard costing system is used by many organizations as a management tool in estimating the overall and general cost of production with the assumption of normal operations. While it has standard costing has been widely used by most production and manufacturing companies, the system has found its great importance and appropriate significance in most organizations and firms whose operations involved are common and repetitive. Standard costing generally involves the development of a product or service cost wit the use of estimates of both the resources consumed as well as the prices of those resources. In producing a standard selling price, the standard cost may then be increased by an estimated profit margin. These estimates of cost and revenue then provide and build up a foundation for additional and supplementary planning and control (Mitchinson 2000 July 1). Traditionally, standard costing is often and frequently associated with manufacturing though it also can be used in other area like the service sector. In support to Drury's (2004) claim that standard costing is appropriate and suitable in common or repetitive operation of an organization, Mitchinson (2000) asserted and alleged that the system, as a method, is essentially apt and fitting to task which is repeated many times. To provide a rationale for this allegation, repeated tasks or operations give organizations and firms the means to estimate the nature of how tasks will be performed in the future and upcoming operation. Information gained previously in a repetitive operation can be used in predicting the income and expense for any period. 1. Problems with Standard Costing The reported setbacks and inappropriateness of standard costing have been spotted in the part of lean companies. Baggaley (2003) strongly argues that the system's measurements motivates and encourage behaviors that are harmful and inappropriate to lean environments. Additionally, standard costing does not provide reliable cost information for decision-making that is important in a lean situation. As a result, Baggaley (2003) suggested an alternative costing approach that goes in line with the goals of lean that also provides the basis for sound management decisions. There are problems with standard costing when used as a system of control in a lean environment that Baggaley (2003) has identified. First predicament is the problem regarding the people and the workforce. Naturally, standard costing sets standard performance that cause people on the shop floor to do the wrong things when just to meet the preset performance level. In further illustrating his contention, Baggaley (2003) specifies the in-depth reason for