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