Drug Testing in Developing Countries
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Does the very nature of conducting clinical trials in developing countries make it unethical? Clearly state why and why not these clinical trials are ethical.
The very nature of conducting clinical researches and trials in developing countries is believed to be unethical. An ethical framework used in such tryouts should ensure that exploitation of communities is minimized. Exploitation is the main reason why clinical trials in developing countries are believed to be unethical. Factors such as poverty, high level of illiteracy, lack of sufficient health-care services, and cultural variations pose a high risk for taking unfair advantages of people by the researchers in developing states (Emanuel, Wendler, Killen, & Grady, 2004). Trials done in developing countries are also deemed unethical because most of the participants do not give informed consent. Researches that use humans as experimental subjects are very sensitive and should ensure that the well-being of the participators is made a priority and any information about their health status remains confidential (Brizi, Filibeck, Kangaspunta, & Liquori O’Neil, 2009; RSAtube, 2012).
Identify the various stakeholders involved in such clinical testing and the reasons they use to defend or oppose such trials.
The stakeholders in clinical trials include the host community, policymakers in the health sector, health care providers an international health care organizations. Many drug tryouts are administered in developing countries where people are poor and would take advantage of taking part in the test to earn a living for their families or even treat diseases they could not afford to pay for in hospitals (Kelly, 2013). Those opposed to trials on humans explain that most organizations distribute their drugs without informing the recipients that they are involved in a test study.
They also argue that since most people are uneducated, they are always misinformed and are made to believe that such organizations can cure them hence are being fully satisfied when given free treatments and paid for participating (Angell, 1997). Due to language barrier or low level of education, researchers take advantage to recruit subjects without taking informed consent from them (Beecher, 1966; CIOMS, 2012). Another reason is that the test may involve the withdrawal of medication after some time, and this may lead to the death of the participants. The best example of this is administering of ARVs to HIV patients. Withdrawing the medication will lead to the death of the person as was observed in Zimbabwe and other African countries.
Those who support these trials argue that giving free medical services to people in developing states is a favour, and they do not have to question individuals or give any additional information. They also find it cheaper to try their drugs in developing countries compared to having them tested in developed states where many peeople may not be willing to take part in the tryout (Kuhrt, 2013). In cases where such trials cause full recovery of the participants, researchers believe that it is a win-win situation that is worth being undertaken in developing countries.
What changes would you recommend to make this process of international clinical trials more transparent, equitable and more strictly regulated?
In order to make the international trials more transparent, equitable and strictly regulated, first, I recommend that all researchers trying out new drugs should adhere to the Helsinki declaration that was revised in 2008. Before administering any new drug on humans, the scientists must ensure that the safety of the subjects comes before every other interest. They should also take into consideration the needs of the disadvantaged people. Failure to adhere to these requirements should be prosecutable by law.
Who should do/oversee the regulating? How do you envision your suggestions being enforced?
Medical practitioners in the local hospitals in collaboration with policy makers in the health care sector should oversee this regulation and ensure that new drugs are tested following the right procedures. To bring this regulation into force, I envision that the health sector would issue a circular to all pharmaceuticals and hospitals stating the enforcement of the new regulation and the penalties for failing to adhere to it.