Reasons for the need for bioethics in the development and testing of new products, drugs and practice protocols

 

Bioethics is important because it forms the ethical basis for several medical and healthcare treatments, and outlines the principles for which new treatments should be evaluated and administered, bearing in mind their ethical implications and potential benefits or harms to their recipients. There are several reasons for the need for bioethics in the development and testing of new products, drugs and practice protocols. These are linked to greater competition in the healthcare and biopharmaceutical sector, calls for greater public accountability in medical products, technological advances and fiduciary duties.

Foremost, greater competition in the healthcare and biopharmaceutical sector has led to several companies cutting corners in compliance, testing, research and development. In an increasingly crowded healthcare and biopharmaceutical market, several companies have been unable to devote sufficient talent, resources and funding to properly research, pilot and validate their products before entering the drug trial phase.(Carr, 2003) As a result of pressure from competitors to roll out blockbuster drugs, and pressure from investors and shareholders to deliver predictable and steady profit margins, pharmaceutical companies are increasingly relying on unethical procedures to get their drugs on the market. These include the use of unreliable prototype drugs in drug trials.

Another important issue has been the use of counterfeit ingredients as a result of greater competitive pressure in the healthcare and biopharmaceutical sector. For example, in 2007, people from Panama were poisoned by cough syrup made from diethylene glycol, a compound frequently used to manufacture brake fluid and anti-freezing compounds.(Bogdanich and Hooker, 2007) Similar cough syrup contamination was found in Nigeria in 2009.(

Orisakwe, O. E., & Nduka, J. K. (2009). Lead and cadmium levels of commonly administered pediatric syrups in Nigeria: a public health concern?. Science of the total environment, 407(23), 5993-5996.

, 2009) A large part of the issue was fuelled by improper regulation and certification on the part of the pharmaceutical producers, which came about through their attempts to streamline costs in the face of increased competition. (Miller, 2013)

Next, calls for greater public accountability in medical products have led to several biomedical issues. (Moore, 2010) One dimension of this issue relates to the need to ensure that product standards are met, and that these products do not inherently harm consumers. For example, in 1938, the sulfanilamide antibiotic was mixed with diethylene glycol and marketed as an elixir drug, which led to over a hundred deaths.( In a separate, more recent case, the FDA found that samples of the drug heparin, which was manufactured in China, was contaminated by chondroitin sulfate and linked to almost 90 deaths and 800 injuries.(Bogdanich and Hooker, 2007) These issues of product safety are indeed problematic, and warrant greater bioethical examination.

However, another dimension of the call for greater public accountability concerns public oversight over procedures such as organ donations, euthanasia, stem cell research and genetically modified organisms. The rapid advancement of these technologies has led several segments of the American public to call for greater oversight over the use and deployment of these technologies, and to make the use of these technologies publicly accountable. For example, the organ donation market has rapidly expanded, as doctors have found new ways of transplanting and stabilizing previously non-transferrable organs.(Danovitch et al, 2013) This has led to the proliferation of a black market for organ sales, operating through illicit means such as criminal syndicates and the dark net. (Jafar, 2009) In the global South, many lower income families, or individuals in poverty, have therefore been enticed by monetary incentives and fraudulent marketing to sacrifice their organs for monetary compensation, such that these organs may be transplanted to patients in higher income families in the global North. (Danovitch et al, 2013) This development has sparked a vigorous debate on bioethics, and on whether it is morally defensible for a person to accept an organ that has been coercively obtained from a donor, or whether healthcare practitioners are morally obliged to decline performing an operation on an organ that has been illicitly obtained.

In another example, rapid progress in stem cell research has led to calls for greater public accountability by religious groups such as churches and evangelical Christians, who consider these technologies to be akin to ‘playing God’ and a deep affront to their religious beliefs. As a result, they have called for greater public regulation and accountability of these technologies. Finally, in the area of geneticall

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