Essay on What Has Given Rise to the Need for Bioethics in the Development and Testing of New Products/Drugs/Practice Protocols?

What has given rise to the need for bioethics in the development and testing of new products/drugs/practice protocols? What segments of the population are more vulnerable than others to ethical violations? What protections are in place to serve as safeguards? What changes in policy – either government or corporate or both – legislation, and/or public education are still needed to protect the rights of individuals?

Several issues related to controversies surrounding abortion, stem cell research, euthanasia and unethical drug trials have arisen in recent years, pitting interest groups such as religious institutions and research bodies against each other. Clearly, bioethics is a critical issue that links these disparate controversies, as these issues are all bioethical problems that affect certain population segments, and require adequate protections to ensure that these segments are not harmed. This essay will discuss the need for bioethics in the development and testing of new products, drugs and practice protocols in the light of greater competition, public accountability, technological advances, experimentation and fiduciary duties. This essay will then discuss the segments of the population that are more vulnerable than others to ethical violations, which include minorities, lower income and lower-educated segments, rare disease sufferers and individuals in developing countries. This essay will also cover the protections that are in place to serve as safeguards, in terms of regulation, democratic deliberation, public-private partnerships, non-governmental organisation campaigns and media exposes. Finally, this essay will discuss how further changes in legislation, public education and policy ( in terms of corporate and government policy) are necessary to improve the state of bioethics.

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 genetically modified organisms (GMOs), several consumers have called for greater public accountability and transparency over the use of GMOs in the global food supply chain, and a closer examination of the impact of using these organisms on the ecosystem, the environment and human health. ( Idris et al, 2013)

A key factor driving the growing need for bioethics in the development and testing of new products, drugs and practice protocols has also been the technological advances in medical products, drugs and healthcare delivery in recent years. Several decades ago, technologies such as stem cell therapy, vaccination and organ transplants would have been unimaginable. However, advances in the technological cost and feasibility of these procedures have also led to the creation of a host of bioethical dilemmas. For example, the safety and success rate of several of these treatments is still uncertain. One relatively recent case in 1998 involves a paper published by the British healthcare researcher Andrew Wakefield, who claimed that the MMR vaccine’s administration was linked to the onset of developmental disorders in children. This led to a global public scandal, as healthcare practitioners and pharmaceutical companies weighed the benefits of vaccinating children from measles, rubella and mumps, against the possibility of introducing the development of autism and ADHD in their young patients. (Flaherty, 2011) The scandal continued until Wakefield was revealed by an independent journalistic investigation to have fabricated evidence, which opened another bioethical debate about the burden of proof that medical researchers have to ensure that their work is not tainted or biased by poor evidence or conflicts of interest. (Flaherty, 2011) In the same light, the rapid growth of the organ transplant market and stem cell therapy market has also led to public bioethics debates over the safety and sustainability of these therapies.

Another major issue that has led to severe bioethics controversies has been the issue of experimentation. Frequently, pharmaceutical companies and healthcare practitioners will have to research and develop novel therapies and drug products in conjunction with clinical testing, which involves inherent risks. However, these experiments may not deliver the promised treatment to their patients, or worse still, may end up harming the patients involved in such clinical trials. In the most infamous example to date, the leading pharmaceutical company at the time, Pfizer, administered an experimental oral antibiotic, Trovan, to children in the Kano state, Nigeria in 1996 who were suffering from meningitis, in place of the standard ceftriaxone treatment. (Nwabueze, 2003) While both treatments inevitably featured patients who died, Pfizer was later accused of faking records and illegitimately administering the experimental treatment on the children in the test group without consent. (Jegede, 2009) Pfizer was also accused of causing brain damage, developmental disorders and paralysis in children in the treatment group, where the experimental Trovan may have led to unintended side effects. (Nwabueze, 2003) The case was widely seen as a gross violation of ethical principles of scientific experimentation, and Pfizer had to pay compensation to the victims and continues to face criminal prosecution by the Nigerian authorities. (Jegede, 2009) Similar controversies have erupted over experiments involving conversion therapy, electroshock therapy, hypnosis and LSD treatments, which have led to unintended and devastating consequences for the patients who received such treatments.

Finally, healthcare practitioners have a fiduciary duty to care for their patients and do no harm. However, several medical treatments, such as abortion procedures, euthanasia, assisted suicide, the termination of mechanical ventilation, and treatments involving informed consent, may lead to bioethics problems as they may cause harm. In the case of abortion, the critics of abortion contend that the ending of a fetal life is a violation of a healthcare practitioner’s fiduciary duty to do no harm. Likewise, euthanasia and assisted suicide, even for a patient who is in great pain or who has voluntarily and consciously consented to such ‘treatments’, may be a violation of a physician’s oath to do no harm to their patients, as the lethal injection administered through such treatments inevitably kills the patient at hand. Likewise, the termination of mechanical ventilation and life support, while it does not harm directly, leads to the ending of a life, which critics have suggested is tantamount to manslaughter.(Lavery et al, 1997) This has led to a major bioethics debate over the responsibilities and scope of a physician’s responsibility, and whether a healthcare practitioner is obliged to safeguard the life of their patients over their expressed wishes on the stewardship of their life.

Segments of the population that are more vulnerable than others to ethical violations

There are specific segments of the population that frequently recur in the media as the victims of these bioethics scandals. The segments of the population that are more vulnerable than others to ethical violations include minorities, lower income and lower-educated segments, rare disease sufferers and individuals in developing countries. Foremost, minorities in several countries, both developed and developing, are more vulnerable to ethical violations as they are typically less informed about their civil rights.(Moore, 2010) Linguistic, cultural and educational barriers may exist for them in their integration into society, which may cause them to be unaware of their individual rights when it comes to consenting to experimental medical treatments, euthanasia, stem cell therapy or GMO products. As a result of their lack of awareness over the potential harms and ethical implications of these products, minorities are often unwitting victims of these treatments.

Secondly, lower income and lower educated segments are also more vulnerable to ethical violations. These segments are typically less educated about the implications and risks of recent scientific advancements such as genetically modified organisms, stem cell therapy and drug trials. They are also often unable to pay for ‘gold standard’ treatments, and may opt for more experimental alternatives due to a lack of financial ability to pay for regular treatments. As a result, these lower income and lower educated segments of a population may fall prey to experimental biomedical trials or novel products that may pose harms or ethical problems, which they may not be aware of.

Thirdly, rare and uncurable disease sufferers are often the target of experimental drug trials that pharmaceutical companies push aggressively, even in the face of potential ethical violations. (Moore, 2010) Individuals suffering from rare forms of cancer, allergic diseases, Creutzfeldt–Jakob disease, HIV-AIDS, Ebola and Hepatitis B may consider their condition hopeless, as there exist no known cures for these treatments. In the face of a lack of treatment options and a lack of time remaining to treat the disease before they succumb to it, such individuals may often opt to be treated by ethically problematic treatments which are still in the experimental phase, and may suffer even more severe health consequences as a result.

Finally, individuals in developing countries often lack basic access to healthcare, sanitation and medication. These individuals may therefore be enticed by clinical trials that offer experimental therapies at low or no cost, or therapies that may even provide financial remuneration for individuals who accept their administration. Several bioethical scandals have also been linked to developing countries, such as organ markets in India, where individuals are coerced through financial or violent means to donate their organs for sale. The stigma surrounding diseases such as HIV-AIDS and mental health is also more severe in developing countries with lower awareness of such diseases, which may make such individuals more susceptible to experimental and ethically problematic forms of treatment. (Yadavendu et al, 2009)

Protections that are in place to serve as safeguards against ethical violations

In response to the above bioethics problems, and to protect the segments of the population that are more vulnerable than others to ethical violations, protections have been put in place to serve as safeguards, in terms of regulation, democratic deliberation, public-private partnerships, non-governmental organisation campaigns and media exposes.

Foremost, regulatory authorities such as the U.S. Food and Drug Administration (FDA), backed by legislation such as the U.S. Federal Food, Drug and Cosmetic Act (FDCA) of 1938, gives the U.S. government the expressed authority to regulate, police and monitor the quality of products manufactured by biomedical and healthcare authorities. (Hoffmaster, 2009) Such regulation ensures that imported products are compliant with FDA regulations, and that counterfeit ingredients are not used which may be harmful to consumers.

Secondly, several countries, such as the United States, feature systems of democratic deliberation that allow citizens a voice to determine the legality of new medical technologies. For example, the U.S. Senate Select Committee on Ethics and the U.S. House Committee on Ethics regularly deliberate on the ethical issues of major bioethical dilemmas such as abortion law, euthanasia law, assisted suicide law and GMO status. (Hoffmaster, 2009) They regularly call upon expert witnesses on both sides of the aisle to testify on the ethical issues at hand, and the representatives of such democratic systems are ultimately held accountable by their electorate and constituents. Furthermore, several leading academic and research institutions also have their own internal bioethics committees, which ensure that their faculty and research staff are producing research that is in line with leading ethical guidelines, in a manner that is publicly accountable.

Thirdly, public private partnerships have allowed for greater scrutiny and best-practice sharing between private players such as pharmaceutical companies, and public stakeholders such as publicly funded hospitals and governmental healthcare authorities. These partnerships allow private players to be certified and audited for their processes, to ensure that they are in line with latest regulatory compliance laws, and that they have not transgressed any ethical boundaries in their research. (Hoffmaster, 2009) Corporate bioethicists, often from public institutions and academic research centers, often partner with private companies as well in order to ensure that these companies are in line with latest ethical standards for research and operations. These experts are often able to dispense advise drawing on a variety of multidisciplinary approaches involving religion, science, ethics and philosophy.

Finally, non-governmental organisations and media exposes form a powerful mechanism to protect and safeguard consumers and the general public against ethical violations in the area of healthcare and medical products. (Hoffmaster, 2009) News agencies such as Reuters, the New York Times and the BBC are often able to expose, in conjunction with watchdogs such as the Nuffield Council on Bioethics and Bioethics International, lapses in bioethics and regulatory compliance among stakeholders such as hospitals, pharmaceutical companies and medical providers. These form an important check and balance to ensure that these stakeholders are held responsible for the ethical implications of their actions.

Recommended changes in legislation, public education and policy to improve the state of bioethics

Much can be done to reform the area of legislation, public education and policy in order to improve the current state of bioethics. Foremost, governments should introduce stronger regulation to ensure that consent is obtained for the administration of any medical treatments that are experimental or that have unproven health consequences. Secondly, governments should work with schools, universities and workplaces to institute greater public education campaigns over contentious bioethics issues such as abortions, euthanasia, assisted suicide, genetically modified organisms, experimental drug therapies and stem cell therapies. By equipping the public with sufficient information that is kept up to date with the latest scientific research, governments can therefore empower their citizens to make informed decisions on bioethics issues, and to vote in accordance with informed opinions during referenda about bioethics. Finally, governments should tighten regulation concerning drug trials and the administration of contentious medical treatments such as euthanasia, to align their policies with the interests of their stakeholders.

Conclusion

Bioethics remains an understudied field with tremendous ramifications to several issues in medicine and healthcare today. In discussing the need for bioethics in the development and testing of new products, drugs and practice protocols in the light of greater competition, public accountability, technological advances, experimentation and fiduciary duties, the segments of the population that are more vulnerable than others to ethical violations, which include minorities, lower income and lower-educated segments, rare disease sufferers and individuals in developing countries, the protections that are in place to serve as safeguards, in terms of regulation, democratic deliberation, public-private partnerships, non-governmental organisation campaigns and media exposes, and the need for further changes in legislation, public education and policy to strengthen the bioethics framework, this essay has proven the need for greater bioethics research and awareness.

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