MBA8000: Applied Business Research & Ethics - Zika Virus - Assessment Answer

Applied Business Research & Ethics Assignment

Assignment Task

Company ABC has produced a gene therapy technique that will reduce the development of microcephaly in the unborn babies of pregnant woman who have become infected with the Zika virus. The therapy requires the use of stem cells and company ABC will need a large supply of them to treat the wider community. Clinical trials have shown that when adult stem cells are used there is a 15% reduction in microcephaly. When embryo stem cells under 14 days old are used there is a reduction in microcephaly of 50%. When embryo stem cells over 14 days old are used there is a reduction in microcephaly of 100%.

Company ABC need a large supply of stem cells for their gene therapy technique but they are unsure of what type of stem cells to use. All they know at this stage is that they want to acquire the stem cells legally and ethically. Company ABC is a huge multinational company and can set up their laboratory anywhere in the world.

They have asked you to do some preliminary research and write a Report to help them decide what type of stem cells to use. In your Report you need to address the legal and ethical issues related to the use of stem cells, the unborn babies, the pregnant women and the potential for further international spread of the Zika virus.

Based on your Report Company ABC will be carrying out some further research to acquire the stem cells that you recommended. Before they can do that research they will need to get approval from the Ethics Committee. So, they need to be aware of the ethical issues when they are designing their research. They want you to briefly outline the steps that they should undertake to ensure that their research is ethical. They will also need to know the essential ethical components that they would have to consider. So, you need to address that in your report.

You do not have enough words in this assignment to cover all of the possible steps and components for all the different types of research available. As you do not know what type of research that Company ABC might decide to use (to acquire the stem cells) you will need to choose one type of research and address the ethical issues related to the steps and components of that particular type of research.

Format of the Assignment

This assignment is to be presented as a full formal report (including letter of transmittal, executive summary etc) See the Communications Skills Handbook for more information if you are unsure of this format and the requirements. Or see this USQ page

Zika Virus

Transmittal Letter

Dear sir/madam

Enclosed herewith is a report done on 8/10/206 regarding the ethical issues concerning use of stem cells in developing a vaccine to reduce the cases and transmission of the virus. The main findings are

• The use of embryo stem cells which are older than 14 days older provide 100% reduction of microcephaly
• Most governments and medical bodies restrict the use of pregnant women and fetuses for conducting such research
• ABC Company needs to acquire consent from the families and individuals participating in the research
• The research should be conducted in Brazil since it is highly affected
• Most women have shied away from getting pregnant due to the virus
• Religion and culture does not permit destruction of embryos that have lived beyond 14 days

It must be considered that this is the first time the medical body is trying to come up with a vaccine for this disease. For that reason a lot of consultation should be done in collaboration with the medical bodies to verify the extent to which pregnant women can be involved in the research.

Finally, I wish to show gratitude for the opportunity given to me to develop this report and provide recommendations in this field of study.

Regards

Executive Summary

The recent upsurge of the Zika virus in the North American continent has caused a lot of grief. This is because the virus has been associated a condition known as microcephaly which causes the newly born children to have reduced size of the head. This paper addresses the ethical concerns regarding the use of embryo stem cells in researching about the zika virus. The paper discusses the ethical issues involved and provides recommendation for the way forward. Introduction

Zika virus is the latest epidemic disease that has affected the world in the recent future. It follows other viral diseases like AIDS that have also caused a lot of deaths in the world. However, it has been quite encouraging on how the world has quickly reacted to the diseases. Most of the scientists have been quick to conduct their research with regard to the possible solutions for the diseases. Even though the Zika virus was first isolated in Uganda in 1947 it only became famous in the latest 2015-2016 Zika virus epidemic. The viral disease has spread faster and is now found in South America and other Asian countries. The disease thrives best at narrow range of hot climatic temperatures found especially along the equator. The good climatic conditions are favorable for growth and breeding of mosquitoes which spread the disease (Jackson, et al., 2012). Zika virus is spread by Aedes mosquitoes which are mostly found in Zika forest in Uganda hence the name Zika Virus. The disease is similar to dengue, yellow fever, and West Nile viruses and hence share most of the symptoms. The recent strain of the virus have been seen to cause a condition called microcephaly (Leviton, Holmes, Allred, & Vargas, 2012). This is a condition in which the head of the born babies are either smaller at birth or will develop to acquire a smaller shape as they grow. The pregnant women can transmit the virus to their born babies at birth or before leading to the condition. A larger percentage of affected people are found in Brazil in South America. The presence of the disease sparked a huge debate in the social arena since many athletes were ready to turn down their chances of participating to the just concluded 2016 Olympics in Rio Brazil.

Approximately, over 30,000 infections have been reported in Brazil in the latest epidemic (Rasmussen, Jamieson, Honein, & Petersen, 2016). However, travel guidance’s and screenings helped in controlling the spread and contact of the disease during the prestigious competitions. In the spirit and urge to control the virus ABC Company a multinational research company has expanded its research base and is willing to conduct stem cells research with the aim of controlling the spread of the disease. A research was conducted to determine ways in which the disease can be controlled and the following recommendations and findings were reported. The following figure shows the affected South American countries

Current studies reveal that the virus plays a huge role of activating the branch of an immune system which later disrupts the activity of the genes which are responsible for the development of the brain hence leading to microcephaly (Shen, et al., 2014). In microcephaly, the brain fails to develop and that is what leads to reduced head size for the new born. That condition may lead to seizures and abnormal development of the baby. Current research also reveals that the immune responses related to the virus that are making the brain stem cells to die can be reduced and that can slow down the birth defects (Alkuraya, et al., 2015). The virus stops neural stem cells from dividing hence reducing the size of the human brain. The virus functions by diverting an important protein which is basically responsible for the cell division of the neural stem cells. There have been reports that drugs used in treatment of hepatitis C virus such as Sofosbvurir and other antiviral nucleoside analogs may be used to reduce the multiplication and division of the virus. Sofosbvurir has been commissioned for treatment of pregnant women suffering from Hepatitis C Virus and no trace of side effect has been detected on the fetus (Jackson, et al., 2012). The Protein mentioned is the TBK1 that is blocked directly hence leading to reduced brain cell divisions. University of San Diego and California in their research considered the protein TLR3 which is also an important protein that plays an important role on the innate body immune response (Buckley & Gould, 2016). Their research concluded that the stem cells that were infected with the Zika virus had higher and elevated levels of TLR3 protein which is an immune protein developed to fight of the disease. It was also noted with regret that the protein TLR3 has a knock-on effect that consequently leading to the regulation of 41 genes including the ones involved in the development hence leading to the shrinking of the organoids (Chen & Hamer, 2016). When the researchers inhibited the production of TLR3 in the zika infected cells the reduction of size of the brain was less and hence the scientists considered that inhibition of the TLR3 protein could offer possible treatment for the virus.

Moreover, ABC Company has also just concluded that when the embryo stem cells that are less than 14 days old are used there is 50% reduction of the microcephaly. Meanwhile if the embryo stem cells are allowed to mature beyond the two weeks there is 100% control of the microcephaly. When the company uses adult stem cells there is only 15% test of viability in success of the research. That means that the easiest and the best solution is to use the embryo stem cells. The other type of stem cells that could be used include the development of the pluripotent stem cells which is the latest. However, the use of pluripotent has also added to the field of controversy that has been existing. Pluripotent stem cells can be differentiated into all types of the specialized cells. There exist three main types of human embryo stem cells. There are those cell lines that are already in existence and there are those that usually remain behind after fertility treatments (Jamuar & Walsh, 2015). The third case involves those that are custom mane which are created from the somatic cell nuclear transfer technique which has been used in creation of the famous sheep Dolly.

There have been sharp criticism and political debates regarding the human stem cells. Most of the arguments roots on what stage the human life begins. Deriving the pluripotent stem cells from the oocytes and embryos has also been greeted with a lot of disputes regarding the personhood of human reproduction. Amongst the most disturbing dilemmas that could pose ethical challenges to ABC Company include gaining consents from the donors for human stem cell research (Smith S, 2014). The use of multipotent stem cells and the cord blood cells have not been barred with a lot of controversies and are widely applied in clinical care and research. However, they cannot be used in vitro studies. In addition they are not pluripotent. The cord blood stem cells have been used by scientists in the field of allogenic and autologous stem cell transplantation. It is one of the few alternatives available for bone marrow transplants. Meanwhile, the adult blood stem cells can either be used under specialized cells according to their tissues of origin. The use of this type of stem cell has not been validated in many experiments despite many scholars claiming so (Dawson L, 2014). While a lot of research has been done considering embryonic stem cells it continues to be one of the most criticized form of human stem cell research processes. That is because the use of that research method leads to destruction of the human embryos. In most cases the process of this research has been linked to the controversial abortion cases over which stage does life begin. A subject of dispute is whether embryos can be implanted and develop into a live born child. At appropriate hormonal phases the embryo implant has the ability to develop into a fetus and live baby (Lyerly AD, 2013). On the other hand, some spiritual groups and cultures treat embryos as a live human being and also asserts that life begins at conception. For that reason, embryos should not be destroyed. In the same view they argue that embryos should be accorded the same human rights and interests like the rest of the living human beings. In support of research and aim of solving some of the environmental challenges like microcephaly most scientists treat embryos as a bunch of cells that can be used in research process. A number of pro life believers have been in the fore front championing the use of embryonic stem cells in research. For example, once a couple decides that they no longer need children frozen embryos may be used. The same view has been on the recode for support by former First Lady Nancy Reaganrch. For example, once a couple decides that they no longer need children frozen embryos may be used. The same view has been on the recode for support by former First Lady Nancy Rea and US Senator Orrin Hatch. Due to that reason, ABC Company has therefore the freedom and support of using stem cells research in thier need to reduce the effects of Zika Virus (Kalfoglou AL, 2012).

There are certain ethical concerns involved in donation of the stem cells. The previous research involved in donation of oocytes have encountered cases of scientific fraud in South Korea in which somatic cell nuclear transfer (SCNT) lines were fabricated. ABC Company will therefore be required to ensure that they obtain their embryonic stem cells genuinely without any case of fraud. ABC Company must also listen to two sides of the argument for the cutoff point that comes two weeks after fertilization. It must be noted that after 14 days the embryo can no longer split into twins and therefore must be protected. Before 14 days the embryo may fail to develop or can still be split into many more babies. However, ABC Company has noted that their embryo stem cells that are still less that two weeks only give 50% chances of treating microcephaly. The research aims at curbing the Zika virus and ensure that pregnant women are only giving birth to fully mature and normal babies. It will be baseless for the ABC Company to engage in such an expensive research process only to give 50% of the research. In most cases research validity and reliability must always be over 70% reliable for it to be considered. Meanwhile, ABC Company is also aware that before the achievement of the two weeks the embryo is usually not having a nervous system hence it has no senses. Current treatments allow the use of organs from patients who clinically have been declared to be having dead brains and whose organs are used in transplants. If that is happening the argument is why shouldn’t embryos which have no nervous senses be used for studies and research? At this point we can conclude that fertilization is a process and so is the process of life. Embryonic stage is simply a stage and not a moment of life (Kalfoglou AL, 2012).

ABC Company is a huge company that has branches all over the world. Obtaining stem cells from all over the branches is a challenging tasks simply because of the differences in cultural and ethical values in different parts of the world. According to a research conducted in 2009 by the National Institutes of Health there is no proper guidelines in the manner in which stem cells can be distributed. However, ABC Company can also request for funding by the NIH and hence the moral responsibility of the research will be fully based on NIH and not be subjected to ABC Company. In addition, NIH has policies and procedures which must be consistent with the executive order of 13505 that govern all the NIH stem cells research (Lomax GP, 2012). There are also ethical concerns that involve the financial gain for companies like ABC that are obtaining the stem cells. ABC Company must understand that stem cells under NIH are subjected to existing patents and hence such stem cells may not create any competition or worthy in gaining any profits. In most cases donors of stem cells have always expressed concerns regarding the benefits that they experience upon success of the research (Dawson L, 2014). Most of the donors always wish to share the financial gain if the research process is successful. ABC Company must therefore ensure while obtaining consent that they inform the donors that such donations usually does not have direct gain upon success. The consent while being obtained must also inform the donors that they will not be receiving any financial gain for such commercial development. Meanwhile it is the duty of ABC Company to inform the donors that there is a possibility that they donations may have commercial value and financial benefits. ABC Company must avoid cases of fraud like that of South Korea in which the donors were coerced to provide the stem cells for research (Lomax GP, 2012). It was noted in that scandal that the donors were workers in that institution who were coerced in donating the embryo stem cells. It must also be noted that the research involved will also be touching on pregnant women further complicating the ethical process.

Recently, a woman was convicted in Brazil for obtaining an abortion since she was Zika infected. The Brazilian government issued strong warnings for women found committing abortions to get rid of fetus suspected to be infected with zika virus. The Brazilian government has also confiscated a lot of the pills shipped to the country for medical abortion purposes (Chen & Hamer, 2016). Meanwhile, that poses greater ethical issues for the ABC Company especially if the company is willing to use samples from pregnant infected women. Global approaches and political arena has made it difficult to use pregnant women for research purposes due to their vulnerability. Their fetuses too have been widely excluded from research. Meanwhile, it will be also difficult for ABC Company to collect samples from pregnant women since most of the countries oppose abortion. It therefore means that ABC will have a difficulty to conduct fetal researches for the Zika virus. Irrespective of that, Brazil still remains a favorable place to collect the embryo stem cells and conduct research for the ABC Company. That is because Brazil is the 5th most populous country in the world. In addition, it is the country with the latest and highest infections of the virus. Moreover, the country is also known for its less immune population with a four year round equatorial climate that favors the growth and development of the mosquitoes. While Zika virus affects more than the pregnant women the effect has been felt more on the pregnant women most of which have been found in the poor rural towns in Brazil (Chen & Hamer, 2016). The next likely challenge for the ABC Company is the advocacy for reduced birth cases by some leaders. Latin America is highly religious and dominated by the Catholics. In the latest pandemic the Catholic Pope Francis announced to the Latin American women to engage in modern contraceptives to reduce the incidences of the virus. Meanwhile, El Salvado, Ecuador, Brazil, and Colombia have advised their women not to be pregnant at least for two years. However, it was noted that women willing to avoid pregnancy had no enough supply of contraceptives (Chen & Hamer, 2016).

In January 26th the US government announced research in Zika Virus. Many companies including ABC are rushing to come up with a vaccine that could control the disease which is estimated to affect over 4 million people by 2017 (Omer SB, 2016). However, if the drugs are developed will they be allowed to be tested on pregnant women who are mostly affected? ABC Company will have to buy time and watch as the international community strive to reduce the potential of the disease. Meanwhile, ABC Company should also be equipped with relevant guidance and cancelling procedures in the event of collecting their samples for testing. Health authorities in Brazil have confirmed that they have not been equipped with relevant guidelines to offer to Zika infected people or pregnant women who test positive. The recent journal published regarding the disease has confirmed the need for the health policies and researchers to overcome the barriers that govern pregnant women and their fetuses (Omer SB, 2016). That comes in after the H1N1 flu and the Ebola virus that threatened the health of pregnant women. There have also been arguments that most of the institutional boards have failed to balance between the risks and benefits of research for pregnant women and only the latter has been always considered. There is need for pregnancy specific ethical framework to be established in order to assist the ongoing research and testing for the zika virus (Omer SB, 2016).

ABC Company will also be faced with ethical dilemmas due to lack of consistent guidance on the way drugs and vaccines will be labeled especially with regard to pregnant women. Most of the governments have also issued travel advisory regarding the zika virus. It is expected that the ABC Company also be aware of the travel restrictions in case the company decides to conduct their test to the rest of the countries. While everyone has shifted their research to the development of stem cells other suggestions by scholars prefer eliminating the vectors that are spreading the disease. For some couples two years is a very long time for them to remain without a child. Sterile mosquitoes can instead be developed and used to reduce the possibilities of infection and spread of the virus. However, it is argued that deferment of pregnancy right now is the most absolute measure to be taken in order to provide scientist with enough time to develop a vaccine that could help reduce the virus.

Conclusion

The world has been caught unawares with the recent upsurge of the zika virus. Every scientists is trying to come up with the most immediate way to control the virus. While most of other measures are still contemplated ABC Company may need to rush and develop a vaccine that can be used to control the disease. It was noted that if the company uses the embryo stem cells that are less than 14 days old there is only half control and possibility of microcephaly. However, if embryos beyond two weeks are used there is 100% success in controlling microcephaly. However, ethical regulations, beliefs, and culture hinder the use of embryo stem cells especially beyond 14 days arguing that such embryos have the right to live and does not deserve to be destroyed. That is because an embryo beyond 14 days can no longer split into twins. However, since embryos beyond 14 days still lack sense organs it is recommended that they be used by ABC Company in their research. In addition, it is recommended that the health agencies reduce their barriers on pregnant women and fetuses to reduce the chances of risks.