Australian Pharmaceutical Vaccine Help

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Australian Pharmaceutical Vaccine Help


Analysis of the case:
The following eight-step decision making process is applied to analyze the given ethical dilemma. The given situation is analyzed on the basis of doing ethical technique and ethically questionable situations are evaluated with the best suited solution and recommendation. This eight step decision making processes will help to determine certain solution to the given scenario.  The discussion will end up by providing the recommendation best suited to the situation. 
Doing Ethical Technique 
What’s going on?
Australian pharmaceutical corporation has been introduced a new experimental vaccine and believed to treat a life threatening virus spreading in West Africa. The vaccine is tested on the Chimpanzees who are infected with the same virus and has provided positive results. The vaccine has not yet tested on human beings and it would take near about 10 years for testing and approval on human, according to Australian health authorities. This is because the side effects of the vaccine on human are not known.  But, our company has received a request from a health worker in Africa and he wants to use the vaccine for the treatment of tens of thousands of West Africans who have infected with the virus. All the ethical criteria and health care regulations need to be checked before making the final decision about the vaccine deployment. 

The following steps will elaborate the relevant factors important to make decision and ethics associated with the situation before reaching towards conclusion.
What are the facts?
Australia based large pharmaceutical company has invented a vaccine through which a deadly virus in West Africa can be treated. But, it is an experimental vaccine and has not tested on humans. According to Australian health authorities it will take ten years to test its side effect and approve vaccine for human use. Yet, a health worker in West Africa has approached corporation and had asked for the experimental vaccine for the people infected due to virus. Is it ethical to deploy the vaccine to the health worker in Africa? What are the ethical or regulatory concerns associated with it? And similar questions should be overviewed before making the final decision. This has been analyzed and discussed in following sections. 
What are the issues?
First issue is about the Australian health authorities who have refused to use the vaccine on human before testing the side effects which would last ten years.  One may say that side effects would be worth in case of deadly virus spread in West Africa.  The side effect of the vaccine on human could complicate the things in West Africa because the health worker is not equipped with the treatment to handle the possible side effect if it occurs. In this case, if patient dies due to a side effect of a vaccine then the things would get complicated and the situation of fear would arise.  
Another issue would be the mistrust on the health-care worker, they would be questioned and it may slow down the development of medicines and other research for the virus spread in West Africa. The political issues and issue of lawsuit may arise. There would be ramifications if a vaccine which has no safety data used to treat patient. The news may spread that Western companies experimenting on African may affect the Australian pharmaceutical companies reputation and corporate image. The political ramification will occur if non-tested vaccine is given and causes side effects. In such cases, company may use the way of indemnification, which may help them lawsuit made for patient who experience side effects. 
Who is affected?
Australian health authorities denied the use of the experimental vaccine before testing its side effect on the human. The first stakeholder would be affected due to the decision of providing the vaccine to the West African health worker is the pharmaceutical corporation who has developed vaccine. The company’s reputation and corporate image would be affected if vaccine laid side effect on patients. Secondly, the political ramification would be there. People may quote the scenario as, the Western companies are experimenting their vaccine on Africans. The patients safety is must and no one has right to make experiment with people’s lives. 
What are the ethical issues and implications?
It is important to check the ethical obstacles that would emerge in case of using vaccine. First ethical question raised would be the patients having the disease should have to make a well-informed decision about using experimental vaccine. “Dying people grasp at straws”, says physician. It is recommended by the physician that the consent should be gained from the affected people, in order to spread understanding of the research. The ethical dilemmas says that one should be transparent about their research to avoid any kind of misunderstanding or mistrust. 
Theory of beneficence and human rights 
The international community and country’s government both are responsible and have duty of care to provide effective and affordable treatment to reduce risk of viruses and unnecessary illness. The ethical duty of care depicted to provide the treatment to the people in need. In case of humanitarian emergencies, risk of spreading the virus and death is higher than other situation. The principle of beneficence provided the duty of care which states that governments are responsible for providing vaccines in the emergency and life threatening situations.  
Theory of non-maleficence
The decision made under the humanitarian crises situation need to make proper balance between beneficence (i.e. doing good in any situation) and non-maleficence (i.e. eliminating harmful situation). Hence, according to this theory, the vaccine that has proven sure and effective results should be used in the humanitarian crisis situation. Those vaccines protect people from the harm of virus and provide immunity benefits which ensure the possibility of disease transmission. The vaccines provide the benefits but the experimental vaccines are associated with the individual and social harm. The patient should be well-informed about the treatment of experimental vaccine. It is unethical to provide the drug with possibility of side effects. 
What can be done about it?
The scientific or medical downside should be tested. The effective treatment is needed to stop spreading the virus in West Africa because tens of thousands people are already affected due to the virus. If people would wait for the human tested vaccine and not use the experimental vaccine there are chances of spreading the disease and death due to no treatment. The organization like WHO also worries about such situation and public response towards existence of treatment. If health-care workers fail to find the treatment there capabilities could be in danger. On the other hand, if available treatment is not promising then also it ends up losing trust on health workers and increasing fear in public. 

One can check for the precedent for using experimental vaccines in special cases.  In 2009, during the spread of H1N1 virus, the FDA has approved the use of experimental vaccine named peramivir. So, in this situation one can take reference of this case for using the vaccine in West Africa. Under the ‘compassionate use’ guidelines patients can be provided with the experimental vaccine. A US Marine, was treated with unapproved vaccine in 2009 against the vaccinia virus. 
What options are there?
Following are the options which can be considered by the Pharmaceutical Corporation to  make decision about providing the vaccine to the West African health worker. 
1. It’s better to use experimental vaccine, instead of letting people dies through virus.
If the possibility of getting proved vaccine is low then patients would die due to no treatment. Hence, instead of letting people die due to lack of treatment the way of using experimental vaccine is much better option. The healthcare worker should gain trust of the affected people, and the people who shows trust on the healthcare worker and agreed to take vaccine can be treated with the vaccine.  There might possibility of getting mistrust and fear review from affected communities but once, you start creating survivors instead of dead bodies then people would come for the treatment and may change their minds.  
2. Scientists would learn from the results of experimental vaccine’s use and can improve the result. 
Once the vaccine is used on people affected with the virus then scientist can try for improvement and better results and it would benefit the critical situation in the west Africa. 
Would scientists learn anything from using the treatments in the current outbreak?
  “While we can likely provide safety data from anywhere in the world, we can only assess whether a vaccine or drug works for Ebola by using it in affected countries with the consent of individuals and communities concerned,” says tropical-medicine physician Jeremy Farrar, head of the UK-based Wellcome Trust, who was one of the 12 experts chosen for the WHO ethics panel.
Which option is best – and why?
Experts have argued that using experimental treatments during an outbreak might be the best way to determine whether they actually work. “While we can likely provide safety data from anywhere in the world, we can only assess whether a vaccine or drug works for Ebola by using it in affected countries with the consent of individuals and communities concerned,” says tropical-medicine physician Jeremy Farrar, head of the UK-based Wellcome Trust, who was one of the 12 experts chosen for the WHO ethics panel.
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