Essay

Running Head: MEDICAL CASE ANALYSIS 1

MEDICAL CASE ANALYSIS 2

Medical case analysis

Name: Thy Hoang Comment by De Luna Zcielo Z: You don't need to have this you can go ahead and just out your name, the isntructor's name, and the date.

Instructor: Tong Hyouk Kang

Date due:

Case summary Comment by De Luna Zcielo Z: The "case summary" heading should be the start of a new page not on your title page.

The case is a demonstration of crisis within a crisis, where the external stakeholders can affect the decision-making process of an organization. The case is about a child; Josh Hardy who was battling kidney cancer since birth and through undergoing various chemotherapy treatments, his immune system weakened, leading to the development of a life-threatening respiratory virus. Josh’s parents were referred to Chimerix Company, which was a drug manufacturing company to get a drug that would save their son’s life. Comment by De Luna Zcielo Z: I would suggest that you introduce what the case is here in the beginning instead of later on.

The physician at St Jude referred the parents to Chimerix Company to seek brincidofovir for Josh’s medication. The parents made a ‘compassionate use’ request to the company. The CEO of the Company Kenneth Moch, was reluctant to approve the drug. He claimed that the company had no resources to support the investigational trials. Additionally, the company argued that the patient was very sick and that the drug might not work on him which would lead to the drug being proved ineffective. The company also questioned of its viability; if the child died the process of approval would be delayed. Comment by De Luna Zcielo Z: The word "of" here is extra and your sentence would work without it.

The family engaged the public thought the social media who then showed lots of concern and started campaigning for release of the drug to save Josh’s life. The CEO received threats from the public through his Twitter account. After further though he allowed Josh to have brincidofovir drug which saved his life. However, making this decision, he lost his job. The company claimed that CEO’s action was unethical. Comment by De Luna Zcielo Z: Did you mean "the public through social media"? Comment by De Luna Zcielo Z: Did you mean "thought"? Comment by De Luna Zcielo Z: As a reader the wording of this sentence sounds confusion. You can try to reword it to "However, making this decision cost him his job" or "Hoever, after making this decision he lost his job".

Ethical issues of the case

The case had questions to answer on ethical consideration.

· One issue was the extent at which social media or special connections can influence the decision to receive an experimental medication. This pressure affects the leaders who might end up making corrupt decisions. Comment by De Luna Zcielo Z: I think the bullet points would work best if you formatted it into a paragraph instead because topic sentence doesn't introduce the information as a list. However, if including a bullet list is part of the assignment you should reword it to say "The case had the following questions to answer on ethical consideration:"

· The other issue was avoiding developmental programs like cases to do with compassionate use to help large numbers in future. This may end up leading to death of some patients while waiting for FDA approval.

· It was also a concern on the limited number of doses available and whether there is a way of choosing the patients who are legible for the medication. Comment by De Luna Zcielo Z: Did you mean eligible?

· Another concern would be whether there are considerations of patients’ death from other body illnesses in the influence of experimental medicine. For instance, Josh died, but the cause of death is something different, what are the steps that are followed?

· The other concern is on the patients who die waiting for the drug to be approved. Is there a body that fights for them or what is the ethical explanation of that?

Company’s stakeholders

The case involves various stakeholders; Kenneth Moch, Chimerix, Josh Hardy and his family, Chimerix, among other organizations. Stakeholders are the bodies that have an agenda, a motive or a need that allows the issue of brincidofovir drug or not. Stakeholders, in this case, gain or lose depending on if the drug is issued or not. Comment by De Luna Zcielo Z: As a reader some of the wording in this sentence makes it a bit confusing. You could try rewording it to "The stakeholders involved in the case were Kenneth Moch, Josh Hardy and his family, Chimerix, and other organizations."

The first stakeholder is Chimerix, which is the inventor of the drug. The whole case of issue or not issue the drug to Josh revolves around this hospital. The company has been struggling with debts since they have been producing drugs but had not sold any due to long approval process. The company has been eyeing on brincidofovir to be the first drug that would be the first batch of revenue to the revenue. The company aims at providing an antiviral drug that would save many people’s lives. Adhering to the compassionate use would bring a negative feedback to the company if unfortunate response is realized with Josh. The other issue was that the company had no revenue to cover compassionate use. The positive side of the compassionate use would be increase in demand of the drug if it succeeded on Josh that means there would be an increment of revenue into the company. Comment by De Luna Zcielo Z: Did you mean "to the company"?

Kenneth Moch was the C.E.O of Chimerix Company at the time of the incidence occurrence. It is a very demanding position since he has to represent the company in decision making with all the public pressure that was arising from social media platforms. He took time to contemplate all the ethical issues concerned. If he allowed compassionate use of the medication, he would be probably killing Josh and by not allowing a compassionate use he would be allowing a greater chance of survival for many other lives later on. He is at a critical position since he has to do a balance of all those surrounding circumstances. He is concerned with the company legacy to the public thus has to protect it. Kenneth is also concerned that compassionate use would result to expense to the company without any revenue realized therefore had no choice but to deny the request. Comment by De Luna Zcielo Z: In order to be consistent I suggest you stick to "CEO" because you have already previously used it. Comment by De Luna Zcielo Z: This should be "public, thus he has to protect it." Comment by De Luna Zcielo Z: Did you mean "too expensive for the company"?

The other stakeholder was Josh Hardy, and his family. Hardy’s family was desperate to have their child treated. Hardy was battling kidney cancer since birth and through undergoing various chemotherapy treatments, his immune system weakened, leading to the development of a life-threatening respiratory virus. The family did their part on trying to use public influence through social media in trying to seek sympathy from Chimerix Company, who had the drug that would change their child’s life. It is through this influence that finally led to the CEO accepting, compassionate use of the drug to save Josh’s life. Comment by De Luna Zcielo Z: It would be more efficient if you used a different word here. For example, "The family did their part by trying".

The other crucial stakeholder was the Food and Drug Administration, which is a body that approves the drug for use. This body carries out the compassionate use of drugs or expanded access. The unapproved drug can be given to the patient in serious and threatening conditions. Josh’s parents were seeking compassionate use of the drug to save their child’s life, which the body delayed. FDA was reluctant to approve the drug after a recent death that occurred from compassionate use.

Chimerix Company’s stakeholders

The CEO of Chimerix was the most involved stakeholder of the case. Kenneth Mosh was reluctant in allowing compassionate use of the drug. However, due to public influence he gave in to the family plea to save their child’s life despite the fact that the drug was not approved by FDA. Previously Chimerix was considered cold-hearted and one that lacked compassion. However, this changed in Hardy’s case where social media influenced the CEO’s decision. The company has various stakeholders; employees, management body, investors, competitors, insurance companies suppliers, the public, the government among others. Comment by De Luna Zcielo Z: Did you mean "Moch"? Comment by De Luna Zcielo Z: When refering to the FDA make sure you say "the FDA" and not just "FDA" . Comment by De Luna Zcielo Z: If you are listing you should use a colon not a semicolon. Comment by De Luna Zcielo Z: To properly use a colon here I would suggest rewording it to "The company's various stakeholders included:"

The stakeholders have economic influence to the company. In this case, hospitals may boycott the company’s drugs if they sense unfair treatment. Employees in the company under the labor unions may also go on strike if there needs are not met. Insurance companies many also fail to offer their services if the company makes reckless mistakes. Comment by De Luna Zcielo Z: This is possesive so it should be "their needs". Comment by De Luna Zcielo Z: This word is misplaced. You can add it in the beginnning to say "Many insurance companies also fail".

The government is a stakeholder in the company. The government together with the tax payer and the public at large has the political power. The government regulates the company’s activities through laws and policies. In Josh’s case, the drug had to be experimented and approved by FDA before being released to the market. The public can has the power of influence where they can support a particular leader who wills hence represent their views in healthcare regulation. Comment by De Luna Zcielo Z: This should be "taxpayers" ,as in plural, because you are talking about the whole group. Comment by De Luna Zcielo Z: This is an extra word that doesn't need to be in the sentence. Comment by De Luna Zcielo Z: The word "hence" seems out of place. This is more effective if you say "who will represent".

The other stakeholders are the suppliers. Suppliers in all companies are very crucial since they provide the raw materials required to daily running of the business. Suppliers’ needs should be met in time to boost their reliability. Chimerix had been struggling with debt which means that their suppliers had not been paid for a long time. Supplier’s power depends on the bargaining power that the company has with their suppliers. Comment by De Luna Zcielo Z: You have the rigth idea, but the words are out of order. You can reword it to say "the raw materials required to run the business on a daily basis." Comment by De Luna Zcielo Z: Can you elaborate more on this?

Stakeholders’ responsibilities in the case

Chimerix Company was started in 2000 to develop antiviral drug against smallpox. The company then expanded to developing other antiviral drugs like brincidofovir among others that would be used to treat many other illnesses. The company was responsible of issuing the drug to FDA for approval and also ensuring that all the required policies were observed. The company is responsible for the outcome of the drug thus there should they should be confident enough when realizing the drug to the patients. The company viewed the CEO’s action of giving in to compassionate use of the drug as unethical and took a step further of replacing him from his position. This is because they feared losing their only hope that brincidofivir would be the source of revenue to the company and that they would save more lives. Comment by De Luna Zcielo Z: There are some extra words tha make this sentence confusing. You can try rewording it to something like "The company is responsible fot the outcome of the drug, thus they should be confident enough when realizing the drug to patients." Comment by De Luna Zcielo Z: Is this the only reason it was deemed unethical? If there are more reasons, can you elaborate?

Josh’s family had a responsibility to ensure that their son’s life is saved. They approached Chimerix Company for the drug but the company denied. They went further to seek public support using social media which contributed to the CEO accepting the public view. The family can be involved in solving the ethical issue by admitting that they were involved in influencing the public to demand compassionate use from the company which contributed to unethical action by the CEO. Comment by De Luna Zcielo Z: I'm not sure what is meant here by "the public view". The CEO didn't accept the public view he accepted the family's request because of the influence of the public. Comment by De Luna Zcielo Z: How does the family admitting to this solve the ethical issue? Are you referring to the CEO and how the blame can be somewhat shifted if the public's influence was seen as overwhelming?

The other crucial stakeholder was the Food and Drug Administration which is a body that approves drug for use. This body carries out compassionate use of drugs or the expanded access. Unapproved drug can be given to the patient in serious and threatening conditions. Josh’s parents were seeking compassionate use of the drug to save their child’s life which the body delayed. FDA was reluctant to approve the drug after a recent death that occurred from compassionate use. FDA’s decision is influenced by the company’s leadership. Sometimes the company has other reasons affecting release of the drug and may request FDA top rush the experiments to achieve their goals. However, on this case, Chimerix Company was not willing to give the drug a compassionate use since they were aiming at providing the drug to many people after undergoing a successful experiment. Comment by De Luna Zcielo Z: This all seems to be repeated information. I think this paragraph should focus solely on the reason's the FDA didn't want to approve compassionate use of the drug and hoe the end decision affected them. Comment by De Luna Zcielo Z: What are these other reasons? Comment by De Luna Zcielo Z: Did you mean "to top rush"?

Ethical theories and principles

There department of justice has various principles that ought to be followed by the employees in their day to day duties. The ethical principles violated in this case are; Comment by De Luna Zcielo Z: Did you mean "the department"? Comment by De Luna Zcielo Z: Not all of the principles you mentioned here were violated, you mentioned some that the CEO was actually abiding by. I would suggest you go back and regroup them according to the ones he violateed and the ones he did not, or else this section can get confusing. Comment by De Luna Zcielo Z: This should be a colon not a semicolon.

· Understanding that public service should be viewed as a public trust where the employees should submit to the laws and ethical principles and not on their personal gain (Nash & Wells, 2020). The CEO failed to consider the set laws in the case. This contributed to him losing his job. The CEO was supposed to wait for the experiment and advise Hardy’s family on the reasons against their will. He would also seek faster action from FDA so that the drug is approved and released to the market.

· Employees should not use the public office allocated to them for their own gain. From the case, when the CEO denied giving the drug to Josh’s family, he received threats from the public where he started fearing on his safety and that of his family. He started to contemplate on the matter and later submitted to the family’s request. By so doing he violated ethical principles. Leaders in top companies face lots of influence from the public which would be leading them to unlawful actions, without a strong stand the leader may end up violating the law while he or she struggles to please the law (Jacobs, 2020). The law is above all. People make laws to govern them, thus it should be respected and followed. Comment by De Luna Zcielo Z: Did you mean "themselves"?

· Utilitarian ethical theory was violated in the case. Allowing compassionate use of brincidofovir was against the utilitarian theory which states that the action whose benefits are realized to more people should be chosen above those that benefit lesser people. In this case, if the unfortunate happened then the drug would be a loss. The CEO did not consider utilitarian principles when he decided on helping Josh. Comment by De Luna Zcielo Z: This is in past tense so it should say "when he decided to help".

· The CEO followed ethical theories based on rights. Every citizen has a right to good healthcare (Scanlon, 2020). The government should ensure that all people have access to medication. FDA needs to be quick in drug approval to minimize mortality rates. It was Hardy’s right to get treatment with the right medication; the physician from St. Jude referred Josh’s parents to Chimerix to get the drug since he knew it would be of great importance to Josh.

· Virtue ethical theories were incorporated in the CEO’s act of allowing compassionate use. He used his own character traits to make his decision. He was a good man who had worked with several other companies and he valued humanity to a point that he could let a child die out of some set company policies. Comment by De Luna Zcielo Z: Did you mean "could not"?

· The principle of the golden rule was incorporated. This principle encourages people to do to others what they would like done to them. Ethical issues can be solved by use of golden rule where you imagine yourself in the victim’s position. The CEO used this principle when he was making the decision. He pictured his own son in such a condition and could not resist any longer. According to this principle his act was ethically right.

Action plan

I recommend a well-structured procedure on medicine approval procedure that would be followed by all without consideration of special cases like compassionate use. If a particular procedure is used by the innovating companies without any linkage of the information to the public then the system would be fair to everyone. Compassionate issue is good but it creates a conflicting interest which would only benefit those in power. All drugs in the companies should be tested and approved before realizing to the public. This will be fair to all people and will end up benefiting masses unlike one individual. We are in a technologically developed world so cases of social media influence will not cease. Comment by De Luna Zcielo Z: This is an extra word that isn't needed. Comment by De Luna Zcielo Z: Did you mean "compassionate use"?

People working in drug manufacturing companies need to be highly intelligent and uphold integrity. They should remain silent to the public on the drugs being developed to reduce public influence on drugs allocation. The companies should work closely with FDA in insuring that all medication produced is well tested and approved later sent out to the market. Comment by De Luna Zcielo Z: Your sentence would work better if you said "before they are sent out to the market".

In carrying out drug experiments the parties involved should consent before taking part in the experiment. The patient should be accompanied by a physician who will monitor and observe closely the patient’s condition. It should be after the experiments that the drugs should be approved for use.

The other crucial action should be giving a timeframe for drugs experiments. The experiment process should not take so long. The period should be reasonable depending on the use of the drug. When the process takes too long patients suffer and also the manufacturing companies realize great losses. Drugs production companies should also ensure flow of drugs production to ensure that there is income generated into the company thus reduce debts. Comment by De Luna Zcielo Z: Can you give examples of the losses manufacturing companies will endure? Comment by De Luna Zcielo Z: As a reader this sentence is confusing. I suggest you reword it to something like "Drug production companies should ensure the flow of drugs so the income generated reduces their debt."

The other issue is to consider all the ethical principles in judging cases. The company did not consider other ethical theories like the right theory, the golden rule, utilitarianism among other theories. The company was quick to charge and replace the CEO. This action may affect the company negatively to the public who had a great influence to the CEO’s decision. Comment by De Luna Zcielo Z: In order for the sentnece to work this should be changed to ", and the utilitarianism theory".

Positive outcomes of the action plan

The action plan recommended will be effective in ensuring justice for all. There are no special cases, all cases are treated equally until the drug is approved and allocated to the patients. The manufacturing company is supposed to be selective on the drugs being manufactured until the drugs are approved.

The plan prevents deaths arising from use of unapproved medication to the patients. Cases have been registered on patients who die after treatment with unapproved medicines. This issue will be prevented by application of this action plan. Comment by De Luna Zcielo Z: This sentence is a repetition of your first sentence. Is there a way you can elaborate more without repeating this?

The plan prevents losses to the manufacturing company which arises after death of patients after use of unapproved drugs. When such cases occur the company loses trust from the public due to failure of their medication. After application of the action plan discussed above, the company losses are minimized since the drugs released are approved and effective for use. Comment by De Luna Zcielo Z: As a reader this sentence has a little of repetition in it, so I would recommend you reword this to say "after the death of patients who use unapproved drugs."

Negative outcomes of the action plan

The plan does not give room for compassionate use. Patients may die during the experimental process. There are special cases, all patients are equal and can only be treated when the drug is approved for use by FDA. Comment by De Luna Zcielo Z: You're contradicting yourself here because previously you mentioned there weren't any special cases with this action plan.

In unfortunate cases, the drug may lead to death of masses. If the drug happen to cause other side effects to the patients the loss is huge compared to when the drug would be administered to one patient. The process also takes long to leading to greater suffering to the patients.

References

Jacobs, L. (2020). Embedding Ethical Principles in the Information Science Research Process. In Handbook of Research on Connecting Research Methods for Information Science Research (pp. 52-79). IGI Global.

Nash, R. R., & Wells, M. J. (2020). Ethical Principles in the Practice of Medicine. In Ethical Issues in Pediatric Hematology/Oncology (pp. 19-35). Springer, Cham.

Scanlon, T. M. (2020). Some Main Points in Rawls’ Theory of Justice. Ethical Reflections, 9-24.