Ever since the mid-1970s, the Federal Drug Administration (FDA) issued stricter rules on informed consent, high compensation has been necessary to attract research subjects for pharmaceutical tests. This generally means that the lowest income people in the U.S. are the ones who participate, since few people with comfortable financial circumstances volunteer to be guinea pigs for the drug companies. Before approving the sale of newly discovered drug, the U.S. Food and Drug Administration requires that the drug is put through 3 phrases of tests after being tested on animals. In phase 1, the drug is taken by healthy human individuals to determine whether it has any side effects. In phase 2, the drug is given to small group of sick patients to determine the dosage levels. In phase 3, the drug is given to large number of sick patients by doctors and hospitals to determine its efficacy.
Seriously, participation in drug and medical studies is a dangerous mission. No one knows the long term side effects of the drugs that volunteers take. Although the drug is tested by the animals, it still has a certain percentage of risk to the test subject. The Wall Street journal published an article that reported Eli Lilly, maker of Prozac, uses homeless people to test drugs for FDA approval. The Eli Lilly program, which pays $85 per day, is reportedly to recruit the people through soup kitchens, prisons, and shelters. This journal has aroused a thrill of discussion and comments from the society. Some critics comment on the Eli Lilly Company’s decision is unethical by recruiting those homeless alcoholics which may harm their life. However, there are some people who support the decision made by Eli Lilly Company. In fact, the decision is hardly to be described either ethical or unethical. Thus, we must analyze the outcome whether it is positive or negative. In the theory of utilitarianism, torturing a person who knows the position of a bomb which will kill a number of people is a good act. It is because this act could prevent the pain or death of the innocent people who are exploded by the bomb.
Do you think Eli Lilly’s practice is the ‘right’ action from the perspective of utilitarianism?
In the perspective of utilitarianism, Eli Lilly Company practices a right action. Based on the theory of utilitarianism, it is hedonistic which focuses on the pursuit of pleasure. An action is good if it brings about the most amount of pleasure or happiness for the most people and the least amount of pain.
1.1 A chance of cure the disease
From the passage, we know that Eli Lilly Company discovered a new drug for sale. The intention of the company is positive which used for curing the specific disease. If the new drug is applicable, it can save a lot of people’s life in the world. When Eli Lilly began using homeless alcoholics for Phase I testing, they met the requirements set forth both by Congress and by the FDA. These subjects came forward, regardless of their personal motivation, to perform a service that would benefit the greater good. This act exemplifies utilitarianism.
1.2 Providing an employment opportunity
The test subject is homeless alcoholics who abide by the Congressional requirements of providing informed consent and making a truly voluntary and un-coerced decision. The target subject from soup kitchen, shelters, jails, and homeless alcoholics who selected by the company is a right decision. It is because these people who are leading a vagrant and poverty life. Moreover, they may not have their family members. Thus, this selection could eliminate their worries on their family members. Besides, Eli Lily Company can employ them as their temporary worker to earn some pocket money. Homeless alcoholics are usually poor and lazy which could not afford to own a house themselves. Thus, with a new employment, they could earn money and spend it whatever they wish. This act exemplifies utilitarianism in providing employment opportunities for those unemployed and homeless people.
1.3 Improvement standard of living
Eli Lily Company provides a set of benefits to the participants who take part in the drug testing. They can earn $85 per day while receiving a warm bed, food and medical care. Besides, the tests runs for months, participants can make money up to $4500 which is abundant in the point of their views. Thus, they can enjoy a better living compared to a vagrant life.
1.4 Exclude the people who have their family
From the decision of Eli Lilly made, the target subject is homeless alcoholics. The reason is the company knows a healthy person will not take an untested substance that is not intended to cure them of anything. Besides, it may have side effects which could lead to unimaginable consequences. Therefore, the company decided to choose those people who do not have a family to have a drug testing. In this case, it can minimize the risk and responsibility that a person has to bear. Besides, the participant will have less worries and burden in taking in a drug test. This act has proved the utilitarianism by minimize the pain in the society.
1.5 Reducing a country’s crime rate
Homeless alcoholics are the person who usually unemployed and do not own a house. They might not have enough money to purchase the alcohol beverages and will think out many negative approaches in order to get it. As a result, crime cases like break-in, rob, snatch handbags, and stealing often exist within a country. In Eli Lily Company decision, it utilizes the homeless alcoholics as test subject is mutual beneficial. Homeless alcoholics can the benefit as they sign an informed-consent form to participate in drug testing. The participants can earn $85 per day while receiving a warm bed, food and medical care. Meanwhile, the company could achieve its objective in launching the drug testing in phase 1. As a result, this act exemplifies utilitarianism in term of reducing the probabilities of potential crime rate within a country.
The concept of a right plays a critical part in many of the moral arguments and moral claims invoked in business discussion. How do you apply the concept of a right in this case study?
2.1 The concept of Right
The Concept of Rights is defending an alternative to both of the traditional views and the justified-constraint theory of rights. On this view of concept, a person has a right if a feature of that person is a sound justification for others to have a particular sort of normative constraint.
The justified-constraint theory is avoiding the problems which have bedeviled the interest, benefit theories and the choice of will theories. It also will solve the puzzle of the relational nature of rights. On the justified-constraint view, an obligation correlative to a right is the right-holder when it is a feature of the right-holder that justifies the obligation. The analysis also shows that, as far as the concept of rights is concerned, any sort of individual or group can have rights. The limits on what sorts of things have rights are substantive, not conceptual. After that, the justified-constraint solves the problem of the rights of past and future generations. It is a theory which applies, without modification, to past, present and future beings. In this study case, the peoples had signed the informed consent and make a truly voluntary and uncoercived decision agreement with the company. They should know about the test may have some effects to their body but they still sign. According to the justified-constraint theory, those peoples had the responsibility to complete the test. Although the test might have some negative effects, the people must know the test clearly before they had to sign any agreement for the company.
The Categorical Imperative is a rule for testing rules of a conduct. It will exclude as immoral any rule of conduct that implies that one person may do something but another, in the similar situation, he will not do the same thing. In other words, it is demands consistency. Contractual right is a part of the concept of right. Contractual rights are deriving from the practice of promise-keeping. They apply to particular individuals to whom contractual promises have been made. Contractual rights arise from specific acts of contract making. They normally come into being when the contract is made, and they reflect the contractual duty that another party has acquired at the same time. Once when they are sign the agreement and get the benefits from the company, they had the contractual duty and provide the service for the company. The test may affect the rest of their life but they still had to do it. So, all the peoples had to understand their reason of choice. Is it a valuable and worthy for them to make this kind of choice. After they make the agreement, they can’t break it and must have to complete it.
What is in your opinion the application of deontological approach to justify Eli Lilly’s action?
The approach used by Eli Lilly’s action not appropriate. This is because, Eli Lilly’s company has been trying to keep the product to be really tested before it is sold to the public. The company is using the drunken and mostly suffering from health issues. As the requirement required by the FDA, the U.S Food and Drug Administration law, the product has to be tested by healthy consumers and approved itself by the FDA rules. Therefore the procedure and application of testing by the Eli Lilly’s action is not fair to all consumers later. The tested drug can be giving a false data as positive. The research for the product to be testified as useable for all consumer later after the product is commercialized will not be accurate.
Therefore, it is not applicable. The Eli Lily Company should hire healthy subjects as a tester towards the product. Eli Lily Company maybe cheating and doing the crime, which providing the false data to FDA to seek approval. Eli Lily should run a proper and correct test so that, the FDA will further approve the product in order to be sold later.
Other than that, the Eli Lily has been forcing the testers to try the drug, because one of the homeless alcoholic do not even know what type of product he has tested. Therefore already, signing the letter of ‘informed-consent’. Informed consent is a type of agreement between two parties which agrees toward the action one tries to take toward another. This is unethical, as it is perceive as the testers are force to do so.
However, the Eli Lily’s is also encouraging the homeless alcoholic drinker to continue drinking and be homeless. This is because of the rewards given to them is hefty and huge to the homeless. After all the testing rewards is given only for one month.
Eli Lily Company should seek true volunteers rather than choosing the drunken homeless. This is because the true volunteers can give a more accurate data, if they are potential product users. Even though Eli Lily is providing good rewards to the homeless, but not drunken homeless are the potential product user later, when the product is commercialized.
Eli Lily Company should not try to cheat the government rules and law, by seeking approval using this way. The accurate data from potential users of the product should be submitted instead of the homeless drunken. However to testify the product as use able, should not only be conduct using human testing. Eli Lily should use the technology and bio-technological experts to testify the product.
In your judgment, is the policy of using homeless alcoholics for test subjects morally appropriate?
No. It is morally inappropriate.
This is a form of discrimination toward the potential costumers and homeless alcoholics. This is because the company is making the homeless alcoholic more addicted to the drinking habits when they have the huge reward. The company do not care if the product is going to cause any side effect such as paralysis, organ damage, and other chronicle damage to the potential costumers. The company is taking advantage of the homeless alcoholic weaknesses to test their product by rewarding them. The homeless people are already suffering from their personal problems. But with the reward given, will make it worst. After that, all the reward only last for a month during the testing period.
The company could care less about the rest of the potential consumer later, for have not doing the proper testing on the product. For example, company should use the bio or chemical-technology expertise to testify the product. The company is not concern about the side effects of the drugs intent to be sale, but trying to make a business in the environment.
4.2 Against the law and regulation of FDA
As stated that the newly discovered drug, it will only be approved for sale by the FDA when the test is on healthy humans only. Therefore, Eli Lily’s is doing an unlawful business. The business may result many of public consumers to be suffering from the drug side effect. This is because the company is relying on the drunken homeless alcoholic’s feedback on their product as a positive feedback in order to get approval from the FDA. The company may be submitting a fraud legal document to the government to be given approval. Therefore many users later, may suffer from the side effect of drugs. The health condition of the homeless drinker maybe different, data cannot be adequate for a positive feedback for use ability for all consumers. The homeless drunk is not appropriate feedback representing to all potential consumers. The product tested by tester should have clue and information about what the product intend to be sold. Therefore, using true volunteer is required.
4.3 Attempt to deceive the participants
In general, drunken people are usually posses an unsound mind. It is because they are poisoned by the alcohol and their thinking might be ambiguous. As a result, they may make a wrong decision in participating in the drug testing. In addition, homeless alcoholics may short of money and desperate to gain money as much as possible. They may not think twice before an act. Therefore, ‘truly and uncoercived decision’ in signing an informed consent is not existed. Besides, the company only pay for the participant $85 a day which is believed as the lowest among its peers. However, because of desperate money in the homeless alcoholics’ mind have no choice to agree and accept the offer given by the company.
4.4 Absence of a compensation plan
Eli Lilly Company did provide the participants in term of money, warm bed, food, and medical care. However, all these things are provided in short term view. The company did not provide them in long term purposes and treat the participants as guinea pigs. Eli Lilly Company did not mention and provided the appropriate compensation plan to the participant in case of death or any side effects. Indeed, they just fulfil the desire of homeless alcoholics and achieve their objective in accomplishing the phase 1 test. The company does not bother a participant’s safety and danger issues by issuing an appropriate compensation to the injured participant.
4.5 Insufficient of explanation
In Eli Lilly Company decision, it did mention the new drug may have dangerous side effect during the testing. Besides, the company also met the requirements set forth both by Congress and by the FDA to launch a drug testing. The FDA requires that participants in such medical test must give their informed consent and make a truly voluntary and uncoercived decision. Unfortunately, the informed consent seems to be failed among the participants. When asking one of the homeless alcoholics, he said he is recruited but he has no idea what kind of drug to be tested on him even though he had signed an informed-consent form. Thus, it has proved that the company did not deliver the adequate information to the intended participant.
Ethics of an organization is important. This is because the ethics will result towards how the company will be successful. The case of Eli Lily’s Company, is a complex situation. The company is at both of moral and ethical clash with law and personal company benefits. Even though the company insist to provide the shelter and financial help to the homeless, but it is still a very selfish act from the company. The FDA, U.S Food and Drugs Administration should consider furthermore of the Eli Lily’s company and brand of product. This is because the drug that Eli Lily’s produce may not be suitable for the real potential consumers because the tester are not true volunteers to critic and giving positive feedback for the company to develop and testify the product before sale.