One of your products is about to go into clinical trials. This product would ass
ID: 468287 • Letter: O
Question
One of your products is about to go into clinical trials. This product would assist with fat loss and muscle development for those who are attempting to strengthen and sculpt their bodies. HR has asked for your policy on how to recruit people for Phase 2 of the research process. During Phase 2, the drug is taken by healthy human individuals to determine whether it has any dangerous side effects. Tests must be done on at least 100 people and continue for six months. Phase 2 is the most difficult to carry out because most healthy individuals are reluctant to take a new and untested medication that is not intended to cure them of anything and that may have potentially crippling or deadly side effects. While your product is designed for fat loss and muscle development, one potential side effect is acceleration of the heart, possible temporary or permanent heart damage, and potential damage to muscle tissue. Further, Phase 2 is very expensive. The industry standard is to advertise widely and pay volunteers as much as $250 a day. If you follow this route, the cost of Phase 2 will be $12 million, which you do not have in reserve. You would have to raise additional capital to begin the process of testing. However, you have been following the case of Eli Lilly who does not advertise as widely and pays its volunteers only $85 per day plus free room and board, the lowest in the industry. One of the reasons that the rates are so low is because Lilly uses homeless alcoholics who are recruited through word of mouth that is spread in soup kitchens, shelters, and prisons all over the United States. Because the test subjects are alcoholics, they are willing to undergo the tests to receive the easy money. However, this approach raises issues for you such as can the subjects freely give their consent given their desperate situation; and will they spend the money they earn from the project on alcohol and unsavory living rather than trying to reestablish themselves. In response to these concerns, you know that many younger people are unemployed or underemployed. By using this population as your healthy subjects, you would be able to help them by giving them income while saving the company lots of money. Because Phase 2 tests can run several months, test subjects can make up to $4,500 – a huge sum for people who would otherwise be unemployable and/or surviving on the street. A review of Lilly’s track record shows that the incidence of lawsuits is much lower than those who use traditional subjects because the homeless and poor people tend not to litigate if they have a “bad result.” Further, the benefit to society is very high in that some tests of potentially good drugs might be delayed several years if testing were not done. The proposal would be to test this product on inner city young adults, people who are over the age of 18 who are hanging out in gyms in major urban centers where the unemployment rate is 13% or more. These individuals tend to be healthier than Lilly’s subjects who have lived on the streets longer. The notion would be that these young people will be willing to receive $85 per day which is the equivalent of about $11.00 per hour. These young people who might otherwise turn to gang activity, drug dealing, or other nefarious activities could get resources to help turn their lives around. Equal Opportunity for Success Next, consider how well each option assures that social and economic inequalities are arranged so that all constituents have an equal opportunity for success. Which option best meets this requirement. Discuss why the other options do not meet the requirement of equal opportunity for success as well.
Explanation / Answer
Option 1: The industry standard is to advertise widely and pay volunteers as much as $250 a day.
Implications:
Option 2: Does not advertise as widely and pays its volunteers only $85 per day plus free room and board
Implications:
Option 2 is suggested:
The option two is the suggested. Because, this option will be beneficial to the society or people who undergo test and uplift their economic conditions on the other hand, the phase 2 would be conducted at a very reasonable cost and ultimately it would decrease the cost of formula to the company and reduces the burden on customer. This option has only disadvantage or ethical issue is the consent from alcoholics to take or undergo test. Normally, alcoholics are mind absent while they consume alcohol but not in the other times. So, the alcoholics are educated and aware about the advantages and disadvantages and how could they change their lives by taking these types clinical tests and convincing them by explaining all the facilities the clinic will provide in case of problem happen to the volunteer.
Reason for leaving the option one:
The option 1 is not suggested because; the test could have a significant impact on clinic’s financial condition and also reflects on the cost of the product and ultimately impact on the consumer of the product. Other reasons include, delay in conducting the test, it may take years to complete the phase 2, getting volunteers for the test would be very difficult, additional burden to company by the way of advertisement despite of various operational problems.
Conclusion: The present study is not for any serious problem that the society is facing. The clinical trials especially on humans may be conducted for only problems which have serious implications on society. For example, Swine flu, Ebola etc., are very complicated and chance to have an impact on society at large and could be considered for such a rigorous research by conducting trails on humans for fast results. So, the present study is not ethically advisable. But upon considering the pros and cons of the option 2, it is considered for the present case.
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