The Problem: The Case of the Indigent Subjects One of your products is about to

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The Problem: The Case of the Indigent Subjects

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.

Please complete each section of this worksheet. Some people find that writing the answers out on another page and then "cutting and pasting" them into the worksheet lets you think through the problem better.

Be Responsible

Choose an Option
Select one option to implement within your Division:

Explain Your Decision

Using the guidelines for how to write a 460 single spaced word memo, write a memo to be shared with the rest of the leadership team which explains your decision.

Communicating with others is key. Often the only chance we get to influence a person is a sound-byte, a short and sweet comment at a meeting or in a memo. Thus, the ability to communicate your decision in a way that will get buy-in from the others is important.

While the full description of the process is in the Library, as you write your memo remember the following steps:

Give the brief background of the problem;

Give a statement of the decision;

Give the reasons for the decision. Use the language of the lens you used to make the decision;

Give a forward looking conclusion that helps people buy-in to the decision.

1.Do not do the testing on the product and recommend the product be sent to market. Because health supplements are not as rigorously monitored by the FDA as other types of medication, a company can slide on the testing and market the product making very casual claims. If a problem arose later, the liability could be resolved through tort litigation. 2. Request $4 million from reserves to test the product with the inner city youth following a program like Lilly's. 3. Request $8 million from reserves to test the product with a better educated, more typical population, paying $200 per day for the test. 4. Do not do the testing and do not send the product to market.

Explanation / Answer

Selected option to be implemented:

2. Request $4 million from reserves to test the product with the inner city youth following a program like Lilly's.

This option will allow the company to send a tested drug to the market at a reasonable cost to their company.

MEMO:

TO: Leadership team

FROM: XYZ, Product Manager

Date: November 04, 2017

SUBJECT: Testing plan for the Phase-2 of the fat loss and muscle development drug.

We have developed a new product that can assist people with fat loss and muscle development. This development process has reached its phase 2, where the drug has to be tested on 100 healthy individuals for six months continuously. We have a few alternatives to achieve this. Firstly, we can advertise widely to attract healthy volunteers and pa them $250 a day like mostly is done in the industry. This method allows us to have the drug tested on healthy individuals but the cost of the phase-2 will come out to be $12 million, which is more than the company has in reserve, so we will need additional capital to begin the testing process.

Another method would be of following the practice of Eli Lily of testing the drug on homeless alcoholics as our subjects and pay them only $85 a day for the same without any need for formal advertising. This method allows phase-2 completion at much lower cost but ethically this method might not be sound for the company as the money earned by our test subjects will be further spent on alcohol and unsavory living rather than on positive re-establishment of themselves.

The last alternative we have is to use the unemployed or underemployed, younger people as test subjects. We can help them by giving them income while saving the company lots of money simultaneously. Also, the incidence of lawsuits is much lower than using traditional subjects because these people tend not to litigate if they have a “bad result”, and, the benefit to society is very high.

We are proposing to test the drug on the inner city young adults, people who are over the age of 18 and are hanging out in gyms in major urban centers where the unemployment rate is 13% or more. They tend to be healthier than homeless alcoholics and these young people will be willing to receive $85 per day, who otherwise might have turned to gang activity, drug dealing, or other nefarious activities. Through our testing they could get resources to help turn their lives around.

Through the testing in phase-2 on test subjects that are unemployed or under employed young adults, we will be saving the company a lot of money, while allowing us to test our drug on comparatively healthier individuals while giving them a chance to improve their living standards and that to at a much lower risk of litigation, if the drug’s results do not come as expected.

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