Ethics Case Study: Design and Analysis of Preclinical Research Studies Carla is

Question

Ethics Case Study: Design and Analysis of Preclinical Research Studies

Carla is a post-market statistician at PharmCo--a mid-size pharmaceutical company that makes over-the-counter pain medications (e.g. ibuprofen). For the most part, she monitors incidence of side-effects reported by comsumers (e.g. upset stomach, heartburn, dizziness). Carla likes her job and finds it rewarding to feel like her work contributes to medicine that helps people. She has also developed a reputation in the company as a careful and talented statistician. A few months after her friend Elijah leaves PharmCo for a job with the pharmaceutical giants PharmTech, he contacts Carla about a job opening as lead statistician in a pre-clinical research arm of the company. The job is a big promotion, and PharmTech has a great reputation for a patient-centered culture and develops life-saving medications used to treat late-stage cancers and severely debilitating medical conditions.

After a bit of research, Carla learns that pre-clinical research at a company like PharmTech usually involves animal research. Carla always thought herself to be against animal research, because she didn't feel that animals should have to suffer for the comfort and benefit of humans. On the other hand, the pre-clinical research phase is mandated by the federal government during early research, so the important medicines made by PharmTech cannot otherwise exist to help the people that depend on them.

What should Carla do? Answer each of the questions in the following ethical framework to structure your response.

1. Consider the options (outcomes, virtues, consequences)?

2. Which is the BEST (or even "least bad") option?

3. How might we prevent this in the future (if possible)?

Explanation / Answer

In the given situation Carla has two options,

If she continues with her position as a post-market statistician(which she finds satisfactory), she would be in the same positon as before. However, if she looks for promotion and decides to join PharmaTech then there are several situations that she might have to face. Given that pre-clinical research in PharmaTech involves animal research and Carla has beleived herself to be against animal research it might raise question on her ethical integrity. Given that it is mandatory to perform clinical research on all life saving drugs before they are administered to actual patients (as mandated by the Federal Government to perform a pre-clinical research on animals), as a part of the team in PharmaTech she will have to perform tests on animals.

if Carla chooses to continue with her old job then though she will not be performing pre-clinical research on animals, it is not going to stop clinical researches being performed on animals all over the world and hence the bigger ethical uestion remains unanswered. On the other hand, Carla can choose to be a part of this team and design, conduct and review the clinical research in such a manner that the animals are not unduly harmed and they are used for research only within an ethical framework. As no responsible scientist wants to cause the animals unnecessary suffering if it can be avoided, therefore controls are administered while using animals for research.

Given that animal research have significantly aided bio-medical advancements in the past century and people have been enjoying better/healthier lives as a result of these medical aids, the removal of animal based medical research will have enormous consequence on scientific research. However, these research can be performed within a framework such that these procedures are fully assesed in terms of any harm caused to the animals. Laws can be put into place ensuring the same.

There is no best answer to this question as there always will be a tradeoff. The least bad that can be done is to CONTROL and MONITOR the way in which these animals are used for medical researches. Under all circumstances cruelity to animals should be avoided.

In order to prevent this we need legal measures to be in place to help set the guidelines as to how the research should be designed and conducted and the extent to which theses animals can be exploited for human benefites. In addition to these we need ethical and moral scientific experts and statisticians who perform these experiments as they are the ones administering the projects in real and it is needed that they do not exploit the animals for their own purposes.

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