Q12. Case Study

Dr. Srinivasan is a senior scientist working for a reputed biotechnology company known for its cutting-edge research in pharmaceuticals. Dr. Srinivasan is heading a research team working on a new drug aimed at treating a rapidly spreading variant of a new viral infectious disease. The disease has been rapidly spreading across the world and the cases reported in the country are increasing. There is huge pressure on Dr. Srinivasan's team to expedite the trials for the drugs as there is a significant market for it, and the company wants to get the first-mover advantage in the market. During a team meeting, some senior team members suggest some shortcut for expediting the clinical trials for the drug and for getting the requisite approvals. These include manipulating data to exclude some negative outcomes and selectively reporting positive results foregoing the process of informed consent and using compounds already patented by a rival company, rather than developing one's own component. Dr. Srinivasan is not comfortable taking such shortcuts, at the same time he realizes meeting the targets is impossible without using these means.

1. What would you do in such a situation?
2. Examine your options and consequences in the light of the ethical questions involved.
3. How can data ethics and drug ethics save humanity at large in such a scenario?

Introduction

In this scenario, Dr. Srinivasan faces a classic ethical dilemma where the pressure to deliver results conflicts with the integrity of the scientific process and professional ethics. 

Body

Stakeholders involved:

1. Dr. Srinivasan
2. Biotechnology Company where Dr. Srinivas works
3. Rival Company
4. Patients 
5. Regulatory Authorities who will give the license

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Ethical Questions Involved

• Integrity in Scientific Research: Does altering data undermine the fundamental ethical principle of honesty in science? 
• Patient Rights and Safety: How do shortcuts compromise the rights of patients to informed consent and to receive a treatment that is safe and thoroughly tested?
• Intellectual Property and Fair Competition: How does violating patent laws affect the ethics of competition and innovation in the biotechnology field?
• Social Responsibility: How does Dr. Srinivasan's decision impacts society at large, especially given the public's dependence on safe pharmaceuticals to combat a dangerous viral disease?

Options Available:

1. Option 1 - Manipulating Data

2. Option 2 - Using Patented Compounds

3. Option 3 - Adhering to Ethical Standards

4. Option 4 - Respecting Intellectual Property and develop one’s own original compound

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In such a situation, as Dr. Srinivasan, I would reject the proposed shortcuts and uphold the highest ethical standards. Even though the pressure to expedite the process is intense, and the company’s desire for a first-mover advantage is significant, compromising on ethics could have severe and long-term consequences for both patients and the company itself.

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Here’s how I would approach the situation:

• Reaffirm Ethical Responsibilities by: Rejecting data manipulation, Insisting  on Informed Consent as its a patient’s right, Respecting Intellectual property laws as using patented compounds from a rival company without proper licensing could lead to legal ramifications and damage the company's reputation. 
• Propose Alternative Solutions: like requesting Additional Resources, Collaborating with Other Institutions, Seeking Expedited Review from Regulators. 
• Communicate Risks of Unethical Actions: I would clearly communicate the potential long-term consequences of unethical behavior to both my team and company leadership, emphasizing that Patient Safety is paramount, there may be regulatory backlash which could lead to long term loss of trust and credibility.
• Leverage Ethics as a Competitive Advantage: While the pressure to be first to market is real, I would argue that maintaining ethical integrity can be a differentiator. If the public and medical community know the company values patient safety and follows rigorous ethical standards, this could lead to stronger long-term trust, brand loyalty, and a better reputation than competitors.
• Establish an Ethical Culture within the Team: I would use this as an opportunity to set a clear precedent for my team that ethical behavior is non-negotiable, even under pressure. This could involve reinforcing ethical training, establishing whistleblower protections for anyone who sees unethical behavior, and encouraging an open dialogue about ethical concerns.

How Data Ethics and Drug Ethics Save Humanity

1. Data Ethics

• Data ethics emphasizes the responsible handling of information, ensuring transparency, accuracy, and accountability. 
• By avoiding data manipulation, researchers protect the integrity of their work, foster trust, and ensure that decisions are made based on reliable evidence. 
• Trust in healthcare and science is fragile, and once eroded, it is difficult to regain..

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2. Drug Ethics

• Drug ethics focuses on the moral principles guiding pharmaceutical research and the duty to "do no harm." 
• Following established ethical protocols, such as informed consent and rigorous clinical trials, ensures patient well-being and fosters ethical innovation in drug development.
• Prioritizing patient safety over profit serves the greater good of humanity. 

Conclusion

While meeting the drug development targets may seem impossible without shortcuts, compromising on ethical standards is never the solution. By adhering to data integrity, respecting patient rights, and following intellectual property laws, I would protect patients, preserve the company’s long-term reputation, and maintain my personal and professional integrity.

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