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Dr. Srinivasan is a senior scientist working for a reputed biotechnology company known for its cutting-edge research in pharmaceuticals.

Last Updated on Oct 03, 2024

Also Read Dr. Srinivasan is a senior scientist working for a reputed biotechnology company known for its cutting-edge research in pharmaceuticals. in Hindi

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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 drug 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 realises meeting the targets is impossible without using these means.

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(a) What would you do in such a situation?

(b) Examine your options and consequences in the light of the ethical questions involved.

(c) How can data ethics and drug ethics save humanity at large in such a scenario?
This case study deals with Dr. Srinivasan’s ethical conflict while heading a team under pressure to expedite clinical trials for a new drug to treat a rapidly spreading viral disease. It involves decisions around data integrity, informed consent, potential patent infringement, and the ethical implications of prioritizing market advantage over scientific and ethical rigor.
This situation mirrors broader concerns of Corporate ethics, researcher’s integrity, and has sparked significant debate over intellectual property rights, manipulation of data, compliance with drug regulatory authority along with endangering lives of patients who would use the aforesaid drug. Dr. Srinivasan’s predicament underscores the complexities of addressing such challenges amid career pressures.

Answer (a)

COURSE OF ACTION

Prioritising ethical integrity over expediency - As Dr. Srinivasan, I would reject the proposed shortcuts, emphasising the importance of upholding ethical research practices.
Emphasising on correct data and research Methodology- Manipulating data can have long term consequences as they are related to efficacy of drugs. Wrong data can overestimate or underestimate the results thus endangering future research.
Reject Data Manipulation and Misrepresentation: Manipulating clinical trial data to exclude negative outcomes and selectively report positive results is unethical. It could lead to approval of a drug that may harm patients. Integrity in research demands that all data, both positive and negative, be transparently presented. I would strongly oppose any suggestion to falsify or omit critical information.
Insist on Informed Consent: Foregoing informed consent violates fundamental ethical principles in medical research. Patients must be fully informed about the potential risks and benefits of participating in clinical trials. Any attempt to bypass this process endangers the well-being of participants and exposes the company to legal liabilities and public backlash.
Collaborate with rival companies to bring in faster and effective results- This was done by many companies during Covid- 19 to produce vaccines at a faster rate.

Answer (b)

Various options and consequences in the light of the ethical questions involved

- Adhere to Ethical Standards:- It is the responsibility of scientists to ensure the safety and efficacy of medical products
  - Advantage- By maintaining rigorous trial protocols, I ensure patient safety and trust in our findings.
  - Disadvantage- However, this may delay the drug's market entry and increase pressure from the company.

Compromise for Expediency- issues of profit over principles

- Advantage- Agreeing to manipulate data or use rival compounds may expedite trials
- Disadvantage- It would lead to harmful consequences for patients and long- term damage to the company's reputation and my professional integrity.
Advocate for Transparent Processes along with collaboration with other stakeholders: Question of ethical obligation towards patient and society.
- Advantage- I would advocate for a transparent, expedited review process with regulatory bodies, which would uphold ethical standards while addressing the urgent need for treatment.
- Disadvantage- Delay in process, reduction in company profits, professional repercussions.

Answer (c)

Data ethics and drug ethics save humanity at large

Upholding data and drug ethics is crucial for safeguarding public health, right to privacy and upholding consent.
Ethical practices ensure that drugs are safe and effective, fostering trust in biomedical research.
Transparent data reporting can lead to better treatment outcomes and promote responsible innovation, ultimately saving lives and preserving the integrity of the scientific community.
Preserves the image of the Indian Scientific community.

As Commerce without morality and Science without humanity are Gandhian sin, action of Dr. Srinivasan should ensure people over profit, service over sales, honour over hustle.

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