Experimental drugs to terminally-ill patients

You are a senior medical researcher developing a life-saving drug for a rare disease. Initial trials are promising, but the full testing process will take five more years before official approval. Meanwhile, thousands of terminally ill patients are desperate for treatment. Ethical dilemmas arise:

Some doctors urge compassionate use, arguing that patients have nothing to lose. Regulatory authorities insist on strict trials, fearing unknown long-term side effects. Pharmaceutical companies push for quick approval, seeing a major profit opportunity. Patient advocacy groups demand access, pressuring the government.

·         Should experimental drugs be given to terminally ill patients before full approval? What ethical safeguards should be in place?

·         How will you handle pressure from pharmaceutical companies while maintaining medical ethics?

·         What role should government agencies play in balancing medical innovation with public safety? (300 words | 20 marks)

Experimental drugs to terminally-ill patients

• Yes – When no approved drug
• Utilitarianism – Potential to save lives
• Rights A – Patient’s choice
• Justice – No favoritism to wealthy or influential patients

Safeguards

• Strict Eligibility Criteria
• Informed voluntary consent
• Monitoring and reporting
• Transparency
• Independent Ethical Review

Pressure Handling

• Reject undue influence
• Profit vs Public Safety
• Document all the interaction with the industry
• Encourage Responsible Collaboration
• Regular contract with regulatory agencies – ICMR/Dept of Bt

Role of Government Agencies

• Rigorous clinical trials
• Prevent premature commercialization
• Clear rules for emergency access
• Procedures for fair distribution
• Effective Monitoring
• Price Regulation
• Prevent Monopoly
• Funding if required – Rare/Poor people