- What would you do in such a situation?
- Examine your options and consequences in the light of the ethical questions involved.
- How can data ethics and drug ethics save humanity at large in such a scenario?
Dr. Srinivasan faces a significant ethical dilemma between meeting corporate expectations and maintaining the ethical standards required in pharmaceutical research. Given the stakes involved it is essential to act in the interest of data integrity and patient safety.
What Would You Do in Such a Situation?
- Reject Unethical Shortcuts: This includes refusing to manipulate clinical data, ignoring informed consent, or using patented compounds illegally.
- Uphold Integrity: Follow all necessary regulatory protocols, such as rigorous testing and informed consent for all participants in clinical trials, and ensure the drug undergoes the full review process by regulatory authorities (e.g., FDA, EMA).
- Communicate with Management: about the dangers and long-term repercussions of unethical practices, including potential legal liabilities, reputational damage, and harm to patients. Eg- Eg. Ranbaxy was fined $500 million by the U.S. FDA for taking unethical shortcuts, including falsifying drug test results
- Seek Alternative Solutions: I would explore alternative solutions, such as increasing resources, extending timelines, or collaborating with external experts to meet the targets ethically.
- Involve Ethical Committees: I would bring the issue to the company’s ethical review board or external advisory committees to ensure that decisions are guided by ethical principles.
- Consider Whistleblowing as a Last Resort if management insists on unethical practices and refuses to address concerns. Eg- Theranos case
Options and Consequences in Light of Ethical Questions Involved:
| Option | Pros | Cons |
| Proceed with Unethical Shortcuts | – Faster market entry, potential financial gains. | – Legal issues, reputational damage, harm to patients. |
| – Short-term pressure relief. | – Loss of trust in the company, future lawsuits. | |
| Follow Ethical Protocols | – Ensures patient safety, scientific integrity. | – Delayed market entry, losing competitive edge. |
| – Avoids legal risks and maintains reputation. | – Financial impact due to slower processes. | |
| Communicate Concerns to Management | – Promotes transparency and prevents long-term risks. | – Possible pushback from management. |
| – Builds trust within the organization. | – Delays in the drug’s market release. | |
| Explore Ethical Alternatives | – Fast-tracks the process within ethical bounds. | – May not fully meet market demands. |
| – Can secure regulatory fast-tracking without risk. | – Requires additional resources and investment. | |
| Whistleblowing | – Protects public safety and maintains integrity. | – Possible personal risks for Dr. Srinivasan. |
| – Ensures accountability and ethical practice in research. | – Internal conflicts and potential legal battles within the company. |
How Can Data Ethics and Drug Ethics Save Humanity at Large in Such a Scenario?
- Data Integrity in Clinical Trials: Ensuring transparency and accuracy in clinical trials prevents the approval of unsafe or ineffective drugs.
Data Ethics
- Data Integrity in Clinical Trials: Ensuring transparency and accuracy in clinical trials prevents the approval of unsafe or ineffective drugs. Eg- in the Vioxx scandal, manipulated data led to thousands of deaths due to concealed adverse effects.
- Preventing Bias and Misrepresentation: Proper data ethics ensures that data is not manipulated to support biased conclusions, preventing harm based on faulty research. Eg- AllTrials campaign
- Safeguarding Privacy: Data ethics involves protecting participants’ personal and medical data, ensuring privacy and fostering trust in the system. Eg- In the UK Biobank, data from over 500,000 participants is securely stored with anonymization protocols
- Informed Decision-Making on accurate, complete information.
Drug Ethics
- Ensuring Patient Safety: by requiring thorough testing before approval, ensuring that drugs are safe for use. Eg- The thalidomide crisis showed how neglecting drug ethics led to widespread harm.
- Upholding Informed Consent: Ethical drug trials ensure participants are fully informed about risks and benefits, respecting their autonomy.
- Respecting Intellectual Property encourage innovation and fair competition in pharmaceutical development. Eg- collaboration between Gilead Sciences and other pharmaceutical companies in sharing patents during the HIV treatment rollout
- Preventing Drug Abuse and Over-Promotion: regulate the marketing and promotion of drugs to prevent abuse and ensure that medicines are not overprescribed.
- Balancing Profit and Public Health: Ethical drug practices ensure that public health is prioritized over corporate profits. Eg- Novartis providing drug Zolgensma for free to eligible patients with spinal muscular atrophy through a lottery system
“Science and ethics are not separate realms; they are intertwined. Integrity in science is essential for the progress of society.”
