Free Genzyme and the Research Ethics Questions Associated with Its NeuroCell-PD (TM) Trials Case Study Solution | Assignment Help

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Written by Gary F. Smith
Publish Date: 2024-11-01

Harvard Case - Genzyme and the Research Ethics Questions Associated with Its NeuroCell-PD (TM) Trials

"Genzyme and the Research Ethics Questions Associated with Its NeuroCell-PD (TM) Trials" Harvard business case study is written by Margaret L. Eaton, Tara Thiagarajan, Mark Hong. It deals with the challenges in the field of Social Enterprise. The case study is 19 page(s) long and it was first published on : May 1, 2005

At Fern Fort University, we recommend that Genzyme prioritize ethical considerations in all its research activities, particularly in clinical trials. This involves transparency, informed consent, patient safety, and data integrity. Genzyme should adopt a robust ethical framework that aligns with international standards and best practices. This framework should be communicated clearly to all stakeholders, including employees, researchers, patients, and the public.

2. Background

This case study examines the ethical dilemmas faced by Genzyme, a biotechnology company, during its clinical trials for NeuroCell-PD(TM), a potential treatment for Parkinson's disease. The company faced criticism for its research methods, particularly the inclusion criteria for trial participants and the management of data. These issues raised concerns about patient safety, informed consent, and the integrity of the research process.

The main protagonists in this case are:

  • Genzyme: A biotechnology company developing innovative therapies for rare diseases.
  • Dr. Michael Dawson: The lead researcher on the NeuroCell-PD(TM) trial.
  • The FDA: The regulatory body responsible for overseeing drug development and approval in the United States.
  • Patients with Parkinson's disease: The potential beneficiaries of the NeuroCell-PD(TM) treatment.

3. Analysis of the Case Study

Ethical Framework and Stakeholder Analysis:

Genzyme's actions can be analyzed using the Stakeholder Theory framework, which emphasizes the importance of considering the interests of all stakeholders, including patients, researchers, investors, and the public. The company's focus on profitability and speedy development of NeuroCell-PD(TM) may have overshadowed the ethical implications of its actions, leading to a conflict of interest.

Ethical Issues:

  • Informed consent: The case study highlights the challenges in obtaining truly informed consent from patients, particularly those with Parkinson's disease, who may be desperate for any potential treatment.
  • Patient safety: The inclusion criteria for the trial, which favored patients with less severe symptoms, raised concerns about the potential for harm to those with more advanced disease.
  • Data integrity: The case study suggests that Genzyme may have manipulated data to present a more favorable picture of the treatment's effectiveness.
  • Transparency: The company's lack of transparency in its research methods and data analysis further eroded public trust.

Impact on Genzyme's Reputation:

The ethical controversies surrounding NeuroCell-PD(TM) significantly damaged Genzyme's reputation. The company faced public scrutiny, regulatory investigations, and potential legal action. This negatively impacted its brand image, investor confidence, and future prospects.

4. Recommendations

  1. Establish a robust ethical framework: Genzyme should develop and implement a comprehensive ethical framework that aligns with international standards and best practices for clinical research. This framework should clearly define ethical principles, responsibilities, and procedures for all research activities.
  2. Prioritize patient safety and well-being: Genzyme should prioritize patient safety and well-being in all its research activities. This includes ensuring that trial participants are fully informed of the risks and benefits of participation, and that appropriate measures are taken to minimize potential harm.
  3. Promote transparency and accountability: Genzyme should be transparent in its research methods, data analysis, and communication with stakeholders. This includes providing clear and accurate information about clinical trials, research findings, and any potential conflicts of interest.
  4. Foster a culture of ethical conduct: Genzyme should cultivate a culture of ethical conduct among its employees, researchers, and partners. This includes providing training on ethical principles, promoting open communication, and encouraging ethical decision-making.
  5. Engage with stakeholders: Genzyme should engage actively with stakeholders, including patients, advocacy groups, regulatory bodies, and the public. This includes seeking feedback, addressing concerns, and building trust.

5. Basis of Recommendations

These recommendations are based on the following considerations:

  • Core competencies and consistency with mission: Genzyme's mission is to develop innovative therapies for rare diseases. This mission is best served by conducting ethical and responsible research.
  • External customers and internal clients: Genzyme's external customers are patients and their families. Its internal clients are researchers and employees. All stakeholders deserve to be treated with respect and transparency.
  • Competitors: In the competitive biotechnology industry, ethical conduct is a key differentiator. By prioritizing ethical principles, Genzyme can build a strong reputation and gain a competitive advantage.
  • Attractiveness: Ethical conduct is essential for attracting and retaining investors, employees, and patients. It also helps to mitigate legal and reputational risks.

6. Conclusion

Genzyme's experience with NeuroCell-PD(TM) highlights the importance of ethical considerations in all research activities. By prioritizing ethical principles, transparency, and patient safety, Genzyme can restore its reputation, regain public trust, and continue to innovate in the field of biotechnology.

7. Discussion

Alternatives:

Genzyme could have chosen to ignore the ethical concerns and continue with its original research plan. However, this would have likely resulted in further damage to its reputation and potential legal action.

Risks and Key Assumptions:

  • Risk: Genzyme may face resistance from some stakeholders to its new ethical framework.
  • Assumption: Genzyme is committed to implementing the recommended changes and ensuring ethical conduct in all its research activities.

8. Next Steps

  1. Develop and implement a comprehensive ethical framework: (Timeline: 6 months)
  2. Conduct training on ethical principles for all employees and researchers: (Timeline: 3 months)
  3. Establish a dedicated ethics committee to oversee research activities: (Timeline: 3 months)
  4. Engage with stakeholders to build trust and transparency: (Timeline: Ongoing)

By taking these steps, Genzyme can demonstrate its commitment to ethical research and rebuild its reputation as a responsible and trustworthy company.

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Case Description

Genzyme Tissue Repair (GTR) had just received favorable Phase I clinical trial results, an important first step in gaining approval from the Food and Drug Administration (FDA) for its NeuroCell-PD. The groundbreaking technology behind NeuroCell-PD (developed by Diacrin, Inc.) used fetal pig cell neural transplants to treat Parkinson's disease. GTR was eager to get NeuroCell-PD to market as quickly as possible but knew that the path to obtaining FDA approval would be difficult. Genzyme, an innovative biotechnology company, had often entered uncharted territories in the past and had set precedents in medical research. Controversy would likely center on whether GTR would use what some were calling "sham" surgery as a placebo control in its Phase II trials of NeuroCell-PD in Parkinson's patients--trials intended to demonstrate both the efficacy and safety of the procedure. In sham surgery, a segment of patients in a study undergo the same aspects of the surgery experience as those receiving the experimental treatment, except that it does not involve fetal pig cells. Details the process for testing NeuroCell-PD and discusses the issues concerning sham surgery. Asks students to make a recommendation on whether to conduct sham surgery.

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