8.6.2 Ethical Considerations

• What is gene therapy defined as?

  Introducing genetic material into cells
• Gene therapy can be used to treat acquired diseases like cancer.


  True
• The body might reject new genetic material, causing inflammation and allergic reactions
• If germline cells are modified in gene therapy, the changes could be inherited by future generations.

  True
• Affluent individuals often have better access to gene therapy, leading to disparities based on socioeconomic status
• What are off-target effects in gene therapy?

  Delivery to unintended cells
• Steps in the regulatory oversight of gene therapy

  1️⃣ Pre-Clinical Testing

  2️⃣ Clinical Trials

  3️⃣ Regulatory Review

  4️⃣ Post-Approval Monitoring
• Rigorous testing and regulation are crucial to ensure gene therapies are safe and effective
• What cultural value might be challenged by gene therapy?

  Valuing natural human variation
• Gene therapy can replace faulty genes with healthy ones to treat genetic disorders
• How can gene therapy improve quality of life for patients and their families?

  By treating debilitating conditions
• What is inaccurate gene delivery in gene therapy?

  Delivering the gene to unintended cells
• Why is gene therapy not widely available, particularly in less developed regions?

  High costs and limited clinical trials
• An immune response is a key safety concern in gene therapy.


  True
• Genetic discrimination is a potential societal implication of gene therapy.


  True
• What is the process of introducing genetic material into cells called?

  Gene therapy
• Gene therapy can enhance the immune response to target cancer cells.


  True
• How does gene therapy improve the quality of life for patients and their families?

  Alleviates symptoms
• Inaccurate gene delivery can disrupt normal cellular function
• What ethical concern is raised by germline modification in gene therapy?

  Passing changes to future generations
• High costs and limited clinical trials restrict access to gene therapy, particularly in less developed regions
• What are the four key components of gene therapy safety management?

  Pre-Clinical Testing, Clinical Trials, Regulatory Review, Post-Approval Monitoring
• Regulatory review ensures that gene therapies meet safety and quality standards.


  True
• What is one potential societal impact of gene therapy regarding insurance and employment?

  Genetic Discrimination
• What societal values does gene therapy challenge regarding healthcare access?

  Equitable distribution and affordability
• What are the potential benefits of gene therapy in treating acquired diseases?

  Enhancing immune response
• Why is germline modification considered ethically controversial in gene therapy?

  Changes passed to future generations
• Gene therapy can treat genetic disorders by replacing faulty genes with healthy ones
• Order the potential risks of gene therapy from most common to least common.

  1️⃣ Immune Response

  2️⃣ Inaccurate Gene Delivery

  3️⃣ Long-Term Effects

  4️⃣ Germline Modification
• The long-term effects of gene therapy are fully understood.

  False
• Match the gene therapy with its approximate cost and region of availability.

  Luxturna ↔️ $850,000, USA / Europe < item2_{e}nd > < pair_{e}nd > < pair_{s}tart > < item1_{s}tart > Zolgensma < item1_{e}nd > < item2_{s}tart >$2.1 million, USA/Europe

  Glybera ↔️ $1.1 million, Europe
• Pre-clinical testing evaluates safety and efficacy in animal models
• Order the steps involved in managing the societal impact of gene therapy.

  1️⃣ Genetic Discrimination

  2️⃣ Health Inequalities

  3️⃣ Valuing Natural Variation

  4️⃣ Healthcare Access
• Unequal access to gene therapies based on socioeconomic status leads to health inequalities
• Valuing natural variation is a cultural consideration related to gene therapy.

  True
• Ongoing monitoring and research is crucial to understand the long-term impacts of gene therapy
• Immune response in gene therapy can lead to inflammation and allergic reactions
• Careful consideration of potential benefits and risks is essential in gene therapy decision-making.


  True