GHS:4000 Midterm 2

female genital mutilation (FGM)

practices that involve the partial or total removal of the external female genitalia, or other injuries inflicted on the female genital organs for non-medical reasons

4

how many different types of FGM are there?

200 million; 30(1) countries

how many women and girls undergo FGM each year and in how many different countries

Africa, Middle East, Asia

What three continents/regions is FGM most prominent?

more than 230 million

how many women and girls alive today have undergone FGM?

3-4 million

how many girls are currently at risk for FGM?

Somalia, Guinea, Djibouti; 90% or higher

what 3 countries have the highest prevalence of FGM and what is the percentage rate?

- cultural and traditional beliefs

- social norms/pressure

- lack of education and awareness

- religious factors

- economic factors

- historical and political factors

- health and medical factors

- inter-generational continuity

determinants of FGM

- physical harm and injury

- violation of bodily autonomy

- psychological and emotional harm

- gender-based violence

- perpetuation of inequality and dis-empowerment

- violation of human rights

- long-term health risks

- social and cultural pressure

- undermines sexual and reproductive rights

- international recognition of gender-based violence

violence against women and girls

Southern Ethiopia

according to the International Journal of Women's Health (2022), what location had the highest rates of FGM?

lower

is prevalence of FGM lower or high in the age group 0-14 years of age?

yes

is the percentage of men opposing FGM higher than the percentage of women?

early drug discovery, pre-clinical phase, clinical phase, regulatory approval

what are the 4 stages of drug development?

- early discovery screens for potential active compounds

- determining whether or not compounds have a therapeutic effect on the disease of interest

- safety and effectiveness

- only 1 out of 5000 drugs make it to the market approval process

the drug discovery process

- provide information about dosage and toxicity levels

- review findings and decide whether the drug should be tested in people

pre-clinical phase

- answer questions about drugs safety

- design the clinical trial

- submit investigational drug to FDA

clinical phase

- FDA has 30 days to review Investigational New Drug submission

- approval to begin clinical trials

- clinical holds can be for various reasons

approval

- following approval, ongoing monitoring ensures long-term safety and effectiveness

- process is rigorous, often spanning 10+ years and requiring large financial investments

post-market safety monitoring

- grants pharmaceutical companies exclusive rights to manufacture and sell a new drug

- granted for 20 years

- incentivizes innovation

- encourages transparency and disclosure

the role of patenting in drug development

- patent thicket: companies file multiple patents around one drug to extend exclusivity

- evergreening: making minor modifications to existing drugs to obtain new patents; raises questions about ethical competition

- global disparities: patent laws vary internationally which impacts availability and pricing, especially in developing countries

challenges in patenting pharmaceuticals

- accelerates compound identification; algorithms can utilize vast datasets to identify possible candidate molecules faster

- predicting drug efficacy and safety; machine learning models can quickly forecast how compounds will behave in human bodies

the impact of AI on drug discovery

- balancing innovation and access; patents award innovation without restricting access to life-saving medications

- integrating emerging technologies; incorporating AI and other technology requires the updating of regulatory and patent frameworks

- addressing global health needs; collaboration b/w governments, NGOs and pharmaceutical companies are essential to making patented drugs accessible

future directions and ethical considerations of drug development

1. voluntary consent

2. fruitful result for the good of the society

3. prior animal experimentation and prior knowledge of the related issues

4. avoidance of any unnecessary physical or mental injury

5. banning of known lethal or disabling procedures

6. degree of risk should never exceed the benefits

7. proper preparation and proper facilities to prevent injury/death

8. experiments be performed only by scientifically qualified persons

9. participants are free to end experimentation at anytime

10. experiments must stop if proven too dangerous

Nuremberg Code

- adopted in June 1964

- undergone 6 revisions and 2 clarifications

- first significant effort by the medical community to regulate research/trials

- prior to Nuremberg Code, only some countries had national policies

- acts as the foundation for many subsequent documents

Helsinki Declaration

Basic ethical principles:

- respect for persons individual autonomy and protection of vulnerable individuals

-beneficence; maximize benefits and minimize harm

- justice; equitable distribution of research costs and benefits

the Belmont Report

- respect for persons

- beneficence/non-malevolence

- justice/non-exploitation

principles of research ethics (almost identical to Belmont Report)

Each individual:

- is unique and free

- has the right and capacity to decide

- has the value and dignity

- has the right to informed consent

autonomy

Protection of study participants

- protect physical, mental and social well-being of each participant

- minimize risk

- maximize possible benefits

- retain community perspective

beneficence/non-maleficence

Fairness in the conduct of research

- ensure fair distribution of risks and benefits

- conduct equitable recruitment

- provide special protection for vulnerable groups

justice/non-exploitation

- used adolescent girls from Gujarat

- 7 girls died post vaccination

- government investigation found that deaths were unrelated to the vaccines and could not be established with certainty

- minor deficiencies in planning and conducting the study; no informed consent and inadequate reports of adverse reactions/events

HPV vaccine trial (2010)

non-communicable

what types of diseases do studies/trials tend to focus on?

- planned by the military

- develop vaccine for deployed troops in developing countries

- locals and volunteers were recruited

- vaccine was never intended for public distribution

- lack of informed consent

- participants and the subsequent community did not receive any benefits

- subjects completely abandoned once trial was over

Hepatitis E Vaccine trial in Nepal (2000-2003)

- clot busting investigational drug used in phase III trial

- 8 patients died

- no ethical committee approval

- subjects were completely unaware of their participation

Streptokinase trial in India (2003)

- informed consent

- community engagement

- benefit sharing

how can clinical research be made more ethical in developing countries?

- pregnant person living with HIV passes it to the baby

- can occur during pregnancy, delivery and breastfeeding

- can be prevented with antiretroviral medications and early detection

perinatal mother-to-child transmission

- proper medical and prenatal care

- test for HIV in all pregnant individuals

- no prenatal care >>> request rapid test prior to delivery

ways to prevent PMTCT

Balancing research and policy

- rapidly changing policies can render trial designs outdated and raise concern about relevance

- trials must demonstrate utility for stakeholders with varying priorities

Regulatory framework

- international guidelines (Dec. of Helsinki) requires that trials use the best proven interventions unless justified by scientific necessity

key considerations in standard-of-care debates

- focuses on the adoption of measures that address dimensions of disaster risk

- seeks to strengthen social and economic resilience to disasters caused by natural biological and technical hazards, which can be further exacerbated by climate extremes and slow-onset events/disaster

Sendai Framework for Disaster Risk Reduction 2015-2030; UN

- understanding disaster risk

- strengthening disaster risk governance to manage risk

- investing in disaster risk reduction to improve resilience

- enhancing disaster preparedness for effective response and to "Build back better" in recovery, rehab and reconstruction

priorities of the Sendai Framework

- policies and practices geared towards disaster management

- vulnerability; capacity; exposure of persons and assets; hazard characteristics; the environment

- help w/ risk assessment, which helps the development and implementation of appropriate preparedness and effective disaster response at the a) national and local levels and b) global and regional levels

understanding disaster risks

- need a clear vision, plan competence, guidance and interdisciplinary cooperation

- prevention, mitigation, preparedness, response, recover and rehab are needed and foster collaboration across the board

- use partnerships across mechanisms and institutions to implant instruments that are relevant to disaster risk reduction and sustainable development at a) national and local levels and b) global and regional levels

strengthening disaster risk governance to manage disaster risk

- public and private investment in disaster risk prevention

- structural and non-structural measures

- enhance the economic, social, health and culture-related resilience of persons, communities, and countries; assets and the environment

- cost effective policies based on saving lives, preventing and reducing losses, and ensuring effective recovery and rehab at a) national and local levels and b) global and regional levels

investing in disaster risk reduction for resilience

- increase person and asset exposure

- learn from past experiences and how they indicate the need to further improve preparedness

- proactive preparation of events

- integrate disaster risk reduction in response preparedness

- empower individuals and promote gender-equitable access to institutions of higher learning

- recovery, rehabilitation, and reconstruction; "build back better"

- at both the national and local levels

enhancing disaster preparedness for effective response

- disaster related deaths and missing persons

- disaster affected populations

- disaster-related economic losses

- damage to critical infrastructure

- nation and local disaster risk reduction strategies

targets of the Sendai Framework

- located on the island of Hispaniola in the Caribbean Sea, shared by the Dominican Republic

- 3rd largest country in the Caribbean

- first colonized by Spain, then France

- first black country to gain independence through a successful slave revolt

- rich in minerals (gold, silver, copper)

Haiti

- January 12, 2010

- earthquake killed 200,000 Haitians

- 2 million people were displaced

- images shown by the media revealed the inequalities the exist in Haiti

- international organizations responded to the crisis in Haiti by sending people to "rescue them"

the Haitian Disaster

- lack of coordination

- little involvement of local government and communities

- questionable result despite massive funds

- projects were poorly implemented and/or short lived

- scandals and ethical concerns; sexual misconduct and UN cholera outbreak

Challenges and criticism of the Haitian Disaster response(s)

- physical injuries and death

- disability worldwide and survivors requiring long-term rehab/care

- PTSD and overall psychological toll

direct health impacts of war

- healthcare facilities are frequently targeted; collapse of healthcare infrastructure

- attacks on healthcare workers

- supply chains are disrupted

- routine and preventative healthcare services are interrupted

destruction and disruption of healthcare systems

- access to clean water, food and sanitation is disrupted >>> communicable diseases and malnutrition

- displacement, internally displaced people and refugees

- vulnerable groups (children, pregnant women, the elderly, chronic healthcare conditions

indirect health impacts

- destruction of healthcare infrastructure and loss of healthcare workers takes a long time to rebuild

- mental health impacts; trauma and community-wide psychological distress and trauma

- collapse of health information systems leads to difficulty of tracking the healthcare needs of individuals

long-term and intergenerational affects

- physical health issues; access to rehab, surgery and assistive devices

- mental health care and emotional wellbeing; stigma-free mental health services

- transition and reintegration support; case management, peer support groups, vocational training

- access to healthcare services and chronic illnesses

- homelessness ad poverty

health needs of veterans

- access to basic healthcare

- treatment for communicable diseases

- mental health care and trauma support

- maternal and pediatric care

- nutrition and sanitation

- culturally sensitive care

health needs of immigrants and refugees

- health resources

- roads, bridges and other means or transportation

- environmental degradation

- increased poverty

- misallocation resources

- increased spending related to healthcare

- increased mortality

- bioterrorism

impact of war on infrastructure

- widespread shock and fear

- reduced morale and will power

- setbacks in overall healthcare needs and universal healthcare

- infrastructure breakdown of hospitals and clinics

- loss of employees

- restoration and reconstruction takes time and financial resources

- delivery of drugs and diagnostic tests is interrupted

- reduced ability to perform routine procedures

- clinical trials may be suspended

- deterioration of sanitation and access to clean water

- food insecurity

- mental health issues increase

- loss of health data and coordination

breakdown of the healthcare system

- trade routes disrupted

- imports and exports are interrupted

- shortages of essential goods

- inflation

- overall reduction of economic activity

- loss of savings and trust in financial systems

financial challenges that result from war

- loss of healthcare funding; government resources are shifted to military healthcare needs

- underpaid/unpaid staff leave

- patients can no longer afford care, especially in private healthcare sectors

financial and economic collapse due to war

- decline in working population

- lost GDP

- damage to buildings and infrastructure

- rise in national debt and increased taxes

- innovation and new technology

- creates employment

economic impacts of war (not all bad!)

- attacks against healthcare workers and facilities

- lost healthcare at the most dire times

- overall loss of people in healthcare

war's impact on healthcare workers