QUIZ 3 Study Guide PDF

QUIZ 3 18 November 2024 20:14 How medical devices affect women Quiz #3 – Study Guide - Women are most at risk...

QUIZ 3 18 November 2024 20:14 How medical devices affect women Quiz #3 – Study Guide - Women are most at risk - even for sex-neutral implants: stronger immunological reactions to Domestic Violence metal in devices, women not included until legislation passed Social Construction, Medicalization & Pharmaceuticalization Be able to identify the components of the cycle of violence “Power and - Social construction: society defines certain conditions as medical issues Control Wheel” with respect to the following two articles: - Medicalization: non-medical problems treated as medical ones; Medicalization does not include the consumption of pharmaceuticals as their main feature - Pharmaceuticalization: Increasing reliance on drugs to treat health conditions; eg. Antidepressant use for mild anxiety Environment, Exposure, and Health Environmental Justice o The Woman on the Bridge - The New York Times.pdf - Fair treatment and involvement of ALL people w respect to o Viewing a Tragic Case Through the Eyes of Investigators - The New York environmental laws Times.pdf - Goal achieved when: same degree of protection from environmental and - Using intimidation: Dion created an atmosphere of continuous fear and health hazards, and equal access to the decision-making process to have control. His ongoing presence despite restraining orders. a healthy environment to live - Emotional abuse: Dion described Tanya as mentally unstable and claimed Environmental Racism she attempted suicide. She returned to work with fresh injuries. - Racial discrimination in environmental policymaking, in enforcement of - Isolation: Dion claimed he was "the only person she had" -> alienate. She rules, and in targeting communities of color was initially in domestic violence shelter then left. EDCs - Gaslighting: Dion’s attorney characterized the relationship as mutually - Endocrine disrupting chemicals interfere w hormonal systems destructive, minimizing Dion's abuse and deflecting responsibility - Sources: Plastics (BPA), pesticides, industrial chemicals, personal care - Economic abuse: Tanya's work at local hotel and need for shelter products - Before 2016, 1978 Toxic substances control act -> not req to test chems Chronic Disease and Disability - In US, Lautenberg 21st century act enacted in 2016 -> EPA req to test chem Goffman and the concept of stigma - In EU, REACH permits regulation of chemicals - an attribute deeply discredited by society results in rejection of person w - 'no data no market' that attribute; reaction of others spoils normal identity What are Superfund sites? - three categories: - Contaminated areas identified by the Environmental Protection Agency 1. stigmatized: those with/who bear stigma, (EPA) for cleanup 2. normal: those without/who don't bear stigma, How many Superfund sites there are in U.S. and NJ 3. wise: normals accepted by stigmatized as 'wise' to their condition - US: 1340 Superfund sites in the US o How do those with disability handle normals? - NJ: 114 sites (highest no. in US) - treat normals as wise, allow intrusive questions and agree to be helped, Major environmental events ignore snubs, assume normals as ignorant not malicious - Love Canal (1978): Toxic waste dump in New York led to health crises o Who determines who gets stigmatized? and evacuation - Those in positions of power or who represent the dominant culture - CERCLA (1980): comprehensive environmental response, compensation, and liability act (CERCLA or superfund) Nagi’s Disablement Process - Hazardous ranking system (HRS) (1982): mechanism to evaluate env o Know the pathway and what falls under each construct hazard of site - describes path w several domains - Environmental justice movement (1982): concern over env racism - (1983) national priorities list (NPL): priorities for cleanup under Superfund - (1989) Crude oil spill in Alaska - (1990) oil pollution act, (1990) pollution prevention act - 1995: Oklahoma city, OK -> terrorist attack - 2000: Hudson river cleanup - 2001: 9/11 NYC - 2005: hurricane Katrina, New Orleans The ranking of chronic diseases for the most direct and indirect costs - BP Oil Spill (2010): Massive oil spill in the Gulf of Mexico, affecting o Where are most of the chronic diseases found – where do they fall in terms of marine ecosystems and coastal communities. States? Brownfields Initiative - Major chronic diseases- heart disease, cancer, diabetes - 1993- Redevelop prior contaminated sites - Most mortality from heart disease AND stroke AND obesity - some southern Different meanings of risk states (poorer) - Giddens & Beck: Risk theory - obesity has been growing rapidly- no state had less than 20% obesity - different meaning of risk: external risks and manufactured risks o Risk factors for chronic diseases - 'risk' gives mechanism to code how hazards and insecurities are - tobacco use, poor nutrition, physical inactivity, alcohol governed o Which factors explain health and disease differences with respect to race? - Risk unevenly distributed in population - Socioeconomic inequalities- poverty and low education access How risk is stratified? - Healthcare quality and access- systemic racism - Classed/Racialized Risks - Chronic stress due to long-term discrimination - Gendered Risks o Which area of the country carries the greatest disease burden? - Geographical/Occupational Risks - Southeastern united states Regulatory principals - Precautionary principles Nutrition/Obesity/Diabetes - new products and policies must be proven safe for public - if no scientific consensus, those taking action must prove that products Who is at risk for obesity and diabetes? aren't harmful - BMI >= 30 = obese soc of med Page 1  - Precautionary principles Nutrition/Obesity/Diabetes - new products and policies must be proven safe for public - if no scientific consensus, those taking action must prove that products Who is at risk for obesity and diabetes? aren't harmful - BMI >= 30 = obese - Permissive principles Prevalence of obesity - shifting nature of (de)regulation to permit products distribution in - World prevalence of childhood obesity has severely increased all over since open markets even if they don't meet safety standards 1960-90 - eg. The dose makes the toxin - Increased trend in obesity among adolescents “The dose makes the toxin” What are people with obesity and diabetes at risk for? - Basic principle of toxicology - POPULATION BASED: - ”All things are poison and nothing is without poison, the dosage alone - Shrinking life expectancy makes it so a thing is not poison" - Enormous economic burden Manufactured doubt - Increased death rate from all causes AND CVD - Harmful products can continue to circulate, generating profits - Inc in mortality from CHD - Organic labels raise the cost - INDIVIDUAL: - Scientists on both sides of a controversy can forms arguments to say the - Higher relative risk (RR) of hypertension, hypercholesterolemia and other side ignored 'the data' diabetes - industries undermine scientific evidence and delay regulation - Fitness level is important Health consequences - Metabolic risks: type 2 diabetes, dyslipidemia, central fat dist is important - Of waste management practices How can diabetes be mitigated? - land filling, incineration, sewage contaminated water, radiation - Weight loss - Of living in E-waste recycling towns - NOT eating ultra-processed foods - reproductive issues - Diet and exercise Colonialism How is obesity medicalized? - Exploitation of natural resources in colonized regions for profit, leaving - Historical roots: obesity was 'bas humor' in ancient Greece (Galen), scales behind environmental degradation became more affordable and weight monitoring became standard - Trump's rollback of environmental regulations - Terminology and standardization: words like 'obese' created negative - The great pacific garbage patch clinical judgement, height and weight charts standardized desirable weights - Treatments and interventions: weight loss drugs and invasive procedures Readings: (classified now under medical insurance coverage) - Institutions influence: national obesity society said obesity req medical Chronic Disease and Disability intervention, AMA resolution 420- obesity classified as disease A Painful Portrait of Disability in America - Economic drivers: pharmaceutical companies, medical-device - Economic struggles for individuals with disabilities. manufacturers and surgery providers influence obesity research, lowering - Disproportionate rates of disability in rural America due to limited access BMI thresholds to healthcare and jobs. - Stigma and challenges associated with long-term disability reliance Mental Health Disabled, or Just Desperate? - lack of job opportunities contribute to increased disability claims. What are the trends for the type of mental health expenditures/treatment - People often face a choice between low-wage, physically demanding from 1986 – jobs and disability benefits. 2014? - disability benefits are a safety net or an enabler of dependency? - Mental health expenditures significantly increased over this period. Nutrition, Obesity, Diabetes - decline in inpatient psychiatric care and an inc in outpatient care, Beyond Arm Chair Social Science – Diabetes and Food Insecurity – The emphasizing community-based treatments Other - a trend toward medicalization of mental health treatment (psychiatric Sociologist medications) o What happens when the food budget is low at the end of the month? Suicide rates…who has the highest; who has the lowest (racial groups)? - People rely on cheaper, calorie-dense, but nutritionally poor foods - Males have higher suicide rates than women o What are the links between food insecurity, poverty, and diabetes? - Major depressive episode (cause of suicide) is greatest for american indian/ - Poverty limits access to healthy food options -> food insecurity alaskan native, lowest for asians - Food insecurity contributes to stress, poor diet quality, and metabolic What are the social determinants of mental health? disorders like diabetes. - Physical disorders are a comorbidity w mental health disorders - Economic instability (poverty, unemployment) Mental Illness - Low education levels - less mental health literacy and access to care Social determinants of mental health - Health care access - Socioeconomic status. - Experiences of discrimination and stigma - Access to healthcare and education. Stages of schizophrenia - Neighborhood conditions and exposure to stressors - prodromal (withdrawal) 12-18 yrs Promising new approach helps curb early schizophrenia in teens, young - acute (psychosis) 18-24 yrs adults - residual (chronic disability) >24 yrs - Early identification and treatment in prodromal phases. Mental Health Illnesses and Disability-adjusted life years - Family therapy, medication, and education to reduce progression to full- - DALYs measure burden of mental illnesses: combine years of life lost to blown psychosis. premature death and years lived w disability (1 DALY = 1 yr of healthy life) Opinion _ It’s misleading to call addiction a disease - Depression is greatest cause of DALYs then anxiety disorders then - Addiction involves behavioral and psychological components influenced schizophrenia by personal choices. Differences in mental illness diagnoses between men, women, and teens and - Calling it a disease may overemphasize biological factors and undermine between race individual agency. - Depressive disorders: increasing trend from older -> younger (20-24yrs) - Anxiety disorders: greatest among 30-44 yrs Pharma - Bipolar disorder: greatest among teens Opioid Epidemic – Big Pharma Not Solely to Blame - Schizophrenia: greatest among 35-44 yrs - Overprescription of opioids for pain management - Substance use disorder: greatest among 50-69 yrs - Lack of public awareness of addiction risks - Mental health disorders: white and black women usually have more; - Social factors like unemployment and economic despair women in general have more How You Helped Pay for America’s Opioid Epidemic - Government subsidies and lax regulations allowed the pharmaceutical soc of med Page 2  - Overprescription of opioids for pain management - Substance use disorder: greatest among 50-69 yrs - Lack of public awareness of addiction risks - Mental health disorders: white and black women usually have more; - Social factors like unemployment and economic despair women in general have more How You Helped Pay for America’s Opioid Epidemic - Government subsidies and lax regulations allowed the pharmaceutical Pharma & Medical Devices industry to profit from opioids - Taxpayers indirectly funded the crisis through Medicaid and Medicare Drug trial phases reimbursements for prescriptions - Preclinical: support development by sponsors, Animal testing to assess Everyday Sociology Blog - Opioids and the Social Construction of Social safety and biological activity, if compound is therapeutic agent then IND Problems.pdf submitted to FDA o What questions does the social constructionist approach ask? - Phase I: approval of clinical trials protocol by review board, small group of - Who defines an issue as a social problem? healthy volunteers (20–80) - Who is most associated with the problem? - Phase II: Larger group (100–300) to test efficacy and further evaluate safety, - When did the issue gain attention? goal: determine max safe dose of drug, compare response achieved to that - How are solutions framed? of current standard treatment - Phase III: Large group (1,000–3,000) to confirm effectiveness, monitor side Environmental effects, many promising drugs fail this, Randomized controlled trial- results Dirty Little Secrets – NJ’s Poorest Live Surrounded by Contamination stratified into diff categories; paperwork and bureaucracy- NDA review - Poor and minority communities in NJ are disproportionately affected by - Post-Marketing: Ongoing studies after approval to monitor long-term industrial pollution. effects and optimize use - Contaminated neighborhoods face health issues How pharmaceuticals spend their money At Hamburger Central, Antibiotics for Cattle - Spend most money on marketing, then research, then taxes - Overuse of antibiotics in livestock contributes to antibiotic resistance in Know the classes of medical devices (definition and examples) humans. - Class I (Low Risk): Minimal harm potential. Examples: Bandages, hand-held - Antibiotic residues in meat may pose health risks. surgical instruments - Regulatory gaps allow continued misuse of antibiotics in food - Class II (Moderate Risk): Requires additional oversight (by FDA) and production. performance standards. Examples: Wheelchairs, infusion pumps, surgical drapes Videos: - Class III (High Risk): Sustains or supports life, implants, or presents a high potential for harm. Examples: Pacemakers, hip replacements Disability Differences between U.S. and EU approval process for medical devices Zoom In - FDA- 2 regulatory paths - Microaggressions faced by individuals with disabilities. - pre-market approval- class III devices (large, randomized trials) Environmental - 510(k) - Class I, II, III (manufacturer only needs to demonstrate that device Tyrone Hayes is 'substantially equivalent' - Research on atrazine, a widely used pesticide, and its endocrine- - EU- Class III approval very diff disrupting effects - approval based on CE mark of conformity Hurricane Maria video - 'notified bodies' (third party) implement regulatory control and - Devastation caused by Hurricane Maria in Puerto Rico and the long-term 'competent bodies' monitor them impact on infrastructure and public health - devices only need to demonstrate safety and performance, not Medical Devices effectiveness The Bleeding Edge History of pharma regulation - The medical device approval process in the U.S. and its weaknesses, such - Regulators identify hazards AFTER release- many deaths in past 10 years as the 510(k) pathway that allows devices to be marketed without - Legislation does nothing- 2007 and 2017 (Medical device monitoring acts) extensive testing Differences in the regulatory process between pharmaceuticals and medical devices - Medical devices have diff efficacy dynamics to pharmaceuticals- medical device effectiveness depends on a lot of variables - R&D models are diff- can't evaluate using randomized clinical trials cuz of ethical and practical issues - Medical devices have regulation based on shorter product life cycles - Sales and marketing models diff- more emphasis on training, education and maintenance; more stakeholders influence adoption/use of device soc of med Page 3