Question

• Three types of physical environment (unaltered, altered, built)
• Goal of environmental health
• Love Canal
• Silent Spring
• Differences between a risk assessment and a public health assessment (which measures theoretical risk, which measures actual risk, which is broader in scope, which takes place over a shorter period of time)
• Ecological risk assessment
• What does the FDA regulate (Dr. Miller)
• Dietary supplements regulated as what? (Dr. Miller)
• Reason for items such as toothpaste and dandruff shampoo to be included as drug products (Dr. Miller)
• Food and drug administration’s control over drug prices (Dr. Miller)
• Off-label prescribing (Dr. Miller)
• Health law and the U.S. Constitution
• Interstate Commerce Clause and public health
• Compare and contrast the two philosophies toward the role of government affecting health policies (Market Justice vs. Social Justice)
• No duty principle
• Nuremburg Code
• Tuskegee study
• Belmont Report
• Internal Review Boards
• Systems thinking and reductionist thinking
• Systems analysis and systems diagrams
• One Health – what is it and be able to identify examples
• Climate change implications
• How a bill becomes a law
• Federalism
• Affordable Care Act features
• Policy Windows – 3 streams

Answer 1

• Three types of physical environment:

  unaltered environment:-

  the natural environment (i.e. radon-naturally occurring breakdown product of uranium which increase risk of lung cancer; sunlight exposure increases chances of skin cancer like melanoma)

  altered environment:-

  impact of chemicals, radiation, and biological products that humans introduce into the environment (i.e. pesticides, benzene, chlorofluorocarbons, elements mined from earth like mercury and lead, radiation from nuclear energy and medical wastes)

  built environment:-

  physical environment constructed by human beings (i.e. the way we build and heat our buildings and cook food, way we travel)

• Goal of environmental health:-

  To Promote healthier environments to improve health.

  More than 12 million people around the world die every year because they live or work in unhealthy environments. Healthy People 2030 focuses on reducing people's exposure to harmful pollutants in air, water, soil, food, and materials in homes and workplaces.
• Love Canal:- Love Canal is a neighborhood in Niagara Falls named after a large ditch. Love Canal Homeowners Association (LCHA) was established to give the community a voice in the decisions made during the Love Canal environmental crisis. LCHA membership consisted of approximately 500 families living within a 10-block area surrounding the Love Canal landfill. Within a week of the health order, the residents held a public meeting, elected officers and set goals for the newly formed organization.
• Silent spring:- Silent Spring is an environmental science book by Rachel Carson.The book was published on September 27, 1962, explaining the adverse environmental effects caused by the indiscriminate use of pesticides.
• Ecological risk assessment:-Ecological Risk Assessments  are performed to evaluate the likelihood of adverse ecological effects occurring as a result of exposure to physical or chemical stressors. These stressors are defined as any biological, physical, or chemical factor that causes adverse responses in the environment.
• The FDA regulates a wide range of products, including foods (except for aspects of some meat, poultry and egg products, which are regulated by the U.S. Department of Agriculture); human and veterinary drugs; vaccines and other biological products; medical devices intended for human use; radiation-emitting electronics etc.
• In the United States, dietary supplements are regulated under the Dietary Supplements Health Education Act of 1994 (DSHEA) as a subset of foods and limited to those taken orally. This approach is primarily post-market in nature. However, it does contain pre-market elements.

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.

• Food and drug administration’s control over drug prices:-However, the FDA has no legal authority to investigate or control the prices set by manufacturers, distributors and retailers. A number of factors can impact drug pricing, such as the costs of research and development and the amount of competition in the marketplace.
• Off-label prescribing :- Off-label prescribing is when a physician gives you a drug that the U.S. Food and Drug Administration (FDA) has approved to treat a condition different than your condition. This practice is legal and common. In fact, one in five pres'criptions written today are for off-label use.
• Interstate Commerce Clause and public health:-Even when Congress has not actively employed its commerce power, state and local public health efforts may be affected by a legal doctrine called the “dormant Commerce Clause.” Not only does the Commerce Clause empower Congress to act, but it can also bar state and local actions that could interfere with interstates.

The provision of the U.S. Constitution that gives Congress exclusive power over trade activities among the states and with foreign countries and Indian tribes. An Interstate commerce, or commerce among the several states, is the free exchange of commodities between citizens of different states across state lines.

• No Duty Principle:-The so-called "no duty" rule under the common legal system may make physicians immune from civil liability for their refusal to treat unless a physician-patient contractual relationship exists.
• Nuremburg Code:-The Nuremberg Code aimed to protect human subjects from enduring the kind of cruelty and exploitation the prisoners endured at concentration camps. The 10 elements of the code are: Voluntary consent is essential. The results of any experiment must be for the greater good of society.
• Tuskegee study:-It was called the “Tuskegee Study of Untreated Syphilis in the Negro Male.”The study initially involved 600 black men – 399 with syphilis, 201 who did not have the disease. The study was conducted without the benefit of patients’ informed consent. Researchers told the men they were being treated for “bad blood,” a local term used to describe several ailments, including syphilis, anemia, and fatigue. In truth, they did not receive the proper treatment needed to cure their illness.
• Belmont Report:-The Belmont Report was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
• Systems thinking and reductionist thinking:-Parts are related through a simple cause effect relationship,In contrast to the reductionist approach, systems thinking is a holistic perspective claiming that the whole is not the sum of its parts but rather is a product of the parts interactions.
• Systems analysis and systems diagrams:-Systems Analysis is a broad term for describing methodologies for developing high quality Information system which combines Information Technology, people and Data to support business requirement; And a system diagram in software engineering and systems engineering is a diagram that defines the boundary between the system, or part of a system.
• One Health :-One Health issues include zoonotic diseases, antimicrobial resistance, food safety and food security, vector-borne diseases, environmental contamination, and other health threats shared by people, animals, and the environment.
• Climate change implications:-Increased heat, drought and insect outbreaks, all linked to climate change, have increased wildfires. Declining water supplies, reduced agricultural yields, health impacts in cities due to heat, and flooding and erosion in coastal areas are additional concerns.
• How a bill becomes a law:-A Bill is the draft of a legislative proposal which has to pass through various stages before it becomes an Act of Parliament. The legislative process starts with the introduction of a Bill in either House of Parliament-Lok Sabha or Rajya Sabha. A Bill can be introduced either by a Minister or by a Private Member.
• Federalism:-Federalism is a mixed or compound mode of government that combines a general government with regional governments (provincial, state,territorial or other sub-unit governments) in a single political system.
• Affordable Care Act features:-1.Providing Access to Insurance for Uninsured Americans with Pre-Existing Conditions.

2.Extending Coverage for Young Adults.

3.Expanding Coverage for Early Retirees.

4.Rebuilding the Primary Care Workforce.

5.Holding Insurance Companies Accountable for Unreasonable Rate Hikes.