Politics of Health Final

What is the "me-too" mentality in cancer medicine development?

Different pharmaceutical firms create very similar drugs, with identical mechanisms of action as those already on the market

What major change to the FDA drug approval process was made by the passage of the 21st Century Cures Act?

The law instructs the FDA to allow the use of "real world" observational data, rather than randomized clinical trials, to support approval of new drugs

Historically, the American Medical Association sanctioned or penalized doctors who agreed to work on salary (rather than charge by procedure) or participate in prepaid insurance plans.

True

What decision did the FDA make regarding the Alzheimer's drug Aduhelm?

The FDA gave the drug "accelerated approval" based on its ability to remove amyloid plaques, but not actually slow the progression of the disease

The two pivotal, late-stage clinical trials for Aduhelm were halted early in 2019 because the drug did not appear to be helping patients.

True

When the new Alzheimer's drug Aduhelm was approved by the FDA, who was expected to pay most of its cost once it became used clinically?

State and federal governments, through Medicare and Medicaid

Really sick buying heath insurance while healthy people who don't expect to go to the doctor not doing so is an example of which of the following?

Adverse selection

Clinical research targeting amyloid beta proteins have produced many effective therapies over the past 20 years.

False

What is the "clock draw" test used to diagnose Alzheimer's Disease?

A test in which someone is asked to draw a clock face indicating a particular time

Substantial progress has been made in finding effective treatments for Alzheimer's Disease since the essayist Lewis Thomas wrote "The Problem of Dementia" in 1981.

False

How does funding from the National Institutes of Health compare for research on Alzheimer's Disease vs. HIV/AIDS?

The government currently spends about equal amounts on research on both diseases.

Dr. Alzheimer's findings had a profound impact on both the diagnosis and treatment of dementia in the remainder of the 20th century.

False

Both former President Ronald Reagan and former UK Prime Minister Margaret Thatcher were diagnosed with Alzheimer's Disease later in life.

True

Which of the following is ***not*** true about the role played by the Alzheimer's Association, a patient advocacy group, in the debates about Aduhelm?

The Alzheimer's Association raised doubts about the clinical trial and opposed the FDA decision to approve the drug

Which of the following is a risk factor (or statistical predictor) for developing Alzheimer's Disease?

All of the above are significant predictors of Alzheimer's risk

Which allele of the APO4 gene results in the **highest** risk of Alzheimer's Disease?

e4

What problem with key research papers on the role of amyloid beta proteins in Alzheimer's Disease have recent investigations uncovered?

Some Western blot images showing presence of the protein appear to have been manipulated

What strategy have supporters of the "amyloid hypothesis" used to keep alternative explanations out of the scientific mainstream?

All of the above

Most clinical trials trying to find effective treatment for Alzheimer's Disease have focused on what mechanism?

Targeting amyloid beta plaques

Why do big pharmaceutical companies not invest more in developing new antibiotics targeting drug-resistant bacteria?

It is hard to make a profit, as doctors try to use new drugs sparingly to avoid development of further resistance

Who provided funding for ads run by the Action Now Initiative, advocating for reforms to reduce "upcoding" in Medicare Advantage?

Oil trader and billionaire John Arnol

What happened with the AstraZeneca vaccine in the United States?

The vaccine never received approval in the United States due to concerns about the pivotal clinical trial on its efficacy.

What happened with the drug Avastin, which initially received "accelerated" FDA approval for use in metastatic breast cancer?

All of the above

What major innovation did British epidemiologist Austin Bradford Hill bring to the design of clinical trials for drugs?

He implemented the blinding of researchers to whether a given patient received an investigational drug or placebo, to prevent them from cheating

What decision did the Centers for Medicare and Medicaid Services make about whether to pay for the Alzheimer's drug Aduhelm?

CMS decided that the government would pay for the drug only for seniors enrolled in clinical trials of the drug

The Centers for Medicare and Medicaid Services, which oversees the largest government-funded health insurance programs, must pay for every FDA-approved therapy, including for off-label use recommended by expert guidelines.

True

What is the cost of a typical new cancer drug?

A typical new cancer drug costs more than $10,000 per month

To receive full FDA marketing authorization, drugs have to be proven to be "effective." What does that usually mean in the context of cancer trials?

Proving that a drug extends how long people live (survival)

What policy intervention do Budish et al. recommend to encourage greater investment in drugs with longer commercialization lags?

All of the above

Why did most cardiologist go from being self-employed in private practice to being salaried hospital employees between 2008 and and 2015?

Medicare reduced reimbursements for in-office screening done by cardiologists

Health insurance companies offering free membership as part of their policies to attract more healthy enrollees is an example of which of the following?

Cream skimming

What is the **most** common cause of dementia?

Alzheimer’s Disease

Prior to the discovery of Alzheimer's Disease, what was understood to be the most common cause of dementia ("dementia paralytica")?

Late-stage syphilis infection

What is the __**least**__ common cause of dementia?

Frontotemporal dementia

Historically, most doctors worked directly for hospitals as salaried employees.

False

Who pays the largest share of expenditures on physician services in the United States?

Private insurance companies

What recommendation did the panel of outside advisors make regarding the approval of the Alzheimer's drug Aduhelm?

The panel unanimously (with one abstention) recommended against approving the drug.

What changes to the drug approval process were made via legislation and regulation in the 1990s and early 2000s?

All of the above

Which of the following is a legal power that the FDA currently has?

The FDA has none of the above powers

When the FDA is reviewing applications for new drugs, it considers their costs and the likely fiscal impact of their approval in addition to their safety and efficacy.

False

When the FDA began reviewing the application to market thalidomide in the U.S., what did the evidence show about its safety?

All of the above

What led to the passage of the Federal Food, Drug, and Cosmetic Act of 1938?

Deaths linked to the use of Dr. Massengill’s Elixir Sulfanilamide

The federal government spends more than $1 trillion per year on health care, out of a total of $3.7 trillion in annual U.S. health care spending.

True

How does government regulation of "food supplements" compare to regulation of medicines?

In contrast to medicine, no proof of effectiveness or safety is needed to market dietary supplements

Gain of function research focuses on the creation of brand new viruses.

False

Which group advised that, in order to engage in gain-of-function research, it must be proven "that there are no feasible alternative method" and that all unnecessary risks are eliminated?

National Science Advisory Board for Biosecurity

Which of the following statements best describes the primary objective of gain-of-function research?

To identify genetic mutations that increase the virulence or transmissibility of pathogens

Which of the following concerns is most commonly associated with gain-of-function research on pathogens?

The dual-use dilemma, where research can be used for both beneficial and harmful purposes such as biological weapons.

Of the $4.3 trillion spent each year on health care in the United States, what is the ***largest*** type or category of expenditures?

Inpatient hospital care

Why do most working-age Americans get their health insurance through their job?

It's a historical accident, with companies initially offering health insurance to evade World War II wage controls.

What role did federal policy play in linking people's health insurance to their jobs?

Health insurance was exempt from wage controls in place during World War II and subsequently received favorable tax treatment by the IRS.

What role did surrogate endpoints play in the development of drugs to reduce the risk of heart disease?

Drugs that effectively reduced LDL cholesterol also reduced heart attacks and death

Researchers have found that infection with the herpes virus is a strong predictor of developing Alzheimer's.

True

Until 1984, hospitals treating Medicare patients were reimbursed on a cost-plus basis, with no incentive for efficiency.

True

How does Medicare compensate doctors and hospitals?

Medicare pays hospitals based on patient diagnoses (and comorbidities) but pays doctors based on the procedures they do

What happened with the anti-malarial drug hydroxychloroquine during the Covid-19 pandemic?

Under pressure from President Trump, the FDA gave the drug Emergency Use Authorization but later withdrew it after randomized studies showed it didn't help (and actually probably increased mortality)

How do intellectual property and patent laws affect private firm investment in cancer drugs, according to Budish et al.?

Because patent length is fixed in law (e.g., 20 years), firms focus their investments on drugs with the shortest development time and quickest route to approval, to maximize the length of patent exclusivity

Which of the following are causes of the opioid epidemic?

All of the above

The Vancouver study of safe injection studies provides strong causal evidence, free of confounding and other sources of bias.

False

The Mayor of New York City, Eric Adams, stated publicly the city needs to increase safe injection sites as a method of reaching the city’s 15% reduction of fatal overdoses by the year 2025.

True

Approximately how many people die from the opioid overdoses in America each year?

47,000

How did the 1962 Kefauver-Harris amendments change the requirements for obtaining FDA marketing approval for new drugs?

Prior to the 1962 amendments, drug manufacturers had to show that their drug was safe but not that it was effective

How did the Healthy Hunger-free Kids Act of 2010 change the requirements around school lunches?

Reduced the number of fats and calories allowed in school lunches

Which of these foods were considered vegetables under the school lunch program in 2009?

All of these foods were considered vegetables under the school lunch program in 2009

As a result of new rules around school lunches in 2010 the USDA limited whole grains and proteins to 12 ounces.

True

What is one of the main concerns critics cite surrounding the stricter nutrition rules for school lunches? 

Increased amounts of food waste

Which of the following was ***not*** an effect of a hospital receiving a large Section 508 payment increase?

All of the above were consequences of Section 508 payments

Which hospitals were ultimately awarded extra funding for treating Medicare patients under the Section 508 program waiver?

Hospitals located in congressional districts represented by legislators who had voted in favor of the Medicare Modernization Act

What is Medicare Advantage?

The privatized version of Medicare Part A and B, provided through private insurance companies.

How did Medicare hospital costs change in the first decade of the program's life (1966 to 1976)?

Hospital costs increased more than three times faster than overall inflation as measured by the Consumer Price Index.

How's Medicare currently funded?

Medicare is funded on a "pay as you go" basis, with payroll taxes paid by current workers funding benefits for current retirees.

At the time the readings you read for class were written, the total amount that Medicare paid physicians each year was fixed using a global budget, so higher compensation for some specialties and procedures necessarily required lower pay for others.

True

When the Medicare legislation was originally passed in 1965, Congress included strict cost-control provisions to ensure that hospitals and doctors would not be able to set their own prices and profit from the program.

False

What was the primary purpose of the Medicare Modernization Act of 2003?

To provide prescription drug coverage for seniors on Medicare

Which part of the Medicare program pays for in-patient hospital care?

Part A

Which parts of the hospital industry were initially most opposed to the move to a prospective payment system under Medicare?

Academic teaching hospitals

How does the government pay for the cost of the Medicare program and the benefits to seniors it provides?

All of the above help pay the cost of Medicare benefits

According to the recent Office of Inspector General investigation, how have hospitals gamed the Medicare reimbursement system in recent years to increase their revenues.

Hospitals have used "upcoding" to classify more patients into the most severe complication categories, which leads to higher reimbursement rates.

People building houses in flood plains because the government provides them subsidized flood insurance is an example of which of the following?

Moral Hazard

How did President Obama and Democrats get Sen. Ben Nelson from Nebraska to vote in favor of the Affordable Care Act?

The agreed to have the federal government pay 100% of the cost of the Nebraska Medicaid expansion

How effective are most newly approved cancer drugs?

The typical new cancer drug extends a patient's life by an average of about 2.5 months

What is a main argument opponents the prison organ donation bill have made?

Reduction of a prison sentence in return for organs constitutes a payment or service and may violate the prohibition on compensation for voluntary organ donation

How are the electoral connections and political incentives affecting the debate about prisoner organ donation?

The sponsors may want to be seen as progressives to reflect their racially diverse constituents, some of whom may have families in prison or need transplants themselves

When Medicare was created in 1965, what system did the law set up for paying physicians?

Medicare required that doctors be paid "customary, prevailing and reasonable charges," based on what they previously charged and what colleagues charged for the same services in the same geographic area.

The peer review process was effective at catching fraud in research on Alzheimer's Disease and preventing its publication.

False

When private, commercial interests fund research on drugs to treat cancer, which types of disease and patients are ***most*** likely to be targeted for clinical trials?

Private industry is most likely to fund clinical trials on recurrent and metastatic cancers, with the shortest survival time

What similarities between people suffering from both presenile and senile dementia did Dr. Alzheimer's notice?

Both groups had fibrous plaques inside and outside their neurons

What were the results of the RCT Duplicate study, commissioned by the FDA to see if analysis of real-world evidence could replicate findings from existing randomized clinical trials?

RCT Duplicate effectively reproduced the results of about half of the clinical trials included in the study

Which of the following factors is ***not*** included in calculating the Resource-Based Relative Value Scale units (RVUs) that are now used to pay physicians through Medicare?

Health outcomes (or outputs) produced by individual medical procedures.

When setting Relative Value Units used to compensate doctors through Medicare, the federal government relies on the private American Medical Association for advice and typically accepts 95 percent of the AMA's recommendations.

True

Which of the following  is ***not*** an accurate summary of which doctors tend to write comments on proposed regulations to change the Medicare Physician Fee Schedule (PFS)?

Doctors who stand to ***gain*** the most money from the proposed PFS changes are most likely to submit comments.

Which of the following was ***not*** a trend in Relative Value Units between 2000 and 2013?

The number of procedures with a work RVU increased over time

The codes with work RVUs shifted from being mostly procedural to being mostly about evaluations and office visits

All of the above happened during this period

Why does the process used to update the RVUs used to compensate physicians under Medicare favor specialty providers rather than primary care physicians?

All of the above contribute to the RVU process favoring specialists over primary care physicians

Why does "real world evidence" -- observational data from electronic medical records -- often fail to provide accurate evidence on the efficacy of drugs?

All of the above

Under the spatial model of politics, which legislators have the most leverage over the policy that gets passed?

The most moderate legislators have the most influence

What are the patterns in doctor compensation by specialty in the United States?

Primary care physicians get paid less than doctors practicing in specialties such as interventional cardiology.

Drugs that are found to improve surrogate endpoints almost always improve longer-term, "hard" endpoints such as death and survival.

False

What is the significance of Johns Hopkins University Hospital in the context of gender-affirming trans care?

Johns Hopkins University Hospital was the first US hospital to offer gender-affirming care

Which of the following is ***not*** a potential negative effect of hormone therapy

Blindness

How many US states have placed restrictions on gender-affirming care?

Over 30 states have placed restrictions on gender-affirming care