Chapter 3: Strength For The U.S. Economy

Question 1

Pharmaceutical companies are generally either research based or focused on the manufacturing of generic drugs. True or false?

Answer 1

True.

Question 2

What companies are the leading edge innovators?

Answer 2

Research based companies.

Question 3

Pharmaceutical companies that develop novel drugs are known as ethical pharmaceutical companies. True or false?

Answer 3

True.

Question 4

What companies employ the most sales representatives?

Answer 4

Research based pharmaceutical companies.

Question 5

What is research and development?

Answer 5

This focuses on discovering new chemicals and molecules, and turning them into safe and effective pharmaceutical products.

Question 6

What is manufacturing and operations?

Answer 6

This is the supply chain, manufacturing, trade, and distribution functions of the business.

Question 7

What is marketing and sales?

Answer 7

This communicates the benefits of the companies pharmaceutical products and creates demand for those products.

Question 8

What is one of the most significant results of the industries continued investment in R&D?

Answer 8

The large number of new drugs approved and in development.

Question 9

Internationally how many new drugs are expected to be approved every year?

Answer 9

Over 100 new drugs.

Question 10

What is PhRMA?

Answer 10

Pharmaceutical Research and Manufacturers of America.

Question 11

What is liver cirrhosis?

Answer 11

Chronic liver damage leading to scarring and liver failure.

Question 12

The field of personalize medicine includes what?

Answer 12

Patients unique molecular and genetic profiles.

Question 13

What is the sixth leading cause of death in the US?

Answer 13

Alzheimer’s disease.

Question 14

How many new medicines are in development for cancer?

Answer 14

3,070 new medicines.

Question 15

What disease causes progressive neurodegeneration, that leads to paralysis and death?

Answer 15

Lou Gehrig’s disease also known as ALS.

Question 16

How many new diabetes medicines are in development?

Answer 16

281 new diabetes medicines.

Question 17

How many medicines are currently in development for HIV/AIDS?

Answer 17

185 new medicines.

Question 18

Someone newly diagnosed with HIV is expected to live an additional 50 years with new medications. True or false?

Answer 18

True.

Question 19

Why is the American pharmaceutical industry a major part of the American economy?

Answer 19

Because of a significant investment in R&D.

Question 20

The pharmaceutical industry has grown twice as fast as the overall economy in the last few decades. True or false?

Answer 20

True.

Question 21

The pharmaceutical industry is one of the key drivers of economic growth. True or false?

Answer 21

True.

Question 22

The pharmaceutical industry employs how many people?

Answer 22

Over 650,000 people directly. 4 million jobs indirectly in other sectors.

Question 23

Since 1890 the average lifespan of an American has increased by how many years?

Answer 23

Nearly 30 years.

Question 24

What is an approvable letter?

Answer 24

Letter sent by the FDA to the applicants, indicating whether the new drug application (NDA) or abbreviated new drug application (ANDA) for a product substantially meets the necessary requirements.

Question 25

What is a NDA?

Answer 25

New drug application.

Question 26

What is an ANDA?

Answer 26

Abbreviated new drug application.

Question 27

What is asymptomatic?

Answer 27

Without signs or symptoms of disease.

Question 28

What is a blinded or masked study?

Answer 28

A study in which participants do not know whether they are in the experimental or control group in a research study.

Question 29

What is a control or control group?

Answer 29

The standard, by which experimental observations are evaluated. Control groups are commonly given a placebo.

Question 30

What is a double blind or double mask study?

Answer 30

This is a study in which neither the participants nor the study staff know which participants are receiving the experimental treatment, and which patients are in the control group.

Question 31

What is edema?

Answer 31

Swelling.

Question 32

What are fast track drugs?

Answer 32

Fast track approval is provided for drugs that meet medical needs for patients with serious or life-threatening conditions.

Question 33

What is indication?

Answer 33

In terms of drug approval, the exact caused or purpose for which the FDA has approved that a drug can be prescribed.

Question 34

What is the institutional review board (IRB)?

Answer 34

A committee of physicians, statisticians, community advocates, and others which ensures that a clinical trial is ethical and the rights of the study participants are protected.

All clinical trials in the US must be approved by the IRB.

Question 35

What is off label?

Answer 35

Usage of a medication for purposes, other than the specific ones appearing in the labeling.

Question 36

What is a placebo?

Answer 36

A placebo is an inactive substance that has no treatment value.

In clinical trials experimental treatments are compared with placebos to assess the effectiveness.

Question 37

What is the placebo effect?

Answer 37

The effect produced by a placebo due to the expectations of the patient.

Question 38

What is study protocol?

Answer 38

The general design, an operating features of a trial.

Question 39

What is toxicity?

Answer 39

The extent quality or degree to which a substance is poisonous or harmful to the body.

Question 40

What is a treatment group?

Answer 40

A group of patients assigned to receive a specified treatment.