Chapter 3 - Strength for the U.S. Economy

Question 1

What must a drug be in order to afford sufficient protection from a patent from imitators?

Answer 1

It must be novel.

Question 2

Once a drug’s patent expires, other companies are free to market drugs with the same active ingredients and efficacies. What are these drugs called?

Answer 2

Generics.

Question 3

What are the three functional categories that exist within a pharmaceutical company?

Answer 3

Research & development (R&D), manufacturing and operations, and marketing & sales.

Question 4

What is one of the most significant results of the pharmaceutical industry’s continued investment in R&D?

Answer 4

The large number of new drugs approved and in development.

Question 5

How many drugs are expected to be approved every year internationally?

Answer 5

Over 100.

Question 6

Of the 5,000 medicines that are currently in development, how many are in the U.S.?

Answer 6

3,400.

Question 7

How long is someone diagnosed with AIDS expected to live if recommended therapy guidelines are followed?

Answer 7

50 years.

Question 8

How many people are directly employed by the pharmaceutical industry?

Answer 8

650,000 people.

Question 9

How much in net economic gains has increased life span created for Americans?

Answer 9

$2.4 trillion (more than 20% or the gross domestic product).

Question 10

What is the key reason for the transfer of R&D investment from Europe to the U.S.?

Answer 10

Differences in national price control policies.

Question 11

What negative impact have price controls and cost containment programs had on R&D in several countries?

Answer 11

Pharmaceutical industries have weakened or have shifted outside their borders.

Question 12

Asymptomatic

Answer 12

Without signs or symptoms of disease.

Question 13

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

Answer 13

Blinded (Masked) Study

Question 14

The standard by which experimental observations are evaluated.

Answer 14

Control Group

Question 15

Neither the participants nor the study staff know which participants are receiving the experimental treatment and which patients are in the control group.

Answer 15

Double-Blinded Study

Question 16

Edema

Answer 16

Swelling

Question 17

Drugs that meet medical needs for patients with serious or life-threatening conditions.

Answer 17

Fast-Track Drugs

Question 18

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

Answer 18

Indication

Question 19

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

Answer 19

Institutional Review Board

Question 20

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

Answer 20

Off Label

Question 21

An inactive pill, liquid, or powder that has no treatment value.

Answer 21

Placebo

Question 22

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

Answer 22

Placebo Effect

Question 23

General design and operating features of a clinical trial.

Answer 23

Study Protocol

Question 24

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

Answer 24

Toxicity

Question 25

A group of patients assigned to receive a specified treatment.

Answer 25

Treatment Group

Question 26

Who qualifies as “payers?”

Answer 26

The insurance company, the employer, managed care organization or the US Government (Medicare, Medicaid).

Question 27

How do third-party “payer” organizations influence what medications a patient receives?

Answer 27

By offering reimbursement for only certain medications and by enforcing a list of approved drugs that are paid for by the insurance company and then sending that list to doctors and pharmacists to guide them on which drugs should be prescribed for patients enrolled in that particular plan.

Question 28

Whose responsibility is it to influence the list of approved drugs that are paid for by insurance companies?

Answer 28

Senior-level Account Managers

Question 29

What defines “ethical pharmaceutical companies?”

Answer 29

Research and development of novel drugs to be protected by patent from imitators.

Question 30

Pharmaceutical companies are generally either (belong to which two categories) _________ or _________.

Answer 30

Research-based or focused on manufacturing generic drugs.

Question 31

One of the most disappointing results of the pharmaceutical industry’s continued investment in R&D is the few new drugs being approved and in development. True or False?

Answer 31

False.

Question 32

In 2012, FDA approved _____ new drugs for use in the U.S., the highest number of approvals since 1996.

Answer 32

39

Question 33

Two treatments have been approved for Hepatitis C, a virus estimated to affect 180 million people. True or False?

Answer 33

True.

Question 34

How long are people newly diagnosed with HIV expected to live?

Answer 34

50 additional years

Question 35

How much has the average lifespan increased since 1890?

Answer 35

30 years

Question 36

What is a treatment group?

Answer 36

A group of patients assigned to receive a specified treatment.

Question 37

What is the main difference between a blinded and double-blinded study?

Answer 37

In a double-blinded study, neither the study staff nor the study participants know which subjects are in the experimental group and which are in the control group.

Question 38

What does asymptomatic mean?

Answer 38

Without signs or symptoms of a disease.

Question 39

How many drugs are in development for cancer?

Answer 39

3070

Question 40

How many new meds are in development for diabetes?

Answer 40

281

Question 41

How many new treatments have been approved for Hepatitis C?

Answer 41

2