Chapter 3 - Strength for the U.S. Economy Flashcards

1
Q

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

A

It must be novel.

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2
Q

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

A

Generics.

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3
Q

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

A

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

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4
Q

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

A

The large number of new drugs approved and in development.

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5
Q

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

A

Over 100.

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6
Q

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

A

3,400.

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7
Q

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

A

50 years.

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8
Q

How many people are directly employed by the pharmaceutical industry?

A

650,000 people.

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9
Q

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

A

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

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10
Q

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

A

Differences in national price control policies.

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11
Q

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

A

Pharmaceutical industries have weakened or have shifted outside their borders.

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12
Q

Asymptomatic

A

Without signs or symptoms of disease.

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13
Q

Blinded (masked) study

A

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

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14
Q

Control group

A

The standard by which experimental observations are evaluated.

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15
Q

Double-blinded study

A

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

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16
Q

Edema

A

Swelling

17
Q

Fast-track drugs

A

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

18
Q

Indication

A

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

19
Q

Institutional Review Board (IRB)

A

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.

20
Q

Off label

A

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

21
Q

Placebo

A

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

22
Q

Placebo effect

A

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

23
Q

Study protocol

A

General design and operating features of a clinical trial.

24
Q

Toxicity

A

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

25
Q

Treatment group

A

A group of patients assigned to receive a specified treatment.