Chapter 3 - Strength for the U.S. Economy Flashcards
What must a drug be in order to afford sufficient protection from a patent from imitators?
It must be novel.
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?
Generics.
What are the three functional categories that exist within a pharmaceutical company?
Research & development (R&D), manufacturing and operations, and marketing & sales.
What is one of the most significant results of the pharmaceutical industry’s continued investment in R&D?
The large number of new drugs approved and in development.
How many drugs are expected to be approved every year internationally?
Over 100.
Of the 5,000 medicines that are currently in development, how many are in the U.S.?
3,400.
How long is someone diagnosed with AIDS expected to live if recommended therapy guidelines are followed?
50 years.
How many people are directly employed by the pharmaceutical industry?
650,000 people.
How much in net economic gains has increased life span created for Americans?
$2.4 trillion (more than 20% or the gross domestic product).
What is the key reason for the transfer of R&D investment from Europe to the U.S.?
Differences in national price control policies.
What negative impact have price controls and cost containment programs had on R&D in several countries?
Pharmaceutical industries have weakened or have shifted outside their borders.
Asymptomatic
Without signs or symptoms of disease.
Study in which participants do not know whether they are in the experimental or control group in a research study.
Blinded (Masked) Study
The standard by which experimental observations are evaluated.
Control Group
Neither the participants nor the study staff know which participants are receiving the experimental treatment and which patients are in the control group.
Double-Blinded Study
Edema
Swelling
Drugs that meet medical needs for patients with serious or life-threatening conditions.
Fast-Track Drugs
In terms of drug approval, the exact purpose for which the FDA has approved that a drug can be described.
Indication
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.
Institutional Review Board
Usage of a medication for purposes other than the specific ones appearing in the labeling.
Off Label
An inactive pill, liquid, or powder that has no treatment value.
Placebo
The effect produced by a placebo due to the expectations of the patient.
Placebo Effect
General design and operating features of a clinical trial.
Study Protocol
The extent, quality, or degree to which a substance is poisonous or harmful to the body.
Toxicity
A group of patients assigned to receive a specified treatment.
Treatment Group
Who qualifies as “payers?”
The insurance company, the employer, managed care organization or the US Government (Medicare, Medicaid).
How do third-party “payer” organizations influence what medications a patient receives?
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.
Whose responsibility is it to influence the list of approved drugs that are paid for by insurance companies?
Senior-level Account Managers
What defines “ethical pharmaceutical companies?”
Research and development of novel drugs to be protected by patent from imitators.
Pharmaceutical companies are generally either (belong to which two categories) _________ or _________.
Research-based or focused on manufacturing generic drugs.
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?
False.
In 2012, FDA approved _____ new drugs for use in the U.S., the highest number of approvals since 1996.
39
Two treatments have been approved for Hepatitis C, a virus estimated to affect 180 million people. True or False?
True.
How long are people newly diagnosed with HIV expected to live?
50 additional years
How much has the average lifespan increased since 1890?
30 years
What is a treatment group?
A group of patients assigned to receive a specified treatment.
What is the main difference between a blinded and double-blinded study?
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.
What does asymptomatic mean?
Without signs or symptoms of a disease.
How many drugs are in development for cancer?
3070
How many new meds are in development for diabetes?
281
How many new treatments have been approved for Hepatitis C?
2
