Lesson A2 - DRUG ADVERTISING, DRUG TRIALS, AND PLACEBO EFFECTS

Question 1

A considerable portion of the revenue required for the publication of medical journals is obtained from _________________

Answer 1

Pharmaceutical advertising

Question 2

What are the 6 steps of advertising techniques?

Answer 2

1. Catch audience attention
2. Use celebrities or authorities to endorse products
3. Fear
4. Offering an easy solution to the problems
5. Before-after technique
6. Discredit drugs produced by other manufacturers and praise your own.

Question 3

What step is this in the advertising techniques? Lincocin offers you a “leading edge” over penicillin in streptococcal infections

Answer 3

• Catch audience attention

- Lincocin → later shown to have severe adverse effects → no longer used

Question 4

What step is this in the advertising techniques? If the authorities chose it → it must be the drug of choice

Answer 4

Use celebrities or authorities to endorse products

Question 5

What step is this in the advertising techniques? “ Every fourth menopausal women may develop osteoporosis OS Cal can help” → inflicting fear that these women may develop hunching over ect.

Answer 5

Fear

Question 6

What step is this in the advertising techniques? “ Problem child or child with a problem?”

Answer 6

• Offering an easy solution to the problems

- This type of advertising has been banned

Question 7

What step is this in the advertising techniques? “ When osteoarthritis to interfere” → Shows unhappy women → and then shows the same women happy

Answer 7

Before-after technique

Question 8

What step is this in the advertising techniques? “ This is no time to have to worry about your antihypertensive But the potential risks of diuretics could make it just the time for lopressor SR

Answer 8

• Discredit drugs produced by other manufacturers and praise your own.
• Implies beta blockers are a better choice (lopressor SR = beta blocker)

Question 9

What are the two most common drugs used in hypertension (blood pressure)

Answer 9

Diuretics + Beta blockers

Question 10

What drug introduced in 1938 ( Not many regulations) caused 100 deaths

Answer 10

sulfonamide –> turned out to be toxic

Question 11

What was the drug introduced in 1962 that caused birth defects in pregnant women and what was it suppose to be used for

Answer 11

Thalidomide (sleeping tablet)

Question 12

What was thalidomide used for and what did it cause?

Answer 12

• Sleeping pill

- Caused birth defects when pregnant women took it

Question 13

How were drug regulations further strengthened?

Answer 13

Drug company’s required to show evidence of both safety + efficacy (effectiveness)

Question 14

What are the 3 steps that a pharmaceutical company has to undergo if they want to introduce a new drug?

Answer 14

• 1. Submit proof of both the safety + efficacy of the drug in several animal species
• 2. Detailed methodology for the proposed clinical trial in humans is required
• 3. Submission carefully evaluated → If regulatory agency is satisfied → permission will be given to for an highly qualified investigator to initiate investigations in humans

Question 15

How many phases are there in a clinical trial?

Answer 15

4

Question 16

What does phase 1 entail in a clinical trial?

Answer 16

Study conducted on a limited number of healthy volunteers → absorption, distribution, elimination and adverse effects of the new drug is carefully studied

Question 17

What does phase 2 entail in a clinical trial?

Answer 17

Check if drug is effective → close attention is paid to the safety of the drug (proof of concept)

Question 18

What does phase 3 entail in a clinical trial?

Answer 18

Drug tested in a large number of people → usually 1,000 or more → safety + efficacy is tested → if found to be safe + effective → realeased for marketing and testing

Question 19

What does phase 4 entail in a clinical trial?

Answer 19

Risks that are delayed or less frequent than 1 in 1000 my be missed in phase 3 → drugs under surveillance after release for general use → postmarketing surveillance

Question 20

_________ is an inert substance which masquerades as a drug → derived from latin “ shall I please”

Answer 20

Placebo

Question 21

Why were placebos administered?

Answer 21

Because sometimes in the past some patients demanded therapy even when there wasn’t any available → therefore placebos were administered

Question 22

______________ are effects which occurs as a result of drug administration and have nothing to do with the pharmacological effects of the drug

Answer 22

Placebo effects

Question 23

• Beecher 1955 → conducted one of the most comprehensive studies of placebo effects → roughly 1,000 people involved → Found satisfactory relief in ____% of patients

Answer 23

35%

Question 24

What conditions that have been found to be responsive to placebo?

Answer 24

asthma, hypertension, mental depression

Question 25

In placebo treatment people still report ___________

Answer 25

Adverse effects

Question 26

Who is the placebo effect greatest in

Answer 26

• Greater in sick, anxious patients under stress than in normal volunteers

Question 27

The Placebo effect is greatest in volunteers and less likely in sick, anxious patients under stress

Answer 27

wrong, it is the opposite

Question 28

It is not ethical to compare a __________ to a __________ if there is an _____________ of proven value because individuals should not be deprived of ______________

Answer 28

New drug, placebo, older drug, effective therapy

Question 29

People must be assigned ___________ to different ___________ or a flaw can exist in a trial

Answer 29

Randomly, experimental groups

Question 30

What are 2 charasteristics of a Double-Blind Design

Answer 30

• 1. Subjects should be unaware of whether they are receiving the new or old drug (or placebo)
• 2. The clinical investigator should be unaware of whether the subjects is receiving the new drug or older drug (or placebo)
• This procedure is necessary in order to eliminate bias → on the part of the subject and the investigator

Question 31

Valid clinical trials must be carried out in a ________________ manner in order to eliminate bias

Answer 31

double blind

Question 32

Method of comparison of new drug with an older drug (Or with placebo if there is no drug available)

Answer 32

Design of a phase 3 study (comparative efficacy trial)

Question 33

What is it called when we divide individuals into two groups randomly. Group A receives the new drug and group B receives the older drug (or placebo). Then you compare the effects of the treatment. You then do the exact same thing but group A gets the older drug ( or placebo) and Group B receives the new drug.

Answer 33

Cross-over design

Question 34

What is the type of trial that can be used in diseased states that are chronic and stable. Limited application ( not used very often)

Answer 34

Cross-Over Design

Question 35

What is it called when a subjects are divided into two groups and one group receives the new drug and the other group the placebo or established drug → Most phase 3 studies done like this

Answer 35

Parallel Design

Question 36

Why did the study of antihistamines for the common cold in 1948 prove to be effective and then in 1950 when done again they proved to be ineffective

Answer 36

• 1948 there were no double blind procedures or randomization
• 1950 there were double blind procedures and randomization of subject to treatment or placebo groups