Testing Medicinal Drugs

Question 1

What has to happen to drugs before they can be released to the public?

Answer 1

They have to go through a thorough testing procedure

Question 2

What are the 3 main stages in drug testing?

Answer 2

1. Drugs are tested on human cells and tissue in the lab
2. Drugs are tested on live animals
3. If pass tests on animals tested on human volunteers in a CLINICAL TRIAL

Question 3

Name an exception to the human cell/ tissue testing stage

(+ example)

Answer 3

If the drugs affects whole or multiple body systems

e.g. test for blood pressure must be done on a whole animal because it has an intact circulatory system

Question 4

What does testing a drug on liev animals do?

(3)

Answer 4

1. To see whether it works
2. To find out about its toxicity
3. To find the best dosage

Question 5

What does the law in Britatin say about animal testing?

Answer 5

That new drugs must be tested on 2 different live mammals

Question 6

Name 2 opinions on animal testing

Answer 6

1. It’s cruel
2. It’s the safest way to make sure a drug isn’t dangerous before it’s given to humans

Question 7

Why do some people argue that animal testing is pointless?

Answer 7

Because they say animals are so different from humans that testing on animals is pointless

Question 8

What are the 2 stages to the clinical trials?

Answer 8

1. Healthy human volunteers
2. People suffering from the illness in two groups

Question 9

What happens in the healthy human volunteer trial?

What happens to dosage?

Answer 9

1. Testing for any harmful side-effects when the body is working normally
2. Low dose at start then increased gradually

Question 10

What needs to happen in the healthy human trials for the testing to move on?

Answer 10

The results have to be good

Question 11

What is found when the drug is tested on people suffering from the illness?

Answer 11

The optimum dosage

(most effective dosage with least side-effects)

Question 12

Why are patients put into 2 groups?

Answer 12

To test for the placebo effect

Question 13

Explain how the placebo effect is tested for

Answer 13

1. Patients split into 2 groups
2. One is given new drug, other is given a placebo
3. So the doctor’s can see the actual difference the drug makes

Question 14

What is the placebo effect?

Answer 14

When a patient feels better because they expect the treament to work, even though the treatment isn’t doing anything

Question 15

Define ‘blind’ and ‘double-blind’ trials

Answer 15

Blind trials are when the patients don’t know if they are taking the drug or the placebo

Double-blind trials are when the doctors don’t know either

Question 16

Why do we use double-blind trials?

Answer 16

So the doctors monitoring the patients and analysing the results aren’t subconsciously influenced by their knowledge

Question 17

Name a drug that caused problems because it wasn’t thoroughly tested

When developed?

Answer 17

Thalidomide

1950s

Question 18

What was thalidomide intended and tested to be used as?

Answer 18

A sleeping pill

Question 19

What was thalidomide used for that it was not tested for?

Answer 19

Relieving morning sickness in pregnant women

Question 20

What happened as a result of thalidomide not being used and not tested as a reliever of morning sickness?

Answer 20

No one knew it could pass through the placenta and affect the fetus, causing abnormal limb development.

Question 21

About how many babies were affected by thalidomide, and about how many survived?

Answer 21

About 10 000 affected

Only about half survived

Question 22

What happened as a result of finding the problems with thalidomide?

(2)

Answer 22

1. It was banned
2. More rigorous testing procedures were introduced

Question 23

What has thalidomide more recently been used in the treatment of?

(2ish)

Answer 23

1. Leprosy
2. Other diseases e.g. some cancers