Testing Medicinal Drugs

Question 1

Before new drugs can be given to the public, they have to go through [ ]

Answer 1

Testing procedures

Question 2

How many stages are there in drug testing?

Answer 2

3

Question 3

What can’t you test in the first stage

Answer 3

You can’t use human calls and tissues to test drugs that affect whole or multiple body systems (eg. drugs for blood pressure)

Question 4

Describe the second stage

Answer 4

• This is to see whether the drug works (produces the effect you want), to find out about its TOXICITY (how harmful) and the best dosage (most effective amount)
• The law in Britain states that new drugs must be tested on 2 different live mammals.

Question 5

What does the fist stage test on?

Answer 5

Human cells and tissues in the lab

Question 6

What does the fist stage test on?

Answer 6

Human cells and tissues in the lab

Question 7

Give an argument for and against animal testing

Answer 7

Some people think it’s cruel to test on animals and some people think that animals are so different from humans that testing on animals is pointless
But others believe that it is the safest way to make sure a drug isn’t dangerous before it’s given to humans

Question 8

What is the drug tested on in the third stage?

Answer 8

Human volunteers in a clinical trial

Question 9

3rd stage: Fist the drug is tested on [ ]. (Make sure it doesn’t have any harmful [ ] when the body is working normally) At the start of the trial, a [ ] dose of the drug is given and this is gradually [ ]

Answer 9

healthy volunteers
side effects
very low
increased

Question 10

3rd stage: If the results of the tests on healthy volunteers are good, the drugs can be tested on [ ]. The [ ] dose is found - this is the dose of the drug that is [ ] and has few [ ]

Answer 10

people suffering from the illness
optimum
most effective
side effects

Question 11

Describe how a placebo is used in the third stage of the third stage of trials

Answer 11

patients are put into 2 groups. 1 is given the new drug, the other a placebo. This is so the doctor can see the actual difference the drug makes - it allows for the placebo effect. - to test how well the drug works

Question 12

What is the placebo effect?

Answer 12

When the patient expects the treatment to work and so feels better, even though the treatment isn’t doing anything

Question 13

Describe what blind and double-blind trials are - used in the 4th step of the 3rd stage in drug testing

Answer 13

Clinical trials are blind - the patient in the study doesn’t know whether they’re getting the drug or the placebo. Double-blind – neither the patient nor the doctor knows until all the results have been gathered. This is so the doctors monitoring the patients and analysing the results aren’t subconsciously influenced by their knowledge

Question 14

When was thalidomide developed?

Answer 14

In the 1950s

Question 15

What was thalidomide intended for? What was it then found to be effective for?

Answer 15

Sleeping pill - tested for that use

relieving morning sickness in pregnant women

Question 16

What was the issue with using thalidomide for Morning sickness?

Answer 16

It hadn’t been tested as a drug for morning sickness, and so it wasn’t known that it could pass through the placenta and affect the fetus, causing abnormal limb development. (Some babies born without arms or legs)

Question 17

How many babies were effected by thalidomide?

Answer 17

About 10,000, only about half survived

Question 18

What happened after thalidomide was found to be causing deformities?

Answer 18

The drug was banned, and more rigorous testing procedures were introduced.
More recently thalidomide has been used in the treatment of leprosy and other diseases (some cancers)