4A.

7 DEVELOPING NEW DRUGS

Describe in stages the work of William weathering

1. What are the requirements/properties of a new medicine?

 Safe – the medicine is non-toxic and does not exhibit sever side effects
 Stable – it can be stored for some time and then used under normal conditions
 Effective – cures, prevents or relives symptoms of the disease it is designed for
 Can be taken in and removed from the body easily
 Can be manufactures in a large scale in a pure form at a cheap cost
2. Describe the stages of testing a new drug
 The compound is first tested on cell cultures, tissue cultures then whole organ tests in the lab
 Once the compound passes these tests, it moves on development and animal testing

The most widely used animals are mice and rat. The number of animals used are kept at a minimum and
the tests used are refined to cause minimum distress. Animals are replaced by tissue cultures and
computer models whenever possible. However, these results are not sufficient enough to move to
testing the drugs on people. So, the law states animal testing should be done first.

 Clinical trials are the next stage. Some people are given a placebo.

A placebo is an inactive substance that resembles the drug being tested. This is given as an experimental
control to prevent the possibility of a placebo effect. A placebo effect is when patients appear to
respond to a drug simply because they think it is doing them good.

These trials are comprised of three phases:

I. Phase 1: the drug is tested in a small number of healthy volunteers. This is done to see if the
drug works as expected and if it causes any unexpected side effects. At the same time, animal
testing is carried out to observe the long-term effects of the drug.
II. Phase 2: the drug is tested on around 100 – 500 volunteer patients with the target disease. A
similar number of volunteer patients are given a placebo or the best current treatment. These
patients are closely monitored to find out the exact ideal dose, the effectiveness of the drug and
any side effects.
III. Phase 3: before the drug is fully approved, it is tested on thousands of volunteer patients with
the target disease. This is done to confirm the effectiveness and safety of the drug. As the
number of patients are large, there is a higher chance of showing up any adverse side effects

3. Explain double-blind trial and placebo effect

Double blind trial is when neither the doctor nor the patient knows if they are receiving the new
medicine, a control medicine or a placebo. A control medicine, the best current treatment, is sometimes
used to ensure that the patient is not denied of their treatment as they take part in the testing.

This is done to prevent the placebo effect where patients appear to respond to the drug simply because
they think it will do them good

4. Why is animal testing less preferred?

It is unethical as animals are kept in captivity and they are incapable of giving consent. It is time
consuming an expensive.

5. Study fig. C for objective questions

6. Compare William weathering’s use of a drug with modern drug testing
 It is more ethical as patients do not have to suffer from severe side effects
 William weathering’s experiment tested the drug on patients without their knowledge or
consent, however modern drug testing only tests on volunteer patients
 Modern drug testing undergoes several drug testings to measure out the dangers and see if they
can be used on humans
 It is conducted more safely and faster