Drug testing and thalidomide Flashcards
What are drugs?
Substances that change chemical reactions in the body
Why do new medical drugs have to be tested extensively?
To check that they work and are safe.
What is the first main stage of medical testing? What generally happens?
The drugs are tested using computer models and human cells grown in the laboratory. Many substances fail this test because they damage the cells or do not seem to work.
What is the second main stage of medical testing? What is legal? What is a typical test?
Drugs that pass the first stage are tested on animals. In the UK, new medicines have to undergo these tests, but it is illegal to test cosmetics and tobacco products on animals. A typical test involves giving a known amount of the substance to the animals, then monitoring them carefully for any side-effects.
What is the third main stage of medical testing? What happens if there are no problems?
Drugs that have passed animal tests are used in clinical trials. They are tested on healthy volunteers to check they are safe. Very low doses of the drug are given to begin with. If there are no problems, further clinical trials are done to find the optimum dose for the drug.
What is the placebo effect?
When people feel better simply because they expect to feel better if they have medicine.
Why are double blind trials important?
To be certain the drug does have positive effects, instead of just the placebo effect.
What happens in a double blind trial?
Some patients are given the drug while others are given a placebo. A placebo is designed to appear exactly the same as the drug itself, but it does not actually contain any of the drug. The doctors and patients are not told who have received the drug and who have received the placebo until the trial is over.
What is thalidomide?
A medical drug that caused unexpected and serious damage to unborn babies in the 1950s and 1960s.
What was thalidomide developed as?
A sleeping pill
What was thalidomide also thought to be useful for, and why was this a problem?
Easing morning sickness in pregnant women, but it had not been tested for use in this way.
By 1960, what had thalidomide been found to do?
Damage the development of unborn babies, especially if it had been taken in the first 4-8 weeks of pregnancy. The drug led to the arms or legs of the baby being very short or incompletely formed.
How many babies were affected by thalidomide?
More than 10,000 around the world
What happened as a result of the thalidomide disaster?
Thalidomide was banned, and drug testing was made more rigorous than before.
What is thalidomide used as now?
A treatment for leprosy and bone cancer, although its use is now heavily regulated to prevent a repeat of its problems.
