The extract from the foxglove plant which is used to

treat patients with heart disease is known as digitalis which was found by William Withering. He bought the recipe for a herbal cure for oedema from a patient. This medicine was a mixture of several herbs and that include Digitalis.

He began with a low dose of his own digitalis soup and increased it until the patient suffered side effects.

He used low levels of this soup where no side effects develop. This was considered as the ideal dosage.
This extract is digitalin and is used to treat heart disease.

It is ethically wrong as the over dose is fatal

In double blind trial neither the participants nor the researchers know which participants belong to the control group and who is being treated. This method can be applied to any experimental situation where there is a possibility that the result will be affected by bias. If the treated group shows significantly better results than the placebo control group, then the treatment has passed the trial.

Medically ineffectual treatment for a disease intended to deceive the patient. In a common placebo procedure a patient is given an inert pill told that it may improve his/her condition.

But not told that it is in fact inert.

This may cause the patient to believe that the treatment will change his/ her condition. They may feel that their condition has improved or there is an actual improvement . This phenomenon is called placebo effect

Loss of trust between the patient and the doctor

Every medicine that comes into the market today is the result of years of research and development. It takes around 10 years to develop a new drug.

A new medicine has to be: Effective-it cures or prevents the disease it is designed for.

Safe- non toxic and without unacceptable side effects.

Stable-able to be stored under normal conditions Easily taken into and removed from the body- able to get into the target. Capable of being made on a large scaleable to be manufactured in large quantities.

Pre-clinical testing- the proposed drug is first tested on cell cultures, tissue cultures and whole organs in the lab. To see if the compound does what the scientist thought it would. Phase 1A small group of healthy volunteers (20-100)is given the drug to see 1. if it is safe 2. how quickly it is absorbed, metabolized and excreted from the body

Phase 2-

A group of volunteers with disease are given the drug to see 1.how effective it is against the signs and symptoms of the disease. 2. what doses are the best.
3. what are the side effects. A control group is given dummy dose (placebo)

Phase 3Hundreds to thousands of patients are given the drug to get more reliable data on its

1. effectiveness
2.safety 3. best dose

4. rare side effects If all goes well it is put forward to licensing authority

Safer:

Use of specific active ingredient should allow a more precise dose to be given. Any serious ill effects may be detected in the animal trials first

More reliable:

Uses larger samples reduces effects of chance/random variation Double blind testing avoids patient/researcher bias in observing, recording and interpreting effects Statistical analysis of data improves accuracy of conclusions as to whether or not drug actually does have an effect or not.

 Similarity

Groups of patients undergoing treatment vary from small to large group. A potentially useful medicine is identified.

William Withering
No trials on healthy people

Contemporary three

phase trial
Trial first carry out on healthy people
Test on laboratory animals

No test on laboratory animals

Approval and licensing not required

Approval and licensing required