Why?

Developing Drugs L.O: To understand how and why new drugs should be tested

What is a drug? “A substance which alters the way your body works, it can affect your mind, body or both.” A good drug needs to be: Effective Safe Stable (to store in normal conditions) Taken in and removed from your body after it has done its work

Drugs Trial We are going to take part in a drugs trial in todays lesson. You will take one of 3 drugs: Drug A – Hyperthermocillin (a drug which increases the temperature of your body) Drug B – Hypothermocillin (a drug which decreases the temperature of your body) Drug C – A placebo (a tablet which doesn’t contain any drug) The drug takes about 30 mins to take effect so we will look at the results later in the lesson

Drugs have been used by indigenous people for years Remains of plants have been found with stone age people. The Greeks, Romans and ancient Middle Eastern all left records of their medical and social drug discoveries. Chloroform was first prepared in 1831 and used as an anesthetic in Before then, a couple of shots of brandy were supposed to get you through major surgery.

Ancient drugs Ancient Egyptians were familiar with drug preparation from plants and herbs such as cumin, fennel, caraway, castor, aloe, safflower, glue, pomegranates botanical, mineral substances and linseed oil. Other drugs were made of mineral substances such as copper salts, plain salt and lead. Eggs, liver, hairs, milk, animal horns and fat, honey and wax were also used. Some medicinal plants used by Pharaohs

What else do you think happens when new drugs are developed? How are the tested?

What happens if they aren’t tested properly? Lets look at the thalidomide story And the elephant man story cal-trials-regulation-and-ethics/1465.html

The pro-test protesters By Brendan O'Neill, BBC News, 22 nd Feb 2006 Until now, animal rights protesters have made all the noise in a dispute over a new research lab in Oxford. But this weekend the city's famed academics are planning to hit back just as loudly, as pro-testing campaigners hit the streets. According to one Oxford academic, a war is looming over "scientific freedom" and the "future of progress", no less. And this Saturday the battle for and against testing will shift from the city's dreaming spires to its historic streets. Over the past two years there have been regular protests by anti- vivisection groups against Oxford University's plans to build an £18m biomedical research laboratory, at which there will be testing on animals. The university says the laboratory is essential for scientific inquiry and for pushing forward medical research and methods. Animal rights groups claim it is unnecessary, that it will be a "prison" for animals which will be treated extremely cruelly by men in white coats.

Why do drugs need to be tested? THALIDOMIDE

THALIDOMIDE – A drug not properly tested. Developed as a sleeping pill so no tests were performed on pregnant mothers Found to be very effective in relieving morning sickness in pregnant women BUT not tested for this use and the babies of mothers who took the drug were born with severe limb abnormalities Early 1960s – The drug was banned worldwide. Around 12,000 deformed Thalidomide babies born, 4,000 died in their first year. Drug was then banned but now being used successfully to treat leprosy in 3 rd world

10/06/2016 Mat Fraser, comedian and actor Tony Melendez, guitarist

To prevent these types of problems, all medical drugs are tested extensively on animals and humans prior to use

The ‘Elephant man’ drug trials You may remember on the news in 2006 the men who took part in a paid drug trail which went very wrong Unfortunately the drug designed to reduce the immune response actually increased it, and the men’s bodies swelled up so much that one man’s girlfriend said he looked like ‘the elephant man’

Drug testing 15 th March Six taken ill after drug trials Six men remain in intensive care after being taken ill during a clinical drugs trial in north-west London. The healthy volunteers were testing an anti- inflammatory drug at a research unit based at Northwick Park Hospital when they suffered a reaction. Relatives are with the patients, who suffered multiple organ failure. Two men are said to be critically ill. The men were being paid to take part in the early stages of a trial for the drug to treat conditions such as rheumatoid arthritis and leukaemia until they were taken ill on Monday within hours of taking it.

The men were left fighting for their lives in hospital as their internal organs started to shut down They all survived although the massive swelling affected the circulation to their fingers and toes The worst affected now face amputation of their fingers and toes Several face a health risk of cancer

When new medical drugs are developed, they have to be tested and trialled before being used. They are tested for toxicity, efficacy and dose. Put the steps in order 1.Researchers target a disease to develop treatment 2.Computer models and chemicals are screened for their use as possible drugs 3.Possible drugs are made in a lab 4.Drugs are tested on cell cultures in a lab to make sure they are not toxic 5.Animal testing takes place 6.Trials on humans begin 7.A licence to a drug and so doctors can prescribe them 8.Drugs are monitored

Do you still feel the same way about testing drugs on animals? Should it be allowed? If so when? What can you do?

What are the results from our drug trial? Should we have used a double blind trial? This strict type of clinical trial eliminates any possibility of bias. Neither the participant or the researcher knows if the treatment or a placebo has been administered.

Would you take part in a well paid drug trial?

Do we need drug trials? Why / why not?