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THE USE AND ABUSE OF DRUGS 1.3 Drugs Summary of Specification content • Testing of new drugs and clinical trials. • Thalidomide Learning Outcomes • Define the term ‘drug’. • Give examples of medical drugs. • Explain why drugs need to be tested before they • • • • can be prescribed. Describe the uses and problems associated with thalidomide. Explain how the drug testing procedure for thalidomide was inappropriate. Describe the main steps in testing a new drug. Explain the terms placebo and double-blind trial. • Discuss: • what is a drug? • Names of medicines. Medicines from plants • Drugs are chemicals • that affect the way cells work • That have an effect on the processes of the body • Medicinal drugs • Have a beneficial effect • Used for treating disease, injury and pain • Example: - Paracetemol • Effective painkiller • High doses can cause liver damage • In extreme cases it can be lethal Recreational drugs • Some drugs are taken for pleasure • These include • Caffeine • Alcohol • Cannabis • Nicotine • Heroin Natural medicines • Many of the chemicals used to make medicines occur naturally in plants • aspirin • white willow bark • quinine • to treat malaria • from Cinchona tree • morphine and codeine • analgesics • from opium poppies Natural medicines • 75 – 80% of the world’s population use medicines originally derived from plants • Many of these plants are found in rainforests • The rosy periwinkle is the source of two chemicals that are used to treat cancer. Obtaining drugs from plants • Many of the plants contain these chemicals to protect them from herbivores • Problem • they are harmful to other living organisms • could be potentially harmful to humans if used in drug preparations • So any potential drug has to be tested for: • efficacy • toxicity Modern Drug Testing • Modern clinical trials are double blind trials, where some patients are given a placebo. • Placebo • compound presented in the same way • Double blind • neither doctors nor patients know who gets drug or placebo • avoids bias in ‘looking for results’ Modern Drug testing Stage 1: Laboratory • Animals or tissues used in a lab to find out • Level of toxicity • Efficacy – does the drug work? Phase 1 Clinical trial • Low doses tested on a group of healthy people • Evaluate safety • Identify side effects Modern Drug testing Phase 2 Clinical trial Phase 3 clinical trial • Larger group of people • See if it is effective • Further evaluate safety • Determine optimum dose • Large groups of people • Confirm effectiveness • Monitor side effects History of drug testing • Digitalis • is a natural toxin found in foxgloves • can be fatal in even quite small doses. • used for centuries in herbal remedies to treat some heart conditions. • William Withering rigorously tested digitalis and brought it into conventional medicine in 1775. Testing a new drug Testing a new drug • Compare the two flow charts by answering the following questions • What similarities are there? • What differences are there? • In what way is the current system of drug testing safer and more reliable? • What do we gain nowadays from testing the drug on healthy volunteers first? • Why is it important to randomly assign patients to the treatments and have a double blind trial? What similarities are there? • In both cases a potentially useful medicinal substance was identified • First small and then larger groups of patients were treated with the drug What differences are there? • The current method seeks single active ingredients • Animal trials are used before testing on humans to assess • efficacy • toxicity • Drug tried out on a group of healthy people first • confirms whether drug behaves in the body in the way predicted by the lab tests • effects of different doses monitored • Independent review of data carried out in current system Further differences • Statistical analysis of data • to see if any difference is due to • chance • the drug • Once regarded as effective and safe drug has to be strictly licensed before it can be marketed In what way is the current system of drug testing safer and more reliable? • 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 • 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 has an effect What do we gain nowadays from testing the drug on healthy volunteers first? • Check no unexpected side effects • Observe behaviour of drug in a human e.g. is the compound absorbed, how is it distributed, is it metabolised and broken down too quickly, is it excreted before it has an effect etc. Why is it important to randomly assign patients to the treatments and have a double blind trial? • Prevents • subconscious prediction or influence of the outcome by both patient and researcher • psychosomatic influences In the news • Sometimes things do go wrong! • http://news.bbc.co.uk/1/hi/england/london/4811626.stm • Ethical issues here! • http://www.bbc.co.uk/science/hottopics/animalexperiments/ • http://www.beep.ac.uk/content/396.0.html • Even licensing can lead to controversy! • http://www.bbc.co.uk/stoke/content/articles/2005/09/26/her ceptin_intro_2005_feature.shtml Even licensing can lead to controversy! • http://www.bbc.co.uk/stoke/content/articles/2005/0 9/26/herceptin_intro_2005_feature.shtml Use of animals in research • http://www.mrc.ac.uk/NewsViewsAndEvents/News/ MRC003445 • http://news.bbc.co.uk/1/hi/sci/tech/5365206.stm Thalidomide • Thalidomide • drug used in the 1960’s as a sleeping pill • Effective at relieving morning sickness in pregnant women, but had not been tested for this use • Reduced the development of blood capillaries in the foetus and babies were born with underdeveloped arms and legs • Banned as soon as these side effects were noticed • Currently used for • Treating leprosy • Treating cancer Thalidomide Activities • Use pictures to relate uses and problems associated with thalidomide. • Research and produce a report on thalidomide – original use, use in pregnant women, current uses. How Science Works - ICT • You have developed a drug that can make people more intelligent. Create a multimedia advertising campaign explaining what your drug can do and showing that it has been properly tested and is safe to use. PPQ Jan 10 (H) Question 4 • (a) • testing for toxicity / see if it is safe / see if it is dangerous / to see if it works • ignore side effects unqualified 1 • (b)(i) • testing for side effects / testing for reactions (to drug) • ignore to see if it works • do not accept dosage • (b)(ii) any one from • dose too low to help patient • higher risk for patient • might conflict with patient’s treatment / patient on other drug • effect might be masked by patient’s symptoms / side effects clearer • ignore immune system • (c) • to find optimum dose • allow testing on larger sample or it makes results more reliable • allow to find out if drug is effective / find out if drug works on ill people • (not just if drug works) • (d)(i) • (tablet / drug / injection) that does not contain drug • allow control / fake / false • allow tablet / injection that does not affect body • do not accept drug that does not affect body • (d)(ii) • neither patients nor doctors Drug trialling – Suggested Activities • Discuss: • Discuss drug safety and how drugs are tested today. • Activity: • Cards/cut-outs to sequence stages in drug testing and trialling and purpose of each stage. Summary of Specification content • Statins lower the amount of cholesterol in the blood. • Recreational drugs Learning Outcomes • Describe and evaluate the effect of statins in cardiovascular disease. Cholesterol Revision • Cholesterol • is produced naturally in the liver • Some people have high cholesterol levels • Too much cholesterol • increases the build up of fatty deposits in artery walls • Increases risk of heart disease • Evidence that reducing cholesterol in the blood reduces the risk of heart disease and heart attacks Statins • Statins • Reduce the production of cholesterol by the liver • Reduces blood cholesterol levels • Used to treat patients who are at risk because they have a high cholesterol and a history of heart disease in their family. Task: Interpret data on statins • any two from: • balance between two important for good heart health • ignore blood pressure • high LDL causes heart disease / high Cholesterol • do not accept converse argument • high HDL reduces heart disease / cholesterol • do not accept converse argument • heart attacks greater amongst patients with low HDL levels • ignore statins cause heart disease • statins reduce heart attacks of patients or placebo is less effective • ignore comparative effects of the two statins • allow pravastatin is more effective supported by appropriate calculations Revision – drug testing •T • toxicity •H • Healthy people for side effects •P • Patients for effectiveness •D • Patients for dose • Make your own mnemonic to remember the sequence of events in drugs testing. Learning Outcomes • Name some recreational drugs. • Describe some effects of caffeine on the body. Recreational drugs • A drug is any chemical that alters how our body works • Drugs that affect the central nervous system control the movement of chemicals across the synapses. • Drugs have similar shapes to these chemicals and can mimic what they do. • Recreational drugs are taken for pleasure Recreational drugs Legal Illegal • Alcohol • Cannabis • Caffeine • Cocaine • Nicotine • Heroin • Ecstasy • All of these may have adverse effects on the heart and circulatory system. Drug Dependence Chemical Dependence • the body adapts to the presence of the drug. • When the chemical is removed the body is no longer able to function normally. • The body then goes into withdrawal symptoms such as hallucinations, fevers, nausea (feeling sick) and shakes. • These are real, physical signs. Psychological dependence • the person feels a need for the drug. • They feel unable to cope without the drug. • For example: • some smokers need to chew sweets after they give up because they miss having a cigarette in their mouths. Caffeine • A stimulant is a drug that increases the activity of the nervous system. • It can raise the alertness, emotions or mood. • Caffeine is a mild stimulant found in tea and coffee. • Prolonged overuse may lead to problems with the heart, stomach and pancreas. • Discuss: Brainstorm on recreational drugs, sort into legal and illegal and discuss why people use them. • How Science Works: Investigate the effect of caffeine on heart rate or reaction time Summary of Specification content • Recreational drugs • Impact of legal drugs on health is greater than illegal drugs as more people use them. Learning Outcomes • Evaluate the impact of smoking on health. • Evaluate why some people use illegal drugs for recreation. • Evaluate claims made about the effect of prescribed and non-prescribed drugs on health. Smoking Benson And Hedges Gold 20 Pack £7.25 Lambert And Butler King Size 20 Pack £6.89 Decide how many cigarettes you are going to smoke in one day • Calculate how much you will spend on cigarettes in a week • Calculate how much you will spend on cigarettes in a year • If you started smoking at 16 and continued to smoke until you were 65, how much money will you have spent on cigarettes? Smoking and Health • To understand the effects of smoking you need to look at the three components of cigarette smoke • Nicotine • Carbon monoxide • Tar Nicotine • Nicotine is • Addictive • a stimulant • make the heart beat faster • Increasing the normal heart beat rate can cause stress for the heart which can lead to heart disease. Carbon Monoxide • This gas binds irreversibly to the haemoglobin in red blood cells preventing them from carrying oxygen. • This will make the smoker more out of breath. • Smoking during pregnancy • Reduces the amount of oxygen which is being passed on to the developing foetus • This slows down the growth of the foetus as it develops. Tar • Tar is a mixture of many different chemicals. • It prevents the cilia in the lungs from working and so the dirt and tar cannot be removed from the lungs. • The tar damages the delicate alveoli, often making them burst. • This reduces the surface area of the lungs and leads to breathing problems like Emphysema and COPD (chronic obstructive pulmonary disease) Carcinogens • Tar contains carcinogens which are chemicals which can cause cancer. • A cancer is an abnormal growth of cells caused by a change in the genes which control growth. • The tumour damages healthy cells and tissues as it grows and can spread to other areas of the body. • Smoking increases the risk of lung cancer, mouth cancer and throat cancer. Pupil Activities • Poster to show effects of chemicals in smoke on the body. • Show health warning on packets of cigarettes; video clips of smoking adverts. Why do people smoke? Further information • Useful information on drugs can be found at www.talktofrank.com • A useful tool about smoking can be found on the NHS website at www.nhs.uk by searching ‘smoking calculator’. • Further information on smoking can be found at www.ash.org.uk Jun 09 Qu 3 BLY1H (a)(i) • tobacco / nicotine / alcohol accept solvent / glue / caffeine • ignore cigarettes / coffee (a)(ii) • cannabis / heroin / cocaine allow eg crack / weed / ecstasy / LSD / amphetamine / speed / steroids / GHB (b)(i) • heroin / cocaine / tobacco / nicotine ignore alcohol / cigarettes / cannabis / caffeine / coffee (b)(ii) • alters body chemistry • ignore withdrawal symptoms / craving • ignore non-chemical effects on nervous system Jun 09 Qu 3 BLY1H (c) • any two from: • increase in cannabis smoking increases (%) depression • greater effect in women • allow women become more depressed • depression linked with / not directly caused by cannabis • not all cannabis smokers get depression • ignore cannabis causes depression Jan 09 Qu 3 BLY1H (a)(i) • does not contain drug / chemical • allow eg fake / sugar pill / dummy drug (a)(ii) • as control or to see if the effects are psychological or allows blind testing • allow ‘to compare (with NRT)’ (b)(i) • gum • allow gum placebo • allow placebo (b)(ii) • high / highest number of participants / people or correct number given ie gum 16706, gum placebo 9319, placebo 16458 (c)(i) • nasal spray (c)(ii) • highest percentage of people stopped / 24% stopped • biggest difference between treatment and placebo • allow ‘highest by 4%’ for 2 marks Summary of Specification content • Recreational drugs • Impact of legal drugs on health is greater than illegal drugs as more people use them. Learning Outcomes • Evaluate the impact of alcohol on health. • Evaluate why some people use illegal drugs for recreation. • Evaluate claims made about the effect of prescribed and non-prescribed drugs on health. Alcohol and Health • The alcohol in alcoholic drinks such as wines, beer and spirits is ethanol. • It is a depressant • It slows down impulses in the nerves and brain. • Health • Small amounts of alcohol help people to relax • greater amounts lead to a lack of self-control. • Long-term effects of alcohol include damage to the liver and brain. • Alcohol may also cause weight gain • it is addictive. In an exam you may be asked to:• Discuss effects of alcohol on the body, • Recommended units for men and women. • Calculate number of units of alcohol consumed. • Relate smoking and alcohol to NHS costs. Summary of Specification content • Recreational drugs • Cannabis • Drug addiction and withdrawal symptoms – heroin and cocaine. Learning Outcomes • Describe the effects of cannabis on the body. • Consider the possible progression from recreational to hard drugs. • Describe the effects of heroin/cocaine addiction and withdrawal symptoms. Cannabis • Cannabis is an illegal drug that can be smoked, producing feelings of well-being. • like tobacco it can cause lung cancer and bronchitis. • it can cause permanent damage to the mental health of its users. • Research has shown that cannabis has some useful painkilling properties, but it is illegal to prescribe it for this use. Card sort • Cut and sort into arguments for pro and anti- legislation for cannabis It can be used for nervous conditions to relieve anxiety due to its relaxing properties Cannabis can be an effective pain killer for diseases such as cancer and multiple sclerosis It would reduce crime as there would be no need for a “black” market for the drug No-one has ever died from an overdose of cannabis Cannabis is addictive due to the tobacco it is mixed with Cannabis can be a starter for harder more dangerous drugs It will make the drug more readily available to younger citizens It can be the cause of many mental conditions later in life It is a stress reliever, which could It slows down your reactions save money for the NHS, and making it almost impossible to reduce the amount of people on make informed decisions sick pay. As well as its own effects, it holds It contains carcinogens 6 times all the bad effects of tobacco, stronger than those in tobacco, when smoked with tobacco. which can cause lung cancer. • Interpret data on cannabis use and progression to hard drugs. Does cannabis lead to hard drugs? • Cannabis can cause mental illness in some people • Cannabis is an illegal drug which is bought from dealers • This brings cannabis users into contact with hard drugs such as heroin • Not all cannabis users go on to hard drugs • Nearly all heroin users previously smoked cannabis. Withdrawal • Once addicted people will suffer withdrawal symptoms if they don’t take the drug. • Withdrawal symptoms can be • Psychological e.g. paranoia • Physical e.g. sweating and vomitting Websites • Information on cannabis can be found on the NHS website at www.nhs.uk by searching ‘the dangers of cannabis’. • Further information on drugs can be found on the following websites www.dare.uk.com • www.nida.nih.gov and on the NHS website at www.nhs.uk by searching for ‘drugs’ Summary of Specification content • Steroids and performance enhancing drugs. Learning Outcomes • Evaluate the use of drugs to enhance performance in sport. • Consider the ethical issues of performance enhancing drugs. • Describe some effects and risks of these drugs. Drugs in sport • Some atheletes use drugs to enhance their performance • Steroids are used to build up muscle mass, other drugs can improve stamina • Strong painkillers are banned • Athlete might ignore an injury, suffering further damage • Performance enhancing drugs can damage the body permanently Drugs in Sport • Some athletes take illegal substances to enhance their performance, an activity known as ‘doping’. • There are 5 'doping classes which are categories of banned drugs: • Stimulants • Anabolic agents - steroids • Diuretics • Narcotic analgesics • Peptides and hormones Drugs in sport Doping class Effect on performance Dangerous side-effects Stimulants Make athletes more alert and mask fatigue Can cause heart failure, addictive Anabolic agents - steroids Help athletes to train harder and build muscle Increased aggression andkidney damage Diuretics •Remove fluid from the body. Used :to make the weight, eg in boxing •to hide other drug use Causes severe dehydration Narcotic analgesics Mask pain caused by injury or fatigue which can make Addictive the injury worse Peptides and hormones EPO (Erythropoietin) red blood cells - gives more energy HGH (Human Growth Hormone) - build muscle EPO - risk of stroke or heart problems. HGH - abnormal growth, heart disease, diabetes, arthritis etc Questions to think about • Is it unethical to take drugs to enhance performance? • Are there any current news items regarding the use of drugs in sport? • Lance Armstrong - cycling • Alan Baxter - Skiing Research: • Research types of drugs used in sport and their effects on the body and produce a table. Activity: • Role play, write a story or debate about using drugs in sport; random drug testing; getting caught cheating.