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Debating pharmaceuticals and

drugs

Student work document (recommended for years 10 - 11 and

5th year of secondary school)

DEVELOPED BY:

Debating pharmaceuticals and drugsDo we use drugs responsibly? Does news about research on new drugs create false

hope? Should illegal drugs and alcoholic drinks come with information on recommended doses?

Find out more, form an opinion and share it!

Before bringing out a new drug onto the market, the pharmaceutical industry has to carry out effectiveness and safety tests in the lab. However, these are not sufficient to ensure the drug can be given to patients. For this there’s something called the European Medicines Agency and, on a local level, the Spanish Agency of Medicines and Medical Devices, which only give authorisation to a medicine after a series of tests have been completed. These start with lab testing and end with testing on people.

But even though a very large number of products are tested to become drugs, only a very small fraction actually ever make it to the human testing phase. When research centres publish the results of their studies and possible drug candidates, they often appear in the media. As a result, researchers find they are contacted by patients requesting the drug or vaccine they’ve discovered to see if it will help cure their illness. Is this due to the fact that there is a general lack of knowledge regarding the stages, costs and time involved in developing a drug so that it can be given to a patient? Does the media explain in enough detail how a pharmaceutical drug is developed and do they give correct information on advances? Or do they only help create false hope?

On the other hand, do you think that the development of illegal drugs or alcohol has to follow similar steps?

In this student work document, we invite you to find out more about and investigate the drug development process and the associated ethical, legal and social aspects. Once you know more, we ask you to analyse different news items from research centres to identify at what stage of drug development the centre is. We also invite you to analyse news items about research on new drugs which appear in the press so that you can answer the question on whether they create false hope. Finally we’ll get you to debate whether you think it’s necessary for illegal drugs and alcoholic drinks to also offer consumers information on ingredients and recommended doses. In summary, all the tasks you complete will help you share your conclusions with politicians, journalists and the public at large.

But before starting on all of that, first of all we need to investigate what pharmaceuticals are and what we mean by drugs.

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A. What is a pharmaceutical drug? The word pharmaceutical comes from the Latin pharmăcus which, in turn, comes from the Greek phármakon meaning drug and medicine, but also poison or magical substance. The Encyclopædia Britannica defines a pharmaceutical as a “substance used [...] for restoring, correcting, or modifying organic functions”.

1. Each of you should now think of a pharmaceutical drug you’ve taken recently. What changes did this drug cause in your body?

2. Share your answers with the rest of your classmates. Make a list of pharmaceuticals you know and, for each one, write down what effect you think they have on the body.

3. Depending on the dictionary we look at, we can find different definitions for pharmaceutical (drug). According to the Oxford English Dictionary, a pharmaceutical is “a compound manufactured for use as a medicinal drug”. So is a pharmaceutical and a medicine the same thing according to the OED? And what about the Encyclopædia Britannica?

4. Now have a look at the following symbols associated with pharmacies. Investigate a little what they are supposed to represent. Make sure you also find out a bit more about the lives of Asclepius (the Greek god of medicine) and his daughters Hygieia (the goddess of health) and Panacea (the goddess of universal remedy).

What is a drug?5. When talking about drugs, we’re referring to substances which temporarily alter how the

nervous system works when introduced into the body and create addiction. Dopamine and serotonin are two substances which act as neurotransmitters regulating hunger, mood, reactions to stress and muscle tension.Check out this mouse party to find out what effects certain drugs have on these neurotransmitters and on the body as a whole.

http://learn.genetics.utah.edu/content/addiction/mouse/

Summarise what you learn in the following table:

Substance taken Neurotransmitters affected Effect on body

What substances were taken by the mice? Which of these could have a possible therapeutic effect? Why?

Can you buy these drugs in a pharmacy? Why?

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What are narcotics? Can we consider them medicines too?

B. How are drugs developed? Now we invite you to watch a video covering the entire drug development process from research carried out in laboratories all the way until it is released onto the market after having passed all of the necessary tests: The long and incredible story of a tablet (http://www.xplorehealth.eu/en/media/long-and-incredible-story-tablet).

6. After watching the video a couple of times, individually write down in the following table all of the ideas you think are relevant and the things you don’t fully understand.

Important concepts and termsThings I don’t fully understand at the

moment(to be resolved as the activity progresses)

Now form groups of three and go through the most important ideas and compare what things you haven’t understood. As far as possible, try and clear up your doubts with the other members of the group and then complete the tables. Make one large group and summarise all the ideas you’ve written down with the others.

7. Answer the following questions individually and then reform the group of three from earlier in the task and share your answers:

Is the process involved in developing new drugs expensive? Compare your answer with other investments with fixed costs such as buying a house or car, or building a road, etc.

Some important concepts when understanding how drugs are developed are: active ingredient, excipients and target. Choose one of the medicines you know about in section A.2 and investigate what its active ingredient and excipients are as well as what it targets exactly in the body.

Where do these active ingredients we can find in drugs come from? Why does the drug development process require input from so many different scientists? Why aren’t in vitro studies sufficient for evaluating the safety of drugs intended to treat

different diseases we might suffer from?

8. Based on the information from the video The long and incredible story of a tablet you’ve already seen and the following multimedia tool, do you think you can describe exactly what the process involved in developing a new drug involves?

http://www.irsicaixa.es/en/place-different-phases-development-vaccine-order

We ask you for the following: describe what each phase consists of justify why each phase is necessary identify which of the following icons best illustrates each phase:

1 2 3 4 5 6

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Use the table you’ll find on the following page to organise all the information we’re asking you for in this activity:

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Phase What does it consist of? Why is this phase necessary? Icon no.

Design

Pre-clinical

Clinical

Phase I

Phase II

Phase III

Health approval

Production and prescribing medicine

Pharmacovigilance

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9. A well-known and respected international pharmaceutical company has contacted you to ask for your help in developing a drug to fight a new disease, cellpox, which at the moment is killing people because there is no medicine on the market that can stop it. Help the company develop this new drug by arranging the cards you’ll find on pages 8, 9 and 10 of the following document:

http://www.centreofthecell.org/lessonplans/lessonplan.php?lp_id=4

10. Finally, go to this last link and take part in a race against the clock to bring a drug to market. Take a screenshot of your score. Who managed to bring their drug onto the market in the shortest time?

http://www.xplorehealth.eu/en/media/develop-drug-race-against-time

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C. What is involved in studies into finding the recommended dose for a medicine?

Any drug, whether it be medicine, alcohol or illegal drugs, all contain a substance which sets off a biological mechanism in our bodies. This is known as the active ingredient or active substance. Now that you’ve completed the tasks in the previous section, you’ve seen how important it is to test first on animals and then on people so that we can define the dose of medicines to give to patients and to ensure their efficiency and safety. This dose is studied in great detail before the medicine can be released for sale in the pharmacy.

When we get a medicine from the pharmacy, we tend to read the information leaflet which gives us all kinds of information on how much of the medicine to take and how often.

11. Why do you think this information is so important?

12. Go back again to activity 2. Try and remember how often and how much of the drug you took. Share this information with your classmates and complete the following table:

Commercial name of medicine

Active ingredient Excipients Dose Frequency

13. Apart from the dose and how often you are meant to take the drug, is there any other information you can find on the leaflet you get in the package?

14. How do you think studies on drug dose and efficiency tests are carried out? In order to answer this question, we invite you to look at this specific case: The study for determining the dosage of an antibacterial drug and the effectiveness of different antibacterial substances.

Do you know what antibacterial drugs are used for?

We suggest you split into groups and as a group choose a substance you’d like to investigate. Choose one of the following: antibacterial drugs from the pharmacy (could be creams), garlic and spices such as black sage, pepper, oregano or lavender, etc.So that you can compare your results with those from the other groups, we recommend you to clearly define the quantities you want to use to prepare the solutions for each chosen substance. To test the antibacterial efficiency of each substance, you’ll use bacterial cultures on agar plates and will add different concentrations of the substance you want to test. What do you think you’ll observe in the bacterial cultures if the substance being tested is an efficient antibacterial?

A. First of all, define your hypothesis and design an experiment to analyse the best dose and its effectiveness. You have the following materials at your disposal: agar plates (*), precipitation vessels, sticky tape, permanent markers, tweezers, scissors, cotton wool buds, antibacterial substances for testing, alcohol, Bunsen burner, etc.

(*) If you don’t have any agar plates, you can make them yourselves following the instructions you can find on the internet, e.g.: http://www.madaboutscience.com.au/store/index.php?main_page=page&id=43.

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When designing the experiment, pay attention to the following points: Specify some of the variables such as the temperature, light and incubation time and

make sure to include them in the experiment design. Indicate the different concentration of the antibacterial substances you’ll be testing.

It would also be a good idea to add a positive control (distilled water) and negative control (an antibiotic with proven efficiency) to the experiment. Why do you think it is so important to add these controls?

Make several copies for each experiment. Sterilise all the materials you’ll be using with a little alcohol. Make sure you use a new cotton wool bud for each time you apply the bacteria to the

dish. You will need to use varying concentrations of the substances in order to investigate

their effectiveness and determine the most appropriate dose.

B. Carry out the experiment and then note down all of your findings in a table. Make graphs showing the results from the different antibacterial substances.

C. Collate your results and draw conclusions in groups:i. What happened for each antibacterial substance?

ii. Which of the antibacterial substances you analysed was the most effective?iii. As you increase the dose, what happens to the surface area of the dead bacterial

colonies? Does your graph show a plateau? How can it be interpreted?iv. Can your results be used to determine which the most appropriate dose is? Support

your answer with the help of your results and put together a proposal for how the experiment can be improved to get this information.

v. Are the results you obtained consistent with the hypothesis? Are you able to confirm the hypothesis or make a new hypothesis?

D. Would increasing the dose lead to other consequences? Back up your answers with the help of the results from your experiment on the antibacterial substances and give examples of other substances where an overdose can be fatal.

E. Write a report with your findings.

F. By way of a conclusion, discuss briefly the meaning of the following quote from Paracelsus, a Swiss doctor born in the 15th century who helped ensure that medicine started to adopt a more rigorous scientific approach:

“Alle Ding’ sind Gift, und nichts ohn’ Gift; allein die Dosis macht, daß ein Ding kein Gift ist ”: “All things are poison, and nothing is without poison; only the dose permits something not to be poisonous”.

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D. What ethical, legal and socials aspects are involved in the development of drugs?

As we’ve seen, the process from carrying out research on a new drug until it is finally approved for sale in pharmacies is long, complex and costly. At the same time, it involves a series of decisions which can sometimes be related to ethical, legal and socioeconomic aspects.

The following section contains different issues for debate so that you can investigate some of these aspects in more detail.

15. Organize yourselves into groups of five.

16. Play one of the card games we suggest here:

Who pays for drug development?This discussion game gives you the chance to investigate the ethical, legal and socioeconomic factors involved in the discovery and subsequent development of new drugs. These include such topics as pharmaceutical testing, investment in marketing and the effects of globalisation. We will also be inviting you to discuss a series of statements and situations regarding the cost of developing drugs and investment in rare illnesses.

http://www.xplorehealth.eu/en/who-pays-develop-drugs?arg0=resources-for-educators

Access to treatmentWhat role does pharmaceutical treatment play and how can patients be given access to different types of treatment? This discussion game offers young people the chance to investigate topics such as overmedication, vaccination and alternative or complementary medicine. We’ll also be asking you to look carefully at a series of statements and situations related to the ethical and social aspects associated with access to treatment with pharmaceuticals.

http://www.xplorehealth.eu/en/access-treatment

17. Before you start with the debate, read carefully the info cards you’ll find at the end of each discussion continuum.

18. Once you’ve finished, write down a few brief conclusions that everyone in the group agrees on. Use the following table to help you organise the different conclusions:

WHO PAYS FOR DRUG DEVELOPMENT?Topic of debate Conclusions

Drugs to combat rare diseasesDrug advertising and marketingPatents and generic medicines

Drug side effectsVolunteers for clinical testing

ACCESS TO TREATMENTTopic of debate Conclusions

Self prescription of drugsLifestyle and disease prevention

Abuse of drugsAlternative treatments

Vaccination

19. Present your conclusions to the other groups.

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E. At what stage of drug development are the researchers close to you? Do news items on advances in research create false hope?

In order to answer these questions, here are some websites for different research centres for which you can find information on breakthroughs in the development of drugs.

a) IrsiCaixa AIDS Research Institute (www.irsicaixa.es/en)b) Centre for Genomic Regulation (CRG)

(http://pasteur.crg.es/portal/page/portal/Internet) c) Institute for Research in Biomedicine (IRB)

(http://www.irbbarcelona.org/index.php/en)d) Vall d’Hebron Research Institute (VHIR) (http://www.vhir.org/index.asp?

Idioma=en)

20. Organise yourselves into groups of four and choose one of the research centres above. Go to their news pages and select two articles which refer to the development of new drugs. Complete the following table:

Name of research

centre

Date the article

was published

Development phase of the drug in question Area of health Conclusions you can

draw from the article

21. Put together a report to present to the other groups. This report should include an evaluation of the scientific news the institution publishes, the areas of health currently under investigation, the phases at which the drugs studies are and the conclusions you can draw from the articles.

22. Still in the same groups, now look in newspapers to find three articles on research into drugs to treat different illnesses. Fill out this bibliography:

Title of article Date of publication

Media in which article is

published

Development phase of the drug

in questionConclusions

23. Do you think these articles create false hope? Give reasons for your answers and then share your findings with the other groups.

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F. Do you think that the stages of testing for drugs should also be applied to other substances such as alcohol or illegal drugs?

24. Illegal drugs don’t come with a leaflet on how much should be taken. Bearing in mind how they are produced - and you can find an example of the production of illegal drugs at this link: http://www.youtube.com/watch?v=ETGDPlcE-NE, make groups of 3-4 and fill out the following table which compares the process of producing medicines with that of an illegal drug.

Medicine Illegal drugPlace of manufactureIs the manufacturing process well planned?Are there phases for analysing efficiency and security?Is there any authorisation from the health authorities?Is there any risk of contamination?

Do you think an information leaflet should be demanded when you acquire this kind of drug? What kind of information should it include?

Do you think that we can compare illegal drug users with the mice used as part of pharmaceutical drug testing? Why?

25. Some legal drugs such as alcohol and tobacco carry labels. Do you think this is the same as an information leaflet? Why? Read the following article:

http://www.nhs.uk/news/2013/09September/Pages/cigarette-packet-picture-warnings-not-strong-enough-to-deter-young-smokers.aspx

What is the message these packets are trying to give? Is it important to inform smokers that tobacco contains addictive substances? How could information on recommended maximum doses be included? Design your own packet.

26. Alcohol is the most widely-consumed legal drug. Read the following article:

http://www.theguardian.com/news/datablog/2013/feb/27/how-much-alcohol-do-we-really-drink

What is the maximum alcohol intake as recommended by the NHS? How much are people actually drinking?

Put together a survey similar to the one on the article, select an example of one of each level to apply it and compare the results with the rest of the students.

27. Do you know what homeopathic remedies are? Do you think that homeopathic remedies should be subject to the same phases as the drugs you have been looking at in this unit? How is the dose for some homeopathic remedies studied? To answer these questions, watch this video made by students at the University of Liverpool:

http://www.youtube.com/watch?v=gZO9J7dDLU4&noredirect=1

You can also consult what the NHS has to say on homeopathic remedies: An introduction to homeopathy:

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http://www.nhs.uk/conditions/Homeopathy/Pages/Introduction.aspx

G. In groups of three, write a manifesto and present it to the media and politicians, etc. and publish it on social networks, the communications channels in your school and on the Xplore Health blog and anywhere else you consider relevant. Include the conclusions you’ve drawn from all the different activities.

Here are some ideas about how to put together this document:

you could write to one of the journalists who wrote an article on drug development but who didn’t explain the process properly and whose article might lead to false hopes;

you could write to the minister of health to explain the importance of labelling bottles of alcohol;

write to someone working at a drug and alcohol treatment charity explaining your findings; make a video 2-3 minutes long covering your most relevant findings and share it through

the channels we have suggested.

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BRIEF TEACHING FOCUSThis student work document proposes a series of teaching topics aimed at discovering more about the scientific, ethical, legal and social aspects related to drug development.

It is meant to be an open proposal which can be used in full, or concentrating on just some of the sections:

A. introduction to the concepts pharmaceutical, medicine and drug;B. analysis of the stages involved in developing pharmaceuticals;C. design of and conducting an experimental study into the correct dose for a

pharmaceutical;D. a debate on the ethical, legal and social aspects related to drug development based on

a card game (discussion continuum);E. analysis of news articles related to drug development appearing in the media and on

the web sites of Catalan research centres;F. consideration of the lack of studies on the efficiency and safety of illegal drugs and

other legal drugs such as alcohol;G. putting together of a manifesto, video, letter, etc. with the idea of thinking more in

depth about the knowledge acquired in the different sections and also informing society in general of the conclusions drawn.

These activities are intended to form the basis of further study in years 10 - 11 in natural sciences for science, and 5th year of secondary school for sciences for the contemporary world and biology. The following page shows a table with the different sections we recommend studying in each school year; however you are free to use the sections you feel are most appropriate when you decide based on your students’ needs and taste.

We hope the tasks we ask you to carry out are useful!

Good luck!

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TABLE OF CONTENTS

Level Areas Blocks Content Class hours

Year 10 Biology and geology

1. Health and disease.2. Coordination in the body. Drugs.

A. What exactly is a pharmaceutical drug?B. How are drugs developed?F. Do you think that the stages of testing for drugs should also be applied to other substances such as alcohol or illegal drugs?G. Presentation of conclusions.

4 sessions

Year 11 Biology and geology 1. Biotechnology.

B. How are drugs developed?E. At what stage of drug development are the researchers close to you? Do news items on advances in research create false hope?G. Presentation of conclusions.

3 sessions

5th year of

secondary school

Sciences for the contemporary world

Biology

1. Health and medical investigation.2. Biotechnology.

B. How are drugs developed?C. What is involved in studies into finding the recommended dose for a medicine?D. What ethical, legal and socials aspects are involved in the development of drugs?E. At what stage of drug development are the researchers close to you? Do news items on advances in research create false hope?F. Do you think that the stages of testing for drugs should also be applied to other substances such as alcohol or illegal drugs?G. Presentation of conclusions.

Two topics spread over 6 sessions

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Authors: Albert Poveda, INS Apel·les Mestres; Lluís Pagès Pons, year 10-11 and 5th year of secondary school teacher of biology and geology; Montse Colilles, INS Can Puig de Sant Pere de Ribes and Rosina Malagrida, Xplore Health coordinator.

Part of the Tandem project of the Catalunya-La Pedrera Foundation