1. 1
   A pharmaceutical company has developed a new antibiotic, Drug X, aimed at treating a bacterial infection of the throat. Before Drug X can be prescribed, it must pass through preclinical testing, which uses cells, tissues and live animals to check that it is not toxic and that it works.

   (a)

   Which type of pathogen can antibiotics such as Drug X be used to treat?

   [1 mark]

   • ABacteria
   • BViruses
   • CProtists
   • DFungi

   (b)

   During preclinical testing, before Drug X is given to live animals, scientists first test it using which of the following?

   [1 mark]

   • AA placebo group only
   • BHealthy human volunteers
   • CPatients with the infection
   • DCells and tissues

   (c)

   The company also wants to develop a drug to treat a common cold, which is caused by a virus rather than bacteria. Explain why it is difficult to develop drugs that kill viral pathogens without also damaging the body's tissues.

   [2 marks]

   Total for question 1: 4 marks

2. 2
   A student is researching the history of medicine and finds that many traditional drugs were extracted directly from living organisms: aspirin from willow, digitalis from foxgloves, and penicillin from Penicillium mould. Most new drugs today, however, are made in a different way.

   (a)

   Which organism was penicillin originally extracted from?

   [1 mark]

   • AFoxglove
   • BWillow
   • CPenicillium mould
   • DA bacterium

   (b)

   The student reads that most new medicines today are no longer extracted from plants or microorganisms. How are most new drugs now produced?

   [1 mark]

   • AExtracted from foxgloves
   • BSynthesised by chemists
   • CExtracted from willow bark
   • DGrown from Penicillium mould

   (c)

   Describe one advantage of synthesising new drugs in a laboratory rather than extracting them from plants or microorganisms.

   [2 marks]

   Total for question 2: 4 marks

3. 3
   A new painkiller has passed preclinical testing and is now ready to begin clinical trials in humans. The company first gives a very low dose to a small group of healthy volunteers, before later testing higher doses on a larger group of patients who actually have chronic pain.

   (a)

   Describe how the clinical trial of this new painkiller should be carried out, from the healthy volunteers stage onward.

   [3 marks]

   (b)

   Later in the trial, some patients are given the real painkiller and others are given a placebo, without either the patients or the doctors assessing them knowing who received which, until the end of the trial.
   
   Explain why this type of double-blind trial, including the use of a placebo, is used, and why the results are published only after peer review.

   [4 marks]

   Total for question 3: 7 marks

4. 4
   A GP sees a patient with a flu-like illness caused by a virus. The GP does not prescribe antibiotics, explaining that they would not help and that overusing antibiotics more generally is a growing problem.

   (a)

   Explain why antibiotics would not be an appropriate treatment for this patient's viral illness, and evaluate the wider consequences for society of prescribing antibiotics when they are not truly needed.

   [6 marks]

   (b)

   The GP mentions that any new antibiotic would take many years and several stages of testing before it could be prescribed to patients like this one.
   
   Discuss the process of discovering and developing a new medicine, from its initial source through to being available for patients, and evaluate why this lengthy process is necessary.

   [6 marks]

   Total for question 4: 12 marks

End of questions