3

testing
Clinical studies of Seretide were carried out with over 2,700 patients. A series of double-blind placebo-controlled studies (neither the people administering the medicine or the people receiving the medicine know which are the real and which are pretend drugs) was carried out in the US to test the usefulness and safety of Seretide. It was found that Seretide used via the single Accuhaler inhaler provides improved lung function in mild asthmatic patients and works faster as well as increasing the number of days patients are symptom-free compared with receiving the same doses of Severent or Flixotide alone. In separate tests, using the Asthma Quality of Life Questionnaire (AQLQ), Seretide was shown to improve overall healthrelated quality of life. Using a three-item sleep scale it was shown that patients experienced improvements in sleep scores. The results of these tests were presented at the annual conference of the American Academy of Allergy, Asthma & Immunology (AAAAI) in March 1999.

question

Discuss this with others in your class. If you were a patient suffering from a disease and asked to take part in a trial to test the effectiveness of a new medicine would you want to take the placebo drug?
You can find out more about Millennium Products by visiting this Design Council website www.sharinginnovation.org.uk

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designing the accuhaler

With advances in the treatment of asthma the number of fatalities will reduce.

In 1996 there were about 100,000 hospital admissions in the UK due to acute asthma and around 1,500 people died from the disease. In the US, there are more than 5,000 deaths from asthma each year.

Asthma can be a killer.

DESIGNING

research and development (r&d)

Developing a system for convenience of use is important because a simpler treatment will mean that users use the therapy correctly to keep their asthma under control. The Accuhaler (also known as Diskus) was the first asthma therapy to offer patients comprehensive asthma control in a single inhaler. Asthma therapy has developed a lot over the last decade, for example in recognising the usefulness of combining a long acting bronchodilator (e.g. Severent) with an inhaled corticosteroid (e.g. Flixotide). This is of benefit to more patients than an increased corticosteroid dose. The Accuhaler uses Seretide which acts as a bronchodilator, to make the muscles round the airways relax, and anti-inflammatory agents to reduce swelling and irritation in the airways. Approval The inhaler was first publicised in March 1998. Glaxo Wellcome applied to market Seretide in Europe a month later. Approval to market Seretide in Sweden was gained in September 1998. This was the first approval in the European Union. The Accuhaler was launched in March 1999. The rounded case of the Accuhaler fits comfortably in the hand and the pocket. This transparent model gives a clue as to the complexity of the mechanism.

question

Look at the shape of the Accuhaler. Discuss with others in your class what you think about the shape. Do you like it? Does it look like a friendly product that will be easy to use? Is it important for medical products to have an attractive modern appearance?

a multi-national company
Glaxo Wellcome spend more than 1 billion a year on research and development (R&D) involving more than 9,000 scientists and engineers. Almost half this is spent in the UK and over a third in the USA. They identify disease areas requiring medicines and develop ways of meeting these needs. As well as medicines, they develop innovative vaccines and diagnostics. Glaxo Wellcome have locations in more than 80 different countries divided into five regions world wide : North America; Latin America; Europe, Africa & the Middle East; Asia Pacific; Japan. The world-wide manufacturing and supply (WM&S) function operates 55 manufacturing sites in 33 countries. They employ over 18,000 staff, supplying around 400 products to customers and patients in 150 markets world wide. WM&S works with a wide network of external suppliers from around the world. 10 sites manufacture and supply most of the active ingredients. 40 sites produce the finished medicines. There are over 6,000 different packaging presentations.

" research
Find out the names of other companies that develop medicines. For each of the companies you identify, find out the following what medicines do they produce? where are the R&D sites? where are the manufacturing sites? how much do they spend on R&D how much government funding do they receive?