Starting or Strengthening a Drug Bulletin - A Practical Manual
(2005; 165 pages) View the PDF document
Table of Contents
View the documentPreface
View the documentHow the manual was produced
View the documentAbout ISDB
View the documentExecutive summary
Open this folder and view contents1. Introduction
Open this folder and view contents2. Rational use of medicines
Open this folder and view contents3. What are drug bulletins?
Open this folder and view contents4. Defining aims, target and type of bulletin
Open this folder and view contents5. Planning resources
Open this folder and view contents6. Planning bulletin production: schedules and timing
Open this folder and view contents7. The editorial process
Close this folder8. Reviewing a new drug: is it a therapeutic advance?
View the document8.1 Introduction
View the document8.2 When is a new treatment a therapeutic advance?
Open this folder and view contents8.3 Collecting evidence about the drug
Open this folder and view contents8.4 Evaluation in terms of efficacy, harm and convenience
Close this folder8.5 Judging the overall value of the drug
View the document8.5.1 Considering the new drug in the local and individual context
View the document8.5.2 Overall rating scales
Open this folder and view contents8.6 Cost
View the document8.7 What patients need to know
View the document8.8 References
Open this folder and view contentsAnnexe to Chapter 8: Evaluating harm
Open this folder and view contents9. Design and production
Open this folder and view contents10. Dissemination
Open this folder and view contents11. Organizational and legal issues
Open this folder and view contents12. Evaluating quality and usefulness
Open this folder and view contents13. Partnership and collaboration
Open this folder and view contents14. Keeping records and creating a memory
Open this folder and view contentsAppendix: Electronic sources of information
 

8.5 Judging the overall value of the drug

Each of the three criteria above cannot be considered in isolation. You will need to make a judgement about the net benefit from the new drug in the context of existing treatments. For example, a small increase in efficacy compared with the standard treatment may not be acceptable if the new drug also has a worse adverse effect profile; a new drug might seem safer, but only because there is less experience with it or perhaps because it is being used at a lower (and so less effective dose) than alternatives (see Box 8.5 for examples); the new drug might have a different safety profile (e.g. because it is excreted by the kidney rather the liver, or is involved in different kinds of interactions), and so it might be considered useful in certain well-defined circumstances.

Box 8.5. Judging the net benefit from a new drug

Example 1. Apparently safer, but also less effective

In a short-term clinical trial, etodolac (a nonsteroidal anti-inflammatory drug first marketed in 1986 in the UK), was reported to cause less damage to the stomach than naproxen. But later the UK Drug Safety Research Unit (DSRU), using a Prescription-Event Monitoring system, rated etodolac effective in only 56% of 9109 patients. The DSRU concluded that the average daily dose of etodolac (400mg) was too low to be effective.17

Example 2. Trading in one type of adverse effect for another

Coxibs seem possibly less likely than conventional nonsteroidal anti-inflammatory drugs (NSAIDs) to cause dyspeptic-type symptoms and are associated with fewer endoscopically visible gastroduodenal ulcers or erosions. Epidemiological data also suggest a lower likelihood of upper gastrointestinal bleeding with celecoxib than with conventional NSAIDs. However, long-term outcome studies have not demonstrated a significant reduction in major ulcer complications (such as bleeding or perforation) with celecoxib compared with commonly used NSAIDs. An important unexpected finding of the VIGOR study was a significantly higher incidence of myocardial infarction with rofecoxib than with naproxen. Also, as experience with the recently withdrawn rofecoxib has demonstrated, there may be a 'trade-off' between better gastrointestinal tolerability with coxibs and a possible increase in the risk of serious cardiovascular events.

Source: Taking stock of coxibs. Drug and Therapeutics Bulletin 2005;43:1-6.

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