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
Open this folder and view contents8. Reviewing a new drug: is it a therapeutic advance?
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
Close this folder11. Organizational and legal issues
View the document11.1 Introduction
View the document11.2 Why does a drug bulletin need a structure?
Open this folder and view contents11.3 Different kind of structures
View the document11.4 How to deal with legal action
Close this folder11.5 Copyright
View the document11.5.1 Limits to copyright
View the document11.5.2 How is copyright created?
View the document11.5.3 How to use copyrighted material
View the document11.5.4 Fair use and quotes
View the document11.6 Further reading
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

11.5 Copyright

Copyright is the law that gives an author or artist ownership of his or her work. It protects against unauthorised use of their work and ensures a share of any earnings from the use of the work. It applies to all types of original expression including art, sculpture, literature, music, songs, choreography, crafts, poetry, flow charts, software, photography, movies, CDROMs, video games and graphic designs. It does not apply to ideas as such. For example, a plan for an article on a certain subject cannot be subject to copyright. It is the article itself that is subject to copyright not the idea behind it.

‘Moral rights’ in copyright law, are rights relating to a creator’s reputation in connection with his or her work. They are additional to, and separate from, the ‘economic’ rights associated with the work, such as the right to reproduce the work. The moral rights protect creators if:

• they are not attributed or credited for their work;
• their work is falsely attributed to someone else; or
• their work is treated in a derogatory way, e.g. by distorting it.

Unlike ‘economic rights’, a creator is not able to assign his or her moral rights. Even if the creator assigns all his or her economic rights in a work, s/he would retain the moral rights.

Spanish drug editor wins case brought by Merck, Sharp & Dohme

A victory for all independent drug bulletins was declared last week when Professor Joan-Ramon Laporte, the editor of Spain's Butlletí Groc, won a district court case brought against it by the pharmaceutical company Merck, Sharp & Dohme.

The multinational firm had sued the editor and the publisher of the bulletin, the Catalan Institute of Pharmacology, over an article that the bulletin had published in 2002. The company said that the article had contained false and inaccurate information about the trial of one of its drugs, the Vioxx gastrointestinal outcomes research (VIGOR) trial, which looked at the safety of its arthritis drug, rofecoxib.

The company had wanted a statement - which it had prepared - to be published in the bulletin and on the Institute's web site under Spain's 1984 "rectification" legislation, which allows anybody the right to rectify any information they consider to be incorrect and whose distribution could cause them harm.

However, the judge, Maria Victoria Salcedo, rejected the demands of the company, absolved Professor Laporte and the Institute, and demanded that the company pay the court costs.

In her judgment on 27 January, she said the contents of the bulletin were accurate as they were based on a series of articles published in journals such as the Lancet and the BMJ, which had mentioned the irregularities surrounding the publication of the VIGOR trial, including a commentary that had said the company knew of the cardiovascular risks in relation to rofecoxib and suggested a bias in the selection process of the trial.

However, one aspect of the bulletin's article was found to be not correct. Judge Salcedo said the institute had not supplied enough evidence to show that distorted information on rofecoxib had been submitted to the EU regulator, the European Agency for the Evaluation of Medicinal Products, unlike that presented to the US Food and Drug Administration. But she said this had taken up only a few lines in the bulletin's article, while the company's rectification text was twice as long as the article, making this disproportionate.

The judge also said the company's text did not limit itself to the contents of the article, and its coverage exceeded what it wanted rectified. The text said, for example, that rofecoxib had better gastrointestinal safety compared with other drugs, but the bulletin had looked only at cardiovascular risk; it had also claimed that Merck, Sharp & Dohme had an ethical tradition, but this too had not been questioned in the bulletin.

Professor Laporte said the judgment "echoes the international debate which took place (in the literature) regarding the irregularities in the VIGOR trial and the omission of cardiovascular adverse effects in Merck, Sharp & Dohme's promotional materials."

The Catalan Institute of Pharmacology said the judgment was a "victory for all those involved in independent information on medicines and therapeutics."

A spokesman for Merck, Sharp & Dohme said after the ruling, which the company is reviewing, that the bulletin's article was almost completely based on a commentary that appeared in the Lancet in 2002 (360:100-1) on the design and conduct of the VIGOR trial. It claims that there were several inaccuracies in the commentary, but a letter to the Lancet's editor spelling these out was not published.

Source: BMJ 2004;328:307 (7 February).

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