Why Was the Database Developed?

The impetus for a major project on pharmaceutical promotion originated at the May 1999 meeting of the WHO/public-interest NGO Roundtable on Pharmaceuticals. Unethical and inappropriate drug promotion has been a continuing concern of both NGOs and the WHO. At the 1997 Roundtable on WHO's Ethical Criteria for Promotion of Medicinal Drugs there was firm agreement that inappropriate promotion of medicinal drugs remains a problem both in developing and developed countries. The Report by the Director-General to the 49th World Health Assembly (A49/4), section III Revised Drug Strategy, para 5 states:

“There continues to be an imbalance between commercially produced drug information and independent, comparative, scientifically validated and up-to-date information on drugs for prescribers, dispensers and consumers.”

Although there is an abundance of information about drug promotion it had never been fully documented and as such organizations, government bodies, individuals and others were restricted in their ability to access the breadth of knowledge that had been accumulated, to analyze it, to learn from it and to expand on it. With these limitations in mind the people planning the project formulated a number of objectives:

• document the volume of inappropriate drug promotion in developing and developed countries;
• document the impact of inappropriate promotion on health;
• identify topics that are not covered by present studies;
• formulate recommendations for needed research;
• provide information about tools that can be used to teach health
  professionals about drug promotion;
• provide tools to monitor drug promotion;
• promote networking of groups and individuals concerned about promotion by providing links through the website.

This database is the first phase of the promotion project. The goal was to collected and analyze as wide a range of material as possible that described, analyzed, reported on or commented on any aspect of pharmaceutical promotion. (Advertisements for drugs were not included unless there was a commentary on the advertisement, either positive or negative).

 

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Who Developed The Website and Database?

The development of this website was co-ordinated by the WHO Department of Essential Drugs & Medicines Policy and Health Action International Europe. The information in the database is published under the technical responsibility of Dr Joel Lexchin, a drug promotion expert from Toronto. A number of other drug promotion experts were involved in the design of the database, namely Dr. Peter R. Mansfield (Healthy Skepticism,Australia), Barbara Mintzes (Canada) and Charles Medawar (Social Audit,United Kingdom). Zulham Hamdan, Universiti Sains Malaysia, designed and maintains the website.

 

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How Was Material Gathered?

 For this project, promotion was broadly defined using the WHO definition:

“all informational and persuasive activities by manufacturers, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs.”

As always, when applying a definition there are some subjective decisions about whether any particular piece of material falls within or outside of the definition. As an example, a journal article that discussed biases in research funded by pharmaceutical companies was considered promotion since this study could be used by firms to induce doctors to prescribe a particular medication. On-the-other hand, if a study only documented the percent of irrational drug combinations that were available in a market then it was not considered to be relevant for the purposes of this database. 

Material on promotion was sought from:

• Articles, letters and news stories in medical and other journals; 
• Magazine articles;
• Articles from drug bulletins/newsletters;
• Unpublished reports/studies;
• Videos;
• Radio/TV reports where transcripts are available;
• Theses;
• Guidelines from organizations and professional bodies;
• Books and chapters from books.

In this initial phase only material in English has been included but there are plans to expand the database to cover material in French and German. 

Material for inclusion in this study was identified from a MEDLINE search covering the period January 1, 1970 to April 30, 2002 and from material in the private library of the primary author. Additional articles, etc. were found by scanning the list of references in the items found through the MEDLINE search, through contacts in the E Drug discussion group and from other experts in drug promotion. The 1970 cut off date was chosen to allow users of the database to be able to identify trends in different aspects of promotion and the analysis of promotion without at the same time including material that is so old as to be irrelevant.

Material was only included if it was possible to currently obtain the item. Therefore, unpublished material was excluded if there was no contact address available, if magazines were no longer being published articles from them were not used, etc.

All material that fit the criteria outlined above was included irregardless of who produced it, i.e., government, industry, NGOs, etc.

 

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What’s In the Database and How Are the Entries Categorized

Currently the database has 2178 entries. Each entry is described by either its methodology and/or the nature of the entry. The following “descriptors” are used for this purpose:

abstract
analysis (this is a general term for any entry that provides an
“analysis” about some aspect of promotion)
analytic survey
bibliography
cohort study
content analysis
controlled trial
cross-sectional study
editorial
educational intervention
ethnographic description
feature story (in a magazine or newspaper)
government report
guideline
interview
letter to the editor
linguistic analysis
longitudinal study
mathematical modeling
meta-analysis
news story (can be in a medical journal, magazine, newspaper, etc.)
noncomparative trial
nonsystematic review
participant observation
policy statement (from an organization)
randomized controlled trial
retrospective observational study
review
systematic review

An entry can have more than one descriptor. For instance, an abstract can report on the results of a systematic survey or a letter to the editor can report on an analytic survey. Each entry has a number of “keywords” that describe the contents of the entry. These keywords are in the Keyword field. Descriptors are the first term in the keyword field and are identified because they have an * before them. The second item in the keyword field is the country or countries that entry applies to. There can be more than one country. If the entry applies to a larger geographic area, e.g., Southeast Asia, then that term appears. If the country or area is in the developing world then the next keyword is “developing countries.” If the entry reports on promotion in a developed country then the next keyword is “developed countries.” The rest of the keywords help to describe the content of the entry.

Besides fields for Author, Title and Keyword, entries may have some or all of the following fields:

Medium designator: This field has the “descriptor” for the entry. The descriptor is entered twice, once in this field and once in the keyword field to make it easier for users to identify the type of entry.

Notes: This field is used for a variety of purposes:

1. To identify a potential conflict-of-interest related to the entry, e.g. if the author works for a pharmaceutical company;
2. To cross-reference entries that are related, e.g., letters to the editor regarding an article; editorials about an article, etc.;
3. To denote where an entry was originally published;
4. To note that the author is the head of an organization such as a regulatory authority or the editor of a journal;
5. To note that most of the material in the entry does not deal with promotion;
6. For the Methodology note—see further on in this Introduction for an explanation about the Methodology Note.

Availability/address: If the entry will not be easily available in a medical or other library then the following is entered: address of the publisher or organization producing the material along with a telephone and fax number and an e mail address.

Location/URL: If the publication or organization has a web site then it is entered here. For journal articles the web site is only included if the full article is available on-line.

Abstract: Each entry has an abstract. If journal articles already had an abstract then it was reproduced in this field. For entries without an abstract one was written.

As mentioned above the Notes field also includes a Methodology Note. The methodology note is reserved for entries that generated new data or that had specific methodologic designs (analytic survey, cohort study, content analysis, controlled trial, cross-sectional study, linguistic analysis, meta-analysis, randomized controlled trial, retrospective observational study, systematic review). The aim of the methodology note is to point out potential weaknesses in the way the study was carried out and limitations in the generalizability of the results.

Finally, each entry was put into one or more Groups depending on the content of the entry. The list of groups is included in the keyword field and can be identified because the name of the groups is capitalized.

 

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Updating the Database

Currently, the database contains just under 2200 entries that covers
virtually all major material on drug promotion that was produced up until
May 2002. Work is currently underway to include an additional 450
supplementary entries. It is expected that this work will be completed by
the mid 2003. Once this material has been entered the database will be
updated on a regular basis.

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Help when using the Database

At the right hand side of the Home screen there is a “Help” button which explains the techniques of searching on Reference Web Poster.

To help people use the database, step-by-step instructions are included. To access these, click on "How to do a Quick Search".

 

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News and Comments Sought

You are invited to submit any interesting article or news on drug promotion, or comments on entries in the database, to the webmaster. We also welcome comments on how you think this web site can be improved.

 

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