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1ISDB Newsletter Vol. 17 No. 2 July 2003

President’s report

Contents

International Society of Drug Bulletins

NewsletterVolume 17 Number 2 July 2003www.isdbweb.org

ISDB CommitteePresidentJoe CollierDrug and Therapeutics BulletinUnited [email protected]

SecretaryMaria FontDialogo sui [email protected]

TreasurerAndrea TarrDrug and Therapeutics BulletinUnited [email protected]

Gita FernandoSri Lanka PrescriberSri [email protected]

Etzel [email protected]

Rokuro [email protected]

Mary Hemming (newsletter editor)Therapeutic Guidelines [email protected]

Ksenija Makar-AuspergerBilten o lijekovima and [email protected]

José Maria Récalde-ManriqueBoletin Terapéutico [email protected]

Walter ThimmeDer [email protected]

The International Society of DrugBulletins (ISDB) is a worldwidenetwork of publications on drugs andtherapeutics that are financially andintellectually independent of thepharmaceutical industry.

Apart from official reports of the society, the views expressed in this newsletter are solelythose of the individual authors and do not necessarily reflect the position of the society.

© 2003 International Society of Drug Bulletins

Joe Collier [email protected]

President’s report 1

Secretary’s report 2

Treasurer’s report 2

Coordinator’s report 2

Brief outline of the work and 3workings of ISDB

Minutes of the executive group 5meeting, 14 March 2003

Drug marketing and irrational 8drug use in developing countries

Global harmonisation of drug 10registration requirements: atechnical and political issue

Media round-up 12

ISDB Europe Regional Workshop 14

In my report to the society in the last issue ofthe newsletter, I said that the byword for mypresidency would be ‘consolidation’. Theprocess of consolidation has now started,and inevitably it is taking time.

Plans are well underway to establish an‘independent’ group to review our constitution(see ‘Revision of the constitution’ on page 7).Darko Vrhovac has agreed to chair the group,and Etzel Gysling will be one of its members.Final details of the membership, and of thegroup’s terms of reference, will be agreed ata meeting of the full ISDB committee inLondon on 17 and 18 September this year.

There have been important developmentsregarding the completion of the ISDBmanual on ‘Starting or strengthening a drugbulletin’. The present plan is that a smalleditorial team composed of 4 or 5 ISDBmembers will work on the chapters alreadysubmitted with the aim of ensuringconsistency, clarity and useability. Eachchapter will then be posted on the society’swebsite for comment.

Once the comments are in, we aim topublish a pilot version of the manual jointly

with WHO. Our target publication date isApril 2004, which will coincide with a WHO-sponsored meeting (ICIUM-2) taking place inChiang-Mai, Thailand. There would then bewide consultation on the pilot version, andthe comments received would be used in theproduction of a definitive version of themanual to be published sometime in late2004. This definitive manual will be availablein hard copy and as a PDF file. DanielleBardelay, Andrew Herxheimer, Rokuro Hamaand Andrea Tarr have already agreed to bemembers of the editorial team, and terms ofagreement determining our relationship withWHO on this project are all but complete.

Arrangements have also been made for ameeting between ISDB and WHO with theaim of establishing our areas of commoninterest and exploring how (in addition to themanual project) we can work together togreatest mutual advantage.

The meeting has been planned in discussionwith Hans Hogerzeil (Team Coordinator,Policy, Access and Rational Use, WHO) andis scheduled to take place in Geneva onFriday 3 October.


In contrast to these ‘positive’ developments,it saddens me to announce that in Marchthis year, and after 12 years in print, theMedicines Information Bulletin, published inNew Zealand by the National PreferredMedicines Centre (PreMeC), ceasedpublication of new material (old material willstill be available on its website, at least forthe time being). Closure occurred becausePreMeC’s main contract was not renewed byPHARMAC, the government’s drug-fundingagency. When I discovered that closure waslikely, I wrote to PreMeC as ISDB President,saying:

It is with great regret that I learn of thepossible demise of the MedicinesInformation Bulletin, an active member ofthe International Society of Drug Bulletins(ISDB). The sort of independentinformation provided by the MedicinesInformation Bulletin is not a luxury, but anasset hard earned and hard to come by. Ittakes years to reach the sort of positionachieved by PreMeC, and I ask that alloptions are explored before any decision ismade that might lead to its closure.

I was able to write this note because I knewPreMeC ‘s work well (I had visited its officein November 2002), and knew how itspublication fully reflected ISDB’s values.

Clearly we should strive to ensure that thesociety can have a similar feeling of securitythat all its members reflect ISDB ideals.Displaying the ISDB logo carries a guaranteethat the material published meets establishedhigh standards. It is for the society tounderwrite that guarantee. To this end, at itsSeptember meeting the committee will bedeveloping ways of regularly reviewing themembership to ensure ongoing eligibility.

It was for Josef Tukker to head up this review,but sadly he has left Geneesmiddelenbulletinand so has resigned from his post as societyand membership secretary. In the short timeJosef has been secretary, he has proved amost valued colleague and I am sorry thathe has had to leave. Nevertheless, we mustmarch on, and it gives me great pleasure towelcome in his place Maria Font (Dialogo suiFarmaci, Italy). Apart from being secretary tothe society, she will, as membership secretary,lead the membership review.

Finally, I need to remind members that at theSeptember meeting of the committee we willbe deciding on the venue of the 2005 GeneralAssembly. If you want to be considered as apossible host, we will need to have yourletter of application by Monday 25 August 2003(see ‘Secretary’s report’ in the next column).

Reminder: Call for bids tohost the 2005 Workshop andGeneral AssemblyAfter the first General Assembly in Stockholmin 1986, subsequent assemblies were heldin Mannheim in 1989, Tokyo in 1992,Granada in 1996, Amsterdam in 1999, andDubrovnik in 2002.

All member bulletins of ISDB are invited tomake a bid for organising and hosting theWorkshop and General Assembly in 2005.The committee would highly recommend acountry outside Europe, and preferably acountry with visa rules that are easy to complywith for participants from developing countries.It should be remembered that ISDB is aworldwide organisation and that so far themajority of the meetings have been in Europe.

The bid should include the following:

• venue location

• venue features and services

• site accessibility (by air, car and train)

• suggested accommodation (includingproximity to the venue)

• experience of the local staff in organisingsuch a meeting

• estimated costs (preferably in US$).

The meeting should take place in July, Augustor September of 2005. Please submit yourletter of application to my successor, MariaFont ([email protected]), byMonday 25 August 2003. The final decisionwill be made by the full committee at itsmeeting in September.

Secretary’s reportJosef Tukker

Coordinator’s reportAndrea Tarr [email protected]

Regional meetingsISDB Western EuropePharmacovigilance Workshop

A meeting in western Europe is beingplanned for 31 October–1 November 2003 inBerlin, Germany, on the topic ‘Getting themost out of pharmacovigilance’. Theprogram for the workshop is on page 14.

Middle East & West Asia Region

A meeting/workshop is being planned formembers in the Middle East & West Asiaregion, to take place in Kathmandu, Nepal,on 19-21 February 2004. This will replacethe regional workshop that was being plannedfor December 2003 in Colombo, Sri Lanka,but which unfortunately had to be cancelledfor local reasons.

The program for the meeting/workshop inKathmandu will be announced later this year.To register your interest in attending, pleasecontact Bimal Shrestha, Drug Bulletin ofNepal, at [email protected].

If you are interested in organising an ISDBmeeting/workshop in one of the otherregions (Africa, America, East Asia & Pacific,or Central & Eastern Europe), pleasecontact Andrea Tarr. See ‘Future meetings’on page 5 for further details.

Committee meetingsA committee meeting is planned for 17-18September in London. A draft agenda isbeing prepared by the executive group andwill be emailed to all members of the societyfor their input.

Newsletter submissionsThe third issue of the newsletter for 2003 willbe published in November. The deadline forcontributions is 30 September.

Please forward submissions or enquiries toMary Hemming at [email protected].

Andrea Tarr [email protected]

ISDB membership feesRecently, you should have received arequest for payment of the ISDB membershipfee for 2003. Thanks to all the members whohave paid promptly. Payment of the fee isnecessary in order to remain a member or arecognised correspondent of ISDB. Thereare three categories of ISDB membershipto ensure that there is no financial barrier tomembership of the society and, for thoseunable to pay, it is possible to apply forexemption.

Treasurer’s report


IntroductionThe International Society of Drug Bulletins(ISDB) is a worldwide network of bulletins ondrugs and therapeutics which are financiallyand intellectually independent of thepharmaceutical industry. Founded in 1986with the support of the World HealthOrganization (WHO) Regional Office forEurope, the overall aim of ISDB is toencourage and assist the development ofindependent drug bulletins worldwide and tofacilitate cooperation amongst them.Independent drug bulletins are recognisedas an important tool in promoting rationaldrug use.

Membership of ISDBISDB has two categories of members: fullmembers and recognised correspondents.Full members fulfil the criteria set out in theconstitution. That is, they must:

• adopt editorial procedures and anorganisational structure that will, in theopinion of the committee or the societyin general meeting, ensure theirindependence and the quality of theircontent

• contain no advertising relating totherapeutic or diagnostic activities

• allow the quality of their contents and theindependence of their editorial system tobe periodically assessed by the society.

Recognised correspondents are either drugbulletins that fulfil some but not allmembership criteria, or are bulletins,organisations or individuals that simplysupport the goals of ISDB.

There are currently 56 full members and 29recognised correspondents from 48countries (see below). Membership isdiverse not only in terms of organisationalcharacteristics, but also in terms of the typeof content and frequency of publication.Organisationally, there is variation in age,structure, circulation figures and funding. Forexample, some bulletins receive financialand practical support from governmentdepartments, while others rely totally onprivate subscription. With respect to content,some publications focus on very specificissues (eg adverse drug reactions orpoisoning), while others publish articles on awide range of topics, such as diseasemanagement, therapeutic choices and policyissues.

Management of ISDBbusinessThe society is run by a committee, themembers of which are appointed by electionat the 3-yearly general assembly. Inexceptional circumstances committeemembers can be coopted.

For the period 2002–2005, the committeemembers are:

• Joe Collier (Drug and TherapeuticsBulletin, United Kingdom)—president

• Josef Tukker (Geneesmiddelenbulletin,The Netherlands)—general secretaryand membership secretary (succeededby Maria Font in July 2003)

• Andrea Tarr (Drug and TherapeuticsBulletin, United Kingdom)—treasurer

• Gita Fernando (Sri Lanka Prescriber, SriLanka)

• Maria Font (Dialogo sui Farmaci, Italy)—webmaster (and general secretary andmembership secretary from July 2003)

• Etzel Gysling (Pharma-kritik, Switzerland)

• Rokuro Hama (Kusuri-no-Check, Japan)

• Mary Hemming (Therapeutic Guidelines,Australia)—newsletter editor

• Ksenija Makar-Ausperger (Bilten olijekovima & Pharmaca, Croatia)

• José Maria Récalde-Manrique (BoletinTerapéutico Andaluz, Spain)

• Walter Thimme (Der Arzneimittelbrief,Germany)

The primary aims of the committee are tohelp strengthen the work of establishedbulletins, to bring new bulletins into themembership, and to empower bulletins toinfluence local practice in the use of drugsand therapeutics.

Brief outline of the work and workings of ISDBAndrea Tarr [email protected]

This paper has been prepared as a ready-to-use summary of information that members of the society can use to inform other organisations andindividuals about ISDB. If you wish to have the paper in electronic format, please contact Andrea Tarr.

Countries in which there are ISDB member bulletins, presented by region

AFRICA AMERICA EAST ASIA & PACIFIC MIDDLE EAST & WEST ASIA CENTRAL & EASTERN EUROPE WESTERN EUROPE

Burkina Faso Canada Australia India Armenia Austria

Eritrea Nicaragua China (Hong Kong) Israel Bosnia & Herzegovina Belgium

Ghana Panama Indonesia Nepal Croatia France

Kenya Peru Japan Pakistan Czech Republic Germany

Madagascar USA Malaysia Sri Lanka Estonia Italy

Nigeria New Zealand Latvia The Netherlands

Zimbabwe Philippines Lithuania Norway

Singapore Moldova Spain

Poland Sweden

Republic of Georgia Switzerland

Romania United Kingdom

Slovenia


The day-to-day business of the society iscarried out by an executive group of thecommittee, consisting of the president,secretary and treasurer. The society employsa coordinator (Andrea Tarr) for half a day perweek, whose responsibilities includecoordinating communication within thecommittee and the society. Regionalcoordinators (to represent the 6 ‘regions’ ofthe world) will be appointed from thecommittee later this year. They will beexpected to play a crucial role in theconsolidation and expansion of theorganisation, for example by providing helpwith identifying new members, evaluatingcurrent members and new applicants,organising regional meetings, and assistingwith contacting bulletins in the region.

Sources of fundingThe primary sources of funding for ISDB arethe annual membership fees and members’donations. The membership fee is not fixed,but is a suggested amount (ranging from £5to £600) based on the member’s overallbudget. Members who cannot afford to payeven the lowest rate can apply forexemption. The total annual income of thesociety is around £10 000. Other funding,which has traditionally been on an ad hocbasis, has come from WHO or, for thegeneral assembly, from local bodies (egministries, city councils).

Work of the societyNewsletter

ISDB publishes a newsletter to informmembers of the society’s business. It isdistributed free-of-charge by email (and bypost to those who have no Internet access)to all members and recognised correspondents.It is planned to publish three issues per year.The newsletter is edited and prepared onbehalf of ISDB by Mary Hemming(Therapeutic Guidelines, Australia).

Website (www.isdbweb.org)

The constitution, a list of members, links tomembers’ websites, and details about howto join the society are available on the ISDBwebsite. The website is maintained on behalfof the society by Maria Font (Dialogo suiFarmaci, Italy).

Meetings

Since it was established, ISDB has heldregular meetings (see below). There areseveral different styles of meeting: general

assemblies; regional and local workshopsdealing with various issues for establishedand new bulletins; formal training courses;and meetings to develop ISDB policy.Several meetings have received financialsupport from WHO (eg East Asia & Pacificregional meeting, 1997; Central & EasternEurope regional meeting, 1998).

Past meetings

1986 Stockholm, SwedenGeneral assembly and workshop

1989 Mannheim, GermanyGeneral assembly and workshop

1991 Reggio, ItalyWorkshop

1992 Algiers, AlgeriaWorkshop

1992 Tokyo, JapanGeneral assembly and workshop

1994 Budapest, HungaryWorkshop

1995 Manila, PhilippinesRegional meeting

1996 Granada, SpainGeneral assembly and workshop

1997 Penang, MalaysiaRegional meeting

1998 Riga, LatviaRegional meeting

1999 Amsterdam, NetherlandsGeneral assembly and workshop

2000 London, UKEditors’ training course

2001 Paris, FranceWorking group meeting

2002 Dubrovnik, CroatiaGeneral assembly and workshop

General assemblies

The meeting of all the full members (thegeneral assembly) is the governing body ofthe society. ISDB holds a general assemblyevery 3 years at which members elect a newcommittee and make other decisions aboutthe society. The general assembly is usuallycombined with a series of workshops atwhich members meet and exchange ideasand information.

Regional and local workshops

These meetings provide an opportunity forparticipants to exchange experiences andacquire the skills necessary to develop andrun a high quality drug bulletin. At thesemeetings, people working on well-established bulletins can share theirexperience with those starting new ones.

For example, the Central and EasternEurope regional meeting in Riga, Latvia, in1998 involved around 35 participants fromArmenia, the Czech Republic, Slovenia,Poland, Croatia, Kazakhstan, Kyrgizstan,Moldova, Estonia, Tajikistan, Bosnia andHerzegovina, the Netherlands, France, andthe UK. Participants discussed ways tostrengthen the regional network and improvethe quality of drug information in order topromote the essential drug concept andrational use of drugs. Workshops focused onpractical skills, such as the development ofan editorial policy, improvement of thereadability of a drug bulletin, independenceand financial sustainability, access to reliablesources of information, and cooperation insharing these sources, for example by usingelectronic communication. Participants alsoanalysed different ways to start a new drugbulletin, given the scarcity of resourcesavailable in the region. They agreed ondifferent methods of cooperation and mutualsupport that would play a significant role inproviding independent information on drugsfor health professionals and consumers.

Training courses

An editors’ training course was held inLondon in 2000. Six editors, from drugbulletins in Sri Lanka, Romania, Lithuaniaand Germany, attended. The course coveredthe responsibilities of members of the team;deciding on the topics of articles; choosingand commissioning external authors; theconsultation process; editing; verification;sources of information; and different types ofevidence.

Meeting to develop ISDB policy

During 2001, editors from severalestablished bulletins collaborated in aworking group to deliberate on the issue of‘What is a real innovation in the use ofmedicines?’ This work culminated in ameeting in Paris and publication of the ‘ISDBdeclaration on therapeutic advance in theuse of medicines’ (the Paris declaration).This document is available, in severaldifferent languages, on the ISDB website.

Ad hoc visits and support

To support the development of new drugbulletins, several ISDB members havehosted visits from editors starting newbulletins to help them gain experience.Some established bulletins provide supportto developing bulletins (eg Prescrire, aFrench member bulletin, supports bulletins inFrench-speaking African countries, includingAlgeria, Burkina Faso and Madagascar).


Future meetings

It is expected that at least one meeting willbe organised in each ISDB region during thenext 2 to 3 years. ISDB has allocated fundsto help support these meetings: a total ofaround £6000 to help support five regionalmeetings during the years 2003–2005, andaround £10 000 for the General Assembly in2005. For a regional meeting to be eligiblefor ISDB funding, it must involve the activeparticipation of at least five ISDB members,of which at least four are based in the regionitself. Moreover, the organisers will need toproduce a report of the meeting with someassessment of the participants’ views of themeeting’s content, perceived value,organisational arrangements, and so on.Once funding is agreed, the money will beguaranteed, with up to 25% paid in advance.

A meeting in western Europe is beingplanned for 31 October–1 November 2003 inBerlin, Germany: the ISDB Western EuropePharmacovigilance Workshop—Getting themost out of pharmacovigilance (see pages14 and 15).

A workshop in the Middle East & West Asiaregion is being planned for 19-21 February2004 in Kathmandu, Nepal (see theCoordinator’s report on page 2).

Manual on ‘Starting orstrengthening a drug bulletin’

Apart from the meetings organised by ISDBand the informal contacts betweenmembers, there are few opportunities forpeople working on independent bulletins toshare experiences. There is also a lack ofwritten information about the work of drug

bulletins. This means that it is difficult forthose involved in new bulletins to benefitfrom the work of others. To fill this gap, aproject to develop and publish a manual on‘Starting or strengthening a drug bulletin’ wasstarted in 1998 by ISDB in collaboration withWHO. The original aim of the manual was todraw from the experience of those involvedin independent drug bulletins and to presentthat experience—and reflect the diversity tobe found among bulletins—in the form of apractical tool to help those involved instarting a new bulletin, or to help strengthenan existing bulletin.

Unfortunately, work on the manual ceased inSeptember 1999. However, the ISDBcommittee has now arranged for work on theproject to be resumed, and it is expectedthat the manual will be published in 2004.

Minutes of the executive group meeting14 March 2003, Drug and Therapeutics Bulletin Office, LondonThe draft agenda had been mailed to all members of the committee 3 weeks prior to the meeting. Responses were received from Gita Fernando, MariaFont, Etzel Gysling, Mary Hemming, Ksenija Makar-Ausperger, José Maria Récalde-Manrique, Walter Thimme, and were, as appropriate, eitherincorporated as a redrafted agenda or considered in discussion.

Present: Joe Collier (president), Josef Tukker (secretary), Andrea Tarr (treasurer)

Report of activities since lastmeetingThe president• visited Berlin and met the editors-in-chief

of the 4 German member bulletins

• met with Kathy Holloway (MedicalOfficer, Department of Essential Drugsand Medicines Policy, WHO) in Londonin January, and with Hans Hogerzeil(Team Coordinator, Policy, Access andRational Use, WHO) in London inFebruary. A report of the meetingprepared by Hans Hogerzeil isreproduced in Appendix 1 on page 7

• after hearing that PreMeC (a memberbulletin in New Zealand) was threatenedwith closure, and following discussion byphone and email, the president sent aletter in support of PreMeC to PatriciaLogan, its general manager. The letterwas used in PreMeC’s ‘survival’campaign

• prepared president’s report for thenewsletter.

The secretary• contacted several potential new members

in Bulgaria, Romania, Tanzania andKyrgyzstan

• continued work on current membershiplist, particularly concentrating on issuessurrounding incorrect entries

• prepared secretary’s report for thenewsletter.

The treasurer• prepared the financial report for 2002,

and a draft budget for 2002–2005

• prepared treasurer’s report fornewsletter.

The coordinator• attended the meeting with Joe Collier

and Kathy Holloway in London

• drafted a proposal for completing theISDB manual, ‘Starting or strengtheninga drug bulletin’, and contacted all originalauthors setting out the proposal andasking if they would be prepared to bringtheir chapters up to date.

Review of roles/titlesMembership secretary

It was noted that the constitution requiresthat there should be a membership secretaryresponsible for membership issues. It isproposed that Josef Tukker formally takeson this role, and so becomes membership

secretary as well as general secretary. Assuch he will be responsible for managing thereview of members and evaluation of newmembers, as well as keeping themembership list up to date. It is envisagedthat the role of membership secretary willinvolve a considerable amount of work.Assistance with the work would be neededfrom the ISDB coordinator and from regionalcoordinators, when identified.

ISDB coordinator

It was felt important to clarify that thecoordinator is not a role represented on thecommittee. To this end, the list of roles of thecommittee originally circulated to membersafter the last meeting will need amending.If possible, this amended list would be theone that would appear in the forthcoming(March 2003) issue of the ISDB newsletter.

Executive group/executivecommittee

To avoid confusion, and to be fully consistentwith the written constitution of the society, itis proposed that the group consisting of thepresident, secretary and treasurer be namedthe ‘executive group’, rather than ‘executivecommittee’, which had been used previously.


‘Executive group’ will be the term used in theISDB newsletter.

Appointment of treasurerIt is a constitutional requirement that thesociety should have a treasurer, and that thetreasurer must be a member of thecommittee. It is also permitted under theconstitution that members can be cooptedon to the committee, although theconstitution does not stipulate mechanismsof, and eligibility for, cooption.

However, concerns have been raised thatcooption of Andrea Tarr as treasurer wascontrary to the constitution, particularly as itmeant that two members on the committeewould come from the same bulletin. This isan important issue and needs resolution.Accordingly the executive group wentthrough in detail the events and proceduresthat led to the present position. During theGeneral Assembly in Dubrovnik nobody fromthe newly elected committee was preparedto stand as treasurer. It was then agreed bythe society at large that Andrea Tarr couldcontinue as interim treasurer for 3 months.Towards the end of the 3 months, and afterfull consideration of constitutional issues,volunteers for treasurer were again soughtfrom the committee, with a note that AndreaTarr would be prepared to continue if namesdid not come forward. No volunteers wereforthcoming, so Andrea Tarr was formallyappointed as treasurer. Commensurate withthe duties of the post and its constitutionalrole, she was then coopted to the committee.The cooption followed full consultation bythe executive group with the membership ofthe committee.

Communication within ISDBIt was decided that this item, which was toconsider in detail how to facilitate ways ofcommunicating between members of ISDB,should be addressed by the full committee atits meeting in September 2003.

Regional coordinatorsThere is a requirement in the constitution forthe society to have regional coordinators(representing the 6 ‘regions’ of the world).They are expected to play a role in theconsolidation and expansion of theorganisation. It was proposed that regionalcoordinators be appointed from the committeeand their roles defined at the meeting of thefull committee in September 2003.

Suggested responsibilities for regionalcoordinators are:

• identifying new members

• helping evaluate current members andnew applicants

• helping organise regional meetings

• assisting in contacting bulletins in theregion.

Membership feesIt was decided that the treasurer should askall members to pay their 2003 fees as soonas the March newsletter (which contained anotice about fee collection) had beendistributed. A review of membership fees for2004 should be an item for discussion at theSeptember 2003 full committee meeting.

Regional meetingsA detailed agenda for the Berlin meeting hasbeen received. It was noted that Joe Collier,as president, would give a brief welcomingaddress. The group felt that the meetingproposals met the criteria for a regionalmeeting and so would make the organiserseligible for financial support from ISDB (up to£2000), if needed. Andrea Tarr will contactthe organisers about this.

The executive group was told that themeeting being arranged for Colombo hadbeen cancelled. The coordinator will explorepossibilities for there to be an alternativemeeting in the region during the same period.

Membership applicationsThe executive group proposes that all newapplications for membership are consideredby the full committee at the Sepember 2003meeting. So far, we have received one newapplication (from Kazakhstan). Josef Tukkerwill contact two US publications (MedicalLetter and Prescriber’s Letter) to askwhether they are interested in joining ISDB.

How can we identifypotential new members?The issue of identifying new members ofISDB will be put on the agenda for theSeptember 2003 meeting of the fullcommittee. This is a potential role forregional coordinators. Regionalrepresentatives of WHO may also be able tohelp identify new members. Joe Collier willask contacts at WHO for contact details ofregional officers.

The re-evaluation of currentmembersThis has already been identified as an itemfor discussion at the full committee meetingin September. Josef Tukker (as membershipsecretary) will develop a proposal for aprocedure for evaluating current members.This will be presented and tested at thecommittee meeting in September.

ISDB manual on ‘Starting orstrengthening a drug bulletin’The ISDB coordinator (Andrea Tarr) hadprepared an outline of a plan to revive theISDB manual project, which had begunseveral years ago in collaboration withWHO, but had stopped in 1999. Andrea Tarrhad contacted the original authors of themanual chapters, setting out broad plans forproceeding with a view to publishing themanual towards the end of this year. Theproposals had been warmly received by themajority of the authors—responses fromthose remaining would be sought.

Full committee meetingA full committee meeting is planned for 17-18September in London. It is hoped that anycommittee members who cannot attend willbe able to participate through telephoneconference or video link at some time duringthe meeting. A draft agenda for the 2-daymeeting will be prepared by the executivegroup and circulated to all other members ofthe committee for their input. Other membersof the society will be invited via email to makecomments or suggestions about themeeting.

Meeting with WHOIt is proposed that a group representingISDB meets in Geneva with members ofWHO’s Policy, Access and Rational Useteam (part of the Department of EssentialDrugs and Medicines Policy). The proposeddate for the meeting is Friday 19 September2003. This has yet to be agreed. A tentativeprogram has been proposed, but will besubject to discussion and negotiation withWHO. The contents of the ISDB side of themeeting will be finalised later, preferably atthe September committee meeting. Areasidentified for discussion are:

• What is ISDB and what is itsimportance?

• What does ISDB want from WHO?


• What can WHO gain from closer linkswith ISDB?

• How can ISDB and WHO collaborateand to what ends?

• the ISDB manual project.

Revision of the constitutionIt has been proposed to set up an‘independent’ expert group, made up ofmembers of the society, to review thecurrent constitution and advise on ways itmight be revised. The recommendations ofthe group would be presented to the GeneralAssembly in 2005. It is proposed that thefollowing people be invited by Joe Collier tobe members of the group: Bozidar Vrhovac,Etzel Gysling and John Dowden.

Summary of the proposals forconsideration by the fullcommitteea. That Josef Tukker formally becomes

membership secretary, as well asgeneral secretary.

b. That the group consisting of thepresident, secretary and treasurer will benamed the ‘executive group’ rather than‘executive committee’.

c. To set up an ‘independent’ expert group,made up of members of the society, toreview the current constitution andadvise on ways it might be revised.

(See Appendix 2 for the committee’sresponse to these proposals.)

Appendix 1. Report by DrHans Hogerzeil (TeamCoordinator, Policy, Accessand Rational Use, WHO) of ameeting with Joe Collier inLondon on 3 February 2003I met with Professor Joe Collier, newlyelected president of ISDB. ISDB has about56 members in 37 countries. It issues about3 newsletters per year. It has five regions;each region is supposed to hold one 2- to 3-day training meeting every three years.Once every three years there is a globalassembly; the next one is planned for 2005.Other office bearers are Josef Tukker(secretary) and Andrea Tarr (treasurer andISDB coordinator). The total budget isroughly US$15 000 per year.

Most outcomes of the earlier meetingbetween Dr K Holloway and Dr Collier wereconfirmed and do not need to be repeated

here. Especially, the following points werereconfirmed:

1. WHO is very willing to support ISDB,both technically and financially. A firstconcrete moment could be the plannedregional training meeting in Sri Lankalater in 2003; this will be discussed withKris Weerasuriya from WHO/SEARO(South East Asia Regional Office). WHOcould perhaps contribute by funding asmall number of extra participants, or aWHO resource person.

2. The work on the draft manual onestablishing and running a drug bulletinin developing countries will be taken upagain. ISDB will prepare and discuss aplan for finalisation of the manual at itsnext committee meeting in March andwill submit this plan to WHO soon after.WHO is eager to see the manualcompleted.

3. Joe Collier and other members of theISDB committee intend to visit Genevain September to present ISDB, and thecase of drug bulletins in general, toWHO colleagues and discuss furthercollaboration.

4. ISDB could send a delegation to ICIUM-2 in April 2004 in Chiang-Mai, Thailand,to present recent developments and anyresearch on drug bulletins in developingcountries.

5. ISDB would like to be involved and/orconsulted on important WHO policiesregarding bulletins and drug information.

Appendix 2. ISDB committeemembers’ responses toexecutive group proposalsa. That Josef Tukker formally becomes

membership secretary, as well asgeneral secretary.

Agree: 10No reply: 1

b. That the group consisting of thepresident, secretary and treasurer will benamed the ‘executive group’ rather than‘executive committee’.

Agree: 10No reply: 1

c. To set up an ‘independent’ expert group,made up of members of the society, toreview the current constitution andadvise on ways it might be revised.

Agree: 9Disagree: 1Defer for discussion at full committeemeeting: 1


‘Children in the sights of thepharmaceutical industry’In 1995, BUKO Pharma-Kampagne,Germany, along with the Doctors’ Initiative ofTerre des Hommes, a non-governmentorganisation working for the worldwideimprovement of rights and living conditionsfor children, began a study of the drugs thatare promoted for use in children by Germanpharmaceutical companies.

The study focused on drugs being marketedto developing countries like India, Pakistan,Mexico, Brazil, Kenya, the Philippines andThailand. The results suggested that severaldrugs, including vitamin combinations, coughsyrups, antidiarrhoeals and appetitestimulants, were being marketed forirrational uses.

The researchers concluded that the Germandrug industry was contributing little to thehealth of children in developing countries. Infact, on several occasions the industryappeared to be causing more harm thangood, by encouraging people to spend theirmeagre economic resources purchasingtotally useless medicines.

BUKO Pharma-Kampagne decided topublish details of the study in order toexpose cases of inappropriate marketing byGerman pharmaceutical companies.

Drug marketing and irrational drug use in developing countriesGopal Dabade, BUKO Pharma-Kampagne [email protected]

This paper is based on a presentation given at the 2002 ISDB Workshop and General Assembly in Dubrovnik.

The paper was titled ‘Kinder im Visier derPharmaindustrie’ (Children in the Sights ofthe Pharmaceutical Industry).1

Three examples of drugs found to beinappropriately marketed for use in childrenwere Bayer’s Tonic, Bayer’s aspirin, andE. Merck’s pyritinol.

India: Bayer’s Tonic for‘rejuvenation and energy’ inchildren

Until recently, Bayer’s Tonic was marketed inIndia for ‘rejuvenation and energy’ forchildren. Each 15 mL of Bayer’s Toniccontains the following:

• liver fraction 2 (12 mg) derived from 300mg of fresh liver

• sodium acid phosphate I.P. 506 mg

• concentrated yeast extract 178.5 mg

• alcohol I.P. 1.65 mL

• flavoured syrupy base q.s.

The alcohol content of Bayer’s Tonic is10.5% (by volume) and Bayer recommendedthat it be taken three times daily. If given to amalnourished child, this could possiblyinitiate cirrhosis of the liver. The drug istherefore potentially very dangerous, asmost children in India are suffering fromsome degree of malnourishment or under-nourishment, depending on the economicstatus of the family.

Bayer’s Tonic isalso expensive.The money spenton buying a bottle(around 40 rupees,which is almost aday’s wage for aperson working ona farm) couldpurchase 1 kg ofvegetables, 1 kg ofrice, 1 kg ofcarrots, and 1banana. This foodwould be muchmore nourishingthan the contentsof a bottle ofBayer’s Tonic.

When this case was described in our BUKOPharma-Kampagne publication, Bayer wasquick to respond by saying that it would stopmarketing the drug for children and that itwould put a warning on the bottle saying‘Keep out of reach of children’. BUKOPharma-Kampagne’s objectives were notfully achieved, however, as the use of thedrug in adults is just as irrational as it is inchildren, although the danger to the liverwould be less.

The interesting point is that, althoughseveral other Bayer products were criticisedin the BUKO Pharma-Kampagne publication,the company only responded to the issue ofBayer’s Tonic, which has a huge market inIndia. Perhaps they believed that admittingtheir error would be better than letting anongoing dispute spoil the image of such aprofitable drug.

South America: Bayer’s aspirin forpain and fever in children

Bayer markets aspirin for use in children inseveral South American countries such asChile, Uruguay and Argentina. The fact thatReye’s syndrome is often associated withthe use of aspirin in children has been moreor less sidelined in the promotional materialof the pharmaceutical company.

Since 1988, Bayer has recommended inGermany that aspirin should not be used inchildren. However, the company hascontinued to promote the drug aggressivelyin developing countries for pain and fever inchildren, thus reflecting a double standard.

When approached about this dubiousmarketing practice, Bayer responded with adrawn-out battle of letters and face-to-facemeetings lasting almost three years. Theirmain argument was that BUKO Pharma-Kampagne and Terres des Hommes wereexaggerating the adverse effects of aspirin inchildren. But, when details of the case werefinally published in an attempt to expose thedouble-standard, the company was quick toreply. However, Bayer failed to explain why itcontinued to recommend aspirin for childrenin developing countries but not in developedcountries. Their contention was that therewas not much evidence for Reye’ssyndrome in developing countries.


India: E. Merck’s pyritinol as a‘memory miracle’ for children

Until recently, E. Merck promoted pyritinol(Encephabol) as a ‘memory miracle’ (or braintonic for memory and growth) for children inIndia.

The company has claimed that pyritinolimproves oxygen consumption and glucoseuptake by brain cells.2 Despite these claims,and despite the drug having been availablefor thirty years, pyritinol fails to receive amention in authoritative texts ofpharmacology.

In 1986, a paper on drug marketing in thedeveloping world in the Lancet reported that:

There is no scientific evidence for thisdrug’s efficacy. I have seen this drugprescribed for children with disabilitiesincluding cerebral palsy, mental retardation,epilepsy and behavioural problems inSyria, India, Sri Lanka, Malaysia,Singapore, and Indonesia.3

In 1987, the World Health Organization(WHO) Regional Office for Europe pointedout that the effectiveness of pyritinol had notbeen demonstrated.4

In 1988, the Medical Lobby for AppropriateMarketing (MaLAM) was unable to find asingle published clinical trial of the efficacyof pyritinol ‘for any indication’.5

BUKO Pharma-Kampagne highlighted E.Merck’s marketing of Encephabol in the

September 2001 issue of Pharma-Brief 6,the widely circulated bulletin on the Germanpharmaceutical industry, discussing one ofthe advertisements for the drug in India.

E. Merck responded by saying that it was a‘technical mistake’ that Encephabol waspromoted as a ‘memory miracle’ and that thesituation would be rectified.

Campaigning againstirrational drug use indeveloping countriesIt is unfortunate that promotional literatureaimed at developing countries oftenbypasses scrutiny by the regulatoryauthority, a problem made worse because:

• most drugs are available over-the-counter without a prescription

• many patients do not have enoughmoney to consult a doctor, so they oftenseek medical advice from a pharmacistinstead

• doctors mostly depend on informationsupplied by the drug industry, as there isno other source of information

• drug regulations are weak.

It is therefore up to organisations like BUKOPharma-Kampagne to challenge drugcompanies about cases of inappropriatemarketing and irrational drug use.

Unfortunately, these campaigns generallyproduce little change. Getting rid of anadvertisement containing inappropriateclaims is a positive step, but it will notnecessarily stop a drug being usedirrationally.

A more successful example of a campaignagainst irrational drug use is the case of thedrug Insogen Plus, a combinationantidiabetic manufactured by the Germancompany Byk Gulden. Insogen Plus containsphenformin, a drug that is banned inGermany and many other countries becauseof the risk of lactic acidosis. Nevertheless,Byk Gulden continued to promote and sellInsogen Plus in Mexico.

BUKO Pharma-Kampagne discovered thisdrug during their 1992 survey on Germandrugs in developing countries, which waspublished under the title ‘Zweite Wahl für dieDritte Welt’ (Second Quality for the ThirdWorld) in 1994.7

BUKO Pharma-Kampagne wrote to BykGulden about Insogen Plus but received noresponse. Then BUKO Pharma-Kampagne

was approached by a German televisionstation, which asked for a ‘bad example’from the survey of a drug that wasmanufactured by a German company andsold in a developing country. BUKO Pharma-Kampagne told the television reporters aboutInsogen Plus, and a documentary was shownshortly after on the regional news. BykGulden reacted immediately by asking for ameeting.

A few days later the same documentary wastelecast on the main nationwide newsprogram. The very next day BUKO Pharma-Kampagne got an urgent fax from BykGulden saying that they wanted to discussthe matter. BUKO Pharma-Kampagneagreed on the condition that Byk Guldenwould be willing to take appropriate actionfollowing the discussion. A few days laterBUKO Pharma-Kampagne received writtenconfirmation that Insogen Plus would bewithdrawn from the market in Mexico.

The lesson is that it can be useful toconfront pharmaceutical companies withcases of inappropriate drug marketing andirrational drug use, but only if there isenough public pressure to make them wantto act.

References1. Pichlbauer K, Will A. Kinder im Visier der

Pharmaindustrie. Bielefeld, Germany: BUKOPharma-Kampagne; 1995.

2. Encephabol prospectus. Darmstadt, WestGermany: E. Merck; 1986.

3. Hosking G. Drug marketing in the thirdworld. Lancet 1986;2(8499):164.

4. Rylance G. Drugs for children. Copenhagen:WHO Regional Office for Europe; 1987.

5. Medical Lobby for Appropriate Marketing.Letter to E. Merck. April 1988.

6. BUKO Pharma-Kampagne.Psychopharmaka für Kinder: UnethischeWerbung in der Dritten Welt. Pharma–Brief2001;(6):5-6 . Available from: http://www.bukopharma.de/Pharma-Brief/PB-Archiv/2001/phbf_2001_06.pdf.

7. Schröder M, Will A. Zweite Wahl für dieDritte Welt. Bielefeld, Germany: BUKOPharma-Kampagne; 1994. (A follow up studyis also available: Pichlbauer K, Pastor U,Rasti Z, Schaaber J, Tuschinsky C,Velbinger K. German drugs: poor choices forpoor countries. Bielefeld, Germany: BUKOPharma-Kampagne; 1999. Available from:http://www.bukopharma.de/English/english/poorchoices.htm.)

Aspirin for children: ‘Life goes on witha smile’


IntroductionIncreasing affluence in many areas,including Europe, North America, and theFar East, has led to the marketplacebecoming both more competitive and moreglobal. At the same time, there have beenmoves to reduce barriers to trade byharmonising many regulations, includingthose relating to pharmaceuticals. Theseefforts initially developed on a regional basis,with the EU (European Union) representingone example, and afterwards on an inter-regional basis, the ICH (InternationalConference on Harmonisation of TechnicalRequirements for Registration ofPharmaceuticals for Human Use) being aprominent example.

In addition, the creation of the World TradeOrganization signalled a drive towardsmarket harmonisation at the global level.Globalisation is leading to complexinterdependence of economies acrossnational borders, and gives rise to increasingconvergence of structures and attitudesbetween countries. However, the implicationsof globalisation for the pharmaceuticalindustry are just beginning to be understood.

A necessary prerequisite for globalisation isthe development of quality control systems.Developing these systems requires anincrease in spending on research anddevelopment; therefore, only thosecompanies that can afford to spend a largeproportion of their budget on research anddevelopment will reap the economic rewardsof globalised pharmaceutical standards.Transnational corporations, which havestrong financial and technologicalcapabilities, are highly competitive in theglobal market. Companies with weaker

Global harmonisation of drug registration requirements:a technical and political issuePatrice Trouiller, Ministry of Health, Antananarivo, Madagascar, and Neglected Diseases Group, Médecins Sans Frontières, Geneva,Switzerland [email protected]

Wilbert Bannenberg, Public Health Consultant, Health Research for Action, Reet, Belgium, and Neglected Diseases Group,Médecins Sans Frontières, Geneva, Switzerland [email protected]

Peter Folb, Department of Pharmacology, University of Cape Town, South Africa, and the World Health Organization CollaboratingCentre for Drug Policy [email protected]

This paper is based on a poster titled ‘Dissemination of high tech quality standards: regulatory imperialism?’, which was prepared by Ragnar Salmen,Kirsten Myhr and Patrice Trouiller, and a report commissioned by Médecins Sans Frontières titled ‘Legal and regulatory issues affecting drugdevelopment for neglected diseases: harmonization of technical requirements for registration of pharmacueticals for human use’, which was written byPatrice Trouiller, Peter Folb and Krisantha Weerasuriya and is available at www.accessmed-msf.org/ndg/documents.asp.

financial and technological capabilities areunable to compete. The danger is thatmeeting drug standards will become sodemanding that only large producers will besuccessful, and smaller enterprises will beforced out of business.

In theory, the movement toward harmonisationof requirements at the global level couldimprove product quality, safety and efficacy,which in turn would improve internationalpublic health. However, if most countriesbecome largely dependent on importedpharmaceuticals, and lose their ability todevelop and produce pharmaceuticalslocally or regionally, their specific needs anddemands will be diluted in the globalagenda. These concerns currently rangefrom economic accessibility to existing drugs(eg antiretrovirals) to the availability of newdrugs for specific diseases (eg antimalarials).

Regional harmonisationHarmonisation of various elements of drugregulatory activities has been undertaken inthe last decade as an initiative of variousintergovernmental organisations at aregional and inter-regional level. The drivingforce behind these efforts was the increasein global trade in pharmaceutical products,along with the growing complexity oftechnical regulations related to drug safety,efficacy and quality.

A prerequisite for the initiation of anyharmonised approach to drug regulation isthe existence in each of the countriesinvolved of a drug regulatory system (eg adrug registration authority). Countries thatonly have a rudimentary drug regulatorysystem, or lack such a system, will notbenefit from the harmonisation process.

Harmonisation activities related to drugregulation are now being pursued all overthe world. The following initiatives arenoteworthy:

• in Asia, the activities of ASEAN (theAssociation of South East AsianNations) and the GCC (Gulf CooperationCouncil)

• in America, the activities of PANDRHA(the Pan American Network for DrugRegulatory Harmonization), which alsoincludes CAN (the Andean Community),CARICOM (the Caribbean Community)and MERCOSUR (the Common Marketof the South)

• in Africa, the activities of AFDRAN (theAfrican Drug Regulatory AuthoritiesNetwork) and SADC (the SouthernAfrican Development Community)

• in EU countries, the activities of theEuropean Medicines Evaluation Agency(EMEA), the Pan European RegulatoryForum (PERF), and CADREAC (theCollaboration Agreement between DrugRegulatory Authorities in EuropeanUnion Associated Countries).

International Conference onHarmonisationA special status in drug regulatoryharmonisation has been attained by the ICH.The ICH initiative, which began in 1990,includes drug regulatory authorities of theEU, Japan and USA on the one hand, andthe research-based pharmaceutical industryassociations of those countries on the otherhand (the International Federation ofPharmaceutical Manufacturers Associations,or IFPMA).

Forty-five guidelines describing technicalrequirements related to the process of drugregistration have been produced by groups


of specialists drawn from the regulatoryauthorities and pharmaceutical companies ofthe ICH countries. Regulatory authorities ofthe ICH countries now implement theseguidelines, most of which represent anup-to-date approach to drug testing andregistration. The costs required to fullyimplement the guidelines can be considerable,but it is argued that they are offset by thetime saved when registering new drugs.

Expansion of ICH guidelinesto non-ICH countriesA new situation concerning ICH activitieshas arisen since 1997 due to the creation,within the ICH Steering Committee, of theICH Global Coordination Group. The aim ofthe group and the new ICH policy is toexpand the use of ICH guidelines to includenon-ICH countries and generic products.This expansion is intended to make the ICHguidelines the ‘global standard’ in the area ofdrug regulation. It will also have importantconsequences for the production of genericdrugs (eg guidelines related to raw materialsand impurities).

The ICH guidelines were originally aimed atnew drugs marketed in high-incomecountries. They describe high safety andquality requirements as appropriate for drugsintended to improve quality of life. Inpractice, however, the ‘judicialisation’ ofpublic life prevailing in Western countriesmeans that these requirements areeffectively based on the risk of legal actiontaking place if a drug was found to beunsafe. Paradoxically, in several cases theWorld Health Organization (WHO) safetyand quality requirements are more strict thanthe corresponding requirements applied bythe ICH.

It appears that the intention of the ICHexpansion process is not simply to improvethe availability of new drugs to worldwidemarkets, nor to decrease the cost andduration of the research and developmentprocess for countries involved. Rather, theprocess seems to be based more onmeeting the requirements of the ICHcountries than satisfying global concerns—aform of ‘global unilateralism’. In fact, the ICHprocess conflicts with WHO policy, becausethe ICH starting position was essentiallycommercial while the WHO approach isguided by international public healthconcerns. In addition, while WHO and 17countries are observers of the ICH process,

there are still 175 non-ICH countries unableto get a word in edgeways.

Is global harmonisation anonsensical constraint?Another issue of importance that has notbeen examined closely is that the currenttrend in global harmonisation of regulatoryrequirements, exemplified by the ICH, couldbe more of a hindrance than a help toevaluating and making available certainmedicinal products, such as drugs forneglected diseases. Harmonising and thenglobalising standards, guidelines andpractices for similar medicinal products fromdifferent countries will only be successful inlowering technical barriers to trade if there isno technical uncertainty involved.

For many technologies and products,technical specifications and other precisecriteria can be used with certainty. This isthe case with most industrial products;however, a recurring feature of medicinalproducts and corresponding regulations isthat the underpinning science is characterisedby considerable uncertainty regarding, forinstance, data sets from toxicology, clinicaltrials, and pharmacovigilance studies. Theseextensive uncertainties in drug testing partlyaccount for the fact that scientists belongingto different national regulatory authoritiescan review the same data about the safetyof a drug but reach entirely contradictoryconclusions. Different examples demonstratethat this is not merely an academic issue (egthe case of the RotaShield vaccine).

The consequences of this technicaluncertainty have not been extensivelyanalysed, even though they are of criticalimportance, particularly in terms of theevaluation and availability of new drugs fordiseases of no specific interest to the majorregulatory authorities. In other words, canwe separate the technical aspects of drugtesting and marketing—which are fraughtwith a number of scientific and technicaluncertainties—from the social andepidemiological context in which a drug willbe used?

ConclusionThe crucial question is whether the currentdrug regulation system, which is increasinglyglobally driven and dominated by a limitednumber of regulatory authorities andmultinational corporations, places the

interests of industry and trade over andabove the interests of patients andinternational public health.

Firstly, the global expansion of ICHrequirements may lead to a considerableincrease in the requirements imposed onlocal manufacturers in non-ICH countries,where the drug market is often based onwell-established products and is linked inmany cases to the manufacture of genericversions of essential drugs. If thesemanufacturers were unable to meet whatmay be deemed unreasonable requirements,the adverse impact of the withdrawal ofthese essential drugs on the health of thepopulation would be far more dramatic thanthat of any hypothetical risk posed by failingto achieve the ICH technology-drivenstandards.

Secondly, in the present globalisedmarketplace, a domestic decision made byone country, or a group of countries, canhave profound implications for the rest of theworld, especially if this country is considered—rightly or wrongly—to have the bestscientific and medical knowledge. Such aset-up is by nature asymmetrical and willusually result in negative consequences forthe less powerful countries.


Overdose: the case against thedrug companies1

Reviewed by Andrew Herxheimer

In this valuable book, Jay Cohen, anacademic physician based in San Diego,outlines his concerns that many official drugdosage recommendations are too high andtake no account of the normal biologicalvariations between people. This situationleads to vast numbers of avoidable adverseeffects, deprives people in whom lowerdoses would work of effective treatments,wastes money, and is counter-educational interms of the rational use of drugs.

Cohen analyses the commercial andregulatory causes of this situation, anddiscusses what needs to be done to solvethe problem. Unfortunately, Cohen focusesheavily on the US, largely ignoring the restof the world. Nevertheless, I stronglyrecommend the book as a source of themes,ideas and examples for all ISDB members.

1. Cohen JS. Overdose: the case against thedrug companies. New York: Tarcher-Putnam;2001.

Drug promotion,misinformation andeconomics: failures of thetherapeutic chainAccording to a recently published editorial1

written by Albert Figueras and Joan-RamonLaporte (from the WHO Collaborating Centrefor Research and Training in Pharmaco-epidemiology in Barcelona, Spain), thepotential causes of therapeutic failure dependon a complex interplay of social as well asmedical factors.

The therapeutic chain includes development,regulation, marketing, distribution, prescription,dispensing, and use of a drug—failures canoccur at each and every point.

Members are encouraged to read the wholearticle, but some of the more importantissues raised are:

• The methods and objectives of medicalresearch are driven mainly by industrialpriorities and regulatory requirements,rather than what is important in thecontext of clinical practice.

Media round-up• Marketing approval tends to be granted

on the basis of superiority over placebo,with efficacy being measured byendpoints of varying clinical relevance.

• Marketing budgets are larger than theresearch and development costs.

• The trade related intellectual propertyrights agreement of the World TradeOrganization has a negative effect onthe equitable access of populations todrugs.

• Less developed countries have poorerstandards of drug regulation, qualitycontrol, education, and drug andtherapeutic information, so theprobability of therapeutic failure is high.

1. Figueras A, Laporte J-R. Failures of thetherapeutic chain as a cause of drugineffectiveness: promotion, misinformation,and economics work better than needs. BMJ2003;326:895-6. Available from: http://bmj.com/cgi/reprint/326/7395/895.pdf.

BMJ theme issue: therelationship between doctorsand the pharmaceuticalindustryThe 31 May 2003 issue of the BMJ was atheme issue exploring the relationshipbetween doctors and the pharmaceuticalindustry. There are many extremelyinteresting and relevant articles in this issue,all of which are well worth reading.

A two-part article by Ray Moynihandescribes relationships existing betweendoctors and the pharmaceutical industry, egfree lunches, pens, funds for research,consultancies, support for professionalsocieties.1,2

Andrew Herxheimer writes about newassociations that are developing, such asthose between the pharmaceutical industryand patients’ organisations.3 Grants fromcompanies can help patients’ organisations‘grow and be more influential but can alsodistort and misrepresent their agendas’.

In an article on public relations, Bob Burtonand Andy Rowell describe the third partytechnique—separating the message from anapparently self-interested messenger.4

Hence the importance of opinion leaders.

Silvio Garattini and others provide a guide toethics committees on trial protocols that domore to market a drug than to advanceunderstanding.5

A systematic review by Joel Lexchin andcolleagues shows that drug studies fundedby the pharmaceutical industry are morelikely to be associated with outcomes thatare favourable to the sponsor’s product thanresearch funded by other sources.6

Other articles examined rules and guidelineson doctors’ relations with drug companies7,and the role of pharmaceutical advertising inmedical journals.8

1. Moynihan R. Who pays for the pizza?Redefining the relationships betweendoctors and drug companies. 1:Entanglement. BMJ 2003;326:1189-92.Available from: http://bmj.com/cgi/reprint/326/7400/1189.pdf.

2. Moynihan R. Who pays for the pizza?Redefining the relationships betweendoctors and drug companies. 2:Disentanglement. BMJ 2003;326:1193-6.Available from: http://bmj.com/cgi/reprint/326/7400/1193.pdf.

3. Herxheimer A. Relationships between thepharmaceutical industry and patients’organisations. BMJ 2003;326:1208-10.Available from: http://bmj.com/cgi/reprint/326/7400/1208.pdf.

4. Burton B, Rowell A. Unhealthy spin. BMJ2003;326:1205-7. Available from: http://bmj.com/cgi/reprint/326/7400/1205.pdf.

5. Garattini S, Bertele V, Li Bassi L. How canresearch ethics committees protect patientsbetter? BMJ 2003;326:1199-1201. Availablefrom: http://bmj.com/cgi/reprint/326/7400/1199.pdf.

6. Lexchin J, Bero LA, Djulbegovic B, Clark O.Pharmaceutical industry sponsorship andresearch outcome and quality: systematicreview. BMJ 2003;326:1167-70. Availablefrom: http://bmj.com/cgi/reprint/326/7400/1167.pdf.

7. Wager E. How to dance with porcupines:rules and guidelines on doctors’ relationswith drug companies. BMJ 2003;326:1196-8.Available from: http://bmj.com/cgi/reprint/326/7400/1196.pdf.

8. Smith R. Medical journals andpharmaceutical companies: uneasybedfellows. BMJ 2003;326:1202-5. Availablefrom: http://bmj.com/cgi/reprint/326/7400/1202.pdf.


Evidence b(i)ased medicine:review of a study carried outby the Medical ProductsAgencyAlso part of the BMJ theme issue coveringthe relationship between doctors and thepharmaceutical industry is an article by BjörnBeermann and colleagues of the MedicalProducts Agency (MPA) in Sweden.1 Thispaper deserves special mention as the studywas the subject of a presentation by BjörnBeermann at the 2002 ISDB Workshop andGeneral Assembly.

The study investigated the relative impacton publication bias caused by multiplepublication, selective publication, andselective reporting in studies sponsored bydrug companies.

The researchers examined 42 placebo-controlled studies submitted to the MPA as abasis for securing marketing approval for 5selective serotonin reuptake inhibitors. Whenapplying for marketing approval for a newdrug, applicants must submit completereports of all studies (published andunpublished) carried out on the drug,including those containing unfavourableresults. The researchers then identified 38published versions of the submitted studiesand compared the results.

The study found evidence of duplicatepublication, selective publication andselective reporting, with selective reporting(the tendency to publish only the morefavourable results) being the major cause forbias in the published data. For example,although both intention to treat analyses andper protocol analyses were available in thesubmissions to the MPA, only 24% of stand-alone publications (a published articlereporting results from a single submittedstudy) reported the usually less favourableintention to treat results.

The authors acknowledge that the results oftheir study ‘should not be used to dispute thevalue of systematic literature reviews andmeta-analyses in general’. However, theycaution that ‘for anyone who relies onpublished data alone to choose a specificdrug, our results should be a cause forconcern. Without access to all studies(positive as well as negative, published aswell as unpublished) and without access toalternative analyses (intention to treat aswell as per protocol), any attempt torecommend a specific drug is likely to bebased on biased evidence.’

1. Melander H, Ahlqvist-Rastad J, Meijer G,Beermann B. Evidence b(i)ased medicine—selective reporting from studies sponsoredby pharmaceutical industry: review ofstudies in new drug applications. BMJ2003;326:1171-3. Available from: http://bmj.com/cgi/reprint/326/7400/1171.pdf.

Gefitinib should not beapproved, Public Citizentells FDAIn the March 2003 edition of the ISDBNewsletter, Rokuro Hama and KeikoSakaguchi discussed the controversy inJapan over the approval of the new anti-cancer drug gefitinib (Iressa, AstraZeneca).

The US watchdog group, Public Citizen, tooknote of the situation in Japan and on 1 Maywrote a letter to the Food and DrugAdministration (FDA) attempting to dissuadethem from approving the drug for use in theUS.1,2 Clinical trials that had already beenconducted showed no benefit associatedwith gefitinib, Public Citizen said.

‘The FDA would be putting patients injeopardy by approving a drug that is alreadyshowing itself to be ineffective anddangerous,’ said Dr Sidney Wolfe, director ofPublic Citizen’s Health Research Group.

Nevertheless, on 5 May 2003, the FDAapproved gefitinib under an acceleratedapproval for the third-line treatment ofnon–small cell lung cancer.

1. Barbehenn E, Lurie P, Wolfe S. Letter toFDA expressing concerns about the pendingapproval of the cancer drug gefitinib (Iressa)(HRG Publication #1665). 2003 May 1.Available from: http://www.citizen.org/publications/release.cfm?ID=7242.

2. Cancer drug Iressa should not be approved,Public Citizen tells FDA [press release].2003 May 1. Available from:http://www.citizen.org/pressroom/release.cfm?ID=1417.

Gefitinib ‘hardly a wonderdrug’ according to NewScientistA recent article in New Scientist by SylviaPagán Westphal discussed the controversialapproval of gefitinib (Iressa) in the US.1

Westphal described how the Food and DrugAdministration (FDA) approved gefitinib inMay 2003 despite there being little scientificevidence that it works and growing concernabout a potentially fatal adverse effect,interstitial lung disease (ILD). She said that

the FDA appeared to give in to pressurefrom patient groups and the drug’smanufacturer, AstraZeneca, by acceleratingthe approval process.

The FDA claims that it did not find out aboutthe significant safety concerns associatedwith Iressa until after a crucial meeting inSeptember last year.

1. Westphal SP. Hardly a wonder drug. NewSci 2003 May 24:12-3.


ISDB Europe Regional WorkshopGetting the most out of pharmacovigilance

Date Friday 31 October and Saturday 1 November 2003

Organisers Arznei-Telegramm, Arzneimittelbrief, Pharma-Brief, Arzneiverordnung in der Praxis

Location Arznei-Telegramm Office, Bergstr. 38A (Water Tower), D-12169 BERLIN (Steglitz)

Language English

Issues to be What is the state of the art and how can it be improved?addressed Which national systems are good examples to learn from?

How can the generation of signals be improved?How can transparency of signal processing be improved?How can information on administrative handling of data be obtained?How can participation in the decision-making process be established?How can transparency of the decision-making process be ensured?What is the role of ISDB journals in drug safety evaluation?What does ISDB expect from national and European legislators?How can freedom of information be achieved and guaranteed?

Friday 31 October

8.30–8.50 Registration ofparticipants

8.50–9.00 Welcome addressesISDB president:Joe CollierHost:Wolfgang Becker-Brüser

9.00–9.15 Who is who?Short introduction of theworkshop participants

9.15–10.00 LectureP.S. SchönhöferHow can data on adversedrug reactions (ADRs) beobtained and what are theproblems?What sort of data do weneed? What are the bestmethods for obtaining data?What are the shortcomingsand pitfalls of ADRmonitoring and processing?How is an early discussionof new ADRs bestorganised?

10.00–11.00 Workshop 1Chairs: Heiner Berthold /Bruno Müller-OerlinghausenArzneiverordnung in derPraxisSpontaneous ADRmonitoring systemWhat can we learn fromdifferent countriesregarding spontaneousreporting?

a) UK—Helen Barnett

b) Sweden—Björn Beerman

c) International (WHO)—Mary Couper

11.00—11.30 Coffee break

11.30—12.30 Workshop 2Chair: Walter ThimmeArzneimittelbriefSystematic monitoring ofADR dataWhat can we learn fromdifferent countries? Whatcan be achieved bypharmacovigilance centres?

a) France—Elisabeth Polard

b) Germany (Bremer Modell)—Hans Wille

12.30–13.00 Discussion

13.00–14.00 Lunch

14.00–14.45 LectureChair: Jörg SchaaberPharma-BriefEMEA in focus: the roleand policy of EMEA withrespect to detection,reporting, processing anddecision-making in drugsafety issues and eventsa) Are EU authoritieswilling and able tocommunicate with ISDBbulletins?—Rudolf Bass

b) Lobbying in Europeanparliament and EUadministration


15.15–15.45 Coffee break

15.45–17.00 Workshop 3Chair: Wolfgang Becker-Brüser Arznei-telegrammRecent events in pharmaco-vigilance and what we canlearn from thema) Gefitinib (Iressa): Whathappens with ADR datafrom clinical studies?—Rokuro Hama

b) Paroxetin (Seroxat): Newways to get information aboutADRs—Andrew Herxheimer

c) Hexavalent vaccines: Whatto do with weak ADR signals—Wolfgang Becker-Brüser

d) Professional or patientreporting of ADRs, or both?—Charles Medawar


Evening DocumentationDrafting of reports andresolution by rapporteurs

Saturday 1 November

9.00–12.00 Discussion of draft ISDBEurope resolution onpharmacovigilanceISDB members andrecognised correspondentsonly

12.00 Close and farewell

For more information, please email WolfgangBecker-Brüser at [email protected]. If youwould like to register for the workshop orreserve a hotel room, please fill out the formon page 15.

Updated agenda


Workshop registration and hotel reservation

A. Workshop registration

I wish to participate in the ISDB Europe Regional Workshopon Friday 31 October and Saturday 1 November 2003

Name

Street

Postcode City

Country

Bulletin/organisation

Phone Fax Email

B. Hotel reservation

We have booked rooms in a hotel a few bus stations away from the Arznei-Telegramm office(for passionate walkers it is within walking distance).

I would like to make a hotel reservation

Name

Bulletin/organisation

Single room(s) (€85 per room)

Double room(s) (€90 per room)

From (check-in date) To (check-out date)

Date Signature

Please fill in this form and fax to (+49 30) 79 49 02 20

international society of drug bulletins · pdf file · 2010-04-07international...

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