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On World AIDS Day (1 December) The European Trade Commissioner, Pascal Lamy confirmed his commitment to take action so that safe, affordable medication is available to all of those who need it. In his statement he said "We are committed to doing whatever is necessary to shape the right conditions so that the poorest of the poor have access to the medicines they deserve. Increasing access to affordable key pharmaceuticals is a MUST in the fight against the three main communicable diseases, that is, malaria, tuberculosis, and of course HIV/AIDS which is in the spotlight today." The EU Commissioners for Development and Humanitarian Aid and Research also showed their support for using all means at their disposal to fight HIV/AIDS.
Later in the month, European and US consumer advocates met with three Presidents to urge immediate action to improve access to essential drugs in developing countries. US President Bill Clinton, European Commission President Romano Prodi and European Council President Jacques Chirac (France) met with members of the Trans Atlantic Consumer Dialogue (TACD) as part of their EU-US Summit on 18 December. The consumer representatives highlighted both the US and EU's responsibility to tackle this problem as primary backers of the TRIPs agreement and as the home to most of the world's research-based pharmaceutical industry. During the discussion, they outlined recommendations put forward by the TACD on access to essential medicines and asked the leaders to make a political commitment to them. (The full recommendations can be found at: http://www.tacd.org).
HAI Europe participated in a consultation about the EU's new health framework programme as part of the multistakeholders' meeting of the European Public Health Alliance. HAI member, David Gilbert (UK) made a presentation on behalf of HAI Europe outlining its current priorities, including concerns about a possible lifting of the current ban against direct-to-consumer advertising in the EU. He and the office's project development officer, Margaret Ewen, used the two-day meeting to network with the diverse European groups working on public health policy.
From 15-22 January, members of the WHO Executive Board met in Geneva to discuss international health challenges and set the agenda for the upcoming World Health Assembly. Two issues of concern to the HAI network were discussed during the meeting: improving access to essential drugs and WHO's increasing role in public/private ventures. HAI spoke out on both issues and copies of its statements can be found by clicking on the links.
It is commonly accepted that the news media are an important source of information for medical treatment, however research indicates some coverage may be inaccurate or exaggerated. One research group has studied US news media coverage of benefits and risks associated with the use of three medications used for disease prevention. The medications were pravastatin, a cholesterol-lowering drug for the prevention of cardiovascular disease; alendronate, abisphosphonate for the treatment and prevention of osteoporosis; and aspirin, for the prevention of cardiovascular disease.
Of the 207 stories examined between 1994 and 1998, 40% did not report benefits quantitavely. Of the 124 that did report benefits, 83% reported only the relative benefits, 2% reported absolute benefits only and the remaining 15% both absolute and relative benefits. In total, 47% of the 207 stories mentioned potential harm to patients but only 30% mentioned costs. There were 170 stories that quoted an expert or a scientific study and of these just 85 (50%) cited a tie between the study and a manufacturer. The authors concluded that media stories regarding drugs might include incomplete information about benefits, risks and costs of drugs. Perhaps more importantly, financial ties between study groups and pharmaceutical manufacturers were often overlooked. (Website of the New England Journal of Medicine http://content.nejm.org/cgi/content/short/342/22/1645)
In December, more than 1,500 health activists came together in Bangladesh for the People's Health Assembly. Participants from more than 90 countries spent a week assessing the state of public health today and devising a framework to improve health for consumers around the world. The Assembly adopted a People's Charter on Health that highlights the idea that health is a basic human right, one that should be given priority before economic or political concerns. To view the whole charter and find out more about planned follow-up activities visit the PHA website: http://www.phamovement.org. (Summarised from material compiled by R. Mokhiber and R. Weissman)
HAI member KILEN hosted an international conference on ways to increase consumer involvement in adverse effect reporting. Approximately sixty countries were involved in the discussions. The meeting provided an opportunity to define the case for direct reporting by consumers of suspected, supposed or proven adverse reactions to medicines. The meeting was structured to provide participants with the tools and the inspiration needed to establish systems that capitalise on user experiences. They examined experience with such schemes in various countries and the role of such approaches in complementing existing professional-based systems for the reporting of supposed adverse drug reactions. The participants agreed that present reporting systems do not give enough knowledge about drug effects. The meeting ended with a consensus document that set out the problems and issues to be tackled. KILEN also presented this information at the People's Health Assembly in December. Copies of the meeting's report "CRM: Policy and Practice" and background information can be obtained from: http://www.kilen.org/indexe.htm (choose: CRM Consensus doc).
Belgium's Project Farmaka has recently made its Geneesmiddelenbrief available on its website, http://www.farmaka.be. While the newsletter is currently available only in Dutch, the group plans to translate sections of the site, such as its reports on academic detailing projects, in the near future. For more information, contact: farmaka@online.be .
HAI-Lights reported last year that Staffan Svensson had organised the production of 30,000 copies of Med-Sense in Albanian in cooperation with Medecins du Monde Sweden, WHO and ECHO. Accompanying posters were also printed.
In October 2000, a one-week pilot project aimed at increasing awareness of rational drug issues was done in the Gjakove area of Kosovo, in collaboration with NGOs and local health facilities. The project aimed to measure health professionals' reaction to the Med-Sense kits, to gain their in distributing the material and to start a dialogue on ways to improve rational drug use in Kosovo.
Since consumers were the primary target group for the Med-Sense kits, the organisers held a media campaign during the promotion week. This featured prominent advertisments in Kosovo's leading newspaper, as well as numerous public information radio broadcasts and interviews. Copies of the Med-Sense kits were distributed at preparatory meetings and by local NGOs and health authorities. Posters, as well as kits, were distributed to all pharmacies in Gjakove.
In order to provide a focal point for the week's activities, a seminar was held in Gjakove. Representatives of the organisers spoke about issues related to the concept of rational drug use and the value of Med-Sense as a product for raising consumer awareness among other topics. Information relating to drug regulation, essential drug lists, rational drug use and other issues were distributed to doctors, pharmacists and consumers. Later that evening, MdM Sweden organised a feedback session involving three of the local NGOs and a number of doctors. The ideas and discussions held during the feedback session may provide the platform for a proposal to provide the rational drug use campaign with greater depth both in Gjakove and in other areas of Kosovo where MdM Sweden will work with the WHO and other partners to carry forward the campaign.
For more information about this campaign, contact: Hugh Griffiths, MdM Sweden, e-mail: mdmsweden@yahoo.com or Staffan Svensson, MdM Sweden Rational Drugs Advisor, e-mail: staffan.svensson@pharm.gu.se (E-drug message, 26 Nov 00)
HAI Europe and BUKO Pharma Kampagne co-sponsored a one-day seminar in November examining public/private "partnerships" and their consequences for public health. A summary of the speakers' presentations and the lively discussion can be found on this site.
A course on the use of pharmacoeconomics in drug selection, developed with WHO's Essential Drugs and Other Medicines Department will be held in Budapest, Hungary from 20-30 May 2001. The programme aims to provide participants with an understanding of the principles and techniques of pharmacoeconomics. It will show how these tools can be used in making decisions about selecting and purchasing pharmaceuticals for use in health care systems.
The course was developed by an international consortium, including departments of clinical pharmacology and public health at the Universities of Newcastle (Australia), Sydney, and Dundee (UK), in collaboration with WHO/EDM. The programme in Budapest will be hosted jointly by the University of Newcastle, Australia, and National Institute of Pharmacy, Hungary. The confirmed faculty include David Henry, Suzanne Hill, Ruth Lopert, Danielle Lang, Glenn Salkeld and Peter Davey.
The course will be problem-based, facilitated by international and national experts. It will provide participants with the opportunity to work in small groups, learning about and using pharmacoeconomic techniques to address common problems in selecting drugs for national and sub-national formularies. Participants should therefore be working in some aspect of the academic or public health sector, and have some responsibility, either at managerial level or "hands on" level, for selection of pharmaceuticals for essential drugs lists or hospital formularies. Participants should also have a basic understanding of the principles of assessing and evaluating data for drug selection.
For more course details, contact: Kerry Mannix, Discipline of Clinical Pharmacology, 5th floor, Clinical Sciences Building, Newcastle Mater Hospital, Waratah NSW 2298, Australia, or e-mail: mannix@mail.newcastle.edu.au.
Stanford University researchers have discovered a "hidden epidemic", compulsive shopping disorder. Seen as a condition thought to affect millions of American women, doctors at Stanford University are now looking at a medication to treat this malady.
Dr. Lorrin Koran, who headed the study, says that compulsive shopping is "motivated by irresistible impulses…has harmful consequences for the individual and tends to be chronic." According to Dr. Koran 8% of all Americans may be "shopaholics" and 90% of these are women.
Compulsive shopping may be the result of American affluence; it may also be a cleverly disguised marketing scheme. The Stanford study, like many other trials, is being funded by a pharmaceutical company. The drug is a FDA-approved antidepressant, a selective serotonin re-uptakeinhibitor (SSRI). The researchers at the Stanford study have not revealed their sponsor but only five SSRIs are currently on the US market, Zoloft by Pfizer, Prozac of Eli Lilly, Paxil of Smithkline Beecham and Luvox of Solvay. None of these companies have reported plans for conducting studies on compulsive shopping. Forest Pharmaceuticals, Producer of Celexa, neither confirmed nor denied any involvement in Koran's study.
If this study proves successful compulsive buyers will be tempted into buying just one more item, a small pill.
The industry-driven, intellectual property agreement known as TRIPs has been questioned by the UN human rights body, the UN Sub-Commission for the Protection and Promotion of Human Rights. The sub-commission feels that agreements that protect corporate patents around the world may prove to be a threat to the human rights of peoples and communities including farmers and indigenous people worldwide.
between the intellectual property rights regime embodied in the TRIPs agreement, on the one hand, and international human rights law on the other." According to Miloon Kothari of the International NGO Committee on Human Rights in Trade and Investment (INCHRITI) this pronouncement is a real breakthrough as it is the first time a UN human rights programme is monitoring the work of the WTO. Kothari said "this historic resolution has affirmed the primacy of human rights and environmental obligations over the commercial and profit driven motives upon which agreements such as TRIPs are based."
Simon Walker of the Office of the United Nations High Commissioner for Human Rights noted that the TRIPs Agreement's requirement that pharmaceuticals be patented by WTO members was appropriate for countries with high investment in drug research. However, he emphasised, most countries with high levels of HIV/AIDS, tuberculosis and malaria do not have a developed drug research base. Walker pointed out that as there is a link between patent protection and higher prices for drugs. He said granting private property rights could be detrimental to public health in developing countries.
For more information contact Miloon Kothari, Habitat International Coalition and INCHRITI, Tel/Fax: (+91-11) 462 8492 or e-mail: hichrc@ndf.vsnl.net.im or contact Peter Prove, Lutheran World Federation and INCHRITI Tel: (+41-22) 791 6364 Fax: (+41-22) 798 8616 or e-mail: pnp@lutheranworld.org .
As developing countries work to revise their legislation and patent laws to bring them into conformity with the WTO Agreement on TRIPs, they must be responsive to health policy objectives, particularly the needs of the poor, argues Correa. The author, a lawyer and economist on intellectual property issues, shows that various options are available to developing countries when formulating their national legislation in line with the provisions of TRIPs. This agreement has introduced a new and important international framework for intellectual property rights, which in turn has important implications for the health sector, the study suggests. While setting out detailed obligations in respect to the protection of inventions, TRIPs, however, does not establish a uniform international law or even uniform legal requirements. "WTO member countries are obliged to comply with the minimum standards of the TRIPs Agreement ," says Prof. Correa. "But they also have considerable room to develop their own patent and other intellectual property laws in response to the characteristics of their legal systems and developmental needs. In implementing the TRIPs provisions, the WTO member countries may legitimately adopt regulations that ensure a balance between the minimum standards of intellectual property rights protection and the public good."
The study explores issues relating to the patentable subject matter, the scope of claims, patentability requirements, special cases involving pharmaceuticals, disclosure, exceptions to exclusive rights, and compulsory licensing. "Public health goals can be significantly advanced through North-South co-operation, involving both the public and private sectors, through official assistance, licensing of technology, joint ventures and other modalities," stresses Prof. Correa. "The climate, scope and effectiveness of such co-operation, however, could be significantly advanced if developed countries abandoned the use of unilateral actions for obtaining the protection of commercial interests of their patent holders in developing countries. International co-operation in this area should recognise the fundamental right of any person to have access to basic health care, and the corresponding obligation of governments to protect and promote public health."
The publication is available from South Centre, 17 Ch. du Champ-d'Anier, POB 228, 1211 Geneva 19, Switzerland, Fax: (+41-22) 798 8531, e-mail: south@southcentre.org. The book's material is also available on the web at http://www.southcentre.org/publications/publichealth/toc.htm .
The World Trade Organisation released a report on Trade and Development entitled Trade, Income Disparity and Poverty just before the UN's second World Summit for Social Development last year. The report asserts that long-term trade liberalism will result in poverty alleviation.
WTO director-General, Mike Moore, insists that "trade alone may not be enough to eradicate poverty, [but] it is essential if poor people are to have any hope of a brighter future." The report quotes a study that looked at living standards in developing countries. Authors Dan Ben-David of Tel Aviv University and L. Alan Winters of Sussex University, see that poor economies who are open to trade stand a better chance of catching up with rich countries than those who put up trade barriers.
The report also addresses the effects of trade reforms on the poor and concludes that generally people living in poverty (approx US$1 a day) benefit from trade liberalisation. The report argues that trade can play an important part in reducing poverty by boosting overall economic growth. The WTO study sees the causes of poverty being lack of access to education (especially for girls and women) and lack of proper health services, as well as unequal distribution of production factors including land and livestock.
(The full text of the report can be seen at http://www.wto.org)
Management Sciences for Health has updated its International Drug Price Indicator Guide. The website now contains data from 1996-1999 and its search capabilities have been improved. A print version of the 1999 Guide is also available. For more information: contact the MSH Bookstore, Fax: (+1-617) 524 2825 or bookstore@msh.org You can also visit MSH Manager's Electronic Resource Center Website at http://erc.msh.org).
The ProCaare (Program for Collaboration Against AIDS and Related Epidemics) now has a discussion group on the web. A joint enterprise between the Harvard AIDS Institute/Harvard School of Public Health and Health and Development Networks, the goal of the discussion group is to "provide a forum for dialogue among clinical and public health physicians, nurses, researchers, policy makers, program managers and other interested health practitioners both in the developing and industrialised world."
In order to keep things lively, moderators will actively monitor the discussion. The network will also be supported by summaries of current research. The overall direction of the discussion group is to be led by a steering committee with representatives from all over the world.
To subscribe to ProCaare send an e-mail to: majordomo@usa.healthnet.org
Essential drugs save lives and reduce suffering. Poor quality drugs kill. Medicines represent the highest out-of-pocket household expenditure in low-income countries. Yet they are often unavailable, unaffordable, unsafe, or used irrationally. Working first from a country perspective and with a variety of development partners, WHO has developed a WHO Medicines Strategy to guide its action in essential drugs and medicines policy for the period 2000-2003. The strategy document aims to provide a one-WHO approach for the pharmaceutical work, and a framework for action with countries and other partners. It describes global progress in the field of pharmaceuticals, includes challenges yet to be addressed, and notes expected outcomes for 2000-2003. The development of the strategy involved a consultation with more than 60 countries, institutions, and WHO programmes.It is meant to be used as a dynamic and active tool in the implementation of WHO's activities, in collaboration with its member states.
The report is now available on line at http://www.who.int/medicines.
This book lists and defines more than 180 terms used to report adverse drug reactions to regulatory authorities and drug manufacturers. The book recommends specific terms, definitions and criteria to ensure that international reporting remains consistent and uniform. In particular, it highlights terms that are not precise, are unclear and which should be avoided. A brief discussion on the need for standard terminology is included.
For more information, or to order, contact: WHO Marketing and Dissemination, 1211 Geneva 27, Switzerland, Tel: (+41-22) 791 2476 or Fax: (+41-22) 791 4857 or e-mail: bookorders@who.ch)
This title consists of 12 WHO guidelines related to good manufacturing practices (GMP) and the inspection of drug manufacturers and distributors. As a single reference book, it contains guidelines and recommendations aimed at ensuring that pharmaceutical products are manufactured in compliance with internationally accepted standards for quality and safety.
The guidelines are presented in chapters which include, core GMP guidelines, guidelines for starting materials and ingredients, specialised guidelines for specific sterile pharmaceuticals and provisional guidelines for the inspection of manufacturing facilities.
For more information or to order, contact: WHO Marketing and Dissemination, 1211 Geneva 27, Switzerland, Tel: (+41-22) 791 2476 or Fax: (+41-22) 791 4857 or e-mail: bookorders@who.ch .
The World Trade Organisation (WTO) will probably become one of the most important influences on international health. This briefing looks at three areas where its impact on health is already being felt, public health regulations, tighter intellectual property rights and the increasing potential for trade in health services.
Rowson holds that WTO agreements carry vast implications for policy-makers and those involved in health debates in both developed and developing countries. His suggestions include the need to review the current state of WTO agreements, informing national health ministries about these implications and he recommends that specialised UN agencies, not the WTO, should deal with public health issues at the international level.
To order, contact: Medact, 601 Holloway Road, London N19 4 DJ, UK, Tel: (+44-20) 7272 2020, Fax: (+44-20) 7281 5717 or visit its website: www.medact.org .
The events surrounding the WTO conference in Seattle focused attention on the rise of social movements opposing globalization and the power of corporations. Naming the Enemy is the first systematic analysis of these diverse, at present uncoordinated, movements. They are a new phenomenon that has as yet received scant media or scholarly attention. But it is likely to assume much greater political prominence as the globalised economy dominated by giant corporations fails to deliver on jobs, social justice, development and the environment. The dialectic between public opposition and the corporate sector s response is likely to shape how our economic institutions will change in the coming years. The outcome of what may turn out to be a new kind of political struggle has enormous implications for both human welfare and civil liberties. The author presents the structural critiques which these movements are making of growth, consumption and dependency, and draws attention to issues of scale and community as they relate to political economy and democratic theory.
To order a copy, contact: Zed Books, 7 Cynthia Street, London N1 9JF, UK. Tel (+44-20) 7837 4014, Fax: (+44-20) 7833 3960 or e-mail: sales@zedbooks.demon.co.uk .
(This announcement was written by Richard Laing and originally published on E-drug)
I would like to recommend a new introductory textbook on Pharmacoepidemiology-Principles and Practice. The book is written by two public health pharmacists, Brenda Waning and Michael Montagne, who teach at the Massachussets College of Pharmacy. They also teach with me at Boston University School of Public Health in a course that I teach on Promoting Rational Drug Use.
The book is aimed at pharmacy students and others interested in pharmacoepidemiology. It includes needed definitions of terms Clear, concise introduction to the epidemiology of drug use, valuable concepts of public health, primarily measures of risk, real-life applications of risk assessment, screening, and diagnostic testing, practical methods in epidemiology, post-marketing drug surveillance studies, and pharmacoeconomics.
The book has exercises which can be used to clarify concepts and is based on the course developed especially for pharmacy students. It serves as a valuable reference to be used in drug literature evaluation courses.
It is a basic introductory text and will not compete with Brian Stroms megabook on pharmacoepidemiology. It is also much less sophisticated than the materials developed in New South Wales by David Henry, Sue Hill and many others. But for teachers in schools of pharmacy this will be a very useful text book which will make the teaching of public health concepts in pharmacy much easier.
