Contents of this issue

News

Europe

The European Agency for the Evaluation of Medicinal Products (EMEA) announced new plans to increase transparency in its work. Importantly, it wants to publish negative as well as positive decisions about drugs under consideration on the day a decision is reached by the appropriate scientific committee. HAI Europe and the International Society of Drug Bulletins (ISDB) both responded to the paper and welcomed the agency’s efforts to reduce the secrecy surrounding its decision-making. To receive a copy of the consultation paper and HAI’s response, contact the HAI Europe office or visit its website at: http://www.haiweb.org/news/emeaconsultation.html.

Sweden

The Consumer Institute for Medicines and Health (KILEN) has announced plans for a meeting designed to increase consumers’ involvement in the reporting of adverse drug effects. EntitledConsumer’s Reports on Medicines, it aims to give participants the tools and inspiration needed to build up national and local reporting systems involving consumers.  The conference also aims on establishing a pharmacovigilance system based on consumers’ experiences of drugs, develop a countervailing force to the marketing efforts of the pharmaceutical industry and emphasise pharmaco-vigilance as an indispensable instrument in working for improved public health.

USA

A beef burger may harm tomorrow’s future

DES (diethylstillbestrol) has been found in beef exported from the US to Switzerland.  In a press release, DES Action USA expressed its outrage and called on the FDA and USDA to move swiftly to enact stringent controls to protect the public and sanction the offenders. Even though a reliable, well-done study in 1953 showed that DES was ineffective to prevent miscarriages, pharmaceutical companies continued to make it and doctors prescribed it to prevent miscarriages until 1971.   Its use in cattle was banned in 1980 but this has not deterred some unscrupulous cattle producers from once again exposing the public to this toxic substance.Given the poor state of beef inspection in the US, DES Action voices its concern that there is no way of knowing the extent of exposure to DES for consumers since the USDA has not tested beef for DES since 1991.  Immediate testing is necessary to rid the food supply of this deadly carcinogen.

DES (diethylstilbestrol) is a synthetic estrogen drug that was given to millions of pregnant women primarily from 1938-1971. Use of DES during pregnancy was thought to prevent miscarriage and ensure a healthy pregnancy. DES did not work, and women who took DES and the children they carried are at risk for certain health problems and may need special care. Find out if you were exposed to DES and if you were, tell your doctor. More information on DES is available on the web at:
http://www.desaction.org

Asia

Representatives from the Ministries of Health, Trade and the Patent Office from member states of the Association for South East Asian Nations (ASEAN) and from NGOs attended a workshop on the impact of the TRIPs Agreement on Pharmaceuticals, in Jakarta, from the 2^nd–4^th May organised by the Ministry of Health, Indonesia.

In his opening address, Dr.Georg Petersen, WHO representative to Indonesia, stated that access to drugs represents a very important measure in the quality of health services, and is one of the key indicators of equity and social justice.  He stressed that essential drugs are not simple commodities, like any other.  Since medicines are traded, the rules governing this trade are crucial.

Grim facts were illustrated by Dr.German Velasquez, Coordinator of WHO’s Action Programme on Essential Drugs.  In 1999, 10.3 million children under 5 years of age died; 8.6 million of these deaths could have been prevented if essential drugs were affordable. Research shows that the wholesale price of AZT varies nearly six-fold, while the wholesale price of fluconazole varies nearly 40-fold with it being most expensive in Guatemala.  For there to be access to medicines, patents granted should benefit the whole society and there should be equity pricing.

Action for Rational Drugs in Asia (ARDA) Coordinator, Dr K Bala presented a paper outlining consumers’ perspectives on the implications of the TRIPs Agreement on pharmaceuticals.  Speaking on the pharmaceutical production capabilities of ASEAN member states, Indonesia, Philippines, Singapore and Thailand produce almost all the drugs required, while Malaysia produces about 50 percent of its requirement.  However, production in these countries is confined mainly to formulation of dosage forms from imported raw materials.  Thus the availability of raw materials at competitive prices in the world market is of critical importance.  Under patent protection, finished products and raw material of patented drugs will be marketed at monopoly prices.  The pharmaceutical industries in ASEAN  and other developing countries are in danger of collapsing.  The only remedy will be introducing compulsory licensing and parallel importing in national legislation on patents as provided in the TRIPs Agreement.  

Among others, participants recommended that national governments should pass patent legislation providing for compulsory licensing and parallel import and include a Bolar provision.  An ASEAN expert group on the impact of globalisation and trade liberalisation on the health sector should be established to develop suitable model legislation on patent.    ASEAN member countries should adopt a common united stand against any pressure, and safeguard public health interests and access to drugs. 

Considerable attention was also given to the issue of traditional systems of medicine and indigenous knowledge.  Participants recommended that member countries need to develop national legislation, as well as an ASEAN position on the protection of traditional/indigenous knowledge.  Member countries should also develop an inventory and registry of their biological resources and traditional knowledge.

5th ASEAN Health Ministers' Meeting

Pakistan

The Network has launched a drug information helpline for patients, doctors, pharmacists and paramedics.  The main objective of the helpline is to provide objective information on the appropriate use of medicines in children, the elderly, and in pregnant women and lactating mothers.  The helpline also provides information on the interaction of allopathic medicines when taken together, and the interaction of drugs with food.  The helpline aims on providing independent, objective, updated and timely drug information.

Philippines

Training seminars on rational drug use

A series of training seminars on rational drug use was organised by Health Action Information Network from November 1999 to April 2000. The objective of the seminars were to promote the concepts of essential drugs and their rational use among medical practitioners and pharmacists; review commonly encountered drug interactions, general principles in the management of poisoning and adverse drug reactions.

On the use and misuse of antibiotics, Dr. Cecilia Maramba- Untalan stated that antibiotics accounted for 15-30 per cent of drug expenditure in the Philippines.  Studies carried out show that 45.7 per cent of antibiotic regimes at the St. Luke’s Medical Centre were considered inappropriate while inappropriate prescription of antibiotics was as high as 35 per cent at the Santo Tomas University Hospital.   Among the common errors in the use of antimicrobial therapy were using antibiotics to treat viral infections, treatment of fever with antimicrobial without clinical evidence, using toxic drugs when less toxic drugs would suffice, and  treatment of infections with a broad spectrum of antibiotics when a more specific, narrow spectrum antimicrobial agent would suffice.  

The dangers arising from antibiotic misuse include the rapid emergence of resistance, super-infection, adverse reaction / toxicity, treatment failures, the occurance of preventable morbidity and mortality, and wastage of resources.  Known emerging resistance are: Shigella resistant to cotrimoxazole, N.gonorrhea resistant to penicillin and quinolones, multi-drug resistant tuberculosis, Pseudomonas aeruginosa resistant to ceftazidime and Gram negative bacilli resistant to aminoglycosides.

Participants were also exposed to the increasing problem of poisoning.  Three leading causes of poisoning  were alcohol intoxication, isoniazid and methaphetamine toxicity.  Participants were briefed on the general approach of managing a poisoned patient, which could be divided into emergency stabilization, clinical evaluation, elimination of poison, excretion of absorbed substance, adminitration of antidotes, supportive therapy and observation, and disposition. 

The training seminars were held in Iloilo City, Manila, Cavite and Davao. Approximately 50 participants attended each of these seminars.

ANY NEWS?

Do share with us your activities/campaigns on rational drug use and access to essential medicines. Please write to: The Editor, HAI news, PO Box 1045, 10830 Penang, Malaysia. Fax No: (60-4) 228 6506; Email: ardaroap@tm.net.my

Latin America

At the 5th AIS/HAI Bolivia National Conference, HAI/AIS Bolivia called for transparency and the involvement of Bolivian civil society in decision making, referring particularly to Bolivian's national position in relation to the WTO Agreements. Citing examples in Thailand, Brazil, Dominican Republic and Guatemala, concerns were expressed on governments' positions being manipulated by some transnational corporations.

About 220 participants, which included international experts and community leaders, attended the conference. The conference achieved its objective of raising awareness on trade issues and its impact of health. The following materials used in the conference, are available in Spanish:

WTO: Health, Medicines, Patents and Trade, No 108. Bulletin AIS-CODEDCO
WTO: Consumers and the WTO, No 109, Bulletin AIS-CODEDCO
WTO: Globalization and Access to Medicines, No 110. Bulletin AIS-CODEDCO
WTO: Trade Liberalisation, Food Security and the Codex Alimentarius, No 111.Bulletin AIS-CODEDCO

Casilla 568,
Avda. Abel Iturralde
1178, Miraflores
Tel: (+591) 2 222987
Email: aisbolol@ceibo.entelnet.bo

News on Bolivia contributed by Oscar Lanza, AIS Bolivia.

Africa

Forum on Traditional Medicines Examines Key Issues Affecting Integration in African Health Systems

WHO AFRO held the African Forum on the role of traditional medicine in health systems in February 2000 in Harare, Zimbabwe as part of the develop-ment of its ten-year (2001-2010) strategy on traditional medicines for the African region.  More than 100 participants from all over the region discussed how best to integrate traditional medicines (TRM) into health systems, reviewed current and needed research in the region on TRM, learned more about country-level experiences in integrating TRM in health systems and identified local production issues and challenges.

Key findings and recommendations included calls for adequate legal and regulatory frameworks to promote TRM, national co-ordinating bodies to promote integration, the establishment and/or strengthening of TRM practitioners associations, strengthened training programmes and research efforts, better collaboration among healers, scientists and clinicians, improved information dissemination and adequate national budgets for TRM. 

Much discussion centred on local production issues, mainly intellectual property rights issues, upon which it called upon WHO for assistance.  Some participants called for partnerships with the private sector.

HAI Africa participated as an observer and Beryl Leach, the HAI Africa co-ordinator, presented a paper*, outlining consumers perspectives on traditional medicines.  HAI, especially in Asia, has long been closely involved in TRM and herbal remedies.  However, HAI Africa is still in the process of working out how it can best integrate TRM perspectives and information into its work and to determine how the HAI Africa network can best contribute to rational use of TRM and improved access to safe, affordable and effective TRM.

She highlighted some of the major consumer concerns about TRM, which are similar to consumer concerns about Western medicines, for example, safety, efficacy and affordability, adequate quality independent information about TRM and their proper use, the stigma of TRM, which causes consumers to conceal their use when visiting doctors and clinics, biased national drug policies and burdensome legal and regulatory frameworks that delay or limit access to safe, effective and affordable TRM.

To address these concerns, she recommended that consumers should be directly and substantively involved in all processes of and policy making on integrating TRM in health care systems in the region, this includes WHO, governments and regulatory bodies.   Consumers groups and NGOs can play a valuable role in public education, information dissemination and advocacy.

Concerning Intellectual Property Rrights and local production issues, Ms. Leach summarised HAI’s campaign internationally and regionally to promote awareness about trade and access to essential medicines, which involves IPR issues.  She made a few recommendations to the meeting, including calling upon a closer integration of WHO work on traditional medicines with ongoing WHO work on trade and access, forging closer links with expert NGOs working on trade and IPR issues, exercising caution and full understanding of the implications of industry partnerships and training government officials and civil society on trade and IPR issues so that everyone can be fully informed about the impacts of trade on public health.

"Traditional Medicines from the Consumers' Point of View" can be found at: http://www.haiweb.org

East African Access to Essential Medicines Conference

Despite improvements in the use of resources, people continue to die form treatable diseases because newer essential drugs remain out of their reach. In poorest areas of East Africa, up to half of the population is without access to basic, essential medicines to treat life threatening and chronic diseases. Medicins Sans Frontieres (MSF) and Health Action International (HAI) will be organising a conference to explore several aspects of the crisis in East Africa. This conference will highlight reasons that make drugs priced beyond the reach of the vast majority of East African and will look at new strategies to dramatically reduce prices and increase access. Please refer to HAI Calendar, p.20 for further details on the conference.

Recognition of the importance of involving consumers in implementing essential drugs programmes (EDPs) was one of the highlights of the third Essential Drug Programme Managers Meeting held in March 2000 in Grabouw, South Africa.  Fifty-five participants from 16 countries came together for a week to tackle the issues around implementing the Intensified Essential Drugs Programme to improve access to essential drugs in the African region.

EDP managers, chief pharmacists, WHO representatives from EDM and AFRO, NGOs (six, including HAI) and invited guests shared experiences and expertise and helped define priorities for implementation of the programme’s five components: capacity building in drug regulation, achieving better access to essential drugs, improving drug supply, improving rational drug use, information exchange and building institutional capacity.

Harmonisation was a key issue in drug regulation discussions.  Participants noted that harmonisation is currently driven by industry needs and the trickle down impact of harmonisation negotiations going on among the United States, Japan and Europe, which account for 72 percent of global medicines market.  One of the meeting recommendations was that harmonisation should be driven by public health needs rather than the interests of the pharmaceutical industry.

Illegal sales of medicines have been identified as a priority area for WHO-AFRO, which is preparing to undertake a study on it.  HAI pointed out that current knowledge of illegal sales does not include information about why consumers buy illegal medicines nor adequate information about illegal medicines vendors.  It is a priority for HAI Africa to explore ways to address this current gap in information.

In achieving better access to essential drugs, direct consumer involvement is vital for success.  According to one participant, public pressure is the only way to make governments accountable on access issues.  Another noted, 'We need to politicise the essential drugs managers and essentialise the politicians/policymakers.”.'

Participants also noted that pricing issues are complex and that more detailed information and understanding are necessary, for example improving easy access to information about pharmaceutical suppliers and prices. WHO supports equity pricing.

Pharmaco-therapeutics committees are effective means for improving rational drug use by prescribers and dispensers, and the participants recommended that they be implemented at all levels of care.  Improving consumers’ rational drug use is hampered in two ways:  (1) a lack of information about consumer drug use behaviours and (2) a tendency in EDPs to see consumers as "targets" rather than as partners in generating information and promoting rational drug use.

At the end of the meeting, the EDP managers endorsed the Intensified Essential Drug Programme Implementation Strategy for the African region and made recommendations to WHO and member states concerning each of the main components.

The meeting was organised and hosted by the South African Drug Action Programme on behalf of the WHO AFRO regional office.  It was an excellent opportunity for HAI partners to make direct contributions to this important meeting and to network.

News on Africa contributed by Beryl Leach, HAI Africa Co-ordinator.

A two-day workshop on the theme, "Advocacy and Campaign for Better Trade, Access to Essential Medicine and Promoting Rational Drug Use in Uganda," was held in Kampala on 17 and 18 February 2000. The workshop was organised and sponsored by Uganda Consumers' Protection Association, Action Aid Uganda, Health Action International and Medecins sans Frontieres.

The workshop was a follow up to an earlier meeting in November 1999 to promote networking on rational drug use. The latest meeting attracted participants from national and international NGOs promoting health issues, officials from Ministry of Health, Ministry of Justice, National Drug Authority, Uganda Revenue Authority, other government agencies, pharmacists, businesses, media organisations, and consumers in general.

The workshop discussed issues pertaining to access to essential drugs; implications of the World Trade Organization’s Trade Related Aspects of Intellectual Properties Rights (TRIPs) on access to drugs; national health and drug policies; trade and medicine laws and irrational use of drugs and cosmetics.  Participants generated much discussion and decided to set up an advocacy and campaign for better trade policy, health services and increased consumers’ awareness.

Participants agreed that access is a crosscutting issue.  They further agreed on the need to network; to create awareness on key issues using various media; to be involved in legislation review and formulation, particularly the draft bill on intellectual property rights; to participate in the current review of the national drug policy; to advocate for infrastructure to, among other things, provide incentives for people to set up drug outlets in rural areas, especially the underprivileged sector; and to promote initiatives to address the important question of access to essential drugs by those who need them.

To follow up on these findings and recommen-dations, a committee of six members has been set up to be the core group to undertake the co-ordination, networking and implementation of the Advocacy and Campaign for Better Trade, Access to Essential Medicine and Promotion of Rational Drug Use in Uganda.

Contributed by Kimera Henry Richard, Executive Director, Uganda Consumers Protection Association.

Olle Hansson Award

Dr Oscar Lanza van Den Berge is recipient of the Olle Hansson Award for 2000. Dr Oscar Lanza is a Professor of Public Health, School of Medicine, University Mayor de San Andres, La Paz, Bolivia. He is also the founder coordinator of Health Action International (HAI/AIS) Bolivia. Based on his research at community and country levels, he has brought to public attention and scrutiny, unethical drug promotion and the harm caused by irrational and hazardous use of drugs, both in Bolivia and Latin America. His pioneering work led to the enactment of the Bolivian national legislation on ethical drug promotion, clear rules for drug prescription and the use of essential drugs in their generic names.

Apart from health research and campaigns, Dr Lanza has for over 18 years lead community health education programmes through daily radio broadcasts. These programmes are broadcasted in 4 local and native languages, reaching even the most remote areas of Bolivia.

Dr Lanza, is also nationally and internationally well recognised as a leader in consumer protection, and a tireless activist of patients' rights, child nutrition, environmental protection.

He has authored and co-authored several books and publications on various aspects of pharmaceuticals. The monthly AIS Bolivia bulletin on Rational Use of Drugs and Primary Health Care has a circulation of 10,000 copies.

He is the founder and co-ordinator of the Bolivian Consumers' Movement (CODEDCO) and the co-ordinator of IBFAN Bolivia. He has been a PAHO/WHO consultant on Epidemiology and Essential Drug Programme in Haiti and Dominican Republic.

JOURNAL SCAN

The Brazilian government is to publish legislation to tighten controls over the sale of antibiotics.

The legislation will specifically prohibit the sale of all prescription antibiotics without a script and will reclassify ‘red-label’ antibiotics as ‘black-label’.  This will require the pharmacist to keep the script when an antibiotic sale is made.  Black-label classification is usually reserved for potentially dangerous or addictive drugs, such as psychotropics or barbiturates whose sale is monitored by the authorities.

In Brazil, although the majority of antibiotics are classified as ‘red-label’ (prescription-only), they are commonly available over-the-counter (without a prescription) or by re-using a script.  Reclassification as black-label will signify to both the pharmacist and the consumer the serious nature of antibiotic use.  (SCRIP No. 2510, UK, Feb 2, 2000)

The Brazilian national healthcare monitoring agency (ANVS) is on the point of approving the country’s first generics.  The agency has now received more than 100 registration applications and is about to give final approval to between 15 and 20 products.

The Ministry of Health is planning a consumer campaign clarifying the definition of a generic to encourage their use.  This will accompany the launch of the first generics, reports Folha de Sao Paulo.  The national health service is itself expected to be the largest purchaser of generics: it accounts for between 20 per cent and 30 per cent of pharmaceutical sales in Brazil.

The generics legislation came into effect in August last year.  Legislation approved in November now gives priority registration to generics over branded and copy products.  (SCRIP No. 2510, UK, Feb 2, 2000)

Drug Safety

Janssen Pharmaceutica stops marketing cisapride in the US

Janssen Pharmaceutica Inc. of Titusville, NJ has announced that it has decided to stop marketing cisapride (Propulsid) in the United States as of July 14, 2000.  The effective date of the voluntary action is intended to provide adequate time for patients and physicians to make alternative treatment decisions.

Cisapride is a prescription drug treatment approved only for severe nightime heartburn experienced by adult patients with gastro-esophageal reflux disease (GERD) that does not adequately respond to other therapies.

As of December 31, 1999, use of cisapride has been associated with 341 reports of heart rhythm abnormalities including 80 reports of deaths.  Most of these adverse events occurred in patients who were taking other medications or suffering from underlying conditions known to increase risk of cardiac arrhythmia associated with cisapride.

Patients who are currently prescribed cisapride are urged to promptly contact their healthcare providers to discuss alternative treatments.  (Website of the Food & Drug Administration, US)

Drug Pricing

The Spanish Ministry of Health announced a project on March 16 to contain spending on drugs, which has been increasing rapidly in Spain over the past few years.

The project is based on a list of 41 generic drugs in 118 dosage forms; these are paid for partly or totally by the National Health Service.  Each drug has a reference price which is normally lower than the price of the brand name equivalent.  Under the new system, pharmacists must exchange a prescribed branded drug for the generic equivalent if the price of the former is higher than the reference price for that compound.  The price of the generic drug chosen by the pharmacist that is dispensed to the patient cannot exceed the reference price.  The patient can still get the prescribed brand name product if he or she pays the difference.  The new pricing system should save at least US$135 million in its first year of use.

pharmaceutical industry’s representative body.  The negative economic impact on drug companies is estimated to be about $91 million in the first year.  (IP-Health correspondence)

Research Findings

Protective role of estrogen disputed

Challenging a medical doctrine that has stood for two decades, a new study has found no evidence that estrogen supplements lower the risk of new heart attacks in women who already had heart disease.

The research is the second major study to question the doctrine that hormone replacement is a powerful way to lower risk in those with heart disease, the leading killer of older women.

Many doctors think estrogen helps the heart largely because it seems to improve cholesterol levels after women go through menopause.  The pills lower total cholesterol and “bad” cholesterol, while raising “good” cholesterol.  Doctors assume these changes translate into less heart disease, even though no experiments definitively prove this.

The first study was the Heart and Estrogen-progestin Replacement Study (HERS) finished two years ago.  Its conclusion shocked doctors: four years of treatment with estrogen and progestin pills failed to lower the risk of heart attacks in women who already had heart disease.

The latest report backs up HERS’s conclusion.  It studied post-menopausal women with heart disease to see if hormone replacement slowed the buildup of fatty deposits in their coronary arteries, the major underlying cause of heart attacks.  It too, found no benefit from hormones.

309 older women with heart disease were randomly assigned to Premarin, the estrogen-progestin combination Prempro or dummy pills.  After four years, doctors measured their heart arteries and found no difference in the progression of their disease among the treatment groups.  (The New York Times, USA, Mar 14, 2000)

Trade and Pharmaceuticals

Patents and generic competition

US antitrust regulators are taking steps to discourage pharmaceutical companies from entering into deals that delay generic competition while patent litigation is underway between innovator and generic firms.

The Federal Trade Commission (FTC) has filed a civil complaint against Aventis and Andrx over their 1997 partial settlement of patent litigation relating to Cardizem CD (extended-release diltiazem).  The regulators have also reached a proposed settlement with Abbott and Novartis generics arm, Geneva, of allegations that the two companies entered into a similar anticompetitive agreement over Hytrin (terazosin).

The FTC is not seeking any financial penalties in either of the cases, although it warns that it might do if any other such deals are struck.  Richard Parker, head of the FTC’s bureau of competition, said that under US antitrust legislation "you cannot pay your competitor not to compete”.  "

The FTC says the 1997 agreement between the then Hoechst Marion Roussel (HMR) (now part of Aventis) and Andrx was illegal attempt to keep a generic version of Cardizem CD off the market for an extended period of time.  But Andrx has always argued that its deal was pro-competitive and benefited consumers.

The case will be heard in the autumn by an FTC administrative law judge, rather than a federal district court.  This means that, at most, the firms will have to cease the practice in the future, and no fines, disgorgement of illegally obtained profits, or other monetary penalties will be sought.  However, the antitrust enforcers have stated that pharmaceutical firms should consider themselves forewarned.  (SCRIP No. 2526, UK, Mar 29, 2000)

Health technology assessment (HTA) draws together information from a variety of sources to provide an evidence-based appraisal of technology.  The results of HTA can help to optimise clinical practice as well as to inform health policy and administration on such issues as coverage decisions and regulations.

In the past, litigation has been used to challenge clinical practice and health-related administrative decisions, especially in the United States.  Court suits brought by industry against researchers constitute a relatively new method to dispute findings and block dissemination of results.  Recent developments suggest that this practice may spread internationally to affect assessors of health technologies.  The following are two examples:

Cholesterol-lowering drugs, Canada

The pharmaceutical company Bristol-Myers-Squibb Canada Inc. (BMS) sought to prevent release by the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) of a summary report on statins, drugs that lower blood cholesterol.  Pharmaceutical companies whose products were analysed had been given the opportunity to review and comment on the draft assessment report; the final version was released in October 1997.  In an executive summary meant for policymakers, CCOHTA took the position that all drugs in the class of statins provided benefit (a “class effect”).  In its lawsuit, BMS stated that the summary was “negligently misleading” for stating that there was a class effect, as there were adequate clinical trials with only two statin drugs.  The court refused to grant an injunction on release of the report, and a higher court denied an appeal of the decision by BMS.

Two features of this case raise concerns for the ability of assessors to provide neutral advice.  First, although the report was technically competent and reflected the available literature, BMS wanted to prevent conclusions of the research from being made public.  Despite suggestions to the contrary in a press release by BMS, such legal action and fear of litigation can impede the free exchange of scientific information.

The second disquieting feature is the cost and administrative impact on an HTA agency with limited resources.  The money spent by CCOHTA on lawyers to defend its right to publish amounted to 13 per cent of its annual budget.  There was also a drain on the limited human resources at CCOHTA.  Overall, the case may have substantially impaired other HTA activities at the agency.

In a similar case, a drug company (Merck) tried through court proceedings to stop distribution of a newsletter from the Norwegian Medicines Control authority containing a critical evaluation of Fosamax, an osteoporosis drug.  Although the judge was critical of the newsletter’s content, he felt that the Authority should be free to publish its view.

Licensing documentation for a contraceptive, Finland

Norplant is a contraceptive method based on slow-release levonorgesterel capsules.  Norplant had been controversial because of doubts concerning its safety and its suitability for developing countries.  Two Finnish researchers wanted to study the documentation for Norplant’s licensing in Finland in 1983.  Licensing data were made available for research through special permission by the Finnish Ministry of Social Affairs and Health (MOH) and a report was written by 1996.  The study showed that the 1983 release of Norplant was premature by current standards; the evidence now usually required for licensing new drugs was not then available.  However, most of these results have remained unpublished because of legal action taken by Leiras, the producer of the drug.

After seeing the manuscript (provided by MOH), Leiras sued MOH for having released confidential data.  It took 2 years for the Supreme Administrative Court of Finland to decide that the case did not have legal merit.

Before taking the case to court, the drug company advised MOH that, if the article were to by published, MOH and the researchers would be “responsible for economic harm resulting to the company”.  A salary-based researcher could not pay compensation even for a small decline in the sales of Norplant.  Either compensation would have been paid by the employer, or the financial threat was intended only to make researchers give up publication of their research.  The legal challenge may affect future decisions of the MOH on whether torelease confidential information for research.  (Science, vol. 285, Jul 9, 99)

Tireless effort by the Treatment Action Campaign (TAC) has lead to Pfizer agreeing to supply Diflucan (fluconazole) to all AIDS patients in South Africa, suffering from crypotococcal meningitis, who are unable to afford the drug. TAC welcomed Pfizer's step and agreed that distribution should take place on the basis of clear medical guidelines and clinical indications.

Medecins Sans Frontieres (MSF)/Doctors Without Borders welcomed the announcement that Pfizer will donate the anti-fungal drug but cautioned that a donation is not a long-term solution for saving the lives of people with AIDS worldwide.

"For the vast majority of the 32 million people with HIV/AIDS in developing countries, Pfizer's action will have no impact,"  continued Dr Pecoul.

MSF is calling on pharmaceutical companies to use mechanisms other than charity to make life-saving drugs available to people in poor countries. This could be done most effectively by lowering prices to affordable levels - through tiered pricing - or by issuing voluntary licenses that would allow for the importation or production of generic versions of treatments.

"We're delighted that at least one step has been made toward providing treatments for AIDS patients - but is it a sustainable option?"  stated Chris Ouma, a physician who works with Doctors Without Borders at Mbagathi Hospital in Nairobi, Kenya. "We're very happy for the South Africans, but for me, as a Kenyan doctor, and for the Kenyan patients dying from cryptoccocal meningitis, it doesn't help much."

In Kenya, where Pfizer continues to hold the patent on fluconazole, the drug remains prohibitively priced and the majority of patients diagnosed with cryptoccocal meningitis die without treatment.

Pfizer takes the Australian PBS to courts

Pfizer Pty. Ltd. took the Australian Pharmaceutical Benefits Committee to the Federal Court in 1999 after the committee recommended against Viagra being listed on the Australian Pharmaceutical Benefits Scheme. On March 20, 2000 the Federal Court dismissed the application for a review of this decision and awarded costs against Pfizer. Justice Jane Mathews found that none of the grounds of complaints had been substantiated and the PBS Committee was not restricted to considering only medical issues as Pfizer had argued. The Federal Health Minister, Dr Wooldridge, was reported to be delighted with the news. Mr Alan Brindell, Pfizer, said the decision was "barbaric" and deprived poorer men of access to the latest health innovation. (Source: E-drug correspondence)

Resources

The Agreement on Trade Related Intellectual Property rights (TRIPs) has massive implications for developing countries particularly with regard to research and development, access to advanced technology and commercial exploitation of their natural resources.  The Agreement has a negative impact on access to essential drugs in developing countries.  There is a strong pressure on developing countries to implement the agreement through national legislation.  But unfortunately very few people can understand the Agreement which is a complex legal document.

This book, by Prof Correa, will enable everyone to easily understand what TRIPs is about; the main provisions are explained in simple language.  He has also examined the important area of the conservation and sustainable utilisation of plant genetic resources for food and agriculture in relation to how access to such resources for research and breeding may be affected by the granting of patent protection.

Prof. Correa has indicated concrete options available to implement the provisions of the TRIPs Agreement in a manner consistent with development objectives and public policy concerns. This book is a good introduction to TRIPs and provides guidelines to develop policies and laws on intellectual property from a developing country perspective. Available from: Third World Network, 228 Macalister Road, 10400 Penang, Malaysia.

· Problem-Orientated Training on Rational Therapeutics, edited by Mohan P. Joshi, May 1999, 72 pp.

Irrational prescribing in Nepal as in other countries is a problem.  Traditional undergraduate teaching does not train the medical students adequately for therapeutics.  Continuing medical education (CME) on rational therapeutics is not available in a systematic and organised manner in Nepal as in several developing countries.

In order to equip new graduates with necessary skills to prescribe rationally, a three-day problem-oriented training programme was conducted by the Medical Education Department of the Institute of Medicine, Tribhuvan University, Nepal.

Twelve topics of immediate relevance to practising clinicians were taken up by a multidisciplinary team of clinicians.  More than 30 clinical cases were discussed; some of them real and others simulated.

There was substantial improvement in the scoring by participants for many of the questions asked in the post-test as compared in the pre-test.  Participants’ evaluation of the programme, carried out anonymously, showed that it was rated very highly by them.

The 16 multiple choice questions given pre- and post-test as well as an analysis of the evaluations by the 29 participants are included in the document.  These will be particularly useful to other medical educators who wish to plan similar problem-oriented training programmes.

Senior medical undergraduate students and new medical graduates will find this report useful.

Available from: Institute of Medicine, Tribhuvan University, Maharajgunj, Kathmandu, Nepal.

· Trick or Treat: A survival guide to health care, by K. R. Sethuraman, JIPMER, Pondicherry, published by The Society of EQUIP, India, 2000, US$5.00, 151 pp.

Healthcare is multifaceted and involves several groups of people.  Lay persons/readers want to know what may happen when they seek healthcare; a woman should be aware of potential gender related risks in hospitals and how to avoid sexual harassment; healthcare professionals need to know how the general public view the present health crisis and how to avoid litigations; healthcare administrators have to understand the complex-nature of healthcare related problems in their countries and health activists should have a very clear understanding of the various aspects of the multifaceted system to enable them to inform and educate the public and to campaign and lobby for an affordable and accessible healthcare system in their countries.

This book provides relevant information to the various key-players and underscores the importance of all these key-players, working and collaborating together, to formulate a national health policy to make health for all a reality.

A well-known clinical pharmacologist once advised his students that every time a patient was given a drug, it was the beginning of a new experiment and, therefore, should be carefully followed and noted down.  Sethuraman believes that every patient has a story to tell and every “case” was a lesson to learn from.  This he has done for over 30 years and this book is the result.

Everyone likes stories; Aesop’s fables, Remus tales and Pancha-thantra stories are very well-known as tools to educate children as well as adults.   Sethuraman has selected relevant stories to illustrate and introduce sometimes complex clinical episodes and interspaced them with interesting graphics to enable lay-readers and health activists to understand and be educated on the multifaceted healthcare.  The two appendices provide further empowerment to the public.  The first appendix is an extract of a letter from the Ministry of Health & Family Welfare guaranteeing every person adequate emergency care.  The second is a model citizen’s charter for government hospitals.

Trick or Treat is enjoyable reading as well as an educational tool for all the key-players involved in healthcare.

Available from: Society of EQUIP, P.B. No. 8, D-Nagar P.O., Pondicherry 605 006, India.  Email:

· Too much Medicine? The Business of Health and the Risks for You, by Ray Moynihan, ABC Books, 1998, 308 pps, Aus$19.95 (US$13) plus shipping.

Are healthcare consumers hooked on too much medicine?  Are doctors pressured to provide a cure for every illness, regardless of proven effectiveness?  Are they even pressured to promote illnesses by drug companies and the healthcare systems themselves?  In this book, Australian reporter Ray Moynihan reveals that in too many cases the answer to these questions is yes.  From Attention Deficit Disorder (ADD) to lower back operations to radiation from x-rays, Moynihan found that doctors often prescribe tests and cures based on flimsy scientific evidence, sometimes with disastrous results.  In part one, the book runs through a litany of drugs, surgeries, tests and devices that have had questionable, even harmful results.  In fact, according to the book, one in six people is admitted to the hospital for an injury caused by the healthcare system itself.  Part two examines the pressures on doctors that lead to these dangerous prescriptions.  The last part briefly discusses a worldwide movement toward an ‘evidence-based’ approach in medicine, enabling doctors and patients to avoid commercial pressures and more often base their decisions on the best available scientific evidence.  The book has provided the basis for a television series produced by the Australian Broadcasting Corporation Network and is an excellent resource for healthcare consumers concerned about the risks involved in today’s medicine.

Available from: ABC Books, Australian Broadcasting Corporation, GPO Box 9994, Sydney, NSW 2001, Australia.

CONSUMER REPORTS ON MEDICINE: THE FIRST INTERNATIONAL CONFERENCE

Sigtuna, Sweden 29 September - 1 October 2000 Contact: Lena Westin, KILEN, Kammakargatan 7, S-111 40, Sweden Tel: +46 8 696 0100 Fax: +46 8 6960110 kilen@kilen-institutet.se

IMPROVING ACCESS TO ESSENTIAL MEDICINES IN EAST AFRICA, PATENTS AND PRICES IN A GLOBAL ECONOMY

Nairobi, Kenya 15-16 June 2000 Contact: Access Conference Secretariat, MSF Nairobi Office, P.O. Box 38897, Nairobi, Kenya Tel: + 254 2 572094, 570021, 570025 (ext 107) Fax: + 254 2 572157
access.conference@msfb.or.ke

· Norplant in the Context of Population and Drug Policies, by Eeva Ollila, Research Report 99, University of Helsinki Department of Health, Finland, 328 pp, US$20 plus postage.

Since its introduction, Norplant, an implantable contraceptive, has been controversial.  Questions have arisen over whether Norplant can be inserted and removed safely, whether there is adequate documentation about its side effects, and the coercion of women in developing countries to use Norplant.  Finnish researcher Eeva Ollila’s doctoral thesis, now a published report, examines the population and drug policies surrounding Norplant as well as issues linked to the introduction and use of the drug in developing countries.

Norplant is manufactured in Finland, the first country to authorise Norplant’s use.  Ollila found that trade secrecy has made it difficult for the public to obtain information about decisions regarding the drug’s authorisation in that country.  This is particularly important when considering use in developing countries, says Ollila, where drug approval is based largely on whether the drug is approved in the country of manufacture.  According to Ollila, who examined case studies in India, safe use of Norplant can be compromised by weaknesses in service provision.  In countries with strong population control policies, there is a risk of coercive use of Norplant.  The report is a well-researched technical examination of these issues, aimed at an audience familiar with Norplant, not the general public.

Available from: STAKES, PO Box 220/Publications, SF-00531 Helsinki, Finland.  Fax: 358-9-396 72450.

TRAINING COURSE FOR BULLETIN EDITORS

London, United Kingdom 2- 6 October 2000 Contact: Andrea Tarr, Drug and Therapeutic Bulletin, 2 Marylebone Road, London, NW1 4DF, United Kingdom Fax: + 44 171 830 7665 tarran@which.co.uk

16TH CONSUMERS INTERNATIONAL WORLD CONGRESS

Durban, South Africa 13 - 17 November 2000 Contact: Dina Musante Durazno 1315, CP 11100, Montevideo, Uruguay Tel: + (598 2) 901 5415 / 901 8081 Fax: + (598 2) 901 8082 dmusante@internet.com.my

US-based corporate accountability experts Robert Weissman and Russell Mokhiber have written a new book about the costs of living in a corporate-dominated society: the growing wealth disparity around the world, pollution, rampant corporate crime, the decline of democracy, and, of course, the costs to our health.  While not focused specifically on corporate influence on medicine and healthcare, one can easily extrapolate the book’s message: We, indeed, have much to fear from the increasing role of corporations in our society, from mergers that consolidate power to corporate influence on government policies to big business sponsorship of our environment, education, and healthcare.  This book is a call to action for anyone concerned about corporate power in today’s world.

Available from: Common Courage Press, PO Box 702, Monroe, Maine 04951, USA.  It can also be ordered from the web at:

PEOPLE'S HEALTH ASSEMBLY

Savar, Bangladesh 4 - 8 December 2000 Contact: PHA Secretariat, 250A Jalan Air Itam, 10460, Penang, Malaysia Tel: + (60 4) 229 1396 Email: phasec@pha2000.org

Health Action International (HAI) is an informal network of individuals and NGOs working towards ensuring the availability of and rational use of medicines. Website: http://www.haiweb.org

HAI Coordinating Offices:

ARDA
c/o Consumers International Regional Office for Asia and the Pacific,
PO Box 1045,
10830, Penang, Malaysia
Tel: (+60-4) 229 1396
Fax:(+60-4) 228 6506
Email: ardaroap@tm.net.my

HAI Europe
Jacob van Lennepkade 334-T,
1053 NJ Amsterdam,
The Netherlands
Tel: (+31-20) 683 3684
Fax:(+31-20) 685 5002
Email: info@haiweb.org

AIS Latin America
Aptdo 41-128,
Lima,
Peru
Tel / Fax: (+51-1) 346 1502
Email: ais@amauta.rcp.net.pe

HAI Africa c/o HAI-Europe,
Jacob van Lennepkade 334-T,
1053 NJ Amsterdam,
The Netherlands
Tel: (+31-20) 683 3684
Fax:(+31-20) 685 5002
Email: info@haiweb.org

Articles in HAI New may be reproduced for non-profit use. Please clearly credit HAI News as the source and send us a copy of the article.

HEALTH ACTION INTERNATIONAL

Press Release
22 May 2000

HAI supports developing countries’ demand for greater WHO involvement in the fight against HIV/AIDS.

A large coalition of developing countries led a successful effort to increase the World Health Organization’s (WHO) role in advising countries about best treatment options for HIV/AIDS and ways to reduce barriers affecting drug pricing and access at the 53rd World Health Assembly (WHA), May 2000, Geneva, Switzerland.

A group of developing countries, led by Brazil and Zimbabwe, pushed to broaden WHO’s field of activities related to HIV/AIDS despite strong opposition from many developed countries, including the United States and some members of the European Union.

"Developing countries made it clear at the Assembly this year that they were not going to back down to Northern pressures on this issue,"   said Bas van der Heide, coordinator of HAI Europe. "WHO's involvement in identifying ways to improve affordability and access must now live up to developing countries' expectations and needs."

A resolution on HIV/AIDS adopted at the WHA calls on the WHO to expand its current databases to include information on the prices of many crucial medicines, including HIV/AIDS drugs. The resolution’s clear language on drug pricing caused tension during the Assembly in light of countries’ mixed response to an earlier announcement by UNAIDS that five drug companies planned to consider price reductions on selected HIV/AIDS medicines in some countries.  HAI believes such efforts are only short-term solutions that will have little impact on getting needed drugs to the poorest people.

At the Assembly, developing countries also urged the WHO to play an active role in advising countries on the public health implications of international trade agreements. During a discussion on the Revised Drug Strategy, numerous countries urged the WHO to guard its independent voice when giving countries’ advice on health-related aspects of trade after some developed countries led by the US signalled they would support an initiative that would force the WHO to clear any advice on trade issues with other international organisations including the World Trade Organization (WTO) and the World Intellectual Property Organization (WIPO).

In the HIV/AIDS resolution and in their formal remarks, developing country representatives also emphasised the need to encourage local manufacturing, greater use of generic drugs and legal import practices-all means to bring down prices and help improve access to essential drugs.