HAI LIGHTS

HAI-Europe, December 1999, Vol. 4, No. 3

How to motivate the market:

Promoting the development of drugs to combat tropical diseases

While the research-based pharmaceutical industry continues to churn out new treatments for a multitude of illnesses, it has largely ignored the infectious diseases that kill seventeen million people each year, ninety percent of whom live in developing countries. Even though scientific discovery has provided many of the necessary medicines to control these killer diseases, the pipeline of drugs currently in development to fight them is almost empty. In a profit-driven, highly competitive market, companies know they will realise a higher return by marketing a new obesity drug in Europe and North America than by pioneering a novel malaria treatment.

1999 Nobel Peace Prize winner Médecins Sans Frontières, in collaboration with the World Health Organization (WHO), is trying to change this situation. The two organisations teamed up in October to sponsor the two-day meeting,"Drugs for Communicable Diseases: Stimulating Development and Securing Availability," in an attempt to spur research and development of drugs that can treat communicable diseases affecting poor countries. Approximately eighty researchers, health economists and representatives from government, the pharmaceutical industry and international organisations, including HAI, met to encourage creative development models that stimulate collaboration to produce the necessary drugs.

The following article, summarised from a presentation made at the meeting by Patrice Trouiller, of Médecins Sans Frontières, Paris explains some of the fundamental issues at hand.

Despite the prevalence of tropical diseases and the ever-increasing demand for effective, safe and affordable treatments, tropical diseases are a low priority for the private sector. As a result, preventive or curative drugs do not exist for many life-threatening and debilitating diseases that largely affect the poor. Statistics confirm that recent pharmaceutical advances are not leading to substantial discoveries for treatments of tropical diseases and the drug development pipeline is drying up for these illnesses. Furthermore, even when effective drugs are available, access is often limited especially to expensive newer drugs.

The research and development process

The research-based pharmaceutical industry has been responsible for the development of more than ninety percent of the new drugs produced worldwide and devotes approximately 15% of its sales revenues to research and development (R & D). A necessary first step in the drug development process is to gain comprehensive knowledge of the biological mechanisms of the targeted disease. Pharmacochemists must then search for suitable and successful drugs that reach the desired molecular target, such as blocking an enzymatic mechanism or compensating for it. Preclinical studies help determine the selected drug's pharmacology and formula. When the results are encouraging and the right economic conditions exist, phase I human clinical trials can start. All these steps result from a collaborative effort between academia and the pharmaceutical industry. However, industry has not shown a great deal of interest in supporting this phase for tropical disease drugs. This is in stark contrast to the active role it plays in carrying out and boosting research involving non-communicable diseases.

The role of the pharmaceutical industry

From 1910 to 1970 the pharmaceutical industry's contribution was crucial in the fight against endemic tropical diseases: trypanocides and amoebicides in the 1930s (by Bayer and Rhône Poulenc), chloroquine during World War II (by Specia or Winthrop) and in the 1960s with the discovery of leading anthelmintics (by Janssen). However, in the past three decades, pharmaceutical companies have severely slowed the development of new, needed drugs to fight tropical diseases. This comes at a time when increasing drug resistance, adverse effects and the inability to use current protocols highlight the need for more research and development on new drugs. In addition, the situation has worsened as pharmaceutical companies have responded to new regulatory and competitive forces by primarily targeting the most profitable markets (see box: World Drug Market, 1993).

Of the 1,233 new chemical entities (NCEs) marketed worldwide between 1975 and 1997, 379 were considered real therapeutic innovations and only 13 were specifically indicated for tropical diseases. Two of these 13 drugs are actually updated versions of previous products (new formulations of pentamidine and amphotericin B), two are the result of military research (halofantrine and mefloquine), and five come from veterinary research (albendazole, benznidazole, ivermectin, oxamniquine, and praziquantel). In total, four are the direct results of industry R&D activities (artemether, atovaquone, eflornithine and nifurtimox). One should note here that the production of pentamidine for sleeping sickness and the clinical development of atovaquone for malaria were made possible primarily because of their effectiveness in fighting acquired immunodeficiency syndrome (AIDS)-related opportunistic infections.

Strategies used to encourage drug development

Pharmaceutical companies operate like all other private industry, to sell a product, maximise profit and maintain a competitive edge, all without any specific social welfare mission. That's why several public and private initiatives have attempted to introduce public health criteria into industry R&D strategies.

These initiatives can be divided into two global categories: "enabling conditions" that create a positive environment for drug development and/or overcoming hindrances; and "discreet mechanisms," strategies that can be planned and have predictable outcomes.

Enabling conditions

Public-private collaboration that includes scientific and/or financial support from both sectors has mainly been used for:

(i) the clinical development phase (e.g., ivermectin and praziquantel both originated as veterinary drugs; and pyronaridine),

(ii) strengthening clinical trials (e.g., artemisinin derivatives development from Chinese pharmacopoeia)

(iii) manufacturing (e.g., good manufacturing practices were upgraded for artemisinin derivatives.

Occasionally, a pharmaceutical company's desire to enhance its public image played a decisive role in getting a drug produced (e.g. atovaquone-proguanil, albendazole, and ivermectin). Advocacy efforts initiated by civil society facilitated development and/or distribution for some compounds abandoned by industry as insufficiently profitable (e.g. pentamidine). Lastly, regulations, such as expiry or absence of patent, a patent approaching expiry, or fast-track approval, also provided leverage for drug development (e.g. eflornithine, paromomycin).

Discreet mechanisms

International institutions, such as the WHO, World Bank and Wellcome Trust, are supporting strategies such as technical assistance, drug donations and in-country production. Technical assistance has proven to be the most productive strategy (e.g. artemisinin derivatives) while donation programmes were commonly used by the industry (e.g. albendazole, atovaquone, azithromycin, ivermectin, and pentamidine). Apart from artemisinin derivatives (e.g. artemether), developing country production to lower costs and transfer technology has not been very successful (e.g. eflornithine, paromomycin, and pyronaridine).

No single global strategy can be drawn from past successes and failures. The dominant approach has been case-by-case with an opportunistic mixing of the above-mentioned strategies. With the exceptions of ivermectin and praziquantel, all of the examples of successful drug development have been for malaria (e.g. artemisinin derivatives, atovaquone, halofantrine, and mefloquine). Sleeping sickness (African trypanosomiasis) appears to be marginalised as production of melarsoprol and nifurtimox will stop in all probability, and eflornithine production may be abandoned as well. Generally, donation programmes, favoured by industrialists to offset market failures, appear an easy way to compensate the lack of tropical R&D policy.

A bleak future?

Pharmaceutical firms operate like any private industry. They do not have a specific social welfare mission and respond to economic rather than social or human imperatives. Thus, drug development for tropical diseases does not have a promising future. The profit-driven system appears unable to keep pace with the current and evolving needs in tropical medicine. Experience shows that no international pharmaceutical company will develop new drugs against parasitic diseases of their own free will and this situation will likely not change even with the technical breakthroughs that are introducing new drugs to the rest of the world.

Those wanting to obtain more information about MSF's campaign on this issue or a copy of the full meeting report can contact MSF-Geneva, 12, rue du Lac, CP 6090, 121 Geneva, Switzerland.

References

Pflaker K, Brudon P. Programmes promoting drug development: WHO experiences DAP/98.6; Geneva, World Health Organization, 1998.

Trouiller P. Olliaro P. Drug development output during 1975-96:what proportion for tropical diseases? International Journal of Infectious Diseases 1999; (2):61-63.

Pécoul B, Chirac P, Trouiller P, Pinel J. Access to essential drugs in poor countries, a lost battle? Journal of the American Medical Association, 1999, 281:361-67.

United States Congress, Office of Technology Assessment, Pharmaceutical R & D, costs, risks and rewards; Federal support for pharmaceutical R & D. OTA-H-522, US Government Printing Office, Washington, DC, 1993.

Grabowski H. Vernon JM. Returns to R & D on new drug introduction in the 1980s. Journal of Health Economics 1994; 13:383-406.

This article is based upon the presentation "Drug development for tropical diseases: 1975-1997 outcomes" by Patrice Trouiller and information provided by MSF-Geneva.

Statement released at the conclusion of the Paris meeting Drugs for communicable diseases stimulating development and securing availability 15 October 1999, Paris A conference convened by Médecins Sans Frontières in collaboration with the World Health Organization and with the support of the Rockefeller Foundation. On this day when Médecins Sans Frontières has been awarded the Nobel Peace Prize, we resolve: Given the acute need for safe, effective and affordable medicines to treat the infectious diseases that are responsible for the majority of the illnesses and deaths in the developing world, and clear evidence that more than 95% of all current drug development is oriented to the medicinal and lifestyle needs of the wealthiest 5% of the planet's population: - A radically new approach must be taken to address this problem which constitutes a massive, and growing global health crisis; - Whatever specific approach is taken must not be mere charity, drug give-aways or donations. Rather, it must involve a hard and fast structure, strong political support both at the international and country levels and a systemic assault on the problem; - Any lasting solutions must offer a sustainable structure that not only results in the research and development of essential drugs and their affordable, effective distribution, but also support of research and public health capacities in needy countries. Therefore, MSF, on behalf of a majority of the group, calls for a global commitment to new, large-scale, ongoing financial support of international drug development of diseases of the developing world, and for sound distribution of those drugs to individuals and communities in need.

Drug policy

Sponsorship concerns cause French bulletin to refuse WHO offer

The French independent drug bulletin, La revue Prescrire, has turned down an invitation to become a World Health Organization (WHO) collaborating centre due to the bulletin's growing concerns about WHO's cooperation with the pharmaceutical industry.

In a letter to WHO Director General Dr Gro Harlem Brundtland, the editor of the bulletin strongly criticised the organisation's recent role in developing the 1999 WHO/ISH Guidelines for the Management of Hypertension. Opponents of the new guidelines have suggested that the pharmaceutical industry had too much influence in the process. As a result, they say the new treatment standards widen the potential patient population for antihypertensives and may seriously increase the use of expensive treatments that should remain second choices.

Prescrire's letter emphasised the different roles that must be played by consumers, health professionals, governments and industry in order to ensure proper use of medicines. It stressed that each actor has its own mission and responsibilities, and providing independent information was not a task that could be given to industry. Instead it suggested that this work must be done by health professionals, national governments and international organisations such as WHO. Prescrire's editor wrote "These actors must assure that public interest prevails over commercial interest. They can only do this by performing their functions independently of commercial influence."

While La revue Prescrire plans to carry out joint work with WHO on an informal basis, the bulletin's editor stated, "Until we see guarantees for safeguarding WHO's independence in the near future, we do not wish to formalise our collaboration and in doing so endorse policies we cannot support." (Correspondence received)

German companies sending low-quality drugs to poor countries

German pharmaceutical companies are a major supplier of drugs for many developing countries. For this reason, BUKO PharmaKampagne recently published a report, Poor Choices for Poor Countries, which examines the marketing of German pharmaceuticals in Third World countries. While collecting data for the study, BUKO found that more than two thousand medicines were being sold in the thirty countries studied. The report looked at the drugs' therapeutic usefulness and its results shake the good image that German medicines now enjoy. For example, the researchers found that 42% of the drugs examined in the study did not cater to the population's health needs and only twenty percent were found to be essential according to the WHO's criteria. BUKO concluded that German pharmaceutical companies have a responsibility to produce safe and effective medicines, and to withdraw harmful and useless products from the market.

English-language copies of the report can be ordered for DM20 or US$9 plus shipping from BUKO Pharma-Kampagne, August-Bebel-Str. 62, 33602 Bielefeld, Germany, fax: +49-521-63789 or e-mail: bukopharma@compuserve.com.(Correspondence received)

Critics claim US lobbies influence funding

"US research funding depends on lobbying, not need" proclaims an article in the British Medical Journal reporting on the first systematic comparison of US National Institutes of Health (NIH) spending on research. The study, according to the article, showed that some diseases with strong political lobbies, such as AIDS, breast cancer, diabetes mellitus and dementia, received a disproportionate amount of federal money in relation to their toll on public health.

The researchers used disability adjusted life years (DALYs)--or the loss of one year of healthy life due to death or disability--to measure the global burden of a disease. AIDS received US$1.4 billion in grant money, with the disease estimated to lead to the loss of 1.27 million DALYs, a breakdown of about US$1,114 per DALY. Breast cancer received US$269 per DALY. By comparison, according to the article, depression, stroke, perinatal conditions and emphysema were judged to be underfunded (US$17 to $27 per DALY).

An NIH editorial in the New England Journal of Medicine, however, explained some of the factors other than current toll of disease that influenced funding allocations. These include public health needs, scientific opportunities, the quality of research proposals, the maintenance of staffing and infrastructure, and importantly, the future impact of a disease. AIDS, for example, is well funded because it is a new and prevalent infectious disease, and the consequent study of retroviruses and the immune system has immense implications for other potentially devastating infectious viral diseases.

The editorial explained that the study actually showed a "reasonable" correspondence between funding and burden of disease, and that given the other factors involved, absolute correspondence should not be expected. Regardless, NIH has implemented two recommendations of the report: a new public liaison office and a Director's Council of Public Representatives, both of which are attempts to give the public greater involvement in funding decisions. (British Medical Journal, 1999;318:1715 and New England Journal of Medicine, 1999, 340:24.)

WHO Revised Drug Strategy Watch WHO and public interest NGOs adopt joint principles for Roundtable In October, the World Health Organization (WHO) confirmed an agreement to general principles for the WHO-Public Interest NGO Pharmaceutical Roundtable. WHO's Roundtables are an initiative of the WHO Director General Dr Gro Harlem Brundtland to engage non-governmental organisations (NGOs) and industry in discussions about issues of mutual interest. Both WHO and NGOs taking part in the public health Roundtable subscribe to the following statement: "Our concern is health. We are lobbyists for equity in access to health-especially concerned about extending access to essential drugs and promoting the rational use of medicines everywhere. Our work centres on reaching decision-makers with a convincing case, and drawing their attention to human need-trying to help break the vicious cycles that link ill-health, poverty and other manifestations of human and social development. Fundamental to our concern is the need for sustainable health systems, giving more access to basic health. More needs to be done. We want to help do it." This statement is meant to be the guiding principle of the roundtables, which will provide a forum for dialogue and a plan for technical cooperation between WHO and public interest organisations. Both WHO and NGOs hope the process will lead to stronger collaboration at the international, national and regional levels, with the views and needs from the field directly expressed and taken into account. Technical cooperation may take the form of joint research, publications, development of materials etc. However, to ensure that these joint efforts are effective, the following points need to be taken into account: - Participants from both the WHO and the NGO community must have a strong commitment to work together over the long term. Both must have an in-depth understanding of the issues discussed. - The cooperation must be based on mutual respect and commitment. - The independence of the organisations involved must be ensured. - Goals of the cooperation and joint projects must be clear. - Openness and transparency are key to the workings of WHO and the roundtable process. - Channels of communication must be easy. - The cooperation between WHO and NGOs at the international level must be reflected at national level. - Expectations should be realistic, particularly with regard to financial constraints. To elaborate on the last point, the implementation of joint activities will depend on available funding--a potential constraint on how quickly objectives can be achieved. NGOs must maintain financial independence and not primarily rely on WHO funding for the implementation of roundtable projects. Independence is also essential for frank exchange of views. Health Action International (HAI) is the NGO focal point for the public health roundtable process. HAI will set up a consultation and steering structure to ensure involvement of a wide range of NGOs and effective communication and coordination. It will also ensure that the process is inclusive and has relevance for national-level activities. The roundtable will meet every six months. WHO and NGOs will develop an agenda together and agree in advance to a meeting format. The agenda for the roundtable meetings will include progress on the joint projects as well as policy-oriented topics. To ensure continuity, a core group will attend meetings and brief new participants.

Drug Promotion

Assessing the power of direct-to-consumer advertising

The fact that US drug companies spent US$1.2 billion on direct-to-consumer (DTC) advertising in 1998 certainly suggests that the drug industry is reaping sales benefits from this type of promotion. But what is the benefit to the consumer and doctor? How does such advertising affect patient expectations regarding their treatment? How does it affect the relationship between doctor and patient? While hard data are still needed to answer these questions, Canadian physician and promotion expert Joel Lexchin has reviewed existing literature and written an article exploring the impact DTC advertising has on patient expectations and patient-doctor relationships.

Lexchin found that many consumers respond to DTC advertising by contacting their health provider to talk about specific medications and many even ask for drugs by their brand name. Lexchin writes that many health professionals respond by prescribing the specific medicine requested even though these drugs tend to be newer, more expensive and riskier as the drug's safety profile is based on limited experience. He found that one-third of patients say they would switch doctors if the doctors do not fulfill their requests.

Lexchin predicts that such prescriptions may not lead to greater patient satisfaction and on the whole, DTC advertising will negatively affect patient expectations. He concludes that DTC advertising may further strain patient-doctor relationships as the clash between consumers' and doctors' expectations erodes patient confidence in the health provider and ultimately, the health care system. The full article is "Direct-to-consumer advertising: Impact on patient expectations regarding disease management," Disease Management Health Outcomes. 1999 May: 5 (5) 273-283. Copies are also available from the HAI Europe office. (Correspondence received.)

Dutch tackle sponsorship issues

The Dutch government is urging hospitals to sign a new code of conduct regulating drug industry sponsorship and funding of their institutions which researchers estimate raise more than US$320 million a year. By some estimates, nearly eighty percent of The Netherlands' four thousand hospitals, nursing homes and psychiatric units seek corporate sponsorship or donations, but few have written contracts with sponsors.

The new code of conduct is voluntary and will be overseen by a supervisory board with powers to inspect participating hospitals' annual accounts. Hospitals could be asked to repay donations. The code bans sponsorships from companies such as tobacco manufacturers or those with a poor environmental or human rights record. In general, according to the code, funds must not "damage a patient's physical or mental condition" or be "in conflict with the generally accepted principles of health policy."

According to Maerten Verstegen, Chairman of the Institute for Sponsoring and Fundraising in Health Care, which drew up the code, it is important for the future to define what is acceptable. Extreme cases such as sponsorship from tobacco manufacturers or asking for preferential treatment is completely unacceptable. (British Medical Journal, 1999;318:1644)

Rep Rap: French medical reps peddle bad information

Medical representatives in France continue to mislead prescribers about the safety and efficacy of drugs, and numerous government attempts to regulate rep visits have done little to remedy the situation. This is the conclusion of a recent report by the French drug bulletin and medical watchdog group La Revue Prescrire, based on eight years of data collection by its representatives monitoring network.

The report's finding is particularly alarming given that drug manufacturers say visits by medical reps remain the most effective way of persuading physicians to prescribe their products. Apparently, the reps' art of persuasion can include expanding indications, increasing recommended doses, and, in 75% of studied rep visits, minimising drug hazards. Hundreds of physicians and pharmacists throughout France participated in the data collection, filling out Prescrire's questionnaires that analyse a rep's visit for misleading information.

The data analysis also found that 16% of medical reps failed to supply the Summary of Product Characteristics to prescribers as required by the French government, and 95% failed to supply government reports of the drug's therapeutic utility, also required by law. In addition, the report found a trend towards presenting drugs to prescribers before release on the market, a "pre-launch" PR effort undertaken even before government analyses of the drugs are ready for distribution.

According to Prescrire, similar findings have been discovered in other countries, and the organisation concludes that as a rule comparative and high quality information should be found elsewhere. Regulations, industrial ethical codes and international recommendations have had no noteworthy effect so far.

For a copy of the full article, contact La Revue Prescrire, P.O. Box 459, 75527 Paris Cedex 11, France. Fax: (+33-1) 480 78732. (Prescrire International, June 1999, 8:41)

The HAI Europe staff wishes all HAI Lights readers a happy new year. We look forward to working with you in the new millennium!

Campaigns

New donations study cites progress and problems

An industry-funded study has found that the majority of donations by US pharmaceutical companies fulfills the basic criteria for appropriate donations although it admits "a substantial proportion failed to do so."

Researchers at Harvard University examined all donations made by US drug companies between 1994-97 that were shipped by two private US-based organisations. In total, data were compiled on about 16,600 drug donations distributed to 129 countries around the world.

The study found that while most donated drugs had a remaining shelf life of more than five hundred days, thirty percent only had less than a year left until they expired (6% had only one hundred days).

Approximately ten to 42% of the studied drugs were found irrelevant as they were not included on the recipient country's essential drugs list or the World Health Organization's model list. Furthermore, even some donated essential drugs caused problems, such as hampering local drug production. For example, a Tanzania drug producer told the study's researchers: "It may be well and good for you to provide acetaminophen (paracetamol), but that is one of the things I make, one of the few things."

Similar to other studies on donations, this study's authors highlighted disposal dilemmas caused by unwanted drugs. In conclusion it recommended that donated medicines be matched more closely with recipient requests and that all donations have an adequate shelf life. It also called for drug companies to make copies of their donations policies available to the public. At present, only four of the ten companies involved in the study have such a policy.

The study's main findings were published in the 16 August Bulletin of the World Health Organization. The article is available at the following address:

http://www.who.int/bulletin/fulltext/issue8/bu0030

The full study can be downloaded from: http://www.hsph.harvard.edu/faculty/reich/donations/

(Scrip No. 2465, August 20, 1999, p. 14)

Canadians promised more transparent health agency

Mounting public pressure in Canada has led the government to announce a new office for public consultation where citizens can express concerns about medical products under consideration for approval. The government hopes the office will help restore the credibility of Health Canada, the Canadian health protection agency, after the agency's reputation was damaged by a tainted blood scandal in the early 1980s. Consumer groups have criticised Health Canada, calling it too secretive and influenced by the pharmaceutical industry. David Dodge, the deputy health minister, said, "Transparency is absolutely key. The public can't have our trust if there is a sense everything is hidden under the rug."(Globe & Mail, 14 May 1999)

Talking with industry: dialogue or distraction?

In September, HAI member BUKO Pharma-Kampagne and other NGOs organised a workshop in Bielefeld, Germany which focused on dilemmas emerging from NGO discussions with the drug industry. The meeting's 15 participants shared a general concern about the industry's increasing use of "dialogue" to approach critics as well as governments and agreed that this strategy has resulted in a shift from public discussions about health care issues to industry talks "behind closed doors." Participants discussed basic guidelines that should govern these meetings and agreed that NGOs must critically analyse any industry offer for dialogue. BUKO emphasised that crucial public support can be lost easily when discussions take place in secretive environments.

The workshop built on the checklist for "Talking with industry" prepared by Judith Richter and Jörg Schaaber for last year's HAI Europe annual meeting in Paris. An updated version of the checklist will be available soon in English and German to HAI members. For a copy, contact BUKO: August-Bebel-Str. 62, 33602 Bielefeld, Germany, fax: +49-521-63789 or e-mail: bukopharma@compuserve.com. (Correspondence received)

Women pay a high price for their extra years

Populations are aging rapidly in almost every country in the world and taking care of growing numbers of older people has become a universal issue. Of particular concern are aging women. First, there are more women than men among the aged, particularly among the very old. Second, older women are more likely to be single than men, mostly from widowhood or lower rates of remarriage. Research unambiguously has identified single, very old women as being socially and economically the most vulnerable segment of the aged.

Concern about aging women comes at a time when policy decisions and health care trends might be exacerbating the plight of older women. For example, many Northern countries are cutting welfare and encouraging the individual to draw more on personal resources. Clearly, these measures have an enormous impact on the lives of those with limited means, including aging poorer people and especially women.

Another problem older women face is a health care system that doesn't adequately cater to their special needs. For example, despite women's vulnerability to depression, US and British studies show that while men often receive specialised psychiatric care, women are treated by their general practitioner. In addition, while men routinely ask for their heart to be checked, older women with heart problems are more likely to have their symptoms dismissed as hyperventilation or stress. Conversely, older women can also receive unnecessary treatment with studies showing unneeded operations on the womb or prescribing of sleeping tablets.

The list of aging women's problems is long, but these women can also be part of the solution. From 20-24 October, Wemos, with the Older Women's Network-Europe, held a conference called "Older Women and Social Exclusion, issues, empowerment and action." The conference focused on women's own views on social protection, empowerment, networking and health. The workshops made clear that European health care still has very little sensitivity to gender issues. Medication is often not properly dosed, misdiagnoses are common and women's own knowledge rarely has the place it deserves in health care policy.

For a free copy of the Wemos brochure "Portraits of aging women, their own views on life, aging and health" and an additional reader on aging women, contact: Wemos, Postbus 1693, 1000 BR Amsterdam. E-mail: wemos@wemos.nl. The conference proceedings will be available in December 1999, contact Wemos for more information.

People's Health Assembly The HIV/AIDs epidemic, racial and gender imbalances, economic policies that deprive the poor of adequate medical care, the vulnerable becoming more so -- now, more than ever, equitable access to health care must be placed at the top of national and international policy agendas. Health professionals, activists, concerned citizens, policymakers, must all work together for a new international health policy agenda created by the people for the people. That is the impetus behind the People's Health Assembly, a year long series of policy analyses, country and regional meetings and experience sharing, all of which will culminate in a conference to be held 4-8 December 2000 near Dhaka, Bangladesh. The People's Health Assembly is a broad, new initiative involving as many people as possible to form their own health agenda and set their own priorities. The conference organisers' ultimate goal is to translate people's rich and varied experiences into clear, practical and democratic policy guidelines. Plan ahead, get involved. For more information: contact: Janet Maychin, PHA Secretariat, Consumers International Regional Office for Asia and the Pacific, 250-A Jalan Air Itam, 10460 Penang, Malaysia. tel: 604-229-1396, fax: 604-228-6506, e-mail: phasec@pha2000.org or visit the meeting's website: http://www.pha2000.org.

Drug information

CA launches independent information source for patients

For many years, the UK's Consumers' Association (CA) has been providing high quality, impartial information about health -- books, magazines, and newsletters -- for both professionals and consumers. Now, the organisation is introducing a new information service for patients.

Today, as more and more patients want to be involved in the increasingly complex decisions regarding their health care, a rich diet of health and medical information has become available, especially on the Internet. At the click of a computer mouse, patients now have access to information that was once the reserve of medical libraries. While the information is welcome, many patients don't have access to the Internet, and for those that do, many can't find the right information when they need it. People have also reported that the quality of Internet resources is mixed and heavily biased toward commercial sources. In reality, there is still a dearth of high-quality, impartial information about drugs and medical treatments designed expressly for patients.

That is why the editors of one of CA's most widely read publications, the Drug and Therapeutics Bulletin (DTB), decided to create an information bulletin just for patients. Since it was founded in 1962, DTB has been used by doctors and pharmacists for up-to-date information about best practices in medical care, and over the years DTB has earned a reputation for providing authoritative, practical guidance for working clinicians. CA now wants to fill the patient's information gap by reinterpreting the information it gives to doctors and pharmacists in DTB in a bulletin for health care consumers, a doctor- or pharmacist-supplied leaflet that is accurate, concise, easy to read and timely.

The bulletin will contain one topic per leaflet, such as "help with losing weight" and "antibiotic resistance." It will give background information for the newly diagnosed patient and advice and recommendations that matches the "parent" DTB bulletin. Pilots of the new bulletin are being tested with patients and health professionals and regular editions should start appearing in spring 2000. DTB hopes local health authorities will purchase the bulletin and make it available free from doctors' surgeries and community pharmacists. An electronic version should follow by the end of the year.

For more information, contact Philip Taylor at UK's Consumer's Association: Drug and Therapeutics Bulletin, 2 Marylebone Road, London NW1 4DF, tel: (+44-171) 830 7608, fax: (+44-171) 830 7664, and E-mail: taylorp@which.co.uk

First ISDB meeting for bulletins in CEEC/NIS

Political and economic upheavals and the growing power of advertising have motivated health professionals in Eastern and Central Europe and the Newly Independent States to find ways to increase the availability of independent drug information. Regional drug bulletins play a key role in providing such information. In early 1999, 34 representatives of drug bulletins from 15 countries met to share ideas and increase cooperation among their publications.

The meeting, which consisted of plenaries on general policy issues and training workshops, was organised by the Latvian drug bulletin CITO in cooperation with the Croatian drug bulletin and the International Society of Drug Bulletins (ISDB). For more information about the meeting, contact ISDB, tel: (+33-1)49 23 72 65 or e-mail: ISDB@compuserve.com, (ISDB Newsletter Vol. 13, No. 1, June 1999)

Drug bulletins warn WHO about industry influence

Independent drug bulletins from around the world are urging the World Health Organization (WHO) to keep its independence. From 16 - 19 September, the International Society of Drug Bulletins (ISDB) held its 5th Congress in Amsterdam, where representatives from 34 countries adopted a resolution stating, "The key task of the World Health Organization is to promote health throughout the world.... ISDB adopts the aim of engaging in actions that ensure that WHO is independent of the pharmaceutical industry in its organisation, political decisions and funding."

The members of ISDB also urged regulatory agencies to place their public health mission above the commercial interests of the drug industry. To this end, ISDB will work to ensure that the medicines agencies provide full, reliable data on drug efficacy and risks.

The conference's main theme was the challenge of providing evidence-based drug information and the need for bulletins to be independent. The meeting started with reports on ISDB's activities in the past three years. Daphne Fresle of WHO's Essential Drugs and Other Medicines Division (EDM) gave an overview of another potential tool for drug bulletins: the WHO-ISDB manual, which will be ready soon.

Other workshops covered editorial processes, ways to influence prescribing, guarding bulletins' independence, making use of electronic media and identifying and confronting the pharmaceutical industry's lobby. The latter meeting on industry tactics was based largely on input from HAI's publication, Blurring the Boundaries: New trends in drug promotion, written by Barbara Mintzes. Bas van der Heide, coordinator of HAI-Europe spoke about new trends in drug promotion, highlighting recent cases of direct-to-consumer promotion of prescription-only medicines in The Netherlands. He argued that drug bulletins must play a much larger role providing high quality drug information to consumers. During the meeting, staff from drug bulletins shared concerns and discussed new initiatives for reaching out to consumers. The Dutch drug bulletin Geneesmiddelenbulletin, for example, will soon open a website providing drug information for lay people. For more information, visit the new ISDB website: http://www.prn.usm.my/isdb.(Correspondence received)

Pharmaceuticals and Trade

AIDS and developing countries

Africa is facing an AIDS epidemic likened by the US Surgeon General to the plague that decimated Europe in the 14th century. But the US government and other Western countries are keeping life-saving drugs out of reach of most Africans. A recent article by corporate accountability activist Robert Weissman discusses the problem and proposes two solutions that could help developing country governments make essential medicines more available and affordable to their citizens.

According to Weissman, HIV/AIDS drug cocktails cost about US$12,000 a year in many African countries and compulsory licensing and parallel imports are two ways that can promote access. Compulsory licensing, explains Weissman, enables any government to instruct a patent holder to allow a company, government agency or other party to use its patent. Zimbabwe, for example, could issue a license to a local company for an HIV/AIDS drug manufactured by Bristol-Myers Squibb. The local firm would sell it in Zimbabwe under a generic name and pay a reasonable royalty to Bristol-Myers Squibb on each sale. This can lower prices by as much as seventy-five percent through greater competition.

Parallel imports allow the resale of a drug without the consent of the original seller, thereby allowing the buyer to search for the lowest world price. Both compulsory licensing and parallel imports are permitted by the General Agreement on Tariffs and Trade (GATT), yet multinational pharmaceutical companies object to the practices. The US government, writes Weissman, has adopted a similar view, strongly opposing compulsory licensing, parallel imports, and other measures that would make essential medicines more available and affordable in developing countries.

Washington echoes industry claims that compulsory licensing unfairly impinges on corporate intellectual property rights. Companies are worried that the industrialised nations might follow the lead of developing countries and pursue compulsory licensing to lower prices. But Weissman argues that compulsory licensing has always been one of many limitations on patent holder rights and patent holders know this when they receive a patent.

Furthermore, writes Weissman, industry's argument that it must determine costs to cover high R&D costs is countered by the fact that governments often finance drug development, as is the case of the two leading AIDS drugs. Companies also routinely exaggerate costs. In addition, compulsory licensing will increase sales and may not harm earnings at all. Finally, there is a moral issue, says Weissman: Should people with HIV/AIDS in poor countries be denied available treatments so that companies can earn higher profits?

Washington is playing tough, exerting pressure on developing countries to keep them from pursuing compulsory licensing and other strategies to make drugs more available. The US has withheld certain trade benefits from South Africa for failing to repeal parts of its Medicines Act that would make essential medicines more available to its citizens. Similarly, Washington has taken actions against Argentina, Brazil, Thailand, India other countries that are considering property rights rules to make medicines more affordable.

Weissman recommends the following for a more just foreign policy:

- The US should terminate all bilateral pressure on countries for pursuing intellectual property policies designed to make essential medicines more available to those in need.

- Aid and trade benefits for developing countries should not be conditioned on their intellectual property rules.

- The US government should license its HIV/AIDS drugs to the World Health Organization for widespread distribution in the developing world.

(Excerpted from AIDS and Developing Countries: Democratizing Access to Essential Medicines, by Robert Weissman, Volume 4, Number 23, August 1999 of the online journal, Foreign Policy in Focus. To view the entire article, visit the Foreign Policy In Focus website: http://www.foreignpolicy-infocus.)

CI launches worldwide campaign for consumer's rights regarding trade

On 16 August, Consumers International (CI), representing 247 consumer organisations in 111 countries, launched a worldwide campaign against the upcoming Millennium Round of trade negotiations "until crucial changes are made in how and for whom the WTO and the trade liberalisation agenda operates." The campaign is calling for a review of the multilateral trading system to ensure that consumer rights are supported by future trade liberalisation. In supporting research documents, CI argues that multinational corporations have used the WTO to weaken consumer protection legislation by intimidating governments to bypass or change their laws.

Position papers and full details of the campaign can be found at http://www.consumersinternational.org/trade or by contacting Jayanti Durai of CI at e-mail address: jdurai@consint.org.

Economic policies and health: a call for action

During the past two decades, not only are the poor getting poorer, but not surprisingly, also sicker. Poor people, primarily in developing countries, fall victim to a disproportionate amount of the world's illnesses and at the same time their access to health care is steadily declining.

International economic policies are contributing, if not causing, the problems. For example, many developing poor countries have been forced to cut spending for health care and other social services through Structural Adjustment Programmes (SAPs), budget-tightening measures that international financial institutions have prescribed to reduce a country's debt and deal with other economic problems. In addition, instead of providing alternative financing for adequate health care, governments have introduced user charges that have delayed medical attention, undermined access to health care and threatened public health and equity. In one region in Nigeria, this led to a rapid 56% increase in maternal mortality.

A number of organisations have joined together to start up an Economic Policies and Health (EPH) programme to address the increasing influence of structural adjustment, debt relief, trade liberalisation and other economic policies on health policies. The central aim is to call for policies that respect the right to adequate health care for everyone. In 1997, Medact (UK), Physicians for Social Responsibility (Finland) and Wemos (The Netherlands) established Health Counts, a European consortium focusing on these same issues, in particular the role played by such economic actors as the World Bank, International Monetary Fund, World Trade Organization and the European Union in national health policies.

With EU funding, Health Counts mobilises the support of the medical profession and cooperates with health organisations. It is also in the process of developing close collaboration with a Southern network, the International People's Health Council (IPHC). In January and March of next year, IPHC and Health Counts will hold meetings in Amsterdam and Managua respectively to define an international capacity building and lobby campaign. The work will start on health sector reform efforts underway in Central America.

Next year's People's Health Assembly will catalyse the collaboration between IPHC and Health Counts. The assembly, which IPHC has been instrumental in organising, is taking place in Bangladesh in December 2000 and will bring together five hundred delegates from community health and other organisations worldwide and provides an excellent opportunity to further develop the international network (see box in this issue on the People's Health Assembly).

Health Counts will lobby for the adoption of a resolution at the World Health Assembly in 2000 or 2001. The resolution, if adopted by member states, will call on the World Health Organisation to monitor and analyse the health impact of economic policies and urge international financial institutions to do the same through an external review process of their policies.

South and North will also work together for debt relief. Wemos and Medact, in cooperation with IPHC, are undertaking a "Health Alert" campaign to strengthen solidarity between the medical profession in Europe and developing countries for debt relief efforts. The campaign will gather concrete, clear, personal information, or "people's stories," from developing countries about the impact of debt burden on poverty and health.

For more information on Health Counts, contact Evert-Jan Visser at Wemos: P.O. Box 1693, 1000 BR Amsterdam, The Netherlands, tel: (+31-20) 4 688 388, fax: (+31-20) 468 6008, or Mike Rowson at Medact: 601 Holloway Road, N19 4DJ, London, UK, tel: (+44-171) 272 2020 or fax: (+44-171) 281 5717.

Publications

Too Much Medicine? The Business of Health and the Risks for You

by Ray Moynihan, ABC Books, 1998, 308 pages, price: Aus$19.95 (about US$13) plus shipping, ISBN 0 7333 0652 7.

Are health care 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 health care 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 health care 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 health care consumers concerned about the risks involved in today's medicine.

To order a copy, contact: ABC Books, Australian Broadcasting Corporation, GPO Box 9994, Sydney NSW 2001, Australia.

Norplant in the Context of Population and Drug Policies

by Eeva Ollila, Research Report 99, University of Helsinki Department of Health, Finland, 328 pages, price: FIM118 or about US$20 plus postage, ISBN 951-33-0824-3, ISSN 1236-0732.

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.

To order, send US$20 plus postage to: STAKES, P.O. Box 220/Publications, SF-00531 Helsinki, Finland fax: +358-9-39672450.

Moving in from the Margin: Increasing Consumer Involvement in the Formulation and Implementation of National Drug Policies

HAI Africa/HAI Europe, price:NLG 25 (about US$12.50), ISBN no.:90-74006-11-16.

Health Action International (HAI) has published a report on its Regional Workshop on Networking for Rational Drug Use in Southern Africa, which was held in Johannesburg, South Africa from 31 May - 5 June 1998.

The most effective national drug policies are developed with input from the public. When the consumers of medicines and health care are left out, the policies usually end up serving the interests of the government health bureaucracies and the pharmaceutical industry meant to be regulated by government.

Since many African governments have already devised national drug policies, HAI organised a regional workshop focused on improving the policies' implementation, especially to increase consumer involvement. The meeting brought together 34 participants from 11 African countries to share experiences and expertise. They examined the strengths and weaknesses in national drug policy development and implementation, discussed ways to reduce irrational drug use and formulated strategies for improving consumer and NGO participation in national drug policies and for increasing rational drug use. This report summarises the participants' presentations, discussions and conclusions.

The workshop was the second in a series held by HAI's Africa Programme. Order the report by contacting the HAI Africa Programme currently located at the HAI Europe office. The price, including postage and shipping, is NLG 25 (approximately US$12.50). Copies of the first workshop report Fragile Economies, Flooded Markets can also be obtained for NLG 25 from the HAI Europe office.

Corporate Predators: The Hunt for Megaprofits and the Attack on Democracy

by Robert Weissman and Russell Mokhiber, Common Courage Press, 213 pages, ISBN 1-56751- 158-9.

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 health care, 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 health care. This book is a call to action for anyone concerned about corporate power in today's world.

To order, send US$11.21 plus shipping costs to Common Courage Press, PO Box 702, Monroe, Maine 04951, USA. It can also be ordered from the web at www.corporatepredators.org or by calling (in the US) 800-497-3207.

Development Dialogue : Focus on transparency The editors of Development Dialogue have published a special issue that explores development challenges for the 21st century, including a series of articles on combating secrecy surrounding medicinal drugs. Three drug policy experts who took part in writing HAI's "Uppsala Statement" on transparency and accountability in drug regulation in 1997 contributed to the issue. Ellen 't Hoen provides a new look at drug regulatory practices and policies within the European Union and developing countries. Charles Medawar and Graham Dukes examine the tradition of secrecy surrounding pharmaceuticals. Those interested in receiving a copy of the issue -- volume 1998:1, ISSN 0345-2328 -- should contact: The Dag Hammarskjold Centre, Ovre Slottsgatan 2, S-753 10 Uppsala, Sweden. Fax: (+46-18) 12 20 72 or e-mail: secretariat@dhf.uu.se

Editors of this issue: Dena Leibman and Lisa Hayes

Contributors to this issue: Danielle Bardelay, Daniel Berman, Babet Bonemeijer, Rose de Groot, Bas van der Heide, Ellen 't Hoen, Beryl Leach, Joel Lexchin, Barbara Mintzes, Ray Moynihan, Olle Nordberg, Eeva Ollila, Trudy van Ommeren, Bernard Pecoul, Kiran Sagoo, Jörg Schaaber, Philip Taylor, Patrice Trouiller, Jan-Evert Visser and Robert Weissman.

Design: Marit van Vliet

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