A WHO press release issued on 30 June stated "We estimate that 50% of the drugs coming into Albania donated by non-medical organisations are inappropriate or useless and will have to be destroyed. We are very concerned that some pharmaceutical companies are using this humanitarian crisis to get rid of unwanted stockpiles."

The situation in this war-torn region underlines an ongoing global problem that many drug donations do not meet the needs of the target population. "Donors and potential donors think any drug is better than no drug at all," said Dr. Hans Hogerzeil, coordinator of the World Health Organization's work on the inter-agency guidelines. "They need to respond to the needs. Drug donation practices should become much more professional. It is not for amateurs."

But having the guidelines in place is not enough to change practices. For two days in June, experts on drug donations from sixty organisations based in sixteen countries in Europe, North America, and Africa met in Leiden, The Netherlands, to discuss effective ways of raising awareness and improving donation practices. The meeting was co-organised by three European NGOs long active in the field of donations, the Dutch NGO Wemos, German group DIFAM and France's PIMED. A fourth coalition partner from Spain, Prosalus, was welcomed during the seminar.

"Although guidelines for drug donations have the potential to improve the quality of drug donations, major educational efforts are needed to actually implement these guidelines," said Mark Raijmakers, coordinator of the NGO consortium on appropriate drug donations.

Providing drugs in emergencies: Kosovo

Donations like those described above have occurred despite the fact that Albania adopted the inter-agency guidelines in 1998 and issued procedures on donations the following year. Many of the country's donations are based upon requests and government officials inspect shipping documents to ensure that such donations adhere to the guidelines' principles. Compared to the situation in Bosnia a few years ago, donations to Kosovo are an improvement said Gilles-Bernard Forte, an advisor for Central and Eastern Europe for the World Health Organization's (WHO) Programme for Pharmaceuticals. However, he estimated that about thirty percent of the drugs donated to Albania have been unusable. He blames the problem partly on the fact that many of the drugs sent were non-essential. And although the guidelines are in place, many donors are not keen on coordinating their work with others. He estimated that only twenty percent of the donated drugs sent to Albania (worth about US$9 million) went through formal donation channels organised by WHO and major relief agencies. Instead, a great deal of medicines crosses borders without any inspection and is delivered directly to refugee camps and health institutions. One consequence has been a huge increase in the number of retail shops in the country now selling medicines. Experts fear that the situation will be worse in Kosovo as refugees start returning home and there is no functioning governmental organisation to oversee donations there.

Donations after Hurricane Mitch

The same pattern emerged after Hurricane Mitch swept through Central America leaving more than 6,000 dead, 285,000 homeless, and many injured and without access to adequate health care services. At the time of the hurricane, one of the hardest hit countries, Honduras, had no donations policy in place. The lack of policy meant that health institutions had no regulatory framework on which to reject inappropriate donations. As a result, the country received a huge amount of unsolicited donations, many duplicate shipments and a large volume of medical samples. "In Honduras," said María Teresa Gago of the Pan-American Health Organization, "we have found that despite the good intentions of many charitable organisations, inappropriate donations were received. For example, pharmaceuticals were not in a familiar language, many donations had expired or were about to expire and some did not correspond to the country's disease patterns."

To deal with the tremendous amount of donations generated by international news reports, drugs and medical equipment had to be stored in giant warehouses until staff could sort through them. This took valuable time away from other needed tasks, Gago stressed. "It was a disaster situation itself" she said. Now that the initial crisis phase has passed, Gago said Hurricane Mitch has provided an opportunity for countries in the region to improve their supplies of essential drugs, including their policies on drug donations.

Donors and aid agencies: providing relief or problems?

"Donating drugs is more than putting some drugs in the boot of your car and driving to Kosovo", remarked Ed Vreeke, a consultant and one of the seminar's workshop moderators. However, very few rules exist regarding who can get involved in donations work and on what basis. For example, many of the US-based pharmaceutical companies which donate drugs may be doing it for less than altruistic reasons. According to one recent report: American companies are eligible for twice the normal tax deduction when they take part in a humanitarian effort. In this way, they can get rid of old or slow-moving products and save on disposal costs. At the same time, charities are under great pressure to show donors what a good job they are doing. Sometimes, companies will even increase the pressure by insisting that charities take unwanted donations as a condition for getting the things they really need. ⁽²⁾

Currently, there are no criteria detailing who can get involved in supplying drug donations. Some aid organisations may already be active in a country when an emergency hits. However, many are not present in the field, and send donations without knowing the actual, local situation. As Forte pointed out, "everyone wants to coordinate, no one wants to be coordinated."

A survey carried out by the World Health Organization (WHO) in May in the Former Yugoslavian Republic of Macedonia highlighted relief agencies' poor compliance with the inter-agency Guidelines for Drug Donations. In one donation examined, more than forty percent of the medicines were non-essential or did not comply with national standards. In total, thirty percent had already expired or had less than one year of shelf life remaining.

The different levels of experience and resources are also a major stumbling block to effective donations. Said Hogerzeil: "There are so many actors in this type of crisis. Many don't even have the means to collaborate or coordinate."

Making the guidelines work

Donations scenarios such as these emphasise the need for countries to implement the inter-agency guidelines. Developed three years ago and revised in March 1999, the guidelines remain unadopted by the United States and the members of the European Union (some of the largest donor countries.) However, the number of aid agencies endorsing the guidelines has continued to grow. A new revised version of the guidelines shows that international agencies such as the World Bank, the UN's High Commissioner on Refugees, UNAIDS, and Médecins Sans Frontières have now all signed on to the guidelines. But, as pointed out by Philippa Saunders of the Essential Drugs Project in the UK, "The guidelines only take you so far. Each endorsing agency then has to take on its own responsibility to help implement them. It's a lot more work than signing onto the guidelines."

At the seminar, Hogerzeil discussed the results of a review carried out by WHO after the guidelines had been in place approximately one year. "Within one year of their release, governments and organisations in more than forty countries, ranging from Australia to Zimbabwe, have adopted donations guidelines and are now using them. The fact that the guidelines have been taken up on a global scale shows that they were really needed. And the most important effect has been that many developing countries now feel empowered to say 'no' to certain drug donations even before they are shipped. Apart from preventing waste of resources and time, this also helps to prevent problems of disposal of unwanted drug donations, which is still such an issue after the war in former Yugoslavia." A copy of WHO's full report on the review will be available from WHO's Department on Essential Medicines and Other Drugs later this year.

Bad donations become chemical waste

In addition to the wasted staff time spent deciphering foreign labels and sorting through stacks of half-used pill bottles, the seminar participants discussed how recipients can properly dispose of inappropriate donations. According to international trade rules, most expired medicines are classified as chemical waste and often will not be accepted for return shipment by donor countries. This leads to a costly dilemma for recipient nations already in the midst of a crisis situation who must now dispose of often huge quantities of medicine in an efficient and safe way.

The price of this problem was recently felt in Bosnia-Herzegovina. According to a late 1997 report in the New England Journal of Medicine, as much as half of the donated medical supplies sent to this region during the war were of little or no use. As a result, more than US$30 million (more than US$2,000/ton) had to be spent to dispose of them. ⁽³⁾

WHO recently released inter-agency Guidelines for the Safe Disposal of Unwanted Pharmaceuticals in and after Emergencies. The document has already been endorsed by many of the major aid agencies. Based upon experiences gleaned from bad donations practices in Eastern and Central Europe, the booklet describes a number of simple disposal methods which pose minimum risks to public health and the environment which can be used when official assistance or advice is unavailable. "There certainly are simple and safe methods to dispose of unwanted drugs," said Dr. Robin Gray of WHO's Department of Essential Drugs and Other Medicines. "But how much better would it be to avoid the problem in the first place!"

New donations video launched

During the seminar, Mark Raijmakers of Wemos presented a new educational video on drug donations targeted at those involved in donations work, including relief workers and pharmacists. The video entitled "Making drug donations better with care" has been produced in Dutch and English. In the autumn of 1999, Spanish and German versions will also be produced. For more information about ordering a copy of the video, contact Wemos.

Meeting material

As one of its outputs, the seminar participants will collaborate on producing two informational booklets in major European languages that focus on raising awareness and improving donation practices. These publications (scheduled for release in October 1999) will be based on partners' experiences with drug donations and existing guides on dealing with drug donations. In addition, the NGO consortium has established a website in seven languages on drug donations (http://www.drugdonations.org).

To receive a copy of the seminar proceedings contact: Mark Raijmakers, Wemos, P.O. Box 1693, 1000 BR, Amsterdam, The Netherlands, fax: (+31-20) 468 6008.

References

1. Abelson, R. "Questionable medical aid being dumped in Kosovo," The International Herald Tribune, p. A1, 30 June 1999.

2. "Among US donations, tons of worthless drugs", New York Times, 29 June 1999.

3. "Inappropriate drug-donation practices in Bosnia and Herzegovina, 1992 to 1996" The New England Journal of Medicine, 337:25;1844.

Drug policy

Regulators post "dirty laundry"

The Estonian State Agency of Medicines launched a new website page in March which aims to make public all violations of advertising regulations and incidents of unethical drug promotion. Each violation is listed according to company and the corresponding law it has broken. The site also includes a listing of drug companies that repeatedly violated the advertising regulations or used unethical practices before the launch of the web page. To view the page, go to: http://www.sam.ee/violations/violations.html

(Correspondence received)

...and assessment data

The Dutch drug regulatory authority is now making assessment information on drugs approved under the European Union's mutual recognition procedure available on its website. The aim is to help health professionals understand the clinical background to recent decisions the agency made. "We have no (legal) obligation to publish an assessment report, but we are doing this after discussion with the industry representatives," said Dr. Frits Lekkerkerker to Scrip. Those interested can visit the website, http://www.cbg-meb.nl

(Scrip, No 2432:3, 28/4/99)

EU to add health department?

Romano Prodi, the European Commission's new President plans to make public health a higher priority. Early reorganisations of the Commission's structure will include a new department to handle public health and consumer protection issues. In response to such recent health scares as "mad cow disease" and dioxin contamination in some Member States, this move will, for the first time, bring public, animal and plant health together with consumer protection in order to improve the EU's coherence on such important issues. The expected director of the new unit will be David Byrne, the Republic of Ireland's attorney general for the past two years.

Earlier this year, members of the European Parliament have urged the European Commission to establish a specific department handling public health issues. The proposal would place such a unit under the responsibility of one of the Commission's twenty commissioners to ensure that health matters were considered in all areas of European policy. Although responsibility for arranging and delivering health services would remain with the Member States, such a change would help countries ensure "a high level of human health protection" as set out in the Amsterdam Treaty.

(British Medical Journal, 319:214 and 318:893)

The Internet and medical product information

To follow up on the World Health Assembly resolution passed in 1998, WHO held a consultation on finding reliable information on medical products using the Internet this spring. Markus Fritz of the Swiss Drug Information Centre in Basel attended the meeting on HAI's behalf as part of a small group of regulators, WHO staff and industry representatives.

During the two days of the meeting, the working group debated the text of a draft guide aimed at helping consumers in Member States find solid information via the Internet. A final text is expected shortly. Copies of the group's draft text can be obtained from the HAI Europe office.

Drug promotion

EU opening door to DTC ads?

Calling the current ban on DTC advertising "out of phase with world developments," the head of the European Commission's pharmaceuticals unit in the industry directorate, Patrick Deboyser, has recommended creating a task force to re-examine the region's ban on DTC ads. While he thought that any change was still five to ten years away, Patrick Deboyser said he thought companies had some room to manoeuvre in the meantime.

(Scrip, No. 2433:5, 30/4/99:5)

ISDB rejects EU proposal to join DTC initiative

European members of the International Society of Drug Bulletins (ISDB) were recently invited to join a new EU working group on direct-to-consumer information on prescription drugs to be disseminated by industry. In their formal letter to the EU's Directorate General III (the division of the European Commission in charge of industrial affairs) rejecting such participation, ISDB stressed that good quality information on prescription drugs should be made available for consumers but must be produced independently from the drug industry. It also emphasised the fact that industry information is not aimed at informing patients as much as increasing drug sales. In its response, ISDB also flagged its concern that allowing industry to produce and distribute information directly to consumers that goes beyond simple labelling bypassed health professionals who are a key component to rational drug use.

(Correspondence received)

BMJ opposes DTC advertising

In a strong editorial, the British Medical Journal called direct-to-consumer advertising in the United Kingdom "an idea whose time should not come." In contrast to an earlier editorial published in The Lancet which favoured DTC advertising, the BMJ called attention to the difference between independent drug information which empowers patients and advertising texts "designed to create demand, in order to maximise profits." It also emphasised the huge amounts of money already put into promotion targeted at doctors in which "pharmaceutical companies provide far less education than jargon and promotion, and many claims prove to be inaccurate or misleading." The editorial reminded readers that doctors have a primary responsibility to act in their patients' best interest which companies do not share. It concluded "though improving the public health may be seen as a desirable byproduct of company activities, concerns about health care cannot take precedence over profits: when the two goals conflict, profit must win."

(British Medical Journal:318:1301, 1999)

No free lunch

A group of US-based physicians are encouraging their peers to just say no to drug promotion. The New York City-based group works mostly with working class and indigent patients and is using their anti-promotion campaign to raise needed funds to help cover medication costs for their clients without insurance. As their website explains, "There is ample evidence in the literature-contrary to the beliefs of most health care providers-that drug companies, by means of samples, gifts, and food exert significance influence on provider behaviour. It is time to Just Say No to drug reps and their pens, pads, calendars, coffee mugs, and of course, lunch (not to mention dinners, basketball games, and ski vacations.) The site provides a list of required reading on pharmaceutical promotion as well as links to other groups working on this issue around the world. In an interesting feature, the site also reports on recent medical meetings and describes the role played by promotional activities. Visit the site at: http://www.nofreelunch.org

Dutch drug sales by Internet

Want to order a drug not yet available in your country? Researchers in The Netherlands found out this was not very hard to do. Although it was already available in other European countries, the fat-fighting pill orlistat (Xenical) was not yet on the Dutch market (even by prescription only) when the research was done. The Dutch Consumers Union (Consumentenbond) ordered a month's supply of the drug via the Internet after filling in a short health questionnaire. One week later, a package containing 84 pills was ready for pick-up at the local post office. The price was UKŁ159 (approximately US$ 262). Consumentenbond concluded that not only was there no medical control about who could order such pills but that the price was approximately three times that found at a pharmacy.

(Gezond Nieuwsbrief Consumentenbond, No. 2)

Campaigns

Dipyrone update

This spring, the Swedish Medical Product Agency and manufacturer Hoechst Marion Roussel Ltd. agreed that national sales of the drug metamizole (Novalgin) would stop at the end of April. Stocks in pharmacies, hospitals and clinics were to be withdrawn. A letter to Swedish doctors and dentists based the decision on the fact that a larger than expected number of reports of agranulocytosis had been reported in the country since 1996. Agranulocytosis is a lack of granulocytes (white blood cells) which are a crucial defence against infection. The condition can be fatal.

The drug was available on the Swedish market from 1934-1974 when it was withdrawn because of agranulocytosis reports estimated at an incidence of 1/3,000. It was re-licensed for "short-term management of acute, moderate to severe pain secondary to tissue damage eg after surgical procedures and colic pain eg from urinary or biliary tract" partly due to the results of a large epidemiological study that showed a much smaller risk of agranulocytosis than previously reported. Since its reintroduction, seven cases of agranulocytosis have been reported and the Medical Products Agency estimates that the actual incidence of this problem is 1/1,700 which is higher than expected.

The drug remains available in many countries around the world. Some reports have stated that the drug is available over-the-counter in many parts of Central and Eastern Europe. A recent series in the Los Angeles Times reported that dipyrone is the most common medicine sold to Mexican immigrants by illegal back-room pharmacy shops in California near the US-Mexican border, although the drug was withdrawn from the US market in 1977.

HAI to gain access at EMEA

HAI has been designated as an "interested party" by the European Medicines Evaluation Agency (EMEA). With this new official status, HAI will have greater access to information from the EMEA and will be able to participate in more of its work. For more information about HAI's work at the EMEA, contact the HAI Europe office.

EMEA documents now on-line

The EMEA has added a catalogue of public documents to its internet website. While the current list only describes those documents available to the public, the agency plans to expand the list to include the titles of some restricted and confidential documents, although the actual document will not be released.

The agency has also produced a CD-Rom containing the publications data. While it is presently only available to subscribers of the EMEA documentation service, the agency is planning to make it available to the wider public due to great demand. Updates on its availability can be found at the agency's website: http://www.eudra.org/emea.html

Concerns raised about US FDA standards

US Food and Drug Administration (FDA) medical officers claim the agency's standards for approving new drugs have been lowered in recent years, allowing drugs to be approved that should not have been, according to a new report released by Public Citizen's Health Research Group.

Nineteen medical officers identified 27 new drugs they had reviewed during the past three years and thought should not be approved, but were approved anyway. In addition, 17 medical officers said the FDA's current review standards for safety and efficacy were "lower" or "much lower" than those in existence before 1995.

"Our findings are shocking by any yardstick," said Dr. Sidney M. Wolfe, Director of the Health Research Group and the study's co-author. "Subtle and not-so-subtle pressure is being brought to bear on FDA physicians who dare to question a drug's safety. Sometimes their safety objections are simply ignored or overruled."

The study also reports that eight medical officers described 14 instances in the past three years in which they had been told not to present their own opinion or data to an FDA Advisory Committee when doing so might reduce the drug's chances of being approved.

The study was conducted during September and October 1998. It followed two new records for the agency. Ninety-two drugs were approved in 1996 and 1997, the largest number ever for a two year period. And three new prescription drugs were banned during a 12-month period because of concerns about safety. Public Citizen reports that for all three of these drugs, dexfenfluramine (Redux), mibefradil (Posicor) and bromfenac (Duract) data available prior to approval raised significant safety concerns and the drug did not offer any real advance over existing choices.

To obtain a copy of the study, visit the Health Research Group's website: http://www.citizen.org or contact the organisation at: tel: (+1-202) 588 1000 or fax: (+1-202) 588 7796.

Every other German drug is illegal

The European Union has requested the German government to take urgent action to stop the sale of grandfather drugs. In response to the 1960s thalidomide tragedy, EU countries agreed to a directive which would make checking drugs for safety and efficacy before marketing compulsory (EEC 65/65). Most member state introduced such drug legislation in the early 1970s.

However, Germany's Medicines Act only came into force in 1978. It allowed the sale of drugs which had already been on the market before that date to be continued and a process of re-evaluation was started. This process has been slow and as of 1998, 22,000 drugs remained unchecked for safety and efficacy. The EU Commission has now ruled that this re-evaluation should have ended by May 1990 and that a period of 15 years was long enough to complete this task. It has stated that the continued marketing of these drugs is "a severe breach of compulsory community legislation." The Commission has also ruled that the sales clause of the German law which permits companies to continue selling grandfather drugs without any controls until January 2005 if the company then stops sales after that date is "in sharp contradiction to existing EU law." The EU Commission has asked the German government to change its legislation quickly. If it does not do so, the Commission can call on the European Court of Justice which can set binding rules and order a heavy fine.

The new German government has reacted to the Commission's demand by drafting an amendment to the drug law. The "sales clause" will be revoked and all drugs which used the clause (approximately 8,000) must go back into the registration process or be taken off the market. The time companies have to do this will be reduced from 18 to six months. This should reduce delays in the decision-making process companies created by simply withholding necessary data. The new draft law is heavily opposed by the over-the-counter (OTC) industry which sells most of the grandfather drugs directly to consumers. Industry is especially unhappy with a clause within the proposed law which would mean all grandfather drugs must be labelled "provisionally licensed."

A background paper on grandfather drugs can be ordered from BUKO Pharma-Kampagne, August Bebelstrasse 62, D-33602, Bielefeld, Germany.

(Correspondence received)

Rational drug use

New directions in self-medication?

The World Self-Medication Industry (WSMI) annual meeting in Berlin this June highlighted the theme "Self-care: a vital element of health policy in the information age." Speakers argued that self-medication empowers consumers to take more responsibility for their own health care and reduces the strain on limited health care resources.

Dr. Gro Harlem Brundtland, Director General of the World Health Organization (WHO) gave the keynote address. She said that self-medication has to be seen within a global public health perspective: one-third of the world's inhabitants continue to have no access to essential drugs and face high levels of poverty and illiteracy. She suggested that self-medication can help the management of symptoms and conditions that do not require medical supervision, such as helping smokers quit.

The increasing numbers of products switching from prescription-only to over-the-counter status was another key focus of the meeting. It emerged in the debate that very few comparative data exist about most self-medication products (other than those previously available only on prescription.)

A copy of the meeting report "World Self-Medication Industry, Guiding Principles in Self-Medication" can be obtained from: WSMI, 15 Sydney House, Woodstock Road, London W4 1DP, United Kingdom.

Drug information

Promoting independent information in Central Europe

The Moldova-based group Association DRUGS held a three-day international conference entitled "Modern aspects of professional drug information" from 22-24 June. The meeting was organised in collaboration with the United States Agency for International Development, United States Pharmacopeia, Management Sciences for Health and the WHO.

On its opening day, approximately 450 physicians, pharmacists, nurses, government officials, NGO representatives and journalists took part. Practical workshop sessions drew 130 participants from Moldova, Ukraine, Russia and Tajikistan. Representatives from these countries discussed information for health professionals and consumers, developing drug formularies, adverse reaction information and held a special session on children and medicines.

Discussions on information for consumers caused the most excitement among the participants including doctors, who until recently did not want to speak about this topic. Doctors pointed out their own concerns about receiving adequate information about drugs citing problems with buying expensive new medical text books and also having fundamental problems in accessing computers and sufficient electricity to use them.

Immediately following the meeting, 25 people participated in a workshop on editing independent drug bulletins. The aim was to improve drug bulletins produced by members of the All-Russia Drug Information Network (ARDIN). At present, twelve drug information centres within the Russian Federation comprise the membership. For more information about the meeting, contact: Natalia Tchebotarenco, Association DRUGS at e-mail: natalie@drugs.mldnet.com.

Spanish-language e-drug launched

Spanish speakers wishing to join discussions on essential drugs and drug policy, can now join the Spanish-language e-mail discussion group "e-medicamentos". Those interested in signing up, should send an e-mail message to: e-medicamentos-subscribe@egroups.com.

Material promoting rational drug use now on web

The materials developed while conducting more than a decade of Promoting Rational Drug Use (PRDU) courses held in Asia and Africa are now available on the web. To view the material available, go to: http://www.dcc2.bumc.bu.edu/prdu/default.html

Portuguese Med-Sense published

HAI is pleased to announce that its publication Med-Sense is now available in Portuguese. HAI contact Karen Ferreira of the Portuguese Pharmacists Association (ANF) kindly translated the text. The Med-Sense boxes contain drug information sheets on common types of drugs and rational drug use principles. They will be distributed widely in Lusophone Africa as part of the HAI Africa network's core activity of increasing access to important reference materials and information to raise public awareness on rational drug use in Africa. HAI contacts within Europe who would like to order copies, should contact the HAI Europe office.

Pharmaceuticals and Trade

Upcoming meeting on globalisation and access to needed medicines

HAI Europe, Médecins Sans Frontières and Consumer Project on Technology will co-organise a 1 ˝ day conference on 25-26 November entitled "Globalisation and strategies for increasing access to essential drugs." The conference will follow up on the collaborators' March meeting on AIDS, essential drugs and compulsory licensing as well as key issues within the Revised Drug Strategy resolution adopted at this May's World Health Assembly. The conference will directly precede HAI Europe's annual meeting and will be held one week before the next Ministerial Conference of the World Trade Organization in Seattle (US).

The organisers expect approximately 300 representatives from public interest NGOs, policy makers, European Parliamentarians, drug policy experts, health economists, academics, researchers, pharmaceutical manufacturers, World Health Organization staff and others to discuss strategies to increase access to essential medicines in an increasingly globalised economy.

For more information about the meeting and to receive the preliminary programme, contact the HAI Europe office or visit its campaigns page announcement of the meeting.

US Vice President charged with opposing access to essential drugs

The Consumer Project on Technology (CPT) has written to US Vice President Al Gore about his role in pressuring South Africa and other developing countries during their struggle to obtain access to essential medicines.

The letter describes the huge impact diseases such as HIV/AIDS have had on the population and criticises current US trade policy which opposes the use of compulsory licensing and parallel importing among other measures aimed at reducing drug prices. James Love, the letter's author and director of CPT, writes "It is shocking that the US government is adapting such an aggressive trade policy on behalf of US pharmaceutical companies, when all of sub-Saharan Africa is confronted with a public health crisis of historical dimensions."

CPT is not alone in its criticism of the US official. Following on momentum built at the WHA in Geneva this May, US-based AIDS activist groups have been outraged by Gore's role as co-chair of the US-South African Binational Commission which, according to a US State Department report, headed "an assiduous, concerted campaign" to stop South Africa from making needed low-cost AIDS drugs available to its citizens. In response, they have organised effective protests on the issue at numerous Gore campaign stops as he begins his candidacy to be the next US President. The need to change policies and make essential drugs more accessible was also the theme of a letter written by Ellen 't Hoen published in The International Herald Tribune in June.

Recently, the vice president wrote to the US Congressional Black Caucus (a powerful group of African-American Parliamentarians) endorsing the use of parallel imports and compulsory licensing. This was done knowing of the group's support to make needed medicines more available to consumers in Africa. US groups are now seeking clarification of Gore's position on the subject. This debate marks the first time that there have been US demonstrations on intellectual property issues and that such an issue has been a core component of a US Presidential campaign. For more information, visit CPT's website: http://www.cptech.org

(Correspondence received)

Consumer dialogue group sets out recommendations

More than sixty consumer leaders from the European Union and the United States met in Brussels last April as participants in the Transatlantic Consumer Dialogue Group (TACD). As part of their agenda, they set out a number of recommendations for the governments of the US and EU, including ideas on trade and health. The priority concerns include requiring that countries involved in a WTO dispute be allowed to request a report from WHO on the public health aspects of the policies, and that countries not be allowed to bring trade sanctions against poor countries attempting to use parallel imports to obtain inexpensive medicines for their citizens. They also highlighted the possibility of using compulsory licensing to increase access to essential medicines.

TACD has now created an informal pharmaceuticals sub-group on which HAI has gained "contributor" status. Members of the network interested in receiving a complete listing of the group's recommendations and more background information about its work, can contact the HAI Europe office. More information about the dialogue's work can be found at its website.

Calendar

16-18 September, Amsterdam

International Society of Drug Bulletins (ISDB) International Conference, Amsterdam

1-3 October, Jerusalem

European Drug Utilization Research Group (EURO DURG) annual meeting

5-9 October, Rome

Cochrane Colloquium (more information can be obtained from its website: http://www.areas.it/Roma99)

25-26 November, Amsterdam

HAI/MSF/CPT Conference on Globalisation and Access to Essential Drugs

26-28 November 1999, Soesterberg, NL

HAI Europe Annual Meeting

30 November-6 December 1999, Seattle, US

WTO Ministerial Meeting

Publications

Responsibility for Drug Induced Injury (second edition)

Edited by G. Dukes et al., 1998, 372 pages (hardcover price NLG 260 (US$125))

ISBN no.: 90-5199-387-0

Adverse effects are a constant source of medical problems but also of professional and legal confrontations. More than a quarter of all malpractice suits brought against physicians or other health professionals revolve around drug injury; for drug manufacturers, civil cases brought by patients are a growing problem. Where conflicts do not reach the courts they are often the subject of settlements or of decisions taken by professional disciplinary councils.

This book analyses and documents the responsibilities which all parties bear in law and ethics to render drug treatment as safe as possible, and the liability which arises when injury is caused. Special attention is given to the apportionment of liability, where faults may have been made by more than one party and to the establishment of facts in a field where the evidence is likely to be heavily challenged. The approach is global, since drugs, their manufacturers and their users are much the same across the world. In addition, systems of law and ethics have borrowed solutions from one another while in some parts of the world--notably in consultations between the United States, Europe and Japan-medicinal policies and regulation are in the process of being harmonised.

The book is divided into 21 chapters: six chapters document the general medical and legal background to drug safety and injury; seven chapters then describe the duties and liabilities of the concerned parties including health professionals, governments and consumers. The remaining eight chapters provide in-depth guidance on special issues such as drug injury to the unborn child, vaccines, liability in alternative medicine and existing compensation schemes.

To order, contact: IOS Press, van Diemenstraaat 94, 1013 CN Amsterdam, The Netherlands, tel: (+31-20)638 2189, fax: (+31-20) 620 3419 or visit their website: http://www.iospress.nl.

Worst Pills, Best Pills, Public Citizen, 1998, price US$16

Preventable adverse drug reactions afflict more than two million consumers in the United States alone, killing 100,000 and hospitalising 1.5 million each year. Often these effects occur because people do not know how to protect themselves from dangerous drugs or drug combinations.

To inform consumers in the US and beyond, Public Citizen has released a new edition of its book Worst Pills, Best Pills: A Consumer's Guide to Avoiding Drug-Induced Death or Illness. It includes in-depth profiles of 456 commonly used drugs, categorised by the type of treatment for which they are prescribed. It also lists 160 drugs that consumers should not take at all-either because they are considered too dangerous or are ineffective-and provides safer alternatives.

More information about the book can be obtained by visiting its website: http://www.worstpills.org where the book can be ordered with a credit card. It can also be ordered by sending a bank cheque or money order to Public Citizen, P.O. Box 9140, Gaithersburg, MD, 20898-9140, United States.

Effective Communications in Pharmacovigilance: The Erice Report, the Uppsala Monitoring Centre

ISBN no. 91-630-6957-1

The meeting upon which this report is based brought together 69 participants from thirty countries representing all players in the field of pharmacovigilance (doctors, lawyers, industry, regulators, media and consumers). It focused on the many problems associated with communicating drug safety information, including: gathering and disseminating safety information on all known medicines, defining drugs and medicines, improving adverse effect reporting, exploiting new information technology, targeting specific groups for education efforts, formulating a good communications practice that is internationally recognised and pursuing related research.

Copies of the report can be obtained from: the Uppsala Monitoring Centre, tel: (+46-18) 65 60 60, fax: (+46-18) 65 60 80 or e-mail: info@who-umc.org.

The Ties That Bind: Weighing the risks and benefits of pharmaceutical industry sponsorship, HAI Europe, price NLG 20

ISBN no.: 90-74006-10-8.

Today public funding for health care initiatives is steadily declining. As a result, many health-related NGOs are debating whether or not to accept funding from the pharmaceutical industry. But is this path so unavoidable and so easily managed into a win-win situation for both industry and health-promoting NGOs? HAI Europe held a one-day seminar to explore this issue and promote discussion between NGOs that do accept industry funding and those who are opposed to it. This report describes the presentations made during the day and the lively debate among the participants. It highlights specific concerns surrounding industry sponsorship and some of its possible consequences for NGOs.

Copies can be obtained from the HAI Europe office.

Practical and Ethical Dilemmas in the Clinical Testing of Microbicides: A report on a symposium, Ed. Lori Heise, et al. International Women's Health Coalition, NY, 1998, 89 pages.

At a time of dire predictions about the spread of HIV and sexually transmitted diseases (STDs), particularly among women in the developing world, this report discusses some of the complex and controversial issues surrounding the development of HIV prevention technologies. Its contents focus on fundamental issues regarding trial design, standards of care, community involvement and informed consent concerning this new area of research. The report focuses on women-controlled prevention of HIV and sexually transmitted diseases and contains recommendations for action and useful addresses for those working in this field.

To receive a copy of the publication: contact: Virginia Kallianes, Population Council, Robert Ebert Program on Critical Issues in Reproductive Health, 1 Dag Hammarksjold Plaza, New York, NY, US, 10017, tel: (+1-212)239 0625, fax: (+1-212) 755 6052 or e-mail: vkallianes@popcouncil.org.

Prescription for Disaster: The hidden dangers in your medicine cabinet, by Thomas J. Moore, Simon & Schuster, 1998, 271 pages, price: US$25

ISBN no.: 0-684-82998-3.

If we are to believe the pharmaceutical industry, we are in a Golden Age of pharmacology. Never before have so many benefited so much from so wide a choice of medication. Generally speaking, modern prescription drugs are "safe and effective."

For those who have always swallowed the above, Prescription for Disaster will come as quite a shock. According to its author, Thomas Moore, a senior research fellow at George Washington University Medical Center, no fewer than 100,000 Americans die each year as the direct result of taking "magical bullets." For many more, a doctor's prescription is the beginning of a lifetime of disability. The risk of being injured by a pill is ten times higher than being injured in a car crash.

To avoid misunderstandings: Moore is neither a sensationalist nor an alarmist. He fully recognises that drugs can be very beneficial. But this does not mean that we should close our eyes to the other side of the coin. Prescription for Disaster is a strong appeal for a safer and more rational drug use.

Moore starts several chapters of his book with harrowing accounts from victims of medication, but he does not confine himself to anecdotes. Throughout the book, there is plenty of scientific evidence of the hazards of drugs. That is to say, as long as this is available. For with a mix of hardly hidden anger and amazement, Moore concludes that neither the pharmaceutical industry nor the regulatory bodies seem to be very keen on really looking into the matter. Why is it not obligatory for doctors, he wonders, to report adverse reactions (in one study cited by Moore only 11 of 26,000 adverse reactions were reported to the FDA). Why do regulatory bodies remain passive even when they do get huge numbers of reports, why are the testing periods for new drugs so short, why is post-marketing surveillance so shockingly inadequate?

Moore does not only offer a keen analysis of the problems, he also makes valuable suggestions to "fix the system". Furthermore, he instructs patients on how to discuss medication with their doctors.

In his book, Moore covers a wide range of potentially dangerous drugs (antihistamines, antidepressants, painkillers, narcotics, calcium channel blockers, to name but a few), but unfortunately he uses brand names only. For non-Americans, this makes recognition sometimes a bit difficult.

Moore is considered one of the best medical authors of the moment. It is easy to see why. In my opinion, Prescription for Disaster is not less than a must for anyone genuinely interested in public health matters. If this book were mandatory reading for doctors and patients alike, public health would be much the better for it.

(Review written by Frank van Meerendonk)

Guide to drug financing mechanisms

by Jérôme Dumoulin, et al. World Health Organization, Geneva. 1998, 55 pages, price: Sw. fr. 19, price in developing countries: Sw. fr. 13.30.

ISBN no.: 92-4-154509-7.

Drugs are a fact of life in health services the world over. Yet half the world's population lacks regular access to necessary drugs. Ensuring that safe and effective drugs are accessible to those who need them is a responsibility of governments, but many factors-economic, legal, cultural and political-influence drug accessibility.

While touching on all of these issues, this book deals particularly with economic influences on the pharmaceutical sector. It looks in detail from an economic perspective at drug selection, procurement, distribution and prescribing. It describes different approaches to each of these steps, listing the benefits and disadvantages in differing situations.

In many places drug supply is a haphazard process that reduces the effectiveness of health services and does little to improve health yet costs a great deal. The authors urge those involved in a national drug supply system to examine the way drug supply is financed and organised and, in light of the policies and strategies described here, to make sure the system reflects the most rational approach for their situation.

Copies are available from: Distribution and Sales Office, WHO, 1211 Geneva 27, Switzerland.

A different prescription: Considerations for women's health groups contemplating funding from the pharmaceutical industry, by Anne Rochon Ford, 1999, price CDN$5

Women's health NGOs know a lot about struggling to stay afloat at a time when funding competition is fierce. In this booklet, Ford uses the experiences gained by a number of women's health organisations in Canada to set out broader recommendations for all NGOs facing the dilemma of accepting industry funding or not. She also explains why industry is so eager to set up "partnerships" with such groups and emphasises the long-lasting effects such cooperation can mean for both individual groups as well as the women's health movement in general.

To order a copy, contact: National Network on Environments and Women's Health, 214 York Lanes, York University, 4700 Keele St., Toronto, ON, M3J 1P3, Canada or e-mail: nnewh@yorku.ca.

WHO "blue book" available from HAI

WHO's publication Globalization and Access to Drugs: Perspectives on the WTO/TRIPS Agreement was used with great success at this year's World Health Assembly to provide additional information to national delegates about the trade and health issues included in the resolution on the Revised Drug Strategy. HAI Europe now has extra copies of the "blue book" available in both English and French for contacts who wish to use the books to carry out WHA follow-up at the national level. To receive copies, contact the HAI Europe office.

Contributors to this issue: Danielle Bardelay, Babet Bonemeijer, Graham Dukes, Karen Ferreira, Anne Rochon Ford, Rose de Groot, Bas van der Heide, Andrew Herxheimer, Ellen 't Hoen, Annemarie Jurg, Beryl Leach, Jamie Love, Frank van Meerendonk, staff of No Free Lunch, Public Citizen's Health Research Group, Mark Raijmakers, Kiran Sagoo, Jörg Schaaber, Staffan Svensson, Natalia Tchebotarenco, and Tracy Weber.

To receive more information about HAI or to subscribe to this newsletter, contact the HAI Europe office.