Drug Policy

WHO/NGO Roundtable

HAI Europe's coordinator organised the fourth meeting of the WHO/NGO Roundtable on Pharmaceuticals in cooperation with WHO staff this October. Representatives from various international NGOs met with the Director General, WHO cabinet members, regional and Geneva-based staff to raise concerns about WHO's policy on public-private interactions, access to needed drugs, direct-to-consumer advertising, the International Conference on Harmonisation (ICH), the revision of the essential drugs list and other issues. HAI Europe's coordinator also facilitated work on two technical projects started by the Roundtable's members on drug pricing and drug promotion.

Drug Promotion

Industry influence on drug trials: news from Canada

Industry efforts to control or prohibit the publication of medical research findings received a blow in October when the Canadian Committee of Inquiry examining the dispute between Dr. Nancy Olivieri (Hospital for Sick Children and the University of Toronto) and the company Apotex urged stronger measures to protect patient rights and ensure clinical trials are free from manufacturers' influences.

Apotex, the sponsor of Olivieri's clinical trials of its drug, tried to suppress her finding of unexpected risks. It also stopped the trial and threatened to take legal action against her if she attempted to inform her patients of her findings or publish them. Public health advocates accused the University of protecting its own financial interests instead of its staff member. In its report, the Committee found that Olivieri had acted ethically. It also said the company and some members of the hospital and university staff had falsely accused her of misconduct. The hospital had used these allegations as the basis for serious public actions against the doctor and Apotex used the hospital's actions to defend the reputation of its drug. "The Hospital and University should have defended vigorously the right of clinical researchers to disclose risks to research subjects and patients. They had a responsibility to protect the public interest and academic freedom from inappropriate actions by Apotex, but they did not do so" said Committee member Dr. Patricia Baird. The Committee's report included 31 recommendations to improve conflict of interest in medical research.

More information about the case and the committee's full report can be downloaded at: http://www.dal.ca/committeeofinquiry/

(Committee of inquiry media release, 26 October 2001)

Failing grade for Russian drug ads

The arrival of drug advertisements for health professionals in Russia has brought little information and has been potentially damaging, a recent study suggests. In one of the first investigations of the quality of drug ads in post-Soviet Russia, researchers scrutinised almost 400 ads to determine the quality of their content. Of the 397 advertisements examined, only about 40% mentioned the drug's generic name and only 11% included any safety warning or contraindications. In total, only eight adverts (2%) mentioned any medical references for the given claims.

Faced with such data, the researchers concluded that almost none of the ads published in the five major Russian medical journals inspected provided the needed information for appropriate prescribing. The authors pointed out that sudden political and economic changes have left both Russian health professionals and consumers without training in judging advertising. For this reason, they can be easily misled by drug promotion. The country's economic situation currently makes it impossible for regional authorities to regulate such advertising. And doctor's low salaries can make them vulnerable to accept rewards for prescribing advertised drugs. "Even the low standards of the IFPMA code are rarely achieved in Russia," the study said, concluding, "pharmaceutical companies appear to be exploiting Russia's lack of defenses for short-term gain at the expense of health care in Russia."

(Vlassov, V. et al. "Do drug advertisements in Russian medical journals provide essential information for safe prescribing?" West J Med Vol. 174, June 2001)

Keeping a healthy distance?

The American Medical Association's (AMA) new leader, Michael D. Maves, has drawn heavy criticism from public health groups in the United States. Maves was executive vice president of the American Academy of Otolaryngology-Head and Neck Surgery from 1995 until 1999 and has held a number of academic positions. However, he was also the head of a powerful industry group representing over-the-counter medicine manufacturers and dietary supplement producers. His position with the Consumer Healthcare Products Association has put him at odds with some of the AMA's own standpoints on issues such as its call for reporting of serious side effects linked to supplement use and pre-screening of supplements for safety and effectiveness before they enter the market. Consumer advocate Sidney Wolfe of the US consumer group Public Citizen called his hiring "unbelievable" and said "We'll be going back to the 19th century, where snake oil and medicine were synonymous."

The AMA's troubles don't stop there. Earlier this year, the AMA's one million dollar campaign aimed at making US doctors more aware of its guidelines against accepting pharmaceutical company gifts came under fire as most of the initiative's funding came from the drug industry. Nine multinational companies were found to be footing about US$700,000 of the total campaign's budget, which targets doctors, medical students and drug company representatives. Although the AMA's guidelines on promotion and gifts were first introduced in 1992, increased public concern about company practices fueled this new effort. Such concern is related to the fact that last year drug companies spent almost US$16 billion on marketing, drug promotion to doctors by company reps made up US$4 billion.

(Okie, S., Washington Post, 29 August 2001, British Medical Journal 2001;323:1268)

French drug reps fail

Questionnaires collected about medical representatives' visits to a group of French health professionals between March 2000-March 2001 show a universal decline in the quality of medical visits, according to the French drug bulletin La revue Prescrire. Although pre-launch visits decreased, Prescrire believes this was due to the fact that such visits are now targeted at hospital doctors and the public instead. In total, only 68% of the indications promoted conformed to the summary product of characteristics (SPC) as compared to 79% in 1997. Warnings about risks were overlooked many times. Reps included them in only 10% of the visits. They talked about drug interactions in only 8% of the visits and completely denied them in 6%. Reps discussed adverse effects in 10% of the cases and dismissed them completely in 9%.

This year's findings concluded that medical reps were less and less likely to supply documents about the drugs they were promoting (only 17%). Only a few gave out copies of the statement devised by the French Transparency Commission that compares a drug to other medicines in its class. Distributing this statement is a legal requirement for all medical reps. The statement uses a scoring system to show benefit and cost effectiveness. This statement was only used in 2% of cases reported by Prescrire's group of doctors. Some reps said they didn't know about the existence of the statement, others said they didn't have a copy or that the statement was unavailable. Some promised to send it to the doctor, but never did.

(Prescrire International, October 2001, Vol. 10, No. 55)

Campaigns - Access: Trade and pharmaceuticals

WTO agreement on TRIPs

A group of more than 80 developing countries led by the African bloc and supported by public health advocates claimed victory in gaining commitments from wealthy nations on ensuring public health protection above patent rights. The 142 countries participating in the meeting clearly affirmed governments' ability to take all necessary measures to protect public health. A declaration on TRIPS and public health adopted by the country delegates clearly recognised the potentially dangerous side effects of the TRIPS agreement and gave teeth to measures that countries can use to override them. These measures include the right to grant compulsory licenses (overriding patents) and the freedom to determine the grounds upon which these licenses are granted. The declaration text highlighted the fact that these situations are not limited to emergencies. Despite the fact that the pharmaceutical industry had called on countries to allow language addressing health crises such as HIV/AIDS, the final text is much broader and could be interpreted to allow compulsory licensing for diseases such as cancer and diabetes. The text states that countries have a right to determine what constitutes a national emergency and when countries do declare an emergency they can override the patent without prior negotiation with the patent owner. Jamie Love, director of the Consumer Project on Technology, called the declaration "the strongest and most important international statement yet on the need to refashion national patent laws to protect public health interests."

The Doha declaration also reaffirms countries' freedom to decide on their own rules for implementing parallel imports (shopping around for the best price of a branded drug on the global market). Plus, least developed countries received a 10-year extension to become TRIPS-compliant, moving the deadline to 2016 for this group.

While strong opposition about more flexible wording on TRIPS and public health came from the US, Japan and Switzerland during the meeting, their arguments about protecting patents were severely weakened by the US's recent threat to override Bayer's patent on the drug Cipro used to treat anthrax. The threat was withdrawn after the company drastically reduced its price for the US government. "We constantly reminded delegates of anthrax" said Paulo Teixeira, Brazil's highest-ranking AIDS official.

Still critics of the declaration managed to halt some wording that would have given poor countries more leverage. One key issue that remained unsolved in Doha was how poor countries lacking capacity to produce cheap, generic drugs can gain access to needed medicines. Many public health NGOS were pushing for the declaration text to include safeguards allowing such nations to import needed medicines from countries such as Brazil and India which have a strong domestic production capacity. "Wealthy countries and drug companies refuse to compromise patent monopolies in poor countries with no domestic capacity," explained Gaelle Krikorian of ACT UP Paris. "The declaration does nothing to remedy this barrier. The majority of people with AIDS and other treatable diseases live in these countries, so a solution is critical." The Doha participants called on the WTO's TRIPS Council to take up the issue next year.

The EU's role in Doha and before the meeting also revealed division among its member states. Shortly before Doha, members of HAI Europe attending its annual meeting, drafted a letter to EU Trade Commissioner Lamy, urging him to support a declaration that clearly placed health concerns over trade. After Doha, Nicole Metz of the Dutch NGO Wemos expressed disappointment at the EU's role in the negotiations on access. "Although EU Trade Commissioner Lamy and Dutch Minister for Foreign Trade Ybema had said at various public events before the WTO Conference that they favoured compulsory licensing in Qatar they kept their mouths shut," she said. During the Doha negotiations, the EU tried to play a brokering role between the US, Japan and Switzerland on one side and the developing countries on the other. Metz said "Although we appreciate the fact that the EU has put so much energy into the process of building a consensus, the Union itself has been too neutral."

Now with the WTO conference completed, Zafar Mirza, executive coordinator of The Network for Consumer Protection in Pakistan and Health Action International's representative at the meeting focused on the challenges still ahead " The declaration is a definite step forward though it could be stronger," he stated. "The declaration explicitly recognises the issues as well as sovereignty of the governments to take appropriate measures to get around to the issues. A lot depends upon the countries now, how they live up to the expectations of the poor patients. The declaration also recognises the problems of countries with insufficient or no pharmaceutical manufacturing capacity and also the limitation of the compulsory license as a solution to these problems. We hope the TRIPS Council will come up with a clear solution to this issue next year. Our challenge now is to get this declaration translated into action, which can save lives."

To read the joint statement released after the meeting by public health NGOs attending the meeting, go to: http://www.haiweb.org/pubs/pressreleases/200111doha.html.

(The report on Qatar is based on material supplied by the Joint NGO Statement on the Conclusions of the Doha Conference, Act-UP Paris, ACT UP Philadelphia, the Health Gap Coalition, Wemos, The Wall Street Journal, BNA's International Trade Reporter)

How important are patents in Africa?

Public interest health NGOs have criticised a recent article which proposes that patents are not the reason HIV/AIDS drugs and other medicines remain out of reach for so many consumers in Africa. The study published in the Journal of the American Medical Association was co-authored by Amir Attaran of the Harvard Center for International Development and Lee Gillespie-White of the International Intellectual Property Institute. The pharmaceutical industry has used the study repeatedly to support its own claim that patents are not the problem. Instead, the authors suggest that poverty and the lack of infrastructure are the main culprits.

However, a group of NGOs led by MSF and Oxfam say the article's data actually support a different conclusion, namely that patent protection is extensive on the most sought after and practical drug combinations needed to treat HIV/AIDS. The NGOs said that many of the non-patented drugs reviewed in the study are not practical as first-line treatments in resource-poor settings and due to complex dietary requirements. The study also revealed that patents are concentrated in the countries having the largest pharmaceutical markets. To read the study, go to: http://www.jama.assn.org/issues/current/fpdf/jsc10222.pdf. To see the joint NGO response, visit: http://www.medaccess-msf.org

Street Price

Voluntary Services Overseas (VSO) Treatment for Life campaign has published a report which proposes a framework for making medicines cheaper and much more available in developing countries. In this way it hopes to help end the current situation in which the average Kenyan has to spend the equivalent of GBP 17,000 to buy a month's course of drugs to treat HIV/AIDS related meningitis. If adopted, the framework would ensure that all developing countries would be offered the same low price for each drug. The measures include a database of prices (including prices from generic producers), a negotiation forum for developing countries and simple mechanisms to prevent cheap medicines from flowing back into richer ones. The framework was developed based on criteria suggested by stakeholders in developing countries during research carried out in Kenya, Uganda and India.

The report, Street Price, is available in print version or from the VSO website: http://www.vso.org.uk
To obtain a print copy, contact: Ken Bluestone, at e-mail: ken.bluestone@vso.org.uk.

Campaigns - Public-Private Interactions

Global Fund moves forward

An NGO consultation meeting was held in Brussels in November to coordinate input to the Global Fund to Fight AIDS, Tuberculosis and Malaria, better known as the Global Fund. Approximately 70 NGO representatives took part. The meeting concluded with a set of key NGO recommendations. At the meeting, NGOs heard that the fund is now being supported by a "transitional support secretariat" based in Brussels. Importantly, the Transitional Working Group (TWG) also met in Brussels later that month to discuss some priority themes including:

• Governance: who will hold the decision-making authority to allocate, prioritise and monitor the use of the Fund?
• Country processes: how will the Fund channel resources at the country level, and how will individual countries submit proposals describing the work that will be done with Fund money?
• Accountability, eligibility and technical review: who will the Fund be answerable to? Who can request support from Fund resources? How will proposals be reviewed to make sure they are well founded and appropriate for a given country?
• Legal issues: will the Fund be a new entity in its own right? Who will provide administrative oversight to the movement of Fund money?

The TWG consists of donor governments (15); developing country governments (13); multilaterals (6) including the European Union Presidency and the European Union, UNAIDS, WHO and the World Bank; NGOs (4); and private foundations (5) including the Gates Foundation, GAVI, the Global Fund for Children's Vaccines and the Coca-Cola company.

A UK-based NGO will act as focal point to coordinate the NGO input on the Fund. The UK AIDS Consortium plans to work with many partners to ensure a wide consultation with NGOs operating around the world. The secretariat urges NGOs to become involved in the consultation by joining its on-line discussion forum and to make their own positions clear. Further background on aspects of the Fund will be circulated on the list serv. A draft paper expressing areas of consensus will be drawn from comments put on the list. For more information about the consultation process, contact Mick Matthews, coordinator, UK NGO AIDS Consortium Secretariat at tel: (+44-207) 251 6201 or at e-mail: ukaidscon@gn.apc.org. To join the discussion forum on the Break the Silence list serv, send a message to join-break-the-silence@hdnet.org. The latest background papers, including NGO papers on specific fund issues and the key NGO recommendations can all be retrieved from http://www.hdnet.org

(Correspondence from Break the Silence list serv, 18 November and 25 October 2001)

Campaigns - Direct-to-Consumer Advertising

Drug companies' promotion of pills to prevent diseases such as breast cancer has motivated a coalition of Canadian and US women's health groups to come together and launch the campaign "Putting People First" in order to counter companies' current advertising efforts. Although research efforts have spent billions looking for a cure, more and more attention is being given to limited and risky "pills for prevention".

While this approach may help individual women beat the odds on getting breast cancer, it ignores the larger public health prevention strategy that would help the entire population by examining the causes of breast cancer, and importantly, the environmental links to the disease. The group believes attempts to follow the "precautionary principle" and keep natural resources such as food, air and water free of pollutants, are drowned out by industry advertising campaigns.

Putting People First plans to promote healthy water, air and food over narrowly focused risk reduction through pharmaceutical interventions that remain unavailable to everyone. It also wants to highlight the dangers of using drugs such as tamoxifen in healthy women. The coalition has already presented testimony to the US Food and Drug Administration on direct-to-consumer advertising and plans to bring its concerns to other government agencies. To learn more about the coalition's work, visit: http://www.bcaction.org/Pages/LearnAboutUs/PuttingPeopleFirst.html.

(Correspondence received)

HAI groups criticise G 10 plan on pharmaceuticals

In response to industry demands that the pharmaceutical sector needs extra support from the European Commission in order to compete with other markets, the EU established the "G 10" group mandated to find ways to maximise trade opportunities for the European pharmaceutical industry while protecting public health. As part of its work, the G 10 group, comprised of representatives from the brand name and generics pharmaceutical industry, government ministries of health, health insurers, and one consumer rep, have drawn up a consultation document on pharmaceutical issues for public review. HAI Europe and a number of its members have submitted critical comments to the G 10. Among other issues, HAI Europe argues that public health needs to receive much more emphasis by the group, and it also criticises the EU's movement towards allowing direct-to-consumer promotion of some prescription-only medicines. The G 10 is to deliver its recommendations to the Commission in April 2002. To read HAI Europe's comments to the G 10, visit http://www.haiweb.org/campaigns/DTCA/responsetotheG10.html

Finnish groups criticise DTCA

The Finnish HAI working group held a seminar on DTCA during November. Participants included representatives from consumer groups, the government, the pharmaceutical industry, pharmacies and the media. One keynote speaker was Charles Medawar who highlighted international experiences. Approximately 60 people took part in the event and the seminar received a great deal of press coverage. Those at the meeting concluded that there was no need to introduce direct-to-consumer advertising in Finland. "Even an industry representative said he was against 'real DTCA'" said Lauri Vuorenkoski, the working group's chairman. "Although he also said the EU Commission's proposal was not DTCA." For more information about the meeting, contact Lauri Vuorenkoski at e-mail: lauri.vuorenkoski@stakes.fi.

Drug Information

Journals aim to reveal authors' interests

Eleven leading medical journals have drawn up tougher rules to fight bias in the reporting of drug trials. The new joint policy gives them the right to refuse to publish industry-sponsored studies unless the researchers can demonstrate their independence. Some of the journals participating in the initiative include The Lancet, the New England Journal of Medicine, the Annals of Internal Medicine and the Journal of the American Medical Association. The editors have said their policy is a result of the pharmaceutical industry's increasing control over research results and decisions about their publication. They also suggest that some trials are done mostly for marketing purposes and not really to answer scientific questions.

(Okie, S., The Washington Post, 5 August 2001)

When journalism teams with advertising

Newsweek, a widely read US weekly published a special health issue "Health for Life: Living Longer, Living Better" in September. Notably, the issue had only one advertiser - PhRMA, the trade association of the US brandname pharmaceutical industry. Featuring articles on aging and its effects, the issue was sent to the magazine's 3.1 million regular subscribers and almost a million copies were expected to be sold at newsstands. Copies were also sent to all members of the US Congress, each state's governor and to leading reporters and business people. Articles on the most recent scientific breakthroughs joined stories on diet and exercise in treating diseases such as Alzheimer's. The issue's coverage received added assistance from special segments on popular daytime talk shows and Newsweek's website planned to hold daily chats on the issues contained in the publication.

(Correspondence from PRNewswire, 5 September 2001)

Publications

Holding Corporations Accountable
Corporate conduct, international codes and citizen action
By Judith Richter

ZED Books. Price: hardback £ 45, paperback £ 15.95

Using the case study of the International Code of Marketing of Breastmilk Substitutes, Richter examines how the Code was formulated, adopted and implemented despite tremendous pressure from industry to abandon the effort. Its findings are relevant to any study on the regulation of multinational companies. Today, co-regulation and industry self-regulation are both presented by some as the most promising ways to ensure corporate social responsibility. The book argues that effective binding regulation of multinationals remains a critical and unfinished task of global democratic governance.

Richter's study describes in detail how the International Code came into being and has been kept alive despite fierce resistance from the infant food industry. It uses the code example to explore wider issues about corporate behaviour. For example, it shows the gulf between corporate statements and actual corporate practice. It also calls attention to international issues management, a strategic public relations discipline, once known as "engineering of consent" and reveals how corporate PR and lobby machinery continue to undermine efforts to establish effective checks and balances on corporate activities.

Richter openly questions the idea of global governance as a harmonious rule-setting process among governments, international organisations, citizen action groups and business. If a particular regulatory framework impacts on profit-making, she argues, conflicts are bound to occur. They must be allowed to happen to ensure that the public interest prevails. This case study also shows how to effect a shift in the power balance.

To order contact Zed Books at www.zedbooks.demon.co.uk

Fatal Imbalance: The crisis in research and development for drugs for neglected diseases
Drugs for Neglected Diseases, Médecins Sans Frontières

Almost no drugs are being developed for diseases that mostly affect the poor, says a new report from MSF. The publication describes survey responses on research and development activities from 11 pharmaceutical companies operating around the world. Within this group, eight reported no research activities in the last year for fatal diseases that almost exclusively affect the poor: sleeping sickness, Chagas disease and leishmaniasis. The report highlights the fact that while 1,393 new drugs were introduced between 1975 and 1999, only one percent (13) were for tropical diseases. "Drugs are not developed according to public health need, but according to profitability," says Dr. Bernard Pécoul, Director of MSF's Campaign for Access to Essential Medicines. "A new paradigm is urgently needed to address this fatal imbalance." MSF calls on strong public leadership and financing as well as private sector support to make this happen.

To receive a copy of the report go to: www.accessmed-msf.org

The Therapeutic Nightmare
By John Abraham and Julie Sheppard

Earthscan. Price: hardcover £ 35, paperback £ 14.95. 192 pages

How do medicines get approved? What controls and procedures are in place to monitor their effects? How well do drug regulators protect public health when medicines are found to have serious side effects? This book uses the story of the sleeping pill, Halcion, to explore these important questions. First marketed in the 1970's, Halcion has been taken by millions of people around the world. Thirteen years after its release, the British government banned it. However, it remains available in the United States and many other countries.

The book explores why consumers have been exposed to the drug's risks and reveals the underlying corporate interests of the manufacturers, the professional interests of scientists and medical researchers and the medical interests of patients. It shows how all of these pressures shape the regulatory decision-making process on drug safety. As the number of new medicines and products grows, the authors suggest that regulators and health professionals face a growing challenge to place public health interests above commercial ones.

To order, contact: Earthscan, Freepost 1, 120 Pentonville Road, London N1 9BR, tel: +44 (0)20 7278 0433, fax: +44 (0)20 7278 1142, or e-mail: earthinfo@earthscan.co.uk.

Whose Trade Organization?
Corporate globalization and the erosion of democracy
By Lori Wallach and Michelle Sforza

Public Citizen's Global Trade Watch

Imagine a powerful company "renting" a WTO Member state to pursue its special interests-and kill a trade-based development policy-behind closed doors in Geneva resulting in loss of jobs and damage to the rented country's own economic and security interests. There's no need to imagine it, this is just one example of many documented cases included in this book showing the WTO's real-life impact on food safety, public health, environmental conservation and protection and economic development. The authors spent more than a year documenting the WTO's consequences for democratic governance, jobs, economic growth, food security, access to health care, labour rights and environmental protection.

The book is designed to show how the WTO's rules and rulings affect everyone and therefore argues that they must be made more accessible to everyday citizens, especially those who are resisting the organisation's increasing involvement in daily life.

Copies can be obtained for US$15 plus shipping charges from the Public Citizen website at: http://www.citizen.org/publications. You can also fax a request to Public Citizen at +1 202 588 7798.