New resolution on HIV/AIDS announced at the 53rd World Health Assembly.

News Companies reduce prices for HIV drugs in developing countries In an unprecedented effort to combat acquired immunodeficiency syndrome (AIDS) in sub-Saharan Africa, five of the world’s leading pharmaceutical companies have agreed to decrease the price of drugs used to treat those infected with the human immunodeficiency virus (HIV). Some of the companies have pledged to sell the pharmaceuticals at prices just above manu- facturing costs, at discounts as great as 90%. Glaxo Wellcome said it would offer its drug Combivir — a mixture of lamivudine and zidovudine — for US$ 3 a day in many of the world’s developing countries. The drug currently costs about US$ 11 a day in Canada and US$ 25 in the United States. ‘‘The HIV epidemic in developing countries threatens to wipe out development and economic gains made in the second half of the last century,’’ Richard Sykes, Chairman of Glaxo Wellcome, said in a prepared statement. ‘‘The private sector has a role to play in contributing to a multisector response to this epidemic,’’ he said. ‘‘It’s really a very exciting announce- ment,’’ said Dr Mark Wainberg, a physi- cian and President of the International AIDS Society. ‘‘It’s something that a lot of pharmaceutical companies have been under pressure to do for a long time.’’ However, Wainberg said, even at these prices, the drugs will be beyond the financial grasp of many in Africa, whose average per-capita income is less than US$ 80 a month. Some experts also fear Africa does not have enough trained medical personnel to administer the drugs. ‘‘If thedrugsarenot takenproperly, then resistance almost certainly will be an aftermath,’’ Wainberg said. In addition to Glaxo Wellcome, the participating companies include Boehringer Ingelheim, Bristol-Myers Squibb, Hoffman- La Roche andMerck&Co.Other companies are preparing to join the group. Experts say that new efforts to improve prevention, medical infrastructure, inter- national funding and political will are also needed. ‘‘Lowering the price of medicines ... is only one critical factor in what must become a much broader and more urgent effort to help people living with HIV and AIDS lead healthier and more productive lives,’’ said Dr Peter Piot, Executive Director of the Joint United Nations Programme on HIV/AIDS (UNAIDS). ‘‘We need signifi- cant new funding that is on a level with the enormous human, social and economic challenges now being imposed by the epidemic.’’ Getting these medications to the world’s developing nations has become a rallying cry for AIDS activists around the world. In recent months, they have disrupted drug firms’ annual shareholder meetings and pressured the Clinton Administration to force the industry to offer the drugs at more affordable prices. Earlier this month, President Clinton issued an executive order suggesting that the United States Trade Representative’s office no longer would threaten trade sanctions against developing nations that use the World Trade Organiza- tion’s intellectual property rules to gain access to cheaper drugs. The World Trade Organization allows countries to manufac- ture generic versions of patented drugs if they are used to combat national health emergencies and some countries like South Africa are considering this option. As a result, industry insiders say the pharmaceutical companies had little choice but to act quickly. Some developing nations were poised to manufacture their own cheap versions of HIV drugs. Brazil, India and Thailand already make generic zidovudine at 10% of the price in the United States. Another proposed United States trade policy would have given authority to companies in Africa to make generic AIDS drugs, regardless of patents. n Scott Gottlieb, New York Controversy surrounds new Editor-in-Chief at the New England Journal of Medicine The Massachusetts Medical Society has named Dr Jeffrey M. Drazen as the new Editor-in-Chief of the 188-year-old New England Journal of Medicine, one of the world’s most prestigious medical journals. Dr Drazen, 53, a leading asthma researcher, is the Chief of Pulmonary and Critical Care Medicine at the Brigham and Women’s Hospital in Boston, and is the Parker B. Francis Professor of Medicine at Harvard Medical School. Dr Drazen was immediately confronted with controversy surrounding his close ties with pharmaceutical companies from which he has received funding. Last year, Dr Drazen had provided an overstated estimation of the efficacy of a drug marketed by Sepracor for the treatment of asthma. The Food and Drug Administration issued a ‘‘notice of violation’’ to the company in March 1999 indicating that they found certain statements used in a company press release for levalbuterol to be misleading. Dr Drazen had been paid by the company to evaluate studies of levalbuterol and acknowledged that his assessment had been ‘‘overzealous’’. TheNew England Journal of Medicines’s conflict-of-interest rules exclude him fromwriting editorials or articles related to his research within two years of accepting commercial funding. To avoid future conflicts of interest, Dr Drazen said he would excuse himself from the editorial process for any papers submitted that relate to asthma, or to nine major companies from which he has received research grants or consultation fees. In accepting the appointment at theNewEngland Journal of Medicine, DrDrazen said: ‘‘We must protect the integrity of the Journal’s editorial process and the integrity of the Journal’s information without com- promise.’’ Last February, after an internal investigation prompted by articles in the Los Angeles Times, the Journal found it had violated its own rules by publishing 19 articles by authors with drug industry ties, including a review authored by Dr Drazen despite his full disclosure. Massachusetts Medical Society President Jack T. Evjy praised Dr Drazen as ‘‘one of the nation’s leaders in academic medicine.’’ President-Elect Virginia T. Latham emphasized that he would enjoy complete editorial freedom and complete authority over the content of the journal, as well as full authority and responsibility for hiring editors and staff. DrDrazen replacesDrMarciaAngell as Editor-in-Chief, who, in turn, had replaced Dr Jerome P. Kassirer, fired by the Journal’s publisher, the Massachusetts Medical Society, after eight years at the helm.DrKassirerhadclashedwithsociety officials over proposals to promote web sites and create new specialty journals 862 # World Health Organization 2000 Bulletin of the World Health Organization, 2000, 78 (6) using the journal’s logo, reputation, and its profitability, estimated at US$ 20 million a year. n Fred Charatan, Florida New resolution on HIV/AIDS announced at the 53rd World Health Assembly One of the highlights of the 53rd World Health Assembly held in Geneva from 15 to 20 May 2000 was a far-reaching resolution on HIV/AIDS. The resolution asks WHOMember States to increase access to treatments for HIV-related illnesses and urges for renewal of efforts to make drugs more available and affordable to developing countries despite recent progress in this area (see accompanying news story: Companies reduce prices for HIV drugs in developing countries). WHO Director-General, Dr Gro Harlem Brundtland, commented: ‘‘Through the enhancing of care and strengthening its linkages to prevention, we are about to give new directions and a new energy to an expanded revitalized response to the HIV/AIDS pandemic.’’ At the Health Assembly, the Dutch government announced that they will contribute US$ 10 million to the Polio Eradication Initiative.The lackof funding to complete the initiative stood at US$ 300 million in February 2000. For more than ten years, the eradication of poliomyelitis by the year 2000 has been a goal of WHO. However, up to 20 countries are likely to have poliovirus circulating at the end of the year 2000. Dr Brundtland stressed the need for efforts to intensify if poliomyelitis is to be eradicated and emphasized that there was no need for complacency in the final phase of the campaign: ‘‘The certificationdate for theglobaleradication ofpolio is2005andweareontrack tomeet that target’’ said Dr Brundtland. Other contributions announced included a grant of US$ 5 million from the Bill and Melinda Gates Foundation to support WHO’s collaborative efforts to eradicate dracunculiasis (guinea-worm disease). Dracunculiasis transmission is now confined to 13 countries in sub-Saharan Africa. Dr Marc Karam of WHO’s Com- municable Diseases Control, Prevention and Eradication Programme commented: ‘‘To date, 151 countries and territories have been certified free of dracunculiasis. For the remaining countries, certification will be granted once transmission has been interrupted and no new cases are reported in a subsequent three-year period.’’ He added: ‘‘The money from the Bill and Melinda Gates Foundation will be used in countries that report zero incidence to carry out verification surveys during the three-year period by international certification teams, to support surveillance and, ultimately, to prepare the certification files for review by the International Commission for the Certification of Dracunculiasis Eradica- tion.’’ Funds will also be used for coordina- tion of global eradication activities. The ethical problems of genetics, biotechnology and related issues and their impact on public health were also con- sidered at the Health Assembly. Repre- sentatives of WHOMember States repeatedly stressed the need to address bioethical issues in these areas on a larger scale.AbdallahDaar,ProfessorofSurgery at SultanQaboosUniversity inOman, has been instrumental in preparing position papers for WHO on human cloning and other ethical issues. He noted: ‘‘Now that WHOhas recognized the need to address the broader ethical issues, it needs to build on the excellent foundational work that has already been done. Because of the complexity of the issues, WHO should identify and form an external bioethics advisory group to provide advice on these important and complex issues ... Expert panels could deal with individual issues on the advice of the advisory group.’’ In an area where ethical considerations are repeatedly outpaced by technological developments, addressing these issues may prove to be a good test of the skills of the Organization. n Barry Whyte, Bulletin World health report 2000: improving health system performance France has the best overall health system performance based on data published in The world health report 2000 –Health systems: improving performance released on 21 June. Surprisingly, the United States is ranked in 37th place. Many health ministers will be looking at this year’s World health report to find out where their countries stand. The report sets out to answer the following questions: What makes for a good health system, what makes a health system fair, and how do we evaluate the performance of existing health systems? Ambitious in scope, any ranking of health systems in different countries is likely to cause vigorous debate. Dr Gro Harlem Brundtland, Director- General of the World Health Organization, commented: ‘‘Dollar for dollar spent on health, many countries are falling short of their performance potential. The result is a large number of preventable deaths ... The impact of this failure is born dispro- portionately by the poor.’’ What is needed, she argues, is a means of evaluating health system performance to tackle the inherent deficiencies: ‘‘Ultimate responsibility for the performance of a country’s health system lies with government.’’ The world health report 2000 presents, for the first time, an index of national health systems’ performance in trying to achieve three overall goals: good health; responsive- ness to the expectations of the population; and fairness of financial contribution. Pro- gress towards achieving these goals, it argues, depends on four functions: providing health services; generating resources that make service delivery possible; raising and pooling resources used to pay for health care; and stewardship — the setting and enforcing of rules to provide strategic direction to all parties involved. The data presented are based on established and new measurement systems including disability-adjusted life expectancy. Disability-adjusted life expectancy has been selected byWHOsince it permits assessment of overall population health, not just mor- tality, in order to shift the focus to healthy years of life rather than only length of life. It has the advantage of readily allowing comparisons across different populations. While data and methods to do so are still imperfect, few would dispute the need to perform this type of analysis. Kei Kawabata, of WHO’s Global Programme on Evidence for Health Policy, who was involved in preparing the report, remarked: ‘‘For the first time, WHO is stating explicitly that there are other consequences of good or bad health systems that matter. It matters how responsive health systems are to the people they are supposed to serve.’’ She adds: ‘‘Health systems have a responsibility to ensure that the services they provide are affordable for the indivi- duals that need to access them — whether they are rich or poor. No one should have tomake a choice between forgoing treatment or becoming impoverished or in debt to get that treatment.’’ The measurement of health systems performance will be a regular feature of future World health reports. n Barry Whyte, Bulletin News 863Bulletin of the World Health Organization, 2000, 78 (6)