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>HOME 2003/08/08 www.nu.ac.za/ccs Date: Fri, 08 Aug 2003 12:53:13 +0200 Subject: [viva_hiv_aids] FW: [CCS-l] Some News Reports From AIDS Conference 感染症研究会の皆様 牧野＠ケープタウンです。 ダーバンで開かれた南アフリカ・エイズ会議関連の報道（TACのザッキー・アハマッ ト氏がナタール大学市民社会センターのMLに投稿したもの）を転送します。 翻訳や要約をする時間がないので、同会議、およびそれに先だって開かれたTACの総 会の内容のポイントをざっと挙げておくと、 ・TAC総会で、TACメンバーの総意として、リーダーのザッキー・アハマット氏にARV 服用の開始を求めることを決定（アハマット氏は公立病院でのARV供給が決定するま で自分も薬を飲まない、というボイコットを続けてきたが、過去１年半で症状が悪化 している）、アハマット氏もこれを受け容れた。いろいろと検査をしてから服用を開 始するので、いますぐに飲み始めるというわけではない。また、服用する薬はジェネ リック薬となる予定。 ・TAC総会は停止していた市民的不服従運動の再開を決定。 ・エイズ会議に参加した政府代表から、ARV供給は「if」ではなく「when」の問題、 との認識が示される。これは実質的に、政府がARV供給へのコミットメントを示した ものと受け取ることができる。 ・南アの製薬会社Aspenがエイズのジェネリック薬の製造開始。これはパテントをも つBristol-Myersとの合意によるもの。 ・南アのMedicines Control Council's (MCC) が母子感染予防に用いられているネヴィ ラピンの安全性や効果の根拠となっていたウガンダでの試験結果を認めないことを決 定、Boehringer Ingelheim社が90日以内に別の証拠を提出しない場合には承認を取り 消すという方針を発表。 とりあえずこんなところでしょうか。 また何かあれば報告します。 牧野久美子 ------ Forwarded Message ------ From: "Centre for Civil Society Centre for Civil Society" Date: Fri, 08 Aug 2003 06:43:38 +0200 Subject: [CCS-l] Some News Reports From AIDS Conference Dear All, Enclosed are nine news reports from the SA AIDS Conference. Remember Bua News is a government sponsored agency. Thanx Zackie ◆The Natal Witness (South Africa) Aids drugs 'are SA's only option' 06 August 2003 Zoubair Ayoob And Reuters 'No programme will be effective without anti-retroviral use', conference told Up to five million South Africans could die from Aids in the next eight to 10 years if a large-scale Aids treatment plan is not soon implemented, the South African Aids Conference in Durban heard on Tuesday. This is according to Western Cape director of health Dr Fareed Abdullah, who said no Aids programme will be effective without the widespread use of anti-retroviral treatment. "No country can survive a calamity of this order. There are two options for South Africa: treatment success or treatment failure. A no-treatment option does not exist," he said. Abdullah said there will be an average of 1,4 million Aids cases a year in South Africa by 2006 if no anti-retroviral therapy is given to prevent and treat Aids. He added that about 700 000 people will die annually from Aids-related illnesses from 2004 without appropriate intervention to treat and prevent HIV. Anti-retroviral treatment would reduce the deaths to 400 000 a year. UNAids said 600 000 people died of Aids in SA last year. Abdullah said government should abandon the focus on primary health care. "A case must be made for a new financing framework that will allow health managers to postpone old reform imperatives that reduce spending on secondary and tertiary hospital care in favour of primary health care," he said. Abdullah showed that if medication is not provided for the prevention of mother-to-child transmission (PMTCT), hospitals will buckle under the pressure created by the requirement of one million additional bed days. Social security pressures will soar 500% and family household incomes will collapse. Addressing nutrition and alternative therapies for Aids, as espoused by Health Minister Manto Tshabalala-Msimang, Abdullah said: "The mainstay of any effective intervention can only be as a result of anti-microbials, anti-fungals and anti-retroviral therapies." Meanwhile, in an interview on Monday, the chairman of the conference said South Africa's increasingly bitter political disputes over Aids mask real advances the country is making against the disease. "The dominant view of our epidemic is of political interference, of politicisation," said Professor Jerry Coovadia of the Nelson R. Mandela School of Medicine at the University of Natal. "But I see a gradual shift. The government is providing more programmes, and is at times showing a new attitude." Coovadia said that beneath the political clamour real progress is being made in both understanding and fighting the Aids epidemic in South Africa - research that could soon apply to other developing countries fighting the disease. "We have the infrastructure, personnel and resources to do an astounding range, diversity and variety of research here," Coovadia said. "There are lessons we can offer the rest of Africa, and the rest of the world." Chief among these, Coovadia said, is a growing body of South African research devoted to preventing mother-to-child transmission of HIV, a major problem in many African countries. Coovadia said South African researchers, aided by the government, are leading the way in establishing how to reduce transmission through breastfeeding, and how to extend treatment programmes to mothers and other relatives so that crucial family units are kept intact. From the Star today - Ralph ----------------------------------- Government makes dramatic Aids pledge August 07 2003 at 05:38AM By Liz Clarke An anti-retroviral treatment programme for the millions of people infected with HIV and Aids is "a reality" - and not a matter of if, but when. In a dramatic closing statement at the South African Aids Conference in Durban on Wednesday, the MEC for health in KwaZulu-Natal, Dr Zwele Mkhize, said the government was committed to a comprehensive plan of Aids treatment for the country. "There is no question about this," Mkhize said. "It must be placed on record that this is not an ideological issue. With the rising mortality rate from Aids, one more death is one too many." Mkhize said he was speaking on behalf of Health Minister Manto Tshabalala-Msimang, who was unable to address delegates at the close of the conference because she was out of the country. 'One more death is one too many' In another breakthrough, government sources confirmed that President Thabo Mbeki had signed the long-awaited Global Fund agreements, which will see more than R500-million coming to KZN to support a wide range of programmes, including the provision of anti-retroviral treatment. The only signature outstanding was that of Deputy President Jacob Zuma, who is expected to sign the agreements "either today or tomorrow" after he returns from a trip to Tanzania. The cabinet also announced on Wednesday that South Africa's first generic anti-retroviral drugs - up to 41 percent cheaper than the original - were being manufactured. Manufacturer Aspen Pharmacare said it hoped the drug, Aspen-Stavudine, would eventually form part of a cocktail for Aids patients costing less than $1 (about R7) a day. It has, to this end, applied to the Medicines Control Council to be allowed to also manufacture generics of the drugs Didanosine, Combivir, AZT, 3TC and nevirapine. 'The value of nevirapine to save babies' lives cannot be undermined' The cabinet welcomed the fact that Aspen had reached the stage of production of some generic anti-retroviral drugs in South Africa. "Already, the first (Aspen-Stavudine) package of such generic drugs - which can be used in various combinations as part of treatment for people with Aids - is being produced, with production of other drugs to start as soon as relevant formalities have been undertaken," the cabinet said in a statement. Regarding the Global Fund agreements, Mkhize said the delays in the signing were of a "technical" nature and that the documents would be signed by the end of this week. He said problems encountered in assessing Global Fund money would not happen again because the correct accounting processes were now in place. On the delivery issue of anti-retrovirals, Mkhize said the cabinet was looking at the most balanced responses and a "phased in" management process, emphasising that "tremendous investment" had put the country in a strong position to embark on the treatment programme. In another surprise development, the government said it supported the use of the controversial single-dose anti-retroviral drug nevirapine, which prevents mother-to-child transmission of the Aids virus. Last week, the Medicines Control Council gave the manufacturer, Boehringer Ingelheim, 90 days in which to provide data relating to the "flawed" Hivnet 012 Ugandan trial of the drug to avoid its deregistration. "While we can't prejudge the decisions of the MCC, which is an independent body, the value of nevirapine to save babies' lives cannot be undermined and the programme itself must not be compromised," Mkhize said. This article was originally published on page 1 of The Star on August 07, 2003 Health-e (South Africa) Nevirapine Decision Causes Government AIDS Head 'Sleepless Nights' 06 August 2003 PRESS RELEASE Government's head of HIV/AIDS, Dr Nono Simelela, says she has been "spending sleepless nights asking what we are to do with mother-to-child-transmission if we can't have nevirapine". "I have 80 000 women on this programme. I have to have an answer for them," Simelela told media shortly before the opening of the first South African AIDS conference in Durban on Sunday (3 August). This follows the Medicines Control Council's (MCC) decision last week to reject the Ugandan study which declared the drug safe and effective in preventing mother-to-child HIV transmission. Simelela said the Department of Health was "informed about the MCC decision at the same time as it hit the media", and that it was "not privy to correspondence between the MCC and nevirapine's manufacturer, Boehringer Ingelheim". "We still have to formulate our Plan B. The Minister needs to meet with the MECs to consider the decision. We have a responsibility in terms of the Constitutional Court to ensure PMTCT," said Simelela. The Constitutional Court ruled last year that government had to offer nevirapine or a suitable alternative to pregnant women with HIV. The MCC has given Boehringer Ingelheim 90 days to provide other evidence that its drug is safe for PMTC, something the manufacturer says it doubts it will be able to do. Conference chairperson Prof Jerry Coovadia said the nevirapine decision had come as a shock, but that such shocks could be avoided if there was a body that brought policy makers and scientists together. Coovadia said there was a danger of "democratic anarchy" unless government had recourse to "the best available science". UN Special Envoy on AIDS, Stephen Lewis, said that most African countries were using nevirapine for their PMTCT programmes. "Africa is entering a desperate and difficult period as the [HIV] infections become full-blown AIDS, and there is a sense that the worst is still to come," said Lewis, who has just completed a tour of Uganda, Rwanda and Mozambique. African countries were "obsessed with treatment" as there was a "desperate feeling that they need to keep people alive [yet] had reached a point of no return". Lewis said that while changing male sexual behaviour had to be addressed, this would take generations as there was "nothing more obdurate". However, the empowerment of women "can be done more rapidly" and there was "no time to lose to stop losing all the women that we are at present". African Eye News Service / East Cape News (SA) Hospital Goes Ahead With Nevirapine Programme 06 August 2003 Steve Kretzmann, Grahamstown Port Alfred hospital in the Eastern Cape will officially launch its Prevention of Mother to Child Transmission (PMTCT) programme on Saturday despite renewed controversy over the anti-retroviral drug nevirapine. The hospital, which serves the entire Ndlambe municipality from Bathurst in the North to Alexandria in the West, will launch the programme on Women's Day. The Medicines Control Council (MCC) last week rejected a Ugandan study on which the registration of nevirapine was based and gave drug manufacturers Boehringer-Ingelheim 90 days to prove the efficacy of the drug. Should Boehringer-Ingelheim not succeed, doctors could be prevented from administering the drug. Eastern Cape health MEC Bevan Goqwana said if the MCC withdrew nevirapine from the market, it would threaten some 20 PMTCT programmes. He said at the moment the department's target was to make sure all HIV positive pregnant women received nevirapine. Provincial health department spokesman Sizwe Kupelo said the MEC and national health minister Manto Tshabalala-Msimang would meet "soon" to discuss the matter." PMTCT programme co-ordinator at Port Alfred hospital, Sister Portia Marais, said the programme, which began in May, included voluntary counselling and testing, a once-off dose of nevirapine to the mother at the onset of labour, nevirapine treatment for the baby shortly after birth, infant feeding and counselling and follow-up care for the mothers and children. She said the administration of nevirapine reduced the "viral load" during birth when the baby was most at risk of contracting the virus. The babies were tested after a year to check if the treatment had been successful. Nine mothers have been treated through the programme since May, two of whom had been under the age of 16. Of the women who gave birth at the hospital, 20% tested positive for HIV. Reuters S. Africa AIDS Meeting Ends with Call for Treatment 06 August 2003 By Andrew Quinn Scientists and activists at South Africa's first national AIDS conference, which drew to a close on Wednesday, urged the government to roll out rapid drug treatment for millions of South Africans dying from the disease. "The message is: don't wait. You've got to do something, and you have got to do it now," Salim Abdool Karim, scientific chair of the conference, told Reuters. "This is not an attack on the government. This is scientific fact." The four-day conference was a watershed in South Africa's public debate on AIDS policy, which is dominated by angry efforts to persuade the government to launch a national treatment program with antiretroviral drugs, which many scientists say represent the only way to avoid catastrophe. Acrimony over the treatment issue has been sharply political, with activist groups blasting President Thabo Mbeki and Health Minister Manto Tshabalala-Msimang for waging "genocide" on AIDS patients and betraying the promise of South Africa's 1994 liberation from white-ruled oppression. AIDS kills an estimated 600 South Africans each day and some 4.7 million people are infected with the virus, the highest caseload in the world. Researchers say the death toll could rise to as many as eight million if nothing is done to stop or treat the disease, which economists say represents a growing threat to Africa's most vibrant economy. Tshabalala-Msimang -- who was jeered at Sunday's opening session of the conference -- has angrily rejected the accusations, repeating that antiretroviral drugs are but one treatment option the government is considering. The government maintains the drugs are unproven, difficult to take and expensive, and says priority must be given to improving the overall state of the health care system. CHANGE ON THE WAY? But other senior officials indicated that change may be coming as the cabinet prepares to receive a long-delayed report on the affordability of a national antiretroviral plan. "All of us are seized with a sense of urgency on this issue," Health Ministry Director General Ayanda Ntsaluba said, adding the question now was "when, not if" South Africa would introduce anti-retrovirals. "(The conference) is very important for us as we find our way forward," Ntsaluba said. "It opens our minds." In preparation for what many hope will be a positive decision, South Africa's largest generic drug maker, Aspen Pharmacare, said it would launch on Wednesday a program to produce Africa's first locally made antiretroviral drug -- a step which could increase both availability and affordability of the life-prolonging medication. The debate over antiretrovirals was given fresh focus last week after independent regulators announced they might withdraw approval for nevirapine, an antiretroviral used to prevent mother-to-child transmission of HIV. The announcement was greeted by howls of dismay from doctors and nurses, and became a major focus of the Durban conference as participants sought to marshal evidence that could prove the drug was both safe and effective. AIDS treatment activists, who marched on the conference center and repeatedly confronted government officials on their treatment policy, said they were heartened by the unequivocal endorsement from the country's scientific community. "What this has shown is that there is overwhelming support for the government to develop a treatment plan," said Zackie Achmat, leader of the Treatment Action Campaign, South Africa's largest AIDS pressure group Associated Press South African company begins production of first generic AIDS drugs in Africa 06 August 2003 By Ravi Nessman A South African pharmaceutical company announced Wednesday it had begun producing the first cheap, generic copies of a major AIDS drug in Africa and was working on versions of several more AIDS medicines. The announcement by Aspen Pharmacare is considered an important step in the effort to bring affordable AIDS treatment to some of the more than 28 million Africans infected with HIV. The company launched the drug Aspen-Stavudine, its version of Bristol-Myers Squibb's Zerit, at a news conference, saying it would be immediately available to any South Africans who need it. Under the terms of Aspen's licensing agreement with Bristol-Myers, it can sell its version of the drug to both public and private patients across Africa, said Stephen Saad, CEO of the company. "We are particularly proud to have developed a home grown solution to what is largely an African problem," he said. The high cost of AIDS medicine is one of several barriers that has prevented the implementation of widespread treatment campaigns across Africa and other parts of the developing world. Even with recent discounts offered by drug companies, the medicine, which has turned AIDS into a chronic instead of fatal disease in the Western world, is out of reach for all but a very few wealthy people in Africa. Poor infrastructure and a shortage of properly trained medical workers are other hurdles that also must be overcome in efforts to provide treatment. Aspen, which invested two years and several million rand (hundreds of thousands of dollars) in Aspen-Stavudine, is offering a month's supply for anything from 24 rand (about US$3) to 33.60 rand (more than US$4), depending on the size of the doze. Zerit is available in South Africa for 40.54 rand (about US$5). Aspen is also in the process of developing generic versions of several other AIDS drugs, including GlaxoSmithKline's Combivir, 3TC and AZT as well as Boerhinger Ingelheim's Nevirapine, Saad said. Once all of those generics are registered with South Africa's Medicines Control Council, Aspen hopes to be able to offer the triple combination therapy that is the standard in AIDS treatment for under US$1 a day, he said. However, unlike Aspen-Stavudine, Aspen will only be able to sell those drugs to the public health system under its agreement with those companies. The South African government, which has come under increasing criticism for refusing to provide AIDS medicine to its people through the public health system, praised the announcement. "For South Africa, for health care and for our pharmaceutical industry, this is the start of a great process," Trade Minister Alec Erwin said. However, it was unclear when the government would announce a program to provide the drugs through the public health system, Erwin said. An estimated 5 million South Africans are infected with HIV. Dr. Ayanda Ntsaluba, director-general of the Health Department, told a South African AIDS conference in Durban that it was not a question of whether there would be a government program to distribute AIDS drugs, but when it would begin, according to the South African Press Association. The Treatment Action Campaign, an AIDS activist group, cautiously welcomed Aspen's announcement, saying the production of generic medicine was the only way to bring down the drug prices. However, the group criticized the exclusive license Bristol-Myers gave Aspen to produce the drug, saying that only when there was free competition among many generic companies would the drugs drop to the lowest possible prices. "While this is an excellent development, and it does move us forward, it is not ideal," said Eduard Grebe, the TAC's treatment project coordinator. "It's in fact a transfer of monopoly and not generic competition." BuaNews (South Africa) Ntsaluba Outlines Issues Around Provision of Antiretrovirals 06 August 2003 Veronica Mohapeloa, Pretoria Health department Director-General Ayanda Ntsaluba says the report on the provision of antiretrovirals in the country will help government answer many important questions regarding this issue. Addressing media at the National AIDS Conference in Durban yesterday, Dr Ntsaluba said when South Africa began rolling out the anti-AIDS drugs it would signal that the country was moving from the issue of 'if' to the issue of 'when' and 'how to do it'. Government last year established a task team of officials from the health department and National Treasury to investigate the cost implications of providing anti-AIDS drugs in the public health sector. Dr Ntsaluba said it should be ensured that the introduction of antiretrovirals did not exacerbate problems in the public health sector, which he said, would happen if only a few institutions in urban settlements had the required capacity. For this reason, he said government should make sure a plan existed to capacitate those who were poor and unable to access the drugs. 'We must make sure that when we deal with this programme, we must also have a plan if it gets executed.' He said there was a sense of urgency in the country regarding the issue. However, by the time the document reached Cabinet, 'it must be of such quality to answer questions in advance so Cabinet is enabled to take a decision.' He said complete work had to be done with the report, to 'avoid political storms' around the issue. On other challenges in the public health sector, he said there was a lot of happenings in the country, however major challenges of implementation existed which required a committed effort. 'That is why I think there needs to be a strong partnership to deal with those,' he said. He said raising the challenges meant focusing minds so that 'we can cautiously' deal with those challenges. 'South Africa has what it takes to mount an effective and very successful response to this major challenge if we pull our resources together.' Cape Argus (South Africa) Study On Babies Shows the Way On Nevirapine 06 August 2003 Di Caelers A study of 300 babies of HIV-positive mothers in a nevirapine programme at a Johannesburg hospital found that just 9% of babies contracted HIV after birth. The study, presented at the SA Aids Conference in Durban yesterday, was conducted at the Coronation Women's and Children's Hospital and points to the efficacy of the anti-Aids drug around which a new controversy broke out last week. Today, the reshuffled programme of the conference will include a special session featuring four speakers to address issues around the drug which has already been used to treat tens of thousands of HIV-positive pregnant women in the country. Last week it emerged that the Medicines Control Council had given nevirapine manufacturers Boehringer-Ingelheim 90 days, from last Tuesday, to prove the efficacy and safety of the drug. The council has rejected the pivotal study, done in Uganda, on which initial registration was based in South Africa Presenting Coronation Hospital's results, paediatrician Dr Ashraf Coovadia told the conference that between October 2001 and the end of last year, 1 234 women from a total of 8 200 had tested HIV positive, pointing to a 15% prevalence. For purposes of the study, 300 babies were examined, a quarter of the total number of women. The babies were tested twice, at six weeks and again at three months old, showing an 8.9% HIV transmission rate from mother to child. Coovadia said the results were much lower than in other similar studies and attributed this to the very high rate of formula feeding. "Our low transmission rate confirms that efficacious prevention of mother-to-child HIV transmission is possible in the routine health service," he said. Cape Argus (South Africa) Group Petitions for Nevirapine's Use 05 August 2003 The South African Aids Conference looks set to get its own "Durban declaration". In the same way scientists flocked to sign their names during the World Aids Conference in Durban in 2000 to the fact that HIV does cause Aids, they have again been called on for their support - this time for nevirapine. The drug is at the centre of a storm following the Medicines Control Council's (MCC) announcement last week it was giving manufacturers Boehringer-Ingelheim 90 days to prove the drug worked and was safe. The Elizabeth Glaser Paediatric Aids Foundation, of Washington, was gathering signatures at the Aids conference yesterday for a petition to Precious Matsoso, registrar of the MCC, telling her "the safety and efficacy of nevirapine in preventing mother-to-child HIV transmission has been clearly demonstrated" The foundation wanted researchers, health professionals, advocates and organisations working to prevent HIV/Aids to sign the call for the MCC to change its mind. They intend releasing the petition officially today. The letter points out that the Ugandan study, on which the MCC based its registration for mother-to-child use in South Africa and which the council has now found to be seriously flawed, was subject to peer review and published in the Lancet. It says, other "highly regarded international studies" had demonstrated nevirapine's safety and efficacy. It urges Matsoso to "look to the solid and incontrovertible scientific evidence when making any decisions on the use of nevirapine". - Staff Reporter ENDS http://www.nu.ac.za/ccs UP:20031228 ◇ＨＩＶ／ＡＩＤＳ2003 ◇全文掲載 |