Treatment Action Campaign (TAC) E-Newsletter: 18 March 2002 To subscribe/unsubscribe, send an email with your request in the header to subscribe@tac.org.za *********************************************** THIS NEWSLETTER IS DIVIDED INTO 2 SECTIONS, "IN BRIEF" AND "IN DEPTH". "IN BRIEF" IS SHORT AND GIVES A QUICK OVERVIEW OF MAJOR ISSUES. ARTICLES WITH A GREATER LEVEL OF DETAIL ARE DESCRIBED BRIEFLY IN THE "IN BRIEF" SECTION AND EXAMINED IN MORE DEPTH IN THE "IN DEPTH" SECTION. *********************************************** IN BRIEF SECTION * Brief TAC statement on Zimbabwe: TAC notes the conclusions of the Norwegian, Commonwealth, SADC Parliamentary and NGO monitoring groups that the Zimbabwean election was neither free nor fair. President Mugabe's track record of failing to adhere to the rule of law, manipulation and intimidation of the judiciary, hate-speech against gays and lesbians, undermining of trade unions, military involvement in the war in the Congo and inflammatory rhetoric against the opposition MDC, as well as the reports of violence and human rights abuses by the Zimbabwean police and Zanu PF are an obstacle to democracy, development, peace and stability throughout Southern and Central Africa. We are also concerned that the South African government's public criticism of the human rights abuses in Zimbabwe has been insufficient. * Mother-To-Child Transmission Prevention (MTCTP) Court Case Timetable: -- Monday 11 March: Pretoria High Court grants TAC interim relief until Constitutional Court hearing. Government given leave to appeal, but must make nevirapine available immediately to hospitals with capacity in the interim. -- Friday 15 March: Government lodges appeal against interim relief. This appeal is legally irregular. -- Monday 18 March: TAC files replying affidavit to government's appeal against interim relief. -- Friday 22 March: Probable date for hearing on appeal against interim relief, Pretoria High Court. -- May 2, 3: Dates set for Constitutional Court hearing on appeal against Pretoria High Court judgment on MTCTP made in December. TAC condemns the government's continued attempts to delay the provision of nevirapine for MTCTP. Their attempt to appeal against the Pretoria High Court's interim relief judgment has no legal foundation. Furthermore, it continues to demonstrate a callous disregard for the health of women and children. See the latest court papers and statements on MTCTP at http://www.tac.org.za See IN DEPTH for a press release earlier this week by TAC on the mtctp interim relief judgment. * TAC welcomes the reported announcement by the North West Government to rollout mother-to-child transmission prevention. The North West Government's reported decision to invest R40 million over the next year into the rollout demonstrates a real commitment to making this programme work. The North West's decision follows the Western Cape, Gauteng, Eastern Cape and Kwazulu-Natal's commitments to implement mother-to-cild transmission prevention. * John Sulston, formerly the Head of the Sanger Institute which played a critical role in the Human Genome Project gave a talk at the TAC/MSF offices in Khayelitsha. He was invited by TAC, MSF and Oxfam. See IN DEPTH. * Academics and doctors condemn the sacking of Dr Thys von Mollendorf, superintendent of Rob Ferreira Hospital in Mpumalanga. Von Mollendorf was fired for allowing GRIP, an NGO that distributes AZT to rape survivors, to operate in Rob Ferreira Hospital. See IN DEPTH for statements by a group of academics and the SA Academy of Family Practice/Primary Care. * "Defeating HIV: Now is the time!" Cosatu President Willy Madisha calls for treatment of people with HIV/AIDS and for local generic production of antiretrovirals. See IN DEPTH. * TAC responds to an article by Richard Tren that appeared in the Wall Street Journal. See IN DEPTH. *********************************************** IN DEPTH SECTION *********************************************** Mother-to-Child Transmission Prevention (MTCTP) Court Case Victory -- 11 March 2002 The Pretoria High Court this morning ordered that the national government and all the Provinces (except the Western Cape and KwaZulu Natal who have already decided to make Nevirapine available outside pilot sites) should carry out part of the original judgement pending the appeal before the Constitutional Court. The relevant part is quoted below: 2 The first to ninth respondents are ordered to make Nevirapine available to pregnant women with HIV who give birth in the public sector, and to their babies, in public health facilites to which the respondents' present programme for the prevention of mother-to-child transmission of HIV has not yet been extended, where in the opinion of the attending medical practitioner, acting in consultation with the medical superintendent of the facility concerned, this is medically indicated, which shall at least include that the woman concerned has been appropriately tested and counselled. This means: (a) doctors have a right to prescribe Nevirapine, after the offer of voluntary counselling and HIV testing, where a pregnant women is HIV positive. (b) the government has a duty to provide Nevirapine to all public health facilities where the medicine is needed and can be properly used. Also from the judgement: (p.12) "If order 2 is implemented, and the [government's] appeal succeeds, the result will be that the health facilities will have suffered some inconvenience here and there and that resources, especially human resources, will have been strained. In many cases that will be an inconvenience that ethically motivated health workers will gladly assume. At the same time there will be a gain in lives saved which cannot be considered a loss even if the Constitutional Court should find that parallel access to Nevirapine should not have ben granted at all. If the order is suspended and the [government's] appeal were to fail, it is manifest that it will result in the loss of lives that could have been saved. It would be odious to calculate the number of lives that one could consider affordable in order to save [the government] the sort of inconvenience they forshadow. I find myself unable to formulate a motivation for tolerating preventable deaths for the sake of sparing [the government] prejudice that cannot amount to much more than organisational inconvenience." *********************************************** Overview of talk by Professor John Sulston Professor John Sulston, a leading scientist in the mapping of the human genome and former head of the Sanger Institute, spoke at the TAC/MSF office in Khayelitsha on Monday. He spoke out against the patenting of genes and also against the inequities in access to health created by trade agreements such as TRIPs. Where there are such wide differences in health expenditure ranging from over $4000 per person in the United States to $5 per person in Malawi, it is essential to ensure that intellectual property rights do not exacerbate these inequities. Sulston drew on parallels between scientists working on the Human Genome Project advocating the public availability of all human genome information and groups, such as TAC, Oxfam and MSF, who are fighting for wider access to essential medicines. He stated that the needs of science and development are often subjugated to business interests and profit. However, scientists, even in the United States, are becoming annoyed with a system of patents and information protection that hampers their research. Sulston stated that it was a victory for the public that the Human Genome Project was able to make all knowledge about the human genome available for free use, despite attempts by powerful private interests to undermine this. *********************************************** STATEMENT BY ACADEMICS ON SACKING OF DR THYS VON MOLLENDORF We believe that the actions of the Mpumalanga MEC for Health, Ms Sibongile Manana, who used a government tribunal to terminate the services of Rob Ferreira Hospital superintendent, Dr Thys von Mollendorff, are ethically indefensible. We call on her to reconsider her actions carefully in the light of doctors' universally recognised ethical obligations to their patients, and to reinstate Dr von Mollendorff. Political interference in healthcare delivery was unambiguously denounced by the World Medical Association at the 38th World Medical Assembly in October 1986, as follows: "Physicians must have the professional freedom to care for their patients without interference. The exercise of the physician's professional judgment and discretion in making clinical and ethical decisions in the care and treatment of patients must be preserved and protected. Physicians must have the professional independence to represent and defend the health needs of patients against all who would deny or restrict needed care for those who are sick or injured." Dr von Mollendorff acted within the letter and spirit of this declaration. To victimise him for having defended the highest principles of his profession, and for standing up for his mostly vulnerable and poor patients, is unjust in terms of all civilised and humane ethical standards. Moreover, we believe that the MEC's actions go against President Thabo Mbeki's call for volunteerism, since the services rendered by GRIP were funded by voluntary contributions from the greater Nelspruit community, and were part of the victim empowerment programme, officially mandated in terms of health policy. SIGNED: Prof Willem Landman, CEO, Ethics Institute of South Africa, and Extraordinary Professor of Philososphy, University of Stellenbosch - contact person Pretoria (082-563-9139 - until 18h00 Thursday, March 7) Prof Udo Schüklenk, Associate Professor Bioethics and Human Rights, University of the Witwatersrand Faculty of Health Sciences, Head: Division of Bioethics, Chair Professional and Ethical Standards Committee - contact person Johannesburg (083-633-6613 or 011 717 2718) Prof Peter Cleaton-Jones, Professor and Chair, Committee for Research on Human Subjects (Medical), University of the Witwatersrand Faculty of Health Sciences Prof Anton van Niekerk, Professor of Philosophy and Director of the Centre for Applied Ethics, University of Stellenbosch Prof Solomon R Benatar, Professor of Medicine and Director Bioethics Centre, University of Cape Town Dr Anant Chetty, Chairperson, Human Rights, Law and Ethics Committee, South African Medical Association (SAMA) (signed in personal capacity) Prof Piet Naude, Professor and Director, University of Port Elizabeth Centre for Ethics Prof Charles Ngwena, Professor, Centre for Human Rights Studies, Faculty of Law, University of the Free State Dr Ames Dhai, Co-Chair Research Ethics Committee and Bioethics Reference Group, Nelson Mandela School of Medicine Prof J Moodley, Professor and Chair, Research Ethics Committee, Nelson Mandela School of Medicine Prof Graham Howarth, Professor, Bioethics, School of Medicine, University of Pretoria (signed in personal capacity) Prof Trefor Jenkins, Lecturer in Bioethics, University of the Witwatersrand Faculty of Health Sciences STATEMENT BY SA ACADEMY OF FAMILY PRACTICE/PRIMARY CARE The SA Academy of Family Practice/Primary Care expresses its disappointment that Dr. Thys Van Mollendorf, Superintendant of Rob Ferreira Hospital in Nelspruit, has been dismissed for allowing an NGO, GRIP, to distribute antiretroviral drugs and provide counseling to rape survivors in the hospital. Dr. Van Mollendorf was carrying out what is regarded as an ethical duty for a medical practitioner to put the well-being of his patients as his primary professional duty. Not allowing rape survivors access to counseling and anti-retroviral drugs where appropriate does not constitute concern for the best interest of the patient. The termination of Dr. Van Mollendorf's services is therefore arbitrary and it will contribute to creating an environment where doctors in the public sector feel demoralised and unable to carry out their ethical duties to their patients. The Academy calls for Dr von Molendorf's immediate reinstatement. The Academy also supports the statement brought out by the group of Prof W Landman and others " Issued by the SA Academy of Family Practice/Primary Care Tel 021 531 8205 ############################################################################ Defeating HIV: Now is the time! Address by Willy Madisha - President COSATU, Sparrow's Nest Aids Village Gauteng (14 February 2002) The Congress of South African Trade Unions (COSATU) has welcomed President Mbeki's comments in relation to HIV made in his state of the Nation address recently. COSATU further made an "appeal to everyone concerned to get out of entrenched positions and public posturing on this grave national crisis and put the needs of the our people first." (Batho Pele is a watchword of our government- and truly we are trying as a public service to do this). In tackling HIV "we must put people first" because - the evidence in the hospitals and our cemeteries confirm that people are dying and that where anti-retrovirals are applied life is clearly extended, and where they are denied, as day follows night, so a premature death follows such denial. Last year, two separate reports confirmed that large numbers of people are now dying of AIDS-related illnesses. The first report by the Medical Research Council (MRC) was contested by the government, particularly because it drew the conclusion that AIDS was now the main cause of death amongst adults and would lead to millions of deaths within the next few years. The second report produced by Statistics South Africa (SSA), the government's "official" analysts, repeated that there have been dramatic changes in (a) the numbers of people dying, which has increased greatly and (b) The patterns of death in South Africa - with large numbers of people now dying.in their 20's and 30's. This report resisted drawing the conclusion that AIDS was the major factor behind this. We on the ground know that there can be no other explanation. What both reports confirm is being felt on the ground and is being reported anecdotally by doctors, nurses, church leaders, community activists and trade unionists. This pattern of increasing sickness and death among young and poor people in SA will continue for many years to come unless there is a deliberate and united intervention to prevent it. When our President talks about a holistic approach, it cannot be faulted; however, two key points need to be stressed. First of all, new HIV infections can be prevented by more effective communication strategies but also by targeting the social conditions that put people at a greater risk of infection. Here we are talking about the urban and rural poor who are the systematic victims of capitalism's ruthless pursuit of profits over all other social and moral considerations. We in COSATU believe that targets must be set - to both reduce the number of infections - currently 1500 per day - as well as having it as a measuring tool to test effectiveness of our strategies. The second point is that there is absolutely no doubt, in my mind, that anti-retroviral medicines lead to a reversal of many of the consequences of HIV infection and, in most instances, dramatically improve and prolong lives. There is ample evidence that anti retroviral therapy is highly effective in reducing a person's level of infection with HIV. That leads to a substantial improvement in the immune system and a longer life. Since the most effective treatment, which combines three of the anti-retrovirals (so called cocktails or combination therapy) was only introduced in 1996, it is not known for how long treatment can be used. A seminal study by Palella and others have shown a decrease of deaths in the USA by more than 70% since the combination therapy was used. A study in a Chilean public hospital between 1997 and 2000 demonstrated an equally remarkable success. Patients getting anti-retrovirals experienced a 60 to 73% fall in Aids - related deaths, whilst Aids related illnesses dropped 65 to 76%. Oesophageal candidiasis dropped 84%, TB75%; cryptococcosis and toxoplasmosis, 66 %, PCP 55%; and bacterial pneumonia, 46%. Overall, hospitalisations were 73% lower for patients getting anti-retrovirals than for patients who did not. Brazil has been cited by UNAIDS as a best practice for its response to HIV - Aids epidemic. The country has about 500 000 people with HIV, substantially less than South Africa. Its government introduced an anti-retroviral programme in the early 1990's. It now ensures universal access to the therapy, including mother-to-child prevention programmes. As a result, mortality rates for people with HIV dropped by 50%. The above facts is the reason for all our focus on Anti Retroviral's (ARVs), but it should not be read as excluding or denying the importance of other interventions. However, the bottom line is that for ± 200 000 people a year access to these medicines is their only hope. The key priorities then for 2002 are: A) Now is the Time / Sekunjalo! The issue of mother-to-child transmission (MTCT) needs to be put to bed and put beyond further controversy, and we - as nation - cannot wait. Despite its opposition to the court case, in 200; senior government figures viz.; · (Zweli Mkhize KZN Minister of Health · Eddie Mahlanga, Director of Maternal and Child Health, · Ayanda Ntsaluba - Director General of Health), have repeatedly accepted that Nevirapine works and that it is safe and that the sole challenges are around implementation. Most recently, our President Thabo Mbeki said that provinces with capacity should be allowed to use this capacity whilst focus should be on improving capacity of the poorest provinces, particularly the Northern province. The essential and yet- not-in-place ingredients of patient counseling have often been raised in the media and public debate. This must be urgently addressed by us all especially those in the service unions (health, education etc) and community organisations. When President Mbeki quoted the case of the teacher from Inkonjane Senior Secondary School in Soweto I was doubly pleased. The teacher, Bathabile Serei, is a member of SADTU and together with the Sunday Times did really good work in supporting learners in the KZN area who are less privileged and suffering from HIV. The other reason for being pleased is that the president underscored the importance of solidarity and the need to rebuild community spirit. Research has it that KZN is at the epicentre of the virus in our country. The impact of the epidemic on students, teachers and institutions is extremely severe as University of Natal's researcher Peter Badcock-Walters argue, that SA is witnessing a decline in the quality of education which negatively impacts on the potential and the productivity. His study estimates that: # 275,000 school-age children in KwaZulu-Natal Province are not attending school. # First grade enrolment has dropped 60 percent since 1998. My union, SADTU has shown that teachers in the province are dying very young - presumably from AIDS. With this in mind, I calling on COSATU leaders - shop-stewards and activist members - as well as the Labour Movement at large, together with all civil society organisations to join in the spirit of Matsema / Letsema and volunteer their time to become counselors. A number of NGO's are willing to do this training and I am going to take up the course myself. I know there are many who are able and willing to do likewise. Every workplace and community must have at least one counselor. B) One giant step towards a holistic health strategy will be to put into place a National Treatment Plan for tackling HIV. This will deal in a comprehensive manner on prevention of HIV. We are fully aware that other illnesses and diseases such as Malaria and TB are widespread. But, by preventing HIV we will go a long way towards freeing the public health system - so that it can deal with other illnesses as well as providing meaningful treatment to those people who are already infected. For this to happen means proper and adequate funding for the public health system, must be forthcoming. c) For the plan to succeed the political will as well as the resources must be put in. We have all along called for HIV to be declared a national emergency, since it is not one equal health issue amongst many, but the determinant of many other epidemics as well as the general ability of health workers and health services to promote and improve health in South Africa. Since the COSATU / TAC /MSF "operation" to bring ARVs back from Brazil and challenge the patent holders, the TAC and COSATU have again been directly approached by the local pharmaceutical industry with proposals for local production of these medicines. This would create jobs, create investment and the possibility of sustaining access to these essential medicines. However, the generic companies cannot produce unless there is political support and political pressure to issue compulsory licenses for local production. Finally, I have spoken above about solidarity and rebuilding community spirit and organisation but it will require a massive injection of urgent treatment to ensure that the hope and resilience of our people is nourished and sustained. This calls for governments - our public sector -do be centrally involved in rolling out the treatment since only it has the leverage and capacity to reach all our people. When I voted for this government I did so with the express understanding that as a government - like all governments it has an obligation to look after the most vulnerable of its people. The case of people living with HIV has become the litmus test of our revolution, since it touches on illnesses, and the impact poverty and other factors has on it. Whilst a rich or relatively well off person living with HIV may truly live, because they can afford to buy all the anti retroviral cocktails, poor people, cannot afford these. Here I am reminded of my good comrade Judge Edwin Cameron, who has been living with the virus for years, and has been eating healthily, going to gym and keeps on taking his cocktail. A poor person, on the other hand, living in an informal settlement without a job and without access to treatment will surely die. Our government will surely, and I sincerely believe, rise to this challenge. Then we as a people -united- civil society, unions and our government will shoulder to shoulder, do what we did to Apartheid: relegate it to the dustbin of history. Our presence here - at the Sparrow Rainbow Village which, we believe will not only be a place to die, but to resist the virus and win. COSATU commits itself to working with all people in our country working to overcome the devastation caused by the virus and poverty. We shall overcome! Venceremos - Victory is certain! ############################################################################ Death is a Steep Price for Future Research Nathan Geffen (for the Treatment Action Campaign) 'Economists set themselves too ... useless a task if in tempestuous seasons they can only tell us that when the storm is long past the sea is flat again', Tract on Monetary Reform by John Maynard Keynes Richard Tren will have 6 million South Africans die of HIV/AIDS so that in some future world, no doubt after a messianic revival, we'll have more medicines to cure all the world's ills. In an article in the Wall Street Journal (25 Feb, 2002) he argues that the importation of generic antiretroviral medicines from Brazil by the Treatment Action Campaign (TAC), Medecins Sans Frontieres and the Congress of South African Trade Unions (Cosatu) will compromise the health of many people in the future. Along with some other phantasmagoria, he also believes that it costs an average of $800 million dollars to develop a new drug, that patents are not an obstacle to access to AIDS drugs in South Africa and that South Africa's disregard for intellectual property and the campaign against drug company profiteering has led to a drying up of funds for new AIDS drugs. He is wrong on all these issues. TAC does not crusade against intellectual property rights or patents. Intellectual property protection is crucial for the innovation of new life-saving medicines. By any reasonable standard the HIV/AIDS epidemic is an emergency in South Africa and globally. In such circumstances, the WTO TRIPs agreement allows for the use of compulsory licenses, a legal mechanism for allowing generic competition, so long as patent-holders are compensated. The purpose of the TAC, Cosatu and MSF importation from Brazil was to issue a challenge to the South African Government to pursue the legitimate and legal process of obtaining compulsory licenses. From TAC's perspective it also draws attention to continued patent abuse and sends a warning to pharmaceutical companies that the best way for them to avoid a repeat of the embarrassment they endured in the court case against the South African Government last year, is to issue non-exclusive voluntary licenses to generic manufacturers. Neither compulsory nor voluntary licenses will be an expropriation of pharmaceutical company property. Nor will either be unprofitable for them as a reasonable royalty will be payable on the sale of all generic antiretrovirals in a potentially massive market, unreachable at current prices. Patents are certainly an obstacle to access to drugs in South Africa, which strictly enforces a patent system that rivals any in the developed world. Indeed South Africa has never issued a compulsory license, unlike the US which has issued many for a variety of products. Furthermore, the legislation to be promulgated as a result of the South African Government's court victory over the Pharmaceutical Manufacturer's Association last year is standard in many European countries and Canada. And as much as we South Africans would like to believe what we do is important, AIDS research is most certainly not drying up because of that court case or recent events in which TAC has been involved. The reality is that if AIDS drug research is drying up (an exaggerated claim), it is because the US market is likely to provide diminishing returns on new antiretrovirals. It is ridiculous to think that events on a continent responsible for 1% of the world's pharmaceutical sales (much of these sales unrelated to AIDS) dictates the world's most successful industry's research agenda. (Incidentally, it was partly a result of pressure from American activists in the 1980s that resulted in the boom in AIDS research.) Despite South Africa's excellent patent protection, newly developed drugs for its TB epidemic and high malaria incidence are not forthcoming, because diseases that effect primarily the poor do not do much for drug company bottom lines. Tren should know this because his pharmaceutical industry financed firm claims to be fighting malaria. Tren quotes a report by Amir Attaran and Lee Gillespie-White (whose company, the IIPI, received a generous gift from Merck after submitting this report for publication) that finds that patents are not generally the problem in access to antiretroviral drugs in Africa. Rather it is poverty and lack of political will. Certainly these are very serious barriers which need to be addressed but they are exacerbated by the high cost of patented antiretrovirals. Attaran and Gillespie-White's report has been widely criticised for reaching conclusions at odds with their own facts. Over 70% of Africans with HIV live in countries where at least one antiretroviral is patented. In South Africa every registered antiretroviral medicine is patented. It is true that as a result of immense pressure antiretroviral prices have fallen substantially, but generic versions are still very often a third of the price of brand-name versions. Tren's claim that innovators patent their products in the US because of its strong protection of intellectual property neglects the obvious point that the US has the world's biggest market to sell new inventions and that the competitive advantage of India, Brazil and Argentina is not in innovation, but in copying. During the Industrial Revolution, the US did not shirk from a necessary measure for its development -- copying British invented machinery. A questionable and widely criticised report published by Tufts and repeated by Tren, states that it costs $800 million to develop a new drug. The report commissioned by the pharmaceutical industry, used unaudited data and highly unusual assumptions to reach the desired conclusion (see a detailed rebuttal at www.cptech.org). It is difficult to make accurate estimates of the cost of privately developed drugs, because the pharmaceutical industry avoids public scrutiny of its R&D financing. However, consider that a public institution such as the US based National Cancer Institute spends less than $15 million per new drug (corrected for inflation from 1988), including failures. An examination by the Consumer Project on Technology of 58 drug trials conducted by the US National Institutes of Health calculates a risk-adjusted cost of $16.1 million (1995 dollars) per drug. This leads to the following inescapable conclusion: Either the R&D of private drug companies is hopelessly inefficient and all R&D should therefore take place in the public sector, or the industry consciously misrepresents its R&D expenditure. Furthermore, nearly every antiretroviral has received some degree of public funding and many of them, including two of the three imported by TAC, MSF and Cosatu from Brazil, have been mostly or wholly funded with public funds. The worst part of Tren's article is that he expects South Africa to put up with unaffordable drug prices so as to protect the future of drug development. Setting aside the poor logic and incorrect facts on which this argument stands, most people with HIV/AIDS in South Africa, like Keynes, would prefer not to have to wait for the sea to be flat again. At current brand-name antiretroviral prices, many South Africans will die in the short-run. Tren likens TAC's strategy on intellectual property to that of Robert Mugabe's on private property. Actually it is Tren who has much in common with Zimbabwe's dictator, not TAC. Like Mugabe, Tren and the brand-name pharmaceutical industry's leaders are happy to sacrifice the lives of Africans for personal profit. -------------------------------------------