- End state sanctioned denial: TAC and South African Medical Association take legal action against Minister of Health.
- Lorna Mlofana murder trial finally proceeds.
- Updated Actuarial Society model of demographics of SA HIV epidemic has been released.
- End state sanctioned denial: TAC and South African Medical Association take legal action against Minister of Health.
- Lorna Mlofana murder trial finally proceeds.
- Updated Actuarial Society model of demographics of SA HIV epidemic has been released.
- New regular feature: How we know that antiretroviral treatment works: Research from South Africa.
- Today’s feature: Study of health-related quality of life in Medecins Sans Frontieres patients on antiretroviral treatment finds substantial improvement from baseline to twelve months.
- Book announcement: HIV/AIDS in South Africa, edited by Salim Abdool Karim and Quarraisha Abdool Karim
End State Sanctioned Denial!
A TAC briefing on why TAC and SAMA are taking the Minister of Health to court
The Treatment Action Campaign and the South African Medical Association (SAMA) have filed court papers against the Minister of Health, the Medicines Control Council (MCC), the Western Cape MEC for Health, as well as pharmaceutical proprietor Matthias Rath and several of his employees and associates, including AIDS denialists Anthony Brink, David Rasnick and Sam Mhlongo (Professor of Family Medicine, MEDUNSA). This briefing explains why.
In addition to Rath, his employees and associates, we are also suing our government and certain statutory bodies. We do so with great reluctance. But it is our mandate and duty to protect the rights of people living with HIV/AIDS. The Minister and the statutory bodies that she oversees have had ample opportunity to avoid this litigation but have chosen not to.
Over 5 million people live with HIV in South Africa. Over 300,000 people died of AIDS last year and more will die this year. It is crucial if we are to make progress against the epidemic that government officials convey accurate information about the disease, especially its prevention and treatment. The scientifically bogus messages engulfing South African society about HIV is leading to confusion and numerous avoidable deaths.
The Minister of Health: A track record of supporting AIDS denialists
The Minister of Health, Manto Tshabalala-Msimang, has a track record of supporting AIDS denialists, including Roberto Girraldo, Tine van der Maas and Matthias Rath. Despite a Cabinet decision in November 2003 to provide antiretroviral (ARV) treatment, the only scientifically proven medicines to reverse the course of AIDS, she has not once encouraged people to seek such treatment. Her exaggeration of the side-effects of ARVs has discouraged people from using them. On numerous occasions she has encouraged people to seek unproven treatments for AIDS including garlic, African potatoes, olive oil and multivitamins.
The consequence of this has been public confusion. Such confusion is likely to have caused many avoidable premature deaths.
The right of patients to receive accurate information is described in the recently adopted National Health Act. Irrespective of Tshabalala-Msimang’s personal opinions, it is her duty as Minister of Health, i.e. an appointed public official, to convey to the public accurate information on HIV, including its prevention and treatment, based on the current scientific consensus. This means she must encourage people to get tested for HIV and, if necessary, get treated using the best available medicines at public health facilities including using opportunistic infection drugs and ARVs.
Matthias Rath’s illegal activities
Since at least November 2004, the German pharmaceutical proprietor Matthias Rath has been openly conducting illegal activities in South Africa to the knowledge of the Minister, Western Cape provincial health department and the Medicines Control Council. These include:
- making false claims about medicines, including that vitamins (which he sells) reverse the course of AIDS and that antiretrovirals make AIDS worse;
- distributing medicines (since 2005), unregistered for the treatment of HIV, with the purpose of treating people with HIV and in doing so persuading them not to seek the services of the public health system; and
- conducting an experiment (since 2005) on humans without the authorisation of the Medicines Control Council
The above activities are in contravention of the Medicines Act (1968). Furthermore Rath has been representing himself as a medical doctor while carrying out these duties, even though he is not registered with the Health Professions Council of South Africa (HPCSA) or any other professional statutory body. This is illegal.
A number of people have died directly as a result of Rath’s illegal activities. TAC has analysed some of these deaths in an article available on our website, http://web.archive.org/web/20070622025819/tac.org.za/. Possibly many more people have died because of the confusion he has created.
Rath’s activities are not only illegal; they also directly contradict government policy, in particular the Operational Plan for HIV/AIDS Care, Management and Treatment (Operational Plan) adopted by Cabinet on 19 November 2003.
TAC’s efforts to get state authorities to stop Rath’s activities
TAC has been trying to get the relevant state authorities to take action against Rath since February 2005. Our efforts included alerting the MCC in February, filing a complaint with the HPCSA which lead to them filing a complaint with the Khayelitsha police, meeting with Department of Health law enforcement agents in April, submitting a detailed affidavit presenting evidence of Rath’s illegal activities to the Department of Health’s Law Enforcement Unit in May and writing several letters to the MCC, Minister of Health and Western Cape MEC for Health. We have also held several demonstrations highlighting Rath’s dangerous activities.
Other organisations including Medecins Sans Frontieres (MSF), as well as a group of about 200 Western Cape doctors have also tried to get government to stop the illegal activities of Rath. Individuals, including journalist Terry Bell, have also laid complaints with the MCC.
Rath has been condemned by the United Nations, SAMA, MSF, Southern African HIV Clinicians Society, SACC, COSATU, SACP, Harvard School of Medicine, ANC MPs Kader Asmal and Ben Turok, ANC Western Cape Health Portfolio Committee member Saadiq Kariem and many others. He has been ordered to withdraw unsubstantiated claims in his adverts by the Advertising Standards Authority of South Africa (ASASA) as well as the British equivalent of ASASA. He has at least two court judgments against him in Germany for making unsubstantiated claims about vitamin supplements in adverts. He also has a court ruling against him in Holland for defamation. The US Food and Drug Administration has cautioned him for making unproven claims about his vitamins.
Government’s failure to act
Despite the TAC’s and others’ efforts to get government to act, nothing systematic has been done to stop the illegal activities of Rath. On the contrary, the Minister of Health’s actions could only have emboldened him. For example:
- Despite having numerous opportunities to condemn Rath, the Minister of Health has never done so. For example, at an Imbizo in Khayelitsha addressed by the Minister of Health on 16 April, numerous members of the community asked the Minister to condemn the activities of Rath. She refused to do so.
- In an answer to a question in Parliament on 15 June 2005, the Minister admitted to having had a meeting alone with Rath on 16 April 2005, and said that they “discussed his concern for people infected with HIV and suffering from the impact of AIDS”. She said she would “only distance myself from Dr Rath if it can be demonstrated that the vitamin supplements that he is prescribing are poisonous for people infected with HIV.”
- She allowed Rath’s agents, David Rasnick and Sam Mhlongo, to present their claims to the National Health Council on 23 September 2005.
- A Rath publication, You Can!, states “The Dr. Rath Health Foundation Africa has the support of our Minister of Health and our Government.” The Minister of Health has not distanced herself from this statement.
- In various radio interviews, the Director-General of Health has made confusing, unscientific statements about Rath’s drugs and antiretrovirals (see TAC founding affidavit or http://web.archive.org/web/20070622025819/http://www.health-e.org.za/ for details). His statements can only be interpreted as supportive of Rath.
- The Minister of Health has also appeared supportingly in a propaganda video produced by another pseudo-scientist, Tine van der Maas. Van der Maas claims that her recipes treat AIDS, as well as other diseases such as diabetes. The Minister has shown this video in some forums. The production of the video was in part supported by the Rath Foundation.
The Medicines Control Council and the MEC for Health in the Western Cape have likewise failed to take any concerted action against Rath. Our court papers, however, do not seek any order against them, unless they oppose the application, in which case we will ask the court for costs.
What is in the TAC/SAMA court papers?
The Notice of Motion asks the court to find that Matthias Rath and his foundation are breaching the law by conducting an illegal clinical trial and distributing medicines in violation of the Medicines Act. We seek an interdict against Rath, his foundation and various Rath agents to stop them from continuing these illegal activities and to stop them from publishing false claims in adverts (including pamphlets and posters) about their products.
We also ask the court to find that the Minister of Health and Director-General have a duty to take measures against these illegal activities. Therefore, we ask the court to order them to report to the court, within a month of judgment, what steps they have taken to ensure the requested court order against Rath and his agents is carried out.
The main founding affidavit presents the evidence that Rath and his agents have broken the law, as well as evidence of the state’s failure to act. It explains the following affidavits:
Robert Dorrington, head of the Centre for Actuarial Research at UCT, describes the state of the HIV epidemic in South Africa and its effect on mortality.
Francois Venter, President of the Southern African HIV Clinicians Society, has provided an affidavit explaining the science of HIV. He explains that there is scientific consensus that antiretrovirals are the only treatments currently available that reverse the course of AIDS. He also explains that although there is evidence that multivitamins slow down progression to AIDS, they are not a substitute for antiretroviral treatment. He points out that Rath does not prescribe the same vitamins in the same dosages as those that have been found to be useful for people with HIV. He also describes some of the poor logic and factual distortions of AIDS denialists. Venter also describes the false claims made by Rath and his agents in advertising.
Andrew Gray, an expert pharmacologist at the Nelson Mandela Medical School, UKZN, explains that in his view Rath’s drugs are being sold in violation of the Medicines Act.
Leslie London, a professor at UCT’s medical school and an expert in public health and bioethics, contends that Rath’s clinical trial is illegal and unethical.
Affidavits by Nandipha Ntsholo and others (some of whom wish to remain anonymous) explain that they visited Rath clinics and were treated as part of a human experiment.
Zondani Magwebu and another deponent (who wishes to remain anonymous) describe how close members died who were being treated by Rath and/or his agents.
Peter Saranchuk, an MSF doctor working in Khayelitsha, and Kevin Rebe, an HIV doctor at GF Jooste Hospital, explain how their patients were confused by Rath and/or his agents. In Saranchuk’s case, one patient he was treating died as a result of the patient’s delay in seeking assistance from the public health system.
Marta Darder of MSF explains the efforts she made to get the relevant authorities to act against the illegal activities of Rath.
Marius Otto, representing SAMA, explains SAMA’s interest in protecting public health.
The issue of choice
It has been alleged that TAC is denying people choices by taking action against Rath. This is not true. The Minister of Health, like all elected and appointed public officials, has a duty to provide the public with scientifically accurate information on HIV treatment, not choices between proven treatments and unproven ones. Individuals then have the choice to follow her advice or ignore it. The same is true for pharmaceutical proprietors. They may not make unproven claims about their products because doing so results in people making poorly informed choices.
TAC’s position on proper nutrition
TAC supports government’s policy of ensuring proper nutrition for people living with HIV including providing food parcels, vitamin supplements and social grants. Good nutrition extends the lives of people with HIV and delays the onset of AIDS. But vitamins are not a substitute for ARVs and should not be prescribed in untested doses, as is being done by Rath and people who work for him.
What TAC hopes to achieve
TAC hopes to bring about an end to the politically supported campaign of AIDS denialism, misinformation and pseudo-science. Yet again we call on the Minister of Health to end her support of Rath, his agents and other pseudo-scientists by agreeing to act decisively against such people. We urge the Minister to not let untested claims fool her. We have lost too many lives because of AIDS denialism. It is time for the Minister to lead, not to confuse.
English and Xhosa
Sipho Mthathi (General Secretary): 021 788 3507
Linda Mafu (National Organiser): 021 788 3507
Vuyiseka Dubula (Western Cape Treatment Literacy Co-ordinator): 082 763 3005
Luyanda Ngonyama (Gauteng Co-ordinator): 011 339 8421
Mandla Majola (Khayelitsha District Co-ordinator): 072 424 7181
English and Zulu
Nokhwezi Hoboyi (Equal Treatment Co-editor): 072 064 4157
Johanna Ncala (Gauteng Treatment Literacy Co-ordinator): 082 735 4265
Pholokgolo Ramothwala (Limpopo Provincial Co-ordinator): 084 300 7006
Fredaline Booysen (Western Cape Organiser): 021 447 2593
[END OF TAC/SAMA LITIGATION AGAINST MOH]
Lorna Mlofana murder trial proceeds
On 28 November, the trial against the alleged murderers of TAC member Lorna Mlofana finally proceeded in the Cape High Court, when the first witness was called. Mlofana was murdered nearly two years ago in December 2003, allegedly after disclosing her HIV status to men who raped her. The trial continues in the Cape High Court today.
We urge the media to cover this trial and to give it the same attention that other high profile murder trials in South Africa have received, such as that of Leigh Matthews.
[END OF BRIEF LORNA MLOFANA REPORT]
Actuarial Society of South Africa releases new model
(Text of following article supplied by ASSA)
PRESS RELEASE: NEW SOUTH AFRICAN AIDS MODEL RELEASED
The Actuarial Society of South Africa (‘ASSA’) has released the new version of its local AIDS and Demographic model that provides insight into the state of the HIV epidemic in each province in South Africa. ASSA2003 is the first AIDS and Demographic model to take the government’s Comprehensive Plan for HIV and AIDS into account at a provincial level. The model has been designed by South African demographers and actuaries based on detailed South African data. Using these data, the model projects the numbers of South Africans living with HIV, new infections, AIDS deaths, AIDS sickness and many more statistics into the future. According to Dominic Liber, convenor of the ASSA AIDS Committee, “this is the most accurate model that ASSA has developed to date, that allows for differing rates of HIV spread and differing levels of intervention by province.”
Differences between ASSA2003 and previous versions of the ASSA model
The previous model, namely ASSA2002, which was released by the AIDS committee of the Actuarial Society in July 2004, will be replaced by ASSA2003. The previous model was the first ASSA model to take the various government and private sector interventions at a national level into account. ASSA2003 allows for government and private sector interventions at a provincial level and can project provincial HIV and AIDS statistics. According to Rob Dorrington, actuary and professor of actuarial sciences at UCT, the ASSA2003 version is the first to model the epidemic in the provinces in a way that is consistent with the model for the country as a whole.
Sources of data
HIV prevalence data up to 2003 from the national antenatal clinic surveys was used to ensure that the model reflects the progress of the HIV/AIDS epidemic in each province as accurately as possible. HIV prevalence amongst pregnant women attending public sector antenatal clinics is measured on an annual basis and used by demographers to inform their models. Adjustments are made in the ASSA model to allow for the higher expected HIV prevalence amongst pregnant women attending public sector clinics than that amongst other women in the South African population. Other HIV prevalence data from the studies done by the Human Sciences Research Council in 2002 and the Reproductive Health Research Unit survey amongst youth has also been taken into account. Data from the censuses and the 1998 Demographic Health Survey were used to set demographic assumptions, and model estimates of deaths were checked for consistency against total reported deaths in South Africa.
Profile of the epidemic in 2005 at a national level
The total number of people living with HIV in South Africa is estimated to be 5.2 million in 2005. It is estimated that there were around 530 000 new HIV infections between the middle of 2004 and the middle of 2005 and around 340 000 AIDS deaths over the same period. As the number of new HIV infections currently exceeds the number of AIDS deaths, the HIV prevalence is still slowly growing in South Africa. The current massive number of HIV positive individuals has resulted in an estimated 520 000 untreated South Africans who are sick with AIDS and in need of antiretroviral treatment. As at the middle of 2005, the model estimates that just over 120 000 South Africans were receiving antiretroviral treatment. ASSA2003 also estimates that around 1.5 million South Africans have died from AIDS-related illnesses since the start of the epidemic. The ASSA2003 model predicts that the total number of HIV infections in South Africa will increase slightly, from 5.2 million currently to 5.8 million by 2010. The annual number of new HIV infections is likely to remain at close to half a million over the next few years, in spite of the significant interventions that have already been introduced to limit the spread of HIV.
Profile of the epidemic in 2005 at a provincial level
The table below shows estimated total HIV infections, total HIV prevalence, HIV prevalence in 15-49 year olds, and life expectancy at birth. KwaZulu-Natal is clearly the province worst affected by the HIV/AIDS epidemic, with the highest rates of HIV prevalence, and the lowest life expectancy. Other severely affected provinces are Gauteng, Free State, Mpumalanga and North West. Differences in life expectancies between the provinces are partly due to differences in the socio-economic profiles of the populations in the different provinces, but are also largely a reflection of the differences in rates of HIV prevalence and consequent AIDS mortality.
[Table might not appear in some email readers – TAC Newsletter Editor]
Table: Provincial indicators in 2005
According to Liber, the reasons for the different epidemics in the different SA provinces are many and varied. One reason is that some provinces are predominantly urban, and others are predominantly rural, with levels of sexual networking usually being higher in urban areas. Geographical factors are also likely to affect access to HIV prevention services. There are also cultural differences between provinces, for example circumcision has been shown to reduce the chance of becoming infected by HIV.
Access to antiretroviral treatment in the provinces
The ASSA2003 AIDS model will become a valuable tool for the provincial health departments in the implementation of the national Comprehensive HIV and AIDS plan. The model provides estimates of the expected numbers of South Africans who are entering the AIDS sick phase and who will be requiring antiretroviral treatment in the future. As at mid-2005, the proportion of AIDS cases on antiretroviral treatment ranged from 15% in KwaZulu-Natal to 50% in the Western Cape. According to Leigh Johnson, actuary and member of the AIDS Committee, these differences are in part due to differences between provinces in terms of the proportion of the population using private facilities, but are also largely a reflection of inequality in access to treatment within the public health sector.
For more information…
ASSA2003 is freely available for download from the Actuarial Society of South Africa’s website: http://web.archive.org/web/20070622025819/http://www.assa.org.za/. Also available on the website is an Excel workbook (ProvOutput_051125.xls) which contains the detailed results of the model for each province. A document containing these results and commentary on their implications will also be made publicly available shortly.
CONTACT DETAILS OF MEMBERS OF THE ASSA AIDS COMMITTEE:
Rob Dorrington: 021 650 2475
Leigh Johnson: 021 650 5761
Sarah Bennett: 011 509 3045
Nathea Nicolay: 021 917 3090
[END OF ASSA STATEMENT]
How we know that antiretroviral treatment works: Research from South Africa
The Minister of Health has on many occasions by implication questioned the safety and efficacy of antiretroviral treatment. The Department of Health says it has been unable to monitor and evaluate the antiretroviral rollout. However, there is substantial evidence that the implementation of highly active antiretroviral treatment in South Africa is saving and improving lives. Some of this evidence has already been published in peer-reviewed credible scientific journals. Much more is expected to be published in the next few months.
We will present some of these findings as part of a regular new feature in our newsletter.
Health-related quality of life of Medecins Sans Frontieres patients in Khayelitsha improves substantially with highly active antiretroviral treatment
A study published in AIDS Care in July examined the health-related quality of life of 117 patients being treated as part of the Medecins Sans Frontieres pilot highly active antiretroviral treatment project in Khayelitsha. There was a substantial improvement in quality of life at twelve months of treatment versus baseline (i.e. immediately prior to commencing treatment). Here is the abstract:
AIDS Care, July 2005; 17(5): 579-588
J. JELSMA, E. MACLEAN, J. HUGHES, X. TINISE, & M. DARDER
The health authorities have recently accepted the routine provision of highly active antiretroviral
therapy to persons living with AIDS in South Africa. There is a need to investigate the impact of
HAARTon the health-related quality of life of people living with HIV/AIDS (PLWHA) in a resourcepoor
environment, as this will have an influence on compliance and treatment outcome. The aim of
this study was to explore whether HAART is efficacious in improving the self-reported health-related
quality of life (HRQoL) in a group of PWLA in WHO Stages 3 and 4 living in a resource-poor
community. A quasi-experimental, prospective repeated measures design was used to monitor the
HRQoL over time in participants recruited to an existing HAART programme. The HRQoL of 117
participants was determined through the use of the Xhosa version of the EQ-5D and measurements
were taken at baseline, one, six and 12 months. At the time of the 12-month questionnaire, 95
participants had been on HAART for 12 months. Not all participants attended all follow-up visits, but
only two participants had withdrawn from the HAART programme, after two or three months.
At baseline, the rank order of problems reported in all domains of the EQ-5D was significantly
greater than at 12 months. The mean score on the global rating of health status increased significantly
(pB/0.001) from a mean of 61.7 (SD/22.7) at baseline to 76.1 at 12 months (SD/18.5) It is
concluded that, even in a resource-poor environment, HRQoL can be greatly improved by HAART,
and that the possible side effects of the drugs seem to have a negligible impact on the wellbeing of the
subjects. This bodes well for the anticipated roll-out of HAART within the public health sector in
[END OF SA ARV FEATURE]
(Text of following article supplied by Cambridge University Press)
HIV/AIDS in South Africa, edited by Salim Abdool Karim and Quarraisha Abdool Karim
This definitive text covers all aspects of HIV/AIDS in South Africa, from basic science to medicine, sociology, economics and politics. It has been written by a highly respected team of South African HIV/AIDS experts and provides a thoroughly researched account of the epidemic in the region.
The book comprises seven sections, the first of which describes the evolving epidemic, presents the numbers behind the epidemic, and captures its nature in one of the worst affected parts of the world. This is followed by a section on the science of the virus, covering its structure and its diagnosis. HIV risk factors and prevention strategies, focal population groups and the impact of HIV/AIDS in all aspects of South African life are discussed in the next four sections. The final sections look at the treatment of HIV/AIDS, the politics of HIV/AIDS treatment, mathematical modelling to extrapolate the potential impact of treatment and finally a discussion of the future of HIV/AIDS in South
Africa. This text has been written at an accessible level for the general reader, undergraduate and postgraduate students, health care providers, researchers and policymakers in this field as well as international scholars studying HIV/AIDS in Africa.
Section 1.The evolving HIV epidemic
Section 2. The virus, the human host and their interactions:
Section 3. HIV risk factors and prevention strategies
Section 4. Focal groups for understanding the HIV epidemic
Section 5. The impact of HIV/AIDS
Section 6. Treating HIV/AIDS
Section 7. What does the future hold?
Cheryl Baxter, Prof. Debbie Bradshaw, Dr. Gavin Churchyard, Tonie
Cilliers, Dr. David Coetzee, Dr. Mark Colvin, Prof. Jerry Coovadia, Dr.
Elizabeth Corbett, Nawaal Deane, Prof. Rob Dorrington, Dr Lara Fairall,
Dr Janet Frohlich, Eleanor Gouws, Andrew Gray, Dr Clive Gray, Dr Abigail
Harrison, Prof. Anthon du P Heyns, Mark Heywood, Leigh Johnson, Prof.
Quarraisha Abdool Karim, Prof. Salim S. Abdool Karim, Ted Leggett, Prof.
Mark Lurie, Dr Gary Martens, Lilian Benita Mboyi, Gethwana Makhaye, Dr
Darren Marten, Dr Catherine Mathews, Prof. Lynn Morris, Dr Landon Myer,
Dr Adrian Puren, Dr Gita Ramjee, Prof. Jerome Singh, Johanna
Swanevelder, Marianne Visser, Prof. Alan Whiteside, Prof. Brian
Williams, Prof. Carolyn Williamson, Dr Douglas Wilson, Prof. Robin Wood.
Contact Anthea Williams at Cambridge University Press African branch on
(021) 4127800, fax (021) 4190594 and e-mail firstname.lastname@example.org
[END OF BOOK ANNOUNCEMENT]
[END OF NEWSLETTER]