TAC Electronic Newsletter 


14 September 2003

Contents


MCC Affirms that Nevirapine is Safe and Effective for Mother-to-Child Transmission Prevention

Decision to Deregister Nevirapine in 90 Days Has Been Rescinded


TAC welcomes the following statement from the MCC


Medicines Control Council Press Release on 12 September 2003

The Medicines Control Council (MCC) recognises that the protection of unborn babies from transmission of HIV is of critical importance, and is committed to ensuring that medicines are both safe and effective.

Nevirapine has been shown to be effective in reduction of the risk of intrapartum transmission of HIV-1 infection from mother to child. Scientific evidence was provided to the MCC to support this. In 2001, it was registered for this indication, subject to a number of conditions, including the provision of any new information.

On 25 July 2003, the MCC decided that, in the interests of public safety, additional information concerning the way in which Niverapine should be used for this indication should be presented within 90 days.

Following this decision, it was brought to the attention of the MCC that additional data from South African researchers is available that may support the continued use of Nevirapine for this indication. Additional information regarding the original study has also now been published.

Recognising the importance of the new information, the MCC, on 5 September 2003, adopted a new resolution, which extends the time period for Boehringer Ingelheim (the supplier of Nevirapine) to review existing evidence, and to submit additional data for expert assessment by the MCC. Discussions have been held with both Boehringer Ingelheim and researchers in the field to determine the nature and extent of the new information that is required. An example of important data that must be submitted is the use of Nevirapine in combination with other antiretroviral agents for the reduction of risk of transmission of HIV infection from mother to child.

The MCC wishes to emphasise that Nevirapine remains registered as part of combination therapy for HIV and AIDS, that it is not and has never been "banned", and that it is still approved for the indication of "reduction of the risk of intrapartum transmission of HIV-1 infection from mother to child".

Appropriate treatment of the mother and the newborn child is also imperative, and the MCC urges healthcare professionals to use available interventions to improve the survival and health status of both mother and child.


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TAC Treatment Project Launched to Provide Antiretrovirals to Community Members and Treatment Activists


On the 8th of August 2003 the South African government instructed the Ministry of Health to develop, within one month, an operational plan for the provision of antiretroviral treatment in the public sector. However, most communities will have to wait years before the phased rollout reaches them. We have a duty to treat as many of these people as possible. In order to ensure that the public sector programme is a success, and that the HIV/AIDS pandemic does not destroy more of our families and communities, other sectors of society like organised business, organised labour, civil society and private healthcare providers have to relieve some of the burden from the public healthcare system.

The TAC Treatment Project (TP) is a Section 21 (Non-Profit) company established by the Treatment Action Campaign to make affordable Highly Active Antiretroviral Therapy (HAART) available to people living with HIV/AIDS in South Africa. This will be done on a fully, partially or unsubsidised basis, depending on patient circumstances.

While the TAC TP has a close relationship with the TAC, it is organisationally and financially independent. Any funds raised by the TAC TP will be used solely for treatment and related support services. As with the TAC, the TAC TP will maintain the highest standards of financial control. Our books will be open to the public for scrutiny upon request and annual reports including audited financial statements will be published. Progress reports will also be made available to the public every 3 months. The TAC TP auditors are Douglas and Velcich. The TAC TP is run entirely on a non-profit basis and none of the directors, except the pharmacist, receive income from the project, now or ever.

Fully subsidised treatment (including medicines, laboratory monitoring and doctors' consultations) will be made available to an equal number of treatment activists and community members not members of the TAC. In other words, for every TAC (or other treatment access) activist treated there will be a corresponding community member treated. TAC activists will be treated directly through TAC TP. While the TAC TP will fund and provide medicines and support for other community members, their actual treatment will be administered through already existing (and preferably public) local health facilities. The TAC TP will only use sites, public and private, that meet rigorous standards with regard to ethical and transparent clinical selection criteria and quality of care.

Only safe and effective medicines, prequalified by the World Health Organisation and authorised by the Medicines Control Council are used. The TAC TP has employed a registered pharmacist to ensure the proper storage and handling of medicines and the processing of scripts. Medicines are stored and dispensed from the premises of a registered pharmacy. We encourage individuals who can afford to pay for medicines to contact us on the understanding that it will, on average, take at least three to four weeks to arrange permission for and importation of generic medicines.

The TAC Treatment Project currently has enough funds to treat fifty people - 25 activists and 25 community members. Of these, eleven activists are currently receiving generic antiretrovirals as well as counselling and treatment support. Some of these patients have started taking their antiretrovirals, while others are going though our treatment readiness programme. The rest of the 25 activists will be selected and the 25 community slots allocated before the end of the year. We hope to place a thousand people on treatment by the end of 2004, but for this we will need the financial support of people in South Africa.

We need your help to save lives. We appeal to everyone who can to contribute to the TAC Treatment Project, because every person has the right to life. Information on how to contribute can be found on the TAC Treatment Project website at http://www.tac.org.za/treatment.

[END OF TAC TREATMENT PROJECT LAUNCH - BACK TO CONTENTS]

TAC Treatment Project Details

Company incorporated under section 21 of the Companies Act, Registration Number: 2003/009927/08
Account Details: Nedbank. Branch Code: 100909. Account number: 1009788914. Swift Code: NEDSZAJJ
Address: PO Box 172, Muizenberg, 7950 Tel: 021-788 3507 Fax: 021-788 3726
Email: tactp@tac.org.za Web: http://www.tac.org.za/treatment/
Directors: Vuyiseka Dubula (chairperson), Gavin Brown (pharmacist), Zackie Achmat (treasurer), Kwezi Matoti (principal medical officer), Sharon Ekambaram (secretary), Colwyn Poole, Nomfundo Dubula, Siphokazi Mthathi, Vuyani Jacobs, Thembi Zungu, Pholokgolo Ramothwala, Thabo Cele, Thembeka Majali, Mandla Majola

[END OF TREATMENT PROJECT DETAILS - BACK TO CONTENTS]

Letter and Memos Handed Over to Dr. Anthony Mbewu, Chairperson of the Operational Treatment Plan Task Team


Dr. Anthony Mbewu
Chairperson
Department of Health ARV Task Team

Medical Research Council
PO Box 19070
Tygerberg
7505
By Hand

9 September 2003


Dear Dr. Mbewu,

On behalf of the Treatment Action Campaign we would like to thank you for the opportunity to meet with you today. The TAC wishes the task team success and offers the task team our full support in its work.

Attached to this letter are two memoranda that we would like to bring to the attention of your team. These memoranda amplify upon and relate specifically to legal and constitutional considerations that are dealt with in appendix three and four of the full report of the Treasury/Health department. We would be grateful if they could be brought to the attention of the relevant sub-committees:

1.The first memorandum makes recommendations on the legal powers and constitutional obligations that we believe already exist that would allow the South African government to source anti-retrovirals for the public and private sectors, at the best possible price.

2.The second memorandum sets out an opinion on the key elements of a treatment programme which would be consistent with the Constitution. We believe this memorandum is necessary because of concerns we have about the statement in the Summary Report to the effect that "once a decision to introduce ART were made, it is the team's view that six to nine months' preparatory activities are required before the first patients would start to receive medication on the ground." Similarly, at a recent presentation made by the Department of Health it was suggested that the programme would start at "six or nine centers in the country as part of the preparatory phase." We are concerned that such an approach is inconsistent with the report's recognition that there are currently 400 - 500,000 people clinically in need of anti-retroviral medicines. As many of these people as feasible/possible are in desperate need of access to health care services and medicines that may save their lives.

Finally, we would like to inform you that to support the work of the Task Team the TAC has been conducting a consultation with health professionals, academics and AIDS activists on steps that can and should be taken to ensure the programme's success. A submission reflecting the proposals flowing from this will be made to you soon. In the meantime we are keen to provide whatever support we can and urge you to feel free to call upon this support.

Best wishes


Mark Heywood
TAC National Treasurer


[END OF LETTER AND MEMOS HANDED OVER TO TASK TEAM - BACK TO CONTENTS]

600 000 New Infections - Redouble Prevention Efforts and Implement a Treatment Plan 

The results of the latest ante-natal survey was released on 9 September 2003, five months later than expected.  In October 2002, the Department of Health conducted the 13th national HIV sero-prevalence study among pregnant women in the public sector.  Despite the unnecessary delay in publishing the results, the government must be commended for maintaining this prevalence study as a measurement tool in the epidemic.

What does the survey show?

This survey demonstrates conclusively that the HIV epidemic remains the most serious health challenge in our country with more than 600 000 new infections in 2002. 16 587 women in 396 public sector facilities across the country participated in this study by the Department of Health.  Of all those tested, 4 395 women or 26.5% of all pregnant women tested positive for HIV.  The Department of Health says that last year, there were about 600 000 new infections. On average, this means more than 1 500 new infections every day.  4.7 million people living with HIV/AIDS in South Africa, this number increased to 5.3 million.

KEY FINDINGS

Pregnant women tested:      16 587
Pregnant women positive:   4 395 or 26.5% [2001= 24.8%)

Projected 95% confidence intervals for the entire public sector antental population
2002: 25.5% to 27.6%
2001: 23.6% to 26.1%


The following statistics given by the Department of Health are  estimated using their demographic modelling utility
New infections:                      600 000 / +1 500 every day
People With HIV                    5.3 million (2001 = 4.7 million)
Women with HIV (15-49)   2.95 million
Men with HIV (15-49)         2.30 million
Estimated MTCT:                  91 271 infants

Source: Department of Health: 2003

What is happening in the provinces?


The survey demonstrates that the most affected province remains KwaZulu-Natal with more than 36.5%.  Western Cape remained the province with the lowest infection rate but it has increased to more than 10% for the first time. Regrettably, the published report does not give the number of women who were tested by province.   This renders the apparent reduction in provinces such as Mpumalanga, Northern Cape and Free State meaningless.

How are different age groups affected?


The Department of Health suggests that the appearance of a decline among women under 20 years of age from 15.4%(2001) to 14.8% (2002).  Again, the survey suffers from over-generalisation.  The total number of pregnant women under 20 is not given in the survey results. The statistic is a total for the whole country.  Everyone would benefit from a provincial age breakdown of the statistics because this will mean better prevention planning and resource allocation by civil society, government and the private sector.

 The most serious news from the survey suggests that new infections occur mostly among women over 20 and particularly those who are married.  The most significant age-group increase was seen in pregnant women over 40 years of age from 9.8% (2001) to 17.2% (2002).  Once again, here it would have been useful to see the provincial breakdown and the total number of women tested.

The Department of Health encourages over-optimism in suggesting that "the observed increase [600 000 new infections] does not raise concern from the perspective of the escalation of the epidemic." The Department's press release sends the wrong message to the public with the argument that:

These findings support the view that although the HIV infection rate is high in South Africa, there has been a significant slowing down in the spread of the epidemic and South Africa can be considered to have a slow developing epidemic.

 Based on this report, the Treatment Action Campaign and its allies want to hear the following message from the Department of Health.

·        The number of new infections in 2002 was more than the total number of people of people living with HIV/AIDS in Botswana.

·        No society can countenance such a high number of new infections. Every effort must be made to reduce new infections.

·        A national treatment and prevention plan is essential to encourage openness. Every person must learn her or his HIV status.

·        Condoms will be made available in every public facility. Schools, colleges, universities and technikons will be required to make condoms and sexuality education available to all learners.

·        Fullest media attention will be given to target all age groups on safer sex practices and behaviour change.

·        Every effort will be made to assist people living with HIV/AIDS to live healthy and productive lives.

TAC appeals to the Department of Health to release the full report immediately to allow the fullest academic and scientific discussion of the implications of the report.  TAC also appeals to our allies and government to join us in convening a national HIV prevention summit.

The hope given to the country by the Cabinet instruction to develop an ARV operational plan by the end of this month will only be strengthened by decisive action along these lines.


[END OF STATEMENT ON ANTENATAL RESULTS - BACK TO CONTENTS]

[END OF NEWSLETTER]