E-drug: Bredell Consensus Statement on Anti-retrovirals
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[warning this is a long message. Please ensure that you send any
endorsements directly to TAC and NOT to the e-drug list - TD]
Hi all
Below is the text of the Bredell Consensus Statement, adopted by
the participants of the Bredell Conference, which was organised by
the South African Treatment Action Campaign (TAC) on 18 & 19
October 2001. The list of participants is a veritable "who's who" in
the HIV/AIDS arena in South Africa.
The question I'd like to pose to the list is: have Essential Drugs
authorities in any other countries been faced with similar broad-
based consensus statements that challenge the EDLs and
Standard Treatment Guidelines then in place in those countries? If
so, how have they reacted? In evidence-based medicine parlance,
consensus statements alone are regarded as the weakest form of
evidence. However, as was pointed out in a previous mailing, there
is considerable support within WHO for at least the MTCT aspects.
[Below the statement is a call for endorsement - please do not
send endorsements to the list, but reply to <info@tac.org.za>]
regards
Andy
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Bredell Consensus Statement on the Imperative to Expand Access
to Anti-Retroviral (ART) Medicines for Adults and Children with
HIV/AIDS in South Africa
Released: 19th November, 2001
On October 18th and 19th 2001 the Treatment Action Campaign
(TAC) hosted an expert consultation of doctors, scientists, nurses,
policy specialists and activists to discuss the benefits of using anti-
retroviral therapies (ART) for the treatment of HIV and AIDS in
South Africa. Participants included specialist clinicians and nurses
who treat people with HIV and AIDS and who prescribe or study
anti-retroviral medications. Included were representatives from
diverse backgrounds, including the public and private health
sectors, academic medicine, tertiary hospitals, urban, peri-urban
and rural clinics. Several internationally respected scientists from
South Africa and elsewhere made presentations. Religious bodies,
trade unions, government and AIDS organizations also participated.
The following consensus emerged:
1.The AIDS epidemic is one of the greatest challenges confronting
South Africans. In facing up to the epidemic we confront not only a
crisis of illness and death and a crisis of action, but a challenge to
accept the truth, to tell the truth and to act on the truth.
2.Very large numbers of people are dying of AIDS or are sick with
AIDS-related illnesses. The Department of Health estimates that
last year 628 000 (25%) public hospital admissions were for AIDS-
related illnesses. The Consultation also heard that AIDS-related
illnesses are the most common causes of death in the medical
wards among adults aged 19-49 at teaching hospitals affiliated to
the Universities of Cape Town, Natal and Witwatersrand. The first
aim of ART is therefore to decrease HIV associated illness
(morbidity) and death (mortality). This goal can be achieved.
3.Access to anti-retroviral therapy is a vital and indispensable
complement to both treatment of HIV disease and effective HIV
prevention. It can restore hope to both health professionals and
patients, and can assist us in regaining control of this epidemic.
Therefore treatment for HIV and AIDS that includes anti-retroviral
medicines should no longer be withheld as a result of government
policy. ART in the public sector is necessary and possible, and a
start must be made to implementing it as a matter of urgency in the
interests of millions of lives.
4.As with any potent and effective medication there are side-effects
and toxicities experienced by some patients taking ART. However,
registered anti-retroviral medicines are effective and safe when they
are appropriately prescribed and monitored. ART significantly
improves the quality and length of life of men, women and children
with AIDS. In South Africa this has been convincingly demonstrated
in managed health care programmes, mainly in the private sector. It
is estimated that 20 000 people are now using ART in South Africa.
Extending access to these life-saving medications has become a
moral, political, social and economic imperative.
5.Further delays in standardizing anti-retroviral use in the midst of a
severe AIDS epidemic will undermine public health. Absence of
appropriate standards is already leading to widespread
inappropriate prescription and misuse - mainly by medical
practitioners operating without training outside the framework of
protocols and guidelines.
6.'Anti-retroviral drug anarchy' may become a danger as more
people need access to ART, prices come down, and untrained
doctors prescribe the medicines. This threatens patient health,
public health and the efficacy of the medicines themselves because
of the possible development of resistant strains of HIV. In some
cases, current prices have resulted in the prescription of sub-
optimal drug combinations with the likelihood that this will result in
the emergence of drug resistance. In view of this, participants agreed on
the need for:
a. respect for patients' rights to information and to fully-
informed consent before starting treatment;
b. comprehensive and urgent training of nurses, doctors and
community health care workers in ART in the public and
private sector throughout South Africa;
c. establishing networks for sharing experience between all
health care professionals;
d. clear and strictly maintained criteria for ART access;
e. standardized but flexible protocols about when to start
therapy and the optimum choice of initial treatment regimens;
f. a minimum of three drugs as the standard of ART care;
g. guidelines for anti-retroviral management of patients with HIV
who also have TB;
h. guidelines for anti-retroviral management of pregnant
women;
i. health systems ensuring patient care and support, efficient
delivery of medicines, adherence monitoring and staff
support; and
j. public information and education that creates a culture of
openness about HIV and AIDS and awareness that it can
now be medically managed with ART.
7. Adherence to treatment requires informed and motivated patients
together with an enabling clinical care environment. These
conditions are practical and feasible. Research and ongoing
treatment access in a variety of settings in South Africa have shown
that people with HIV in poor and disadvantaged areas can adhere
successfully to treatment regimens and thus can achieve treatment
outcomes that are the same as in developed countries.
8.The capacity and infrastructure to use anti-retrovirals safely and
effectively and to treat tens of thousands of people with AIDS
already exists within the private health sector, parts of the public
sector, and within some non-governmental organizations. These
provide a foundation to devise and implement a national treatment
plan, while simultaneously identifying needs and gaps in under-
resourced sectors to promote equity.
9. Administration of anti-retroviral medications to reduce mother-to-
child transmission must be introduced country-wide.
10. Post-exposure anti-retroviral prophylaxis for sexual assault is a
moral necessity and an essential public health intervention.
11.Tuberculosis (TB) is the most common AIDS-related
opportunistic infection and cause of death amongst HIV patients in
South Africa. ART substantially reduces the risk of acquiring TB
disease. Access to ART will relieve the burden and cost of TB and
other common AIDS-related opportunistic infections on the public
health system. New and recurring TB cases will be reduced and
prevented by ART and TB treatment.
12.Anti-retroviral medicine prices must be further reduced. Price
reductions should be across the board, and not limited to the public
sector. Generic competition of bio-equivalent medicines is essential
in order to arrive at the lowest and most sustainable prices for
essential medicines. This is especially important if treatment is to
be accessible to and sustainable by all people in South Africa.
13.Price reductions for diagnostic tests and tests monitoring the
efficacy of ART are a priority. The price of these tests contributes
substantially to ART costs and can result in inadequate clinical
management.
14.However, even at current prices, HIV/AIDS medications could
pay for themselves through reduced hospitalisation, prevention of
opportunistic infections, and improved quality of life and productivity
of persons with AIDS. This has been demonstrated worldwide,
including developing countries such as Brazil.
15.Most clinical research into ART in South Africa is currently driven
and funded by pharmaceutical companies. This needs to change to
grant-driven research that investigates issues such as:
� determining the most appropriate and well-tolerated
combinations of medicines taking into account the needs of
women and children as well as conditions that exist in
developing countries such as South Africa;
� improved clinical algorithms or simple laboratory markers that
can replace some expensive current laboratory monitoring;
� long-term cohort studies investigating adverse drug events;
� interactions between TB and HIV therapies.
On the basis on the above points of consensus we state our belief
that advocacy for access to anti-retroviral treatment is an ethical
duty for health professionals. In addition, expanded capacity to
treat HIV is an immediate imperative. Treatment literacy, support
systems and de-stigmatising HIV/AIDS is a duty of community
activists and institutions of civil society such as trade unions, faith-
based organizations, community organizations and NGOs at every
level. Ensuring expanded, equitable and sustainable access to life-
saving and prolonging medicines is a moral and legal responsibility
for government, business, international agencies and private health-
care funders.
Signed:
Individuals endorsing statement: Professor Quarraisha Abdool
Karim, Epidemiologist, Nelson Mandela School of Medicine,
University of Natal, Durban and past national Director of HIV/AIDS
and STD Programme, Department of Health; Mr. Zackie Achmat,
Chairperson, TAC; Dr Steve Andrews, GP with special interest in
HIV; Mr. Ralph Berold, University of Witwatersrand, HIV/AIDS Co-
ordinator; Ms. Edna Bokaba, Registered Nurse, HOSPERSA; Dr
Brian Brink, Board of Health Care Funders; Justice Edwin Cameron,
Supreme Court of Appeal; Mr. Henri Carrara, Epidemiologist;
Professor Sharon Cassol, Molecular Virologist, Nelson Mandela
School of Medicine, University of Natal, Durban; Professor Salim S.
Abdool Karim, Epidemiologist and Head of Research, University of
Natal Durban; Dr. David Coetzee, Epidemiologist, Department of
Community Health, University of Cape Town; Dr. Karen Cohen,
Clinician, University of Cape Town; Dr. Francesca Conradie,
Clinician, Wits HIV Clinical Research Unit; Dr. Shaun Conway,
Physician, International Association of Physicians in AIDS Care;
Professor Hoosen Coovadia, Head: HIV/AIDS Research, Nelson
Mandela School of Medicine University Natal Durban; Ms. Sharon
Ekambaram, AIDS Consortium; Professor Gerald Friedland,
Director AIDS Program, Yale School of Medicine; Dr. Eric
Goemaere, M�decins Sans Fronti�res, Head of Mission, South
Africa; Professor Gary Maartens, Senior HIV Physician, Groote
Schuur Hospital; Rev. J.P. Heath, Aids Co-ordinator, Anglican
Church; Mr. Mark Heywood, Head of the AIDS Law Project; Dr.
Prudence Ive, Physician, HIV Clinical Trial Unit, Wits Health
Consortium; Ms. Jenifer Joni, Attorney AIDS Law Project; Ms. Anita
Kleinsmidt, Attorney AIDS Law Project; Ms. Mapule Khanye,
Director, AIDS Consortium; Mr. Teboho Kekana, TAC NEC
Member; Ms. Nonkosi Khumalo, TAC Executive Secretary; Mr.
Stephen Laverack, HIV/AIDS Education Awareness Consultant;
Sister Tshidi Mahlonoko, Registered Nurse; Ms. Thembeka Majali,
TAC Co-ordinator; Sister Nondala Noziphiwo. Registered Nurse;
Ms. Tsakane Mangwane, Southern African Catholic Bishops
Conference HIV/AIDS Office; Dr. Nyameka Mankhayi, Psychologist;
Dr. Des Martin, Chairperson Southern African HIV Clinicians
Society; Mr Willie Madisha, President COSATU; Sister Zola
Mathebula, Registered Nurse; Professor James McIntyre, Chris
Hani Baragwanath Hospital; Ms. Tanya van Meelis, CEPPAWU
Researcher; Ms. Anneke Meerkotter, Researcher, Community Law
Centre, University of Western Cape; Dr. Tammy Meyers, Chris Hani
Baragwanath Hospital; Dr. Clarence Mini, NAPWA Board Member;
Ms. Precious Modiba, Senior Researcher, Centre for Health Policy;
Mr. Tumi Modise, HIV Co-Ordinator, National Council of Trade
Unions; Ms. Teboho Motebele, Attorney AIDS Law Project; Mr. Dan
Mullins, HIV/AIDS Co-Ordinator OXFAM; Archbishop Njongonkulu
Ndungane; Dr. Lana Oatway, Ethembeni Clinic; Mr. Lew Oatway,
Ethembeni Clinic; Ms. Annie Parsons, SHARPP; Ms. Joyce Pekane,
Vice-President COSATU; Sister Penny Penhall, Registered Nurse;
Mr. Pholokgolo Ramothwala, TAC Co-ordinator; Dr. Leon
Regensberg, AID for AIDS; Sister Sue Roberts, Registered Nurse,
Helen Joseph Hospital; Dr. Ian Sanne, Specialist HIV/AIDS
Physician, University of Witwatersrand Health Consortium; Ms.
Mercedes Sayagues, Advocacy and Media Officer OXFAM; Ms.
Judy Seidman, Graphic Artist; Mr. David Shaproski, OXFAM; Mr.
Christopher Shaw, Registered Nurse Saint Mary's Hill Hospital; Dr
John Sim, Virologist; Ms. Theo Steele, Campaigns Co-ordinator
Cosatu; Dr. Francois Venter, Johannesburg General Hospital
Infectious Diseases Clinic and Wits Health Consortium; Professor
Robin Wood, Senior HIV Specialist and Infectious Diseases
Specialist, Somerset Hospital; Mr. Zamokuhle Zwane, TAC
Organiser.
Organizations endorsing statement:
AIDS Law Project, AIDS Consortium, Board of Healthcare Funders,
Church of the Province of Southern Africa, Congress of South
African Trade Unions (Cosatu), Federation of Unions of South Africa
(Fedusa), HIV Clinicians Society, Hospersa, M�decins Sans
Fronti�res, National Council of Trade Unions (Nactu), Oxfam GB,
Southern African Catholic Bishops Conference, University of
Witwatersrand Health Consortium, Ethembeni Clinic.
We encourage you to endorse it. If you wish to endorse it, please
send an email to info@tac.org.za with your name, designation and
organisation in the body.
In the subject line, please write:
endorse bredell