Date: Fri, 08 Aug 2003 12:53:13 +0200
Subject: [viva_hiv_aids] FW: [CCS-l] Some News Reports From AIDS Conference
・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
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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
Enclosed are nine news reports from the SA AIDS Conference. Remember Bua
News is a government sponsored agency.
◆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
Up to five million South Africans could die from Aids in the next eight to
years if a large-scale Aids treatment plan is not soon implemented, the
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
"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
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
created by the requirement of one million additional bed days. Social
pressures will soar 500% and family household incomes will collapse.
Addressing nutrition and alternative therapies for Aids, as espoused by
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
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
"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
devoted to preventing mother-to-child transmission of HIV, a major problem
many African countries.
Coovadia said South African researchers, aided by the government, are
the way in establishing how to reduce transmission through breastfeeding,
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,
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
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
"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,"
This article was originally published on page 1 of The Star on August
Health-e (South Africa) Nevirapine Decision Causes
AIDS Head 'Sleepless Nights' 06 August 2003
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
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
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
the same time as it hit the media", and that it was "not privy to
correspondence between the MCC and nevirapine's manufacturer, Boehringer
"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
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
recourse to "the best available science".
UN Special Envoy on AIDS, Stephen Lewis, said that most African countries
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
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
Lewis said that while changing male sexual behaviour had to be addressed,
would take generations as there was "nothing more obdurate".
However, the empowerment of women "can be done more rapidly" and there was
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
of Mother to Child Transmission (PMTCT) programme on Saturday despite
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
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
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
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
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
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
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
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
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
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
prepares to receive a long-delayed report on the affordability of a national
"All of us are seized with a sense of urgency on this issue," Health
Director General Ayanda Ntsaluba said, adding the question now was "when,
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
largest generic drug maker, Aspen Pharmacare, said it would launch on
Wednesday a program to produce Africa's first locally made antiretroviral
-- a step which could increase both availability and affordability of the
The debate over antiretrovirals was given fresh focus last week after
independent regulators announced they might withdraw approval for
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
confronted government officials on their treatment policy, said they were
heartened by the unequivocal endorsement from the country's scientific
"What this has shown is that there is overwhelming support for the
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
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
to any South Africans who need it.
Under the terms of Aspen's licensing agreement with Bristol-Myers, it can
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
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
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
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
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
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
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.
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
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
did not exacerbate problems in the public health sector, which he said,
happen if only a few institutions in urban settlements had the required
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
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
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
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
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
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
efficacy of the anti-Aids drug around which a new controversy broke out last
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
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
women from a total of 8 200 had tested HIV positive, pointing to a 15%
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
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,"
Cape Argus (South Africa) Group Petitions for Nevirapine's
05 August 2003
The South African Aids Conference looks set to get its own "Durban
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
(MCC) announcement last week it was giving manufacturers
90 days to prove the drug worked and was safe.
The Elizabeth Glaser Paediatric Aids Foundation, of Washington, was
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
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
now found to be seriously flawed, was subject to peer review and published
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