at the Treatment Action Campaign, SECTION27, Médecins Sans Frontières and Oxfam pre-meeting we mentioned last week identified five crucial
interventions to reduce TB cases and mortality in South Africa.
“The partnership between science, community, and policy
makers is the only thing that changes reality,” said Dr. Gustaaf Wolvaardt, of
the Foundation for Professional Development, as he and Professor Martie van der
Walt, Chairperson of the 3rd South African Tuberculosis (TB) Conference
(SATB) accepted a memorandum delivered by Treatment Action Campaign (TAC),
SECTION27, Médecins Sans Frontières (MSF) and Oxfam just before the opening of
the meeting on last Tuesday afternoon, 12 June in Durban.
The memorandum highlighted five interventions that civil
society had identified as critical for the reduction of TB cases and mortality
in South Africa,
based upon presentation and discussions at their conference pre-meeting.
Some of presentations that morning will be discussed more
detail in upcoming HATIPs. To quickly review the morning’s proceedings, this
post will describe the demands as presented by Leka Dlamini on behalf of TAC,
augmented with a sometimes horrifying factoid or two from the presentations and
from discussions among participants during the tea breaks, where it may be
important to consider the source.
Diagnose all people living with TB and
drug-resistant TB (DR-TB)
“In terms of diagnosis of people living with TB and DR-TB,
we need active case finding coupled with better diagnostics. We welcome the use
of GeneXpert but we must put pressure on Cepheid to reduce the cost of the
machinery and cartridges,” Dlamini said.
The Gene Xpert situation in southern Africa
is discussed in a bit more detail in a separate blog post that you can read
Ensure access to the
best available medicines and regimens
“There are new TB medicines that show promising results –
for instance bedaquiline and delaminid. These important medicines really need
to be looked at by the Department of Health and the Medicines Control Council,
to facilitate access to patients dying because of DR-TB,” said Dlamini.
Dr Helen Cox from MSF had described the ongoing process to
get bedaquiline approved for compassionate use. Bedaquiline is being developed by Janssen at the same time as Otsuka is developing
delaminid, a novel antibiotic which inhibits synthesis of mycolic acid, a
critical component of the mycobacterial cell wall. (Data from the phase 2b
study of delaminid were published
earlier this month in the New England Journal of Medicine). HATIP has
wondered why both drugs can’t be offered on compassionate use together,
increasing the possibility of a more rapid cure. However, Dr. Cox said that the
two drugs have overlapping toxicities, and may not be well tolerated together.
to TB advocates last week to outline its development plans for the two
drugs, and to address concerns about the need for safety studies. In particular
the company stressed that a short safety study of the two drugs in combination
in healthy volunteers would not be sufficient, and that a longer safety study,
possibly in patients with MDR-TB, would be necessary.
It is peculiar that Janssen found no interactions when it tested bedaquiline with a compound from its own library from the same class as delaminid, and found no drug interactions. Could this be another case of a pharmaceutical company not wanting to study their drug with another company's drug because they own a similar drug in the same class (even though it is nowhere near clinical approval), as we have seen recently in the hepatitis C field? Would it rather co-formulate its own drugs together, even if patients might have to wait?
Regardless, one has to wonder whether the two drugs could really be more toxic together than
the second-line regimens currently available, and the lack of available data does not negate the argument that XDR-TB patients who have no other options should have the right to try it, unless they can show us the data from safety studies suggesting they are horribly toxic together.
“The medicines are very expensive. And while
the Department of Health has successfully brought down the prices of a number
of TB medicines during a previous tender, South Africa continues to pay high
prices and needs to look at different strategies to drop prices,” said Leka
Dr Cox had reviewed much of this during her
presentation at the pre-meeting. For
instance, linezolid [a second or rather, third-line TB drug — often one of last
recourse for extensively drug resistant-TB—] costs about R282 per pill at South Africa’s
public tender price, or R8460.00 per month (over $1000). One particular bit of
unpleasantness is that MSF has around five South African patients on the drug
but, as outrageous as the price is, the South African government won’t let MSF
purchase it at the tender price. Instead, they have to pay the private sector
price: R676 per tablet.
“Pfizer, the company that makes linezolid, has
not responded to a request to lower the price for use among XDR-TB patients,”
While Dr Norbert Ndjeka who manages the drug-resistant TB programme for the Department of Health detailed how the government
has obtained significant price reductions on several of the drugs through its
tender process, the prices are still outrageous compared to what the country
would pay if it started importing lower cost medicines from overseas or pooling
procurement with other high burden countries.
When you consider how many people are showing
up as having drug-resistant TB on GeneXpert — around 7% — it is hard to
understand why the government is so reluctant to do this. That would mean, if
Xpert were being rolled out all at once (and it isn’t), that 7% of the annual
burden of around 400,000 cases (28,000 people) would have drug-resistant TB.
However, Dr Ndjeka told HATIP that he doesn’t think it is anywhere near that —
partly because South Africa’s figures for the last five years are being
down-revised by the National Health Laboratory Service. Apparently there was
significant double counting of patients, which isn’t surprising given the mobility
of much of the population. (Men go to the gold mines, get TB, are counted up
there, get sent home, and are then counted again at home.)
So, the actual number of MDR-TB cases in 2009
was more like 5600 and not over 8000. Dr Ndjeka doesn’t believe they will be
diagnosing more than 12,000 MDR-TB cases per year for all of the provinces excluding
KwaZulu Natal (KZN).
But KZN has a country’s worth of MDR-TB on its
own. GeneXpert has rolled out more rapidly in parts of that province, and is adding
large numbers of patients to the tally.
to do with all these drug-resistant TB patients? Decentralise DR-TB care!
“Decentralise DR-TB care —we only have 2500
beds in SA for admitting patients with DR-TB, so we need care to be decentralised
to facilities that are closer to people, so that people who don’t need to be
admitted can just be administered with treatment at their own home,” said Leka Dlamini.
the numbers of MDR-TB patients, the country really has little choice but to
decentralise care. Bruce Margot of the KZN Department of Health told HATIP that
they have several hundred more MDR-TB patients diagnosed this year than in
previous years — and Xpert is only partially rolled out — and they are
continually playing catch-up trying to get the patients on treatment. At
present, they have 100 mobile injection teams in operation, but need to put 100
more into the field by year end. He noted however, that Xpert was not
outstripping the province’s capacity to manage drug-sensitive TB. However, he
has done some modelling of the figures for other provinces, and thinks “a few
such as the Eastern Cape,
are in for a shock for both drug-sensitive and DR-TB."
The Department of Health has developed a policy
framework for decentralised care of TB — however some provinces are lagging
behind developing their own operation plans.
HATIP will cover this issue in more detail in the future, but one
thing that was clear in the meeting — to scale up decentralised MDR-TB care in
the country, nurses will have to be trained to initiate and manage treatment
for drug-resistant TB, and community health care workers will need to be
trained to support care.
crowding in prisons and implement active case finding and infection control
“The last point is reducing crowding in prison
and implementing active case finding and infection control measures. For
instance, in Pollsmoor prison, prisoners are commonly held in mass cells in
extremely close proximity for up to 23 hours per day,” said Dlamini.
Indeed, Professor Robin Wood gave the most
harrowing presentation of the morning on this issue, which merits more detailed
coverage in the near future.
and activists in union
“We’d really appreciate if the people at this
conference continue deliberating on these issues because it’s important for all
of us, and also for the pharmaceutical companies who are here, to continue
manufacturing treatment but to not only think of making profits but also to
think of our lives, of people who are infected with TB and DR-TB,” concluded
“What the patients in South Africa need is what stands
here,” responded Professor Martie van der Walt who accepted the memorandum from
Dlamini. “It’s also what we at the conference would like to see addressed at
the policy making level. As for the scientists what we need to do there is
determine the impact it will have individual and specific patient impact. But
we’ve reached a stage where patients need to take ownership of their own
health; we need community mobilisation.”
Professor van der Walt singled out the high cost of treatment. “We will need to
address this, going forward as civil society, advocacy and the scientists
“I think that’s why it’s so important that you’re here at
the conference,” said Dr. Wolfaardt. “If you look back at the 2000 conference
that was in Durban,
remember what impact that had on the prices of drugs? Before the conference it
was about twelve to sixteen thousand dollars for treatment a year, and after
the conference it had come down to about five hundred dollars. “