March 31st, 2011

Last week saw the passing of another World TB Day (March 24th), the third since the founding of Moxafrica. This time, we spent the day itself training carers in Robertson, South Africa.

As usual, it was accompanied by a report from the WHO on the state of global drug resistance.

What follows below is a summary of our analysis of the report from the perspective of the Moxafrica charity.

It is not all bad news, but it does smack a little of papering over the cracks. It fails to set the alarm bells ringing nearly as loudly as it should do, and also continues to pretty much generally ignore African countries - the only ones identified as having DR problems in fact are South Africa, the DR of Congo, Nigeria and Ethiopia (and only South Africa has any sort of diagnostic or surveillance infrastructure so it is hard to understand how they have definitively worked these others out). With regards to Africa, it is hardly possible that the report is in any way accurate and is merely reflective of the huge epidemiological hole which the continent is suffering from in terms of available data. We are reminded of the stament made by Dr Jim Yong Kim a year ago. Dr Kim is a Professor of Medicine and Social Medicine at Harvard Medical School, and is former Director of the WHO HIV/AIDS Department. He wrote chillingly: "Every time we look the problem is worse than we thought. Now it is coming together with HIV in sub-Saharan Africa, and it could be the most frightening thing we are ever going to see."

Part of the current upbeat news on TB pins hope on a new fast action diagnostic ("Xpert") device which is already being used in South Africa and elsewhere for fast track diagnosis of TB, although frankly it may not add up to as much as is hoped. TB can already normally be identified in a minute through a microscope so speed of diagnosis may not seem much of an issue if the strain is drug sensitive - but sputum testing is known to be unreliable when there is co-infection with HIV - making commenvement of pharmaceutical treatment impossible, so this device is clearly a step forwards. The critical issue for effective pharmaceutical treatment of drug resistant strains - and the containment of the disease - is the rapid accurate identification of drug resistant strains for immediate treatment. This is something which currently takes weeks or months of culturing blood - if it can be done at all because the facilities required are so scarce in Africa. This period is obviously far too long. Unfortunately this new gizmo can only identify resistance to one type of drug (out of fourteen plus), so it can hardly be expected to make as much of an impact as is being claimed.
This is one of the reasons why the development of non-phatrmaceutical approaches might be so important - we are clear that moxa doesn't need a positive diagnosis. It can be implemented if there is mere suspicion of disease - as is being done with one of the workers on the project in South Africa who has all the symptoms but no positive diagnosis.
While in South Africa we also learnt (surprisingly) that newly diagnosed TB patients wait a matter of weeks after initial TB diagnosis before culture-testing for drug resistance anyway. We suspect that this is because of the limited resource even in this country which has a higher ratio of diagnostics to population than practically any country on earth. Given the rates of DR, however, this was shocking to learn because in each and every case it provides possible windows of opportunity of up to three months (or maybe more) for the resistant strain to circulate in the community, when this time could be halved.
Some of the statistics contained within the report are hard to make poper sense of. The report identifies 27 "high burden" countries in terms of DR-TB, and suggests that, based on modelling from previous estimates, an anticipated 250,000 cases of DR-TB were expected in these countries in the course of the year. It then reports that actually only 24,511 were actually enrolled on treatment programmes in these countries (less than 10% of the anticipated total), and of these success rates varied between 25% and 82%. We wonder whether it is fair to assume that even in countries which are officially identified as having a problem and where the Green Light Committee (GLC) supports the provision of subsidised second line drugs there is really any sort of successful current containment of the disease using the existing pharmaceutical resource. It seems unlikely given these figures.
A treatment for treating "normal" drug-susceptible TB now costs as little as $19 total per person in high burden countries - which is amazing and is a testament to past work done by the WHO and Partners in Health in driving down the costs of the drugs. But to treat MDR-TB this cost soars to between $4700 and $9000 per patient. With XDR-TB it may be even higher. The fact that anyone survives for any length of time with DR-TB anywhere in Africa seems amazing given these figures.
An MSF report was also released last week to coincide with TB day and casts a deeper and quite disturbing perspective on the WHO report:(http://www.msf.org.uk/UploadedFiles/MSF_Report_DRTB_Drugs_Under_the_Microscope_short_201103215822.pdf)
It tends to point towards some of the less comfortable elephants in the room of the fight against DR-TB.
Amongst other things, it identifies blatant drug profiteering within the second line drug market ("second line drugs" are those used for treating DR-TB). According to MSF, the price of the DR-TB drug Amikacin 500mg has increased by a staggering 864%between July 2001 and April 2011. Kanamycin has increased by 617% in the same period and Cycloserine and Capreomycin around 300%. Patents are simply not an issue for these drugs as they are all forty plus years old - but quality approved manufacturers are so reluctant to manufacture relatively unprofitable drugs that increased demand and deliberately reduced manufacture inflates prices with no working mechanism in place to control them.

The report also identifies that there are literally no paediatric drugs available for treating DR-TB, while between 10 and 15% of DR-TB patients are estimated to be kids...

Appallingly, it also looks like the South African public sector is paying way more than others who are also treating DR TB. PAS 4g sachets, which are being sold to the South African government at R80 per sachet (daily dose), are being bought by MSF international for R21....

What a business.

It also suggests that, in contrast to the WHO report, as few as 6,000 patients were enrolled in GLC-approved treatment programmes, in comparison to their own estimated 440,000 new cases of DR-TB (around 1.4% ot the total, or a tenth of the WHO estimate).

Furthermore (and these quotations are of direct relevance to the non-pharmaceutical approach which lies at the heart of the Moxafrica project) they state that -

- "The interactions of DR-TB drugs with AIDS medicines are largely unknown...This is particularly problematic given that TB is the biggest killer of people lving with HIV today"

- "Today's treatment for DR-TB is largely based on experience and expert opinion, not studies or clinical trials, with a large number of "gray areas" where expert opinion may be conflicting"

and

- "The current objective is to develop and deliver a new short term regimen able to treat drug-sensitive and drug-resistant TB, and is also compatible with HIV treatment...it is questionable whether this objective can be achieved within reasonable time lines".

Once again we ask whether moxa treatment just might fill these gaps on exactly these terms. Step by step we are committed to continuing to find out.