In hope for 2016...

Even an intermittent reader of these blogs will know that the underlying themes of our blogs revolve around our struggles to make coherent sense of all that’s evolving in the world of TB.

We recently made special efforts to explain some of our confusions to the WHO itself in Geneva. Amongst other things we tried to describe what we experience as a ‘curtain’ existing between two specific types of stakeholders in the fight against this disease. On the inside of the curtain there are the likes of the WHO itself, the Stop TB Partnership, the Global Caucus (of parliamentarians), USAIDS, Results.org, and even the likes of MSF and PIH. All of these appear have a good handle on the precariousness of the situation and have good access to each other. On the outside we have the small NGOs, activist groups like the Treatment Action Group [TAG], charities like ourselves, individual clinicians and patients and their families – all of whom comprise so-called ‘civil society’ which is being invited to crucially engage itself in helping to turn the tide of this disease. And all of these agencies and individuals certainly have an instinctive idea of what’s unravelling with TB but we encounter nowhere near enough coherency in the facts that are presented for us to get a true picture of what’s happening and therefore how best we should respond.

In fact we believe that this ‘curtain’ is actually stymying the sort of quality of activism that’s now needed to help turn the tide of this pandemic. Whilst everyone on both sides of this imaginary ‘curtain’ certainly share the same fundamental goal (which is the earliest possible elimination of this curable disease) it’s certainly not the case that everyone is as privy to the same epidemiological intelligence. What worries us most, however, is that this gap of knowledge may be sometimes being deliberately engendered for reasons of political expediency.

Another thing that anyone who’s been reading these blogs will know is that far too much of the intelligence that is available is (at least on this side of the curtain if not on both) too incoherent for it to be appropriately useful.

Over this Christmas period, however, we’ve encountered some fresh incoherencies – but these aren’t appearing in the data this time. They're in the political sphere – specifically in relation to the recent publication of the U.S. public policy on tuberculosis.

Nearly two months ago (on 3rd November) 642 American TB experts wrote an open letter to President Obama. Co-ordinated by the Infectious Diseases Society of America and the American Thoracic Society, its message was pretty direct: “We urge you [Mr President] to formally release the Plan to Combat Drug-Resistant Tuberculosis that your administration announced earlier this year … and to follow release of the Plan with a budget request that will support its implementation.”

We weren’t at all sure what this Plan was about but we were immediately interested so we read on.

It implored: “A plan is needed now, complete with research and development and programmatic goals and outcomes and a proposed budget, beginning in fiscal year 2017, that will ensure its implementation and success.” And their final message to the President was blunt: “Global leadership to respond to drug-resistant tuberculosis is long overdue.”

This all actually sounded very encouraging: some sort of ‘Plan’ must surely be in the pipeline but it sounded like it must be encountering some final delays so these doctors were trying to chivvy things along. There even seemed to be a possibility that President Obama was about to stake his political leadership in the struggle against TB! But once we started peering further around our fabled ‘curtain’ to find out more we came across something else which set our alarm bells ringing. It was a piece on the same subject of TB and relating to President Obama, and it was written by Joanne Carter of Results and it was published in the Washington Post just a week later on November 11th. She reported:

“The President’s proposed budget request has proposed slashing international funding for TB in each of the last four years including a planned cut for the year of $45 million from the previous budget level of $236 million.”

What?!! According to our numbers that pretty much amounted to an intended 20% cut in funding for TB, something which we found pretty shocking. Our concern was reinforced by a further sentence in Ms Carter’s piece which reported: “Public Health experts believe that … American government funding should be far higher than its current level.” Those public health experts clearly would include those 642 physicians who’s written that open letter, and we certainly agree with them.

“Fortunately,” Ms Carter continued, “Congress has recognised the essential role that the United States plays in combating the global threat of TB. Bipartisan opposition has rejected the proposed cuts.” That at least was reassuring. But, while on December 16th it was reported that the USAID’s budget for TB for the 2016 financial year hadn’t been cut as had been intended by the President, it was still formally announced that it was being ‘flatfunded’ at $236 million – i.e. set at the same level as in 2015 in spite of what those public health experts had said was needed.

We saw both a worrying an an encouraging picture emerging from all of this: here was a significant group of experts putting significant pressure on the U.S. President to reconsider his position. It’s something which could have given the whole world of TB activism a positive message for Christmas, but unfortunately it hardly gives us much cause to rejoice because the response amounted to a lot less than is needed. In fact the positive response that manifested had come from Congress and not from the President at all! So the critical issue for us all to consider as we enter 2016 is how public and how critical this sort of pressure can and should become for it to be as effective and game changing as it surely needs to be in the coming months.

The new National Plan for MDR-TB

Then a week ago, with three days to go before Christmas, the Obama administration finally got around to releasing its new Plan for MDR-TB. The White House PR department trumpeted it as “a comprehensive plan that identifies critical actions to be taken by key Federal departments and agencies to combat the global rise of multidrug-resistant tuberculosis”.

The Plan is organized around just three goals:

Goal 1: Strengthen Domestic Capacity to Combat MDR-TB. This goal relates to the efforts which are to be made within the United States itself. Each year just under 100 individuals are diagnosed with MDR-TB in the U.S., and the Plan’s aim for 2020 is to reduce this by 15%. Reducing a numerical incidence by just 15 cases-a-year over five years hardly seems much of an ambition when compared to the sort of challenges we’re contemplating elsewhere, but perhaps such a modest goal provides a reminder that the challenge of reducing incidence of this disease should never be underestimated.

Goal 2: Improve International Capacity and Collaboration to Combat MDR-TB. This goal relates to the wider international efforts that are well recognised to be required from the United States (and other donor nations), particularly through strategic investments to broaden access to diagnosis and treatment. This surely should be seen as the most crucially important goal of the five year Plan.

Goal 3: Accelerate Basic and Applied Research and Development to Combat MDR-TB. This relates to R&D into new rapid diagnostics, into new shortened and less toxic drug regimens, and into new vaccines, all of which could and should be used both at home and abroad.

It’s important to realise that this new Plan isn’t the first one that’s been developed by the U.S. government in order to combat MDR-TB. To date two other national action plans on MDR-TB have been published by the Center for Disease Control – one way back in 1992 and the other in 2009. Each one laid out its own goals for both prevention and for research -- but (and we feel it’s really very important to point this out since this is so relevant to the current Plan) they never got the funding to get off the ground for them to be implemented.

We feel we particularly need to stress this because the new Plan itself cautions that its own ultimate success will be “subject to budgetary constraints and other approvals, including the weighing of priorities and available resources by the Administration”. In other words, given the story of the previous Plans, and the administration’s own record of trying to cut its national TB budget in recent years, the new Plan comes with no guarantee at all that it will ever be usefully implemented.

But we also think that it’s worth recording what that very first National Action Plan to Combat Multidrug-Resistant Tuberculosis back in 1992 actually said. A full 23 years ago it made no bones at all about the threat that was faced – “At no time in recent history has tuberculosis (TB) been as great a concern as it is today. TB cases are on the increase, and the most serious aspect of the problem is the recent occurrence of outbreaks of multidrug-resistant (MDR) TB, which pose an urgent public health problem and require rapid intervention.”

The Plan itself then meticulously identified a full nine objectives that were believed needed to be met if MDR-TB was to be successfully contained (not just three like the current Plan). We think it’s worth listing them here exactly as they were listed nearly a quarter of a century ago because of what they collectively imply.

a) surveillance and epidemiology -- determining the magnitude and nature of the problem;

b) laboratory diagnosis -- improving the rapidity, sensitivity, and reliability of diagnostic methods for MDR-TB;

c) patient management -- effectively managing patients who have MDR-TB and preventing patients with drug-susceptible TB from developing drug-resistant disease;

d) screening and preventive therapy -- identifying persons who are infected with or at risk of developing MDR-TB and preventing them from developing clinically active TB;

e) infection control -- minimizing the risk of transmission of MDR-TB to patients, workers, and others in institutional settings;

f) outbreak control;

g) program evaluation -- ensuring that TB programs are effective in managing patients and preventing MDR-TB;

h) information dissemination/ training and education; and

i) research to provide new, more effective tools with which to combat MDR-TB.

Not one of these objectives has yet been properly achieved. But for us it’s more striking still that the very first one is so bizarrely omitted from the current Plan (i.e. “the intention to determine the true magnitude and nature of the problem”).

Surely, if there are just two things that we know about MDR-TB today, one is how little we still know about how much drug-resistant disease is really out there, and the other is where (or how) we should be properly starting to “improve International Capacity and Collaboration to Combat MDR-TB” (which is the second goal of last week’s National Plan). And such hapless lack of intelligence still persists a full twenty-three years down the road as much as the WHO may be quoting their 27 'high burden MDR-TB countries', so surely it should be the very first thing for the key donors now to be considering investing in if they want to see their money well spent. For us at least, the very first place to start (again) would be by implementing proper global surveillance and analysis.

Another part of the White House's proposal to deal with the disease is to “initiate treatment [by the end of 2016] for 25% of patients with MDR-TB in 10 countries with the highest burdens of MDR-TB”. Given that currently the WHO estimates (very optimistically indeed as far as we are concerned) that 20% of MDR-TB patients globally are already getting treatment, this hardly seems that ambitious or aggressive a target.

In fact, if we unpack this part of the proposal a little further, this offers us just another incoherence in the existing analyses of the estimated numbers (and in the consequent implementation of strategies): because what this appears to translate into (at least in terms of the new American National Plan) is an additional 200,000 MDR-TB cases being treated over the next five years, but these patients will mainly be in Russia, China and India–in three middle-income countries that currently self-fund most of their TB programs anyway. This is planned simply because these three countries are estimated to have the highest numerical burdens of MDR-TB (and they certainly all do have terrifying MDR epidemics). But none of these three huge nations (we believe) is among the ten nations where the highest proportional (not numerical) burdens of MDR-TB currently occur: all of these countries (we believe) are in southern Africa, and almost all are low-income ones. The problem, of course, is that no-one can either say or gainsay whether this opinion is true and this in turn is because the surveillance of MDR-TB (that very first item on the 1992 list of objectives) is still so appallingly deficient for this region.

Whether or not our suspicions about where the worst problems now lie are correct, this new National Action Plan (in its own words) also “serves as a call to action for other bilateral and multilateral donors, private sector partners, and affected countries to further their investments in this critical area of worldwide concern”. Mario Raviglione, the WHO’s TB czar, has picked up on this. He’s described the new Plan as a bold move by the U.S. administration and he hopes that it will be followed “by a similar type of attitude and bold moves by other European countries. Especially in Europe, people are simply ignoring the fact that MDR-TB is at the border”. Let’s hope he’s right but with Europe confronting so many other acute problems on its borders, it’s difficult to be too confident in the broader judgement of Europe’s politicians.

Meanwhile for Joanne Carter, who wrote that piece in the Washington Post and who is also the executive director of Results, the National Plan that's emerged is much more than an example for countries in Europe or elsewhere. “We see it as a really important Christmas present,” she says now that she’s finally seen it. “We're really, honestly, just happy [it came out] ... in advance of final revisions of the 2017 budget.”

We guess we should be happy as well but we have to admit to being not quite so optimistic about those final revisions to the budgets. We know that the financial input, not just from the U.S. but from every other donor nation as well, is going to hold the key to any real success. We really hope that she’s right in how she sees it because otherwise in another twenty-three years we may be commenting on yet another National Plan responding to what has become an intractable drug-resistant pandemic that’s spiralled out of control because of lack of political will, which by then will almost certainly also have become the dominant part of the wider global tuberculosis pandemic.

We’re certain that it will now be down to the commitment and persistence of ‘civil society’ to maintain pressure on politicians to prise the appropriate funding out of their respective treasuries, and to ensure that this won’t be just turn out to be another empty pledge without proper implementation.

As Stop TB’s Lucica Ditiu advocates: “We can only end TB if we are willing to commit our hearts, minds, and resources to combating this terrible disease.” But we’re sure we first need to find out much, much more about where the problems really are, and then respond coherently and efficiently to what is found.

In hope for more progress in 2016!