Preventing and managing M/XDR-TB: a global health imperative

Dr Margaret Chan
Director-General of the World Health Organization

Opening remarks at a ministerial meeting of high M/XDR-TB burden countries

Mister Chairman, President Sampaio, your Excellency, Vice-Premier Li Keqiang, honourable ministers, colleagues and partners in public health, ladies and gentlemen,

First, let me thank the Ministry of Health of the People’s Republic of China and the Bill and Melinda Gates Foundation for joining WHO in making this ministerial meeting possible.

At a time of financial crisis and economic downturn, we need to look very carefully at areas of public health where any lapse in current efforts will bring us a much bigger bill very soon. Tuberculosis control is a prime example.

Tuberculosis also illustrates the need for comprehensive pro-poor health and development policies that tackle the underlying social determinants of ill health. I will focus on challenges, and consequences, that go beyond national TB programmes.

Viewed from one perspective, global TB control is an encouraging success story. In the late 1980s, TB resurged with a vengeance, largely fuelled by the HIV/AIDS epidemic. In 1993, WHO declared tuberculosis a global public health emergency. The world responded with commitment, a standardized treatment that works, a comprehensive and costed global strategy, and an effective partnership for coordinated implementation.

The international response also brought pioneering mechanisms for ensuring that anti-TB medicines are available in sufficient quantities, of assured quality, at affordable prices. Partly as a result, the rate of new TB cases peaked in 2004 and then began a slow decline, which continues today.

Viewed from another perspective, tuberculosis has again placed the world in a precarious situation. This is the perspective created by the emergence and spread of drug-resistant tuberculosis. The situation is already alarming, and it is poised to grow much worse, very quickly.

Last year, the WHO report on anti-TB drug resistance documented the highest levels of multi-drug resistance ever recorded in a general population. The 2009 WHO TB Report estimated that more than half a million new cases of MDR-TB occurred during 2007.

Even more alarming, well over half of these cases were resistant to multiple drugs right from the start, and not as a direct result of substandard treatment. This is the true alarm bell. This tells us that resistant strains are now circulating in the general population, spreading widely and largely silently in a growing pool of latent infection.

This is the true warning signal: if MDR-TB is not vigorously addressed, it stands to replace the mainly drug-susceptible strains currently responsible for 95% of the world’s TB cases.

Even more ominous is the emergence of extensively drug-resistant TB, or XDR-TB, which has now been reported in 55 countries. In most low-income countries, especially in Africa, the magnitude of the problem is unknown, as this form of TB is so difficult to diagnose. But we do know this: unchecked, XDR-TB could take us back to the treatment era that predates the development of antibiotics.

Preventing and managing drug-resistant TB is a global health imperative.

We need a ministerial meeting on MDR and XDR-TB because threats of this magnitude demand high-level political awareness and commitment. They need to be countered by pro-poor policy decisions.

We need high-level political attention because national TB programmes cannot, by themselves, manage these new threats. The problem has become too big, and the danger has become too great.

Simply stated, we will not be able to manage drug-resistant TB in the absence of a well-functioning health system. We need an across-the-board response.

MDR and XDR-TB are threats that will take advantage of every opportunity to spread and amplify. As we now know, these opportunities come from system-wide weaknesses in the provision of health care.

Sound basic TB control is the best way to prevent drug-resistant TB. Fundamental weaknesses in health systems impede sound TB control. Substandard treatment of normal TB drives the development of multi-drug resistant strains. In turn, substandard treatment of MDR-TB drives the development of XDR-TB.

Equally of concern, drug-resistant TB creates enormous additional demands and pressures on components of the health system that are already weak. In other words, drug-resistant TB severely strains and erodes the very capacities needed to prevent it in the first place.

Ladies and gentlemen,

Let us look at what this means.

Diagnosis of MDR-TB is challenging and depends on high-quality, well-staffed, and well-equipped laboratories, ideally operating at biosafety level 3. Laboratories are arguably the most neglected component of health systems. The capacity is simply not there in most high-burden countries.

New diagnostic tools have become available, but technology transfer is slow and too many laboratories are not equipped and staffed to absorb these technical advances.

Fixed-dose combinations were developed specifically to reduce the risk of drug resistance. Logistically, they are easier to store and distribute. Prices are the same as, or lower than, loose pills, and treatment is easier to finance. Yet these drug formulations are still underutilized in nearly all high-burden countries. If health authorities were fully aware of the consequences, would utilization improve?

The current recommended second-line treatment regimens are complex, of long duration, and require intensive monitoring of adverse events and treatment outcomes. Stringent efforts are needed to ensure treatment adherence. We already face a critical shortage of health-care personnel.

Compared with normal TB, the costs of treating MDR-TB can be as much as 200 times higher, and this is when the country benefits from the concessional prices offered by the Green Light Committee initiative. If drugs are procured on the open market, the price increase can soar one thousand-fold. Either way, patients and their families face catastrophic expenditures.

Ways need to be found to make care available at no cost. We know this brings the best results, especially in resource-poor settings. Patients, communities, and civil society need to be fully engaged in prevention, treatment, and care.

Procurement systems must be able to ensure an uninterrupted supply of drugs. Systems for regulatory control must ensure that these drugs meet acceptable quality standards, are sold on prescription only, and are prescribed only by accredited practitioners.

Infection control for airborne pathogens must improve in hospitals and other congregate settings, especially where HIV/AIDS is widespread. Better collaboration is needed with HIV programmes. People living with HIV have a higher risk of MDR-TB, with a greatly increased mortality and a greatly reduced survival time.

All of these constraints are also an inventory of the most common and most crippling weaknesses in health systems.

Currently, less than 5% of the estimated MDR-TB cases are being detected by national TB programmes. Fewer than 3% are being treated according to WHO recommended standards. The costs, as I said, are catastrophic. In all 27 high-burden countries, the costs of treating a single patient vastly exceed average annual per capita income.

Poor case detection means poor data, and this means poor drug forecasting and weak incentives for manufacturers, who tend to produce on demand. Supplies of second-line drugs are inadequate to manage even the small proportion of cases enrolled for treatment.

Most, if not all, second-line drugs are sold in the private retail market, often over-the-counter. Where is the monitoring of adverse events? Where is the assurance of treatment adherence?

Obviously, this is a situation set to spiral out of control. Call it what you want: a time-bomb or a powder keg. Any way you look at it, this is a potentially explosive situation.

The conclusion is equally obvious. We need dramatic improvements in case detection and standardized management with quality-assured drugs across the health system. This means in the public, private, and voluntary sectors, in HIV programmes, and in hospitals as well as national TB programmes.

The best way to do so is through a policy that strives for universal, equitable, and affordable health coverage, and strengthens all capacities needed to reach this goal.

I urge you to make the right policy decisions with appropriate urgency. At a time of economic downturn, the world simply cannot afford to let a threat of this magnitude, complexity, and cost spiral out of control.

It is in your hands. Rest assured of full support from WHO and its Stop TB partners.

Thank you.