Imagine needing treatment for a life-threatening infectious disease like tuberculosis and the only drug available to you often causes deafness.
That’s what happened to an extraordinary young woman I met in Mumbai, India, earlier this year. In many ways, Prisha (not her real name) is just like many other women in their late 20s: She has a successful career and ambitious dreams for her future. But she is also a two-time survivor of multidrug-resistant tuberculosis (MDR-TB) — a strain of the bacterial infection that does not respond to the most commonly used anti-TB drugs.
During Prisha’s second bout of the disease, her doctor prescribed painful daily injections of powerful antibiotics. Three months later, she awoke to find she could no longer hear — she had gone deaf as a side effect of her treatment. It turned her entire world upside down.
Far too many people with multidrug-resistant TB have had the same experience as Prisha. That’s one of the reasons why the United Nations is convening its first-ever high-level meeting on TB in New York in late September. Tuberculosis is an ancient plague that has in recent years resurged to become the world’s deadliest infectious disease. More than one-quarter of the world’s population — 2 billion people — are infected with Mycobacterium tuberculosis, the bacterium that causes this lung disease. In most of them, the infection is in a dormant state. But every year, 10 million people develop active tuberculosis and more than 1.7 million people die of it.
As you might expect, key debates are happening right now regarding the political declaration that U.N. member states will adopt at the high-level meeting. One of them is focused on — and will have major implications for — how we sustain and encourage innovation against TB.
Many of the drugs used to treat TB, especially multidrug-resistant-TB, are decades old and can cause debilitating and potentially even fatal side effects. Injectable antibiotics — which are currently part of the first-line drug regimen for treating multidrug-resistant TB — cause deafness in as many as 3 out of every 5 people taking them. Other commonly used drugs cause liver and kidney damage and psychosis. To make matters worse, the cure rates associated with these treatments have historically been low.
We urgently need new drugs to treat TB and multidrug-resistant TB. We also need accurate diagnostic tests that can quickly detect TB and identify which drugs a patient will respond to, even in settings with limited health infrastructure. Equally important, we desperately need a more effective vaccine to prevent TB.
Fortunately, there are signs of hope. The first new drugs in over four decades with novel mechanisms of action against TB were recently approved. These are the oral medicines bedaquiline from Johnson & Johnson, where I work, and delamanid from Otsuka. There has also been progress in diagnostics: Cepheid’s GeneXpert test can now confirm multidrug-resistant TB in just two hours, a major advance compared to the weekslong diagnostic methods of the past.
These are significant innovations, and we need to find collaborative ways to accelerate access to them globally. National governments like South Africa and India, where TB is endemic, global bodies like the World Health Organization, and multisector alliances like the Stop TB Partnership, of which I am a board member, and its unique Global Drug Facility are now focused on doing just that.
But while we work to optimize access to the latest advances in TB treatment and prevention, we also need to encourage the pharmaceutical industry’s efforts and investments to develop new innovations for the disease. Experts widely accept the fact that the U.N.’s Sustainable Development Goal of ending this pandemic by 2030 cannot be achieved using today’s tools alone. That means innovation isn’t an option, it’s a matter of life and death. If we start investing now in research and development for new TB technologies, millions of people with the disease could be treated over the next decade and millions of infections could be averted.
Some people in the TB community are calling for the political declaration from the U.N. high-level meeting to mention flexibilities in the international agreement on Trade-Related Aspects of Intellectual Property Rights. These let countries, in exceptional circumstances, override drug patents to produce generic versions of medicines. However, if drug makers are unable to make returns on their investments when they bring medicines to market, they may be deterred from developing the next generation of therapies — therapies that are urgently needed.
From the perspective of the pharmaceutical industry, TB is unique. Unlike HIV/AIDS, for example, which affects people in both high- and low-income countries, the vast majority of people with TB live in low-income countries. As a result, drug makers have a limited financial incentive to prioritize research into new TB technologies. That means we need to think creatively if we want major innovator companies to develop tomorrow’s novel TB therapies, diagnostics, vaccines, and cures.
At the high-level meeting on TB, the global health community will have a unique opportunity to lay the foundation for a vibrant innovation ecosystem to end TB. Models for pricing and access must be designed to ensure that TB medicines are affordable and accessible to all patients while also encouraging the pharmaceutical industry to identify the treatments of the future.
Millions of people around the world — people who should not have to suffer the same fate as Prisha — are counting on us to get this right.
Adrian Thomas is the private sector constituency board member for the Stop TB Partnership and vice president for global public health and access at Johnson & Johnson.