TB

TB has reclaimed its place as the world’s biggest infectious killer – but are its days numbered?

dlegge — Sat, 08 Jun 2024 06:42:30 +0000

TB has reclaimed its place as the world’s biggest infectious killer – but are its days numbered?

20 May 2024

dlegge Sat, 08/06/2024 - 16:42

Author/s

Ben Farmer and Sarah Newey

The Telegraph

TB has reclaimed its place as the world’s biggest infectious killer – but are i…

Health experts pin their hopes on long-awaited trials into a new potential vaccine for tuberculosis.

In the few minutes it takes to read this article, some 15 people are likely to have died from humanity’s worst infectious killer disease. Over the course of the day, the toll will be around 3,600.

The victims are likely to have died slowly, spending months or years coughing and wasting away as their lungs were relentlessly weakened.

Those victims are also all likely to have been poor and from the developing world, or middle income countries.

The killer is not an exotic new superbug, or recently-emerged virus, but one of the world’s oldest pandemics, caused by a bacterium which has plagued humanity for an estimated 40 millennia.

Locked in a constant arms race against human immune systems, the bug has in that time evolved into a stubborn, stealthy and difficult-to-stop killer.

Some 10.6m people fell ill with tuberculosis, or TB, in 2022 and 1.5m people died, which is an average of 2.5 deaths per minute.

At the height of the Covid-19 pandemic, tuberculosis was temporarily eclipsed as the biggest infectious killer in the world, but has now reclaimed its top slot.

[...]

The second obstacle has been a lack of funding. As recently as the 1970s and 1980s, there was complacency that BCG and existing drugs were enough to beat TB. That changed with the HIV/AIDS epidemic. As patients’ immune systems were weakened by the new disease, there was a surge in TB.

In South Africa alone, between 1990 and 2019, nearly nine million people developed TB, and 2.1 million lives were lost. HIV caused 55 per cent of those TB cases and 69 per cent of the TB deaths.

Yet the fact that the disease mainly affects developing or middle income countries has meant it has been low priority for donors or pharmaceutical companies in the developed world.

“TB is a disease of the socio-economically dispossessed,” says Willem Hanekom, AHRI’s executive director and principal investigator for the South African trial.“Soci-economic compromise results in immune compromise: the stress, the poor nutrition. That’s why TB is extraordinarily common there. TB is not that common in people who are well fed and happy and well resourced.”

Keywords

R&D for Health Products

GLOBAL PLAN TO END TB, 2023-2030 – HOW FEASIBLE? HOW DESIRABLE?

dlegge — Thu, 23 May 2024 02:18:50 +0000

GLOBAL PLAN TO END TB, 2023-2030 – HOW FEASIBLE? HOW DESIRABLE?

09 January 2024

dlegge Thu, 23/05/2024 - 12:18

Author/s

Sundararaman T.

Conversations on health policy

GLOBAL PLAN TO END TB, 2023-2030 – HOW FEASIBLE? HOW DESIRABLE?

There has been very limited comments on the media and even in academic journals on the major changes in the strategies of tuberculosis, globally and at the national level.

At the Global level a High-Level meeting of the United Nations General Assembly on the End TB Strategy was held in September 2023. In the same week there were similar high-level meetings on pandemic preparedness and on Universal Health Coverage (UHC) – and these got more attention. The meeting on Tuberculosis has adopted the “ Political Declaration on the High-Level Meeting on the Fight Against Tuberculosis” (1)(UNGA,2023)

The declaration on tuberculosis is a welcome international call for ending the TB epidemic by 2035. This is a reiteration of the call that was first adopted by the UN in 2018. In public discourse this is often expressed as eliminating the disease as a public health problem by 2030, or as making the country or the world TB free. A more precise definition of the goal would be achieving the SDG 2030 targets for TB, followed by WHO End TB targets by 2035 globally, and that means achieving an annual TB incidence of <10 per lac population. Achieving this increases chances of eliminating TB by 2050. The SDG 2030 target is a 90 percent reduction in the incidence of all active disease in adults, children and drug resistant cases and a 90 percent decline in the number of people who die from TB annually by 2027, compared to 2015. It also aims for achieving preventive treatment of 90 percent of all latent TB, and all active cases being diagnosed with molecular diagnostics as compared to sputum microscopy and X-rays and treated with the latest recommendation in drug regimens. Further all, 100 percent of tuberculosis patients would be protected from financial hardship due to TB care.

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Tuberculosis and Inequality: How Race, Caste, and Class Impact Access to Medicines

dlegge — Sat, 17 Feb 2024 05:28:51 +0000

Tuberculosis and Inequality: How Race, Caste, and Class Impact Access to Medicines

16 December 2023

dlegge Sat, 17/02/2024 - 16:28

Author/s

Maayan Hoffman

HPW

Tuberculosis and Inequality: How Race, Caste, and Class Impact Access to Medici…

The elimination of tuberculosis cannot be achieved if medicines are locked in a “patent panoply,” according to Indian author and journalist Vidya Kishnan.

Speaking to Garry Aslanyan on the most recent episode of Dialogues, a new series from the Global Health Matters podcast, the author of “Phantom Plague: How Tuberculosis Shaped History” said that “everything that happened in COVID has been happening for decades with TB.

“In India, the entire TB program got ‘Covidized,’ down to the helpline of the Ministry [of Health], and infections and respiratory diseases don’t simply go away,” Kishnan said. “So, the first thing we need to do is look at how technology is transferred because vaccines and drugs first and foremost, it’s technology. It’s somebody’s intellectual property. And I feel like TB elimination cannot, will not be achieved if the medicines, the latest most humane therapy, is locked in a patent panoply.”

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Tuberculosis and Inequality: How Race, Caste, and Class Impact Access to Medicines

dlegge — Sat, 27 Jan 2024 00:53:47 +0000

Tuberculosis and Inequality: How Race, Caste, and Class Impact Access to Medicines

16 December 2023

dlegge Sat, 27/01/2024 - 11:53

HPW

Tuberculosis and Inequality: How Race, Caste, and Class Impact Access to Medici…

The elimination of tuberculosis cannot be achieved if medicines are locked in a “patent panoply,” according to Indian author and journalist Vidya Kishnan.

Keywords

Johnson & Johnson’s Patenting & Pricing Strategy for TB Medicine Bedaquiline: A Cautionary Tale for New TB Medicines

dlegge — Sat, 20 Jan 2024 23:43:44 +0000

Johnson & Johnson’s Patenting & Pricing Strategy for TB Medicine Bedaquiline: A Cautionary Tale for New TB Medicines

06 October 2023

dlegge Sun, 21/01/2024 - 10:43

GHF

Bedaquiline patenting and pricing

In August 2023, Johnson & Johnson (J&J) reduced the price of the lifesaving tuberculosis (TB) medicine, Bedaquiline, from US$272 to $130 per treatment course of six months for many low- and middle-income countries (LMICs). This price reduction was the result of a competitive tender by the Stop TB Partnership’s Global Drug Facility (GDF), an international pooled procurement mechanism for procurement of TB health products, and represents a watershed moment in the decade-long struggle for expanding access to Bedaquiline.

The high prices J&J charged in the decade prior to the August 2023 price reduction were entirely unjustified, especially as the development of Bedaquiline was funded predominantly through public money: the US government’s investments exceeded J&J’s by up to five times. Had J&J offered a significantly lower price closer to $130 when Bedaquiline was launched, hundreds of thousands more people with drug-resistant TB (DR-TB) would have had an opportunity to access this revolutionary medicine. However, the story of Bedaquiline played out very differently and it is worth revisiting it from the start for the lessons it holds for access to lifesaving medicines.

Keywords

A2M (Access to health technologies)

How Advocates Pushed Big Pharma to Cut Tuberculosis Drug Prices

dlegge — Tue, 15 Aug 2023 03:01:03 +0000

How Advocates Pushed Big Pharma to Cut Tuberculosis Drug Prices

14 August 2023

dlegge Tue, 15/08/2023 - 13:01

SciAm

How Advocates Pushed Big Pharma to Cut Tuberculosis Drug Prices

… The two issues of underdiagnosis and restricted access to low-cost TB drugs are inseparable, says Helen Cox, an epidemiologist at the University of Cape Town in South Africa, who specializes in TB. “Patents on drugs like bedaquiline make TB so expensive to treat,” she says, adding that many high-burden TB countries are reluctant to fund diagnostic services. “If you don’t diagnose the problem, you don’t have to pay for the treatment.” She’s hopeful that the recent J&J-GDF agreement will encourage these countries to invest into diagnosing TB. … Currently, U.S.-based corporations such as Cepheid hold a monopoly over TB DNA diagnostic tests such as GeneXpert MTB/RIF and MTB/RIF Ultra, which are priced at $9.98 per test cartridge. The Doctors without Borders/Médecins Sans Frontières Access Campaign, which advocates for affordable medical treatments, has argued that public funds largely underwrote the development of these tests. Organizers have also claimed that Cepheid’s manufacturing costs are estimated to be as low as $3 per cartridge, meaning the company could still make a substantial profit if it lowered the costs of cartridges to $5. “Lowering the price of diagnostic tests is the next fight, and I’m confident that Johnson & Johnson will join us in that battle based on their statement,” Green says. “And if Cepheid pushes back, well, it’s sunny in California,” which is where Cepheid’s headquarters are located. “Maybe we’ll take a trip there.”

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Open letter: Requesting clarification from J&J on the recent deal for generic bedaquiline supply

dlegge — Thu, 03 Aug 2023 04:00:04 +0000

Open letter: Requesting clarification from J&J on the recent deal for generic bedaquiline supply

01 August 2023

dlegge Thu, 03/08/2023 - 14:00

MSF

Open letter: Requesting clarification from J&J on the recent deal for generic b…

Treatment Action Group, Partners in Health and Medécins Sans Frontières wrote an open letter to Johnson & Johnson seeking clarification on its deal with Global Drug Facility to supply generic versions of TB drug bedaquiline and also reiterated its demand for a public announcement of non-enforcement of secondary patents on bedaquiline in all low-, lower-middle, https://upper-middle, and high-TB- or MDR-TB-burden countries.

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Gates Foundation to fund trial of long-awaited new tuberculosis vaccine candidate

dlegge — Tue, 01 Aug 2023 00:33:54 +0000

Gates Foundation to fund trial of long-awaited new tuberculosis vaccine candidate

28 June 2023

dlegge Tue, 01/08/2023 - 10:33

Stat News

Gates Foundation to fund trial of long-awaited new tuberculosis vaccine candida…

The Gates Foundation unveiled plans Wednesday to fund a long-awaited trial for what, if proven effective, would be the first new tuberculosis vaccine in over a century. … The Gates Foundation, which also funded early research on the shot, has committed $400 million to the trial, and the U.K.’s Wellcome Trust is committing up to an additional $150 million. The trial will take place across more than 50 sites in Africa and Asia and likely take four to six years to complete, Trevor Mundel, the Gates Foundation president of global health, told reporters. … Although the Gates Medical Research Institute is assuring manufacturing the vaccine, GSK will continue supplying an adjuvant, a molecule designed to amplify the vaccines’ signal to the immune system. A GSK spokesperson said that given the complexity of running a Phase 3 trial in lower-income countries, the company believed the institute was the best organization to move forward with the vaccine, and that GSK’s “most important contribution to global health is the science, investigating proof-of-concept through phase 2.” If the vaccine succeeds, the Gates Foundation’s work will be far from over. Mundel said the foundation would need to find a partner to manufacture the drug for a commercial market. And given that tuberculosis primarily affects the poorest groups in low-income countries, experts warn rollout will be daunting.

Keywords

Vaccines, Immunisation

Global Drug Facility Update on Access to Bedaquiline

dlegge — Tue, 01 Aug 2023 00:32:34 +0000

Global Drug Facility Update on Access to Bedaquiline

13 July 2023

dlegge Tue, 01/08/2023 - 10:32

Stop TB Partnership

Global Drug Facility Update on Access to Bedaquiline

Following lengthy negotiations, Johnson & Johnson has granted Stop TB Partnership's Global Drug Facility’s licenses that enable Global Drug Facility (GDF) to tender, procure, and supply generic versions of SIRTURO® (bedaquiline) for the majority of low-and middle-income countries, including countries where patents remain in effect. GDF has shared with the TB community important updates on plans to launch a global, competitive tender for bedaquiline by end July 2023. All bedaquiline suppliers that meet GDF`s quality criteria are eligible to participate in the GDF bedaquiline tender and have been briefed on the tender goals, processes, and timelines.

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TAG Encouraged by J&J Deal to Reduce Bedaquiline Prices, but Company’s Action Falls Short of Community Demands

dlegge — Tue, 01 Aug 2023 00:30:39 +0000

TAG Encouraged by J&J Deal to Reduce Bedaquiline Prices, but Company’s Action Falls Short of Community Demands

13 July 2023

dlegge Tue, 01/08/2023 - 10:30

Treatment Action Group

TAG Encouraged by J&J Deal to Reduce Bedaquiline Prices, but Company’s Action F…

We are heartened that this arrangement will likely reduce the cost of bedaquiline around the world. And we celebrate author John Green and his many followers for shining a light on this cause and campaigning with creativity and spirit to amplify the longstanding demands of TB survivors, communities, and civil society. Nonetheless, this deal falls short of the clearly articulated demands of communities affected by TB for patent non-enforcement or withdrawal. It is a creative procurement solution that will address the acute crisis in access to this lifesaving drug without solving the larger structural injustices that led to inequitable access to bedaquiline in the first place. Patent “evergreening” tactics like those deployed by J&J allow pharmaceutical companies to game an intellectual property regime in order to extend monopoly rights over publicly funded innovations. … While the deal between J&J and the STBP GDF will allow countries buying through GDF access to generics and lower prices, countries that don’t buy from the STBP GDF such South Africa and countries in the Commonwealth of Independent States (CIS), where J&J licensed bedaquiline to Pharmstandard, the unjustified secondary patents are still in play and blocking access to generics. A competitive tender through GDF might also lower the price of bedaquiline available in these places, many of which have high TB burdens. But it raises the question of why this is only now suddenly possible. As TAG TB Project Co-Directors Mike Frick and Lindsay McKenna demonstrated three years ago in PLOS ONE, public and philanthropic entities invested up to five times as much in bedaquiline R&D as J&J did.

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