Every 20 seconds, someone dies of tuberculosis. But health advocates and experts hope that a newly announced reduction in the cost of TB testing might change that.
On Tuesday, several TB-focused organizations announced a major victory after the multinational conglomerate Danaher Corp. cut the cost of a key test — for TB infection and resistance to a commonly used drug — by 20 per cent.
Danaher has also committed to make no profit on the sale of this specific TB test to low- and middle-income countries going forward, and to a yearly third-party assessment to ensure that remains the case.
It’s the first time the cost of the test has been reduced in more than 13 years, says Stijn Deborggraeve, diagnostics adviser for the Médecins Sans Frontières (MSF) Access Campaign.
“Five million additional tests can be procured with this lower price,” said the Global Fund to Fight AIDS, Tuberculosis and Malaria in a statement.
John Green, a best-selling author, philanthropist and TB advocate, said he’s “very happy” — but still sounded a cautious note.
It’s pure price gouging. It’s pure profiteering.– Stijn Deborggraeve, diagnostics adviser for the Médecins Sans Frontières Access Campaign
“When good things happen, you want to celebrate,” he said. “But at the same time, I’m conscious of the fact that 1.6 million people are going to die of TB this year.”
TB is the deadliest disease in human history and has killed an estimated one billion people in the last 200 years. Caused by the bacterium M. tuberculosis, TB is curable in virtually all cases, and has been for 70 years, thanks to powerful tests, medications and treatment regimes.
But according to experts, pharmaceutical companies are overcharging for critical treatments, developed with hundreds of millions of dollars in public funding, locking out those who need them most.
The fact that 1.6 million still die of the disease every year is a testament to what happens when you put profit over patients, says Green.
“The real cause of tuberculosis in the 21st century is not a bacteria,” said Green. “It’s human-built systems. It’s human choice.”
On Friday, world leaders are set to meet in New York for the second United Nations High Level Meeting on TB. Advocates and experts hope to see promises of progress, not just from governments, but corporations as well.
“We can choose a world where no one dies of TB, just as we are currently choosing a world where 1.6 million people do,” Green said.
TB is an airborne infectious disease that typically infects the lungs, but can colonize almost any part of the body. A third of all people globally are estimated to have a latent TB infection and more than 10 million get sick every year.
It has remained the world’s deadliest infectious disease since the Black Death; the only exceptions being in 2020 and 2021, when it took second place after COVID-19.
TB tends to strike the most vulnerable, including young children and the immunocompromised. People in poor living conditions or with little access to health care, such as in impoverished countries or Canada’s Indigenous communities, are also at higher risk.
‘Printer ink’ model
But diagnosing TB is a challenge. One of the only reliable methods is to use molecular tests, says Carole Mitnick, a professor of global health at Harvard Medical School and a leading expert in TB treatment.
Part of the problem, Mitnick said, is that Danaher holds a virtual monopoly through its subsidiary Cepheid, which produces the GeneXpert molecular testing system.
Since GeneXpert went to market in 2006, it has been sold under what Danaher CEO Rainer Blair publicly described as the “razor-blade” model. Sometimes also called the “printer ink” model, that’s when a company charges relatively little for the base of a product (like a printer or razor handle) but more for the required disposable components (like ink cartridges or razor blades).
The testing machine, which can also be used to diagnose HIV, hepatitis, COVID-19, Ebola and a host of other diseases, is relatively affordable, Deborggraeve said. MSF gets machines that can run four tests at a time for $17,000 to $20,000. (All figures in U.S. funds.)
Many low-income countries got them years ago, when sales were subsidized by public funding, says Mitnick.
But that locks them into the GeneXpert system and forces them to buy the company’s single-use TB test cartridges, which have been sold at a high markup for over a decade.
For all tests but one, those markups will continue.
Danaher and Cepheid did not respond to CBC News’s request for comment.
We can choose a world where no one dies of TB– Author and TB advocate John Green
Danaher is a multinational conglomerate and holding company that had profits of $7 billion in 2022.
GeneXpert was developed using more than $250 million in public funding, much of which came from Canadian and U.S. taxpayers, according to one study.
The company has long refused to disclose the cost of producing the test cartridges. But in 2018, MSF commissioned an independent analysis that concluded each costs around $3 to $4.50 at the volume required then.
In its statement on Tuesday, Danaher claimed that, at $7.97, it would be selling the basic TB cartridges at cost.
For decades, the company has sold them to impoverished countries and organizations delivering treatment within them for $10 to $15 apiece, a markup of 122 to 400 per cent. At this price point, widespread molecular testing is out of reach for many countries with the highest burdens of TB.
The experts who CBC spoke with said that since MSF’s study in 2018, the number of cartridges sold has increased dramatically, meaning the cost of production is now likely even lower.
With the new pricing, Danaher now charges almost double for other cartridges capable of detecting extensively drug-resistant TB (XDR-TB), despite the fact they cost the same to produce.
“It’s pure price gouging. It’s pure profiteering,” said Deborggraeve before the announcement.
“We invite the companies to be transparent in the costs … so that countries don’t have to buy blindly,” Deborggraeve said in an interview Tuesday.
Still a threat
In 2021, the last year for which complete data has been published, 1,904 active TB cases were reported. Nearly 200 were drug-resistant. The vast majority were among Indigenous peoples or those born outside Canada.
Compared to the Canadian-born, non-Indigenous population, the rate of TB among First Nations was more than 80 times higher in 2021. Among Inuit, rates were nearly 700 times higher.
In Canada, along with other high-income countries, a single GeneXpert cartridge costs around $100 US, Deborggraeve said — a markup of approximately 3,000 per cent.
Canadian hospitals don’t typically use GeneXpert machines for TB diagnosis, since they have the resources for other techniques, such as skin tests, chest X-rays and mycobacterial cultures.
But for remote communities, GeneXpert machines may be the only option. In Nunavut, the Qikiqtaaluk region uses the GeneXpert system to test for TB out of Iqaluit.
‘Time for $5’ campaign
Last week, Green joined organizations like MSF and Boston-based Partners in Health in calling for the price of the testing cartridges to be lowered to $5. The “Time for $5” movement was started in 2019.
WATCH | Green launches anti-TB pressure campaign:
Advocates say at that price, Danaher would continue making a healthy profit and that the number of tests that could be purchased and administered would jump dramatically.
Experts say it could save hundreds of thousands of lives over the next decade.
Being able to buy enough cartridges is among the barriers faced by countries struggling with TB, says Deborggraeve.
The campaign is backed by TB experts, organizations that deliver on-the-ground treatment and Nerdfighteria, the community that has formed around Green and his brother, science communicator Hank Green.
The Greens and Nerdfighteria have raised tens of millions of dollars for Partners in Health, which provides critical health-care services, including TB treatment, in low-income countries.
John Green also previously spearheaded a pressure campaign against pharmaceutical giant Johnson & Johnson, which was fighting to extend its patents for the TB drug bedaquiline.
Sometimes referred to as a “miracle drug,” bedaquiline is a first-line treatment for multi-drug resistant tuberculosis (MDR-TB).
The experts and advocates who CBC spoke with felt that Green’s boosting of the TB campaign likely had something to do with Tuesday’s announcement. Lucica Ditiu, executive director of the Stop TB Partnership, said Stop TB and the Global Fund had been in talks with Danaher for months with little progress until Green got involved.
But there may have been other factors at play as well, said Mitnick.
Molbio Diagnostics, a molecular diagnostics company based in India, is one of Cepheid’s few competitors. Earlier this year, Molbio said it was dropping the price of its drug-resistant TB test to $7.95 — roughly the same price, now, as GeneXpert.
Chandrasekhar Nair, Molbio’s director and CTO, said at that price they still make a profit, even with the much lower production volumes compared to Cepheid. He also said it costs them roughly the same amount to manufacture their dozens of types of tests — and they all sell for around the same price.
When increased demand and production volume meant the cost of producing TB tests came down, they lowered the price, said Nair.
Mitnick says there are several reasons the Molbio testing machine, known as Truelab, may be preferred over Cepheid’s GeneXpert machines. It’s more resilient and portable, can be brought closer to where people live and doesn’t require a constant supply of electricity or air conditioning.