NEW BRUNSWICK, NEW JERSEY, OCTOBER 10, 2019—The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) today launched its global campaign to demand that pharmaceutical giant Johnson & Johnson (J&J) lower the price of its tuberculosis (TB) medicine bedaquiline. As TB activists protest outside of J&J headquarters in New Brunswick, New Jersey, and its offices in South Africa, Brazil, Belgium, Ukraine, and Spain, the organization is demanding the corporation make the drug available at no more than $1 per day for people with drug-resistant TB (DR-TB) everywhere so treatment can be scaled up and more lives can be saved.
MSF demands this price cut because joint contributions made the development of this drug possible, including by MSF itself.
“Bedaquiline was developed using taxpayer money and contributions from the global TB community,” said Sharonann Lynch, HIV & TB policy advisor for MSF’s Access Campaign. “Those who contributed to bedaquiline’s development should have a say in how the drug is priced. We’re calling on J&J to price bedaquiline at no more than $1 per day so that it can be made available to all people with drug-resistant TB. We will not back down until the price of bedaquiline is brought down."
J&J currently charges double the price that MSF is asking for bedaquiline, which was developed with considerable taxpayer, non-profit, and philanthropic support. Much of the critical work to prove this drug’s efficacy was conducted by the TB research community, health ministries, and treatment providers like MSF, and it was financed by taxpayers and other donors. Despite this joint research and development effort by the global TB community, J&J alone owns the patent on the drug in many countries and has sole rights to determine where the drug will be sold. In addition to this funding and support, J&J also received a Priority Review Voucher from the US Food and Drug Administration (FDA) because of this drug, which is a voucher that can be used to accelerate the FDA review of any of their drugs or vaccines or be sold by J&J to another entity.
Bedaquiline is one of only three new TB drugs to be developed in over half a century—the others being delamanid and pretomanid. The previously recommended DR-TB treatment regimens used by most countries required people to take as many as 20 pills a day for up to two years and endure painful daily injections and severe side effects ranging from psychosis to persistent nausea to deafness. These suboptimal treatments only managed to cure 55 percent of people with multidrug-resistant tuberculosis (MDR-TB) and just 34 percent of people with extensively drug-resistant tuberculosis (XDR-TB).
“Bedaquiline saved my life,” said Noludwe Mabandlela, who was treated by MSF for MDR-TB in Khayelitsha, South Africa and was cured in early 2019. “I was experiencing a lot of side effects during my previous treatment which included drugs that need to be injected. After switching to bedaquiline, my health improved much faster. I wouldn't wish anyone to go through what I experienced. Pharmaceutical corporations like J&J should stop inflating the price of the drug that offers a lifeline to people affected with drug-resistant forms of tuberculosis.”
J&J has priced bedaquiline at $400 for a six-month treatment course for countries eligible to buy the drug through the Global Drug Facility (GDF), a TB drug and diagnostic procurement mechanism operating out of a United Nations agency. However, researchers from the University of Liverpool have calculated that bedaquiline could be produced and sold at a profit for much less—as little as 25 cents per day if at least 108,000 treatment courses were sold per year. At $1 per day, the price of bedaquiline would be $600 per person for the 20 months of treatment that many DR-TB patients require. In comparison, the lowest price J&J charges today for 20 months of bedaquiline is nearly $1,200—or $2 per day—in countries eligible to purchase through GDF, while J&J charges other countries much more. This high price affects the scale-up of the drug in many countries struggling with DR-TB epidemics, considering that bedaquiline is just one of multiple drugs required in a DR-TB treatment regimen.
Based on data generated by the TB community showing improved treatment outcomes in people who received bedaquiline, the World Health Organization (WHO) in 2018 recommended bedaquiline be used as a core part of an all-oral treatment regimen, replacing the injected drugs, but this can’t happen as long as it remains priced out of reach for people and governments. Increased use of bedaquiline has already shown benefits, even among people more likely to have poorer treatment outcomes, including people living with HIV, and people with pre-XDR-TB and XDR-TB. For example, in Belarus, among 244 people who were treated with bedaquiline—96 percent of whom had either pre-XDR-TB or XDR-TB—the treatment success rate increased to 87 percent.
“We have seen so many patients go deaf, lose their jobs, or lose their lives because they had no option other than the excruciating TB drugs that had to be injected,” said Pilar Ustero, medical advisor for MSF’s Access Campaign. “Bedaquiline is proving to be a game changer, giving those people with DR-TB who can access it a better chance to be cured, without the toxic side effects. We need this drug to be affordable for everyone who needs it, everywhere.”
Since WHO recommended the use of bedaquiline a year ago as a core drug for the treatment of MDR-TB, fewer than 12,000 people were treated with a regimen including bedaquiline according to national TB programs. This is a paltry figure considering that an estimated 80 percent of the 558,000 people who develop DR-TB annually should be treated with this drug. Rapid rollout of better-tolerated treatment containing bedaquiline will happen only if J&J makes it widely available in an affordable way, including by allowing other TB drug manufacturers to make generic versions.
MSF is the largest non-governmental provider of TB treatment worldwide and has been involved in TB care for 30 years, often working alongside national health authorities to treat people in a wide variety of settings, including chronic conflict zones, urban slums, prisons, refugee camps, and rural areas. As of September 2018, across MSF projects in 14 countries, more than 2,000 people have been treated with the newer drugs, including 633 with delamanid—one of the other new TB drugs developed in more than 50 years—1,530 with bedaquiline, and 227 with a combination of these two medicines.