Millions could soon have access to lifesaving tuberculosis drug following online uproar

Pharma giant Johnson & Johnson says it will expand bedaquiline access.

July 19, 2023, 3:49 PM

In a move welcomed by advocates, a treatment for multi-drug resistant tuberculosis could soon become more accessible for millions of people worldwide.

Although tuberculosis is uncommon in the U.S., it is the top infectious disease killer worldwide after COVID-19, claiming an estimated 1.6 million lives in 2021, according to the World Health Organization.

A lifesaving drug called bedaquiline, when used along with other medications, works to kill the bacteria that causes multi-drug resistant tuberculosis (MDR-TB). While the drug's primary patent was set to expire this week, allowing less-expensive generic versions to be manufactured and distributed, Johnson & Johnson, which makes and markets bedaquiline under the brand name Sirturo, had planned to utilize a secondary patent to extend their control of it until the end of 2027, advocates say.

In a now-viral YouTube video, author and advocate John Green protested Johnson & Johnson's patent extension on bedaquiline and rallied his 4.5 million Twitter followers to pressure the company to change course.

Amid the Twitter uproar, Stop TB Partnership – a United Nations-hosted organization that works to address tuberculosis worldwide – announced a partnership with the pharma giant 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."

Researchers have estimated prices of generic versions of bedaquiline could be up to 94% lower than current costs, with large-scale manufacturing.

The availability of the generic drug could provide six million people with treatment over the next four years, according to Carole Mitnick, Sc.D., a professor of global health and social medicine at Harvard Medical School and a senior research associate at Partners in Health.

While advocates celebrated the news, Johnson & Johnson said the partnership was already in the works prior to the media uproar and that it was "false to suggest" that patents were being used to prevent broader access to bedaquiline.

"We've been in lengthy discussions with the Global Drug Facility regarding access to bedaquiline. We had our first meeting with them at the beginning of this year and reached an agreement on June 13," a Johnson & Johnson spokesperson told ABC News via email.

Pharmaceutical companies often file for patent extensions on their drugs to prevent market competition, a strategy called "evergreening." However, advocates say this system hinders access to affordable medicines globally, sometimes for many years after a drug is first launched.

"Patents are supposed to last for a limited period of time. After that, competitors should enter the market to drive prices down. But that's not what's happening," said Robin Feldman, professor of law at University of California Law San Francisco. "Instead, drug companies pile new protections onto their drug to extend that protection."

Patents serve a key role, however, by incentivizing innovation. "Companies fund an extraordinary amount in researching and producing and we want to encourage companies to engage in that research. The patent is a reward for that successful research," Feldman added.

But Feldman's research shows that here in the U.S., an estimated 78% of drugs with new patents in the Food and Drug Administration's records were evergreening extensions for existing drugs.

John Green, who created the YouTube video addressing the bedaquiline issue, told ABC News he was first exposed to the devastation of tuberculosis during a trip to Sierra Leone.

"When I was there, I met a young man who looked to be my son's age, who looked 9 at the time but was in fact 16 and was just really emaciated, stunted by really severe multi-drug resistant tuberculosis," said Green.

"Then when I got home, I started to wonder why I didn't know more about this disease that kills more people than HIV. Kills more people than malaria and war and cholera combined, every year," he added.

"Despite causing millions of deaths each year and the avail of treatment and vaccines, tuberculosis remains a largely ignored global health issue," said John Brownstein, Ph.D., ABC News contributor and chief innovation officer at Boston Children's Hospital.

The disease is much rarer in the U.S. compared to other countries. There were an estimated 8,300 reported cases of tuberculosis in 2022, with rates steadily declining since the early 1990s, according to the Centers for Disease Control and Prevention.

A vaccine exists to protect against tuberculosis and is typically given to young children in countries where the disease is more common. But the vaccine does not always fully protect against infection.

"[Tuberculosis] disproportionately affects people who are most impoverished and most marginalized. It is highly stigmatized and has a lot of overlap with important chronic diseases like HIV and diabetes," Harvard Medical School's Carole Mitnick said.

Tuberculosis is curable with antibiotics. However, people in lower-income countries have a higher risk of developing an infection that is resistant to multiple medications.

Nearly 500,000 new cases of MDR-TB occur each year and only about one in three people with the disease accessed treatment in 2021, according to the World Health Organization. Those infection numbers have been trending upward, which scientists attribute to the impact of the COVID-19 pandemic.

Advocacy groups like Doctors Without Borders and Partners in Health, who for years have been pushing for greater access to tuberculosis medications, called for more action to ensure patients have better access to them.

"We reiterate our call on [Johnson & Johnson] to publicly announce it will not enforce any secondary patents on bedaquiline in any country with a high burden of TB, and withdraw and abandon all pending secondary patent applications for this lifesaving drug," Doctors Without Borders said in a press release.

In answer to an ABC News request to respond to the Doctors Without Borders statement, Johnson & Johnson said, in part, that it was "deeply committed to patient needs around the world, particularly in providing access to innovation for the most vulnerable populations in low- and middle-income countries," and highlighted what it said were the company's "broad access efforts" in providing bedaquiline to those who need it.

"This includes entering into a collaboration in June this year with the Stop TB Partnership's Global Drug Facility ("GDF") – the largest procurer of TB medicines – which enables them to invite potential generic suppliers and purchase generic versions of SIRTURO® 100mg," the statement further declared.

The Johnson & Johnson statement did not specifically address bedaquiline patents and patent applications.

"I think it's a profoundly unacceptable injustice," Green said of the overall bedaquiline access issue. "And we need to react appropriately. And to see that over the last few days has been extremely encouraging to me."