In a move welcomed by proponents, a cure for multidrug-resistant tuberculosis could soon become more accessible to millions of people around the world.
Although rare in the United States, tuberculosis is the world’s leading infectious disease killer after COVID-19, with an estimated 1.6 million deaths in 2021. world health organization.
A life-saving drug called bedaquiline works with other drugs to kill the bacteria that cause multidrug-resistant tuberculosis (MDR-TB). Johnson & Johnson, which manufactures and sells bedaquiline under the brand name Surturo, planned to use the secondary patent to extend its control until the end of 2027, proponents say, while the primary patent for the drug is due to expire this week, allowing a cheaper generic version to be manufactured and distributed.
Now on YouTube videoauthor and advocate John Green protested Johnson & Johnson’s patent extension on bedaquiline, rallying his 4.5 million Twitter followers to pressure the company to change course.
Stop TB Partnership – UN-sponsored organization working to fight tuberculosis worldwide – announced A partnership with a major pharmaceutical company to “bid, procure and supply generic versions of SIRTURO® (bedaquiline) to the majority of lower and middle income countries, including countries with active patents.”
Researchers estimate that large-scale manufacturing could drive the price of generic versions of bedaquiline up to 94% below current costs.
The availability of generic drugs could potentially treat 6 million people over the next four years, according to Dr. Carol Mitnick, professor of global health and social medicine at Harvard Medical School and senior fellow at Partners in Health.
While proponents welcomed the news, Johnson & Johnson said it was “wrong” to suggest that the partnership was already in the works even before the media hype and that the patent was being used to block wider access to bedaquiline.
“We have had lengthy discussions with the Global Medicines Facility regarding access to bedaquiline.
Pharmaceutical companies often apply for patent extensions for their drugs to prevent market competition, a strategy called “evergreening”. Proponents, however, argue that the system prevents access to affordable medicines around the world, and in some cases, years after the drugs were first launched.
“Patents are supposed to last for a limited period of time. Then competitors have to enter the market and lower the price. But that’s not what’s happening,” says Robin Feldman, a law professor at the University of California, San Francisco School of Law. “Instead, pharmaceutical companies are piling up new protections on their drugs to extend that protection.”
However, patents play an important role in fostering innovation. “Companies invest huge amounts of money in research and production, and we want to encourage companies to do that research. This patent is a reward for successful research,” Feldman added.
But Feldman’s research found that here in the United States, an estimated 78% of newly patented drugs in Food and Drug Administration records are perpetual extensions of existing drugs.
John Green, who created a YouTube video on the bedaquiline issue, told ABC News that he was first exposed to the scourge of tuberculosis while traveling to Sierra Leone.
“When I was there, I met a young man who looked about the same age as my son. He looked nine years old at the time, but he was actually 16, stunted with severe multidrug-resistant tuberculosis, and just really haggard,” Green said.
“And when I got home, I started to wonder why I didn’t know more about this disease that kills more people than HIV. More people die each year than malaria, war and cholera combined,” he added.
“Despite millions of deaths each year and the availability of treatments and vaccines, tuberculosis remains a largely ignored global health problem,” said ABC News contributor and chief innovation officer at Boston Children’s Hospital, Dr. John Brownstein.
The disease is much rarer in the United States than in other countries. According to the report, an estimated 8,300 tuberculosis cases will be reported in 2022, and the incidence has been steadily declining since his early 1990s. Centers for Disease Control and Prevention.
Vaccines exist to prevent tuberculosis and are usually given to young children in countries where the disease is more common. However, vaccines do not always completely prevent infection.
“[Tuberculosis] It disproportionately affects the most impoverished and most marginalized. It’s highly stigmatized and has a lot of overlap with important chronic diseases like HIV and diabetes,” said Carol Mitnick of Harvard Medical School.
Tuberculosis is cured with antibiotics. However, people in low-income countries are at increased risk of developing infections that are resistant to multiple drugs.
Nearly 500,000 new cases of MDR-TB occur each year, according to the report, and in 2021, only about one in three patients with the disease received treatment. world health organization. The number of these infections is on the rise, and scientists believe this is the impact of the COVID-19 pandemic.
advocacy groups like Doctors Without Borders and partner in healthA longtime advocate for greater access to TB medicines, he called for more action to ensure better access for TB medicines for patients.
“We repeat the call to: [Johnson & Johnson] We have publicly announced that we will not enforce any secondary patents on bedaquiline in countries with a high prevalence of tuberculosis, and we are withdrawing and abandoning all pending secondary patent applications on this life-saving drug,” said Doctors Without Borders. press release.
In response to ABC News’ request for a response to Médecins Sans Frontières’ statement, Johnson & Johnson is “deeply committed to providing access to innovation for the needs of patients around the world, particularly the most vulnerable in low- and middle-income countries,” in part, highlighting the company’s “broad access efforts” to bring bedaquiline to those in need.
“This includes entering into a partnership in June this year with Stop TB Partnership’s Global Medicines Facility (“GDF”), the largest sourcing company for TB drugs, which will invite potential generic suppliers to purchase the generic version of SIRTURO® 100mg. ‘, the statement further declared.
Johnson & Johnson’s statement did not specifically mention bedaquiline’s patents and patent applications.
“I think this is a highly unacceptable injustice,” Green said of the whole issue of access to bedaquiline. “And we have to respond appropriately. And it’s been very encouraging for me to see that over the last few days.”
