NAIROBI — Sheila Baraza, a 30-year-old resident of Ruaka, a city to the northwest of Nairobi, unsuccessfully fought back tears as she recalled the pain of seeking and then undertaking a two-year treatment for drug-resistant tuberculosis.
“I was always in pain. I was in pain when I took medicine, and I was in pain when I wasn’t taking the medicine. I threw up and fainted almost every time I took medication. I used to lose my memory, could barely hear, and would not know where I was when I went for my daily medication,” Baraza said.
A group of independent experts advising the U.S. FDA recently voted on a new drug to be part of a combination regimen for highly resistant tuberculosis. Will the regulatory body heed their advice?
According to the World Health Organization, there were hundreds of thousands of new cases of multidrug-resistant TB in 2018, only half of which can be successfully treated. That same year, WHO recommended bedaquiline, a drug developed by the American pharmaceutical company Johnson & Johnson, as the first line of treatment for MDR TB.
While Baraza’s treatment course required daily injections for eight months and oral tablets taken for two years, bedaquiline offers an oral-only alternative with fewer harmful side effects. However, during Baraza’s treatment, bedaquiline was yet to be introduced in Kenya. As of March 2018, fewer than 25 patients in the country were taking the drug.
Johnson & Johnson, which markets bedaquiline under the brand name Sirturo, has been accused of employing unfair tactics in an attempt to retain the drug’s patent and tighten its grip on the monopoly. Critics say this maintains high prices and makes the drug inaccessible to many, despite the involvement and contribution of public and philanthropic institutions in its development.
“The sale of bedaquiline by global pharma giant J&J at a price of $2 a day continues to deny much-needed treatment to hundreds of thousands.”— Sharonann Lynch, HIV and TB policy adviser, MSF Access Campaign
Médecins Sans Frontières is campaigning for J&J to cut the price of bedaquiline by half and to stop the company’s efforts to retain a monopoly on the drug. MSF says J&J has pursued a strategy of “patent evergreening,” which the humanitarian organization characterizes as the “filing of additional, often unmerited patents … by corporations to extend monopolies on their drugs beyond the standard 20 years.”
In the U.S., J&J is among the top pharmaceutical companies engaged in patent evergreening, according to the 2018 “Overpatented, Overpriced” report from the Initiative for Medicines, Access & Knowledge. I-MAK concluded that drug-makers are using patent systems to exclude competition and earn outsized profits.
Allan Maleche, executive director of the Kenya Legal & Ethical Issues Network on HIV and AIDS — a Kenyan nongovernmental organization that advocates for health rights — told Devex that patent evergreening is a “dangerous and dubious mechanism of pharma making more money.” Generic production of bedaquiline would allow more people to access the drug at a lower price, which is needed in the fight against MDR TB, he said.
J&J defends the manner in which it patented the drug. Writing to Devex, a spokesperson said that the company appropriately pursued patents for bedaquiline, filing patent applications for the active pharmaceutical ingredient, or API, and for the formulation of bedaquiline, as is standard when developing novel medicines.
“Notably, formulation patents do not prevent generic manufacturers from developing the API in their own formulations, after the API patent expires locally,” the J&J spokesperson said in an email.
J&J disputes that finding.
The company’s spokesperson wrote that “Janssen Pharmaceutical Companies of Johnson & Johnson fully funded all 14 studies that were included in the initial submission that supported the regulatory approval of bedaquiline by the U.S. Food and Drug Administration – including 11 Phase I studies and 3 Phase II studies. We are continuing to invest significant resources in the clinical development of bedaquiline via the STREAM Stage 2 study, as well as paediatric clinical trials.”
While it is more expensive in other countries, a six-month treatment of bedaquiline is sold at a price of $400 in countries such as South Africa and Kenya, which are eligible to buy the drug through the Global Drug Facility, an organization run by the Stop TB Partnership that supplies TB drugs to low- and middle-income countries.
According to Sharonann Lynch, HIV and TB policy adviser for the MSF Access Campaign, that price is still too high.
“The sale of bedaquiline by global pharma giant J&J at a price of $2 a day continues to deny much-needed treatment to hundreds of thousands suffering from drug-resistant tuberculosis in some of the TB-high-burden countries,” Lynch told Devex.
MSF says J&J is prioritizing profit over access to the drug.
“We are calling on J&J to halve the price of bedaquiline to no more than a dollar a day. This is because of the need and because of all of the public and collective effort behind the drug’s development and what we know about the benefits of the drug today, and it is a matter of urgency,” Lynch said.
J&J defends its pricing of the drug as cost-effective and on par with, or cheaper than, some generic drugs used to treat TB, such as clofazimine and linezolid. However, unlike these drugs, bedaquiline is the core treatment to be used in regimen with other drugs.
A J&J spokesperson told Devex the company has donated 782 courses of bedaquiline to Kenya through its four-year donation program, including 217 shipped in January 2020.
While J&J has donated more than 100,000 courses of bedaquiline to different countries, MSF argues this is not a sustainable approach to expanding access to the drug.
Baraza, the resident of Ruaka, benefited from free treatment and a monthly stipend of $60 for its duration. This was made possible by The Global Fund to Fight AIDS, Tuberculosis and Malaria, which has spent more than $162 million on tuberculosis projects in Kenya.
Baraza acknowledged that without access to a better treatment option, her experience with drug-resistant tuberculosis, while painful and debilitating, was better than the alternative.
“I don’t think that I could have afforded even a quarter of it,” Baraza said. “I would have died.”
Update, July 1, 2020: This article has been updated to clarify that fewer than 25 patients in the country were taking bedaquiline by March 2018, and adds information on the number of courses of treatment donated by Johnson & Johnson.