When Phumeza Tisile was diagnosed with drug-resistant tuberculosis in 2010, she had two choices: death or deafness.
The University of Cape Town student chose a life of silence.
The harsh treatment, which included being injected with toxic drugs, left Tisile hard of hearing.
Now Tisile, 28, has joined forces with another TB survivor, Nandita Venkatesen from Mumbai in India, to fight American multinational medical devices, pharmaceutical and consumer packaged goods manufacturing company Johnson & Johnson.
Their legal bid is being supported by international medical humanitarian organisation, Doctors Without Borders/Médecins Sans Frontières (MSF).
“The J&J patent application being challenged is for the salt form of bedaquiline – the first ever challenge against a TB drug patent in India. A new formulation of an old drug does not merit patenting under India’s patent law,” said MSF.
The organisation said the two tuberculosis survivors filed a patent challenge in India last week in an attempt to block Johnson & Johnson from “extending its monopoly on bedaquiline, a critical medicine in the treatment of drug-resistant tuberculosis (DR-TB)”.
“Both women survived DR-TB but lost their hearing because of the toxicity of their treatments.
“They are now fighting to ensure that newer drugs like bedaquiline – which are safer and more effective – are made affordable and accessible to everybody with DR-TB, so fewer people have to use painful and toxic alternatives.
“Despite the benefits of the drug, high prices remain a significant barrier. J&J recently announced a reduced the price of R5,400 for six months of bedaquiline treatment for South Africa and countries procuring the drug through the Global Drug Facility, but this falls short of making the drug affordable in all countries affected by the DR-TB epidemic,” MSF said.
As of November 2018, only 28,700 people had received bedaquiline worldwide, nearly 70% of whom were treated in SA.
“If granted, J&J’s monopoly on bedaquiline would be extended from 2023 to 2027, delaying the entry of generics by four additional years.
“Preventing this patent barrier is expected to encourage TB drug manufacturers from India to enter the market with generics and supply bedaquiline at lower prices to national TB programmes and treatment providers globally,” MSF added.
The World Health Organisation recently recommended bedaquiline as a core part of an all-oral treatment regimen for DR-TB, and relegated drugs that must be injected and cause serious side-effects to last-resort options only.
Tisile, who is in her final year of studying towards a bachelor of social science degree, said: “I know what it means to be faced with the choice of being deaf or dead because the only drugs that can save your life will also rob you of your hearing.”
She was diagnosed in 2010 and completed her treatment for drug-resistant TB (XDR-TB) in 2013, which included toxic injected drugs.
“I wouldn’t wish anyone to go through what I did ... Pharmaceutical corporations like J&J should stop controlling the price of the drug that will restrict people’s access to safer and more effective tuberculosis treatment,” she said.
Venkatesan said she lost her hearing when she was 24 “because of the brutal side-effects of an injected DR-TB drug”.
“I was devastated by this loss, which took a heavy financial, emotional and mental toll on me. How many more people will have to die or go deaf waiting to access safer and more effective drugs that can save their lives without such devastating side-effects?”
Dr Anja Reuter, a drug-resistant TB doctor with MSF in Khayelitsha, Cape Town, said: “Bedaquiline is crucial to offering patients a fighting chance without the toxic side-effects of drugs that need to be injected.
“This treatment revolution is already a reality in South Africa, but DR-TB programmes elsewhere need this drug at an affordable price. If this patent application is rejected, generic versions of this drug could be available sooner at reduced prices, saving hundreds of thousands of lives and reducing immense suffering around the world.”
Johnson& Johnson said it was “committed to ensuring that bedaquiline reaches as many patients as possible, and we are a committed partner in India’s efforts to combat TB”.
“The patent application in question – for the formulation of bedaquiline – was filed in 2007, and became publicly available in 2008, as part of standard procedures when developing new medicines.
“The application was first considered by the Indian Patent Office in 2012 and remains under review.
“If granted, a formulation patent would not prevent generic manufacturers from developing the active pharmaceutical ingredient in their own formulations after July 2023, when the API patent expires in India.
“Since the introduction of bedaquiline in India, Johnson & Johnson has donated more than 10,000 courses of the medicine to support the government’s efforts to scale up access.
“Beyond providing access to bedaquiline, we have also supported efforts to improve diagnostic capacity, train health workers on the clinical management of TB, and raise awareness about TB at the community level,” the company said...