The deaf girl fights to be heard about a life-saving TB drug
Nandita Venkatesan, a 29-year-old TB survivor from Mumbai, gives
new meaning to the proverbial David and Goliath story. She has
challenged an attempt by Janssen, a sister concern of the
pharmaceuticals giant Johnson & Johnson, to extend its patent on
bedaquiline, an important drug for those with drug-resistant TB.
The patent is set to expire in 2023, and the company wants an
extension till 2027.
Venkatesan, and 28-year-old Phumeza Tisile of South Africa, both lost their hearing as they were prescribed an older anti-TB drug, kanamycin which had side effects. Their challenge to Janssen’s application in the Indian Patent Office might be the last hope for thousands suffering from multi-drug-resistant TB to get affordable bedaquiline.
What chance do two young women stand against the might of a pharma giant? “They may have all the resources, but we have our own powerful testimonies. They might be an eye-opener for the people examining the patent. No one should lose their hearing and suffer like us because of lack of access to bedaquiline. The suffering is not just mental and emotional but also financial. My family had to sell assets to treat me,” says Nandita. The TB treatment alone cost her family Rs 40 lakh. With no money left for cochlear implant surgery to restore her hearing, she had to raise funds from four donors.
For Nandita, the decision to oppose the patent extension started with WHO’s treatment recommendation for multi-drug-resistant TB (MDR-TB) in July 2018. It listed bedaquiline among the medicines to be used in longer MDR-TB regimens and said drugs like kanamycin and capreomycin were no longer recommended. Before this, questions abounded about how good and safe bedaquiline was. “When I heard that the drug which robbed us of our hearing was not recommended, I thought: why should a company limit access to the better life-saving drug,” says Nandita, who was stuck with kanamycin because bedaquiline wasn’t available in India then.
When contacted, a J&J spokesperson said the company was committed to ensuring that bedaquiline reaches as many patients as possible. It also clarified that the application they have filed is a formulation patent which “would not prevent generic manufacturers from developing the active pharmaceutical ingredient in their own formulations after July 2023”.
But Nandita opposes the patent extension beyond 2023. “No one else should suffer like me or Pfumeza. I have seen how life-altering the toxic old drugs like kanamycin and capreomycin are. Not only did I lose 90% of hearing, I also suffered severe kidney malfunctioning, skin rashes, and other known and long lasting side-effects. Bedaquiline can replace these. I am aware of the cardiotoxicity of bedaquiline.But even the director-general of Indian Council of Medical Research has gone on record to say that the benefits outweigh the risks and that TB patients on it have half the mortality of those not on it,” says Nandita.
Once it is off-patent, generic manufacturers in India could bring the price down to just $16 per month or less than $100 for six months. Today, the drug costs several thousand dollars for one person’s treatment, and even at reduced cost for low and middle-income countries like South Africa, it’s $400 for a six-month regimen. Often the treatment lasts much longer. In India, the government provides the drug free under a donation programme funded by J&J with USAID. However, the programme expires next month. Moreover, it covers only 10,000 courses though the number of patients who need it is several times more. The programme is also plagued by shortages and long waits. “After next month, one is not sure the government can afford to provide the drug even at South African prices,” says Nandita.
Nandita, who woke up deaf from an afternoon nap just two days after her 24th birthday, had told the UN General Assembly on TB earlier this year: “I cannot hear you today. But I will make sure you hear me, loud and clear!”