INVESTIGATIVE JOURNALISM TECHNIQUES// STORY MEMO

 

Athira Elssa Johnson

                                                                             STORY MEMO

• Hypothesis: (1) The initial track of the story was an investigation into - Medication for drug-resistant TB - how are these drugs administered? Is it leading to issues for patients? How are clinical trials done for these drugs?

• Subject description:

 Drug-resistant tuberculosis (DR-TB) happens when bacteria become resistant to the anti-tuberculosis drugs-- the drug that is meant to kill TB bacteria no longer works in that situation. DR-TB is also spread through the air. If untreated DR-TB is life-threatening. A person living with Drug-resistant tuberculosis will be put through constant monitoring – of whether the medicines are responsive or not and also drug susceptibility tests to see if the body is resistant to any more drugs. 

 In medical terms <Resistance to one first-line anti-TB drug is mono resistance, resistance to more than one first-line anti-TB drug other than both isoniazid and rifampicin is called polyresistance, resistance to at least both isoniazid and rifampicin is called Multidrug resistance (MDR). Resistance to any fluoroquinolone, and at least one of three second-line injectable drugs (capreomycin, kanamycin, and amikacin), in addition to multidrug resistance, is called Extensive drug resistance (XDR). Then Rifampicin resistance (RR) is resistance to rifampicin, mono-resistance, poly-resistance, MDR, or XDR.> 

The medication regimen to treat DR-TB includes daily injections that come with adverse side effects ranging from skin rashes to disabilities like hearing loss. 

The injectables like Kanamycin and Capreomycin that might not even pass the safety trials today were part of the DR-TB medication regimen.

 There are safer options to tackle this. Bedaquiline enables an all-oral, safer, effective medication that can help in DR-TB recovery but there are hindrances to the availability of bedaquiline, and capitalist big pharma corporate monopolies are one major challenge to this access.

The latest Global tuberculosis report 2022 shows a big fall in the number of tuberculosis (TB)cases reported which means there is a hike in undiagnosed, untreated TB. This also means a high chance of drug-resistant tuberculosis cases. 

• Abstract: As the story progressed, talking to the medical professionals and DR-TB community, there are new findings which state that: 

• According to the new WHO recommendation, the use of injectables is banned and an all-oral regimen is the medication model followed since the recommendation in 2022. According to Dr. Theresa(WHO), all-oral regimen is followed. 

• But when I talked to a WHO consultant based in Kerala, they said that – under certain circumstances, a special meeting will be held to prescribe the "injectables to some patients – they meant- as a last resort—this part is unclear, and need more -sources, talking and follow-up and there is the story which I initially wanted to pursue.  

•  I talked to people (TB community) and came to know that the latest update on this issue- is the movement led by DR-TB survivors to push for a shorter regimen- which means fewer to manageable side effects and fast recovery rather than longer regimens which mean loss of years for people living with DR-TB. (an all-oral regimen too necessarily doesn’t mean an easy medication- side effects still affect for the longevity of the treatment, it can go on for years, for some survivors it took 5-8 years, a shorter regimen will make this better) 

• For the purpose of this story- I would like to focus on “the longer regimens cause long-term side-effects and issues that interrupt daily functioning” and implementing shorter regimens is crucial. 

• Ganesh Acharya (TB-survivor-HIV -activist) said: “ We demand 6month MDR-TB treatment-means all 1,19,000 people with MDR-TB should be on 6month regimen (short regimen)”// 

• Findings – I talked to a few on longer medication regimens (all oral regimen + injectables) and found that – blurred vision, other organ failures, tingling sensation in the body, prolonged skin rashes, hair loss, buzzing in the ears, inflammation in the body, injection swelling, etc were some of the side effects – it depends on the type of tuberculosis and medication regimen they were on 

For instance: Someone with spinal tuberculosis, and on medication since 2021, had to stop one of the medicines called ethambutol- as they started getting vision issues. The patient is still on rifamycin and isoniazid which gives other side effects but has no other option than continue the drugs.

• The TB activists and survivors are pushing a for short regimen, with medicines that do not give side effects like these.// they say it’s their goal for this World TB day- March 24- 

• Background : 

The dangers of drug resistance and how despite having the means to treat patients using safe drugs, the accessibility is compromised due to the capitalist structures exerting their control over TB healthcare through patents. 

It is a life-threatening situation when big pharmaceuticals like Johnson&Johnson(J&J) (Jansen) overprice drugs like bedaquiline. By granting J&J’s monopoly on bedaquiline, the patent control would be extended from 2023 to 2027, delaying the entry of generics by four more years. Corporate monopolies restrict the making of generic versions that can help many.

 The development of bedaquiline by big pharma benefitted from public investment, and the efficacy and potential cure rates with fewer side effects were the results of collective efforts of the global TB community. This is where the patent challenge by DR-TB survivors becomes revolutionary. 

Patent evergreening has been one of the strategies that big pharmaceuticals play through the filing of additional mostly unmerited patents to extend monopolies on their drugs beyond the standard 20 years. Overcoming this patent barrier will encourage TB drug manufacturers from India to enter the market with generics, and supply bedaquiline at lower prices to national TB programs. It is important to block corporations like J&J from attempting to extend a monopoly that will delay the availability of quality-assured generic versions of bedaquiline in India and other countries

• Issue: There is the availability of lifesaving drugs like bedaquiline that can be taken orally for shorter regimens that shows better result.  According to the updated WHO guidelines, Bedaquiline-based treatments are now recommended for DR-TB treatment. Implementation of WHO’s recommendations by countries can increase the number of people who should receive this drug.

• Affected community and legal battles: 

TB Survivors challenging the Patent monopolies for access to life-saving drugs

--big pharmaceuticals like Johnson&Johnson overprice life-saving TB drugs like bedaquiline through patent extensions --

• Tuberculosis survivors Nandita Venkatesan from India and Phumeza Tisile from South Africa filed a patent challenge in India in 2019 to try to block J&J from extending its monopoly on bedaquiline, under Section 25(1) of the Indian patent law.  The J&J patent application challenged is for the salt form of bedaquiline which is only a formulation of an old drug that does not merit patenting under India’s patent law.

Petitioners who are also survivors of DR-TB fought bouts of TB undergoing various medication regimens that had injectables. Nanditha Venkatesan suffered a relapse after her first treatment. She underwent at least five surgeries and multiple medicines including painful injections during the course of her treatment. She lost her hearing as a result of injectable TB drugs (Kanamycin).

 Phumeza Tisile is an extreme drug-resistant TB (XDR-TB) survivor. First diagnosed with TB, then multi-drug-resistant TB (MDRTB), and thereafter with XDR-TB. She lost her hearing to XDR-TB treatment.

Survivors of longer DR-TB regimens: 

I have talked to many in the community – but not all are on record and the ones who talked to me also find it difficult to remember the details of their medication time—this is taking time—but I am positive that I can file profiles of the survivors and patients with their full informed consent as most of them also showed interest to initiate discourse on this. 

Vijetha // 2013-2019 regimen

Sadhana: 2019-2021, coping with side-effects – cholesterol, inflammation // 

Debashree: hearing loss// 

Deepthi Chavan: had to undergo surgery// long regimen medication//sideffects

Ganesh Acharya:  TB survivor/TB-HIV activist, said monthly meetings are held with all stakeholders of the TB program in the country to increase community engagement and push governments in implementing shorter regimens.

Patients still on longer TB regimens that I talked to:

• Patients:  Aparna 

                 Vishnu 

                 Kritika 

• Solutions: Bedaquiline is a crucial drug in offering patients a chance without the toxic side effects of injectables and longer regimens Bedaquilin is a 6-month-old regimen on the other side a longer regimen to go on for years. 

 The rejection of the bedaquilin patents (J&J patent application) will make generic versions of this drug available sooner at reduced prices, saving lives and reducing immense suffering. It’s a need to report on why this short regimen has to be implemented soon. 

The story will focus on how the implementation of patient rights and inclusive healthcare is a need and how the TB community is at the forefront to make that happen. 

• Community response: The shorter duration of the treatment, the replacement of an injectable agent with a medication administered orally, and the use of drugs with better safety profiles, are the key improvements of the regimen to increase the likelihood of successful treatment for people with DR-TB.

• Medical community reactions: Challenges in Drug-Resistance

• HIV – TB co-infection 

I talked to Dr.Babi at The Tamil Nadu AIDS control society : 

Full adherence to the HIV treatment regimens is advised by the UNAIDS (Joint united nations program on AIDS/HIV) as treatment interruptions can cause resistance to drugs- which means fewer options for treatment. 

There are 1.25 patients, this includes HIV-TB co-infection and drug resistance. 

Tamil Nadu State AIDS Control Society, TANSACS, therefore, keep a track of all opportunistic infections that can indicate any symptoms of drug resistance. 

CD4 testing (to check the health of your immune system) and culture testing are the diagnostics followed to track this. 

“We keep track of immunological failures, as we have departments assigned to track drug response, this is done on a routine basis,” said Dr. Babi at TANSACS

TANSACS work as per the guidelines from the national AIDS control organization (NACO) to ensure the functioning of diagnostics and deliverance of ART.

 Antiretroviral therapy for people living with HIV is delivered through a single-window system followed by district prevention and control units (DAPCO) and ART centers in all districts and zones.

 A fully functioning 55 ART centers are available in the state. Dr. Babi at TANSACS explains, “we take instructions from the apex body- NACO, we have a chain of systems from UNAIDS to the ICTC (Integrated counseling and testing center- MAMBIKAI MAIYAM in Tamil) which ensures services to diagnostics and lifelong treatment”

TANSACS works as a medicine-delivering agency also that functions according to the NACO’s treatment protocols, so in case of a drug shortage, NACO is in charge of the procurement. The national functionaries work as per the UNAIDS guidelines, and NACO’s team of experts decides the regimen, and district functionaries follow that.

Dr. Babi talked about the logistics of the HIV and TB drugs and how in case of a drug shortage they have the means to procure them locally.

• Story to pursue further: 

Blessina Kumar, CEO of the global coalition of TB advocates, Ganesh Acharya, TB survivor-activist, and other patients in treatment support groups confirm that – the injectables are no longer part of the regimen. WHO Kerala consultant – told me that the injectables are still on some regimens in specific cases- which I need to verify and would want to pursue to find out if it’s the case. 

• Reporting Plan: 

I will talk to the TB research center in Chennai, I couldn’t make it at the scheduled time and lost some contacts, so I have to follow up on that. 

I will talk to the doctor at DHS, Chennai about clinical trials- they have agreed to talk to me.

•  Have scheduled an interview with Dr.Rambha at the Directorate of preventive medicine and public health // Tenyampet, Chennai,  (DHS) – she told me, the senior doctors would be available in the coming days for me to follow up on these. 

Some more WHO consultants and doctors. And I am in touch with epidemiologist Dr. Anant Bhan -- will talk to him. 

I remember TB survivor and filmmaker Rhea Lobo mentioning how the health system in India does not distribute bedaquilin efficiently, I will follow up on that. 

References: 

Testimonies from Patients and Survivors

DHS, Tamil Nadu

TB research center Tamil Nadu Website

The patent database, 

MSF/Doctors without borders-letters to J&J , 

Webinars on Personal accounts and updates from community group Organisations like : The International Union against Tuberculosis and lung disease, StopTB Partnership ,

The World Health Organisation stats and latest TB report.

The Wire reports

The Hindu /report on Nandita Venkatesan and Phumeza Tisile.

TB health rights and support groups: TB Proof, Survivors against Tuberculous 

The Panos Journal on Public Health.

TB Do Die -SouthAsian Journalists report on tuberculosis 

Lectures on Patents by Jaya Shreedhar/ACJ

Expert Advice expected: Madhukar Pai, Anant Bhan