There is a young teenage woman in India gasping for air today — she is dying, slowly and painfully. For five years she has battled against multidrug-resistant tuberculosis (MDR-TB), which means that the bacteria that cause her tuberculosis (TB) are resistant to the antimicrobial drugs used to cure the disease. Every day, the bacteria are consuming or eating away her lungs, and life.
She has been debilitated by the MDR-TB, and has suffered from the permanently disabling effects of highly toxic second-line antibiotics used in the hope of a cure, only to find that these drugs had no effect on the resistant bacteria. These chemo-pharma drugs are over fifty years old, and most have been ‘retired’ due to dangerous toxicity. Now, the first new drug specifically for MDR-TB, bedaquiline, has been developed, but this poor teenager is being denied access to it by the Government of India due to “politics and protocol”. Without this new antibiotic, she will soon join the 250,000 other Indians that needlessly die each year from TB, which is classified as a ‘curable’ disease. For decades, far more people die from TB in India than any other country, and it now leads the world in MDR-TB cases and deaths although all figures for drug resistance are estimates or guesswork, often proved to be wrong later.
Around the world, an estimated 580,000 people get MDR-TB each year, but only 20 per cent are treated. For over half of these 120,000 patients, the treatment is not effective and they will die. As antibiotic resistant strains of the disease grow and spread, new medical classifications are being announced – there is now extensively drug resistant tuberculosis (XDR-TB) which is even more resistant, and more lethal than MDR-TB. The bottom line is that whatever the terminology, untreated or poorly treated drug resistant TB kills some half a million people every year.
According to the WHO, the 2 reasons why multidrug resistance exists and continues to spread are mismanagement of TB Control programmes and person-to-person transmission. Most people with ‘classic’ tuberculosis are cured by 6 to 9 months of antibiotics that are provided to patients, taken under observation of medical personnel. Inappropriate or incorrect use of antimicrobial drugs, or use of ineffective formulations of drugs (such as use of single drugs, poor quality medicines or bad storage conditions), and premature treatment interruption can cause drug resistance, which can then be transmitted, especially in crowded settings such as where the impoverished are forced to live.
Globally, the WHO estimates that over ten million mostly poor people caught tuberculosis in 2015, and almost two million died. The TB death toll is higher than from any other infectious disease. In spite of decades of billions of dollars of annual investment to ’stop TB’, the epidemic continues to destroy people, families and communities, without much progress in reducing the devastation. Although tuberculosis became a ‘curable’ disease some sixty years ago with the development of antibiotics, some 100 million people have died since then. Clearly, ‘TB Control’ has been a massive failure for public health institutions on both global and national levels, and the growing incidence of drug-resistance is a direct result.
Those who design, develop and direct the TB programmes at both at national and global level are almost entirely medical physicians and public health experts coming from a far higher socio-economic class. The absence of patients in decision-making processes further widens the divide between those on top that seek ways to ‘control’ and the millions who need dignified TB Care.
It is those on the bottom of their societies, people without decent nutrition, housing, education and justice that become ill and need treatment, which is often provided by doctors and staff that show little respect for the dignity of their patients. The stigma of this disease of the poor, and the discrimination that comes down from above is inherent in TB programmes, which sees patients as problems not partners in its solution. This perspective has been the at the core of ‘TB Control’ for over fifty years, and its lack of respect for those with the disease has contributed substantially to the present crisis of the growing epidemic of drug resistant tuberculosis. The TB Controllers must be held to account for millions of preventable death.
In the second part of this blog next week, we will outline a few specific suggestions for the ‘TB Controllers’ that may save some lives. Words like dignity, rights, respect and participation will surely be included. We have ‘experience’ – most of the IMAXI Cooperative are former TB patients, including XDR/MDR-TB. But for now, we’ll return to the dire situation of the young woman suffering in India. Below is a copy of a letter recently sent to Prime Minister Modi, in the hope of saving her life.
Text of Letter to Indian Prime Minister – Urgent need to save a young girl with XDR TB and ensure availability of new TB drugs in India to combat DR TB
Honorable Shri Narendra Modi
Prime Minister of India
Prime Minister’s Office
152, South Block
13 January 2017
RE: Urgent need to save a young girl with XDR TB and ensure availability of new TB drugs in India to combat drug resistant tuberculosis
Respected Prime Minister,
Patients in India with drug-resistant tuberculosis (DR TB) are struggling to access effective treatment regimens. It is reflected in the case currently pending in the Delhi High Court over lack of access to new TB drugs – bedaquiline and delamanid – for a young woman who has been slowly dying of extremely drug-resistant TB (XDRTB).
We, therefore, write to you as concerned citizens and organizations working on treatment and public health to express our concern on the bureaucratic delay in the roll out of diagnostics and new anti TB drugs to tackle the growing burden of DR TB in India and respectfully urge your attention and swift action.
Patients with multi- or extremely drug-resistant TB (M/XDR TB) are treated inadequately in India and often die because not enough medications are available to compose a suitable regimen. Current treatment for DR TB can involve people having to take almost 15,000 pills for two years, plus a daily painful injection for eight months. Side effects caused by the drugs are horrendous, ranging from persistent nausea to deafness and psychosis. There is a desperate need for new drugs to improve not just treatment outcomes but also to provide safer alternatives to the most toxic DR TB drugs.
The impact of introducing new drugs to the armamentarium of old TB drugs which are currently available under the RNTCP’s Programmatic Management of Drug Resistant TB (PMDT) will enable clinicians in many settings across the country to improve care for their patients. The effect of introductions of two new drugs has substantial public health implications on reduced transmission of M/XDR TB.
Given the great urgency of the TB and DR-TB epidemics, we have been appalled by the slow roll out of life-saving innovations such as new TB drugs – bedaquiline and delamanid, and the necessary second line drug susceptibility testing (DST) – in India. Failure to ensure access to these interventions is a clear violation of the rights to health and to the benefits of scientific progress.
As such, we implore you to rectify this horrifying situation and ensure:
1. immediate scale up of bedaquiline—the new medicine has only reached fewer than 200 of the estimated 42,900–85,800 Indians with DR-TB, who are eligible for the drug according to WHO guidance. As reflected in the above-mentioned court case, Lal Ram Sarup TB Hospital, in line with RNTCP guidelines,has denied this young woman access to bedaquiline simply because she is not a domicile of Delhi. We urge you to ensure that bedaquiline is immediately made available nationwide to individuals suffering from M/XDR TB regardless of their domicile. To support the national effort, RNTCP should also accredit treatment providers in the non-governmental or private sector to provide M/XDR treatment with effective DR TB drugs such as bedaquiline.
2. registration of delamanid—Delamanid is also a new essential medicine for patients with M/XDR TBdisease. It should be available under RNTCP’s Programmatic Management of Drug Resistant TB (PMDT) and to other accredited health care providers with experience of treating M/XDR TB patients based on their drug susceptibility testing (DST) reports. Delamanid is also becoming increasingly important for treating children with DR-TB. Yet, it is still not available in India. The young woman in the above illustrated court case is also struggling to access this drug which together with bedaquiline and other DR TB drugs could form an optimized regimen to save her life. We urge you to ensure thatthe Ministry of Health and RNTCP make efforts to get delamanid – a patented medicine – registered and available in India so that treatment needs can be met immediately. If necessary public health safeguards in the patent law should be operationalised to ensure the life saving drug becomes available in India and there is no abuse of the monopoly enjoyed by Otsuka the Japanese company.
3. expansion of drug susceptibility testing—The lack of access to second line drug susceptibility testing (DST) impacts access to appropriate M/XDR treatment for patients and will impact the scale up of new TB drugs and regimens. By late 2016, just 25 laboratories were certified to perform DST. As a result, only one in five DR-TB cases in India are laboratory confirmed. The young woman with XDR in the above illustrated court case was treated in 2013 with MDR TB drugs without a comprehensive DST report which may have amplified her resistance to TB drugs. Now, instead of owning up for and rectifying its failure to implement both appropriate diagnosis and treatment, the TB programme is denying her bedaquiline, which is extremely shameful.DST is an essential component of management of DR TB and as such we urge you to step in to ensure that RNTCP is implementing its promises that second line DST will be accessible throughout India to guide proper treatment.
We,the undersigned, strongly urge you to take action to save the young woman from Bihar who has been diagnosed with XDR TB and is struggling to access new TB drugs from RNTCP. Her plea to access bedaquiline from RNTCP and to import delamanid in small quantities for personal use on compassionate use grounds is pending before the Delhi High Court. Every day’s delay brings her closer to death. We request you to direct RNTCP to provide her with life-saving drug on an immediate basis.
Please keep your promises to your people to end TB, and ensure access to innovations on diagnostics and treatment in India.
So many lives depend on it.
ARK foundation, Nagaland (India)
Asia Catalyst (Thailand & USA)
Community Research Advisors Group (Global)
Delhi Network of Positive People (DNP+) Evergreen Welfare Society, Nagaland (India)
Global TB Community Advisory Board (Global)
Health GAP (Global Access Project) (Global)
HepCoN, Nagaland (India)
Hepatitis Coalition of Sikkim (India)
IMAXI Cooperative (Global)
Indian Drug Users Forum (IDUF) (India)
Kekhrie Foundation, Nagaland (India)
Mon Users’ Network, Nagaland (India)
Nagaland Users’ Network (India)
Network of Naga People Living with HIV/AIDS, Nagaland (India)
Network of Nagaland Drugs and AIDS organisation (NNagaDAO) (India)
Sankalp Rehabilitation Trust
Sikkim Drug Users’ Network (India)
South Indian Drug Users Forum (India)
South Indian Harm Reduction Network (India)
Treatment Action Group (USA)
Manipur Network of People living with HIV/ AIDS ( MNP+)
Rural Area Foundation, Nagaland HepFoM, Meghalaya
Enrique Delgado, TB activist and XDR-TB survivor (Spain)
Paul Lhungdim, President – The Delhi Network of Positive People (India)
Ketho Angami, Nagaland (India)
Stephen Lewis and Paula Donovan, Co-directors, AIDS-Free World (Global)
Brook Baker, Northeastern University School of Law (USA)
BazoKire, Treatment Activist (India)
Abou Mere, Kripa Foundation (India)
Nini Pakma, President, Meghalaya Drug Users Network (MeDUNet) (India)
Pravasinin Pradhan, President, Kalinga Network of People living with HIV/AIDS (KNP+), Odisha (India)
A.Sankar, Executive Director, Empower India, Tamil Nadu (India)
Aditi Sharma, health activist (UK)
Prashant Sharma, Sikkim (India)
Tadokera, Human Sciences Research Council (South Africa)
S.Srinivasan, LOCOST, Vadodara, Gujarat (India)
Dr Mohan Rao, Professor, Social Medicine and Community Health, Jawaharlal Nehru University, Delhi (India)
V.Karthi Krishnan, Hoper’s Foundation, Chennai (India)
IvyreenWarjri, Meghalaya (India) Lalruatfeli, Mizoram
ShriJagat Prakash Nadda, Minister of Health and Family Welfare, India
Shri, C.K. Mishra, Secretary, Dept. of Health and Family Welfare, India
ShriArun Panda, Additional Secretary, Dept. of Health and Family Welfare, India
Dr. Soumya Swaminathan, Director General, Indian Council of Medical Research
Dr. Sunil Khaparde, DDG TB, Central TB Division
Dr. V S Salhotra, Addnl. DDG TB, Central TB Division
Dr. GN Singh, Drug Controller General of India
Dr. Henk Bekedam, WHO representative to India
Dr. Perry Mwangla, Senior Fund Portfolio Manager, Global Fund
Dr. Lucica Ditiu, Executive Secretary of the Stop TB Partnership
Dr. Mario Raviglione, Director of the Global Tuberculosis Program, World Health Organization
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