The modern way

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The passage of the Mental Healthcare Bill in the Lok Sabha, putting it on course to become law and repealing the Mental Health Act of 1987, will potentially help India catch up with the advances made in the field by other countries. India urgently needs to make a transition from old-fashioned approaches to providing care for those suffering from mental illnesses, something that China, for example, has achieved through state-led policy reform. Even the sketchy studies on the nature of care available to Indians indicate that in terms of population coverage the new law faces a big challenge. The country’s grossly inadequate base of professional resources is evident from its ratio of 0.3 psychiatrists for 100,000 people (with marginally higher numbers taking independent private practitioners into account), compared to China’s 1.7. Then there are massive deficiencies in the availability of trained clinical psychologists and psychiatric social workers. Evidently, the National Mental Health Programme has not been sufficiently funded within the health budget; neither has capability been built in most States to absorb the meagre allocation. Delayed though it is, the new legislation can bring about change with its positive features. The important provisions relate to the recognition of the right to medical treatment, decriminalisation of attempted suicide, explicit acceptance of agency of people with mental illness and their freedom to choose treatments, prohibition of discrimination and regulation of establishments working in the field.

Raising effective primary and district-level coverage of mental health services for the general population, without requiring people to travel long distances to see a specialist and get medicines, should be a priority. Since the base of psychiatrists is low in relation to the need, the use of trained general practitioners as the first line of contact assumes importance. Some studies show many of them are not confident enough with their training to detect, diagnose and manage mental illnesses. With a concerted effort, primary care physicians can be trained to help people with mild and severe problems, ranging from anxiety disorders to depression, psychoses and conditions arising from alcohol and substance abuse. Being able to get professional counselling will reduce the complications arising from extreme stress, often the trigger for suicide. Extending health insurance cover is also a step forward, since out-of-pocket expenditure has risen along with the expansion of the private sector in this sphere, just as for other ailments. The provision in the new legislation prohibiting seclusion of patients, something that is frequently resorted to in asylums, and the general use of electro-convulsive therapy must be welcomed. Modern treatment approaches rely more on family and community support. The new Central and State regulatory authorities should speedily weed out shady non-governmental rehabilitation organisations in this field.

TB vaccine trial on adults begins in June

In June this year, the Pune-based Serum Institute of India Pvt. Limited will begin a Phase II/III vaccine trial for tuberculosis using a novel, recombinant BCG (bacillus Calmette-Guérin) vaccine.

The double-blind, placebo-controlled, randomised trial will be carried out on 2,000 adults who have been successfully treated (and cured) for TB. While 1,000 adults will receive the vaccine, the remaining volunteers will receive a placebo. A single dose of the vaccine will be administered, and the volunteers will be followed up for a year. The trial will be conducted in 15-17 centres across the country.

The new TB vaccine (VPM1002), which will be tested, is based on the BCG vaccine that is in use. However, it is more powerful and efficacious as it contains a gene, better recognised by the immune system.

Safety test

“Adults who have completed TB treatment will be first screened and enrolled if found eligible 2-4 weeks after completion of TB treatment,” says Dr. Prasad S. Kulkarni, Medical Director at Serum Institute.

“Traces of the drugs may be present in the body for two weeks after completion of the treatment. Since the vaccine contains live, weakened bacteria, the drugs can kill them if given earlier than two weeks after completing the treatment.”

The vaccine will be first administered in 200 volunteers to test its safety. “If there are no safety concerns, the trial will continue in the remaining 1,800 volunteers,” he says.

The safety of the vaccine has already been tested in two Phase I trials — 80 adults in Germany (2009) and 24 in South Africa (2010) — and one Phase 2a trial in South Africa in 2012 in 48 newborns who have not been exposed to HIV. “These trials have confirmed the safety of the vaccine,” says Umesh Shaligram, Director-R&D, Serum Institute.

The results of the Phase 2a trial in newborns in South Africa, published in February this year in Clinical and Vaccine Immunology, has confirmed the safety of the vaccine.

Doctors call off strike in Ahmedabad

More than 500 resident doctors at civil hospital in Ahmedabad ended their strike after the authorities accepted their demand to provide protection to the doctors on duty. On Sunday, the doctors had gone on strike after a lady doctor was assaulted by relatives and family members of one 64 year old man who died during treatment in the hospital.

“After Lataprasad, who was admitted in the civil for brain hemorrhage, died in the hospital, his family and relatives started abusing a team of doctors who were attending him. A lady doctor was assaulted and she suffered bruises in the neck,” said a body of resident doctors while announcing strike.

However, on Monday after a several meetings between the junior doctors and authorities, the doctors announce to end their strike and return to work as the authorities have accepted their demands including deployment of armed policemen in ICU ward and also in each floor of the hospital.

According to sources, in view of increasing attacks on medical staff and doctors by relatives and family members of patients, the government has decided to deploy State Reserved Police (SRP) personnel in the hospital premises and armed policemen at ICU ward, trauma ward and other areas of the sprawling hospital campus spread in over 100 acre and caters to more than six lakh people annually.

The strike by junior doctors at Ahmedabad civil hospital, largest public hospital in Asia, comes on the heels of a similar incident in Maharashtra where more than 4,500 junior doctors had gone on strike to protest a series of assaults by relatives of patients in government run hospitals.

The doctors’ body in Maharashtra ended their strike only after Chief Minister Devendra Fadanvis intervened and assured better security at hospitals in the state.

Suicide no more a crime, patients to get cover

The Mental Healthcare Bill, which decriminalises suicide and guarantees the right to better healthcare for people with mental illness, was unanimously passed in the Lok Sabha on Monday.

It mandates that a person attempting suicide shall be presumed to be suffering from “severe stress” and, therefore, shall not be tried or punished by law. Further, the Bill mandates that persons with suicidal tendencies be provided help and rehabilitated.

The Bill was passed after a disruption-free five-hour debate, placing mental health patients at the centre of the legislation. “It was heartening to see parliamentarians discuss for five hours how to improve this Bill. We are, potentially, opening a new chapter in mental healthcare in India. Patients rights have been put at the heart of the legislation and the Bill approaches it from a rights-based perspective,” said Dr Soumitra Pathare, mental health expert who was a member of the drafting committee for the Bill.

This is the first mental health law to take a “rights-based” approach to mental illness by consolidating and safeguarding the rights of fundamental human rights of the patients.

“The Bill empowers the patients for mental healthcare. It gives them the right so that they are not denied [treatment] or discriminated against. The focus is on community mental healthcare … it is a rights-based Bill,” Union Health Minister J.P. Nadda said. While suicides due to insanity declined from 7% in 2010 to 5.4% in 2014, data from the National Crime Records Bureau say nearly 7,000 people killed themselves because of mental disorders in 2014.

Advance directives

The Mental Healthcare Bill was passed by the Rajya Sabha with 134 official amendments last August. A unique feature of the Bill is that it allows adults to make an advance directive on how they wish to be treated in case they got mental illness in the future.

Such a person can chose a nominative representative who would take care of him or her, the Minister said. The Bill also promises free treatment for such persons if they are homeless or fall below the poverty line, even if they do not possess a BPL card. The Bill clearly defines mental illness adding that the earlier definition, under Mental Helath Act 1987 was vague. There are also provisions under which a person cannot be sterilised just because he or she is a mental patient. “As per this law, we cannot separate a child for three years… Also, one cannot chain a mentally-ill person,” Mr Nadda said in Parliament while introducing the Bill. “We tried to see that the patient is protected and no coercive methodology is adopted. Persons who will not adhere to it will be liable to penalty and imprisonment. This is a very progressive bill,” he added.

India is a signatory to the Convention on the Rights of Persons with Disabilities, an international human rights treaty of the United Nations. Around 6-7% of India’s population suffers from some kind of mental illnesses, while 1-2% suffer from acute mental disease.

A new frontier for TB diagnosis

In a marked departure from the current methods for active TB diagnosis that are based on the presence of live bacteria in sputum samples, a rapid blood test that relies on two proteins for diagnosis and quantification of the severity of active TB has shown promise.

The blood test accurately detects minute levels of two biomarkers — CFP-10 and ESAT-6 — that TB bacteria release only during active infections. In a pilot study, the new blood test was able to diagnose active TB cases with “high sensitivity and specificity”. It was able to diagnose active TB even in people co-infected with HIV.

It was able to diagnose both pulmonary and extra-pulmonary TB cases with high sensitivity — over 91% in the case of culture-positive pulmonary TB (PTB) and above 92% extra-pulmonary TB (EPTB), and 82% in culture-negative PTB and 75% in EPTB in HIV-positive patients. In the case of HIV coinfected cases, the sensitivity was 87.5% for PTB and 85.7% for EPTB cases.

Obtaining sputum samples is not always easy. Biopsy samples are needed in the case of EPTB cases. Even Gene Xpert, introduced a few years ago to improve sensitivity and specificity, relies on sputum samples, and as per a 2014 WHO update, Xpert has “very low quality evidence” for EPTB diagnosis.

As per the results of the study published on Monday in the Proceedings of the National Academy of Sciences, the two peptides that are actively secreted by virulent Mycobacterium help in early diagnosis of active TB.

For the first time, quantitative results can be obtained that will help knowing the severity of active TB and in monitoring treatment outcomes.

It takes about four hours for the NanoDisk-MS assay to accurately detect the presence of the two peptides in the blood.

Government to increase 5,000 more PG seats in medical institutes

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With an aim to increase the availability of specialist doctors at secondary and tertiary levels, the government will introduce as many as 5,000 post-graduate (PG) seats. During this year’s budget, the Centre had announced the creation of additional medical seats every year. Health Minister J P Nadda today informed the Lok Sabha, “The government has taken a number of steps to improve the health sector in the country including the creation of 5,000 additional PG seats in medical institutions.”

Nadda recently said, there had been a total addition of 4,193 PG seats in the country so far. In March this year, there will be a further addition of more than 1000 seats.

Further, the Health Minister elaborated there has been 27.7 per cent more allocation to the health sector in the 2017-18 budget. “We are also planning to allocate 2.5 per cent of the GDP to the health sector in phase-wise,” he said during Question Hour.

However, many state governments have returned the funds earmarked for the health sector as they have not been able to spend them, he said.

The Minister said the Centre has been offering help to the states to improve infrastructure and institutions in the health sector besides providing financial support, but the states have to spend the funds properly and submit the utilisation certificates.

Building a healthy India: The government’s National Health Policy will improve health outcomes and reduce out of pocket expenses

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By JP Nadda, MOHFW, Govt. of India

Over the last decade, India has made noteworthy strides in health. We built an extensive, sophisticated system to deliver multiple doses of polio vaccine to every child in this vast country, eradicating the disease. Nationwide, our infant and maternal mortality rates have declined by more than one-third. We have learnt to manufacture high quality drugs that are exported to the rest of the globe; an estimated 20% of generic drugs supplied globally are produced in India.

While we have much to be proud of, we know that we can do much better. Health outcomes can improve further and out of pocket expenses on health can reduce, to better protect citizens from financial risk. We can build on our progress to reach the goal of an India in which every citizen lives a healthy and productive life.

The National Health Policy, developed after extensive consultations with state governments and other stakeholders, aims to shape our health system in all its dimensions – by investment in prevention of diseases and promotion of good health; by access to technologies; developing human resources; encouraging medical pluralism; and by building knowledge for better health, financial protection and regulation. The Policy is aimed at reaching healthcare in an assured manner to all, particularly to the underserved and underprivileged.

Fortunately, we have made significant advances, which puts us in an excellent position to address the needs the health system isn’t meeting yet – starting with strengthening and delivering good quality maternal and child healthcare and ensuring availability of emergency care, and moving on eventually to create robust infrastructure and capabilities to deliver universal health coverage. We have clearly prioritised four investments, through which we can build the Indian health system of the future.

The first is our focus on prevention of diseases, promoting good health and assuring quality comprehensive primary care to all. The emphasis, therefore, is to move away from sick care to wellness. Seven areas for inter-sectoral action and peoples’ campaign under ‘Swasth Nagrik Abhiyan’ have been identified so that people stay healthy and rely less on hospital care.

The need is also to shift from selective primary healthcare services to assured comprehensive primary healthcare with two-way referrals, which include care for major non-communicable diseases (NCDs), mental health, geriatric care, palliative care and rehabilitative care. As a critical element, the Policy proposes to raise public health expenditure to 2.5% of the GDP in a time-bound manner with allocation of a major proportion (two-thirds or more) of resources to primary care.

The second critical focus of this Policy is strengthening and designing our health systems such that affordable healthcare is made available to all. Chiefly, through free access to universal comprehensive primary healthcare, free drugs, diagnostics and essential emergency services in government hospitals as well as strategic purchasing through government financed insurance programmes. To facilitate access within the ‘golden hour’, the Policy aims to ensure availability of 2,000 beds per million population across all geographies.

Empowering citizens and providing quality patient care is our third critical pillar. Hospitals will undergo periodic measurements and will be certified on level of quality.

The Policy recommends establishing mechanisms for speedy resolution of disputes, and of National Healthcare Standards Organisation to develop evidence-based standard guidelines for care. Resource allocation to government hospitals will be made responsive to quantity, diversity and quality of caseloads.

The fourth pillar of our Policy is focussed on leveraging the power of India’s innovation, technology and ICT capability. The Policy advocates the need to incentivise local manufacturing to promote customised indigenous products such that healthcare is made more accessible and affordable for our citizens, while simultaneously generating employment.

The Policy recommends establishing federated national health information architecture, consistent with Metadata and Data Standards (MDDS), introduces use of Electronic Health Records (EHR), use of digital tools for AYUSH services by AYUSH practitioners, for traditional community level healthcare providers and for household level preventive, promotive and curative practices.

Additionally, to address the shortage of specialised care especially in some states, besides upgrading district hospitals to medical colleges, use of technology to scale initiatives such as tele-consultation, which will link tertiary care institutions (medical colleges) to district and sub-district hospitals with secondary care facilities, will ensure that excellent medical care reaches the remotest locations. To build capacity and knowledge at the last mile, the policy promotes utilisation of National Knowledge Network for Tele-education, Tele-CME, Tele-consultations and access to the digital library.

Holding ourselves accountable to meet a clear set of measurable health sector goals relating to mortality and morbidity on life expectancy and a healthy life, on reducing mortality and disease prevention and incidence, the government of India is committed to a healthy future of all its citizens.

By recognising and prioritising the role of the government in shaping and delivering equitable quality health to all, we have announced the National Health Policy 2017, and are committed to implementing it in close cooperation with the state governments, in a time-bound manner with clear deliverables and milestones, so that Indians stay healthy and reach their full potential.

TB time bomb: the price of policy inertia

A crumbling health system, slashed budgets and an overcrowded country — these factors make India the perfect playground for one of the world’s oldest diseases, tuberculosis.

In the past year, the global public health community, led by World Health Organization (WHO), has been looking at India with trepidation. In 2015 alone, 4.8 lakh Indians died of the airborne disease. In fact, India’s leading chest physician Dr. Zarir Udwadia called it “Ebola with wings” earlier this week during a TED Talk to mark World Tuberculosis Day, which fell on Friday, March 24.

 Thousands without access

Two new TB drugs, Bedaquiline and Delamanid, being used in Europe and the United States for several years, are yet to be made available in India’s national health-care system. In January, an 18-year-old Patna girl took the government to court after she was refused Bedaquiline on the grounds that she was not a resident of Delhi. The drug is available only in six sites across the country and, according to Health Ministry’s annual TB report released on Friday, only 207 patients have access to the drug needed by at least 79,000 patients. Herein lies the crux of the matter, making India’s bureaucratic inertia the world’s problem: TB does not respect geographical boundaries and these patients continue to transmit drug-resistant forms of the disease due to the poor access to medicines. Not only does India shoulder the highest TB burden in the world with over 2 million of the 10 million cases reported here, it also accounts for the most drug-resistant patients — nearly 1.3 lakh people who do not respond to first-line drugs. “Transmission of drug-resistant TB will continue unabated unless patients get early diagnosis and the right treatment. India has to invest extensively and urgently if it has to expand the testing facilities and get the drugs to the patients. Currently, there is a mismatch between the urgency with which the government is talking and the resources we are committing,” says Chapal Mehra, a public health specialist on TB.

In a major embarrassment for the government, WHO had to revise global TB estimates last year after India informed that it had been under-reporting TB cases from 2000 to 2015. The global estimates were revised upwards to 10.4 million people infected with TB — a jump of 5,00,000 from 2014. In its annual TB report, the Health Ministry explained that “this apparent increase in the disease burden reflects the incorporation of more accurate data. With backward calculations, both tuberculosis incidence and mortality rates are decreasing from 2000 to 2015”.

 The intent-action deficit

While the global spotlight for urgent action has sent the government back to the drawing board, experts maintain that it is not putting its money where its mouth is. The budget estimates in the annual TB report are in fact lower than that of 2014-15. As against ₹1,358 crore requested, the government approved ₹710 crore in 2014-15. In 2016, however, in the face of trenchant criticism, the budget requested actually went down to ₹1,000 crore and the approved budget was a measly ₹640 crore. “By no means is this enough to expand the programme. For the strategic plan to show impact, we must allocate enough resources,” says Mr. Mehra.

The government will soon be launching a new strategy, and Union Health Minister J.P. Nadda has announced that his Ministry will aim to “eliminate TB” by 2025. “Ensuring affordable and quality health care to the population is a priority for the government and we are committed to achieving zero TB deaths and therefore we need to re-strategise, think afresh and have to be aggressive in our approach to end TB by 2025,” he said on World Tuberculosis Day.

During the TED Talk, Dr. Udwadia, one of the first doctors to make Bedaquiline available in India, called tuberculosis patients “therapeutic destitutes”, adding, “Drug-resistant TB represents a collective indictment of all of us as a society. Of the tests too slow. The drugs too toxic. Of the government programme that’s underfunded and inefficient. Of the private practitioners who’ll dole out the drugs but not compassion. Of the public policy failure.”

For taking on government inertia, Dr. Udwadia was profiled by The New York Times in September 2016 in a report titled “Battling Drug-Resistant TB, and the Indian Government”.

The battle, for him, for patients and for caregivers is far from over.

The TB time bomb

Disease control in India is a story of contradictions and tuberculosis (TB) is no exception. Earlier this week, India’s Health Minister, J.P. Nadda, spoke at the World Health Organisation (WHO) Regional Health Ministers’ meeting in Delhi — on TB — stating his government’s intention to address the disease aggressively. Not too long ago, India’s Finance Minister too spoke of TB elimination.

Welcome and well-intentioned, these claims are at odds with India’s full-blown epidemic of TB and drug-resistant (DR) TB — a crisis that is decades in the making, from benign neglect by successive administrations. TB is a staggering epidemic that affects 2.8 million and kills 485,000 Indians, pushing individuals, families and communities into poverty, suffering and debt. Such claims then must be borne out by thoughtful strategy, commitment backed by sufficient funding. However, these seem to be missing. India recently released a draft of its latest strategic five-year plan to control TB which takes the approach to find, treat, prevent and build for TB control on a massive scale. However, the plan ignores the fact that most Indians affected by TB do not seek care under the government programme. It is usually their last choice. Even the poorest prefer to pay and go to the private sector because it is efficient and accessible. They land up in the public sector penniless and much sicker. That most TB-affected need efficient care with dignity and respect has escaped India’s health programme planners.

Glossed over

TB’s institutionalised neglect is not limited to the government alone. In its recently released first ever priority list of antibiotic-resistant bacteria, the WHO didn’t include DR-TB. The list is supposed to provide direction globally to government priorities for research on bacteria for which we need new antibiotics. There is already shrinking support for research into new TB antibiotics primarily because TB is a disease with a large market at the base of the pyramid. This is borne by the fact that despite its massive human costs, only two drugs have been developed in four decades and remain expensive and inaccessible to most. Such omissions let the pharmaceutical sector and government off the hook from pressure to invest in research for new drugs.

Why is TB ignored? Perhaps because its fundamentals are beyond the capacity of the health establishment. A lack of preventive strategies, poor nutrition, and rapid urbanisation with limited public awareness all feed India’s epidemic. Many of these are domains traditionally outside of disease control programmes though they have an impact on disease control.

Mr. Nadda listed numerous achievements among which were mandatory case notification from the private sector, inclusion of new Cartridge Based Nucleic Acid Amplification Test (CB NAAT) machines for early detection, and the introduction of new drugs such as Bedaquiline. What missed mention was that the increased case notification is but only a fraction of the cases detected and treated privately. The government has failed to implement TB notification successfully. India does have 500 new CB NAAT machines but they remain underutilised, highly rationed and of limited reach to most of the TB-affected. We still don’t know the government’s forecasting mechanism for procuring cartridges to make these tests accessible. What’s more, most TB patients rarely get tested upfront for drug resistance. As a result, numerous cases of DR-TB remain undiagnosed, poorly treated and often lost or what the WHO terms “missing”.

Access to new drugs like Bedaquiline is best explained in the struggle of an 18-year-old girl who desperately needed the drug and went to the Supreme Court to get it. Had she got this treatment sooner, she may not have died.

India’s spending per TB patient is the least among BRICS countries. The answers lie in expanding the capacity of the public sector, aggressively engaging the private sector, increasing budgets, and creating a massive campaign to ensure awareness and empowerment among those most severely affected. We need access to a free and reliable TB test, counselling, free high-quality treatment, and economic and nutritional support. Until then, TB will continue to devastate the foundations of this aspirational superpower.

IIT Bombay researchers find a novel target for blocking cancer metastasis

Researchers from IIT Bombay have found a novel pathway that is responsible for the progress of cancer metastasis — spread of cancer cells from its primary site of origin to new areas of the body. The finding holds potential in controlling metastasis to reduce cancer deaths. The study was published in the journal Oncotarget.

Treating metastasis

Surgical removal of primary tumours has long been used as a standard treatment for localised tumours, but treating cancer metastasis remains a formidable challenge. “Cancer stem cells (CSCs) are one cause of cancer metastasis. However, there is no study done so far to examine the impact of biophysical properties of cancer stem cells in cancer metastasis,” says Dr. Rahul Purwar, Assistant Professor at Department of Biosciences & Bioengineering, IIT Bombay.

Contractile dynamics of a tumour cell represents one of the most important biophysical properties and is closely associated with cell spreading and cell adhesion properties of tumour cell. Increased cell contractility in breast cancer can initiate the escape of cancerous cells from their primary sites to distant organs, that is, metastasis.

Dr. Purwar’s investigating team as well as other, earlier researchers have shown a close relationship between cell contractility (ability of cells to contract) and invasiveness in breast cancer cells, ovarian cancer cells and melanoma cells. Increased contractility is correlated with increased migration of cells which helps in metastasis.

However, it remains unknown whether contractile dynamics of CSCs are distinct as compared to the bulk tumour population and contribute in CSC-mediated metastasis.

Robust remission

Study lead author Dr. Purwar explains that “With this study, we identified a distinct pathway which CSCs use to invade the extracellular matrix and metastasise to other organs. Surprisingly, we observed that blockade of this pathway by pharmaceutical drugs completely abolished the invasion of CSCs as well as other tumour cells. Thus, targeting this distinct pathway may lead to the development of robust and long-term remission of cancer metastasis’’.

Cell contractility is regulated by two groups of enzymes including myosin light chain kinase (MLCK) and Rho associated protein kinase (ROCK). The team found that pharmacological targeting of ROCK prevents contractility and cell invasion potential of both CSCs and non-cancer stem cells, and is therefore a novel strategy for the treatment of cancer metastasis.

“Our work provides the first evidence of targeting biophysical properties of cancer stem cells for controlling metastatic cancer. However, further work is required to translate our findings before it goes to clinic,” he says.