Aditi (name changed), 18, sat cross-legged on her private hospital bed in Kolkata. The black scarf covering her mouth did little to hide her emaciated face. Cheeks stained with long-dried tears, she stared at the ceiling unsure of whether she’d live or die – unsure of whether or not there was a real cure for her.
It had all begun about a year before our meeting, when she’d started experiencing severe bouts of coughing and unexplained weight loss. Her parents initially took her to a homeopathic doctor who had prescribed medicines. As is the norm in most homeopathic clinics, no diagnosis or pathological tests were done and whatever was given to her as medicine was to treat the symptoms.
The reason for choosing the local homeopathy practitioner was an obvious one – his fee was what Aditi’s parents could afford and they trusted him to keep the disease a secret.
Needless to say, her condition worsened.
It was only after her parents finally decided to take her to a mainstream doctor that she was diagnosed with tuberculosis (TB).
Her condition had by then deteriorated and X-ray images of her chest revealed several anomalies.
“This restricted her medication to only three options,” a source in the government department that oversees hospitals told The Diplomat. “But then again, there are only four which are ever prescribed.”
Full Blown Epidemic, Half Baked Measures
Aditi is far from alone in this horrid story of social stigma, lack of medication and awareness, and unaffordable medical care.
As of 2018, India is home to the world’s largest number of patients suffering from TB. And at 2.74 million reported cases every year, India has the world’s highest share of all TB cases.
China, the other Asian behemoth, lags far behind at only 1 million cases per year.
To counter this affliction, the National Strategic Plan (NSP) 2017-2025 was set up under the Revised National Tuberculosis Control Program (RNTCP). The stated aim was complete elimination of the disease by 2025.
However, since 2016, India’s TB incidence has dropped by a mere 1.7 percent annually. In contrast, even considerably poorer countries that have TB in significant numbers have seen sharper falls. For example, South Africa (4.6 percent), Eswatini (3.7 percent), Lesotho (3.5 percent), Namibia (4 percent), and Zimbabwe (4.1 percent), have been more successful in curbing TB cases.
One of the reasons for India’s poor performance in curbing TB is the shifting of healthcare to private hands.
Even as the call for nationalization of healthcare grows louder the world over, India has walked firmly in the opposite direction. Post-liberalization, India has steadily moved healthcare into private hands with little to no regulation. As a result, Indian cities are awash in everything from small two-rooms clinics to swanky hospitals run by global corporations. Sustained PR-campaigns about the efficiency of the private sector as opposed to the corrupt, insular, and meritless public sector have ensured that most patients in Indian cities make a beeline for private clinics as the first point of treatment.
As a result, the private sector in India currently handles an estimated two-thirds of India’s 2.74 million new TB cases every year.
A recent study in the Indian cities of Mumbai and Patna revealed that only 35 percent of cases of TB were handled correctly by the private sector between November 2014 and August 2015.
The study was conducted by experts from a number of organizations including the World Bank, the McGill International TB Center, and the Institute for Socio-Economic Research on Development and Democracy, and funded by the Grand Challenges Canada, the Bill & Melinda Gates Foundation, and the Knowledge for Change Program at the World Bank.
According to the same study, unnecessary medicines were given to nearly all patients and only 45 individuals were lucky enough to receive the correct treatment. In many cases, even noncertified doctors – ones legally barred from prescribing medication – were found doling out TB medication.
Not only has this unregulated work resulted in patient deaths and delayed treatments, it has resulted in the emergence of drug resistant strains of TB.
“Fueled by inadequate treatment, the TB bacteria* develops a lethal and drug-resistant version of its original self,” says Dr. Asutosh Ghosh, a pulmonologist who heads the Department of Critical Care Medicine at IPGME&R hospital, Kolkata. “And this in turn leads to an increase in the number of TB-related deaths as most of the modern allopathic medicine is rendered ineffective by the mutating bacteria.” (Editor’s Note: “allopathic” refers to modern or “Western” medicine in contrast to alternative or traditional practices.)
As of 2019, India has the largest number of individuals suffering from drug-resistant versions of the TB, like Multi-Drug Resistant Tuberculosis (MDR TB), Extensively Drug-Resistant Tuberculosis (XDR TB), and the Totally Drug-Resistant Tuberculosis (TDR TB).
Delays in treatment are another major factor for death due to TB in India. And this comes from a mixture of the aforementioned social stigma and lack of access to sound and affordable medical care.
For example, three months after Aditi’s initial diagnosis, her parents married her off without telling her husband-to-be and in-laws about her disease. One year into the marriage she experienced a series of wild convulsions and then fell unconscious in front of her husband. Devastated, her husband took her to yet another private establishment.
As Aditi’s past TB illness was not disclosed, the physician at the new private establishment mistook her diagnosis as a fresh case of TB and formulated treatment accordingly. Aditi was provided with inadequate doses of the medicine – leading to drug resistance.
The later diagnosis at the district hospital confirmed that inadequate doses of TB drugs in the private sector had left Aditi with XDR-TB.
A study to measure delays in treating TB patients in Chennai’s private sector was conducted in 2016. According to the study, 84 percent and 10 percent of the total patients in Chennai first sought care in the formal and informal private sector, respectively. Only a meager 6 percent of patients came to the public sector first. Hence, the data for treatment delay in the public sector, in this case, has not been considered.
Patient delay is defined as the interval between the onset of symptoms suggestive of tuberculosis and the patient’s first contact with an HCP (health care provider). Health system delay is the time from the patient’s first contact with any HCP to the initiation of anti-tuberculosis treatment. Total delay is the time from symptom onset to the initiation of anti-tuberculosis treatment.
The study revealed that patients seeking care from formal private sectors providers, including mainstream and traditional medicine practitioners, experienced health system delays exceeding 40 days. Patients in the informal private sector (pharmacists and traditional healers or other providers) experienced an almost four week increase in the total symptomatic time prior to treatment initiation.
Thus, 94 percent of patients in Chennai who are being served by formal and informal private sector HCPs, are bound to face potentially life-ending delays in treatment.
“Missing Cases” in the Private Sector
Unlike government healthcare, where it is mandatory to disclose data, the private sector is under no obligation to reveal the total number of cases or what their outcomes were. This has left a gaping hole in formulating policies that could tackle the TB epidemic.
For example, a study in 2014 revealed 17.93 million patient-months of tuberculosis treatment were completed in the private sector. This was calculated by taking into account the sale of TB drugs the same year.
If even 40 to 60 percent of these private-sector diagnoses were correct, and if private-sector tuberculosis treatment lasts on average two to six months, an estimated 1.9 to 5.34 million tuberculosis cases were treated in the private sector in 2014. The midpoint of these ranges yields an estimate of 2.2 million cases, which was more than double the number of patients officially declared by the private sector in 2014 alone.
As per the most recent data, the RNTCP was notified of only 39,000 out of 2.74 million TB patients across all healthcare sectors in the country in 2017. As the trend suggests, the missing cases are most probably still in the private sector.
This opacity in the private sector has also led to the abuse of bedaquiline. While the drug has been approved in the United Stated and elsewhere, it has not yet been approved for the treatment of multidrug resistant TB by Indian authorities.
Bedaquiline is being developed as a “last resort” solution for drug-resistant TB patients as per WHO guidelines. Despite widespread drug resistant TB, only 27 percent of India’s TB patients will qualify for treatment with this medicine when it clears the tests.
Janssen Pharamceutica, the makers of bedaquiline, lobbied the Indian government and worked out a loophole.
With USAID as an intermediary, Janssen’s parent company Johnson & Johnson began donating the drug to patients in countries that can ill afford treatment and in return the Indian government chose not to classify TB treatment with the donated bedaquiline as an official clinical trial for testing the drug.
If it had, the government hospitals would have required approval for a clinical trial under Schedule Y to the Drugs & Cosmetics Rules, 1945. This would have entailed the vetting of the entire treatment protocol by external experts on various scientific and ethical parameters, to mitigate potential conflicts of interest. Accountability for adherence to ethical protocols during the trial would have been affixed to specific doctors. Most importantly, patients would have been entitled to compensation in case they faced adverse effects due to the drug.
Nevertheless, the manner in which the six government hospitals involved have been administering the donated bedaquiline reveals that the Indian government has been running an unofficial clinical trial at these establishments. Patients are required to sign an informed consent form prior to treatment and are then monitored closely for adverse side effects from the drug. The Drug Controller General of India’s approval of bedaquiline is conditioned on the manufacturer conducting a post-marketing surveillance study and not Phase 3 trials for global approval of the drug. Phase 3 trials are the testing of an experimental drug in humans, to confirm and expand on data gathered regarding safety and effectiveness in Phase 1 and 2 trials.
Thus, despite the approval of the drug being based on a different condition altogether, the government hospitals are obliged to turn over the data from the unofficial clinical trial to the manufacturer, which can then use the data to claim the effectiveness of their drug when used by patients on a large scale.
As a result, Johnson & Johnson now can not only access clinical trial data on bedaquiline form India, but also use it as Phase 3 trial data without any accountability to how the drug works (if at all) and what side effects it may have on patients.
An Impossible Dream?
The RNTCP has set the goal of eliminating TB by 2025. However, going by the government’s current trajectory in combating TB, achieving such a goal seems highly implausible.
Previously, the National Strategic Plan (NSP) for 2012-2017 had suffered due to a shortage of funds and the inability of the public sector to effectively collaborate with the private sector in reporting TB cases.
A few doctors from the reputed Post Graduate Institute of Medical Education & Research, Chandigarh have now decided to analyze the state of TB treatment in private healthcare establishments. Their research will take into account hospitals in the four major metropolitan cities of the country.
A doctor involved with the Post Graduate Institute of Medical Education & Research, Chandigarh project – a not-for-profit collective of doctors researching TB in India – said: “The Indian government will not be able to eradicate TB by 2025 if it is not made aware of the actual number of TB patients in India currently. And with the private health establishments refusing to report on the missing cases, there is no hope that data will ever come by.”
Siddharthya Roy is a New Delhi-based correspondent on South Asian affairs for The Diplomat.
Sayan Ghosh is a post-graduate student at the Symbiosis Institute of Media and Communication and works with data driven investigative stories.
*In an earlier version of this article, tuberculosis was erroneously referred to as a virus. TB is caused by a bacteria, not a virus.