In 2006, when BBC Radio asked Leena Menghaney, from Médecins Sans Frontières to talk on tuberculosis, she agreed readily. She decided to speak on drug-resistant TB, an emerging public health threat leading to increasing number of deaths in developing countries like India – a subject that not many governments and policymakers were talking about then.
“I got tirades from World Health Organisation officials,” said Menghaney, who is the Regional Head – South Asia, MSF Access Campaign. "Officials from the South East Asia regional office of WHO when they met me at a meeting said we had embarrassed India and questioned the Directly Observed Therapy Shortcourse model."
This model, generally known by its acronym DOTS, involves a TB patient taking treatment from a centre each day for six months. Ten years ago, the WHO and the Indian government, refused to accept the increasing number of drug-resistant TB patients.
Said Menghaney: “They were still in denial about the growing burden of drug-resistant tuberculosis then and failed to acknowledge the shortcoming of the DOTS model, which WHO had backed heavily through guidelines and technical support to Ministries of Health.”
Double standards
A paper published recently in the June issue of the Health and Human Rights Journal examined the role of protocols set by WHO for treating drug-resistant TB in the world. It speaks of “double standards” on the part of the organisation, which recommended unsound medical treatment for multi-drug resistant TB in developing countries such as India from 1993 to 2002, citing cost considerations.
In 1995 when there was a multi-drug resistant outbreak reported in a slum area in Lima, Peru, the WHO advised the government to use “untested standardised therapy” of adding a single drug – streptomycin – to the first line treatment for regular TB of four drugs. The cost of this treatment was one-fifth the cost of the treatment recommended in European Countries. This treatment protocol did not even include the patients' samples testing for drug sensitivity.
India is still reeling from the effects of this policy. The treatment protocol was called Category-II (after the failure of Category I treatment for first line TB). “Category II protocol never went through any clinical trial,” said Dr Sowmya Swaminathan, director-general of Indian Council for Medical Research who has worked extensively on TB. "The regimen is not based on evidence and was blindly done. It works well with drug sensitive cases, but doesn’t work for multi drug resistant tuberculosis. The same problems continue."
In Lima, the outcome of this policy was not surprising, the authors say – only 48% achieved cure and a significant number of people died. Many also acquired further drug resistance. A non-profit that worked in the area modified the treatment as per the approach used to stem the epidemic in New York city in the late 1980s and the cure rates shot up to 66% for all multi-drug resistant patients who took treatment.
The five-drug regimen violated a basic microbiological principle of never adding a single drug (streptomycin) to a failing regimen of the four first line drugs, said Dr Yogesh Jain, founder of Jan Swasthya Sahyog, Bilaspur, Chhattisgarh.
But for many countries, the problem of multi-drug resistant TB worsened between 1995-2005. In Belarus, for instance, where they adopted WHO treatment protocols, nearly half of the diagnosed TB patients had either multi-drug resistant TB or extensively drug resistant TB (a further resistance). The paper pointed out:
“By acting as a strategic gatekeeper in its technical advisory role to donor agencies and countries, it also facilitated the global implementation of a double standard for TB care in low- and middle-income countries (LMICs), upending important legal and scientific priorities. This raises serious questions about whether the organisation violated international human rights standards and those established in its own constitution.”
Dr Lalit Anande from the TB Hospital in Mumbai, the hotbed of TB as it’s known, said that they had seen drug-resistant TB in 1995-'96. “One of our very senior doctors died of drug-resistant tuberculosis then,” said Dr Anande. "But we had no sound rules to treat drug resistant TB then."
India started DOTS-plus treatment for drug-resistant TB in 2005, but it was very slow on picking cases. Not all patients with multi-drug resistant TB go through the drug sensitivity test where the sputum sample culture is grown and checked for sensitivity with four first line TB drugs, which take at least a month’s time.
Many, however, go through a GeneXpert test, which only checks for sensitivity to one drug – rifampicin – that is backed by the WHO. The reason – the test results are faster and can be made available in two hours. The drawback, however, is that the test misses patients with resistance to the three other drugs in the first line TB treatment.
“We have made guidelines for DST [Drug-susceptibility testing] for all followed by appropriate tailor-made treatment. But it may take some time implementing them,” said Dr Swaminathan.
Experts question the WHO for its recommendation of alternate-day regimen for TB patients. The patients would have to visit the DOTS centre on Monday, Wednesday, and Friday (with a two day gap for weekend). The treatment failure rate was 50% among HIV positive patients suffering from TB and 10% among other patients.
“WHO can be faulted for backing intermittent treatment by completely ignoring the resistance patterns seen in India and many other poor countries," said Dr Jain, who is also in the steering group for the National Health Mission. "We have had fights with the WHO people in India in 2007 when we argued for daily treatment and they stonewalled our suggestion and evidence,” he added. The WHO now recommends a daily regime, as opposed to an alternate day one.
The government recently announced that they would begin the daily regime for patients in some pockets, including Mumbai. It may take a few years for the regime to be established in all parts of the country.
“But the damage [of this WHO policy] still continues," said Dr Jain. "India will possibly have a daily treatment regimen for all only in another five years.”
WHO officials failed to respond to questions emailed to them.