Weeks after several children died of encephalitis-related complications at the Baba Raghav Das (BRD) Medical College, Gorakhpur, the Centre is looking to introduce a new drug, traditionally used for acne, to deal with the seasonal outbreaks of acute encephalitis.
Last year the Indian Council of Medical Research (ICMR) said the drug did not appear potent enough to merit being immediately rolled out as a standard treatment for treating patients afflicted with the Japanese encephalitis (JE) virus.
In 2008, researchers at the National Brain Research Centre (NBRC), Manesar found that minocycline — an antibiotic typically used to treat severe acne — surprisingly seemed to cure rats infected with the JE virus.
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Independent teams of doctors and researchers between 2008 and 2013 have conducted trials on patients and have concluded, that minocycline worked well on patients with AES symptoms, who survived the first day of hospitalisation. According to the studies the drug did not measurably protect patients beyond three months.
The studies included a trial on 50 patients, time at the BRD Medical College, Gorakhpur itself on the use of minocycline, in specific cases of JE. The researchers found that using the medicine reduced hospital stay but didn’t significantly improve overall mortality.
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The ICMR said last year that the trials showed that the number of patients who seemed to benefit wasn’t “statistically significant” and a larger, more systematic trial at multiple locations was needed to establish the efficacy of the drug. “We’d been planning such a trial for many months…but there wasn’t an ethics committee in place and doctors at the BRD hospital couldn’t get their act together in time,” said Dr Soumya Swaminathan, Director-General, ICMR.
Provided such a form of the medicine was available, doctors would be allowed to administer it to patients from next year (in keeping with the seasonality of the AES outbreak in Uttar Pradesh) and report treatment progress to the ICMR. “ I wouldn’t link it (administering minocycline) to the recent tragedy in BRD…but the doctors involved with the trial in previous years have even written to Yogi Adityanath, (Chief Minister, Uttar Pradesh) asking that this drug be made available. I had a discussion with them,” she added.
Rashmi Kumar, who heads the paediatric department at KGMU and lead one of the earliest minocycline trials, said that an extremely heavy patient load and children usually being brought only in the last stages in hospitals such BRD, made it extremely hard to conduct systematic clinical trials of new drugs. “The laws that govern the conduct of clinical trials also make several hospitals wary of undertaking them,” she added.