Many children could have been saved if Minocycline was part of treatment protocol, say researchers.
In 2008, scientists at the National Brain Research Centre, Manesar in Haryana demonstrated that Minocycline, an inexpensive antibiotic often prescribed for pimples, can be equally effective against Japanese encephalitis, the potentially lethal brain infection for which no specific treatment exists even today.
Minocycline, after the approval of the Drug Controller General of India, underwent clinical trial in 2012-13 at the King George Medical University (KGMU), Lucknow. The trial conducted among Acute Encephalitis Syndrome (AES) patients further proved its efficacy not only in Japanese Encephalitis but also in other forms of brain infection clubbed under AES.
Five years later, Minocycline is yet to reach AES patients even as it continues to kill one in three infected children. Over 1,000 children below 15 die annually in eastern Uttar Pradesh because of AES, which is identified with high-grade fever and convulsions leading to swift damage of the brain and spinal cord.
The case for prescribing Minocycline is stuck with the Union Health Ministry and the Indian Council of Medical Research (ICMR). Repeated communications and requests by researchers to take the drug ahead have yielded no results.
Dr Rashmi Kumar, head of the paediatrics department at KGMU, who led the clinical trial of Minocycline in 2012-13, says, “When so many children are dying because of AES, it’s high time the authorities approve Minocycline usage for patients.”
Dr Kumar says Minocycline with excellent penetration in cerebrospinal fluid has neuro-protective and anti-inflammatory properties.
Apart from neuro-protective properties, Minocycline also has anti-viral effect and is known for its action against non-viral agents such as Scrub Typhus (rickettsia) and mycoplasma which are known to cause AES in eastern UP.
The pimple drug has been found to be more effective than Doxycycline, another antibiotic included in the AES protocol by the Uttar Pradesh government last year when Scrub Typhus emerged as the major cause of AES, beating Japanese encephalitis which played havoc in the region for years.
Minocycline is an approved drug with a long standing record of acceptable safety and has a similar spectrum to Doxycycline, say doctors associated with encephalitis studies. The trial showed that there was a significant advantage for patients who survived their first day in hospital.
Another small trial (with 50 patients) conducted by the BRD Medical College and Hospital, Gorakhpur also strengthened the findings of Dr Rashmi Kumar.
The ICMR seems unimpressed though. While the Council chief couldn’t be reached for comments, sources said the body wants to have a large scale clinical trial before seeking its inclusion in the AES protocol.
“However, no hospital has been roped in for the work so far,” says Dr Anirban Basu, the NBRC scientist who headed the Minocycline research in 2008, and who is now pursuing the case with the Centre and ICMR.
Since Gorakhpur is endemic to AES, the BRD Hospital could have been the first choice of ICMR to conduct large scale trial, but it has shown little interest in the ICMR proposal due to various reasons, including the clause of “compensation” in the case of the patient’s death during the trial.
The ICMR has even asked KGMU doctors to repeat the trial to “confirm” the findings but researchers haven’t shown willingness so far.
Dr Kumar insists the sample size of her 2012 clinical trial (281) was good and findings were encouraging. “We followed all norms and procedures to come out with the findings. There is no point repeating the trial especially when Minocycline is an old and safe drug which is in use for years for a range of diseases including acne. Besides, it would take another few years which is unjustified when so many kids are dying every monsoon.”
Researchers now hope that after the recent tragedy at Gorakhpur, the ICMR and Union Health Ministry take cognisance of their work on Minocycline.