MUMBAI: The travails of a Nepalese citizen who flew to Lucknow to undergo a tummy tuck has all the hallmarks of a medical thriller – from near-death state to revival – due to the “compassionate use” of an antibiotic that is still being tested. The antibiotic is not a drug produced overseas, but developed in an Aurangabad laboratory by an Indian pharmaceutical company.
“Our drug, WCK5222, which is currently undergoing clinical trials in some European countries, has been cited by the World Health Organization as a promising research antibiotic,” said scientific director Mahesh Patel of Wockhardt Aurangabad Research Center.

go up (2)

In early August, a couple of days after the tuck, the 50-year-old Nepalese woman developed a fever that quickly escalated into a lung infection. A few days later, his liver and her kidneys were also affected. The sepsis quickly set in and was put on ventilatory support, with the culprit identified as a gram-negative bacterium named Pseudomonas aeruginosa. Gram-negative bacteria are resistant to multiple drugs and in his case, the bacterium Pseudomonas A was resistant to all antibiotics, expect colistin. Three weeks later, he became resistant to colistin as well, meaning no medication was available to treat the patient who had been transferred from a local hospital in Medanta Lucknow.
India, where antibiotics are often self-prescribed or by chemists, has seen alarming levels of antibiotic or antimicrobial resistance. The Indian Council for Medical Research (ICMR) fifth detailed report on trends and patterns of antimicrobial resistance (AMR) showed that many ICU patients no longer benefit from carbapenems, a potent antibiotic used to treat pneumonia and septicemia.
The level of resistance increases 5% to 10% annually for broad spectrum antimicrobials, mainly due to discriminatory use leading to subsequent resistance. “India has high rates of multidrug resistance between enterobacteria and non-fermenting gram-negative bacteria such as Acinetobacter baumanii and Pseudomonas aeruginosa. New treatment options are urgently needed for such multi- or highly drug-resistant pathogens,” said Kamini Walia, scientist. senior of the ICMR, which coordinates diagnostic and antimicrobial resistance initiatives across the country.
Fortunately for the Nepalese national ICU specialist at Medanta Lucknow, Dr. Dilip Dubey he remembered reading about WCK5222 in research papers and called Wockhardt. He was told that only families could apply for the drug for compassionate reasons and that even after seeking permission from the Drugs Controller General of India (DCGI). The family immediately wrote to DCGI and got approval within the next 48 hours, the doctor said.
A 10-day course of WCK5222 was offered to the patient free of charge. “Even though we administered the medicine for 10 days, it was free of bacteria by the fifth day,” said Dr. Dubey. The patient was discharged on 12 September and underwent five follow-up visits in Medanta Lucknow. A couple of weeks ago, she received medical clearance to return to Nepal.
The next step is the start of the clinical trial in India. “For WCK5222, we have special USFDA approvals and plan to start trials in India soon,” said Wockhardt researchers Mahesh Patel and Sachin Bhagwat.
Work on WCK5222 began in 2012 with 130 scientists working on it. In the United States, a Phase 1 study of 200 patients was conducted which revealed that the drug is safe for use in humans. The company has received inquiries from other parts of the world and four inquiries from India. “But we didn’t have enough time to process the paperwork,” she said. The drug already has 25-30 publications.

Leave a Reply

Your email address will not be published. Required fields are marked *