Monday, August 20, 2012

India: Still Looking For A Policy On Antibiotics



Inoculated MacConkey agar culture plate cultivated colonial growth of Gram-negative, small rod-shaped and facultatively anaerobic Klebsiella pneumoniae bacteria. – CDC PHIL.

# 6502


Although the antibiotic resistance enzyme now known as NDM-1 (New Delhi metallo-ß-lactamase-1) was first detected in a patient in Sweden (albeit with Indian origins) four years ago, it didn’t capture much attention until the publication of an eye-opening research paper in The Lancet in August of 2010.


Emergence of a new antibiotic resistance mechanism in India, Pakistan, and the UK: a molecular, biological, and epidemiological study

Dr David Livermore, Prof Timothy Walsh, et al.


Published Online: 11 August 2010


This study linked the recent importation of a handful of NDM-1 infections into the UK, US, and other countries  to `medical tourism’ on the Indian Sub-continent (see NDM-1: A New Acronym To Memorize).


NDM-1 is an enzyme confers resistance to certain gram negative bacteria like E.coli and Klebsiella against a class of antibiotics called carbapenems. Carbapenems are often our drug of last resort against a variety of bacterial infections.


Of particular concern, this enzyme is carried by a plasmid – a snippet of portable DNA  - that can be transferred to other types of bacteria (see Study: Adaptation Of Plasmids To New Bacterial Species).



The rise of antibiotic resistance has long been linked to the overuse and misuse of antibiotics.


Citing a lack of doctors and low family incomes, the Indian government allows the unfettered sale of antibiotics to the public without a doctor’s prescription.


Indian officials swiftly reacted to the Lancet paper, but rather than taking immediate action against a growing public health menace, they took umbrage instead.


They condemned of the use of `New Delhi’ in the naming of this resistance gene and called the paper a `conspiracy theory’.  They issued broad denials of its prevalence in India or that medical tourism to their nation was responsible for its spread.


It is worth noting that the naming convention for pathogens that invoked India’s ire has long used the pathogen’s place of discovery or emergence. India was certainly not singled out.


After intense pressure from the International community and scathing editorializing in Indian newspapers, the Indian Health Ministry announced in October 2010 that they would impose new restrictions on the sale of 90 antibiotics that were currently sold over-the-counter.


But that plan was eventually abandoned. Two years later, the sale of antibiotics remains rampant and unregulated in India.


This article appeared last week in The Hindu.



Wanted: a policy on antibiotics

R. Sujatha

It needed a scare like NDM-1 for the country to wake up to a policy to regulate antibiotics. But after announcing with much fanfare that a policy would be in place, the government withdrew the decision. We have arrived at a crossroads and there is no solution to the crisis yet.

(Continue . . .)



The story goes on to say that next week doctors from around the country will meet in Chennai to try to come up some kind of  `road map’ for the government to use to implement an antibiotic policy. 


Whether they will succeed, and whether the government will follow through, remains to be seen.


Meanwhile, as policy makers dither, the NDM-1 enzyme continues its evolution and spread.


Six months after the first Lancet article in April, 2011, the same researchers published a another study that found the NDM-1 enzyme in 4% of New Delhi’s sampled drinking water sources, and 30 per cent of the sewage tested.


The Lancet Infectious Diseases, Early Online Publication, 7 April 2011


Dissemination of NDM-1 positive bacteria in the New Delhi environment and its implications for human health: an environmental point prevalence study

Prof Timothy R Walsh PhD , Janis Weeks BS, David M Livermore PhD , Mark A Toleman PhD


And most alarmingly, the researchers also identified 11 new species of bacteria carrying the NDM-1 gene, including strains which cause cholera and dysentery.


Once again the reaction out of India was one of denial (see Hopefully, It’s Just A Stage They Are Going Through)


Last fall, despite ongoing denials from the Indian government, we saw a number of stories that helped to corroborate the findings of these two much-maligned-in-India Lancet studies.


First stop, the The Economic Times.

Ganga Ram study finds high levels of superbug NDM1

5 Oct, 2011, 1114 hrs IST, Durgesh Nandan Jha, TNN

NEW DELHI: India might have vehemently opposed an antibiotic-resistant superbug being named New Delhi Metallo-beta-lactamase 1 (NDM1), but a study in a leading city hospital has found a worryingly high prevalence of the deadly gene.

(Continue . . . )



The study, conducted over a 5-month period, examined 10,889 samples from patients. The NDM1 resistance gene was found in 8.1% of E. coli samples and 38.02% of samples of K. pneumoniae.


In the article, Dr S P Byotra, chairperson of medicine at the Ganga Ram Hospital, is quoted as saying:


"The idea behind this study is to stop denying the crisis NDM1 poses and work out strategies to check its spread. Antibiotic usage needs to be monitored strictly and good infection-control methods should be put in place at hospitals."


Another related article, that appeared in the International Business Times, quotes Former Indian Council of Medical Research chief and chairman N.K. Ganguly as saying that the multi-drug resistant New Delhi metallo-beta-lactamase-1 or NDM-1 comes from hospital waste that goes into Delhi's sewage water.


Presence of Antibiotic-Resistant Bacteria in Delhi Confirmed

October 5, 2011 1:26 PM EST



Last March (see Chan: World Faces A `Post-Antibiotic Era’), World Health Organization Director-General Margaret Chan – delivering the  keynote address to the Conference on Combating Antimicrobial Resistance in Copenhagen, Denmark - painted a bleak picture of the future of antibiotic availability if action is not taken.


The D-G’s entire remarks may be viewed on the WHO’s website at Antimicrobial resistance in the European Union and the world, but I’ve excerpted a few choice statements below, after which you’ll find a link to the World Health Organization’s latest publication on antibiotic resistance.


Excerpts from D-G Chan’s March 14th, 2012 speech.


Antimicrobial resistance is on the rise in Europe, and elsewhere in the world. We are losing our first-line antimicrobials. Replacement treatments are more costly, more toxic, need much longer durations of treatment, and may require treatment in intensive care units.




If current trends continue unabated, the future is easy to predict. Some experts say we are moving back to the pre-antibiotic era. No. This will be a post-antibiotic era. In terms of new replacement antibiotics, the pipeline is virtually dry, especially for gram-negative bacteria. The cupboard is nearly bare.




A post-antibiotic era means, in effect, an end to modern medicine as we know it. Things as common as strep throat or a child’s scratched knee could once again kill.

The evolving threat of antimicrobial resistance - Options for action

World Health Organization



To be fair, India isn’t the only country with NDM-1 cases or growing carbapenem resistance. But the Indian sub-continent does appear to be a focal point – a situation often linked to their lax controls on the sale and use of antibiotics.


Short of seeing a hyper-virulent pandemic someday, I can think of no public health crisis with a bigger potential impact than the growth of antibiotic resistant pathogens.


While I dabble in the subject from time to time, without a doubt  the `go to’ blogger on all things antibiotic resistant is Maryn McKenna, author of Superbug: The Fatal Menace of MRSA. 



If you aren’t a regular visitor to her Superbug Blog, you should be.


If and when the Indian government imposes meaningful restrictions on the sale of antibiotics, I’ll report it. 


One just hopes that happens before the point becomes moot.

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