This Article was originally posted here by By Habil Khorakiwala
The Centre for Disease Control (CDC), USA, believes that a single infectious organism, methicillin-resistant Staphylococcus Aureus (MRSA), kills more people in the US than AIDS, Parkinson’s and homicide combined. The chief medical officer of England believes hip surgery in a not-too distant future may be life threatening because of infections which may not have antibiotic treatment available.
These are examples from millions of issues that underline the new reality of an anti-infective vacuum. The worldwide problem of rising anti-infective resistance, new strains of known infections and new infections are significantly, and sometimes totally, resistant to the available medicines across the entire anti-infective spectrum.
Rise of the Microbes
In America alone, over two million people are infected with antibiotic resistant bacteria of which over 23,000 die annually and many more from conditions which were actually complicated by one of the resistant infections. Another infectious organism, C.difficile, causes another 14,000 deaths per year.
In Europe, annually over 25,000 deaths are attributed to five common multidrug-resistant bacterial infections. A scary concern is the rise in carbapenem-resistant bacteria like New Delhi Metallo or NDM-1.
Carbapenems are one of the last lines of defence, beyond which a patient is engulfed by infection and dies. These startling occurrences in developed nations are worrying as they have better medical facilities than developing nations. One wonders what havoc this can cause in places like India. India, for its part, witnessed a strong rise in infectious diseases like multi-drug resistant tuberculosis or swine-flu which were repeatedly reported in recent past. India bears the global burden of over 2.2 million or 25% of global tuberculosis occurrences, which is very dangerous as it can spread by air. Pneumonia, another major infection, causes over 400,000 deaths per year in India and is the largest killer among children.
Across developed and developing geographies, a threatening situation is the rise of MRSA infections which can be fatal and untreatable.
The prevalence of MRSA among hospital patients is as high as 42% in USA, between 30% and 40% in UK, France, Spain, Italy, Japan and 45% in India. The Indian situation is more dangerous, as spread of infection can be rampant and even unreported given the lack of medical reach and diagnosis.
Sadly, few organisations are engaged in development of new anti-infective drugs. New antibiotic product approvals shrunk from 30 during 1983-92, to 17 during 1993-2002 and only eight during 2003-12. Most global majors choose segments like oncology, diabetes, or cardiology as they have a higher potential for multi-billion dollar sales, while anti-infective drugs are less remunerative. Alarmed by this, regulatory agencies like USFDA and Europe’s EMA, have revisited the new drug approval process and drafted guidelines to shorten them. There are incentives for antibiotic programmes.
Fill the Vacuum
America has instituted a Generating Antibiotic Incentives Now Act (GAIN), to counter the rise in infections. GAIN cuts the time for drug development for qualified products, and eases the clinical studies requirements any product has to undertake.
There are various funding alternatives to ensure successful development as well as a minimum five year marketing exclusivity.
For the sake of its citizens, India has to develop safe and potent antibiotics for its own good and also to encourage R&D at home. The need of the hour is to come out with a special policy on anti-infectives which should be based on scientific approach in line with development in the US, Europe and Japan.
Many Indian companies like Piramal, Serum Institute, Wockhardt and so on are engaged in development of new and improved drugs. New drug development, however, is along drawn and expensive proposition and a supportive policy will definitely encourage it.
The enormity of concessions and rewards in developed nations highlights the gaping hole current medical alternatives have against resistant infections. In India, the high prevalence of anti-infective related issues and poor medial support among the masses is akin to a ticking bomb. While with advancement in modern medicine it may be hard to believe that the situation can be as apocalyptic as in the pre-anti-infective era when diseases like smallpox would ravage entire villages and towns, this anti-infective vacuum, left for long, could prove calamitous.