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Pratap Ravindran

"All antibiotics could become redundant in 12 years and that the resulting crisis may be as big as the AIDS crisis."

Pune , Dec. 14

EVEN as the Union Health Minister, Ms Sushma Swaraj, continues to make threats of legislating death for the manufacturers of fake medicines without having exhausted remedies in the existing law and the Union Government mulls over the Mashelkar Committee report on the overhaul of the country's pharma regulatory system, Prof Hugh McGavock of the University of Ulster, has held out a warning.

Gross over-prescription of antibiotics by the medical profession is making them useless and that an "antibiotics crisis," which could result in the death of thousands from treatable illnesses, is imminent, Prof McGavock said.

Prof McGavock, who specialises in prescribing science, recently told the BBC that, by his reckoning, all antibiotics could become redundant in 12 years and that the resulting crisis may be as big as the AIDS crisis.

Major surgical procedures would have to be stopped by 2015 as antibiotics which work are essential for their performance, he said.

By way of illustration, Prof McGavok pointed to the emergence of the MRSA super-bug, now prevalent in many hospitals.

Studies suggest that the number of reports of MRSA infections is rising every year - and that deaths due to MRSA are increasing at a similar rate.

To make matters worse, the threat of a bug resistant to all antibiotics looms with reports coming in of VRSA (vancomycin resistant staphylococcus aureus), which is impervious to the drug acknowledged to be last line of defence.

It may be recalled that, in 1977, Dr Michael Jacobs, currently the director of clinical microbiology at Case Western Reserve University, had documented the first cases of resistance of streptococcus pneumoniae, a common cause of pneumonia, ear and sinus infections, to several classes of antibiotics.

Now, S. pneumoniae resists a whole bunch of drugs. Amoxicillin, an antibiotic first developed by GlaxoSmithKline and available generically these days is still the preferred drug for treating it but according to Mr Jacobs, the standard dosage of amoxicillin has increased fourfold in a quarter of a century with bacteria mutating to resist it.

The world medical community has long been aware of the threat posed by the emergence of super-bugs. However, some doctors and scientists, while conceding that Prof McGavock has a valid point when he talks of the excessive use of antibiotics in medicine and agriculture, observe that efforts are underway to evolve a new strain of drugs, called "Ramp" anti-microbials, which may address the problem of antibiotic immunity. These anti-microbials work in the same way as the human body in fighting off bacterial infections.

Other scientists warn that bacteria will eventually become immune to these drugs too - and that the body's natural resistance will be rendered less effective by these anti-microbials, making even a minor wound dangerous.

They say that the regulatory agencies are not competent enough to evaluate the risks to public health that may arise from the use of these anti-microbials and that they do not take a long-term view while granting licences for them.

The nay-sayers may be right but the plain fact is that the big-league pharma companies the world over have pretty much given up on their search for new antibiotics and are turning increasingly to biotechs. This is evident from the fact that, in the last 35 years, only one new class of anti-bacterial drugs has been introduced in the market - Zyvox by Pfizer.

And the reason for this industry-wide loss of interest in new antibiotics? To quote Mr Hank A. McKinnell, Pfizer Chief Executive: "There are a number of organisms where we're one antibiotic away from a worldwide disaster... "

The money is now in treating resistant infections, estimated at about $30 billion a year in the US alone.

The big drug companies have begun to think of antibiotics as an external category and handed them over to small biotechs, which basically work on achieving incremental improvements on old drugs.

These biotechs have been able to get approvals for new versions of existing drugs and are also taking research forward.

By way of illustration, the privately-held GeneSoft Pharmaceuticals of South San Francisco has succeeded in winning the Food and Drug Administration approval early this year for Factive, a quinoline pill similar to ciprofloxacin used in the treatment of lower respiratory infections.

And then again, Cubist Pharmaceuticals in Lexington, Massachusetts, is planning to come out with Cidecin, an injection for treating hospital-acquired skin infections. The drug had been created - and then out on the backburner - by Eli Lilly.

The good news is that Vertex Pharmaceuticals, Paul Charifson is researching a new way to kayo gyrase, an enzyme bacteria used in DNA replication.

While fluoroquinolones, which work by targeting the gyrase molecule, are already well established, Vertex is looking for a way to cut off the gyrase's supply of energy.

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