The Hindu Business Line : Drug-resistance, a new disease?

According to FDA: "Part of the problem is that bacteria and other micro-organisms... are remarkably resilient and develop ways to survive drugs meant to kill or weaken them. This resistance... is due largely to the increasing use of antibiotics."

A FULL five years after its initial recommendation of the measure, the US Food and Drug Administration (FDA) has banned the use of Baytril, a poultry antibiotic made by Bayer, to slow the increase of antibiotic-resistant infections in people. This is the first time that the FDA has withdrawn an antibiotic drug for animals because of concerns about its impact on human beings.

Baytril, manufactured by Bayer of Leverkusen, Germany, is part of a family of potent antibiotics known as fluoroquinolones — which includes Cipro, widely used by physicians in the treatment of serious infections in humans.

According to public health experts, the use of Baytril by livestock farmers is one of the reasons that more germs are becoming resistant to other fluoroquinolones.

The FDA commissioner, Mr Lester M. Crawford, has ordered that approval for use of the drug, known generically as enrofloxacin, be withdrawn from September 12, citing particular concerns about campylobacter bacteria, a growing source of serious illness in humans.

The central concern is that antibiotics used to treat the bacteria may become less effective if the germ develops resistance to Baytril. The ruling, effective September 12, does not affect other approved uses of the drug.

The Union of Concerned Scientists has welcomed the FDA order as a "big victory for public health."

According to the interest group, Keep Antibiotics Working, several leading poultry producers in the US — Tyson, Gold Kist, ConAgra, Perdue, Foster Farms and Claxton — have already declared that they do not to administer such drugs to chickens produced for human consumption.

The major buyers of chicken — McDonald's, Wendy's, Dairy Queen, Burger King and so on — are understood to have advised their suppliers to stop using this class of drugs in the chickens they supply.

Bayer, for its part, has said that it is "surprised and disappointed" by the ruling and that it is reviewing the ruling from a scientific and legal position before deciding whether to appeal against it in court. The company has 60 days to appeal the FDA order in a federal appeals court. Bayer has further stated that Baytril does not represent a major part of the company's revenue.

Public health experts in the West have recognised the growing threat of disease-causing microbes becoming resistant to drug therapy.

According to the FDA, tuberculosis, gonorrhoea, malaria, and childhood ear infections are just a few of the diseases that have become hard to treat with antibiotic drugs.

"Part of the problem is that bacteria and other micro-organisms that cause infections are remarkably resilient and can develop ways to survive drugs meant to kill or weaken them. This antibiotic resistance, also known as anti-microbial resistance or drug resistance is due largely to the increasing use of antibiotics."

Although food-producing animals are given antibiotic drugs for therapeutic, disease prevention or to aid production, these drugs can cause microbes to become resistant to drugs used to treat human illness, ultimately rendering some human sicknesses difficult to treat.

According to a cross-section of public health activists in India, drug resistance and the emergence of super bugs have not been accorded due importance in spite of warnings by experts.

In February, 2003, Dr Ashesh Tayal, Scientific Advisor to Greenpeace India, had published a paper titled Why GM Mustard is Bad for India in which it had been pointed out that corporates pushing genetically engineered (GE) mustard were promising a 20 per cent increase in productivity and better oil content over the levels prevalent then.

Illustrating this point, the author had cited the instance of rapeseed, which does not compete well with weeds in the early growth stages.

"Therefore farmers use herbicides to overcome this problem. Some transnational corporations have worked on the development of herbicide-resistant GE rape varieties. For example, AgrEvo has the `Innovator', which is glufosinate-resistant, whereas Monsanto has a glyphosate-resistant variety and Pioneer an imidazolinon-resistant product. These crops allow the use of a non-selective herbicide which kills every plant except those which have a herbicide-resistance gene suited to the company's chemicals incorporated. As the genetic engineering process is used, risks and hazards multiply. A fairly significant number of genes are used as `promoters' and `markers'."

The article added: "Apart from the above mainframe foreign genes, antibiotic resistant `marker genes' with no agronomic interest whatsoever are used to select transformed cells in the crop. These include a gene for resistance to antibiotics Kanamycin and Neomycin, isolated from E. coli, bacteria usually found in the gastrointestinal tract of warm blooded animals... ."

And then again, Arti Kapil of the Department of the Department of Microbiology, All India Institute of Medical Sciences, New Delhi, had published a paper in the Indian Journal of Medical Research in February, stating that "A limited population of bacteria which has become pathogenic was also sensitive to antibiotics to begin with.

"It is man-made antibiotic pressure which has led to the emergence and spread of resistant genes amongst bacteria... This is more evident in the hospital settings where the antibiotic usage is maximum... The major reason for this is the inappropriate use of antibiotics due to a lack of uniform policy and disregard to hospital infection control practices.

"The antibiotic cover provided by newer antibiotics has been an important factor responsible for the emergence of multi-drug resistant bacteria. Bacterial infections increase the morbidity and mortality, increase the cost of treatment, and prolong hospital stay adding to the economical burden on the nation.

"The problem is further compounded by the lack of education and over-the-counter availability of antibiotics in developing countries."

Independent public health experts concur with the views expressed in Arti Kapil's paper and allege that the indiscriminate prescription of antibiotics by physicians — as also their unlawful dispensation across the counter by pharmacists — will, sooner than later, make the problem of drug-resistance a pervasive one in India.

They further point out that drug companies do little to educate people about the correct use of antibiotics and to insulate them from the abuse of their products by doctors and pharmacists.

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