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THE ANTIBIOTICS CRISIS
P A Francis | Wednesday, June 12, 2013, 08:00 Hrs  [IST]

Drug resistance is turning into one of the world's most pressing public health problems of today with some of the infectious diseases becoming untreatable with the existing drugs. Resistance is being experienced more in the case of antibiotics use as the doctors tend to prescribe that class of drugs as an easy option even for a minor infection. And there has been no control over the prescriptions written by doctors because it being a technical work and the authorities left that decision totally to their judgement. Almost 50 per cent of antibiotic prescriptions in developing world and in some developed countries are not actually needed for treating diseases. Antibiotics need to be prescribed in optimal doses, regimens and should be stopped when the infection is treated. It is important that the use of last line antibiotics should be restricted to serious infections and only when simpler therapeutic agents turn ineffective. Now, with the emergence of microorganisms which developed antibiotic resistance, humanity is once again facing a major threat of many incurable infectious diseases. Drug resistant infections are difficult to treat and have resulted in an increase in medical costs and mortality in recent years.

With the outbreak of antibiotic resistance worldwide and in the context of no newer drugs for infectious diseases in the pipeline of the global pharmaceutical industry, the US government is pushing the international pharma companies to find new molecules and persuading the Food and Drug Administration to speed up the approval process for new antibiotics. The Health and Human Services Department of the US government last month announced an agreement under which it will pay $40 million to GlaxoSmithKline, to help it develop drugs to combat antibiotic resistance and biological agents that terrorists might use. Under the plan, the federal government could give the drug company as much as $200 million over the next five years for developing new antibiotics. As the US government thinks the need for new antibiotics is urgent, it is even considering to cut short the lengthy clinical studies involving hundreds or thousands of patients and allowing to use new drugs directly in very sick patients. As per a plan put forth by a medical group namely, the Infectious Disease Society of America, new antibiotics should be approved through fast track testing and should carry a special label specifying that their use be limited to very sick patients. The objective is to speed up the process of drug approval which is usually a tough and time consuming procedure. Just placing a restrictive label on new medicine after limited clinical trials may not be adequate to determine a drug’s safety and effectiveness. Such desperate steps in clearing new drugs for marketing by any drug authority can only lead to medical disasters as many medical practitioners usually do not exercise adequate caution while they treat patients.

Comments

Srinivas Dubba Jun 13, 2013 10:18 PM
The crisis not only for Antibiotic drugs, also for Innovator companies.

Most of the pharma companies ready to release generic version of actual product, then who will going to be invented said actual product ?

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