08-19-2013, 08:05 AM
Since past few years, there has been a growing concern about the discrepancy which exists between antibiotic resistance and the activities of drug manufacturers. Namely, Aaron Kesselheim, M.D., who is an assistant professor at Harvard Medical School, says that the antibiotic resistance is rapidly increasing, but, despite that, drug developers and manufacturers are turning away from the antibiotics development and focus more on other, more profitable products.
Frightening Statistics
In the world of hospital infections, which take $32 billion every year only in US, that trend is not favorable. In the last few years, only two antibiotics for serious infections are developed, and several are still in the process of development. Among them there are only a few which are effective against Methicillin Resistant Staphylococcus Aureus (MRSA) – today’s greatest threat in bacterial world. Global Information, Inc. estimates that there are only 66 companies dealing with antibiotics development and searching for new antibiotics, and more than 85% of them are small companies. Of the total 109 antibiotics that were in the process of development, 70% are in the Phase I (preclinical studies on laboratory animals). It will take 10-15 years for those medications to be approved and distributed to the market.
It is well – known that irrational use of antibiotics is the main causes of increasing antibiotic resistance. It takes a lot of time, money, resources, and professionals to develop and test a new drug, but if it is not conserved and carefully prescribed, all the effort is futile. In that case, the development of bacterial resistance to antibiotic is fast, progressive, and inevitable. Dr. Kesselheim has recently pointed out to this problem, and proposed a new reimbursement system in which an important factor for getting the grants would be a good plan for conservation of antibiotics.
Improving The Efficacy of Antibiotics
One way to address antibiotic resistance is to improve the efficacy of current antibiotics. Scientists from Enbiotix, a newly founded drug development company, claim that silver can be added to current antibiotics in order to improve their efficacy. Silver enhanced antibiotics are especially efficient against gram-negative bacteria, which are generally the most problematic group. Silver also enlarges the spectrum of many antibiotics such as vancomycin. Dr Morones Ramirez from Enbiotix says that silver-enhanced antibiotics have great possibilities, and believes that silver can be easily implemented in standard antibiotics in five years. Of course, the most important step is to investigate the safety of use and the toxicity of silver in laboratory animals, mammals, and finally in humans. Many big companies such as Pfizer are interested in this idea too.
Cubist Pharmaceuticals is a company founded in 1992, which emphasizes greatly the importance of antibiotics development. The scientists from that facility claim that the antibiotics will play an important role in the future. They are focusing their attention mainly on antibiotics for gram-negative bacteria, which they consider a greater concern than MRSA, because of the wide distribution. One of Cubist’s antibiotics against gram-negative bacteria – Ceftolozane, is currently in the Phase III of trials. Another drug they are developing is called Surotomycin, and it is intended for patients suffering from gram-negative infections caused by Clostridium Difficile. Clostridium difficile is a gram-negative, spore-forming bacterium which is responsible for a great number of hospital infections, and it manifests as pseudomembranous colitis.
Using Bacterial Toxins as Targets
Other than focusing on the elimination of bacteria, another approach is to develop the drugs which would target bacterial toxins, thus inactivating their toxic effects. Merck Company is currently testing several medications which are consisted of antibodies targeting the toxins of C. difficile (A and B). Merck is also working on antitoxin antibodies for hepatitis C virus (HCV), human cytomegalovirus (CMV), and human immunodeficiency virus (HIV). GlaxoSmithKline is putting much hope into its drug called Relenza, which is designed to inhibit the function of neuraminidase of influenza virus. Neuraminidase is an enzyme produced by influenza virus which allows it to destruct tissues, spread and attach human cells. They are also dealing with new solutions for malaria, HCV, and infections caused by bacteria. Basilea Pharmaceutica has also several drugs in different phases of clinical and preclinical trial. They have recently raised $89 million in order to intensify their study on carbapenems, a very powerful, broad - spectrum group of antibiotics used in the treatment of gram-negative as well as gram-positive infections.
Microbiome Regulation Approach
It is well known that different pathogenic and non-pathogenic bacteria are fighting for resources in our body. That means that if we could increase the number of non – pathogenic bacteria (commensal bacteria) at the place of infection, we would lower the number of pathogenic bacteria, thus helping our immune system to win the fight against the enemy. Second Genome is a pharmaceutical company which tries to apply this approach by modulation of gut microbiome. That could be particularly useful for hospital infections caused by Clostridium difficile.
With such a low number of pharmaceutical companies interested in antibiotics development, and the rapidly increasing problem of antibiotic resistance, it is unknown for how long are we going to be protected from serious bacterial infections. Scientists suggest that policy changes are needed in order to encourage companies to give more attention to this problem. Also, the control of antibiotic use has to be improved at all levels. Most of the countries have the laws prohibiting the purchase of antibiotics without prescriptions, but the problem lies in the small markets and stores that are still not under a strict surveillance. Unaware of the consequences of their actions, they are using their position in order to get personal benefit.
Frightening Statistics
In the world of hospital infections, which take $32 billion every year only in US, that trend is not favorable. In the last few years, only two antibiotics for serious infections are developed, and several are still in the process of development. Among them there are only a few which are effective against Methicillin Resistant Staphylococcus Aureus (MRSA) – today’s greatest threat in bacterial world. Global Information, Inc. estimates that there are only 66 companies dealing with antibiotics development and searching for new antibiotics, and more than 85% of them are small companies. Of the total 109 antibiotics that were in the process of development, 70% are in the Phase I (preclinical studies on laboratory animals). It will take 10-15 years for those medications to be approved and distributed to the market.
It is well – known that irrational use of antibiotics is the main causes of increasing antibiotic resistance. It takes a lot of time, money, resources, and professionals to develop and test a new drug, but if it is not conserved and carefully prescribed, all the effort is futile. In that case, the development of bacterial resistance to antibiotic is fast, progressive, and inevitable. Dr. Kesselheim has recently pointed out to this problem, and proposed a new reimbursement system in which an important factor for getting the grants would be a good plan for conservation of antibiotics.
Improving The Efficacy of Antibiotics
One way to address antibiotic resistance is to improve the efficacy of current antibiotics. Scientists from Enbiotix, a newly founded drug development company, claim that silver can be added to current antibiotics in order to improve their efficacy. Silver enhanced antibiotics are especially efficient against gram-negative bacteria, which are generally the most problematic group. Silver also enlarges the spectrum of many antibiotics such as vancomycin. Dr Morones Ramirez from Enbiotix says that silver-enhanced antibiotics have great possibilities, and believes that silver can be easily implemented in standard antibiotics in five years. Of course, the most important step is to investigate the safety of use and the toxicity of silver in laboratory animals, mammals, and finally in humans. Many big companies such as Pfizer are interested in this idea too.
Cubist Pharmaceuticals is a company founded in 1992, which emphasizes greatly the importance of antibiotics development. The scientists from that facility claim that the antibiotics will play an important role in the future. They are focusing their attention mainly on antibiotics for gram-negative bacteria, which they consider a greater concern than MRSA, because of the wide distribution. One of Cubist’s antibiotics against gram-negative bacteria – Ceftolozane, is currently in the Phase III of trials. Another drug they are developing is called Surotomycin, and it is intended for patients suffering from gram-negative infections caused by Clostridium Difficile. Clostridium difficile is a gram-negative, spore-forming bacterium which is responsible for a great number of hospital infections, and it manifests as pseudomembranous colitis.
Using Bacterial Toxins as Targets
Other than focusing on the elimination of bacteria, another approach is to develop the drugs which would target bacterial toxins, thus inactivating their toxic effects. Merck Company is currently testing several medications which are consisted of antibodies targeting the toxins of C. difficile (A and B). Merck is also working on antitoxin antibodies for hepatitis C virus (HCV), human cytomegalovirus (CMV), and human immunodeficiency virus (HIV). GlaxoSmithKline is putting much hope into its drug called Relenza, which is designed to inhibit the function of neuraminidase of influenza virus. Neuraminidase is an enzyme produced by influenza virus which allows it to destruct tissues, spread and attach human cells. They are also dealing with new solutions for malaria, HCV, and infections caused by bacteria. Basilea Pharmaceutica has also several drugs in different phases of clinical and preclinical trial. They have recently raised $89 million in order to intensify their study on carbapenems, a very powerful, broad - spectrum group of antibiotics used in the treatment of gram-negative as well as gram-positive infections.
Microbiome Regulation Approach
It is well known that different pathogenic and non-pathogenic bacteria are fighting for resources in our body. That means that if we could increase the number of non – pathogenic bacteria (commensal bacteria) at the place of infection, we would lower the number of pathogenic bacteria, thus helping our immune system to win the fight against the enemy. Second Genome is a pharmaceutical company which tries to apply this approach by modulation of gut microbiome. That could be particularly useful for hospital infections caused by Clostridium difficile.
With such a low number of pharmaceutical companies interested in antibiotics development, and the rapidly increasing problem of antibiotic resistance, it is unknown for how long are we going to be protected from serious bacterial infections. Scientists suggest that policy changes are needed in order to encourage companies to give more attention to this problem. Also, the control of antibiotic use has to be improved at all levels. Most of the countries have the laws prohibiting the purchase of antibiotics without prescriptions, but the problem lies in the small markets and stores that are still not under a strict surveillance. Unaware of the consequences of their actions, they are using their position in order to get personal benefit.
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