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Antibiotic Resistance: The Greatest Threat To Modern Medicine.

M2 EQUITYBITES-April 24, 2015-Antibiotic Resistance: The Greatest Threat To Modern Medicine


Our increasing resistance to antibiotics is a crisis that could slip health systems back hundreds of years and is becoming one of the most significant threats to patient safety across the globe.

In the EU alone, the impact of drug-resistant infections is responsible for approximately 25,000 deaths every year, and the annual treatment and social costs have been estimated at some EUR1.5 billion, says Michael Goldman, executive director of the Innovative Medicines Initiative.

This is far from an issue exclusive to developed countries. In April 2015, the Washington Post reported that even people from an isolated village in Venezuela - part of the Yanomami tribe whose first had contact with the outside world in 2009 - carried germs resistant to some antibiotics.

Ten million extra deaths a year, at a worldwide cost up to $100tn by 2050, have been forecast in a report by the healthcare unit of KPMG consultancy.

"We need to work with everyone to ensure the apocalyptic scenario of widespread antimicrobial resistance does not become a reality. This is a threat arguably as important as climate change," Dame Sally Davies, the UK government's chief medical officer, even goes so far as to say.

The more often bacteria are exposed to certain antibiotics, the more opportunities they have to develop the defences to combat it. As a result, both new infectious diseases and those that were previously thought to be under control are becoming increasingly harder to treat.

This is a problem that is not exclusive to a particular part of the planet - it's a worldwide concern and the need to develop new antibiotics has been described by the World Health Organization (WHO) as a "race against time," with anti-microbial resistance having the potential to "affect anyone, of any age, in any country."

The world's first antibiotic, penicillin, was discovered in 1928 and since then more than 100 different compounds have been found to keep it effective. However, it has been 28 years since the introduction of a new penicillin class.

Similarly, between 1940 and 1962, in the region of 20 new classes on antibiotics were introduced to medicine. Over the subsequent 50 years there have been just two.

Innovating in a mature field is by no means easy, but surely pharmaceutical companies aren't out of ideas?

"The concept that we've exhausted the pantry is ridiculous. Now we have to dig deeper, think harder and more cleverly," said infectious disease specialist Dr Brad Spellberg.

As Spellberg points out, it is not that pharmaceutical companies lack the knowledge or ability to develop new types of antibiotics. Rather, now we have picked the "low hanging fruit", further discoveries can be a prohibitively costly endeavour.

Not only are pharmaceutical companies faced by an increasing number of scientific and regulatory hurdles, on average inventing new medicines costs pharmaceutical companies in the region of $5 billion in research and testing for each drug that comes to market, according to an estimate published in Forbes. Considering that about 80 percent of drugs don't even make it that far (most having failed safety or efficacy tests), that means a huge amount of money needing to be recouped from each drug that does get to market.

At the same time, even those drugs that are able to meet the regulatory requirement are not necessarily being developed. If a new antibiotic is only going to be used on a small number of patients, the drug is not a financially viable option as it cannot generate enough of a return on investment. Quite simply, companies are able to make much greater profits on drugs that do not lose effectiveness.

"Many pharma companies are trying to focus on the most expensive drugs, the ones they can sell a lot over a long cycle. It means they typically stay away from researching into new drugs or antibiotics," adds Jim O'Neill, former chairman of Goldman Sachs, when speaking to the Economic Times. "We need to either force or encourage pharma companies to think it is in their own long-term interest to start trying to devote more money into producing new drugs."

The increasing resistance to antibiotics has long been attributed to inappropriate prescribing. Not just those medicines that are unnecessary or unsuitable, but also the wrong selection being chosen for an incorrect duration or dose. This issue is not limited to humans, either.

"In some countries antibiotics are readily available over the counter and they are being given to cattle and painted on to boats to prevent algae," said Karl Rotthier, chief executive of Dutch-based DSM Sinochem Pharmaceuticals, when speaking to British daily newspaper the Telegraph.

Rotthier goes on to explain another issue that he believes is having even more of an impact on antibiotic resistance that overprescribing - poor controls. With many antibiotics now produced in China and India (the latter being the world's largest consumers of antibiotics), fears are that the standards of drug manufacture in these countries can be inconsistent.

One result of this includes antibiotics leaking out and getting into the drinking water. A study by Swedish scientists in 2009 titled "The landscape of antibiotic resistance" revealed that levels of antibiotics measured in streams, lakes and well water near pharmaceutical factories in India are between 100,000 and one million times higher than waters in the US and China. This means it gets into people, as well as fish and cattle that is eaten and exported around the world.

"We cannot have companies discharging untreated waste water into our environment contributing to illness and worse, to antibacterial resistance. We cannot accept that rivers in India show higher concentrations of active antibiotic than the blood of someone undergoing treatment," adds Rotthier.

Another problem is the manufacture and use of counterfeit and substandard drugs. While an issue that is worse in Southeast Asia and China, is also happening in the West too.

"Substandard medicines can create resistance such that the bona fide medicine can't treat the patient when he gets it eventually," said John Clark, Pfizer's chief security officer, when speaking to Bloomberg.

In 2013, Bloomberg reported that India implemented a rule in 2014 requiring pharmacies to dispense second- and third-tier antibiotics because the standard treatments are no longer effective and may be fakes.

With the fears being very real and the implications extremely serious, action is being taken to address the issue. At the 2014 World Health Assembly, the WHO was requested to develop a global action plan to combat antimicrobial resistance, the results of which will be revealed in May 2015. The draft of the plan contained a number of strategic objectives, which include improving awareness and understanding of antimicrobial resistance; reducing the incidence of infection; optimising the use of antimicrobial agents; and increase investment in new medicines, diagnostic tools and other interventions.

In the US, President Obama took a big step towards encouraging companies back to antibiotic research and development with a national strategy to combat antibiotic resistance.

In 2012, the Generating Antibiotic Incentives Now (GAIN) Act was signed into law. In addition to creating the Antibacterial Drug Development Task Force (which will support innovation in antibacterial drug development), the law aims to help companies by offering drug-patent exclusivity for an additional five years, fast-tracks the FDA-approval process, and requires the FDA to provide updated trial guidance. According to PEW Charitable Trusts, this has helped with the development of 17 new antibiotics as of February 2014.

Although some of a biggest pharmaceutical companies need to generate a huge income to recoup R&D costs, smaller companies can operate much more cost effectively. As a result, a lot of the larger companies are helping smaller companies fund the discovery and development costs in exchange for the chance to buy the successful drugs that they make.

Some examples, according to a report from Healthline, include Cubist Pharmaceutical's $400 million pledge for antibiotic discovery, and GlaxoSmithKline's partnership with the Wellcome Trust, US Defense Threat Reduction Agency, and start-up Spero Therapeutics. Similarly, AstraZeneca has recently entered into a research and development agreement with biotech company FOB Synthesis to develop an antibiotic to treat gram-negative bacteria.

When it comes to the misuse of antibiotics, the problem is as much about availability as patients demanding them for conditions that do not call for them.

In the WHO Global Strategy for Containment of Antimicrobial Resistance, guidelines have been laid out to help prescribers educate patients on measures to reduce the transmission of infections and make more informed health care decisions, as well as offer alternatives to antimicrobials for the relief of their symptoms.

For prescribers and dispensers, the WHO promotes the education off all groups on the importance of appropriate antimicrobial use and containment of resistance.

In order to help this, new technologies, such as Alere's point-of-care diagnostics machines, allow for rapid diagnosis, giving results within hours rather than days. Using rapid diagnosis can ensure that the correct antibiotics are used to match a specific strain of bacteria - if antibiotics need to be used at all.

Not all of the steps to resolve the issue of antimicrobial resistance are simple. But many are easy to implement. True, changing the bad habits of seven billion people is going to take one heck of a marketing campaign but the sooner we can encourage the development of new drugs, and lessen the dependency on others, the better.

By Shaun Curnow

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Publication:M2 EquityBites (EQB)
Date:Apr 24, 2015
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