1000 Year Old Remedy Maybe a Solution to a $100 Trillion Pharmaceutical Problem

1000 year old remedy maybe a solution to a $100 trillion pharmaceutical problem

Researchers at the University of Nottingham’s Centre for Biomolecular Sciences have demonstrated that Bald’s Leechbook, an Old English leather-bound manuscript, has a one thousand year old Anglo-Saxon remedy for eye infections, which can kill the modern-day superbug Methicillin-Resistant Staphylococcus Aureus (MRSA).

The remedy, verified in university labs in both the United States and United Kingdom, worked better than the current gold standard for MRSA flesh infections, the antibiotic vancomycin.

With our past analysis varying from ‘APIs urgently needed in US and Canada’ to ‘Are assessments of foreign regulatory (USFDA & EDQM) inspections fair?’, one might wonder why focus on spinning tales like Harry Potter... Well, the answer could be worth $100 trillion!

Antibiotics, those boring commodity molecules, which humans consumed more than 3 million kg of in 2009, and animals were fed almost 13 million kg in 2010, have now started gaining global attention due to concerns of antibiotic resistance.

How serious is the focus and how bad is the concern?

2012 - Law passed in the United States, commonly known as the GAIN Act, or the Generating Antibiotics Incentives Now Act, to help stimulate the development of new antibiotics to treat serious or life-threatening infections. Under the GAIN Act, certain antibacterial or antifungal drugs can be designated as “Qualified Infectious Disease Products” (QIDPs), which allows the drug to get priority review, eligibility for fast track designation and the possibility of an additional five years of marketing exclusivity.

April 2014 - WHO’s first global report on antibiotic resistance in 114 countries reveals a serious, worldwide threat to public health. The loss of effectiveness of antibiotics can create a “post-antibiotic era” in which, common infections could become deadly again.

December 2014 - Former Goldman Sachs chief economist, Jim O'Neill, chairs UK report, which warns that failure to tackle the antibiotic resistance problem, will make it bigger than cancer by 2050 on one hand, will also cost the global economy up to $100 trillion, and could cause at least 10 million extra deaths a year.

March 2015 - The White House releases a five year - $1.2 billion National Action Plan, for combating antibiotic resistant bacteria. The fight is officially declared a “national security priority”.

Recognizing the multiple challenges faced due to antibiotic resistance, the USFDA & Center of Disease Control have launched a partnership, the Get Smart Campaign, which seeks to ensure that patients get the right antibiotic at the right dose for the right amount of time.

However, studies are now beginning to show that the problem is spiraling out of control, since it is more than just an antibiotics prescription issue.

Earlier this month, analysis of urine samples of almost 60% of over 1000 school children in China, were found to contain antibiotics. As the tested antibiotics have been clinically discontinued, the most likely source of exposure is the food and the environment.

In addition to the China schoolchildren study, a Swedish study around Hyderabad (the heart of the Indian pharmaceutical industry), found a number of drugs contaminating the water, some in concentrations higher than in patients’ blood.

As antibiotic production is heavily polluting, the residual traces of antibiotics in the waste water are also responsible for growing antibiotic resistance in many areas.

So while governments continue to battle with the major health challenge of antibiotic resistance, the entire supply chain is currently linked to China, where the environmental concerns are continuing to grab attention of local authorities.

The United States is almost completely reliant on China for its supply of life-saving antibiotics; India, the world's pharmaceutical factory, imports 80% of its bulk drugs from China; it is worth wondering how a cooperative, global solution will be arrived at.

While the Indian government is promoting self-sufficiency of antibiotic supply, by trying to revive the almost defunct Hindustan Antibiotics Limited (HAL), the challenges faced are gigantic.

So how are the scientists and industry helping?

Companies are actively developing new antibiotics and there are many in the pipeline, however "of the 32 or so companies with antibiotics in clinical development today, only five rank among the top 50 pharmaceutical companies by sales."

In June 2014, Actavis acquired Durata Therapeutics for about $675 million to get their lead product DALVANCE (dalbavancin), the first drug approved as a QIDP. Merck followed suit in December by acquiring Cubist Pharmaceuticals, a company specializing in developing treatments for superbugs for $9.5 billion.

The Medicines Company is the only company left with an approved new antibiotic that has not been acquired by Big Pharma. Their antibiotic Oritavancin, has Orange Book patent expiries starting in 2015 but exclusivities are valid until 2019.

A team from Northeastern University along with others, earlier this year, published a paper in Nature on a new antibiotic, Teixobactin, which has a novel mechanism of action and is a new discovery technology platform. This is the first big antibiotic breakthrough in decades. Under accelerated regulatory approval the molecule will take about five years to reach the clinic.

Our ‘Phisper’:

While everybody is trying new, innovative solutions to address this global problem, you can consider the “Ancientbiotic” way from Bald's Leechbook. It is after all, widely thought of as one of the earliest known medical textbooks, and contains Anglo-Saxon medical advice and recipes for medicines, salves and treatments.

The simple eye salve used by the researchers contains two species of Allium (garlic and onion or leek), wine and oxgall (bile from a cow's stomach) brewed in a brass vessel. The ingredients are pounded together and left to stew for days. The resulting mash kills germs as well as germs that form a sticky mess called a biofilm; modern antibiotics find this difficult to achieve.

If you wish to get ahead, contact Dr Christina Lee, the Anglo-Saxon expert from the School of English who enlisted the help of microbiologists from the University’s Centre for Biomolecular Sciences to recreate the 10th century science... She is looking for funding support!

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Image Credit : The Making of Harry Potter by Dave Catchpole is licensed under CC BY 2.0

“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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