The market
The global antibiotics market is projected to grow from $26 billion in 2002 to $40.3 billion in 2015. This growth is expected to be strong, despite the industry's failure to discover entirely new antibiotics. Instead, it is driven by a favorable regulatory environment where government insurance programs are willing to pay more for medications following widespread awareness of antibiotic resistance and the resurgence of diseases once thought to be under control, such as tuberculosis. The United States is the world's largest market for antibiotics, where prescription consumption of these drugs has quadrupled in just one decade. Antibiotics were first discovered when Alexander Fleming, in 1929, accidentally learned how penicillin controls bacteria. Fleming never patented penicillin and offered it to the medical community and society. This earned him the Nobel Prize in Medicine in 1945. Surprisingly, the fastest-growing market for antibiotics today is not for protecting human health. It is estimated that 50 to 70% of antibiotics are administered to healthy animals to stimulate their growth by 2 to 3%, instead of being given to sick animals. While the European Union recently banned most uses of antibiotics for animals, countries like Denmark were among the first to ban this policy as early as 2000. After a decade, statistics indicate that bacterial resistance to antibiotics is decreasing. The number of new antibiotics is extremely low. Only five of the thirteen largest pharmaceutical companies are trying to discover new antibiotics. Only five new variations of existing antibiotics were approved by the FDA between 2003 and 2007, compared to 16 twenty years earlier. The problem is that antibiotics are administered for only one or two weeks to cure a patient, whereas a patient with cancer or diabetes might need to take medication for life, representing a more profitable market. At the same time, mutations in E. coli have left specific strains of this germ completely invulnerable to almost all modern antibiotics. Approximately 100,000 Americans now contract illnesses in hospitals each year. Methicillin-resistant Staphylococcus aureus (MRSA), a mutated bacterial strain, now kills more Americans than AIDS. Clearly, both technology and the market have failed. When an antibiotic's patent expires, it is sold as a generic drug at a fraction of the original price, leading to increased consumption, which in turn contributes to increased mutations and bacterial resistance. Simultaneously, the patent expiration results in lower revenues, meaning that reduced returns eliminate the budget allocated to research and development. Ultimately, the inventor, the former patent holder, or the generic drug manufacturer does not monitor the acquisition of resistance to that particular antibiotic.
Innovation
Scientists warn that everyday infections could soon become a major cause of death again. While the idea of subsidizing drug development to the tune of a billion dollars per drug and guaranteeing coverage for patients seems like an expensive solution, many are wondering how to bridge the gap between society's urgent need for new antibiotics and their low returns—despite the massive subsidies that antibiotic sales through government health plans provide to pharmaceutical companies. Experts are urging policies to preserve the effectiveness of existing drugs by preventing their overuse in medical care and livestock farming, while simultaneously ensuring better infection control in hospitals. The innovative thinking is that antibiotics are like biodiversity: a natural resource that must be preserved and used with the utmost care. James Colthurst, a British surgeon and great-grandson of Sir Almroth Wright, inventor of the typhoid vaccine, who worked in the same laboratory as Alexander Fleming, had been studying the effects of electrical stimulation on the body ever since his sister suffered a serious head injury. Because of his known involvement in this field, he was approached by a group of scientists in the USSR who were exploring the concept of electrical stimulation as a futuristic tool for healthcare in space travel. He helped develop their equipment for wider use. Once perestroika took place and they decided to commercialize their work, Dr. Colthurst sought to develop his own ideas on electrobiofeedback. Building on the work he had undertaken during his Bachelor of Science degree as a neuroanatomy student at St. Thomas' Hospital in 1978, he conceived the Fenzian hypothesis. This hypothesis is based on the fact that nerves originate from the same embryonic layer as the skin – the neuroectoderm. A network of nerves, both central (the central nervous system, or CNS, comprising the brain and spinal cord) and peripheral (PNS), collects, integrates, and disseminates information throughout the body via electrical impulses. These impulses are converted into chemical messengers that regulate cellular activity. Electrical stimulation using a simple device that meets all European Union and US FDA regulations is akin to nerve impulses that create a biofeedback process through simple skin contact by engaging in a dialogue with the CNS. Soon, Dr. Colthurst and his team were able to gather anecdotal evidence ranging from the treatment of asthma and wound healing to Bell's palsy (loss of control of facial muscle movements) and the treatment of Crohn's disease and systemic lupus erythematosus. The case where pharmaceutical and surgical products could be replaced by no drug or surgical operation is one of the characteristics of the Blue Economy simplified under the concept of "replace something with nothing".
The first cash flow
Following a retrospective audit of 600 patients published in The Pain Clinic (2007 Vol. 19 No. 1), an initial pilot study on the use of Fenzian-based electrical stimulation in asthma was published as a letter in the European Respiratory Journal in 2009 (Vol. 34 No. 2, pp. 515-517). This study demonstrated proof of concept for a new treatment without the use of pharmaceuticals. Although scientists agree that the exact mechanism remains unknown, they concurred that biofeedback could induce changes in the central nervous system. This led to the establishment of clinical trials at six medical centers, including UCLA, Johns Hopkins Hospital, and the University of Cape Town. Simultaneously, funding was made available for in-depth studies at the Manchester Interdisciplinary Biocentre. Scientific research on wounds conducted in Manchester continues to yield extremely positive results. A number of in vitro studies are now needed to support the in vivo work and prove the scientific validity of the approach. Meanwhile, Dr. Colthurst has established Fenzian Limited, a private medical research and development company registered in the UK, with the support of European investors who have had varying degrees of positive experiences with the Fenzian approach to medicine and healthcare.
The opportunity
Governments face multiple challenges. On the one hand, an aging population means ever-increasing healthcare costs. On the other hand, governments face growing budget deficits, and it is increasingly difficult for a ministry to approve multi-billion-dollar grants. Meanwhile, pharmaceutical companies face a growing burden in obtaining approvals for new drugs, litigation costs are rising, many drugs are nearing the end of their patent life, and counterfeit medicines are a growing problem, while surgery and prolonged hospital stays expose patients to potential infections. The wide range of potential applications of Dr. Colthurst's pioneering approach with Fenzian technology offers a fresh perspective that allows pharmaceutical companies to focus solely on pharmacological chemistry. Fenzian reduces the need for subsidies, lowers the costs of side effects, and works with the body's inherent ability to heal itself. Utilizing what you have is one of the fundamental principles of the Blue Economy.
