Alternative Therapies, Incentive Models Eyed For Antibiotic Resistance 28/03/2014 by Julia Fraser for Intellectual Property Watch Leave a Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)As bacteria become more and more resistant to existing medicines, product pipelines are drying up. A solution may lie in a forgotten therapy developed in 1917, the use of which has been restricted to certain parts of Eastern Europe ever since the discovery and universal use of antibiotics. But business models and intellectual property regimes need to change to provide incentives for research and development in this area. At an alarm-sounding 20 March event called, “Antibiotics no longer work: a global emergency,” organised by the NGO Forum for Health last week, Garance Upham, president of Safe Observer and administrative board member of the World Alliance Against Antibiotic Resistance, and Frédérique Carrié, from nongovernmental group Médecins du Monde, Mexico, spoke about the growing emergency of anti-microbial resistance, actions and recommendations to control it, and renewed research on alternative therapies. Earlier this year, Margaret Chan, director general of the World Health Organization, said the world is entering a “post antibiotic era.” There is “enormous use worldwide” of antibiotics, said Upham, mostly due to overuse in husbandry (to fatten animals), hospitals, and family practitioners. This has created the problem whereby “5 million people are hospitalised each year in rich countries for multi drug resistant bacterial infections,” and the rate is even greater in lower and middle income countries, she said. Totally drug resistant bacteria, resistant to both first and second line drugs and for which options for treatment are severely limited, is present in most countries, and the frequency of worldwide travel and medical tourism exacerbates the problem. The stakes are high. People will die from infections of small everyday cuts, the speakers said. “If you cut yourself tomorrow in the metro … you’re as good as dead. Antibiotics are the main class of medicines keeping us alive when we have an injury,” said Upham. Modern medicine as it is known will come to an end, the speakers asserted. Upham drew attention to a study (Biomérieux, 2011) that concluded that within 5 years (by 2016), surgical wards will have to be closed as the risk of catching drug resistant infections will be too high. Upham emphasised the need for collective action. Patients, hospitals, doctors, and meat- or fish-farms can make individual efforts, but this is not enough as contamination is everywhere in the environment and spreads from person to person. Bacteria exist in “soil, water, waste water, sewage, husbandry waste,” and this requires a “collective approach” for regulation, monitoring, investment and research to control the spread of bacteria, she said. A serious problem is that there are “very few new antibiotics,” and industry admits there is nothing in pipeline, said Upham. There have been proposals to promote research in the US for example by assigning “extravagant prices” to antibiotics or extending patent life by 5 or 10 years or indefinitely. This will mean “only very wealthy patients will have access,” putting antibiotics out of reach of poor countries, and even for the advanced Organisation for Economic Cooperation and Development countries with growing health budget restrictions. Upham warned of depending on the private sector for a solution. Quoting Marie-Paule Kieny, assistant director general at the World Health Organization, she said there is “no market” for antibiotics. The course of treatment for patients is short, and bacteria are constantly mutating and becoming rapidly resistant, so pharmaceutical companies constantly have to come up with new products. Therefore, extending patent life does not provide the right incentives for innovation, she said. Additionally, the pressure on pharmaceutical companies to sell their products quickly within the short life cycle only increases the occurrence of resistance, the speakers said. “Pharma has to reward its stockholders,” said Upham. “They are in the highest profit logic which they can’t get out of.” They will put products on the market only if they have a high reward. But from the public health perspective, “any new antibiotic put on the market has to be considered as a precious resource,” she said, so pharmaceutical companies cannot make a profit. According to Upham, John-Arne Røttingen, chair of the Advisory Panel for the WHO’s Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), previously told her that delinking between innovation and product prices applies to neglected diseases and is also relevant to the problem of antibiotic resistance. Upham is advocating for alternative approaches: for publicly funded research and development, for knowledge sharing, for prize mechanisms, and pull and push funding bodies. Upham called it “a pity” that a proposal by Knowledge Ecology International for an Antibiotics Innovation Funding Mechanism (AIFM) at the CEWG was not selected by the group. The project put forward a “new open innovation business model for the development of antibiotic drugs.” It supports financial innovation incentives such as the use of grants and prizes to delink the cost of innovation from product prices. It also provides incentives for “open source development of new antibiotics” and sharing of technology, which she said is equally important, as well as competitive production of generic supplies of products to reduce costs. Upham and Carrié also said: doctors should start having to justify prescriptions for antibiotics; there is a need for development of new diagnostic tests to target prescriptions; and there should be public campaigns to raise awareness of the danger of antibiotic overuse. Bacteriophage Therapy an Alternative Treatment Meanwhile, Carrié presented bacteriophage therapy as a possible alternative, last resort treatment for multi-resistant bacterial infections. The procedure was discovered in 1917, but its use was continued only in the Soviet Union and neighbouring areas after the discovery and rapid uptake of antibiotics. Carrié said some Swiss universities and the Swiss authorities have recently shown an interest in this area of research following growing concerns for increasing microbial resistance. Bacteriophages are viruses that infect and replicate within specific subgroups of bacteria cells, causing them to burst and release new phages. These phages exist wherever there is a presence of corresponding bacteria in the environment, including in the intestines of animals and humans. The preparation of phages is rapid and very cheap in comparison to development of new antibiotics, said Carrié. There has been little interest by pharmaceutical companies to date because they are naturally occurring and therefore cannot be patented. However, cocktails of phages and proteins produced as a result of phage use could potentially be patented. A “new legal framework” is also needed to start researching and using this therapy in Europe, she said. Present at the event was a patient with cystic fibrosis who has successfully been using regular bacteriophage therapy in Georgia to control his condition. The current EU regulations restricting use of this therapy has resulted in mass medical tourism to hospitals in countries such as Georgia and Poland who do offer these therapies. [Update:] As part of an ongoing initiative, Chatham House recently published a report by Boston University Law Prof. Kevin Outterson entitled, “New Business Models for Sustainable Antibiotics,” available here [pdf]. Julia Fraser is an intern at Intellectual Property Watch. She is currently training to be a solicitor and will start work at an international law firm in London in 2015. She has a BSc Honours in Biology from Edinburgh University where she developed an interest in public health related intellectual property issues. 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