Antibiotic Resistance: Universities & Industry
Author: Disabled World : Contact: Disabled World
Published: 2015-04-01 : (Rev. 2015-04-04)
Over the last years introduction of new antibiotics has slowed to a near halt and a dangerous increase in antibiotic-resistant bacteria has been observed.
An academic-industrial partnership published in the journal Nature presented the results of the development of antibiotic teixobactin. The reported work remains at an early, pre-clinical stage yet despite this fact is good news. Over the last decades the introduction of new antibiotics has slowed to a near halt over the same period of time. Over the same period of time, a dangerous increase in antibiotic-resistant bacteria has been observed.
Antibiotic resistance is defined as the ability of bacteria or other microbes to resist the effects of an antibiotic. Antibiotic resistance occurs when bacteria change in some way that reduces or eliminates the effectiveness of drugs, chemicals, or other agents designed to cure or prevent infections. The bacteria survive and continue to multiply causing more harm. The increasing rates of antibiotic resistant infections are due to antibiotic use both within human and veterinary medicine. Any use of antibiotics can increase selective pressure in a population of bacteria that promotes resistant bacteria to thrive and the susceptible bacteria to die off.
The magnitude of the issue has attracted the attention of the United States Government. Accepting a number of recommendations presented by the President's Council of Advisers on Science and Technology or, 'PCAST,' in their report, the Obama Administration issued an Executive Order establishing an inter-agency Task Force for fighting antibiotic-resistant bacteria and directing the Secretary of Human and Health Services (HHS) to establish an Advisory Council concerning the matter. Even more recently, the White House issued a strategic plan to deal with the issue.
The Causes of Antibiotic Resistance
Infectious diseases have been a large cause of morbidity and mortality for an exceptionally long time. The early discovery of sulfa drugs during the 1930's, followed by the discovery of antibiotics in the 1940's notably helped the fight against infectious diseases. After World War II, society experienced incredible gains in both life expectancy and the overall quality of people's lives. During that period of time, a number of people resumed a victory over infectious diseases had been achieved. Overuse of antibiotics; however, as well as a slowdown of innovation, permitted bacteria to develop resistance at an incredible pace - so much so that some experts now talk about a, 'post-antibiotic era.'
The issue is manifold and includes slow innovation, overuse of antibiotics, as well as the evolution of bacteria. The overuse of antibiotics in both people and livestock also helped with the emergence of antibiotic resistant bacteria. Responsibility falls to health care providers who prescribed antibiotics liberally and people who did not complete their prescribed dosages. With awareness of this issue, the medical community has been training doctors to avoid pressures to prescribe antibiotics for children and their parents who experience infections that are most likely viral in origin.
Continuing educational efforts have been and are being made to encourage people to complete their full course of each prescribed antibiotic and not to stop treatment simply because their symptoms have eased. The excessive use of antibiotics in food-producing animals is perhaps less manageable due to its effect on the bottom line of farm operations. For example, the Food and Drug Administration (FDA) reported that even though farmers were aware of the risks involved, use of antibiotics in feed-stock increased by 16% between the years of 2009 and 2012.
The development of antibiotics, maybe more adequately termed,'anti-bacterial agents,' indirectly contributed to the issue by being incremental and by almost stalling entirely twenty years ago. A number of revolutionary innovations in antibiotics were introduced during a first period of development that began in the 1940's and lasted approximately two decades. Building on scaffolds and mechanisms found before, a second period of incremental development followed over three decades - through the 1990's, with about three new antibiotics introduced each year. Steep competition and little differentiations made antibiotics decreasingly profitable and over a third period covering the last twenty years pharmaceutical companies have cut development and new antibiotics cut development of new antibiotics down to next to none. The misguided overuse and misuse of antibiotics, along with the economics of antibiotic innovation, compounded the issue taking place in nature - bacteria does evolve and adapt quickly.
The, 'PCAST,' report recommended federal investment and leadership with the goal of fighting antibiotic-resistant bacteria in three different areas which include:
- Improving surveillance
- Increasing the longevity of current antibiotics through moderated use
- Picking up the pace of development of new antibiotics and additional effective interventions
In order to implement this strategy, PCAST suggested an oversight structure that includes a Director for National Antibiotic Resistance Policy, an Advisory Council to be established by the HHS Secretary, as well as an inter-agency Task Force for Combating Antibiotic Resistance Bacteria. PCAST also recommended increasing federal support from $450 million to $900 million for main activities such as development of transformative diagnostics and treatments and a surveillance infrastructure. In addition to these, it proposed $800 million in funding for the Biomedical Advanced Research and Development Authority to support public-private partnerships for the development of antibiotics.
The Obama Administration took up a number of these recommendations and directed their implementation with the Executive Order. The Administration announced a National Strategy for Combating Antibiotic-resistant Bacteria to implement the recommendations of the PCAST report. The national strategy has five, 'pillars,' which include:
- Establish national surveillance efforts that build surveillance capabilities across human and animal environments
- Advance development and use of rapid and innovative diagnostics to provide more accurate care delivery and data collection
- Slow the emergence and spread of resistant bacteria by decreasing the abusive use of antibiotics in health care and in farm animals
- Emphasize the importance of international collaboration and endorse the World Health Organization Action Plan to address antimicrobial resistance.
- Seek to accelerate the invention process related to new antibiotics, vaccines, as well as additional therapeutics across all stages including basic and applied research and development
University and Industry Partnerships
An important cause of our antibiotic troubles; therefore, appears to be driven by economic logic. Pharmaceutical companies; however, have by and large abandoned investment in the development of antibiotics. Competition and high-substitute-ability have led to lower prices and in the financial calculations of these companies - they cannot justify new efforts at development. Farmers, on the other hand, have found the use of antibiotics to be very profitable and therefore have no financial incentives to stop using them.
The federal government allocates approximately $30 billion for research in health and medicine through the National Institutes of Health (NIH). The government does not desire to, 'crowd out,' private research investment. Instead, the goal is to fund research the private sector would not conduct because the financial return of that research remains too uncertain. Economic theory prescribes government intervention to address this type of market failure.
The government's policy; however, is also to privatize patents to discoveries made with public monies to facilitate their transfer from public to private organizations. An unanticipated risk of this policy is the re-balancing of the public research portfolio in order to accommodate the increasing demand for the kind of research that feeds into attractive market niches. The risk is that the more aligned public research and private demand become, the less research attention will be directed to medical needs without great market prospects.
The development of new antibiotics appears to be just that kind of neglected medical public need. If antibiotics are unattractive to pharmaceutical companies, development of antibiotics should be a research priority at the NIH. While it is unlikely that Congress will increase public spending for antibiotic research and development in the proportion suggested by PCAST, the NIH could step in and re-balance its own portfolio to increase antibiotic research. Either increasing NIH funding for antibiotics or NIH re-balancing of its own portfolio are political decisions, ones that are certain to meet organized resistance stronger than antibiotic resistance.
Farmers have a well-organized lobby. It is not surprising that the Executive Order gently treads over recommendations for the farming sector and avoids any hint at an outright ban of antibiotic use, lest the administration is perceived as being heavy-handed. Considering the large magnitude of the issue, a political solution is warranted. Farmers' cooperation with facing this national issue will have to be traded for subsidies and additional extra-market incentives that compensate for lost revenues or increased costs. The administration should work out the politics with farmer associations first - before they organize in strong opposition to any measure to curb antibiotic use in feed-stock.
Facing this challenge adequately will therefore require working out solutions to the economic and political dimensions of the issue. Public-private partnerships, to include university-industry collaboration, might prove to be a useful mechanism to balance the two dimensions of the equation. The development of teixobactin is a good example of this prescription as it resulted from collaboration between the universities of Bonn Germany, Northeastern University, as well as Novobiotic Pharmaceutical in Cambridge Massachusetts.
If the NIH is unable to secure an increase in research funding for the development of antibiotics and is unable to re-balance substantially its portfolio it can encourage Cooperative Research and Development Agreements and university startups with the goal of developing new antibiotics. To promote public-private and university-industry partnerships, policy coordination is advised. Enterprises will be greatly helped if the government can help them raise money connecting them to venture funding networks, or implementing loan guarantees programs specific to antibiotics.
It may also allow for an expedited FDA approval, something that would decrease the regulatory burden. In the same way, farmers might be convinced to cease the risky practice if innovation in animal husbandry may effectively replace the use of antibiotics. Public-private partnerships, especially through university extension programs, could provide an adequate framework to test alternative methods, scale them up, as well as subsidize the transition to new and sustainable practices which are not financially painful financially to farmers.
Antibiotic resistance has been called one of the world's most pressing public health problems. Almost every type of bacteria has become stronger and less responsive to antibiotic treatment when it is really needed.
Antibiotic resistance occurs when bacteria change in some way that reduces or eliminates the effectiveness of drugs, chemicals, or other agents designed to cure or prevent infections.
Reasons for the widespread use of antibiotics include:
- Increasing global availability over time since the 1950s,
- Uncontrolled sales in many low or middle income countries, where they can be obtained over the counter without a prescription, potentially resulting in antibiotics being used when not indicated.
- Prescribing or obtaining broad-spectrum antibiotics when not indicated: these are more likely to induce resistance than narrow-spectrum antibiotics.
An April 30, 2014, report by WHO addressed ways people can help tackle resistance by:
- using antibiotics only when prescribed by a doctor
- completing the full prescription, even if they feel better
- never sharing antibiotics with others or using leftover prescriptions
Policymakers can help tackle resistance by:
- regulating and promoting appropriate use of medicines
- strengthening resistance tracking and laboratory capacity
Policymakers and industry can help tackle resistance by:
- fostering innovation and research and development of new tools
- promoting cooperation and information sharing among all stakeholders
Health workers and pharmacists can help tackle resistance by:
- enhancing infection prevention and control
- prescribing and dispensing the right antibiotic(s) to treat the illness
- only prescribing and dispensing antibiotics when they are truly needed
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