Medical research (or biomedical research ), also known as health research , refers to the process of using scientific methods with the aim to produce knowledge about human diseases, the prevention and treatment of illness, and the promotion of health.
115-693: The Australian Stem Cell Centre is an Australian medical research and development centre which focuses on regenerative medicine through the use of stem cells . Founded in 2003, the Centre is the National Biotechnology Centre of Excellence and has received over $ 100 million in funding in recent years. It is Australia's premier stem cell research organisation. In June 2008, the Centre announced that it had begun working on induced pluripotent (iPS) cells (human embryonic stem cells, artificially created without human eggs or embryos). This
230-425: A 7.8% increase (adjusted for inflation). In 2007 the most heavily funded institutions received 20% of HIN medical research funding, and the top 50 institutions received 58% of NIH medical research funding, the percent of funding allocated to the largest institutions is a trend which has increased only slightly over data from 1994. Relative to federal and private funding, health policy and service research accounted for
345-576: A US regulatory standpoint where great investment has been made in research ethics and standards, yet trial results remain inconsistent. Federal agencies have called upon greater regulation to address these problems; a spokesman from the National Institute of Neurological Disorders and Stroke, an agency of the NIH, stated that there is "widespread poor reporting of experimental design in articles and grant applications, that animal research should follow
460-434: A climate of secrecy and self-protection, stifling creativity and collaboration. The power imbalance in academic hierarchies exacerbates these issues, with junior researchers often subjected to exploitative practices and denied proper recognition for their contributions. After clinical research, medical therapies are typically commercialized by private companies such as pharmaceutical companies or medical device company. In
575-692: A conflict of interest in the field of biomedical research. Survey results from one study concluded that 43% of scientific investigators employed by a participating academic institution had received research related gifts and discretionary funds from industry sponsors. Another participating institution surveyed showed that 7.6% of investigators were financially tied to research sponsors, including paid speaking engagements (34%), consulting arrangements (33%), advisory board positions (32%) and equity (14%). A 1994 study concluded that 58% out of 210 life science companies indicated that investigators were required to withhold information pertaining to their research as to extend
690-631: A core set of research parameters, and that a concerted effort by all stakeholders is needed to disseminate best reporting practices and put them into practice". Medical research is highly regulated. National regulatory authorities are appointed in most countries to oversee and monitor medical research, such as for the development and distribution of new drugs. In the United States, the Food and Drug Administration oversees new drug development; in Europe,
805-454: A decline in the share of key research grants going to younger scientists, as well as a steady rise in the age at which investigators receive their first funding. A significant flaw in biomedical research is the toxic culture that particularly impacts medical students and early career researchers. They face challenges such as bullying, harassment, and unethical authorship practices. Intense competition for funding and publication pressures fosters
920-628: A defense against drugs used to treat them, or certain strains of microbes that have a natural resistance to antimicrobials becoming much more prevalent than the ones that are easily defeated with medication. While antimicrobial resistance does occur naturally over time, the use of antimicrobial agents in a variety of settings both within the healthcare industry and outside of has led to antimicrobial resistance becoming increasingly more prevalent. Although many microbes develop resistance to antibiotics over time though natural mutation, overprescribing and inappropriate prescription of antibiotics have accelerated
1035-407: A doubling of NIH funding, spurring an era of great scientific progress. There have been dramatic changes in the era since the turn of the 21st century to date; roughly around the start of the century, the cost of trials dramatically increased while the rate of scientific discoveries did not keep pace. Biomedical research spending increased substantially faster than GDP growth over the past decade in
1150-402: A drug is brought to the market. The Kefauver-Harris amendments were met with opposition from industry due to the requirement of lengthier clinical trial periods that would lessen the period of time in which the investor is able to see return on their money. In the pharmaceutical industry patents are typically granted for a 20-year period of time, and most patent applications are submitted during
1265-517: A higher yield of crops has resulted in many of these microbes evolving a tolerance against these antimicrobial agents. Currently there are over 4000 antimicrobial pesticides registered with the US Environmental Protection Agency (EPA) and sold to market, showing the widespread use of these agents. It is estimated that for every single meal a person consumes, 0.3 g of pesticides is used, as 90% of all pesticide use
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#17327877616051380-408: A limited amount of time or money to see a doctor. This increased access makes it extremely easy to obtain antimicrobials. An example is India, where in the state of Punjab 73% of the population resorted to treating their minor health issues and chronic illnesses through self-medication. Self-medication is higher outside the hospital environment, and this is linked to higher use of antibiotics, with
1495-464: A limited number of competitors. Another visible shift during the era was a shift in focus to late stage research trials; formerly dispersed, since 1994 an increasingly large portion of industry-sponsored research was late phase trials rather than early-experimental phases now accounting for the majority of industry sponsored research. This shift is attributable to a lower risk investment and a shorter development to market schedule. The low risk preference
1610-611: A major threat to public health." Each year, nearly 5 million deaths are associated with AMR globally. In 2019, global deaths attributable to AMR numbered 1.27 million in 2019. That same year, AMR may have contributed to 5 million deaths and one in five people who died due to AMR were children under five years old. In 2018, WHO considered antibiotic resistance to be one of the biggest threats to global health, food security and development. Deaths attributable to AMR vary by area: The European Centre for Disease Prevention and Control calculated that in 2015 there were 671,689 infections in
1725-442: A microbe. All types of microbes can develop drug resistance. Thus, there are antibiotic, antifungal, antiviral and antiparasitic resistance. Antibiotic resistance is a subset of antimicrobial resistance. This more specific resistance is linked to bacteria and thus broken down into two further subsets, microbiological and clinical. Microbiological resistance is the most common and occurs from genes, mutated or inherited, that allow
1840-487: A microbial community, it can then spread to other microbes in the community, potentially moving from a non-disease causing microbe to a disease-causing microbe. This process is heavily driven by the natural selection processes that happen during antibiotic use or misuse. Over time, most of the strains of bacteria and infections present will be the type resistant to the antimicrobial agent being used to treat them, making this agent now ineffective to defeat most microbes. With
1955-461: A nominal amount of sponsored research; health policy and service research was funded $ 1.8 billion in 2003, which increased to $ 2.2 billion in 2008. Stagnant rates of investment from the US government over the past decade may be in part attributable to challenges that plague the field. To date, only two-thirds of published drug trial findings have results that can be re-produced, which raises concerns from
2070-471: A pattern which may have worsened during the COVID-19 pandemic. Studies have shown that common misconceptions about the effectiveness and necessity of antibiotics to treat common mild illnesses contribute to their overuse. Important to the conversation of antibiotic use is the veterinary medical system . Veterinary oversight is required by law for all medically important antibiotics. Veterinarians use
2185-621: A primary interest (such as a person's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)." Regulation on industry funded biomedical research has seen great changes since Samuel Hopkins Adams declaration. In 1906 congress passed the Pure Food and Drugs Act of 1906. In 1912 Congress passed the Shirley Amendment to prohibit the wide dissemination of false information on pharmaceuticals. The Food and Drug Administration
2300-661: A reduction of the prevalence of antimicrobial resistance in humans. In the United States the Veterinary Feed Directive went into practice in 2017 dictating that All medically important antibiotics to be used in feed or water for food animal species require a veterinary feed directive (VFD) or a prescription. Most pesticides protect crops against insects and plants, but in some cases antimicrobial pesticides are used to protect against various microorganisms such as bacteria, viruses, fungi, algae, and protozoa. The overuse of many pesticides in an effort to have
2415-496: A result of the Human Genome Project . Many challenges remain, however, including the appearance of antibiotic resistance and the obesity epidemic . Example areas in basic medical research include: cellular and molecular biology , medical genetics , immunology , neuroscience , and psychology . Researchers, mainly in universities or government-funded research institutes, aim to establish an understanding of
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#17327877616052530-408: A screening of 3,537 articles published in Europe, Asia, and North America was done. Of the 55,225 total people surveyed in the articles, 70% had heard of antibiotic resistance previously, but 88% of those people thought it referred to some type of physical change in the human body. Clinical misuse by healthcare professionals is another contributor to increased antimicrobial resistance. Studies done in
2645-736: A service. They can also help to make the research more grounded in the needs of the specific communities they are part of. Public contributors can also ensure that the research is presented in plain language that is clear to the wider society and the specific groups it is most relevant for. Research funding in many countries derives from research bodies and private organizations which distribute money for equipment, salaries, and research expenses. United States, Europe, Asia, Canada, and Australia combined spent $ 265.0 billion in 2011, which reflected growth of 3.5% annually from $ 208.8 billion in 2004. The United States contributed 49% of governmental funding from these regions in 2011 compared to 57% in 2004. In
2760-713: A significant AMR subset, enables bacteria to survive antibiotic treatment, complicating infection management and treatment options. Resistance arises through spontaneous mutation, horizontal gene transfer , and increased selective pressure from antibiotic overuse, both in medicine and agriculture, which accelerates resistance development. The burden of AMR is immense, with nearly 5 million annual deaths associated with resistant infections. Infections from AMR microbes are more challenging to treat and often require costly alternative therapies that may have more severe side effects. Preventive measures, such as using narrow-spectrum antibiotics and improving hygiene practices, aim to reduce
2875-401: A stark contrast in federal investment, from 1994 to 2003, federal funding increased 100% (adjusted for inflation). The NIH manages the majority, over 85%, of federal biomedical research expenditures. NIH support for biomedical research decreased from $ 31.8 billion in 2003, to $ 29.0 billion in 2007, a 25% decline (in real terms adjusted for inflation), while non-NIH federal funding allowed for
2990-798: A stark contrast to 25% increase in recent years. Of industry sponsored research, pharmaceutical firm spending was the greatest contributor from all industry sponsored biomedical research spending, but only increased 15% (adjusted for inflation) from 2003 to 2007, while device and biotechnology firms accounted for the majority of the spending. The stock performance, a measure that can be an indication of future firm growth or technological direction, has substantially increased for both predominantly medical device and biotechnology producers. Contributing factors to this growth are thought to be less rigorous FDA approval requirements for devices as opposed to drugs, lower cost of trials, lower pricing and profitability of products and predictable influence of new technology due to
3105-556: A virus for example. Excessive antimicrobial use has become one of the top contributors to the evolution of antimicrobial resistance. Since the beginning of the antimicrobial era, antimicrobials have been used to treat a wide range of infectious diseases. Overuse of antimicrobials has become the primary cause of rising levels of antimicrobial resistance. The main problem is that doctors are willing to prescribe antimicrobials to ill-informed individuals who believe that antimicrobials can cure nearly all illnesses, including viral infections like
3220-414: A wide array of research, extending from " basic research " (also called bench science or bench research ), – involving fundamental scientific principles that may apply to a preclinical understanding – to clinical research , which involves studies of people who may be subjects in clinical trials . Within this spectrum is applied research , or translational research , conducted to expand knowledge in
3335-508: A working partnership between patients, caregivers, people with lived experience, and researchers to shape and influence what is researcher and how. PPI can improve the quality of research and make it more relevant and accessible. People with current or past experience of illness can provide a different perspective than professionals and complement their knowledge. Through their personal knowledge they can identify research topics that are relevant and important to those living with an illness or using
3450-411: Is a major weakness, as livestock accounts for around 73% of global sales of antimicrobial agents, including antibiotics , antivirals , and antiparasitics . Considering the complex interactions between humans, animals and the environment, it is also important to consider the environmental aspects and contributors to antimicrobial resistance. Although there are still some knowledge gaps in understanding
3565-426: Is a naturally occurring process. Antimicrobial resistance can evolve naturally due to continued exposure to antimicrobials. Natural selection means that organisms that are able to adapt to their environment, survive, and continue to produce offspring. As a result, the types of microorganisms that are able to survive over time with continued attack by certain antimicrobial agents will naturally become more prevalent in
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3680-431: Is a potential metric for the rate of AMR in the environment. This surveillance also allows for further investigation into the transmission routs between different ecosystems and human populations (including domesticated animals and livestock). Such information gathered from wild bird biomes, can help identify patterns of diseased transmission and better target interventions. These targeted interventions can inform
3795-435: Is also reflected in the trend of large pharmaceutical firms acquiring smaller companies that hold patents to newly developed drug or device discoveries which have not yet passed federal regulation (large companies are mitigating their risk by purchasing technology created by smaller companies in early-phase high-risk studies). Medical research support from universities increased from $ 22 billion in 2003 to $ 27.7 billion in 2007,
3910-508: Is an online global map of antimicrobial resistance developed by HealthMap which displays aggregated data on antimicrobial resistance from publicly available and user submitted data. The website can display data for a 25 miles (40 km) radius from a location. Users may submit data from antibiograms for individual hospitals or laboratories. European data is from the EARS-Net (European Antimicrobial Resistance Surveillance Network), part of
4025-559: Is funded by industry can be considered valid after a 2003 publication of "Scope and Impact of Financial Conflicts of Interest in Biomedical Research" in The Journal of American Association of Medicine. This publication included 37 different studies that met specific criteria to determine whether or not an academic institution or scientific investigator funded by industry had engaged in behavior that could be deduced to be
4140-546: Is illogical as antibiotics are used to treat infections and not prevent infections. 80% of antibiotic use in the U.S. is for agricultural purposes and about 70% of these are medically important. Overusing antibiotics gives the bacteria time to adapt leaving higher doses or even stronger antibiotics needed to combat the infection. Though antibiotics for growth promotion were banned throughout the EU in 2006, 40 countries worldwide still use antibiotics to promote growth. This can result in
4255-724: Is in agriculture. A majority of these products are used to help defend against the spread of infectious diseases, and hopefully protect public health. But out of the large amount of pesticides used, it is also estimated that less than 0.1% of those antimicrobial agents, actually reach their targets. That leaves over 99% of all pesticides used available to contaminate other resources. In soil, air, and water these antimicrobial agents are able to spread, coming in contact with more microorganisms and leading to these microbes evolving mechanisms to tolerate and further resist pesticides. The use of antifungal azole pesticides that drive environmental azole resistance have been linked to azole resistance cases in
4370-606: Is limited, the World Health Organization Advisory Group on Integrated Surveillance of Antimicrobial Resistance strongly recommended the reduction of use of medically important antimicrobials in livestock. Additionally, the Advisory Group stated that such antimicrobials should be expressly prohibited for both growth promotion and disease prevention in food producing animals. By mapping antimicrobial consumption in livestock globally, it
4485-497: Is managed and made publicly available on usaspending.gov. Aside from the main source, usaspending.gov, other reporting mechanisms exist: Data specifically on biomedical research funding from federal sources is made publicly available by the National Health Expenditure Accounts (NHEA), data on health services research, approximately 0.1% of federal funding on biomedical research, is available through
4600-519: Is only a small part of medical research. Most of the research in the field is pursued by biomedical scientists , but significant contributions are made by other type of biologists . Medical research on humans has to strictly follow the medical ethics sanctioned in the Declaration of Helsinki and the institutional review board where the research is conducted. In all cases, research ethics are expected. The increased longevity of humans over
4715-435: Is scarce, but needed to support antibiotic stewardship in veterinary medicine. By comparison there is a lack of national and international monitoring programs for antifungal resistance. Antimicrobial stewardship programmes appear useful in reducing rates of antimicrobial resistance. The antimicrobial stewardship program will also provide pharmacists with the knowledge to educate patients that antibiotics will not work for
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4830-403: Is that of which industry is the financier for academic institutions which in turn employ scientific investigators to conduct research. A fear that exists wherein a project is funded by industry is that firms might negate informing the public of negative effects to better promote their product. A list of studies shows that public fear of the conflicts of interest that exist when biomedical research
4945-516: Is through increased contact with densely populated areas, human waste, domestic animals, and domestic animal/livestock waste. Wild migrating birds interact with sedentary birds in different environments along their migration route. This increases the rate and diversity of AMR across varying ecosystems. Neglect of wildlife in the global discussions surrounding health security and AMR, creates large barriers to true AMR surveillance. The surveillance of anti-microbial resistant organisms in wild birds
5060-601: The Bill and Melinda Gates Foundation , contributed about 3% of the funding. These funders are attempting to maximize their return on investment in public health . One method proposed to maximize the return on investment in medicine is to fund the development of open source hardware for medical research and treatment. The enactment of orphan drug legislation in some countries has increased funding available to develop drugs meant to treat rare conditions, resulting in breakthroughs that previously were uneconomical to pursue. Since
5175-415: The COVID-19 pandemic redirected resources and scientific attention away from AMR, intensifying the challenge. The WHO defines antimicrobial resistance as a microorganism's resistance to an antimicrobial drug that was once able to treat an infection by that microorganism. A person cannot become resistant to antibiotics. Resistance is a property of the microbe, not a person or other organism infected by
5290-531: The ECDC . ResistanceMap is a website by the Center for Disease Dynamics, Economics & Policy and provides data on antimicrobial resistance on a global level. The WHO's AMR global action plan also recommends antimicrobial resistance surveillance in animals. Initial steps in the EU for establishing the veterinary counterpart EARS-Vet (EARS-Net for veterinary medicine) have been made. AMR data from pets in particular
5405-621: The European Medicines Agency (see also EudraLex ); and in Japan , the Ministry of Health, Labour and Welfare . The World Medical Association develops the ethical standards for medical professionals involved in medical research. The most fundamental of them is the Declaration of Helsinki . The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) works on
5520-687: The Pharmacokinetic /pharmacodynamic model (PK/PD) approach to ensuring that the correct dose of the drug is delivered to the correct place at the correct timing. Increased antibiotic use during the early waves of the COVID-19 pandemic may exacerbate this global health challenge . Moreover, pandemic burdens on some healthcare systems may contribute to antibiotic-resistant infections. On the other hand, "increased hand hygiene, decreased international travel, and decreased elective hospital procedures may have reduced AMR pathogen selection and spread in
5635-709: The United Kingdom , funding bodies such as the National Institute for Health and Care Research (NIHR) and the Medical Research Council derive their assets from UK tax payers, and distribute revenues to institutions by competitive research grants . The Wellcome Trust is the UK's largest non-governmental source of funds for biomedical research and provides over £600 million per year in grants to scientists and funds for research centres. In
5750-431: The experimental subjects . It is generally supervised by physicians and conducted by nurses in a medical setting, such as a hospital or research clinic, and requires ethical approval. Besides being participants in a clinical trial, members of the public can actively collaborate with researchers in designing and conducting medical research. This is known as patient and public involvement (PPI). Public involvement involves
5865-520: The 30 most common infections in adults and children to reduce inappropriate prescribing in primary care and hospitals. Narrow-spectrum antibiotics are preferred due to their lower resistance potential, and broad-spectrum antibiotics are only recommended for people with more severe symptoms. Some antibiotics are more likely to confer resistance, so are kept as reserve antibiotics in the AWaRe book. Various diagnostic strategies have been employed to prevent
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#17327877616055980-448: The AMR umbrella, posing significant challenges to healthcare worldwide. Misuse and improper management of antimicrobials are primary drivers of this resistance, though it can also occur naturally through genetic mutations and the spread of resistant genes. Microbes resistant to multiple drugs are termed multidrug-resistant (MDR) and are sometimes called superbugs . Antibiotic resistance,
6095-829: The Coalition of Health Services Research, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, and the Veterans Health Administration. Currently, there are not any funding reporting requirements for industry sponsored research, but there has been voluntary movement toward this goal. In 2014, major pharmaceutical stakeholders such as Roche and Johnson and Johnson have made financial information publicly available and Pharmaceutical Research and Manufacturers of America (PhRMA),
6210-409: The EU and European Economic Area caused by antibiotic-resistant bacteria, resulting in 33,110 deaths. Most were acquired in healthcare settings. In 2019 there were 133,000 deaths caused by AMR. AMR is driven largely by the misuse and overuse of antimicrobials. Yet, at the same time, many people around the world do not have access to essential antimicrobials. This leads to microbes either evolving
6325-567: The FDA remained stagnant over the same time span. Financial projections indicate federal spending will remain constant in the near future. The National Institutes of Health (NIH) is the agency that is responsible for management of the lion's share of federal funding of biomedical research. It funds over 280 areas directly related to health. Over the past century there were two notable periods of NIH support. From 1995 to 1996 funding increased from $ 8.877 billion to $ 9.366 billion, years which represented
6440-800: The UK," highlights the urgency of reevaluating antibiotic treatment durations amidst the global challenge of antimicrobial resistance (AMR). It investigates the effectiveness of shorter versus longer antibiotic regimens for respiratory tract infections (RTIs) in a UK secondary care setting, emphasizing the need for evidence-based prescribing practices to optimize patient outcomes and combat AMR. There are multiple national and international monitoring programs for drug-resistant threats, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant S. aureus (VRSA), extended spectrum beta-lactamase (ESBL) producing Enterobacterales , vancomycin-resistant Enterococcus (VRE), and multidrug-resistant Acinetobacter baumannii (MRAB). ResistanceOpen
6555-400: The US has seen great movement over the years. The 1980 Bayh–Dole Act was passed by Congress to foster a more constructive relationship between the collaboration of government and industry funded biomedical research. The Bayh Doyle Act gave private corporations the option of applying for government funded grants for biomedical research which in turn allowed the private corporations to license
6670-542: The US show that the indication for treatment of antibiotics, choice of the agent used, and the duration of therapy was incorrect in up to 50% of the cases studied. In 2010 and 2011 about a third of antibiotic prescriptions in outpatient settings in the United States were not necessary. Another study in an intensive care unit in a major hospital in France has shown that 30% to 60% of prescribed antibiotics were unnecessary. These inappropriate uses of antimicrobial agents promote
6785-430: The US, between the years of 2003 and 2007 spending increased 14% per year, while GDP growth increased 1% over the same period (both measures adjusted for inflation). Industry, not-for-profit entities, state and federal funding spending combined accounted for an increase in funding from $ 75.5 billion in 2003 to $ 101.1 billion in 2007. Due to the immediacy of federal financing priorities and stagnant corporate spending during
6900-687: The United States, data from ongoing surveys by the National Science Foundation (NSF) show that federal agencies provided only 44% of the $ 86 billion spent on basic research in 2015. The National Institutes of Health and pharmaceutical companies collectively contribute $ 26.4 billion and $ 27 billion, which constitute 28% and 29% of the total, respectively. Other significant contributors include biotechnology companies ($ 17.9 billion, 19% of total), medical device companies ($ 9.2 billion, 10% of total), other federal sources, and state and local governments. Foundations and charities, led by
7015-533: The United States, one estimate found that in 2011, one-third of Medicare physician and outpatient hospital spending was on new technologies unavailable in the prior decade. Medical therapies are constantly being researched, so the difference between a therapy which is investigational versus standard of care is not always clear, particularly given cost-effectiveness considerations. Payers have utilization management clinical guidelines which do not pay for "experimental or investigational" therapies, or may require that
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#17327877616057130-503: The aggressive prescription of antibiotics as necessary to avoid failing to provide adequate care. This demonstrates how a majority of doctors underestimate the impact that their own prescribing habits have on antimicrobial resistance as a whole. It also confirms that some physicians may be overly cautious and prescribe antibiotics for both medical or legal reasons, even when clinical indications for use of these medications are not always confirmed. This can lead to unnecessary antimicrobial use,
7245-515: The amount of anti-microbial resistance (AMR) to the bird population. The introduction of AMR to wild birds positively correlates with human pollution and increased human contact. Additionally, wild birds can participate in horizontal gene transfer with bacteria, leading to the transmission of antibiotic-resistant genes (ARG). For simplicity, wild bird populations can be divided into two major categories, wild sedentary birds and wild migrating birds. Wild sedentary bird exposure to AMR
7360-492: The bacteria to resist the mechanism to kill the microbe associated with certain antibiotics. Clinical resistance is shown through the failure of many therapeutic techniques where the bacteria that are normally susceptible to a treatment become resistant after surviving the outcome of the treatment. In both cases of acquired resistance, the bacteria can pass the genetic catalyst for resistance through horizontal gene transfer: conjugation, transduction , or transformation . This allows
7475-419: The cellular, molecular and physiological mechanisms of human health and disease. Pre-clinical research covers understanding of mechanisms that may lead to clinical research with people. Typically, the work requires no ethical approval, is supervised by scientists rather than physicians , and is carried out in a university or company, rather than a hospital. Clinical research is carried out with people as
7590-443: The chances of members of the population acquiring a mutation that increases resistance. Many individuals stop taking antibiotics when they begin to feel better. When this occurs, it is possible that the microbes that are less susceptible to treatment still remain in the body. If these microbes are able to continue to reproduce, this can lead to an infection by bacteria that are less susceptible or even resistant to an antibiotic. AMR
7705-518: The clinical setting. The same issues confront the novel antifungal classes (e.g. orotomides ) which are again being used in both the clinic and agriculture. Wildlife, including wild and migratory birds , serve as a reservoir for zoonotic disease and antimicrobial-resistant organisms. Birds are a key link between the transmission of zoonotic diseases to human populations. By the same token, increased contact between wild birds and human populations (including domesticated animals), has increased
7820-401: The common cold. In an analysis of drug prescriptions, 36% of individuals with a cold or an upper respiratory infection (both usually viral in origin) were given prescriptions for antibiotics. These prescriptions accomplished nothing other than increasing the risk of further evolution of antibiotic resistant bacteria. Using antimicrobials without prescription is another driving force leading to
7935-427: The contemporary bacteria from the active layer of thawed ground above them, which may mean that this risk is "no greater" than from any other soil. There have been increasing public calls for global collective action to address the threat, including a proposal for an international treaty on antimicrobial resistance. Further detail and attention is still needed in order to recognize and measure trends in resistance on
8050-402: The creation of rules and guidelines for the development of new medication, such as the guidelines for Good Clinical Practice (GCP). All ideas of regulation are based on a country's ethical standards code. This is why treatment of a particular disease in one country may not be allowed, but is in another. A major flaw and vulnerability in biomedical research appears to be the hypercompetition for
8165-480: The early stages of the product development. According to Ariel Katz on average after a patent application is submitted it takes an additional 8 years before the FDA approves a drug for marketing. As such this would leave a company with only 12 years to market the drug to see a return on their investments. After a sharp decline of new drugs entering the US market following the 1962 Kefauver-Harris amendments economist Sam Petlzman concluded that cost of loss of innovation
8280-494: The environment, and those without this resistance will become obsolete. Some contemporary antimicrobial resistances have also evolved naturally before the use of antimicrobials of human clinical uses. For instance, methicillin -resistance evolved as a pathogen of hedgehogs , possibly as a co-evolutionary adaptation of the pathogen to hedgehogs that are infected by a dermatophyte that naturally produces antibiotics. Also, many soil fungi and bacteria are natural competitors and
8395-493: The establishment of the National Institutes of Health (NIH) in the mid-1940s, the main source of U.S. federal support of biomedical research, investment priorities and levels of funding have fluctuated. From 1995 to 2010, NIH support of biomedical research increased from 11 billion to 27 billion Despite the jump in federal spending, advancements measured by citations to publications and the number of drugs passed by
8510-399: The evolution of antimicrobial resistance by supporting the bacteria in developing genetic alterations that lead to resistance. According to research conducted in the US that aimed to evaluate physicians' attitudes and knowledge on antimicrobial resistance in ambulatory settings, only 63% of those surveyed reported antibiotic resistance as a problem in their local practices, while 23% reported
8625-490: The field of medicine . Both clinical and preclinical research phases exist in the pharmaceutical industry 's drug development pipelines, where the clinical phase is denoted by the term clinical trial . However, only part of the clinical or preclinical research is oriented towards a specific pharmaceutical purpose. The need for fundamental and mechanism-based understanding, diagnostics , medical devices , and non-pharmaceutical therapies means that pharmaceutical research
8740-418: The first time reporting regulations that were previously not required. The 2006 Federal Funding Accountability and Transparency Act mandates that all entities receiving over $ 25,000 in federal funds must report annual spending reports, including disclosure of executive salaries. The 2010 amendment to the act mandates that progress reports be submitted along with financial reporting. Data from the federal mandate
8855-487: The food industry, specifically with food producing animals. With an ever-increasing human population, there is constant pressure to intensify productivity in many agricultural sectors, including the production of meat as a source of protein. Antibiotics are fed to livestock to act as growth supplements, and a preventive measure to decrease the likelihood of infections. Farmers typically use antibiotics in animal feed to improve growth rates and prevent infections. However, this
8970-718: The inability of known causative agents of contagious diseases to survive being frozen and thawed makes this threat unlikely. Instead, there have been suggestions that when modern pathogenic bacteria interact with the ancient ones, they may, through horizontal gene transfer , pick up genetic sequences which are associated with antimicrobial resistance, exacerbating an already difficult issue. Antibiotics to which permafrost bacteria have displayed at least some resistance include chloramphenicol , streptomycin , kanamycin , gentamicin , tetracycline , spectinomycin and neomycin . However, other studies show that resistance levels in ancient bacteria to modern antibiotics remain lower than in
9085-416: The increased use of antimicrobial agents, there is a speeding up of this natural process. In the vast majority of countries, antibiotics can only be prescribed by a doctor and supplied by a pharmacy. Self-medication by consumers is defined as "the taking of medicines on one's own initiative or on another person's suggestion, who is not a certified medical professional", and it has been identified as one of
9200-454: The infection and other health problems a person may have. For many infections once a person has improved there is little evidence that stopping treatment causes more resistance. Some, therefore, feel that stopping early may be reasonable in some cases. Other infections, however, do require long courses regardless of whether a person feels better. Delaying antibiotics for ailments such as a sore throat and otitis media may have not different in
9315-501: The international level; the idea of a global tracking system has been suggested but implementation has yet to occur. A system of this nature would provide insight to areas of high resistance as well as information necessary for evaluating programs, introducing interventions and other changes made to fight or reverse antibiotic resistance. Delaying or minimizing the use of antibiotics for certain conditions may help safely reduce their use. Antimicrobial treatment duration should be based on
9430-401: The lack of knowledge of the public on, firstly, the dangerous effects of certain antimicrobials (for example ciprofloxacin which can cause tendonitis , tendon rupture and aortic dissection ) and, secondly, broad microbial resistance and when to seek medical care if the infection is not clearing. In order to determine the public's knowledge and preconceived notions on antibiotic resistance,
9545-459: The life of the interested companies' patents. Rules and regulations regarding conflict of interest disclosures are being studied by experts in the biomedical research field to eliminate conflicts of interest that could possibly affect the outcomes of biomedical research. Two laws which are both still in effect, one passed in 2006 and the other in 2010, were instrumental in defining funding reporting standards for biomedical research, and defining for
9660-408: The maintenance of government financial support levels through the era (the 0.7% four-year increase). Spending from industry-initiated research increased 25% (adjusted for inflation) over the same time period of time, from 2003 to 2007, an increase from $ 40 billion in 2003, to $ 58.6 billion in 2007. Industry sourced expenditures from 1994 to 2003 showed industry sponsored research funding increased 8.1%,
9775-419: The majority of antibiotics being used in the community rather than hospitals. The prevalence of self-medication in low- and middle-income countries (LMICs) ranges from 8.1% to 93%. Accessibility, affordability, and conditions of health facilities, as well as the health-seeking behavior, are factors that influence self-medication in low- and middle-income countries. Two significant issues with self-medication are
9890-400: The mechanisms and transmission pathways, environmental pollution is considered a significant contributor to antimicrobial resistance. Important contributing factors are through "antibiotic residues", "industrial effluents", " agricultural runoffs ", "heavy metals", " biocides and pesticides " and "sewage and wastewater" that create reservoirs for resistant genes and bacteria that facilitates
10005-475: The most prominent professional association for biomedical research companies, has recently begun to provide limited public funding reports. The earliest narrative describing a medical trial is found in the Book of Daniel , which says that Babylonian king Nebuchadnezzar ordered youths of royal blood to eat only red meat and wine for three years, while another group of youths ate only beans and water. The experiment
10120-400: The next six years. In their first major declaration on the issue since 2016, global leaders also committed to raising $ 100 million to update and implement AMR action plans. However, the final draft of the declaration omitted an earlier target to reduce antibiotic use in animals by 30% by 2030, due to opposition from meat-producing countries and the farming industry. Critics argue this omission
10235-444: The original antibiotic penicillin discovered by Alexander Fleming rapidly lost clinical effectiveness in treating humans and, furthermore, none of the other natural penicillins (F, K, N, X, O, U1 or U6) are currently in clinical use. Antimicrobial resistance can be acquired from other microbes through swapping genes in a process termed horizontal gene transfer . This means that once a gene for resistance to an antibiotic appears in
10350-506: The overuse of antibiotics to self-treat diseases like the common cold, cough, fever, and dysentery resulting in an epidemic of antibiotic resistance in countries like Bangladesh, risking its spread around the globe. Introducing strict antibiotic stewardship in the outpatient setting to reduce inappropriate prescribing of antibiotics may reduce the emerging bacterial resistance. The WHO AWaRe (Access, Watch, Reserve) guidance and antibiotic book has been introduced to guide antibiotic choice for
10465-426: The overuse of antifungal therapy in the clinic, proving a safe alternative to empirical antifungal therapy, and thus underpinning antifungal stewardship schemes. Antimicrobial stewardship teams in hospitals are encouraging optimal use of antimicrobials. The goals of antimicrobial stewardship are to help practitioners pick the right drug at the right dose and duration of therapy while preventing misuse and minimizing
10580-558: The past century can be significantly attributed to advances resulting from medical research. Among the major benefits of medical research have been vaccines for measles and polio , insulin treatment for diabetes , classes of antibiotics for treating a host of maladies, medication for high blood pressure , improved treatments for AIDS , statins and other treatments for atherosclerosis , new surgical techniques such as microsurgery , and increasingly successful treatments for cancer . New, beneficial tests and treatments are expected as
10695-450: The permafrost, and it is possible for microorganisms to resume their life functions once it thaws. While some common pathogens such as influenza , smallpox or the bacteria associated with pneumonia have failed to survive intentional attempts to revive them, more cold-adapted microorganisms such as anthrax , or several ancient plant and amoeba viruses, have successfully survived prolonged thaw. Some scientists have argued that
10810-406: The primary reasons for the evolution of antimicrobial resistance. Self-medication with antibiotics is an unsuitable way of using them but a common practice in resource-constrained countries. The practice exposes individuals to the risk of bacteria that have developed antimicrobial resistance. Many people resort to this out of necessity, when access to a physician is unavailable, or when patients have
10925-488: The problem. It is possible that as many as 1 in 3 prescriptions written for antibiotics are unnecessary. Every year, approximately 154 million prescriptions for antibiotics are written. Of these, up to 46 million are unnecessary or inappropriate for the condition that the patient has. Microbes may naturally develop resistance through genetic mutations that occur during cell division, and although random mutations are rare, many microbes reproduce frequently and rapidly, increasing
11040-410: The rate of complications compared with immediate antibiotics, for example. When treating respiratory tract infections , clinical judgement is required as to the appropriate treatment (delayed or immediate antibiotic use). The study, "Shorter and Longer Antibiotic Durations for Respiratory Infections: To Fight Antimicrobial Resistance—A Retrospective Cross-Sectional Study in a Secondary Care Setting in
11155-677: The recession, biomedical research spending decreased 2% in real terms in 2008. Despite an overall increase of investment in biomedical research, there has been stagnation, and in some areas a marked decline in the number of drug and device approvals over the same time period. As of 2010, industry sponsored research accounts for 58% of expenditures, NIH for 27% of expenditures, state governments for 5% of expenditures, non NIH-federal sources for 5% of expenditures and not-for-profit entities accounted for 4% of support. Federally funded biomedical research expenditures increased nominally, 0.7% (adjusted for inflation), from 2003 to 2007. Previous reports showed
11270-449: The resistance to spread across the same species of pathogen or even similar bacterial pathogens. WHO report released April 2014 stated, "this serious threat is no longer a prediction for the future, it is happening right now in every region of the world and has the potential to affect anyone, of any age, in any country. Antibiotic resistance—when bacteria change so antibiotics no longer work in people who need them to treat infections—is now
11385-567: The resources and positions that are required to conduct science. The competition seems to suppress the creativity, cooperation, risk-taking, and original thinking required to make fundamental discoveries. Other consequences of today's highly pressured environment for research appear to be a substantial number of research publications whose results cannot be replicated, and perverse incentives in research funding that encourage grantee institutions to grow without making sufficient investments in their own faculty and facilities. Other risky trends include
11500-419: The short term" during the COVID-19 pandemic. The use of disinfectants such as alcohol-based hand sanitizers, and antiseptic hand wash may also have the potential to increase antimicrobial resistance. Extensive use of disinfectants can lead to mutations that induce antimicrobial resistance. A 2024 United Nations High-Level Meeting on AMR has pledged to reduce deaths associated with bacterial AMR by 10% over
11615-654: The spread of resistance. The WHO claims that AMR is one of the top global public health and development threats, estimating that bacterial AMR was directly responsible for 1.27 million global deaths in 2019 and contributed to 4.95 million deaths . Moreover, the WHO and other international bodies warn that AMR could lead to up to 10 million deaths annually by 2050 unless actions are taken. Global initiatives, such as calls for international AMR treaties, emphasize coordinated efforts to limit misuse, fund research, and provide access to necessary antimicrobials in developing nations. However,
11730-495: The start of what is considered the "doubling period" of rapid NIH support. The second notable period started in 1997 and ended in 2010, a period where the NIH moved to organize research spending for engagement with the scientific community. Since 1980 the share of biomedical research funding from industry sources has grown from 32% to 62%, which has resulted in the development of numerous life-saving medical advances. The relationship between industry and government-funded research in
11845-420: The technology. Both government and industry research funding increased rapidly from between the years of 1994–2003; industry saw a compound average annual growth rate of 8.1% a year and slowed only slightly to a compound average annual growth rate of 5.8% from 2003 to 2008. " Conflict of interest " in the field of medical research has been defined as "a set of conditions in which professional judgment concerning
11960-788: The therapy is medically necessary or superior to cheaper treatments. For example, proton therapy was approved by the FDA, but private health insurers in the United States considered it unproven or unnecessary given its high cost, although it was ultimately covered for certain cancers. Fields of biomedical research include: Antibiotic resistance Antimicrobial resistance ( AMR or AR ) occurs when microbes evolve mechanisms that protect them from antimicrobials , which are drugs used to treat infections. This resistance affects all classes of microbes, including bacteria ( antibiotic resistance), viruses ( antiviral resistance), protozoa ( antiprotozoal resistance), and fungi ( antifungal resistance). Together, these adaptations fall under
12075-814: The transfer of human pathogens. Unused or expired antibiotics, if not disposed of properly, can enter water systems and soil. Discharge from pharmaceutical manufacturing and other industrial companies can also introduce antibiotics and other chemicals into the environment. These factors allow for creating selective pressure for resistant bacteria. Antibiotics used in livestock and aquaculture can contaminate soil and water, which promotes resistance in environmental microbes. Heavy metals such as zinc , copper and mercury , and also biocides and pesticides, can co- select for antibiotic resistance, enhancing their speed. Inadequate treatment of sewage and wastewater allows resistant bacteria and genes to spread through water systems. The antimicrobial resistance crisis also extends to
12190-413: The transfer of resistant bacterial strains into the food that humans eat, causing potentially fatal transfer of disease. While the practice of using antibiotics as growth promoters does result in better yields and meat products, it is a major issue and needs to be decreased in order to prevent antimicrobial resistance. Though the evidence linking antimicrobial usage in livestock to antimicrobial resistance
12305-404: The use of antimicrobial agents and reduce the persistence of multi-drug resistant organisms. Permafrost is a term used to refer to any ground that remained frozen for two years or more, with the oldest known examples continuously frozen for around 700,000 years. In the recent decades, permafrost has been rapidly thawing due to climate change . The cold preserves any organic matter inside
12420-417: The world to date and claims responsibility for numerous innovations that have improved global health. The historical funding of biomedical research has undergone many changes over the past century. Innovations such as the polio vaccine, antibiotics and antipsychotic agents, developed in the early years of the NIH lead to social and political support of the agency. Political initiatives in the early 1990s lead to
12535-467: Was created to support and regulate this curiosity. In 1945, Vannevar Bush said that biomedical scientific research was "the pacemaker of technological progress", an idea which contributed to the initiative to found the National Institutes of Health (NIH) in 1948, a historical benchmark that marked the beginning of a near century substantial investment in biomedical research. The NIH provides more financial support for medical research than any other agency in
12650-637: Was formally created in 1930 under the McNarey Mapes Amendment to oversee the regulation of Food and Drugs in the United States. In 1962 the Kefauver-Harris Amendments to the Food, Drug and Cosmetics Act made it so that before a drug was marketed in the United States the FDA must first approve that the drug was safe. The Kefauver-Harris amendments also mandated that more stringent clinical trials must be performed before
12765-662: Was greater than the savings recognized by consumers no longer purchasing ineffective drugs. In 1984 the Hatch-Waxman Act or the Drug Price Competition and Patent Term Restoration Act of 1984 was passed by congress. The Hatch-Waxman Act was passed with the idea that giving brand manufacturers the ability to extend their patent by an additional 5 years would create greater incentives for innovation and private sector funding for investment. The relationship that exists with industry funded biomedical research
12880-424: Was intended to determine if a diet of vegetables and water was healthier than a diet of wine and red meat. At the experiment endpoint, the trial accomplished its prerogative: the youths who ate only beans and water were noticeably healthier. Scientific curiosity to understand health outcomes from varying treatments has been present for centuries, but it was not until the mid-19th century when an organizational platform
12995-414: Was part of the team that delivered Australia's first IVF baby in 1980. Trounson has also made several ground-breaking discoveries in stem cell research. In 2000, Trounson led the team of scientists which first reported nerve stem cells derived from embryonic stem cells, which led to a dramatic increase in interest in the potential of stem cell research. Medical research Medical research encompasses
13110-409: Was predicted that in 228 countries there would be a total 67% increase in consumption of antibiotics by livestock by 2030. In some countries such as Brazil, Russia, India, China, and South Africa it is predicted that a 99% increase will occur. Several countries have restricted the use of antibiotics in livestock, including Canada, China, Japan, and the US. These restrictions are sometimes associated with
13225-475: Was the first time in Australia that such research had been carried out, and the first time that scientists had worked on this type of stem cell outside the US or Japan. It is based at Monash Science Technology Research and Innovation Precinct and was founded by nine leading Australian universities and medical research institutes. One of the founders of the Centre is Dr Alan Trounson , a Monash scientist who
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