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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.

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101-585: The Lions Eye Institute (LEI) is an Australian medical research institute affiliated with the University of Western Australia . It was established in 1983 with support of the Lions Clubs of Western Australia and headquartered in the Perth suburb of Nedlands , Western Australia . The LEI is a not-for-profit centre of excellence that combines an ophthalmic clinic with scientific discovery developing techniques for

202-425: 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

303-537: A Laser Vision Centre, Western Australia's refractive surgery centre; the Lions Eye Bank , Lions Outback Vision, Lions Optics and the LSSF. The LEI actively participates in numerous clinical trials for the development of new treatments for eye diseases, in collaboration with scientists, ophthalmologists, and pharmaceutical companies. The Institute receives funds from clinic operations and its grants from organisations such as

404-565: 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

505-418: A chronic, painless buildup of pressure in the eye. In primary angle closure glaucoma, the iridocorneal angle is narrowed or completely closed obstructing the flow of aqueous humor to the trabecular meshwork for drainage. This is usually due to the forward displacement of the iris against the cornea, resulting in angle closure. This accumulation of aqueous humor causes an acute increase in pressure and damage to

606-434: 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

707-692: 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

808-616: 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,

909-454: 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

1010-407: 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

1111-402: 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

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1212-531: A family history of glaucoma, and certain medical conditions or the use of some medications. The word glaucoma comes from the Ancient Greek word γλαυκός ( glaukós ), meaning 'gleaming, blue-green, gray'. There are different types of glaucoma, but the most common are called open-angle glaucoma and closed-angle glaucoma . Inside the eye, a liquid called aqueous humor helps to maintain shape and provides nutrients. The aqueous humor normally drains through

1313-402: A lack of aqueous misdirection. Also, the corneal appearance is not as hazy. A reduction in visual acuity can occur followed neuroretinal breakdown. Absolute glaucoma (H44.5) is the end stage of all types of glaucoma. The eye has no vision, absence of pupillary light reflex and pupillary response , and has a stony appearance. Severe pain is present in the eye. The treatment of absolute glaucoma

1414-464: 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

1515-412: A medical emergency due to the risk of impending permanent vision loss, is characterized by sudden ocular pain, seeing halos around lights, red eye , very high intraocular pressure , nausea and vomiting, and suddenly decreased vision. Acute angle closure glaucoma may further present with corneal edema, engorged conjunctival vessels and a fixed and dilated pupil on examination. Opaque specks may occur in

1616-458: 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

1717-608: 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

1818-457: A primary neurodegenerative process may be responsible for degeneration at the optic nerve head in glaucoma. This would be consistent with a possible mechanism of normal tension glaucoma (those with open-angle glaucoma with normal eye pressures) and is supported by evidence showing a correlation of glaucoma with Alzheimer's dementia and other causes of cognitive decline. Both experimental and clinical studies implicate that oxidative stress plays

1919-487: 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

2020-642: A role in the pathogenesis of open-angle glaucoma as well as in Alzheimer's disease. Degeneration of axons of the retinal ganglion cells (the optic nerve) is a hallmark of glaucoma. The inconsistent relationship of glaucomatous optic neuropathy with increased intraocular pressure has provoked hypotheses and studies on anatomic structure, eye development, nerve compression trauma, optic nerve blood flow, excitatory neurotransmitter, trophic factor, retinal ganglion cell or axon degeneration, glial support cell, immune system, aging mechanisms of neuron loss, and severing of

2121-736: 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

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2222-401: 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

2323-798: 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

2424-508: 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

2525-575: Is applied research , or translational research , conducted to expand knowledge in 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

2626-464: Is a destructive procedure like cyclocryoapplication, cyclophotocoagulation, or injection of 99% alcohol. In glaucoma visual field defects result from damage to the retinal nerve fiber layer (RNFL). Field defects are seen mainly in primary open angle glaucoma. Because of the unique anatomy of the RNFL, many noticeable patterns are seen in the visual field. Most of the early glaucomatous changes are seen within

2727-406: Is a function of production of liquid aqueous humor by the ciliary processes of the eye, and its drainage through the trabecular meshwork. Aqueous humor flows from the ciliary processes into the posterior chamber , bounded posteriorly by the lens and the zonules of Zinn , and anteriorly by the iris . It then flows through the pupil of the iris into the anterior chamber , bounded posteriorly by

2828-546: Is a leading cause of blindness in African Americans , Hispanic Americans , and Asians. It occurs more commonly among older people, and closed-angle glaucoma is more common in women. In 2013 for the population aged 40-80 years the global prevalence of glaucoma was estimated at 3.54%, thus affecting 64.3 million worldwide. The same year, there were 2.97 million people in North America with open angle glaucoma. By 2040,

2929-612: Is a matter of debate whether every person with an elevated intraocular pressure should receive glaucoma therapy. As of 2018, most ophthalmologists favored treatment of those with additional risk factors. For eye pressures, a value of 28 hPa (21 mmHg) above atmospheric pressure 1,010 hPa (760 mmHg) is often used, with higher pressures leading to a greater risk. However, some may have high eye pressure for years and never develop damage. Conversely, optic nerve damage may occur with normal pressure, known as normal-tension glaucoma. In case of above-normal intraocular pressure,

3030-488: Is also associated with genetic mutations (including OPA1 and OPTN genes). Additionally, there are some rare genetic conditions that increase the risk of glaucoma, such as Axenfeld-Rieger syndrome and primary congenital glaucoma , which is associated with mutations in CYP1B1 or LTBP2 . They are inherited in an autosomal recessive fashion. Axenfeld-Rieger syndrome is inherited in an autosomal dominant fashion and

3131-503: Is also considered as consequence and cause of vision loss which means that stress management training, autogenic training and other techniques to cope with stress can be helpful. There are several pressure-lowering medication groups that could be used in lowering the IOP, usually eyedrops. The choice of medication usually depends on the dose, duration and the side effects of each medication. However, in general, prostaglandin analogues are

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3232-435: 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,

3333-436: Is an emergency requiring immediate attention. If treated early, it is possible to slow or stop the progression of glaucoma. Regular eye examinations, especially if the person is over 40 or has a family history of glaucoma, are essential for early detection. Treatment typically includes prescription of eye drops, medication , laser treatment or surgery. The goal of these treatments is to decrease eye pressure. Glaucoma

3434-560: Is associated with PITX2 or FOXC1 . The total prevalence of glaucoma is about the same in North America and Asia. However, the prevalence of angle-closure glaucoma is four times higher in Asia than in North America. In the United States, glaucoma is more common in African Americans , Latinos and Asian-Americans . Other factors can cause glaucoma, known as "secondary glaucoma", including prolonged use of steroids (steroid-induced glaucoma); conditions that severely restrict blood flow to

3535-598: Is expected to accelerate the development of ARMD leading to an effective treatment. At the LEI, the first artificial cornea , the AlphaCor was developed and implanted into a human eye. The LEI is acknowledged as a core academic centre involved in clinical trials of new pharmaceutical therapies and surgical procedures before government approval. For example, the Xen Gel Stent , an implantable transcleral microsurgical device developed at

3636-544: 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

3737-601: Is increased about two- to four-fold for people who have a sibling with glaucoma. Glaucoma, particularly primary open-angle glaucoma, is associated with mutations in several genes , including MYOC , ASB10, WDR36 , NTF4 , TBK1 , and RPGRIP1 . Many of these genes are involved in critical cellular processes that are implicated in the development and progression of glaucoma, including regulation of intraocular pressure, retinal ganglion cell health, and optic nerve function. Normal-tension glaucoma, which comprises 30-90% of primary open-angle glaucoma (depending on ethnic group),

3838-483: 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

3939-513: 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

4040-431: Is open-angle glaucoma with an unexplained significant rise of intraocular pressure following unknown pathogenesis. Intraocular pressure can sometimes reach 80 mmHg (11 kPa). It characteristically manifests as ciliary body inflammation and massive trabecular edema that sometimes extends to Schlemm's canal. This condition is differentiated from malignant glaucoma by the presence of a deep and clear anterior chamber and

4141-403: 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

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4242-597: 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

4343-601: 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

4444-649: The National Health and Medical Research Council , individual benefactors and the LSSF. The LEI provides a range of services including standard clinical services, LASIK surgery at the Lions Laser Vision Center, cataract micro-surgery and lens implantation, plastic surgery of the eyelids and full optometric service at Lions Optics. The Lions Eye Bank collects and distributes corneal tissue, scleral tissue and supplies thousands of corneal transplants throughout Western Australia. The Institute initiated

4545-681: 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

4646-431: 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

4747-585: The lamina cribrosa . Thus increases in intraocular pressure would cause nerve damage as seen in glaucoma. The vascular theory hypothesizes that a decreased blood supply to the retinal ganglions cells leads to nerve damage. This decrease in blood supply may be due to increasing intraocular pressures, and may also be due to systemic hypotension, vasospasm or atherosclerosis. This is supported by evidence that those with low blood pressure, particularly low diastolic blood pressure, are at an increased risk of glaucoma. The primary neurodegeneration theory hypothesizes that

4848-409: The optic nerve . The optic nerve transmits visual information from the eye to the brain. Glaucoma may cause vision loss if left untreated. It has been called the "silent thief of sight" because the loss of vision usually occurs slowly over a long period of time. A major risk factor for glaucoma is increased pressure within the eye, known as intraocular pressure (IOP) . It is associated with old age,

4949-421: The retina or ciliary body . Individuals with poor blood flow to the eye are highly at risk for this condition. Neovascular glaucoma results when new, abnormal vessels begin developing in the angle of the eye that begin blocking the drainage. People with such condition begin to rapidly lose their eyesight. Sometimes, the disease appears very rapidly, especially after cataract surgery procedures. Toxic glaucoma

5050-425: The trabecular meshwork . In open-angle glaucoma, the draining is impeded, causing the liquid to accumulate and pressure inside the eye to increase. This elevated pressure can damage the optic nerve. In closed-angle glaucoma, the drainage of the eye becomes suddenly blocked, leading to a rapid increase in intraocular pressure. This may lead to intense eye pain , blurred vision , and nausea . Closed-angle glaucoma

5151-596: The American Academy of Ophthalmology. There is a glaucoma screening program in the UK. Those at risk are advised to have an eye examination at least once a year. The goal of glaucoma management for patients with increased intraocular pressure is to decrease the intraocular pressure (IOP), thus slowing the progression of glaucoma and preserving the quality of life for patients, with minimal side-effects. This requires appropriate diagnostic techniques and follow-up examinations, and judicious selection of treatments for

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5252-621: The American Juvenile Diabetes Foundation, Swedish University of Agricultural Sciences , University of Missouri and the National Eye Institute (USA). Research carried out by the Institute teams led to the first retinal vein bypass treatment of blockages, and the development of the first transgenic mouse model for Age-Related Macular Degeneration , the leading cause of blindness for people over 55. This model

5353-559: The Australian Foundation for the Prevention of Blindness. Its ophthalmologists also consult at Perth's main teaching public hospitals including Sir Charles Gairdner Hospital , Royal Perth Hospital and Fremantle Hospital . The LEI teams investigate all major causes of blindness including cataracts, diabetes related eye disease, glaucoma , retinal degenerations, corneal , and immune -based diseases. More than 70 scientists at

5454-803: 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),

5555-564: 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

5656-711: The Institute created in partnership with the University of Western Australia , the Centre for Ophthalmology and Visual Science (COVS). This centre has an independent University status within the Faculty of Medicine and Dentistry. In 2003, the LEI revised its basis of incorporation from a public benevolent charitable institution to a not-for profit limited liability company. The LEI employs scientists, clinicians , and support staff to conduct scientific research into blindness with known ophthalmic practices in Australia. The Institute also includes

5757-513: The LEI use a range of technologies to develop treatments for blinding diseases, including gene therapy and telemedicine . The LEI has national and international institutional partnerships including American Juvenile Diabetes Foundation, Shanghai University, Swedish University of Agricultural Science, University of Missouri and the National Eye Institute (USA). For example, the LEI participates in joint research and development projects with

5858-452: The LEI's core activities. In 1983, under Professor Ian Constable 's guidance, the LEI, a not-for-profit organisation was established. With Constable, the LEI became an international centre for scientific research into blindness. Following its development, it relocated to the grounds of Sir Charles Gairdner Hospital. Its current Managing Director Bill Morgan leads a team of clinicians, medical professionals, researchers and support staff. In 1994,

5959-447: The LEI, was approved for use in the US by the FDA in 2016. Medical research Medical research encompasses 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

6060-974: The Pilbara Aboriginal Eye Health Program, a strategy targeting indigenous people who suffer from diabetes and associated blinding eye diseases prevalent within the Aboriginal population . As part of the Australian Government aid to the Indonesian Government, In July 2007, the LEI was instrumental in setting up the Bali Mandara Eye Hospital which was handed over to the Indonesian Government on 13 October 2015. The LEI provides open consultations and health education seminars in cooperation with several organisations including Glaucoma Australia, Retinitis Pigmentosa Society of Western Australia, Macular Degeneration Foundation and

6161-498: The U.S. had glaucoma, with 1.49 million experiencing vision impairment due to the condition, according to a meta-analysis. The study found that Black adults were about twice as likely to be affected by glaucoma as white adults. Glaucoma prevalence was 1.62% among individuals aged 18 and older and 2.56% among those aged 40 and older, while vision-affecting glaucoma occurred in 0.57% and 0.91% of these age groups, respectively. Open angle glaucoma usually presents with no symptoms early in

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6262-400: 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

6363-430: 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

6464-676: 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

6565-533: 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

6666-439: The aqueous humor from the eye. This contact between iris and trabecular meshwork (TM) may gradually damage the function of the meshwork until it fails to keep pace with aqueous production, and the pressure rises. In over half of all cases, prolonged contact between iris and TM causes the formation of synechiae (effectively "scars"). These cause permanent obstruction of aqueous outflow. In some cases, pressure may rapidly build up in

6767-419: 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

6868-460: The central visual field, mainly in Bjerrum's area, 10-20° from fixation. Following are the common glaucomatous field defects: The United States Preventive Services Task Force stated, as of 2013, that there was insufficient evidence to recommend for or against screening for glaucoma. Therefore, there is no national screening program in the US. Screening, however, is recommended starting at age 40 by

6969-491: The course of the disease. However, it may gradually progress to involve difficulties with vision. It usually involves deficits in the peripheral vision followed by central vision loss as the disease progresses, but less commonly it may present as central vision loss or patchy areas of vision loss. On an eye examination, optic nerve changes are seen indicating damage to the optic nerve head (increased cup-to-disc ratio on fundoscopic examination ). Acute angle closure glaucoma,

7070-402: 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

7171-431: The drainage angle ( gonioscopy ), and retinal nerve fiber layer assessment with a fundus examination, measuring corneal thickness ( pachymetry ), and visual field testing . Glaucoma has been classified into specific types: Primary glaucoma (H40.1-H40.2) Variants of primary glaucoma Primary angle closure glaucoma is caused by contact between the iris and trabecular meshwork, which in turn obstructs outflow of

7272-480: 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

7373-484: 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

7474-407: The eye) is an important risk factor for glaucoma, but only about 10-70% of people - depending on ethnic group - with primary open-angle glaucoma actually have elevated ocular pressure. Ocular hypertension—an intraocular pressure above the traditional threshold of 21 mmHg (28 hPa) or even above 24 mmHg (32 hPa)—is not necessarily a pathological condition, but it increases

7575-408: The eye, causing pain and redness (symptomatic, or so-called "acute" angle closure). In this situation, the vision may become blurred, and halos may be seen around bright lights. Accompanying symptoms may include a headache and vomiting. Diagnosis is made from physical signs and symptoms: pupils mid-dilated and unresponsive to light, cornea edematous (cloudy), reduced vision, redness, and pain. However,

7676-553: The eye, such as severe diabetic retinopathy and central retinal vein occlusion (neovascular glaucoma); ocular trauma (angle-recession glaucoma); plateau iris ; and inflammation of the middle layer of the pigmented vascular eye structure ( uveitis ), known as uveitic glaucoma . The main effect of glaucoma is damage to the optic nerve. Eventually, this damage leads to vision loss, which can deteriorate with time. The underlying cause of open-angle glaucoma remains unclear. Several theories exist on its exact etiology. Intraocular pressure

7777-418: 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

7878-510: The individual patient. Although increased IOP is only one of the major risk factors for glaucoma, lowering it via various pharmaceuticals and/or surgical techniques is currently the mainstay of glaucoma treatment. Vascular flow and neurodegenerative theories of glaucomatous optic neuropathy have prompted studies on various neuroprotective therapeutic strategies, including nutritional compounds, some of which may be regarded by clinicians as safe for use now, while others are on trial. Mental stress

7979-479: The iris and anteriorly by the cornea . From here, the trabecular meshwork drains aqueous humor via the scleral venous sinus ( Schlemm's canal ) into scleral plexuses and general blood circulation. In open/wide-angle glaucoma, flow is reduced through the trabecular meshwork, due to the degeneration and obstruction of the trabecular meshwork, whose original function is to absorb the aqueous humor. Loss of aqueous humor absorption leads to increased resistance and thus

8080-415: The lens in glaucoma, known as glaukomflecken. The word is German, meaning "glaucoma-specks". Glaucoma can affect anyone. Some people have a higher risk or susceptibility to develop glaucoma due to certain risk factors . Risk factors for glaucoma include increasing age, high intraocular pressure, a family history of glaucoma, and use of steroid medication. Ocular hypertension (increased pressure within

8181-459: 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

8282-408: 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%,

8383-524: The majority of cases are asymptomatic. Prior to the very severe loss of vision, these cases can only be identified by examination, generally by an eye care professional. Developmental glaucoma (Q15.0) Secondary glaucoma (H40.3-H40.6) Neovascular glaucoma , an uncommon type of glaucoma, is difficult or nearly impossible to treat, and is often caused by proliferative diabetic retinopathy (PDR) or central retinal vein occlusion (CRVO). It may also be triggered by other conditions that result in ischemia of

8484-431: The mechanism of open-angle glaucoma is believed to be the impeded exit of aqueous humor through the trabecular meshwork, while in closed-angle glaucoma the iris blocks the trabecular meshwork. Diagnosis is achieved by performing an eye examination . Often, the optic nerve shows an abnormal amount of cupping . Positive family history is a risk factor for glaucoma. The relative risk of having primary open-angle glaucoma

8585-471: 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

8686-467: The nerve fibers at the scleral edge. Screening for glaucoma is an integral part of a standard eye examination performed by optometrists and ophthalmologists. The workup for glaucoma involves taking a thorough case history, with the emphasis on assessment of risk factors. The baseline glaucoma evaluation tests include intraocular pressure measurement by using tonometry, anterior chamber angle assessment by optical coherence tomography , inspecting

8787-438: The optic nerve. The pathophysiology of glaucoma is not well understood. There are several theories regarding the mechanism of the damage to the optic nerve in glaucoma. The biomechanical theory hypothesizes that the retinal ganglion cell axons (which form the optic nerve head and the retinal nerve fiber layer) are particularly susceptible to mechanical damage from increases in the intraocular pressure as they pass through pores at

8888-558: 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

8989-756: The prevalence of all types of glaucoma was projected to increase to 111.82 million worldwide and to 4.72 million in North America. Globally, glaucoma is the second-leading cause of blindness , while cataracts are a more common cause. In the United States, glaucoma is a leading cause of blindness for African Americans, who have higher rates of primary open-angle glaucoma, and Hispanic Americans . Bilateral vision loss can negatively affect mobility and interfere with driving. A meta-analysis published in 2009 found that people with primary open angle glaucoma do not have increased mortality rates , or increased risk of cardiovascular death. A 2024 JAMA Ophthalmology reports that in 2022 an estimated 4.22 million people in

9090-978: The prevention of blindness and the reduction of pain from blinding eye conditions. At a 1970 convention in Albany, Western Australia , the Western Australian Lions Clubs created the Lions Save Sight Foundation (WA) Inc. with the aim of leading the development of ophthalmic care. In 1975 the Lions Save-Sight Foundation (LSSF) established the Lions Chair in Ophthalmology at the University of Western Australia. Since its establishment, clinical facilities, new equipment, and research laboratories have been strategically commissioned to support

9191-677: 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

9292-567: 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

9393-479: The risk of developing glaucoma. A study with 1636 persons aged 40-80 who had an intraocular pressure above 24   mmHg in at least one eye but no indications of eye damages showed that after five years 9.5% of the untreated participants and 4.4% of the treated participants had developed glaucomatous symptoms, meaning that only about one in ten untreated people with elevated intraocular pressure will develop glaucomatous symptoms over that period of time. Therefore, it

9494-495: 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

9595-420: 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

9696-420: 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: Glaucoma Glaucoma is a group of eye diseases that can lead to damage of

9797-417: 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

9898-467: 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

9999-612: 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

10100-644: 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

10201-424: 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

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