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115-426: Medical foundations are independent organizations of scientists, physicians and support personnel to investigate key medical challenges and emerging health needs. They provide more flexibility than traditional clinics and hospitals, but more stability than many university-based research organizations. Most focus on stated research priorities and governed by a board of medical and scientific experts. Foundations often have

230-424: A retrovirus that attacks the immune system . It is a preventable disease . There is no vaccine or cure for HIV. It can be managed with treatment and become a manageable chronic health condition. While there is no cure or vaccine, antiretroviral treatment can slow the course of the disease and enable people living with HIV to lead long and healthy lives. An HIV-positive person on treatment can expect to live

345-621: A 10- to 20-fold reduction in transmission risk. Pre-exposure prophylaxis for HIV (" PrEP ") with a daily dose of the medications tenofovir , with or without emtricitabine , is effective in people at high risk including men who have sex with men, couples where one is HIV-positive, and young heterosexuals in Africa. It may also be effective in intravenous drug users, with a study finding a decrease in risk of 0.7 to 0.4 per 100 person years. The USPSTF , in 2019, recommended PrEP in those who are at high risk. Universal precautions within

460-425: 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

575-576: 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

690-532: A brief period of influenza-like illness . During this period the person may not know that they are HIV-positive, yet they will be able to pass on the virus . Typically, this period is followed by a prolonged incubation period with no symptoms. Eventually the HIV infection increases the risk of developing other infections such as tuberculosis , as well as other opportunistic infections , and tumors which are rare in people who have normal immune function. The late stage

805-434: 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

920-692: 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

1035-631: 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,

1150-406: A couple in which one person is infected, the rate of HIV infection is less than 1% per year. There is some evidence to suggest that female condoms may provide an equivalent level of protection. Application of a vaginal gel containing tenofovir (a reverse transcriptase inhibitor ) immediately before sex seems to reduce infection rates by approximately 40% among African women. By contrast, use of

1265-454: 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

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1380-407: 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

1495-402: 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

1610-451: A factor. During the chronic phase, the consequences of generalized immune activation coupled with the gradual loss of the ability of the immune system to generate new T cells appear to account for the slow decline in CD4 T cell numbers. Although the symptoms of immune deficiency characteristic of AIDS do not appear for years after a person is infected, the bulk of CD4 T cell loss occurs during

1725-404: A high viral load and the cut was deep. In the United States, intravenous drug users made up 12% of all new cases of HIV in 2009, and in some areas more than 80% of people who inject drugs are HIV-positive. HIV is transmitted in about 90% of blood transfusions using infected blood. In developed countries the risk of acquiring HIV from a blood transfusion is extremely low (less than one in half

1840-464: 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

1955-402: A long incubation period . Lentiviruses are transmitted as single-stranded, positive- sense , enveloped RNA viruses . Upon entry into the target cell, the viral RNA genome is converted (reverse transcribed) into double-stranded DNA by a virally encoded reverse transcriptase that is transported along with the viral genome in the virus particle. The resulting viral DNA is then imported into

2070-589: A medical facility or medical university, which provides patients for whom traditional therapies have not been effective. These include the Duke ALS clinic. Some provide social psychological therapies, such as the Freedom from Torture foundation in the UK, which provides treatment for victims of torture. Medical research Medical research (or biomedical research ), also known as health research , refers to

2185-493: A million) where improved donor selection and HIV screening is performed; for example, in the UK the risk is reported at one in five million and in the United States it was one in 1.5 million in 2008. In low-income countries, only half of transfusions may be appropriately screened (as of 2008), and it is estimated that up to 15% of HIV infections in these areas come from transfusion of infected blood and blood products, representing between 5% and 10% of global infections. It

2300-401: A needle during drug injection is between 0.63% and 2.4% per act, with an average of 0.8%. The risk of acquiring HIV from a needle stick from an HIV-infected person is estimated as 0.3% (about 1 in 333) per act and the risk following mucous membrane exposure to infected blood as 0.09% (about 1 in 1000) per act. This risk may, however, be up to 5% if the introduced blood was from a person with

2415-461: 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

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2530-468: A normal life, and die with the virus, not of it. Effective treatment for HIV-positive people (people living with HIV ) involves a life-long regimen of medicine to suppress the virus, making the viral load undetectable. Without treatment it can lead to a spectrum of conditions including acquired immunodeficiency syndrome ( AIDS ). Treatment is recommended as soon as the diagnosis is made. An HIV-positive person who has an undetectable viral load as

2645-621: 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

2760-616: A process of cell-to-cell spread. The hybrid spreading mechanisms of HIV contribute to the virus' ongoing replication against antiretroviral therapies. Two types of HIV have been characterized: HIV-1 and HIV-2. HIV-1 is the virus that was originally discovered (and initially referred to also as LAV or HTLV-III). It is more virulent , more infective , and is the cause of the majority of HIV infections globally. The lower infectivity of HIV-2 as compared with HIV-1 implies that fewer people exposed to HIV-2 will be infected per exposure. Because of its relatively poor capacity for transmission, HIV-2

2875-430: A result of long-term treatment has effectively no risk of transmitting HIV sexually. Campaigns by UNAIDS and organizations around the world have communicated this as Undetectable = Untransmittable . Without treatment the infection can interfere with the immune system , and eventually progress to AIDS , sometimes taking many years. Following initial infection an individual may not notice any symptoms, or may experience

2990-496: 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

3105-736: 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

3220-406: A sexually transmitted illness. In many areas of the world, a third of HIV carriers only discover they are infected at an advanced stage of the disease when AIDS or severe immunodeficiency has become apparent. Most people infected with HIV develop seroconverted (antigen-specific) antibodies within three to twelve weeks after the initial infection. Diagnosis of primary HIV before seroconversion

3335-401: 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

3450-798: 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

3565-508: 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

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3680-575: 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

3795-433: Is almost invariably associated with activation of CD8 T cells , which kill HIV-infected cells, and subsequently with antibody production, or seroconversion . The CD8 T cell response is thought to be important in controlling virus levels, which peak and then decline, as the CD4 T cell counts recover. A good CD8 T cell response has been linked to slower disease progression and a better prognosis, though it does not eliminate

3910-538: Is also believed to carry an increased risk of HIV transmission as condoms are rarely worn, physical trauma to the vagina or rectum is likely, and there may be a greater risk of concurrent sexually transmitted infections. The second-most frequent mode of HIV transmission is via blood and blood products. Blood-borne transmission can be through needle-sharing during intravenous drug use, needle-stick injury, transfusion of contaminated blood or blood product, or medical injections with unsterilized equipment. The risk from sharing

4025-435: 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,

4140-478: Is called acute HIV, primary HIV or acute retroviral syndrome. Many individuals develop an illness like influenza , mononucleosis or glandular fever 2–4 weeks after exposure while others have no significant symptoms. Symptoms occur in 40–90% of cases and most commonly include fever , large tender lymph nodes , throat inflammation , a rash , headache, tiredness, and/or sores of the mouth and genitals. The rash, which occurs in 20–50% of cases, presents itself on

4255-653: Is defined as an HIV infection with either a CD4 T cell count below 200 cells per μL or the occurrence of specific diseases associated with HIV infection. In the absence of specific treatment, around half of people infected with HIV develop AIDS within ten years. The most common initial conditions that alert to the presence of AIDS are pneumocystis pneumonia (40%), cachexia in the form of HIV wasting syndrome (20%), and esophageal candidiasis . Other common signs include recurrent respiratory tract infections . Opportunistic infections may be caused by bacteria , viruses , fungi , and parasites that are normally controlled by

4370-760: Is disputed, and whether it is of benefit in developed countries and among men who have sex with men is undetermined. Programs encouraging sexual abstinence do not appear to affect subsequent HIV risk. Evidence of any benefit from peer education is equally poor. Comprehensive sexual education provided at school may decrease high-risk behavior. A substantial minority of young people continues to engage in high-risk practices despite knowing about HIV/AIDS, underestimating their own risk of becoming infected with HIV. Voluntary counseling and testing people for HIV does not affect risky behavior in those who test negative but does increase condom use in those who test positive. Enhanced family planning services appear to increase

4485-422: Is done by measuring HIV- RNA or p24 antigen . Positive results obtained by antibody or PCR testing are confirmed either by a different antibody or by PCR. Antibody tests in children younger than 18 months are typically inaccurate, due to the continued presence of maternal antibodies . Thus HIV infection can only be diagnosed by PCR testing for HIV RNA or DNA, or via testing for the p24 antigen. Much of

4600-595: Is especially high, estimated as 1.4–1.7% per act in both heterosexual and homosexual contacts. While the risk of transmission from oral sex is relatively low, it is still present. The risk from receiving oral sex has been described as "nearly nil"; however, a few cases have been reported. The per-act risk is estimated at 0–0.04% for receptive oral intercourse. In settings involving prostitution in low-income countries, risk of female-to-male transmission has been estimated as 2.4% per act, and of male-to-female transmission as 0.05% per act. Risk of transmission increases in

4715-559: 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

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4830-400: Is largely confined to West Africa . After the virus enters the body, there is a period of rapid viral replication , leading to an abundance of virus in the peripheral blood. During primary infection, the level of HIV may reach several million virus particles per milliliter of blood. This response is accompanied by a marked drop in the number of circulating CD4 T cells . The acute viremia

4945-497: 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

5060-531: Is often also associated with unintended weight loss . Without treatment a person living with HIV can expect to live for 11 years. Early testing can show if treatment is needed to stop this progression and to prevent infecting others. HIV is spread primarily by unprotected sex (including anal and vaginal sex ), contaminated hypodermic needles or blood transfusions , and from mother to child during pregnancy , delivery, or breastfeeding. Some bodily fluids, such as saliva, sweat, and tears, do not transmit

5175-519: 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

5290-565: Is possible to acquire HIV from organ and tissue transplantation , although this is rare because of screening . Unsafe medical injections play a role in HIV spread in sub-Saharan Africa . In 2007, between 12% and 17% of infections in this region were attributed to medical syringe use. The World Health Organization estimates the risk of transmission as a result of a medical injection in Africa at 1.2%. Risks are also associated with invasive procedures, assisted delivery, and dental care in this area of

5405-420: Is referred to as post-exposure prophylaxis (PEP). The use of the single agent zidovudine reduces the risk of an HIV infection five-fold following a needle-stick injury. As of 2013 , the prevention regimen recommended in the United States consists of three medications— tenofovir , emtricitabine and raltegravir —as this may reduce the risk further. PEP treatment is recommended after a sexual assault when

5520-542: Is spread by three main routes: sexual contact , significant exposure to infected body fluids or tissues, and from mother to child during pregnancy, delivery, or breastfeeding (known as vertical transmission ). There is no risk of acquiring HIV if exposed to feces , nasal secretions, saliva, sputum , sweat, tears, urine, or vomit unless these are contaminated with blood. It is also possible to be co-infected by more than one strain of HIV—a condition known as HIV superinfection . The most frequent mode of transmission of HIV

5635-403: 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

5750-467: Is through sexual contact with an infected person. However, an HIV-positive person who has an undetectable viral load as a result of long-term treatment has effectively no risk of transmitting HIV sexually, known as Undetectable = Untransmittable . The existence of functionally noncontagious HIV-positive people on antiretroviral therapy was controversially publicized in the 2008 Swiss Statement , and has since become accepted as medically sound. Globally,

5865-601: 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

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5980-621: 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

6095-661: 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

6210-590: The WHO disease staging system for HIV infection and disease , and the CDC classification system for HIV infection . The CDC's classification system is more frequently adopted in developed countries. Since the WHO's staging system does not require laboratory tests, it is suited to the resource-restricted conditions encountered in developing countries, where it can also be used to help guide clinical management. Despite their differences,

6325-622: The World Health Organization (WHO) African Region. HIV/AIDS is considered a pandemic —a disease outbreak which is present over a large area and is actively spreading. The United States' National Institutes of Health (NIH) and the Gates Foundation have pledged $ 200 million focused on developing a global cure for AIDS. There are three main stages of HIV infection: acute infection, clinical latency, and AIDS. The initial period following infection with HIV

6440-431: 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

6555-609: The spermicide nonoxynol-9 may increase the risk of transmission due to its tendency to cause vaginal and rectal irritation. Circumcision in sub-Saharan Africa "reduces the acquisition of HIV by heterosexual men by between 38% and 66% over 24 months". Owing to these studies, both the World Health Organization and UNAIDS recommended male circumcision in 2007 as a method of preventing female-to-male HIV transmission in areas with high rates of HIV. However, whether it protects against male-to-female transmission

6670-493: The CCR5 protein when present in both chromosomes very effectively prevents HIV-1 infection. HIV seeks out and destroys CCR5 expressing CD4 T cells during acute infection. A vigorous immune response eventually controls the infection and initiates the clinically latent phase. CD4 T cells in mucosal tissues remain particularly affected. Continuous HIV replication causes a state of generalized immune activation persisting throughout

6785-829: 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),

6900-567: 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

7015-634: The Medical Research Foundation in London and Doris Duke Charitable Foundation. A research foundation is focused on making laboratory breakthroughs that have a tangible impact on human health. They push the boundaries of biomedical science by performing basic and applied research into the causes of diseases and novel treatment therapies. Clinical research foundations provide independent treatment centers with emerging treatments and drugs. Clinical foundations tend to be associated with

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7130-400: 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

7245-430: 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

7360-687: 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

7475-533: 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

7590-565: The absence of treatment will eventually progress to AIDS, a small proportion (about 5%) retain high levels of CD4 T cells ( T helper cells ) without antiretroviral therapy for more than five years. These individuals are classified as "HIV controllers" or long-term nonprogressors (LTNP). Another group consists of those who maintain a low or undetectable viral load without anti-retroviral treatment, known as "elite controllers" or "elite suppressors". They represent approximately 1 in 300 infected persons. Acquired immunodeficiency syndrome (AIDS)

7705-499: The absence of treatment, the risk of transmission before or during birth is around 20%, and in those who also breastfeed 35%. Treatment decreases this risk to less than 5%. Antiretrovirals when taken by either the mother or the baby decrease the risk of transmission in those who do breastfeed. If blood contaminates food during pre-chewing it may pose a risk of transmission. If a woman is untreated, two years of breastfeeding results in an HIV/AIDS risk in her baby of about 17%. Due to

7820-515: The acute phase of disease. HIV/AIDS is diagnosed via laboratory testing and then staged based on the presence of certain signs or symptoms . HIV screening is recommended by the United States Preventive Services Task Force for all people 15 years to 65 years of age, including all pregnant women. Additionally, testing is recommended for those at high risk, which includes anyone diagnosed with

7935-406: The cell nucleus and integrated into the cellular DNA by a virally encoded integrase and host co-factors. Once integrated, the virus may become latent , allowing the virus and its host cell to avoid detection by the immune system. Alternatively, the virus may be transcribed , producing new RNA genomes and viral proteins that are packaged and released from the cell as new virus particles that begin

8050-419: 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

8165-425: The chronic phase. Immune activation, which is reflected by the increased activation state of immune cells and release of pro-inflammatory cytokines , results from the activity of several HIV gene products and the immune response to ongoing HIV replication. It is also linked to the breakdown of the immune surveillance system of the gastrointestinal mucosal barrier caused by the depletion of mucosal CD4 T cells during

8280-402: 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

8395-620: The early 1980s, HIV/AIDS has had a large impact on society, both as an illness and as a source of discrimination . The disease also has large economic impacts . There are many misconceptions about HIV/AIDS , such as the belief that it can be transmitted by casual non-sexual contact. The disease has become subject to many controversies involving religion , including the Catholic Church's position not to support condom use as prevention. It has attracted international medical and political attention as well as large-scale funding since it

8510-480: 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

8625-424: The end of this stage many people experience fever, weight loss, gastrointestinal problems and muscle pains. Between 50% and 70% of people also develop persistent generalized lymphadenopathy , characterized by unexplained, non-painful enlargement of more than one group of lymph nodes (other than in the groin) for over three to six months. Although most HIV-1 infected individuals have a detectable viral load and in

8740-493: 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

8855-465: The first 2.5 months of an HIV infection, a person's infectiousness is twelve times higher due to the high viral load associated with acute HIV. If the person is in the late stages of infection, rates of transmission are approximately eightfold greater. Commercial sex workers (including those in pornography ) have an increased likelihood of contracting HIV. Rough sex can be a factor associated with an increased risk of transmission. Sexual assault

8970-418: 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

9085-491: The first weeks of infection, especially in the intestinal mucosa, which harbors the majority of the lymphocytes found in the body. The reason for the preferential loss of mucosal CD4 T cells is that the majority of mucosal CD4 T cells express the CCR5 protein which HIV uses as a co-receptor to gain access to the cells, whereas only a small fraction of CD4 T cells in the bloodstream do so. A specific genetic change that alters

9200-409: The flexibility to transcend local barriers and collaborate internationally. While all medical foundations are non-profits focused on creating advances in medical knowledge, there are a variety of types of foundations, providing funding, research or clinical trials. Some medical foundations exist to fund focus donations from private and corporate funds into strategic research efforts. Examples include

9315-414: The health care environment are believed to be effective in decreasing the risk of HIV. Intravenous drug use is an important risk factor, and harm reduction strategies such as needle-exchange programs and opioid substitution therapy appear effective in decreasing this risk. A course of antiretrovirals administered within 48 to 72 hours after exposure to HIV-positive blood or genital secretions

9430-425: The human immune system such as CD4 T cells, macrophages and dendritic cells . It directly and indirectly destroys CD4 T cells. HIV is a member of the genus Lentivirus , part of the family Retroviridae . Lentiviruses share many morphological and biological characteristics. Many species of mammals are infected by lentiviruses, which are characteristically responsible for long-duration illnesses with

9545-400: The immune system. Which infections occur depends partly on what organisms are common in the person's environment. These infections may affect nearly every organ system . People with AIDS have an increased risk of developing various viral-induced cancers, including Kaposi's sarcoma , Burkitt's lymphoma , primary central nervous system lymphoma , and cervical cancer . Kaposi's sarcoma is

9660-407: The increased risk of death without breastfeeding in many areas in the developing world, the World Health Organization recommends either exclusive breastfeeding or the provision of safe formula. All women known to be HIV-positive should be taking lifelong antiretroviral therapy. HIV is the cause of the spectrum of disease known as HIV/AIDS. HIV is a retrovirus that primarily infects components of

9775-460: The infection in five groups. In those greater than six years of age it is: For surveillance purposes, the AIDS diagnosis still stands even if, after treatment, the CD4 T cell count rises to above 200 per μL of blood or other AIDS-defining illnesses are cured. Consistent condom use reduces the risk of HIV transmission by approximately 80% over the long term. When condoms are used consistently by

9890-528: The layer that lines the inner part of eyelids and the white part of the eye) is also more common in those with HIV. Additionally, people with AIDS frequently have systemic symptoms such as prolonged fevers, sweats (particularly at night), swollen lymph nodes, chills, weakness, and unintended weight loss . Diarrhea is another common symptom, present in about 90% of people with AIDS. They can also be affected by diverse psychiatric and neurological symptoms independent of opportunistic infections and cancers. HIV

10005-459: 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

10120-413: The likelihood of women with HIV using contraception, compared to basic services. It is not known whether treating other sexually transmitted infections is effective in preventing HIV. Antiretroviral treatment among people with HIV whose CD4 count ≤ 550 cells/μL is a very effective way to prevent HIV infection of their partner (a strategy known as treatment as prevention, or TASP). TASP is associated with

10235-408: 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%,

10350-539: The many common infectious diseases with similar symptoms. Someone with an unexplained fever who may have been recently exposed to HIV should consider testing to find out if they have been infected. The initial symptoms are followed by a stage called clinical latency, asymptomatic HIV, or chronic HIV. Without treatment, this second stage of the natural history of HIV infection can last from about three years to over 20 years (on average, about eight years). While typically there are few or no symptoms at first, near

10465-437: The most common cancer, occurring in 10% to 20% of people with HIV. The second-most common cancer is lymphoma, which is the cause of death of nearly 16% of people with AIDS and is the initial sign of AIDS in 3% to 4%. Both these cancers are associated with human herpesvirus 8 (HHV-8). Cervical cancer occurs more frequently in those with AIDS because of its association with human papillomavirus (HPV). Conjunctival cancer (of

10580-608: The most common mode of HIV transmission is via sexual contacts between people of the opposite sex ; however, the pattern of transmission varies among countries. As of 2017 , most HIV transmission in the United States occurred among men who had sex with men (82% of new HIV diagnoses among males aged 13 and older and 70% of total new diagnoses). In the US, gay and bisexual men aged 13 to 24 accounted for an estimated 92% of new HIV diagnoses among all men in their age group and 27% of new diagnoses among all gay and bisexual men. With regard to unprotected heterosexual contacts, estimates of

10695-475: 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

10810-558: 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

10925-453: The presence of many sexually transmitted infections and genital ulcers . Genital ulcers increase the risk approximately fivefold. Other sexually transmitted infections, such as gonorrhea , chlamydia , trichomoniasis , and bacterial vaginosis , are associated with somewhat smaller increases in risk of transmission. The viral load of an infected person is an important risk factor in both sexual and mother-to-child transmission. During

11040-529: 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. 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

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

11270-434: The replication cycle anew. HIV is now known to spread between CD4 T cells by two parallel routes: cell-free spread and cell-to-cell spread, i.e. it employs hybrid spreading mechanisms. In the cell-free spread, virus particles bud from an infected T cell, enter the blood/extracellular fluid and then infect another T cell following a chance encounter. HIV can also disseminate by direct transmission from one cell to another by

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

11500-487: The risk of HIV transmission per sexual act appear to be four to ten times higher in low-income countries than in high-income countries. In low-income countries, the risk of female-to-male transmission is estimated as 0.38% per act, and of male-to-female transmission as 0.30% per act; the equivalent estimates for high-income countries are 0.04% per act for female-to-male transmission, and 0.08% per act for male-to-female transmission. The risk of transmission from anal intercourse

11615-495: 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

11730-420: 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

11845-400: 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: AIDS The human immunodeficiency virus ( HIV ) is

11960-480: The trunk and is maculopapular , classically. Some people also develop opportunistic infections at this stage. Gastrointestinal symptoms, such as vomiting or diarrhea may occur. Neurological symptoms of peripheral neuropathy or Guillain–Barré syndrome also occur. The duration of the symptoms varies, but is usually one or two weeks. These symptoms are not often recognized as signs of HIV infection. Family doctors or hospitals can misdiagnose cases as one of

12075-552: The two systems allow a comparison for statistical purposes. The World Health Organization first proposed a definition for AIDS in 1986. Since then, the WHO classification has been updated and expanded several times, with the most recent version being published in 2007. The WHO system uses the following categories: The U.S. Centers for Disease Control and Prevention also created a classification system for HIV, and updated it in 2008 and 2014. This system classifies HIV infections based on CD4 count and clinical symptoms, and describes

12190-502: The virus. Ultimately, HIV causes AIDS by depleting CD4 T cells. This weakens the immune system and allows opportunistic infections . T cells are essential to the immune response and without them, the body cannot fight infections or kill cancerous cells. The mechanism of CD4 T cell depletion differs in the acute and chronic phases. During the acute phase, HIV-induced cell lysis and killing of infected cells by CD8 T cells accounts for CD4 T cell depletion, although apoptosis may also be

12305-463: The virus. Oral sex has little risk of transmitting the virus. Ways to avoid catching HIV and preventing the spread include safe sex , treatment to prevent infection (" PrEP "), treatment to stop infection in someone who has been recently exposed (" PEP "), treating those who are infected , and needle exchange programs . Disease in a baby can often be prevented by giving both the mother and child antiretroviral medication . Recognized worldwide in

12420-559: The world lacks access to reliable PCR testing, and people in many places simply wait until either symptoms develop or the child is old enough for accurate antibody testing. In sub-Saharan Africa between 2007 and 2009, between 30% and 70% of the population were aware of their HIV status. In 2009, between 3.6% and 42% of men and women in sub-Saharan countries were tested; this represented a significant increase compared to previous years. Two main clinical staging systems are used to classify HIV and HIV-related disease for surveillance purposes:

12535-417: 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

12650-482: The world. People giving or receiving tattoos , piercings , and scarification are theoretically at risk of infection but no confirmed cases have been documented. It is not possible for mosquitoes or other insects to transmit HIV. HIV can be transmitted from mother to child during pregnancy, during delivery, or through breast milk, resulting in the baby also contracting HIV. As of 2008, vertical transmission accounted for about 90% of cases of HIV in children. In

12765-467: 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

12880-637: 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

12995-662: 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

13110-634: Was identified in the 1980s. HIV made the jump from other primates to humans in west-central Africa in the early-to-mid-20th century. AIDS was first recognized by the U.S. Centers for Disease Control and Prevention (CDC) in 1981 and its cause—HIV infection—was identified in the early part of the decade. Between the first time AIDS was readily identified through 2024, the disease is estimated to have caused at least 42.3 million deaths worldwide. In 2023, 630,000 people died from HIV-related causes, an estimated 1.3 million people acquired HIV and about 39.9 million people worldwide living with HIV, 65% of whom are in

13225-424: 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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