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Kano Trovafloxacin Trial Litigation
The Kano trovafloxacin trial litigation arose out of a clinical trial conducted by the pharmaceutical company Pfizer in 1996 in Kano, Nigeria, during an epidemic of meningococcal meningitis. To test its new antibiotic, trovafloxacin (Trovan), Pfizer gave 100 children trovafloxacin, while another 100 received the gold-standard anti-meningitis treatment, ceftriaxone, a cephalosporin antibiotic. Pfizer gave the children a substantially reduced dose of the ceftriaxone (specifically, 33 mg/kg) relative to that described on the US FDA-approved prescribing information. The allegation is that this was done to skew the test in favor of its own drug. Pfizer claimed that the dose used was sufficient even though a clinical trial performed by ''Médecins Sans Frontières'' recommends a dose of 50–100 mg/kg. Five children given trovafloxacin died, as did six of those given ceftriaxone. The lead investigator, Abdulhamid Isa Dutse, later provided a letter of approval for human t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Company
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%. History Mid-1800s – 1945: From botanicals to the first synthetic drugs The modern era of pharmaceutical industry began with local apothecaries that expanded from their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid-1800s, and from discoveries resulting from applied research. Intentional ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Tom Lantos
Thomas Peter Lantos (born Tamás Péter Lantos; February 1, 1928 – February 11, 2008) was a Holocaust survivor and American politician who served as a U.S. representative from California from 1981 until his death in 2008. A member of the Democratic Party, he represented the state's 11th congressional district until 1993 and from then the 12th congressional district, which both included the northern two-thirds of San Mateo County and a portion of the southwestern part of San Francisco after redistricting. Lantos, who served as Chair of the House Foreign Affairs Committee in his last term, announced in early January 2008 that he would not run for reelection because of cancer of the esophagus. He died before finishing his term. A Hungarian Jew, Lantos was the only Holocaust survivor to have served in the United States Congress; he survived the genocide with help from Raoul Wallenberg. In speaking before the House of Representatives after his death, Speaker Nancy Pelosi state ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Alien Tort Claims Act
The Alien Tort Statute ( codified in 1948 as ; ATS), also called the Alien Tort Claims Act (ATCA), is a section in the United States Code that gives federal courts jurisdiction over lawsuits filed by foreign nationals for torts committed in violation of international law. It was first introduced by the Judiciary Act of 1789 and is one of the oldest federal laws still in effect in the U.S. The ATS was rarely cited for nearly two centuries after its enactment, and its exact purpose and scope remain debated.Stephen P. Mulligan''The Rise and Decline of the Alien Tort Statute'', Congressional Research Service (June 6, 2018). The U.S. Supreme Court has interpreted the Act's primary purpose as " romotingharmony in international relations by ensuring foreign plaintiffs a remedy for international-law violations in circumstances where the absence of such a remedy might provoke foreign nations to hold the United States accountable.". Since 1980, courts have generally interpreted the ATS t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Informed Consent
Informed consent is a principle in medical ethics and medical law, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research and to disclosing a person's medical information. Definitions of informed consent vary, and the standard required is generally determined by the state. Informed consent requires a clear appreciation and understanding of the facts, implications, and consequences of an action. To give informed consent, the individual concerned must have adequate reasoning faculties and possess all relevant facts. Impairments to reasoning ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States District Court For The Southern District Of New York
The United States District Court for the Southern District of New York (in case citations, S.D.N.Y.) is a federal trial court whose geographic jurisdiction encompasses eight counties of New York State. Two of these are in New York City: New York (Manhattan) and Bronx; six are in Downstate: Westchester, Putnam, Rockland, Orange, Dutchess, and Sullivan. Appeals from the Southern District of New York are taken to the United States Court of Appeals for the Second Circuit (except for patent claims and claims against the U.S. government under the Tucker Act, which are appealed to the Federal Circuit). Because it covers Manhattan, the Southern District of New York has long been one of the most active and influential federal trial courts in the United States. It often has jurisdiction over America's largest financial institutions and prosecution of white-collar crime and other federal crimes. Because of its age and influence, it is sometimes colloquially called the "Mother C ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Trovafloxacin
Trovafloxacin (sold as Trovan by Pfizer and Turvel by Laboratorios Almirall) is a broad spectrum antibiotic that inhibits the uncoiling of supercoiled DNA in various bacteria by blocking the activity of DNA gyrase and topoisomerase IV. It was withdrawn from the market due to the risk of hepatotoxicity. It had better Gram-positive bacterial coverage but less Gram-negative coverage than the previous fluoroquinolones. Adverse reactions Trovafloxacin use is significantly restricted due to its high potential for inducing serious and sometimes fatal liver damage. Currently, the drug is not approved for use in the U.S. or the European Union due to association with cases of acute liver failure and death. Manufacturing The key reaction in building the ring consists of 1,3-Dipolar cycloaddition of ethyl diazoacetate to N-Cbz- 3-pyrroline to afford the pyrrazolidine (3). Pyrolysis results in loss of nitrogen and formation of the cyclopropylpyrrolidine ring. The stereochemistry of th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Sub-Saharan Africa
Sub-Saharan Africa is, geographically, the area and regions of the continent of Africa that lies south of the Sahara. These include West Africa, East Africa, Central Africa, and Southern Africa. Geopolitically, in addition to the List of sovereign states and dependent territories in Africa, African countries and territories that are situated fully in that specified region, the term may also include polities that only have part of their territory located in that region, per the definition of the United Nations (UN). This is considered a non-standardized geographical region with the number of countries included varying from 46 to 48 depending on the organization describing the region (e.g. UN, WHO, World Bank, etc.). The Regions of the African Union, African Union uses a different regional breakdown, recognizing all 55 member states on the continent - grouping them into 5 distinct and standard regions. The term serves as a grouping counterpart to North Africa, which is instead ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
African Meningitis Belt
The African meningitis belt is a region in sub-Saharan Africa where the rate of incidence of meningitis is very high. It extends from Senegal to Ethiopia, and the primary cause of meningitis in the belt is ''Neisseria meningitidis''. The belt was first proposed by Léon Lapeyssonnie of the World Health Organization (WHO) in 1963. Lapeyssonnie noticed that the disease occurred in areas receiving 300-1,100 mm of mean annual rainfall, which is the case in sub-Saharan Africa. The intercontinental spread of meningitis has also been traced to South Asia, brought by those making the haj, a pilgrimage to Saudi Arabia, in 1987, leading to epidemics in Nepal, Saudi Arabia, and Chad. Regions It consists of part of or all of (from West to East), the Gambia, Senegal, Guinea-Bissau, Guinea, Mali, Burkina Faso, Ghana, Niger, Nigeria, Cameroon, Chad, Central African Republic, Sudan, South Sudan, Uganda, Kenya, Ethiopia, Eritrea. Many other countries in Africa experience outbreaks as w ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Northern Nigeria
Northern Nigeria was an autonomous division within Nigeria, distinctly different from the southern part of the country, with independent customs, foreign relations and security structures. In 1962 it acquired the territory of the British Northern Cameroons, which voted to become a province within Northern Nigeria. In 1967, Northern Nigeria was divided into the North-Eastern State, North-Western State, Kano State, Kaduna State, Kwara State, and the Benue-Plateau State, each with its own Governor. History Prehistory The Nok culture, an ancient culture dominated most of what is now Northern Nigeria in prehistoric times, its legacy in the form of terracotta statues and megaliths have been discovered in Sokoto, Kano, Birinin Kudu, Nok and Zaria. The Kwatarkwashi culture, a variant of the Nok culture centred mostly around Zamfara in Sokoto Province is thought by some to be the same or an offshoot of the Nok. The Fourteen Kingdoms The Fourteen Kingdoms unified the diverse ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Epidemic
An epidemic (from Greek ἐπί ''epi'' "upon or above" and δῆμος ''demos'' "people") is the rapid spread of disease to a large number of patients among a given population within an area in a short period of time. Epidemics of infectious diseases are generally caused by several factors including a significant change in the ecology of the areal population (e.g., increased stress maybe additional reason or increase in the density of a vector species), the introduction of an emerging pathogen to an areal population (by movement of pathogen or host) or an unexpected genetic change that is in the pathogen reservoir. Generally, epidemics concerns with the patterns of infectious disease spread. An epidemic may occur when host immunity to either an established pathogen or newly emerging novel pathogen is suddenly reduced below that found in the endemic equilibrium and the transmission threshold is exceeded. For example, in meningococcal infections, an attack rate in excess of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Alien Tort Statute
The Alien Tort Statute ( codified in 1948 as ; ATS), also called the Alien Tort Claims Act (ATCA), is a section in the United States Code that gives federal courts jurisdiction over lawsuits filed by foreign nationals for torts committed in violation of international law. It was first introduced by the Judiciary Act of 1789 and is one of the oldest federal laws still in effect in the U.S. The ATS was rarely cited for nearly two centuries after its enactment, and its exact purpose and scope remain debated.Stephen P. Mulligan''The Rise and Decline of the Alien Tort Statute'', Congressional Research Service (June 6, 2018). The U.S. Supreme Court has interpreted the Act's primary purpose as " romotingharmony in international relations by ensuring foreign plaintiffs a remedy for international-law violations in circumstances where the absence of such a remedy might provoke foreign nations to hold the United States accountable.". Since 1980, courts have generally interpreted the AT ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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