Answer: Sally Hemings

Context: Of numerous relationships between male slaveholders, overseers, or master's sons and women slaves, the most notable is likely that of President Thomas Jefferson with his slave Sally Hemings. As noted in the 2012 collaborative Smithsonian-Monticello exhibit, Slavery at Monticello: The Paradox of Liberty, Jefferson, then a widower, took Hemings as his concubine for nearly 40 years. They had six children of record; four Hemings children survived into adulthood, and he freed them all, among the very few slaves he freed. Two were allowed to "escape" to the North in 1822, and two were granted freedom by his will upon his death in 1826. Seven-eighths white by ancestry, all four of his Hemings children moved to northern states as adults; three of the four entered the white community, and all their descendants identified as white. Of the descendants of Madison Hemings, who continued to identify as black, some in future generations eventually identified as white and "married out", while others continued to identify as African American. It was socially advantageous for the Hemings children to identify as white, in keeping with their appearance and the majority proportion of their ancestry. Although born into slavery, the Hemings children were legally white under Virginia law of the time.

Question: President Thomas Jefferson had a relationship with who?


Answer: Slavery at Monticello: The Paradox of Liberty

Question: What was the name of the Smithsonian-Monticello exhibit that discussed their relationship?


Answer: nearly 40 years

Question: How long were Jefferson and Hemmings in a relationship?


Answer: Madison Hemings

Question: Which child of Jefferson identified as black?


Answer: Seven-eighths

Question: How much of the children of Jefferson and Hemmings were white?


Answer: traditionally free people of color in Louisiana

Context: After the Civil War, racial segregation forced African Americans to share more of a common lot in society than they might have given widely varying ancestry, educational and economic levels. The binary division altered the separate status of the traditionally free people of color in Louisiana, for instance, although they maintained a strong Louisiana Créole culture related to French culture and language, and practice of Catholicism. African Americans began to create common cause—regardless of their multiracial admixture or social and economic stratification. In 20th-century changes, during the rise of the Civil Rights and Black Power movements, the African-American community increased its own pressure for people of any portion of African descent to be claimed by the black community to add to its power.

Question: As an example, whose status was downgraded after the civil war?


Answer: people of any portion of African descent

Question: Who were increasingly included as African Americans in the 20th century?


Answer: primarily on the West Coast and in western territories

Context: Chinese men entered the United States as laborers, primarily on the West Coast and in western territories. Following the Reconstruction era, as blacks set up independent farms, white planters imported Chinese laborers to satisfy their need for labor. In 1882, the Chinese Exclusion Act was passed, and Chinese workers who chose to stay in the U.S. were unable to have their wives join them. In the South, some Chinese married into the black and mulatto communities, as generally discrimination meant they did not take white spouses. They rapidly left working as laborers, and set up groceries in small towns throughout the South. They worked to get their children educated and socially mobile.

Question: Where did most Chinese men enter the US?


Answer: white planters

Question: Who imported Chinese laborers?


Answer: the Chinese Exclusion Act

Question: What cause wives to be unable to move to the US with their Chinese husbands after 1882?


Answer: they did not take white spouses

Question: What did racial bias generally mean for Chinese people?


Answer: set up groceries in small towns throughout the South

Question: What did Chinese laborers do after they left that line of work?


Answer: the Office of Management and Budget (OMB)

Context: Multiracial people who wanted to acknowledge their full heritage won a victory of sorts in 1997, when the Office of Management and Budget (OMB) changed the federal regulation of racial categories to permit multiple responses. This resulted in a change to the 2000 United States Census, which allowed participants to select more than one of the six available categories, which were, in brief: "White," "Black or African American," "Asian," "American Indian or Alaskan Native," "Native Hawaiian or other Pacific Islander," and "Other." Further details are given in the article: Race (U.S. census). The OMB made its directive mandatory for all government forms by 2003.

Question: What office is responsible for the census form changes?


Answer: 1997

Question: When did the OMB change racial guidelines for the census form?


Answer: participants to select more than one of the six available categories

Question: What did the OMB vote to allow on the 2000 census?


Answer: 2003

Question: When were the OMB racial directive made mandatory for every government form?


Answer: born into slavery

Context: Laws dating from 17th-century colonial America defined children of African slave mothers as taking the status of their mothers, and born into slavery regardless of the race or status of the father, under partus sequitur ventrem. The association of slavery with a "race" led to slavery as a racial caste. But, most families of free people of color formed in Virginia before the American Revolution were the descendants of unions between white women and African men, who frequently worked and lived together in the looser conditions of the early colonial period. While interracial marriage was later prohibited, white men frequently took sexual advantage of slave women, and numerous generations of multiracial children were born. By the late 1800s it had become common among African Americans to use passing to gain educational opportunities as did the first African-American graduate of Vassar College Anita Florence Hemmings. Some 19th-century categorization schemes defined people by proportion of African ancestry: a person whose parents were black and white was classified as mulatto, with one black grandparent and three white as quadroon, and with one black great-grandparent and the remainder white as octoroon. The latter categories remained within an overall black or colored category, but before the Civil War, in Virginia and some other states, a person of one-eighth or less black ancestry was legally white. Some members of these categories passed temporarily or permanently as white.

Question: What was the result of a child having an African mother?


Answer: partus sequitur ventrem

Question: What is the rule that allows children with white fathers to be slaves?


Answer: Anita Florence Hemmings

Question: Who was the first African American to gradute from Vassar College?


Answer: parents were black and white

Question: What makes a person mulatto?


Answer: one black great-grandparent and the remainder white

Question: What does a person have to have to be an octoroon?


Answer: Because he has no slave blood in him

Context: Reacting to media criticism of Michelle Obama during the 2008 presidential election, Charles Kenzie Steele, Jr., CEO of the Southern Christian Leadership Conference said, "Why are they attacking Michelle Obama, and not really attacking, to that degree, her husband? Because he has no slave blood in him." He later claimed his comment was intended to be "provocative" but declined to expand on the subject. Former Secretary of State Condoleezza Rice (who was famously mistaken for a "recent American immigrant" by French President Nicolas Sarkozy), said "descendants of slaves did not get much of a head start, and I think you continue to see some of the effects of that." She has also rejected an immigrant designation for African Americans and instead prefers the term "black" or "white" .

Question: Why did Steele think people were not attacking Barrack Obama?


Answer: "black" or "white"

Question: What does Condoleeza Rice prefer to term people as?


Answer: recent American immigrant

Question: What did President Sarkozy think Secretary of State Rice was?


Answer: CEO of the Southern Christian Leadership Conference

Question: Who is Charles Kenzie Steele Jr?


Answer: to be "provocative"

Question: Why did Steele say what he did?


Answer: April 5, 1614

Context: Some early male settlers married Indigenous American women and had informal unions with them. Early contact between Indigenous Americans and Europeans was often charged with tension, but also had moments of friendship, cooperation, and intimacy. Marriages took place in both English and Latin colonies between European men and Native women. For instance, on April 5, 1614, Pocahontas, a Powhatan woman in present-day Virginia, married the Englishman John Rolfe of Jamestown. Their son Thomas Rolfe was an ancestor to many descendants in First Families of Virginia. As a result, English laws did not exclude people with some Indigenous American ancestry from being considered English or white.

Question: When was the wedding of Rolfe and Pocahontas?


Answer: considered English or white

Question: What did English laws not exclude people with some native blood from being?


Answer: male settlers

Question: Who married Indigenous women early on?


Answer: present-day Virginia

Question: Where did Rolfe marry Pocahontas?


Answer: Thomas Rolfe

Question: Who was an ancestor of the First Families of Virginia?


Answer: Colonial records of French and Spanish slave ships and sales, and plantation records in all the former colonies

Context: Colonial records of French and Spanish slave ships and sales, and plantation records in all the former colonies, often have much more information about slaves, from which researchers are reconstructing slave family histories. Genealogists have begun to find plantation records, court records, land deeds and other sources to trace African-American families and individuals before 1870. As slaves were generally forbidden to learn to read and write, black families passed along oral histories, which have had great persistence. Similarly, Native Americans did not generally learn to read and write English, although some did in the nineteenth century. Until 1930, census enumerators used the terms free people of color and mulatto to classify people of apparent mixed race. When those terms were dropped, as a result of the lobbying by the Southern Congressional bloc, the Census Bureau used only the binary classifications of black or white, as was typical in segregated southern states.

Question: What has helped geneologists researching slaves?


Answer: learn to read and write

Question: What were slaves usually not allowed to do?


Answer: oral histories

Question: What replaced written records for black families?


Answer: Southern Congressional bloc

Question: Who caused the Census Burea to drop the terms free people of color and mulatto?


Answer: 1930

Question: When were the terms mulatto and free people of color taken off the census?


Answer: Indigenous American tribes

Context: European colonists created treaties with Indigenous American tribes requesting the return of any runaway slaves. For example, in 1726, the British governor of New York exacted a promise from the Iroquois to return all runaway slaves who had joined them. This same promise was extracted from the Huron Nation in 1764, and from the Delaware Nation in 1765, though there is no record of slaves ever being returned. Numerous advertisements requested the return of African Americans who had married Indigenous Americans or who spoke an Indigenous American language. The primary exposure that Africans and Indigenous Americans had to each other came through the institution of slavery. Indigenous Americans learned that Africans had what Indigenous Americans considered 'Great Medicine' in their bodies because Africans were virtually immune to the Old-World diseases that were decimating most native populations. Because of this, many tribes encouraged marriage between the two groups, to create stronger, healthier children from the unions.

Question: Who did colonists ask for help in returning runaway slaves?


Answer: 1726

Question: When was a treaty with the Iroquis made to return slaves?


Answer: Numerous advertisements

Question: What asked for the return of slaves who married indigenous americans or spoke their language?


Answer: through the institution of slavery

Question: How did natives and Africans come to know each other?


Answer: because Africans were virtually immune to the Old-World diseases

Question: Why did natives consider Africans to have a 'Great Medicine'?


Answer: gave children the social status of their mother

Context: Interracial relationships, common-law marriages, and marriages occurred since the earliest colonial years, especially before slavery hardened as a racial caste associated with people of African descent in the British colonies. Virginia and other English colonies passed laws in the 17th century that gave children the social status of their mother, according to the principle of partus sequitur ventrem, regardless of the father's race or citizenship. This overturned the principle in English common law by which a man gave his status to his children – this had enabled communities to demand that fathers support their children, whether legitimate or not. The change increased white men's ability to use slave women sexually, as they had no responsibility for the children. As master as well as father of mixed-race children born into slavery, the men could use these people as servants or laborers or sell them as slaves. In some cases, white fathers provided for their multiracial children, paying or arranging for education or apprenticeships and freeing them, particularly during the two decades following the American Revolution. (The practice of providing for the children was more common in French and Spanish colonies, where a class of free people of color developed who became educated and property owners.) Many other white fathers abandoned the mixed-race children and their mothers to slavery.

Question: What did the laws passed in the 17th century do?


Answer: partus sequitur ventrem

Question: What is the rule called that causes a father's race to not matter?


Answer: paying or arranging for education or apprenticeships and freeing them

Question: What did white fathers do after the American Revolution to provide for mixed children?


Answer: a man gave his status to his children

Question: English common law generally said what?


Answer: mestizo, Amerindian, or other mixed race

Context: Many Latin American migrants have been mestizo, Amerindian, or other mixed race. Multiracial Latinos have limited media appearance; critics have accused the U.S. Hispanic media of overlooking the brown-skinned indigenous and multiracial Hispanic and black Hispanic populations by over-representation of blond and blue/green-eyed white Hispanic and Latino Americans (who resemble Scandinavians and other Northern Europeans rather than they look like white Hispanic and Latino Americans mostly of typical Southern European features), and also light-skinned mulatto and mestizo Hispanic and Latino Americans (often deemed as white persons in U.S. Hispanic and Latino populations if achieving the middle class or higher social status), especially some of the actors on the telenovelas.

Question: What are many Latin American migrants?


Answer: white

Question: What do latinos consider a light skinned mulatto to be?


Answer: the U.S. Hispanic media

Question: Who is overlooking darker skinned latino multiracial people?


Answer: blond and blue/green-eyed white

Question: What does the typical latino in media look like?


Answer: if having seven-eights or more white ancestry

Context: In Virginia prior to 1920, for example, a person was legally white if having seven-eights or more white ancestry. The one-drop rule originated in some Southern United States in the late 19th century, likely in response to whites' attempt to maintain white supremacy and limit black political power following the Democrats' regaining control of state legislatures in the late 1870s. The first year in which the U.S. Census dropped the mulatto category was 1920; that year enumerators were instructed to classify people in a binary way as white or black. This was a result of the Southern-dominated Congress convincing the Census Bureau to change its rules.

Question: Before 1920, how would a person be white by law?


Answer: 1920

Question: What year was mulatto left off the US Census?


Answer: Southern-dominated Congress

Question: Who is responsible for the Census Bureau discarding the mulatto category?


Answer: Stanley Crouch

Context: Stanley Crouch wrote in a New York Daily News piece "Obama's mother is of white U.S. stock. His father is a black Kenyan," in a column entitled "What Obama Isn't: Black Like Me." During the 2008 campaign, the African-American columnist David Ehrenstein of the LA Times accused white liberals of flocking to Obama because he was a "Magic Negro", a term that refers to a black person with no past who simply appears to assist the mainstream white (as cultural protagonists/drivers) agenda. Ehrenstein went on to say "He's there to assuage white 'guilt' they feel over the role of slavery and racial segregation in American history."

Question: Who wrote an article in the New York Dail News about Obama?


Answer: "Magic Negro",

Question: What did David Ehrenstein call Obama in 2008?


Answer: assuage white 'guilt'

Question: What did Ehrenstein say Obama does for white people?


Answer: "What Obama Isn't: Black Like Me."

Question: What was the title of Crouch's article?


Answer: cannot be racially categorized

Context: The 2000 U.S. Census in the write-in response category had a code listing which standardizes the placement of various write-in responses for automatic placement within the framework of the U.S. Census's enumerated races. Whereas most responses can be distinguished as falling into one of the five enumerated races, there remains some write-in responses which fall into the "Mixture" heading which cannot be racially categorized. These include "Bi Racial, Combination, Everything, Many, Mixed, Multi National, Multiple, Several and Various".

Question: What does the "mixture" heading mean?


Answer: 2000

Question: What year did the US Census write in response category have a code-listing?


Answer: Mixture

Question: Bi-racial would be coded as what?


Answer: five enumerated races

Question: How many race options were there?


Answer: Interracial relations between Indigenous Americans and African Americans

Context: Interracial relations between Indigenous Americans and African Americans is a part of American history that has been neglected. The earliest record of African and Indigenous American relations in the Americas occurred in April 1502, when the first Africans kidnapped were brought to Hispaniola to serve as slaves. Some escaped, and somewhere inland on Santo Domingo, the first Black Indians were born. In addition, an example of African slaves' escaping from European colonists and being absorbed by Indigenous Americans occurred as far back as 1526. In June of that year, Lucas Vasquez de Ayllon established a Spanish colony near the mouth of the Pee Dee River in what is now eastern South Carolina. The Spanish settlement was named San Miguel de Gualdape. Amongst the settlement were 100 enslaved Africans. In 1526, the first African slaves fled the colony and took refuge with local Indigenous Americans.

Question: What is considered to be neglected in American history?


Answer: April 1502

Question: When is it recorded that Africans and natives interacted earliest?


Answer: Santo Domingo

Question: Where did Africans escape and mate with naitves?


Answer: near the mouth of the Pee Dee River

Question: Where did Ayllon lay down a Spanish colony?


Answer: 100 enslaved Africans

Question: How many slaves were at San Miguel de Gualdape at its inception?


Answer: Anatole Broyard

Context: Some biographical accounts include the autobiography Life on the Color Line: The True Story of a White Boy Who Discovered He Was Black by Gregory Howard Williams; One Drop: My Father's Hidden Life—A Story of Race and Family Secrets written by Bliss Broyard about her father Anatole Broyard; the documentary Colored White Boy about a white man in North Carolina who discovers that he is the descendant of a white plantation owner and a raped African slave; and the documentary on The Sanders Women of Shreveport, Louisiana.

Question: Who is related to Bliss Broyard?


Answer: autobiography

Question: Gregory Howard Williams wrote what type of book?


Answer: Colored White Boy

Question: What documentary features a white man in North Carolina?


Answer: the 1980s

Context: By the 1980s, parents of mixed-race children (and adults of mixed-race ancestry) began to organize and lobby for the ability to show more than one ethnic category on Census and other legal forms. They refused to be put into just one category. When the U.S. government proposed the addition of the category of "bi-racial" or "multiracial" in 1988, the response from the general public was mostly negative. Some African-American organizations and political leaders, such as Senator Diane Watson and Representative Augustus Hawkins, were particularly vocal in their rejection of the category. They feared a loss in political and economic power if African Americans abandoned their one category.

Question: When did people lobby for allowing more than one category to be selected on legal forms?


Answer: mostly negative

Question: How did the public react to the categories of "bi-racial" and "multiracial"?


Answer: Senator Diane Watson and Representative Augustus Hawkins

Question: Which political leaders spoke out against the proposed designations?


Answer: a loss in political and economic power

Question: What did they fear would happen?


Answer: French trapper Toussaint Charbonneau

Context: In the early 19th century, the Indigenous American woman Sacagawea, who would help translate for and guide the Lewis and Clark Expedition in the West, married the French trapper Toussaint Charbonneau. Most marriages between Europeans and Indigenous Americans were between European men and Indigenous American women. Depending on the kinship system of the woman's tribe, their children would be more or less easily assimilated into the tribe. Nations that had matrilineal systems, such as the Creek and Cherokee in the Southeast, gave the mixed-race children status in their mother's clans and tribes. If the tribe had a patrilineal system, like the Omaha, the children of white fathers were considered white. Unless they were specifically adopted into the tribe by an adult male, they could have no social status in it.

Question: Who married Sacagewea?


Answer: European men and Indigenous American women

Question: Who made up most unions between Europeans and natives?


Answer: the kinship system of the woman's tribe

Question: What factor affected the ability of a child to be in a tribe?


Answer: Creek and Cherokee

Question: What nations are considered matrilineal?


Answer: adopted into the tribe by an adult male

Question: How could a white child be considered a member of the Omaha tribe?


Answer: the one-drop rule

Context: For African Americans, the one-drop rule was a significant factor in ethnic solidarity. African Americans generally shared a common cause in society regardless of their multiracial admixture, or social/economic stratification. Additionally, African Americans found it, near, impossible to learn about their Indigenous American heritage as many family elders withheld pertinent genealogical information. Tracing the genealogy of African Americans can be a very difficult process, especially for descendants of Indigenous Americans, because African Americans who were slaves were forbidden to learn to read and write, and a majority of Indigenous Americans neither spoke English, nor read or wrote it.

Question: What brought African Americans together?


Answer: family elders

Question: Who made it next to impossible to learn about their heritage for African Americans?


Answer: to learn to read and write

Question: Slaves were not allowed to do what?


Answer: spoke English, nor read or wrote it

Question: What did Indigenous Americans not do that makes it difficult to trace their heritage?


Answer: their multiracial admixture, or social/economic stratification

Question: What factors did not affect racial solidarity amoung African Americans?


Answer: "tragic octoroon"

Context: The figure of the "tragic octoroon" was a stock character of abolitionist literature: a mixed-race woman raised as if a white woman in her white father's household, until his bankruptcy or death has her reduced to a menial position She may even be unaware of her status before being reduced to victimization. The first character of this type was the heroine of Lydia Maria Child's "The Quadroons" (1842), a short story. This character allowed abolitionists to draw attention to the sexual exploitation in slavery and, unlike portrayals of the suffering of the field hands, did not allow slaveholders to retort that the sufferings of Northern mill hands were no easier. The Northern mill owner would not sell his own children into slavery.

Question: What stock character lived with her white father until he left the picture?


Answer: Lydia Maria Child

Question: Who was the first to use the tragic octoroon?


Answer: "The Quadroons"

Question: What story was written by Child in 1842?


Answer: sexual exploitation in slavery

Question: What does the tragic octoroon point out?


Answer: abolitionists

Question: Who used the figure of the tragic octoroon?


Answer: John Abel

Context: By the 1890s the profound effect of adrenal extracts on many different tissue types had been discovered, setting off a search both for the mechanism of chemical signalling and efforts to exploit these observations for the development of new drugs. The blood pressure raising and vasoconstrictive effects of adrenal extracts were of particular interest to surgeons as hemostatic agents and as treatment for shock, and a number of companies developed products based on adrenal extracts containing varying purities of the active substance. In 1897 John Abel of Johns Hopkins University identified the active principle as epinephrine, which he isolated in an impure state as the sulfate salt. Industrial chemist Jokichi Takamine later developed a method for obtaining epinephrine in a pure state, and licensed the technology to Parke Davis. Parke Davis marketed epinephrine under the trade name Adrenalin. Injected epinephrine proved to be especially efficacious for the acute treatment of asthma attacks, and an inhaled version was sold in the United States until 2011 (Primatene Mist). By 1929 epinephrine had been formulated into an inhaler for use in the treatment of nasal congestion.

Question: Who identified the active substance?


Answer: Jokichi Takamine

Question: Who developed the method to obtain epinephrine in a pure state?


Answer: Parke Davis

Question: Who marketed epinephrine?


Answer: Adrenalin

Question: What trade name was epinephrine marketed under?


Answer: nasal congestion

Question: As an inhaler, what was epinephrine used to treat?


Answer: Jokichi Takamine

Question: Who developed the method to get epinephrine in it's pure form?


Answer: nasal congestion

Question: What could epinephrine treat?


Answer: 2011

Question: When did epinephrine stop being available in the United States?


Answer: Adrenalin

Question: What trade name was epinephrine marketed under?


Answer: 1897

Question: In what year was epinephrine discovered?


Answer: Adrenalin

Question: What was the trade name of epinephrine?


Answer: John Abel

Question: Who first discovered epinephrine?


Answer: asthma attacks

Question: What is epinephrine used to treat?


Answer: 2011

Question: In what year was Primatene Mist no longer sold in the United States?


Answer: Smith, Kline and French

Context: While highly effective, the requirement for injection limited the use of norepinephrine[clarification needed] and orally active derivatives were sought. A structurally similar compound, ephedrine, was identified by Japanese chemists in the Ma Huang plant and marketed by Eli Lilly as an oral treatment for asthma. Following the work of Henry Dale and George Barger at Burroughs-Wellcome, academic chemist Gordon Alles synthesized amphetamine and tested it in asthma patients in 1929. The drug proved to have only modest anti-asthma effects, but produced sensations of exhilaration and palpitations. Amphetamine was developed by Smith, Kline and French as a nasal decongestant under the trade name Benzedrine Inhaler. Amphetamine was eventually developed for the treatment of narcolepsy, post-encepheletic parkinsonism, and mood elevation in depression and other psychiatric indications. It received approval as a New and Nonofficial Remedy from the American Medical Association for these uses in 1937 and remained in common use for depression until the development of tricyclic antidepressants in the 1960s.

Question: Who developed Amphetamine?


Answer: Gordon Alles

Question: Who synthesized Amphetamine for asthma?


Answer: sensations of exhilaration and palpitations

Question: What are common side effects of Amphetamine?


Answer: 1960s

Question: When were tricyclic antidepressants developed?


Answer: narcolepsy, post-encepheletic parkinsonism, and mood elevation in depression and other psychiatric indications

Question: What were some uses for Amphetamine?


Answer: asthma

Question: Ephedrine was used as an oral medicine for what illness?


Answer: 1929

Question: In what year was amphetamine first tested on asthma patients?


Answer: Benzedrine Inhaler

Question: What was the trade name of amphetamine as a nasal decongestant?


Answer: 1937

Question: In what year did the American Medical Association approve amphetamine for medical use?


Answer: 1960s

Question: In what decade were tricyclic antidepressants created?


Answer: absence of a substance normally produced by the pancreas

Context: A series of experiments performed from the late 1800s to the early 1900s revealed that diabetes is caused by the absence of a substance normally produced by the pancreas. In 1869, Oskar Minkowski and Joseph von Mering found that diabetes could be induced in dogs by surgical removal of the pancreas. In 1921, Canadian professor Frederick Banting and his student Charles Best repeated this study, and found that injections of pancreatic extract reversed the symptoms produced by pancreas removal. Soon, the extract was demonstrated to work in people, but development of insulin therapy as a routine medical procedure was delayed by difficulties in producing the material in sufficient quantity and with reproducible purity. The researchers sought assistance from industrial collaborators at Eli Lilly and Co. based on the company's experience with large scale purification of biological materials. Chemist George Walden of Eli Lilly and Company found that careful adjustment of the pH of the extract allowed a relatively pure grade of insulin to be produced. Under pressure from Toronto University and a potential patent challenge by academic scientists who had independently developed a similar purification method, an agreement was reached for non-exclusive production of insulin by multiple companies. Prior to the discovery and widespread availability of insulin therapy the life expectancy of diabetics was only a few months.

Question: What is diabetes caused from?


Answer: difficulties in producing the material in sufficient quantity and with reproducible purity

Question: Why was insulin therapy delayed?


Answer: surgical removal of the pancreas

Question: How can diabetes be induced in dogs?


Answer: only a few months

Question: Before insulin, what was the life expectancy of diabetics?


Answer: Frederick Banting and his student Charles Best

Question: Who discovered that pancreatic extract reversed symptoms of pancreas removal?


Answer: pancreas

Question: Diabetes is caused by the removal of what organ?


Answer: a few months

Question: Left untreated, how long were diabetic patients were expected to live?


Answer: pH

Question: What could be adjusted in a sample of pancreatic extract to produce purer insulin?


Answer: Eli Lilly and Co.

Question: To purify insulin, Banting and Best sought the assistance of what company?


Answer: dogs

Question: Minkowski and von Mering did surgical tests on what animal?


Answer: epilepsy

Context: In 1903 Hermann Emil Fischer and Joseph von Mering disclosed their discovery that diethylbarbituric acid, formed from the reaction of diethylmalonic acid, phosphorus oxychloride and urea, induces sleep in dogs. The discovery was patented and licensed to Bayer pharmaceuticals, which marketed the compound under the trade name Veronal as a sleep aid beginning in 1904. Systematic investigations of the effect of structural changes on potency and duration of action led to the discovery of phenobarbital at Bayer in 1911 and the discovery of its potent anti-epileptic activity in 1912. Phenobarbital was among the most widely used drugs for the treatment of epilepsy through the 1970s, and as of 2014, remains on the World Health Organizations list of essential medications. The 1950s and 1960s saw increased awareness of the addictive properties and abuse potential of barbiturates and amphetamines and led to increasing restrictions on their use and growing government oversight of prescribers. Today, amphetamine is largely restricted to use in the treatment of attention deficit disorder and phenobarbital in the treatment of epilepsy.

Question: What is phenobarbital used for?


Answer: Hermann Emil Fischer and Joseph von Mering

Question: Who discovered a reaction that induced sleep in dogs?


Answer: Veronal

Question: What sleep aid was marketed in 1904?


Answer: attention deficit disorder

Question: What is amphetamine used for today?


Answer: addictive properties and abuse potential

Question: Why was barbiturates and amphetamines restricted?


Answer: diethylbarbituric acid

Question: What compound was discovered to induce sleep?


Answer: Veronal

Question: What was the first trade name of diethylbarbituric acid?


Answer: epilepsy

Question: What is phenobarbital mainly used to treat today?


Answer: 1911

Question: In what year was phenobarbital discovered?


Answer: sleep aid

Question: What was Veronal used for when Bayer put it on the market?


Answer: Paul Ehrlich and chemist Alfred Bertheim

Context: In 1911 arsphenamine, the first synthetic anti-infective drug, was developed by Paul Ehrlich and chemist Alfred Bertheim of the Institute of Experimental Therapy in Berlin. The drug was given the commercial name Salvarsan. Ehrlich, noting both the general toxicity of arsenic and the selective absorption of certain dyes by bacteria, hypothesized that an arsenic-containing dye with similar selective absorption properties could be used to treat bacterial infections. Arsphenamine was prepared as part of a campaign to synthesize a series of such compounds, and found to exhibit partially selective toxicity. Arsphenamine proved to be the first effective treatment for syphilis, a disease which prior to that time was incurable and led inexorably to severe skin ulceration, neurological damage, and death.[citation needed]

Question: Who developed Arsphenamine?


Answer: Arsphenamine

Question: What was the first effective treatment for Syphilis?


Answer: severe skin ulceration, neurological damage, and death

Question: What complications are associated with Syphilis?


Answer: Institute of Experimental Therapy

Question: What is Amphetamine's market name?


Answer: Berlin

Question: Where is the Institute of Experimental Therapy located?


Answer: arsenic

Question: Bacterial infections could be treated with medicines containing what kind of dye?


Answer: arsphenamine

Question: What was the name of the first synthetic bacterial drug?


Answer: syphilis

Question: Arsphenamine became the first treatment for what previously incurable disease?


Answer: 1911

Question: In what year was arsphenamine discovered?


Answer: Salvarsan

Question: What was the commercial name of arsphenamine?


Answer: mid 1800s

Context: The modern pharmaceutical industry traces its roots to two sources. The first of these were local apothecaries that expanded from their traditional role distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid 1800s. Rational drug discovery from plants started particularly with the isolation of morphine, analgesic and sleep-inducing agent from opium, by the German apothecary assistant Friedrich Sertürner, who named the compound after the Greek god of dreams, Morpheus. Multinational corporations including Merck, Hoffman-La Roche, Burroughs-Wellcome (now part of Glaxo Smith Kline), Abbott Laboratories, Eli Lilly and Upjohn (now part of Pfizer) began as local apothecary shops in the mid-1800s. By the late 1880s, German dye manufacturers had perfected the purification of individual organic compounds from coal tar and other mineral sources and had also established rudimentary methods in organic chemical synthesis. The development of synthetic chemical methods allowed scientists to systematically vary the structure of chemical substances, and growth in the emerging science of pharmacology expanded their ability to evaluate the biological effects of these structural changes.

Question: When was Morphine and Quinine first available?


Answer: Morpheus

Question: Who was the compound named after?


Answer: Friedrich Sertürner

Question: Who came up with the name Morphine?


Answer: opium

Question: Where were was Morphine extracted from?


Answer: German dye manufacturers

Question: Who is responsible for purification of compounds found in mineral sources?


Answer: Morpheus

Question: Morphine was named after what Greek god?


Answer: Glaxo Smith Kline

Question: Burroughs-Wellcome is now part of what medical company?


Answer: Friedrich Sertürner

Question: Who discovered morphine?


Answer: opium

Question: What is the name of the plant that produces morphine?


Answer: Gerhard Domagk

Context: Ehrlich’s approach of systematically varying the chemical structure of synthetic compounds and measuring the effects of these changes on biological activity was pursued broadly by industrial scientists, including Bayer scientists Josef Klarer, Fritz Mietzsch, and Gerhard Domagk. This work, also based in the testing of compounds available from the German dye industry, led to the development of Prontosil, the first representative of the sulfonamide class of antibiotics. Compared to arsphenamine, the sulfonamides had a broader spectrum of activity and were far less toxic, rendering them useful for infections caused by pathogens such as streptococci. In 1939, Domagk received the Nobel Prize in Medicine for this discovery. Nonetheless, the dramatic decrease in deaths from infectious diseases that occurred prior to World War II was primarily the result of improved public health measures such as clean water and less crowded housing, and the impact of anti-infective drugs and vaccines was significant mainly after World War II.

Question: Who received the Nobel Prize in Medicine in 1939?


Answer: antibiotics

Question: Prontosil is in what drug class?


Answer: Josef Klarer, Fritz Mietzsch, and Gerhard Domagk

Question: Who is responsible for creating Prontosil?


Answer: pathogens

Question: What causes Streptococci?


Answer: infectious diseases

Question: Many deaths occurred before World War II due to what?


Answer: Prontosil

Question: What was the name of the first sulfonamine antibiotic?


Answer: Nobel Prize in Medicine

Question: What award did Domagk receive in 1939?


Answer: World War II

Question: Anti-infective drugs became more prominent after what war?


Answer: less

Question: Were sulfonamides more or less toxic than arsphenamine?


Answer: sulfonamides

Question: Streptococci and other pathogens could be treated by what type of antibiotics?


Answer: Louis Pasteur and Pierre Paul Émile Roux

Context: Early progress toward the development of vaccines occurred throughout this period, primarily in the form of academic and government-funded basic research directed toward the identification of the pathogens responsible for common communicable diseases. In 1885 Louis Pasteur and Pierre Paul Émile Roux created the first rabies vaccine. The first diphtheria vaccines were produced in 1914 from a mixture of diphtheria toxin and antitoxin (produced from the serum of an inoculated animal), but the safety of the inoculation was marginal and it was not widely used. The United States recorded 206,000 cases of diphtheria in 1921 resulting in 15,520 deaths. In 1923 parallel efforts by Gaston Ramon at the Pasteur Institute and Alexander Glenny at the Wellcome Research Laboratories (later part of GlaxoSmithKline) led to the discovery that a safer vaccine could be produced by treating diphtheria toxin with formaldehyde. In 1944, Maurice Hilleman of Squibb Pharmaceuticals developed the first vaccine against Japanese encephelitis. Hilleman would later move to Merck where he would play a key role in the development of vaccines against measles, mumps, chickenpox, rubella, hepatitis A, hepatitis B, and meningitis.

Question: Who created the first rabies vaccine?


Answer: 206,000

Question: How many cases of Diphtheria were there in 1921?


Answer: formaldehyde

Question: In 1923, what was discovered to be safer to treat Diphtheria Toxin?


Answer: Maurice Hilleman

Question: Who created a vaccine to treat Japanese Encephalitis?


Answer: 15,520

Question: How many deaths occurred due to Diphtheria?


Answer: 1885

Question: The rabies vaccine was created in what year?


Answer: 1914

Question: In what year was the diphtheria vaccine made?


Answer: formaldehyde

Question: What compound made the diphtheria vaccine safer to use?


Answer: Maurice Hilleman

Question: Who developed the first encephalitis vaccine?


Answer: Merck

Question: What company did Hilleman later work for?


Answer: S.E. Massengill Company

Context: In 1937 over 100 people died after ingesting "Elixir Sulfanilamide" manufactured by S.E. Massengill Company of Tennessee. The product was formulated in diethylene glycol, a highly toxic solvent that is now widely used as antifreeze. Under the laws extant at that time, prosecution of the manufacturer was possible only under the technicality that the product had been called an "elixir", which literally implied a solution in ethanol. In response to this episode, the U.S. Congress passed the Federal Food, Drug, and Cosmetic Act of 1938, which for the first time required pre-market demonstration of safety before a drug could be sold, and explicitly prohibited false therapeutic claims.

Question: Who manufactured "Elixir Sulfanilamide"?


Answer: explicitly prohibited false therapeutic claims

Question: What was one of the things the Federal Food, Drug and Cosmetic Act do?


Answer: 1938

Question: What year did Congress pass the Federal Food, Drug, and Cosmetic Act?


Answer: Elixir Sulfanilamide

Question: What drug killed 100 people in 1937?


Answer: antifreeze

Question: What is Diethylene Glycol commonly used for now?


Answer: S.E. Massengill Company of Tennessee

Question: What company manufactured Elixir Sulfanilamide?


Answer: Elixir Sulfanilamide

Question: What drug killed over 100 people in 1937?


Answer: antifreeze

Question: Diethylene glycol is mainly used today as what liquid?


Answer: Federal Food, Drug, and Cosmetic Act of 1938

Question: What law did Congress pass following the Elixir Sulfanilamide incident?


Answer: ethanol

Question: The name "elixir" implied a solution in what liquid?


Answer: 1943

Context: The aftermath of World War II saw an explosion in the discovery of new classes of antibacterial drugs including the cephalosporins (developed by Eli Lilly based on the seminal work of Giuseppe Brotzu and Edward Abraham), streptomycin (discovered during a Merck-funded research program in Selman Waksman's laboratory), the tetracyclines (discovered at Lederle Laboratories, now a part of Pfizer), erythromycin (discovered at Eli Lilly and Co.) and their extension to an increasingly wide range of bacterial pathogens. Streptomycin, discovered during a Merck-funded research program in Selman Waksman's laboratory at Rutgers in 1943, became the first effective treatment for tuberculosis. At the time of its discovery, sanitoriums for the isolation of tuberculosis-infected people were an ubiquitous feature of cities in developed countries, with 50% dying within 5 years of admission.

Question: When was the first effective treatment for Tuberculosis discovered?


Answer: cities in developed countries

Question: 50% of tuberculosis-infected people died within 5 years where?


Answer: Streptomycin

Question: What drug effectively treated Tuberculosis?


Answer: Giuseppe Brotzu and Edward Abraham

Question: Who was Eli Lilly's work based off of?


Answer: Lederle Laboratories

Question: Where was Tetracyclines discovered?


Answer: Streptomycin

Question: What was the first treatment for tuberculosis?


Answer: 50%

Question: What percentage of patients infected with tuberculosis died within 5 years?


Answer: 1943

Question: In what year was streptomycin discovered?


Answer: World War II

Question: Many more antibiotics were made following the end of what war?


Answer: Merck

Question: What company funded the research that led to the discovery of streptomycin?


Answer: 1954

Context: During the years 1940-1955, the rate of decline in the U.S. death rate accelerated from 2% per year to 8% per year, then returned to the historical rate of 2% per year. The dramatic decline in the immediate post-war years has been attributed to the rapid development of new treatments and vaccines for infectious disease that occurred during these years. Vaccine development continued to accelerate, with the most notable achievement of the period being Jonas Salk's 1954 development of the polio vaccine under the funding of the non-profit National Foundation for Infantile Paralysis. The vaccine process was never patented, but was instead given to pharmaceutical companies to manufacture as a low-cost generic. In 1960 Maurice Hilleman of Merck Sharp & Dohme identified the SV40 virus, which was later shown to cause tumors in many mammalian species. It was later determined that SV40 was present as a contaminant in polio vaccine lots that had been administered to 90% of the children in the United States. The contamination appears to have originated both in the original cell stock and in monkey tissue used for production. In 2004 the United States Cancer Institute announced that it had concluded that SV40 is not associated with cancer in people.

Question: When was the Polio vaccine created?


Answer: United States Cancer Institute

Question: Who announced that SV40 was not associated with cancer?


Answer: Maurice Hilleman

Question: Who identified the SV40 virus?


Answer: cause tumors

Question: What was a complication of the SV40 virus?


Answer: National Foundation for Infantile Paralysis

Question: Who funded the Polio vaccine?


Answer: 1954

Question: In what year was the polio vaccine created?


Answer: Jonas Salk

Question: Who created the polio vaccine?


Answer: SV40

Question: What virus caused tumors in most mammals?


Answer: Maurice Hilleman

Question: Who identified the SV40 virus?


Answer: polio

Question: SV40 was present in what vaccine?


Answer: $3 billion

Context: On 2 July 2012, GlaxoSmithKline pleaded guilty to criminal charges and agreed to a $3 billion settlement of the largest health-care fraud case in the U.S. and the largest payment by a drug company. The settlement is related to the company's illegal promotion of prescription drugs, its failure to report safety data, bribing doctors, and promoting medicines for uses for which they were not licensed. The drugs involved were Paxil, Wellbutrin, Advair, Lamictal, and Zofran for off-label, non-covered uses. Those and the drugs Imitrex, Lotronex, Flovent, and Valtrex were involved in the kickback scheme.

Question: How much was the settlement GlaxoSmithKline agree to?


Answer: illegal promotion of prescription drugs

Question: What was one of the causes of the health-care fraud case?


Answer: 2 July 2012

Question: When did GlaxoSmithKline plead guilty?


Answer: Imitrex, Lotronex, Flovent, and Valtrex

Question: What drugs were related to a kickback scheme?


Answer: Paxil, Wellbutrin, Advair, Lamictal, and Zofran

Question: What drugs were used for off-label uses?


Answer: 2012

Question: In what year did GlaxoSmithKline pay a $3 billion dollar settlement?


Answer: $3 billion

Question: How much was the largest healthcare fraud case in the US settled for?


Answer: GlaxoSmithKline

Question: What company was sued for promoting medicines for unlicensed uses and bribing doctors?


Answer: become fully transparent.

Context: In the US, starting in 2013, under the Physician Financial Transparency Reports (part of the Sunshine Act), the Centers for Medicare & Medicaid Services has to collect information from applicable manufacturers and group purchasing organizations in order to report information about their financial relationships with physicians and hospitals. Data are made public in the Centers for Medicare & Medicaid Services website. The expectation is that relationship between doctors and Pharmaceutical industry will become fully transparent.

Question: What is the speculation of the relationship between doctors and the drug industry?


Answer: Sunshine Act

Question: What is the Physician Financial Transparency Report part of?


Answer: Centers for Medicare & Medicaid Services website

Question: Where can you obtain information about the Sunshine Act?


Answer: financial relationships with physicians and hospitals.

Question: What information is collected by Centers for Medicine & Medicaid Services?


Answer: starting in 2013

Question: When did Centers for Medicine & Medicaid Services have to start collecting information?


Answer: Sunshine Act

Question: The Physician Financial Transparency Reports was part of what other act?


Answer: 2013

Question: In what year were Medicaid and Medicare required to disclose information about their relationships with doctors and hospitals?


Answer: Centers for Medicare & Medicaid Services website

Question: Where can financial relationships between Medicaid, Medicare and pharmaceutical companies be found?


Answer: relationship between doctors and Pharmaceutical industry will become fully transparent

Question: What is expected when the relationships are made public?


Answer: tuberculosis

Context: A Federal Trade Commission report issued in 1958 attempted to quantify the effect of antibiotic development on American public health. The report found that over the period 1946-1955, there was a 42% drop in the incidence of diseases for which antibiotics were effective and only a 20% drop in those for which antibiotics were not effective. The report concluded that "it appears that the use of antibiotics, early diagnosis, and other factors have limited the epidemic spread and thus the number of these diseases which have occurred". The study further examined mortality rates for eight common diseases for which antibiotics offered effective therapy (syphilis, tuberculosis, dysentery, scarlet fever, whooping cough, meningococcal infections, and pneumonia), and found a 56% decline over the same period. Notable among these was a 75% decline in deaths due to tuberculosis.

Question: What disease had the biggest decline of deaths?


Answer: use of antibiotics, early diagnosis, and other factors

Question: What was responsible for the decline in spreading diseases?


Answer: 1946-1955

Question: What period was the report issued in 1958 cover?


Answer: Federal Trade Commission

Question: Who issued the report in 1958?


Answer: mortality rates

Question: What were eight diseases examined for?


Answer: 56%

Question: How much did the mortality rate of common bacterial infections decline between 1946-1955?


Answer: 75%

Question: How much did the mortality rate of tuberculosis drop between 1946-1955?


Answer: Federal Trade Commission

Question: Who issued a report describing the effects of antibiotic developments?


Answer: 1958

Question: In what year was the FTC's report issued?


Answer: 10,000 and 15,000 USD per patient per year

Context: In March 2001, 40 multi-national pharmaceutical companies brought litigation against South Africa for its Medicines Act, which allowed the generic production of antiretroviral drugs (ARVs) for treating HIV, despite the fact that these drugs were on-patent. HIV was and is an epidemic in South Africa, and ARVs at the time cost between 10,000 and 15,000 USD per patient per year. This was unaffordable for most South African citizens, and so the South African government committed to providing ARVs at prices closer to what people could afford. To do so, they would need to ignore the patents on drugs and produce generics within the country (using a compulsory license), or import them from abroad. After international protest in favour of public health rights (including the collection of 250,000 signatures by MSF), the governments of several developed countries (including The Netherlands, Germany, France, and later the US) backed the South African government, and the case was dropped in April of that year.

Question: How much did treatment for each patient in Africa cost?


Answer: The Netherlands, Germany, France, and later the US

Question: Who backed the South African government which caused the case to be dropped?


Answer: 40 multi-national pharmaceutical companies

Question: Who brought litigation to South Africa?


Answer: 250,000 signatures

Question: How many signatures were collected by MSF?


Answer: March 2001

Question: When was litigation brought to South Africa?


Answer: 40

Question: How many companies sued South Africa for its Medicines Act?


Answer: antiretroviral

Question: South Africa's Medicines Act allowed for the generic production of what kind of drugs?


Answer: between 10,000 and 15,000 USD

Question: How much did ARV drugs cost patients yearly?


Answer: 250,000

Question: How many signatures were collected supporting public health rights?


Answer: Pure Food and Drugs Act

Context: Prior to the 20th century drugs were generally produced by small scale manufacturers with little regulatory control over manufacturing or claims of safety and efficacy. To the extent that such laws did exist, enforcement was lax. In the United States, increased regulation of vaccines and other biological drugs was spurred by tetanus outbreaks and deaths caused by the distribution of contaminated smallpox vaccine and diphtheria antitoxin. The Biologics Control Act of 1902 required that federal government grant premarket approval for every biological drug and for the process and facility producing such drugs. This was followed in 1906 by the Pure Food and Drugs Act, which forbade the interstate distribution of adulterated or misbranded foods and drugs. A drug was considered misbranded if it contained alcohol, morphine, opium, cocaine, or any of several other potentially dangerous or addictive drugs, and if its label failed to indicate the quantity or proportion of such drugs. The government's attempts to use the law to prosecute manufacturers for making unsupported claims of efficacy were undercut by a Supreme Court ruling restricting the federal government's enforcement powers to cases of incorrect specification of the drug's ingredients.

Question: What Act forbade misbranded drugs?


Answer: contaminated smallpox vaccine and diphtheria antitoxin

Question: What caused a Tetanus outbreak?


Answer: The Biologics Control Act of 1902

Question: What act allowed premarket approval for drugs?


Answer: 1906

Question: When did the Pure Food and Drugs Act get implemented?


Answer: Supreme Court

Question: Who restricted the federal government's enforcement powers?


Answer: Biologics Control Act of 1902

Question: What was the name of the law that required premarket approval for producing drugs?


Answer: Pure Food and Drugs Act

Question: What law banned the interstate distribution of mislabeled food and drugs?


Answer: 1906

Question: In what year was the Pure Food and Drugs Act passed?


Answer: World Trade Organization

Context: Patents have been criticized in the developing world, as they are thought to reduce access to existing medicines. Reconciling patents and universal access to medicine would require an efficient international policy of price discrimination. Moreover, under the TRIPS agreement of the World Trade Organization, countries must allow pharmaceutical products to be patented. In 2001, the WTO adopted the Doha Declaration, which indicates that the TRIPS agreement should be read with the goals of public health in mind, and allows some methods for circumventing pharmaceutical monopolies: via compulsory licensing or parallel imports, even before patent expiration.

Question: Who adopted the Doha Declaration?


Answer: countries must allow pharmaceutical products to be patented

Question: What did the TRIPS agreement accomplish?


Answer: thought to reduce access to existing medicines

Question: Why are patents criticized?


Answer: indicates that the TRIPS agreement should be read with the goals of public health in mind, and allows some methods for circumventing pharmaceutical monopolies

Question: What did the Doha Declaration do?


Answer: 2001

Question: When was the Doha Declaration adopted?


Answer: Patents

Question: What has been accused of reducing access to medicines in developing countries?


Answer: compulsory licensing or parallel imports

Question: The Doha Declaration allows for what ways for monopolies to be bypassed?


Answer: 2001

Question: When did the World Trade Organization adopt the Doha Declaration?


Answer: $2.5 billion

Context: Pharmaceutical fraud involves deceptions which bring financial gain to a pharmaceutical company. It affects individuals and public and private insurers. There are several different schemes used to defraud the health care system which are particular to the pharmaceutical industry. These include: Good Manufacturing Practice (GMP) Violations, Off Label Marketing, Best Price Fraud, CME Fraud, Medicaid Price Reporting, and Manufactured Compound Drugs. Of this amount $2.5 billion was recovered through False Claims Act cases in FY 2010. Examples of fraud cases include the GlaxoSmithKline $3 billion settlement, Pfizer $2.3 billion settlement and Merck & Co. $650 million settlement. Damages from fraud can be recovered by use of the False Claims Act, most commonly under the qui tam provisions which rewards an individual for being a "whistleblower", or relator (law).

Question: How much money was recovered through the False Claims?


Answer: Good Manufacturing Practice (GMP) Violations, Off Label Marketing, Best Price Fraud, CME Fraud, Medicaid Price Reporting, and Manufactured Compound Drugs.

Question: What are some of the schemes used to defraud the health care system?


Answer: deceptions which bring financial gain to a pharmaceutical company

Question: What is pharmaceutical fraud?


Answer: GlaxoSmithKline

Question: Who had the biggest fraud case settlement?


Answer: qui tam

Question: What provision rewards "whistle-blowers"?


Answer: Pharmaceutical fraud

Question: What kind of fraud financially benefits a drug company?


Answer: individuals and public and private insurers

Question: Who is affected by pharmaceutical fraud?


Answer: $2.5 billion

Question: How much money lost to pharmaceutical fraud was recovered in 2010?


Answer: False Claims Act

Question: Which act allows whistleblowers to recover money lost from pharmaceutical fraud?


Answer: thiazide antihypertensive drugs

Context: A 2009 Cochrane review concluded that thiazide antihypertensive drugs reduce the risk of death (RR 0.89), stroke (RR 0.63), coronary heart disease (RR 0.84), and cardiovascular events (RR 0.70) in people with high blood pressure. In the ensuring years other classes of antihypertensive drug were developed and found wide acceptance in combination therapy, including loop diuretics (Lasix/furosemide, Hoechst Pharmaceuticals, 1963), beta blockers (ICI Pharmaceuticals, 1964) ACE inhibitors, and angiotensin receptor blockers. ACE inhibitors reduce the risk of new onset kidney disease [RR 0.71] and death [RR 0.84] in diabetic patients, irrespective of whether they have hypertension.

Question: What drugs reduce the risk of death and other events in people with high blood pressure?


Answer: Cochrane

Question: Who conducted the review on Thiazide Antihypertensive drugs?


Answer: combination therapy

Question: What were Thiazide Antihypertensive drugs used with?


Answer: reduce the risk of new onset kidney disease [RR 0.71] and death [RR 0.84] in diabetic patients

Question: What do ACE inhibitors do?


Answer: 2009

Question: In what year did Cochrane release the report?


Answer: ACE inhibitors

Question: What reduces the risk of new onset kidney diseases and death?


Answer: thiazide antihypertensive drugs

Question: What type of drugs reduced the risk of strokes and heart disease for people with high blood pressure?


Answer: 2009

Question: In what year was thiazide antihypertensive drugs shown to help those with heart problems?


Answer: President's Council of Advisors on Science and Technology

Context: Others have argued that excessive regulation suppresses therapeutic innovation, and that the current cost of regulator-required clinical trials prevents the full exploitation of new genetic and biological knowledge for the treatment of human disease. A 2012 report by the President's Council of Advisors on Science and Technology made several key recommendations to reduce regulatory burdens to new drug development, including 1) expanding the FDA's use of accelerated approval processes, 2) creating an expedited approval pathway for drugs intended for use in narrowly defined populations, and 3) undertaking pilot projects designed to evaluate the feasibility of a new, adaptive drug approval process.

Question: Who put out a report in 2012?


Answer: excessive regulation

Question: What has been argued restricted innovation?


Answer: expanding the FDA's use of accelerated approval processes

Question: What was a recommendations brought about from the report?


Answer: therapeutic innovation

Question: What is one thing excessive regulations causes?


Answer: pilot projects

Question: What can be used to evaluate new approval processes?


Answer: therapeutic innovation

Question: What is excessive drug regulation said to suppress?


Answer: 2012

Question: In what year was a report made to reduce the burdens of drug development?


Answer: current cost of regulator-required clinical trials

Question: What was argued to be holding back new knowledge for treating diseases?


Answer: researchers at Ciba

Context: In 1952 researchers at Ciba discovered the first orally available vasodilator, hydralazine. A major shortcoming of hydralazine monotherapy was that it lost its effectiveness over time (tachyphylaxis). In the mid-1950s Karl H. Beyer, James M. Sprague, John E. Baer, and Frederick C. Novello of Merck and Co. discovered and developed chlorothiazide, which remains the most widely used antihypertensive drug today. This development was associated with a substantial decline in the mortality rate among people with hypertension. The inventors were recognized by a Public Health Lasker Award in 1975 for "the saving of untold thousands of lives and the alleviation of the suffering of millions of victims of hypertension".

Question: Who discovered Hydralazine?


Answer: the saving of untold thousands of lives and the alleviation of the suffering of millions of victims of hypertension

Question: Why were the researchers recognized in 1975?


Answer: Karl H. Beyer, James M. Sprague, John E. Baer, and Frederick C. Novello of Merck and Co

Question: Who developed Chlorothiazide?


Answer: hypertension

Question: What is Chlorothiazide used to treat?


Answer: lost its effectiveness over time

Question: What was the main shortcoming in the drug Hydralazine?


Answer: hydralazine

Question: What was the name of the first oral vasodilator?


Answer: chlorothiazide

Question: What is the most used antihypertensive drug today?


Answer: Public Health Lasker Award

Question: Beyer, Sprague, Baer, and Novello received what award in 1975?


Answer: 1952

Question: In what year was hydralazine discovered?


Answer: hypertension

Question: Chlorothiazide helped reduce the mortality rate among those with what disease?


Answer: FD&C

Context: In the U.S., a push for revisions of the FD&C Act emerged from Congressional hearings led by Senator Estes Kefauver of Tennessee in 1959. The hearings covered a wide range of policy issues, including advertising abuses, questionable efficacy of drugs, and the need for greater regulation of the industry. While momentum for new legislation temporarily flagged under extended debate, a new tragedy emerged that underscored the need for more comprehensive regulation and provided the driving force for the passage of new laws.

Question: What act needed provisions?


Answer: Senator Estes Kefauver

Question: Who led the congressional hearings?


Answer: advertising abuses, questionable efficacy of drugs, and the need for greater regulation of the industry

Question: What were the major issues that needed to be addressed?


Answer: a new tragedy emerged

Question: What caused a need for more regulation?


Answer: 1959

Question: When did this push occur?


Answer: FD&C

Question: Congressional hearings emerged addressing revisions to what act?


Answer: Senator Estes Kefauver

Question: Who led the Congressional hearings in 1959?


Answer: greater

Question: Did the US Congress call for more or less regulation of pharmaceuticals?


Answer: an estimated 52 million cases of the disease, 17,400 cases of mental retardation, and 5,200 deaths

Context: Other notable new vaccines of the period include those for measles (1962, John Franklin Enders of Children's Medical Center Boston, later refined by Maurice Hilleman at Merck), Rubella (1969, Hilleman, Merck) and mumps (1967, Hilleman, Merck) The United States incidences of rubella, congenital rubella syndrome, measles, and mumps all fell by >95% in the immediate aftermath of widespread vaccination. The first 20 years of licensed measles vaccination in the U.S. prevented an estimated 52 million cases of the disease, 17,400 cases of mental retardation, and 5,200 deaths.

Question: What did the first measles prevent in it's first 20 years?


Answer: John Franklin Enders

Question: Who originally created the measles vaccine?


Answer: >95%

Question: How much did the occurrence of serious diseases shortly after the release of the measles vaccine?


Answer: 1969

Question: When did the Rubella vaccine come out?


Answer: Maurice Hilleman

Question: Who recreated the measles vaccine?


Answer: 1962

Question: In what year was the measles vaccine made?


Answer: Maurice Hilleman

Question: Who helped refine the measles vaccine?


Answer: 1967

Question: In what year was the mumps vaccine made?


Answer: >95%

Question: How much did rubella, measles, and mumps infections drop after vaccination?


Answer: 52 million

Question: Measles vaccinations helped prevent how many estimated cases of the illness?


Answer: 10 October 1962

Context: The thalidomide tragedy resurrected Kefauver's bill to enhance drug regulation that had stalled in Congress, and the Kefauver-Harris Amendment became law on 10 October 1962. Manufacturers henceforth had to prove to FDA that their drugs were effective as well as safe before they could go on the US market. The FDA received authority to regulate advertising of prescription drugs and to establish good manufacturing practices. The law required that all drugs introduced between 1938 and 1962 had to be effective. An FDA - National Academy of Sciences collaborative study showed that nearly 40 percent of these products were not effective. A similarly comprehensive study of over-the-counter products began ten years later.

Question: When did the Kefauver-Harris Amendment become a law?


Answer: all drugs introduced between 1938 and 1962 had to be effective

Question: What did this new law require?


Answer: nearly 40 percent of these products were not effective

Question: What did the National Academy of Science's study discover?


Answer: ten years later

Question: How long after the National Academy of Science's study did a study on over the counter drugs occur?


Answer: The thalidomide tragedy

Question: What brought up enhancement of drug regulations?


Answer: 10 October 1962

Question: When did the Kefauver-Harris Amendment became law?


Answer: FDA

Question: What federal agency regulated the advertising of prescription drugs?


Answer: 1938 and 1962

Question: Drugs made between which years had to be tested before going to market?


Answer: 40 percent

Question: What percentage of drugs were shown to be ineffective after an FDA study?


Answer: Over 20,000

Context: The firm continued to pressure Kelsey and the agency to approve the application—until November 1961, when the drug was pulled off the German market because of its association with grave congenital abnormalities. Several thousand newborns in Europe and elsewhere suffered the teratogenic effects of thalidomide. Though the drug was never approved in the USA, the firm distributed Kevadon to over 1,000 physicians there under the guise of investigational use. Over 20,000 Americans received thalidomide in this "study," including 624 pregnant patients, and about 17 known newborns suffered the effects of the drug.[citation needed]

Question: How many Americans were given the drug Kevadon?


Answer: November 1961

Question: When was the drug taken off shelves in Germany?


Answer: about 17

Question: How many newborns were born with issues due to Kevadon?


Answer: under the guise of investigational use

Question: How was Kevadon distributed to doctors?


Answer: association with grave congenital abnormalities

Question: Why was this drug pulled off shelves?


Answer: 1961

Question: In what year was thalidomide banned in Germany?


Answer: congenital abnormalities

Question: What adverse effect was thalidomide associated with?


Answer: Kevadon

Question: Thalidomide was distributed in the USA by what name?


Answer: Over 20,000

Question: About how many Americans received thalidomide in a supposed study?


Answer: 17

Question: How many newborn American babies were affected by thalidomide?


Answer: Comstock laws

Context: Prior to the second world war, birth control was prohibited in many countries, and in the United States even the discussion of contraceptive methods sometimes led to prosecution under Comstock laws. The history of the development of oral contraceptives is thus closely tied to the birth control movement and the efforts of activists Margaret Sanger, Mary Dennett, and Emma Goldman. Based on fundamental research performed by Gregory Pincus and synthetic methods for progesterone developed by Carl Djerassi at Syntex and by Frank Colton at G.D. Searle & Co., the first oral contraceptive, Enovid, was developed by E.D. Searle and Co. and approved by the FDA in 1960. The original formulation incorporated vastly excessive doses of hormones, and caused severe side effects. Nonetheless, by 1962, 1.2 million American women were on the pill, and by 1965 the number had increased to 6.5 million. The availability of a convenient form of temporary contraceptive led to dramatic changes in social mores including expanding the range of lifestyle options available to women, reducing the reliance of women on men for contraceptive practice, encouraging the delay of marriage, and increasing pre-marital co-habitation.

Question: What law prohibited birth control?


Answer: 1960

Question: When was Enovid first approved?


Answer: pre-marital co-habitation

Question: What increased due to the availability of birth control?


Answer: E.D. Searle and Co

Question: Who created the first oral birth control?


Answer: 6.5 million

Question: In 1965, how many women were on the birth control pill?


Answer: Comstock laws

Question: Discussing contraception sometimes led to prosecution under what laws?


Answer: Enovid

Question: What was the name of the first oral contraceptive?


Answer: 6.5 million

Question: By 1965, about how many American women were taking Enovid?


Answer: 1960

Question: When did the FDA approve Enovid?


Answer: second world war

Question: Birth control was prohibited in most countries before what war?


Answer: Endo

Context: In April 1994, the results of a Merck-sponsored study, the Scandinavian Simvastatin Survival Study, were announced. Researchers tested simvastatin, later sold by Merck as Zocor, on 4,444 patients with high cholesterol and heart disease. After five years, the study concluded the patients saw a 35% reduction in their cholesterol, and their chances of dying of a heart attack were reduced by 42%. In 1995, Zocor and Mevacor both made Merck over US$1 billion. Endo was awarded the 2006 Japan Prize, and the Lasker-DeBakey Clinical Medical Research Award in 2008. For his "pioneering research into a new class of molecules" for "lowering cholesterol,"[sentence fragment]

Question: Who received the Laser-Debakey Clinical Medical Research Aware?


Answer: over US$1 billion

Question: How much money did Merk make in 1995?


Answer: 4,444

Question: How many patients received Zocor?


Answer: Scandinavian Simvastatin Survival Study

Question: What study did Merk sponsor in 1994?


Answer: a 35% reduction in their cholesterol, and their chances of dying of a heart attack were reduced by 42%

Question: What did the study reveal after 5 years?


Answer: Zocor

Question: What was the brand name of simvastatin?


Answer: 35%

Question: Patients treated with Zocor had their cholesterol reduced by how much?


Answer: 42%

Question: How much did Zocor reduce the chance of dying from a heart attack?


Answer: over US$1 billion

Question: How much money did Merck make from sales of Zocor and Mevacor?


Answer: Lasker-DeBakey Clinical Medical Research Award

Question: Endo received what award in 2008?


Answer: the process by which potential drugs are discovered or designed

Context: Drug discovery is the process by which potential drugs are discovered or designed. In the past most drugs have been discovered either by isolating the active ingredient from traditional remedies or by serendipitous discovery. Modern biotechnology often focuses on understanding the metabolic pathways related to a disease state or pathogen, and manipulating these pathways using molecular biology or biochemistry. A great deal of early-stage drug discovery has traditionally been carried out by universities and research institutions.

Question: What is a drug discovery?


Answer: universities and research institutions

Question: Who is usually responsible for early stages of drug discovery?


Answer: molecular biology or biochemistry

Question: What is used to manipulate pathways?


Answer: isolating the active ingredient from traditional remedies or by serendipitous discovery

Question: What is involved in drug discovery?


Answer: biotechnology

Question: What focuses on metabolic pathways?


Answer: Drug discovery

Question: What is the name of the process in which possible drugs are discovered?


Answer: research institutions

Question: What groups carry out most early drug discoveries?


Answer: biotechnology

Question: What kind of technology studies the understanding and manipulation of disease states and pathogens?


Answer: active ingredient

Question: Most drugs have been found by isolating what from traditional remedies?


Answer: about 1.3 billion

Context: Drug discovery and development is very expensive; of all compounds investigated for use in humans only a small fraction are eventually approved in most nations by government appointed medical institutions or boards, who have to approve new drugs before they can be marketed in those countries. In 2010 18 NMEs (New Molecular Entities) were approved and three biologics by the FDA, or 21 in total, which is down from 26 in 2009 and 24 in 2008. On the other hand, there were only 18 approvals in total in 2007 and 22 back in 2006. Since 2001, the Center for Drug Evaluation and Research has averaged 22.9 approvals a year. This approval comes only after heavy investment in pre-clinical development and clinical trials, as well as a commitment to ongoing safety monitoring. Drugs which fail part-way through this process often incur large costs, while generating no revenue in return. If the cost of these failed drugs is taken into account, the cost of developing a successful new drug (new chemical entity, or NCE), has been estimated at about 1.3 billion USD(not including marketing expenses). Professors Light and Lexchin reported in 2012, however, that the rate of approval for new drugs has been a relatively stable average rate of 15 to 25 for decades.

Question: How much does it cost to develop a new drug?


Answer: averaged 22.9 approvals

Question: How many approvals of new drugs happen every year?


Answer: Center for Drug Evaluation and Research

Question: Who is responsible for approval or rejection of new drugs?


Answer: 18 approvals

Question: How many drugs were approved in 2007?


Answer: Professors Light and Lexchin

Question: Who reported the stable average rate in 2012?


Answer: New Molecular Entities

Question: What does NMEs stand for?


Answer: 22.9

Question: How many pharmaceutical drugs were approved on average since 2001?


Answer: 1.3 billion USD

Question: What is the approximate cost of developing a new drug, including the costs of failure?


Answer: 15 to 25

Question: What has been the stable approval rate of new drugs?


Answer: those based on re-formulation of an existing active ingredient

Context: Some of these estimates also take into account the opportunity cost of investing capital many years before revenues are realized (see Time-value of money). Because of the very long time needed for discovery, development, and approval of pharmaceuticals, these costs can accumulate to nearly half the total expense. A direct consequence within the pharmaceutical industry value chain is that major pharmaceutical multinationals tend to increasingly outsource risks related to fundamental research, which somewhat reshapes the industry ecosystem with biotechnology companies playing an increasingly important role, and overall strategies being redefined accordingly. Some approved drugs, such as those based on re-formulation of an existing active ingredient (also referred to as Line-extensions) are much less expensive to develop.

Question: What drugs are the least expensive to develop?


Answer: opportunity cost of investing capital

Question: What accounts for nearly half of the costs to develop drugs?


Answer: increasingly outsource risks related to fundamental research

Question: What is the consequence in the value chain?


Answer: somewhat reshapes the industry ecosystem with biotechnology companies

Question: What happens when companies outsource?


Answer: Line-extensions

Question: What is re-formulations of active ingredients referred to?


Answer: nearly half the total expense

Question: Investing capital can increase drug development costs by how much?


Answer: biotechnology

Question: What kind of companies have had a more important role in drug development?


Answer: major pharmaceutical multinationals

Question: What firms tend to outsource drug development?


Answer: adverse effects of tumors, muscle deterioration, and sometimes death

Context: In 1971, Akira Endo, a Japanese biochemist working for the pharmaceutical company Sankyo, identified mevastatin (ML-236B), a molecule produced by the fungus Penicillium citrinum, as an inhibitor of HMG-CoA reductase, a critical enzyme used by the body to produce cholesterol. Animal trials showed very good inhibitory effect as in clinical trials, however a long term study in dogs found toxic effects at higher doses and as a result mevastatin was believed to be too toxic for human use. Mevastatin was never marketed, because of its adverse effects of tumors, muscle deterioration, and sometimes death in laboratory dogs.

Question: Why was Mevastatin never marketed?


Answer: Akira Endo

Question: Who discovered Mevastatin?


Answer: cholesterol

Question: What is HMG-CoA responsible for producing?


Answer: Penicillium citrinum

Question: Where did Endo discover ML-236B?


Answer: too toxic for human use

Question: What was discovered in long term studies?


Answer: 1971

Question: In what year was mevastatin discovered?


Answer: Akira Endo

Question: Who discovered mevastatin?


Answer: Penicillium citrinum

Question: What organism produces mevastatin?


Answer: HMG-CoA reductase

Question: What enzyme helps produce cholesterol?


Answer: $301 million

Context: Every major company selling the antipsychotics — Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson — has either settled recent government cases, under the False Claims Act, for hundreds of millions of dollars or is currently under investigation for possible health care fraud. Following charges of illegal marketing, two of the settlements set records last year for the largest criminal fines ever imposed on corporations. One involved Eli Lilly's antipsychotic Zyprexa, and the other involved Bextra. In the Bextra case, the government also charged Pfizer with illegally marketing another antipsychotic, Geodon; Pfizer settled that part of the claim for $301 million, without admitting any wrongdoing.

Question: How much did Pfizer settle the illegal marketing suit for?


Answer: Zyprexa, and the other involved Bextra

Question: What drugs were involved in cases of the largest criminal fines?


Answer: Geodon

Question: What was Pfizer accused of illegally marketing?


Answer: Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson

Question: What companies have been involved with health care fraud cases?


Answer: False Claims Act

Question: What do illegal marketing cases fall under?


Answer: False Claims Act

Question: Firms such as Eli Lilly, Pfizer, and AstraZeneca have settled claims under what act?


Answer: Eli Lilly

Question: Zyprexa was owned by what company?


Answer: Geodon

Question: Pfizer was charged with illegally marketing what antipsychotic drug?


Answer: $301 million

Question: Pfizer settled the Geodon lawsuit for how much money?


Answer: World Economic Forum, the Gates Foundation, the Wellcome Trust, and the Food and Drug Administration

Context: In contrast to this viewpoint, an article and associated editorial in the New England Journal of Medicine in May 2015 emphasized the importance of pharmaceutical industry-physician interactions for the development of novel treatments, and argued that moral outrage over industry malfeasance had unjustifiably led many to overemphasize the problems created by financial conflicts of interest. The article noted that major healthcare organizations such as National Center for Advancing Translational Sciences of the National Institutes of Health, the President’s Council of Advisors on Science and Technology, the World Economic Forum, the Gates Foundation, the Wellcome Trust, and the Food and Drug Administration had encouraged greater interactions between physicians and industry in order to bring greater benefits to patients.

Question: Who were some of the companies that encouraged the interactions between doctors and the pharmaceutical industry?


Answer: May 2015

Question: When did the article come out about the importance of interactions?


Answer: bring greater benefits to patients

Question: What was the reason behind these interactions?


Answer: moral outrage over industry malfeasance

Question: What was believed to have created a financial conflict of interest?


Answer: New England Journal of Medicine

Question: Who printed the article about the importance of interactions?


Answer: New England Journal of Medicine

Question: What publication had an article about the importance of pharmaceutical industry-physician interactions in 2015?


Answer: May 2015

Question: When was the editorial published?


Answer: encouraged greater interactions

Question: Did major healthcare organizations support or discourage interactions between doctors and industries?


Answer: ProPublica

Context: An investigation by ProPublica found that at least 21 doctors have been paid more than $500,000 for speeches and consulting by drugs manufacturers since 2009, with half of the top earners working in psychiatry, and about $2 billion in total paid to doctors for such services. AstraZeneca, Johnson & Johnson and Eli Lilly have paid billions of dollars in federal settlements over allegations that they paid doctors to promote drugs for unapproved uses. Some prominent medical schools have since tightened rules on faculty acceptance of such payments by drug companies.

Question: Who conduced an investigation on doctors?


Answer: AstraZeneca, Johnson & Johnson and Eli Lilly

Question: Billions of dollars have been paid by which companies?


Answer: more than $500,000

Question: How much was discovered to have been paid to doctors by drug companies?


Answer: allegations that they paid doctors to promote drugs for unapproved uses

Question: What was the reason these companies have to pay fines?


Answer: at least 21

Question: How many doctors have been paid by varies companies?


Answer: more than $500,000

Question: A ProPublica study found that some doctors were being paid how much money for speeches?


Answer: psychiatry

Question: Half of the top earners were mostly in what field?


Answer: $2 billion

Question: Drug manufacturers paid off doctors a total of how much money?


Answer: to explore the potential of new drug substances

Context: Often, large multinational corporations exhibit vertical integration, participating in a broad range of drug discovery and development, manufacturing and quality control, marketing, sales, and distribution. Smaller organizations, on the other hand, often focus on a specific aspect such as discovering drug candidates or developing formulations. Often, collaborative agreements between research organizations and large pharmaceutical companies are formed to explore the potential of new drug substances. More recently, multi-nationals are increasingly relying on contract research organizations to manage drug development.

Question: Why are collaborative agreements important?


Answer: participating in a broad range of drug discovery and development, manufacturing and quality control, marketing, sales, and distribution

Question: How do large corporations show vertical integration?


Answer: to manage drug development

Question: What are large companies relying on outside organizations for?


Answer: focus on a specific aspect such as discovering drug candidates or developing formulations

Question: What are smaller organizations responsible for?


Answer: vertical

Question: What type of integration do large corporations often do?


Answer: a specific aspect

Question: What type of integration do smaller organizations do?


Answer: collaborative agreements

Question: What type of agreements are made to research potential new drugs?


Answer: contract research

Question: What type of organizations are multinational corporations increasingly rely on?


Answer: The British National Formulary

Context: In the UK, the Medicines and Healthcare Products Regulatory Agency approves drugs for use, though the evaluation is done by the European Medicines Agency, an agency of the European Union based in London. Normally an approval in the UK and other European countries comes later than one in the USA. Then it is the National Institute for Health and Care Excellence (NICE), for England and Wales, who decides if and how the National Health Service (NHS) will allow (in the sense of paying for) their use. The British National Formulary is the core guide for pharmacists and clinicians.

Question: Who is the core guide?


Answer: Medicines and Healthcare Products Regulatory Agency

Question: Who is responsible for approving drugs in the United Kingdom?


Answer: comes later

Question: After an approval in the United States, when does an approval occur in the United Kingdom and other countries?


Answer: National Institute for Health and Care Excellence (NICE)

Question: Who decides how NHS will allow drugs?


Answer: European Medicines Agency

Question: Who does the evaluations for drugs in the United Kingdom?


Answer: Medicines and Healthcare Products Regulatory Agency

Question: What UK firm approves pharmaceutical drugs?


Answer: European Medicines Agency

Question: What UK organization evaluates drugs?


Answer: National Institute for Health and Care Excellence

Question: What firm in England and Wales decides if the NHS allows drugs?


Answer: British National Formulary

Question: What is the name of the core guide for pharmacists and clinicians?


Answer: diseases involving fewer than 200,000 patients in the United States, or larger populations in certain circumstances

Context: There are special rules for certain rare diseases ("orphan diseases") in several major drug regulatory territories. For example, diseases involving fewer than 200,000 patients in the United States, or larger populations in certain circumstances are subject to the Orphan Drug Act. Because medical research and development of drugs to treat such diseases is financially disadvantageous, companies that do so are rewarded with tax reductions, fee waivers, and market exclusivity on that drug for a limited time (seven years), regardless of whether the drug is protected by patents.

Question: What is subject to the Orphan Drug Act?


Answer: tax reductions, fee waivers, and market exclusivity on that drug for a limited time (seven years), regardless of whether the drug is protected by patents

Question: What is given to companies who develop drugs for "orphan diseases"?


Answer: Because medical research and development of drugs to treat such diseases is financially disadvantageous

Question: Why are these companies rewarded?


Answer: fewer than 200,000 patients

Question: What size of disease populations are subject to the Orphan Drug Act?


Answer: tax reductions

Question: What is one financial benefit to researching orphan drugs?


Answer: seven years

Question: What is the length of time of market exclusivity of an orphan drug?


Answer: orphan diseases

Question: What is a term for rare diseases in some territories?


Answer: Ben Goldacre

Context: Ben Goldacre has argued that regulators – such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, or the Food and Drug Administration (FDA) in the United States – advance the interests of the drug companies rather than the interests of the public due to revolving door exchange of employees between the regulator and the companies and friendships develop between regulator and company employees. He argues that regulators do not require that new drugs offer an improvement over what is already available, or even that they be particularly effective.

Question: Who argued against regulators?


Answer: Ben Goldacre

Question: Who argued that drug regulators were greater serving the interests of the drug companies than the patients?


Answer: regulator and company employees

Question: The business friendships between which parties have been criticized?


Answer: regulators

Question: Goldacre argued that which party didn't require that new drugs be improved at all?


Answer: England and Wales

Context: In many non-US western countries a 'fourth hurdle' of cost effectiveness analysis has developed before new technologies can be provided. This focuses on the efficiency (in terms of the cost per QALY) of the technologies in question rather than their efficacy. In England and Wales NICE decides whether and in what circumstances drugs and technologies will be made available by the NHS, whilst similar arrangements exist with the Scottish Medicines Consortium in Scotland, and the Pharmaceutical Benefits Advisory Committee in Australia. A product must pass the threshold for cost-effectiveness if it is to be approved. Treatments must represent 'value for money' and a net benefit to society.

Question: NICE decides the availability of drugs in which two countries?


Answer: Scottish Medicines Consortium

Question: What is the name of the organization in Scotland that decides the availability of drugs?


Answer: cost-effectiveness

Question: What threshold must a drug pass before it is approved?


Answer: $75.6 billion

Context: The top ten best-selling drugs of 2013 totaled $75.6 billion in sales, with the anti-inflammatory drug Humira being the best-selling drug worldwide at $10.7 billion in sales. The second and third best selling were Enbrel and Remicade, respectively. The top three best-selling drugs in the United States in 2013 were Abilify ($6.3 billion,) Nexium ($6 billion) and Humira ($5.4 billion). The best-selling drug ever, Lipitor, averaged $13 billion annually and netted $141 billion total over its lifetime before Pfizer's patent expired in November 2011.

Question: How much money did the top ten bestselling drugs make in 2013?


Answer: Humira

Question: What was the name of the top-selling anti-inflammatory drug in 2013?


Answer: Lipitor

Question: What was the bestselling drug in history?


Answer: $141 billion

Question: How much money did Lipitor make before the patent expired?


Answer: 2011

Question: In what year did Pfizer's patent over Lipitor expire?


Answer: 20 years

Context: Depending on a number of considerations, a company may apply for and be granted a patent for the drug, or the process of producing the drug, granting exclusivity rights typically for about 20 years. However, only after rigorous study and testing, which takes 10 to 15 years on average, will governmental authorities grant permission for the company to market and sell the drug. Patent protection enables the owner of the patent to recover the costs of research and development through high profit margins for the branded drug. When the patent protection for the drug expires, a generic drug is usually developed and sold by a competing company. The development and approval of generics is less expensive, allowing them to be sold at a lower price. Often the owner of the branded drug will introduce a generic version before the patent expires in order to get a head start in the generic market. Restructuring has therefore become routine, driven by the patent expiration of products launched during the industry's "golden era" in the 1990s and companies' failure to develop sufficient new blockbuster products to replace lost revenues.

Question: How long do drug exclusivity rights usually last?


Answer: 10 to 15 years on average

Question: Governments grant permission to market drugs after how many years?


Answer: Patent protection

Question: What enables a drug's owner to recover R&D costs?


Answer: generic

Question: What kind of drug is produced by competitors once a patent expires?


Answer: 1990s

Question: What decade was the pharmaceutical industry's "golden era"?


Answer: Food and Drug Administration

Context: In the United States, new pharmaceutical products must be approved by the Food and Drug Administration (FDA) as being both safe and effective. This process generally involves submission of an Investigational New Drug filing with sufficient pre-clinical data to support proceeding with human trials. Following IND approval, three phases of progressively larger human clinical trials may be conducted. Phase I generally studies toxicity using healthy volunteers. Phase II can include pharmacokinetics and dosing in patients, and Phase III is a very large study of efficacy in the intended patient population. Following the successful completion of phase III testing, a New Drug Application is submitted to the FDA. The FDA review the data and if the product is seen as having a positive benefit-risk assessment, approval to market the product in the US is granted.

Question: The safety and efficacy of new drugs must be approved by what organization in the US?


Answer: Investigational New Drug

Question: What type of filing is used before beginning human trials?


Answer: three

Question: How many phases of human trials may be done after IND approval?


Answer: New Drug Application

Question: What type of application is filed after completing three phases of human trials?


Answer: positive benefit-risk

Question: What type of risk assessment results in approving the drug to go on the market?


Answer: Pharmaceutical companies

Context: Advertising is common in healthcare journals as well as through more mainstream media routes. In some countries, notably the US, they are allowed to advertise directly to the general public. Pharmaceutical companies generally employ sales people (often called 'drug reps' or, an older term, 'detail men') to market directly and personally to physicians and other healthcare providers. In some countries, notably the US, pharmaceutical companies also employ lobbyists to influence politicians. Marketing of prescription drugs in the US is regulated by the federal Prescription Drug Marketing Act of 1987.

Question: "Drug reps" are usually hired by what type of firms?


Answer: Prescription Drug Marketing Act of 1987

Question: What law regulates drug marketing in the US?


Answer: directly and personally to physicians

Question: Who do drug reps market to?


Answer: 'gifts' and biased information

Context: There has been increasing controversy surrounding pharmaceutical marketing and influence. There have been accusations and findings of influence on doctors and other health professionals through drug reps, including the constant provision of marketing 'gifts' and biased information to health professionals; highly prevalent advertising in journals and conferences; funding independent healthcare organizations and health promotion campaigns; lobbying physicians and politicians (more than any other industry in the US); sponsorship of medical schools or nurse training; sponsorship of continuing educational events, with influence on the curriculum; and hiring physicians as paid consultants on medical advisory boards.

Question: Drug reps have been accused of giving what to health professionals?


Answer: physicians

Question: Drug marketers have hired who as paid consultants?