Divyanshu67/squad_v2 huggingface dataset:
Pharmaceutical_industry

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: Pure Food and Drugs Act

Question: What caused a Tetanus outbreak?
Answer: contaminated smallpox vaccine and diphtheria antitoxin

Question: What act allowed premarket approval for drugs?
Answer: The Biologics Control Act of 1902

Question: When did the Pure Food and Drugs Act get implemented?
Answer: 1906

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

Question: What was the name of the law that required premarket approval for producing drugs?
Answer: Biologics Control Act of 1902

Question: What law banned the interstate distribution of mislabeled food and drugs? 
Answer: Pure Food and Drugs Act

Question: In what year was the Pure Food and Drugs Act passed?
Answer: 1906

Question: What Act forbade misbranded laws?

Question: What caused a law outbreak?

Question: What act allowed premarket approval for laws?

Question: When did the Pure Food And Laws Act get implemented?

Question: Who restricted the federal drug powers?
Pharmaceutical_industry

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: World Trade Organization

Question: What did the TRIPS agreement accomplish?
Answer: countries must allow pharmaceutical products to be patented

Question: Why are patents criticized?
Answer: thought to reduce access to existing medicines

Question: What did the Doha Declaration do?
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: When was the Doha Declaration adopted?
Answer: 2001

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

Question: When did the World Trade Organization adopt the Doha Declaration?
Answer: 2001

Question: The Doha Declaration allows for what ways for monopolies to be bypassed?
Answer: compulsory licensing or parallel imports

Question: Who adopted the TRIPS Declaration?

Question: What did the WTO agreement accomplish?

Question: Why is the WTO criticized?

Question: What did the WTO Declaration do?

Question: When was the TRIPS Declaration adopted?
Pharmaceutical_industry

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: $2.5 billion

Question: What are some of the schemes used to defraud the health care system?
Answer: Good Manufacturing Practice (GMP) Violations, Off Label Marketing, Best Price Fraud, CME Fraud, Medicaid Price Reporting, and Manufactured Compound Drugs.

Question: What is pharmaceutical fraud?
Answer: deceptions which bring financial gain to a pharmaceutical company

Question: Who had the biggest fraud case settlement?
Answer: GlaxoSmithKline

Question: What provision rewards "whistle-blowers"?
Answer: qui tam

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

Question: Who is affected by pharmaceutical fraud?
Answer: individuals and public and private insurers

Question: How much money lost to pharmaceutical fraud was recovered in 2010?
Answer: $2.5 billion

Question: Which act allows whistleblowers to recover money lost from pharmaceutical fraud?
Answer: False Claims Act

Question: How much money was recovered through CME Fraud?

Question: What are some of the schemes used to defraud companies?

Question: What is relator fraud?

Question: Who had the biggest relator case settlement?
Pharmaceutical_industry

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

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

Question: Who conducted the review on Thiazide Antihypertensive drugs?
Answer: Cochrane

Question: What were Thiazide Antihypertensive drugs used with?
Answer: combination therapy

Question: In what year did Cochrane release the report?
Answer: 2009

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

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

Question: In what year was thiazide antihypertensive drugs shown to help those with heart problems?
Answer: 2009

Question: What do RRE inhibitors do?

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

Question: Who conducted the review on RRE drugs?

Question: What were RRE drugs used with?

Question: In what year did ACE release the report?
Pharmaceutical_industry

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: President's Council of Advisors on Science and Technology

Question: What has been argued restricted innovation?
Answer: excessive regulation

Question: What was a recommendations brought about from the report?
Answer: expanding the FDA's use of accelerated approval processes

Question: What is one thing excessive regulations causes?
Answer: therapeutic innovation

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

Question: What is excessive drug regulation said to suppress?
Answer: therapeutic innovation

Question: In what year was a report made to reduce the burdens of drug development?
Answer: 2012

Question: What was argued to be holding back new knowledge for treating diseases?
Answer: current cost of regulator-required clinical trials

Question: Who put out a report in 2011?

Question: What has been argued restricted population?

Question: What was a recommendation brought about from human disease?

Question: What is one thing excessive development causes?

Question: What can be used to evaluate new human diseases?
Pharmaceutical_industry

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: researchers at Ciba

Question: Why were the researchers recognized in 1975?
Answer: the saving of untold thousands of lives and the alleviation of the suffering of millions of victims of hypertension

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

Question: What is  Chlorothiazide used to treat?
Answer: hypertension

Question: What was the main shortcoming in the drug Hydralazine?
Answer: lost its effectiveness over time

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

Question: What is the most used antihypertensive drug today?
Answer: chlorothiazide

Question: Beyer, Sprague, Baer, and Novello received what award in 1975?
Answer: Public Health Lasker Award

Question: In what year was hydralazine discovered?
Answer: 1952

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

Question: Who discovered Lasker?

Question: Why were the researchers recognized in 1952?

Question: who developed Ciba?

Question: What is Ciba used to treat?

Question: What was the main shortcoming in the drug Ciba?
Pharmaceutical_industry

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: Who led the congressional hearings?
Answer: Senator Estes Kefauver

Question: What act needed provisions?
Answer: FD&C

Question: What were the major issues that needed to be addressed?
Answer: advertising abuses, questionable efficacy of drugs, and the need for greater regulation of the industry

Question: What caused a need for more regulation?
Answer: a new tragedy emerged

Question: When did this push occur?
Answer: 1959

Question: Congressional hearings emerged addressing revisions to what act?
Answer: FD&C

Question: Who led the Congressional hearings in 1959?
Answer: Senator Estes Kefauver

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

Question: Who led the congressional passages?

Question: What congress needed provisions?

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

Question: What caused a need for more industry?

Question: When did questionable efficacy occur?
Pharmaceutical_industry

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

Question: Who originally created the measles vaccine?
Answer: John Franklin Enders

Question: How much did the occurrence of serious diseases shortly after the release of the measles vaccine?
Answer: >95%

Question: When did the Rubella vaccine come out?
Answer: 1969

Question: Who recreated the measles vaccine?
Answer: Maurice Hilleman

Question: In what year was the measles vaccine made?
Answer: 1962

Question: Who helped refine the measles vaccine?
Answer: Maurice Hilleman

Question: In what year was the mumps vaccine made?
Answer: 1967

Question: How much did rubella, measles, and mumps infections drop after vaccination?
Answer: >95%

Question: Measles vaccinations helped prevent how many estimated cases of the illness?
Answer: 52 million

Question: What did the first measles prevent in its first 10 years?

Question: Who originally created rubella?

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

Question: When did measles come out?

Question: Who recreated measles?
Pharmaceutical_industry

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: 10 October 1962

Question: What did this new law require?
Answer: all drugs introduced between 1938 and 1962 had to be effective

Question: What did the National Academy of Science's study discover?
Answer: nearly 40 percent of these products were not effective

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

Question: What brought up enhancement of drug regulations?
Answer: The thalidomide tragedy

Question: When did the Kefauver-Harris Amendment became law?
Answer: 10 October 1962

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

Question: Drugs made between which years had to be tested before going to market?
Answer: 1938 and 1962

Question: What percentage of drugs were shown to be ineffective after an FDA study?
Answer: 40 percent

Question: When did the FDA Amendment become a law?

Question: What did this new law prohibit?

Question: What did the FDA study discover?

Question: How long after the FDA's study did a study on over the counter drugs occur?

Question: What brought up enhancement of Congress regulations?
Pharmaceutical_industry

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: Over 20,000

Question: When was the drug taken off shelves in Germany?
Answer: November 1961

Question: How many newborns were born with issues due to Kevadon?
Answer: about 17

Question: How was Kevadon distributed to doctors?
Answer: under the guise of investigational use

Question: Why was this drug pulled off shelves?
Answer: association with grave congenital abnormalities

Question: In what year was thalidomide banned in Germany?
Answer: 1961

Question: What adverse effect was thalidomide associated with?
Answer: congenital abnormalities

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

Question: About how many Americans received thalidomide in a supposed study?
Answer: Over 20,000

Question: How many newborn American babies were affected by thalidomide?
Answer: 17

Question: How many Americans were given the drug thalidomide?

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

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

Question: How was Kevadon distributed to the USA?

Question: Why was this drug put on shelves?
Pharmaceutical_industry

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: Comstock laws

Question: When was Enovid first approved?
Answer: 1960

Question: What increased due to the availability of birth control?
Answer: pre-marital co-habitation

Question: In 1965, how many women were on the birth control pill?
Answer: 6.5 million

Question: Who created the first oral birth control?
Answer: E.D. Searle and Co

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

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

Question: When did the FDA approve Enovid?
Answer: 1960

Question: By 1965, about how many American women were taking Enovid?
Answer: 6.5 million

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

Question: What law prohibited severe pills?

Question: When was Colton first approved?

Question: What increased due to the availability of severe pills?

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

Question: Who created the first marriage control?
Pharmaceutical_industry

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: Endo

Question: How much money did Merk make in 1995?
Answer: over US$1 billion

Question: How many patients received Zocor?
Answer: 4,444

Question: What study did Merk sponsor in 1994?
Answer: Scandinavian Simvastatin Survival Study

Question: What did the study reveal after 5 years?
Answer: a 35% reduction in their cholesterol, and their chances of dying of a heart attack were reduced by 42%

Question: What was the brand name of simvastatin?
Answer: Zocor

Question: Patients treated with Zocor had their cholesterol reduced by how much?
Answer: 35%

Question: How much did Zocor reduce the chance of dying from a heart attack?
Answer: 42%

Question: How much money did Merck make from sales of Zocor and Mevacor?
Answer: over US$1 billion

Question: Endo received what award in 2008?
Answer: Lasker-DeBakey Clinical Medical Research Award

Question: Who received the Zocor Research Reward?

Question: How much money did Simvastatin make in 1995?

Question: How many patients received Simvastatin?

Question: What study did Merk sponsor in 2008?

Question: What did the study reveal after 2 years?
Pharmaceutical_industry

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: the process by which potential drugs are discovered or designed

Question: Who is usually responsible for early stages of drug discovery?
Answer: universities and research institutions

Question: What is used to manipulate pathways?
Answer: molecular biology or biochemistry

Question: What is involved in drug discovery?
Answer: isolating the active ingredient from traditional remedies or by serendipitous discovery

Question: What focuses on metabolic pathways?
Answer: biotechnology

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

Question: What groups carry out most early drug discoveries?
Answer: research institutions

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

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

Question: What is a remedy discovery?

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

Question: What is used to manipulate institutions?

Question: What is involved in remedy discovery?

Question: What focuses on early-stage pathways?
Pharmaceutical_industry

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: about 1.3 billion

Question: How many approvals of new drugs happen every year?
Answer: averaged 22.9 approvals

Question: Who is responsible for approval or rejection of new drugs?
Answer: Center for Drug Evaluation and Research

Question: How many drugs were approved in 2007?
Answer: 18 approvals

Question: Who reported the stable average rate in 2012?
Answer: Professors Light and Lexchin

Question: What does NMEs stand for?
Answer: New Molecular Entities

Question: How many pharmaceutical drugs were approved on average since 2001?
Answer: 22.9

Question: What is the approximate cost of developing a new drug, including the costs of failure?
Answer: 1.3 billion USD

Question: What has been the stable approval rate of new drugs?
Answer: 15 to 25

Question: How much does it cost to develop approvals?

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

Question: Who is responsible for approval or rejection of centers?

Question: How many drugs were approved in 2012?

Question: Who reported the stable average rate in 2007?
Pharmaceutical_industry

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

Question: What accounts for nearly half of the costs to develop drugs?
Answer: opportunity cost of investing capital

Question: What is the consequence in the value chain?
Answer: increasingly outsource risks related to fundamental research

Question: What happens when companies outsource?
Answer: somewhat reshapes the industry ecosystem with biotechnology companies

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

Question: Investing capital can increase drug development costs by how much?
Answer: nearly half the total expense

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

Question: What firms tend to outsource drug development?
Answer: major pharmaceutical multinationals

Question: What drugs are the least fundamental to develop?

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

Question: What is the consequence in the research chain?

Question: What happens when companies approve drugs?

Question: What is re-formulations of approved drugs referred to?
Pharmaceutical_industry

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

Question: Who discovered Mevastatin?
Answer: Akira Endo

Question: What is HMG-CoA responsible for producing?
Answer: cholesterol

Question: Where did Endo discover ML-236B?
Answer: Penicillium citrinum

Question: What was discovered in long term studies?
Answer: too toxic for human use

Question: In what year was mevastatin discovered?
Answer: 1971

Question: Who discovered mevastatin?
Answer: Akira Endo

Question: What organism produces mevastatin?
Answer: Penicillium citrinum

Question: What enzyme helps produce cholesterol?
Answer: HMG-CoA reductase

Question: Why was Penicillium never marketed?

Question: Who discovered Penicillium?

Question: What is Penicillium responsible for producing?

Question: What was discovered in short term studies?

Question: In what year was Penicillium discovered?
Pharmaceutical_industry

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: $301 million

Question: What drugs were involved in cases of the largest criminal fines?
Answer: Zyprexa, and the other involved Bextra

Question: What was Pfizer accused of illegally marketing?
Answer: Geodon

Question: What companies have been involved with health care fraud cases?
Answer: Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson

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: False Claims Act

Question: Zyprexa was owned by what company?
Answer: Eli Lilly

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

Question: Pfizer settled the Geodon lawsuit for how much money?
Answer: $301 million

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

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

Question: What was Johnson & Johnson accused of illegally marketing?

Question: What companies have been involved with wrongdoing?

Question: What do Johnson & Johnson marketing cases fall under?
Pharmaceutical_industry

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

Question: When did the article come out about the importance of interactions?
Answer: May 2015

Question: What was the reason behind these interactions?
Answer: bring greater benefits to patients

Question: What was believed to have created a financial conflict of interest?
Answer: moral outrage over industry malfeasance

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: New England Journal of Medicine

Question: When was the editorial published?
Answer: May 2015

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

Question: Who were some of the companies that encouraged the interactions between doctors and the National Center for Advancing Translational Sciences of the National Institutes of Health?

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

Question: What was the reason behind these conflicts?

Question: What was believed to have created physician interactions?

Question: Who printed the article about the importance of malfeasance?
Pharmaceutical_industry

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: ProPublica

Question: Billions of dollars have been paid by which companies?
Answer: AstraZeneca, Johnson & Johnson and Eli Lilly

Question: How much was discovered to have been paid to doctors by drug companies?
Answer: more than $500,000

Question: What was the reason these companies have to pay fines?
Answer: allegations that they paid doctors to promote drugs for unapproved uses

Question: How many doctors have been paid by varies companies?
Answer: at least 21

Question: A ProPublica study found that some doctors were being paid how much money for speeches?
Answer: more than $500,000

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

Question: Drug manufacturers paid off doctors a total of how much money?
Answer: $2 billion

Question: Who conducted an investigation on drugs?

Question: Billions of drugs have been paid why which companies?

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

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

Question: How many companies have been paid by various doctors?
Pharmaceutical_industry

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: to explore the potential of new drug substances

Question: How do large corporations show vertical integration?
Answer: participating in a broad range of drug discovery and development, manufacturing and quality control, marketing, sales, and distribution

Question: What are large companies relying on outside organizations for?
Answer: to manage drug development

Question: What are smaller organizations responsible for?
Answer: focus on a specific aspect such as discovering drug candidates or developing formulations

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

Question: What type of integration do smaller organizations do?
Answer: a specific aspect

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

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

Question: Why is collaborative distribution important?

Question: How do large corporations show multi-nationals integration?

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

Question: What are smaller drugs responsible for?

Question: What type of integration do large drugs often do?
Pharmaceutical_industry

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: The British National Formulary

Question: Who is responsible for approving drugs in the United Kingdom?
Answer: Medicines and Healthcare Products Regulatory Agency

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

Question: Who decides how NHS will allow drugs?
Answer: National Institute for Health and Care Excellence (NICE)

Question: Who does the evaluations for drugs in the United Kingdom?
Answer: European Medicines Agency

Question: What UK firm approves pharmaceutical drugs?
Answer: Medicines and Healthcare Products Regulatory Agency

Question: What UK organization evaluates drugs? 
Answer: European Medicines Agency

Question: What firm in England and Wales decides if the NHS allows drugs?
Answer: National Institute for Health and Care Excellence

Question: What is the name of the core guide for pharmacists and clinicians?
Answer: British National Formulary

Question: Who is the core clinician?

Question: Who is responsible for approving drugs in the NHS?

Question: After an approval in the UK, when does an approval occur in the NHS and other countries?

Question: Who decides how the USA will allow drugs?

Question: Who does the evaluations for drugs in the United States?
Pharmaceutical_industry

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

Question: What is given to companies who develop drugs for "orphan diseases"?
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: Why are these companies rewarded?
Answer: Because medical research and development of drugs to treat such diseases is financially disadvantageous

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

Question: What size of disease populations are subject to the Orphan Drug Act?
Answer: fewer than 200,000 patients

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

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

Question: What is subject to patients in the United States?

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

Question: Why are these rules rewarded?

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

Question: What size of disease populations are subject to patents?
Pharmaceutical_industry

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: Ben Goldacre

Question: The business friendships between which parties have been criticized?
Answer: regulator and company employees

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

Question: Who argued against the public?

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

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

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

Question: Who argues that regulators do not require that new regulators offer an improvement?
Pharmaceutical_industry

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: England and Wales

Question: What is the name of the organization in Scotland that decides the availability of drugs?
Answer: Scottish Medicines Consortium

Question: What threshold must a drug pass before it is approved?
Answer: cost-effectiveness

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

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

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

Question: Where does QALY decide whether decide in what circumstances drugs and technologies will be made available?

Question: What must the NHS do in order to be approved?
Pharmaceutical_industry

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: $75.6 billion

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

Question: What was the bestselling drug in history?
Answer: Lipitor

Question: How much money did Lipitor make before the patent expired?
Answer: $141 billion

Question: In what year did Pfizer's patent over Lipitor expire?
Answer: 2011

Question: How much money did the top ten bestselling drugs make in 2011?

Question: What was the name of the top-selling anti-inflammatory drug in 2011?

Question: What was the bestselling drug in 2011?

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

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