derek-thomas/squad-v1.1-t5-question-generation huggingface dataset:
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: What has been argued restricted innovation? Question: What is one thing excessive regulations causes? Question: What is excessive drug regulation said to suppress? Question: What was argued to be holding back new knowledge for treating diseases? Question: In what year was a report made to reduce the burdens of drug development? Question: Who put out a report in 2012? Question: What was a recommendations brought about from the report? Question: What can be used to evaluate new approval processes?
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: In what year was hydralazine discovered? Question: Who discovered Hydralazine? Question: What was the name of the first oral vasodilator? Question: What was the main shortcoming in the drug Hydralazine? Question: Who developed Chlorothiazide? Question: What is the most used antihypertensive drug today? Question: What is  Chlorothiazide used to treat? Question: Chlorothiazide helped reduce the mortality rate among those with what disease? Question: Beyer, Sprague, Baer, and Novello received what award in 1975? Question: Why were the researchers recognized in 1975?
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? Question: Congressional hearings emerged addressing revisions to what act? Question: Who led the congressional hearings? Question: Who led the Congressional hearings in 1959? Question: When did this push occur? Question: What were the major issues that needed to be addressed? Question: Did the US Congress call for more or less regulation of pharmaceuticals? Question: What caused a need for more regulation?
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: In what year was the measles vaccine made? Question: Who originally created the measles vaccine? Question: Who recreated the measles vaccine? Question: Who helped refine the measles vaccine? Question: When did the Rubella vaccine come out? Question: In what year was the mumps vaccine made? Question: How much did the occurrence of serious diseases shortly after the release of the measles vaccine? Question: How much did rubella, measles, and mumps infections drop after vaccination? Question: What did the first measles prevent in it's first 20 years? Question: Measles vaccinations helped prevent how many estimated cases of the illness?
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: What brought up enhancement of drug regulations? Question: When did the Kefauver-Harris Amendment become a law? Question: When did the Kefauver-Harris Amendment became law? Question: What federal agency regulated the advertising of prescription drugs? Question: What did this new law require? Question: Drugs made between which years had to be tested before going to market? Question: What did the National Academy of Science's study discover? Question: What percentage of drugs were shown to be ineffective after an FDA study? Question: How long after the National Academy of Science's study did a study on over the counter drugs occur?
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: When was the drug taken off shelves in Germany? Question: In what year was thalidomide banned in Germany? Question: Why was this drug pulled off shelves? Question: What adverse effect was thalidomide associated with? Question: Thalidomide was distributed in the USA by what name? Question: How was Kevadon distributed to doctors? Question: How many Americans were given the drug Kevadon? Question: About how many Americans received thalidomide in a supposed study? Question: How many newborns were born with issues due to Kevadon? Question: How many newborn American babies were affected by thalidomide?
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: Birth control was prohibited in most countries before what war? Question: What law prohibited birth control? Question: Discussing contraception sometimes led to prosecution under what laws? Question: What was the name of the first oral contraceptive? Question: Who created the first oral birth control? Question: When was Enovid first approved? Question: When did the FDA approve Enovid? Question: In 1965, how many women were on the birth control pill? Question: By 1965, about how many American women were taking Enovid? Question: What increased due to the availability of birth control?
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: What study did Merk sponsor in 1994? Question: What was the brand name of simvastatin? Question: How many patients received Zocor? Question: What did the study reveal after 5 years? Question: Patients treated with Zocor had their cholesterol reduced by how much? Question: How much did Zocor reduce the chance of dying from a heart attack? Question: How much money did Merk make in 1995? Question: How much money did Merck make from sales of Zocor and Mevacor? Question: Who received the Laser-Debakey Clinical Medical Research Aware? Question: Endo received what award in 2008?
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 the name of the process in which possible drugs are discovered? Question: What is a drug discovery? Question: What is involved in drug discovery? Question: Most drugs have been found by isolating what from traditional remedies? Question: What focuses on metabolic pathways? Question: What kind of technology studies the understanding and manipulation of disease states and pathogens? Question: What is used to manipulate pathways? Question: Who is usually responsible for early stages of drug discovery? Question: What groups carry out most early drug discoveries?
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: What does NMEs stand for? Question: How many drugs were approved in 2007? Question: Who is responsible for approval or rejection of new drugs? Question: How many approvals of new drugs happen every year? Question: How many pharmaceutical drugs were approved on average since 2001? Question: How much does it cost to develop a new drug? Question: What is the approximate cost of developing a new drug, including the costs of failure? Question: Who reported the stable average rate in 2012? Question: What has been the stable approval rate of new drugs?
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 accounts for nearly half of the costs to develop drugs? Question: Investing capital can increase drug development costs by how much? Question: What firms tend to outsource drug development? Question: What is the consequence in the value chain? Question: What happens when companies outsource? Question: What kind of companies have had a more important role in drug development? Question: What drugs are the least expensive to develop? Question: What is re-formulations of active ingredients referred to?
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: In what year was mevastatin discovered? Question: Who discovered Mevastatin? Question: Who discovered mevastatin? Question: Where did Endo discover ML-236B? Question: What organism produces mevastatin? Question: What enzyme helps produce cholesterol? Question: What is HMG-CoA responsible for producing? Question: What was discovered in long term studies? Question: Why was Mevastatin never marketed?
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: What companies have been involved with health care fraud cases? Question: What do illegal marketing cases fall under? Question: Firms such as Eli Lilly, Pfizer, and AstraZeneca have settled claims under what act? Question: Zyprexa was owned by what company? Question: What drugs were involved in cases of the largest criminal fines? Question: What was Pfizer accused of illegally marketing? Question: Pfizer was charged with illegally marketing what antipsychotic drug? Question: How much did Pfizer settle the illegal marketing suit for? Question: Pfizer settled the Geodon lawsuit for how much money?
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 printed the article about the importance of interactions? Question: What publication had an article about the importance of pharmaceutical industry-physician interactions in 2015? Question: When did the article come out about the importance of interactions? Question: When was the editorial published? Question: What was believed to have created a financial conflict of interest? Question: Who were some of the companies that encouraged the interactions between doctors and the pharmaceutical industry? Question: Did major healthcare organizations support or discourage interactions between doctors and industries? Question: What was the reason behind these interactions?
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? Question: How many doctors have been paid by varies companies? Question: How much was discovered to have been paid to doctors by drug companies? Question: A ProPublica study found that some doctors were being paid how much money for speeches? Question: Half of the top earners were mostly in what field? Question: Drug manufacturers paid off doctors a total of how much money? Question: Billions of dollars have been paid by which companies? Question: What was the reason these companies have to pay fines?
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: What type of integration do large corporations often do? Question: How do large corporations show vertical integration? Question: What are smaller organizations responsible for? Question: What type of integration do smaller organizations do? Question: What type of agreements are made to research potential new drugs? Question: Why are collaborative agreements important? Question: What type of organizations are multinational corporations increasingly rely on? Question: What are large companies relying on outside organizations for?
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 responsible for approving drugs in the United Kingdom? Question: What UK firm approves pharmaceutical drugs? Question: Who does the evaluations for drugs in the United Kingdom? Question: What UK organization evaluates drugs? Question: After an approval in the United States, when does an approval occur in the United Kingdom and other countries? Question: Who decides how NHS will allow drugs? Question: What firm in England and Wales decides if the NHS allows drugs? Question: Who is the core guide? Question: What is the name of the core guide for pharmacists and clinicians?
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 a term for rare diseases in some territories? Question: What is subject to the Orphan Drug Act? Question: What size of disease populations are subject to the Orphan Drug Act? Question: Why are these companies rewarded? Question: What is given to companies who develop drugs for "orphan diseases"? Question: What is one financial benefit to researching orphan drugs? Question: What is the length of time of market exclusivity of an orphan drug?
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? Question: Who argued that drug regulators were greater serving the interests of the drug companies than the patients? Question: The business friendships between which parties have been criticized? Question: Goldacre argued that which party didn't require that new drugs be improved at all?