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

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

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

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

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

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

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: 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: 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: 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