ch7 Flashcards
What are the six steps in the lifecycle of a new drug?
- find chemical compound that may treat a disease
- test on animals
- test on people
- get approved for sale by FDA
- Company has legal monopoly protected by patent
- After patent it up, other companies can make drug, lowering profits
The life cycle of a new drug is costly and complex, thus it is hard to find a promising ________ in the first place
chemical
Only _______ of drugs that enter phase 1 pass to phase 3
21.5%
The whole process can cost _______ million or more to bring a drug to the point of approval
500
Only the top ______ of drugs manage to make back money even with the patent
30%
What are the 3 downsides to stronger patents?
- customers pay monopoly prices for a longer time
- less incentive for further innovation by same company
- legal barriers to subsequent innovation by another company
What is the innovation vs. access tradeoff?
A U.S. Patent system that creates a monopoly for medicines (17 years), allowing for substantial profit, and creating an incentive for innovation. this leads to higher prices, which lowers the number of people who can access the treatment
What is a potential incentive created by the innovation vs access tradeoff?
Rent seeking
maintaining the status quo (keeping out competition without innovation)
What is the regulation vs speed of new treatments tradeoff?
Science based regulation should lower the risk of harmful medicine getting out to the public, however good treatments might be held up do to too strong of regulations. people that could be saved might not be saved from taking to long.
Draw a graph that demonstrates the innovation vs access tradeoff.
Skeleton 7-3
discoveries that result when innovators change their research agenda in response to profit opportunities?
Induced innovation
What are some examples of ways pharma responds to incentives caused by induced innovation?
- changing demographics (investment in drugs follows population trends)
- funding by the government, nonprofits, and academic institutions (incentives thru direct funding)
what are operation warp speed for the covid vaccine and the large-scale production of penecillin during ww2 examples of?
induced innovation through funding
what is the problem with induced innovation?
it takes the focus off low-profit but harmful problems
what are orphan diseases?
diseases that are rare or occur in developing countries that receive less attention from researchers, because there is less profit to be made
what is the tradeoff caused by FDA regulation?
safety and quality vs. speed of innovation
describe the issue of Thalidomide & Europe?
- prescribed to pregnant women with morning sickness
- caused birth defects in over 10000 newborns
- pulled from shelves and promoted stricter regulation
What was the Kefauver-Harris Amendment in the US (1962)?
- companies must prove new drugs are safe through clinical trials
- stricter regulations led to lower number of new chemical entities on market
type of permissive regulation in which a bad drug is approved -> people die from bad drugs
type I error
type of restrictive regulation which a good drug is rejected or delayed -> people die waiting
type II error
phase III trials do not have _________. thus we must ___________.
complete information about a drug.
making informed decisions based on statistical probabilities