DRUG SAFETY
RESEARCH
June 16, 2006
ISSUES
• Pharmaceutical Industry Depends on
Block Buster Model (currently ~80 BBs).
• Block Buster Model requires fast and
broad market penetration immediately
following the drug’s approval.
• Broad market reach can be achieved
mainly by Direct to Consumer
Advertisement (DTCA).
CONSEQUENCES
• Drugs are used by millions of people
based on clinical trial results (very limited
data).
• Increasing number of drugs are being
pulled out of the market due to their
unacceptable side-effects, causing big
financial losses for businesses.
CURRENT DRUG SAFETY
RESEARCH
• Impact of DTCA on drug safety
– Does DTCA lead to unsafe use of drugs
increasing adverse drug effects?
– Study benefit/risk relationship for DTCA for
select drugs?
• An alternative to the current drug safety
approval process
– Under what conditions staged market
approval of all drugs is economically viable