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Lecture

Pharmaceuticals cont'd


Department
Science
Course Code
SCIE 1P51
Professor
Caroline Starrs

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3(23) Pharmaceuticals
March-23-12
10:54 AM
Bill C-91
20 years Patent from previous 17 years
Notice of compliance
Generic drugs
Canada- 20 years of patent protection
Extension up to 8 years
USA- 20 years of protection
Extension up to 5 years plus up to 3 years if a new use is discovered
Thalidomide
1956-Sleeping pill
Anti-nausea during pregnancy
Clinical trials 1949-1958 no birth defects
1959-1 case of birth defect reported
1960-30 cases
1961-154 cases
Amelia (absence of limbs)
Phocomelia (reduction of long bones of limbs)
1961 Lenz in Germany identified Thalidomide as culprit
Drug withdrawn 1961
More than 12,000 deformed due to drug, many others had died during first year of life
40% died within a year od birth, 5000 survivors today
Used widely in England, Ireland, Germany, France, USA
New uses
Leprosy (pain killer)
cancer (restrict angiogenesis)
AIDS (mouth ulcers)
Vioxx-Merck
Anti-inflammatory drug
Approved by FDA 1999
Increased risk of heart attacks after 18 months on drug noted in clinical trials
Withdrawn 2004
130,000- 953,000 cardiac events
9,650 court cases
Parecel- TGN 1412
March 2006
6male volunteers (19-34)
Phase I study
Within hours, multiple organ failure
Put on life support, no one died
3 have permanent kidney damage, others have liver damage, 1 developed cancer
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