IN THE HIGH COURT OF SOUTH AFRICA (TRANSVAAL PROVINCIAL DIVISION)
Case No: 4183/98
In the matter between:
PHARMACEUTICAL MANUFACTURERS’ ASSOCIATION OF SOUTH AFRICA AND OTHERS
and
THE PRESIDENT OF THE REPUBLIC OF SOUTH AFRICA AND OTHERS
and
Amicus Curiae
AFFIDAVIT of JAMES PACKARD LOVE
signed April 9, and filed April 10, 2001. Everything is in MS Word format. If you have trouble downloading try holding down the shift key when you click on the link.
Text of affidavit in MS Word format and in html format.
14 Tables
Table 1: NCI Role in the Development of 37 Cancer Drugs.
MS Word format and html format.
Table 2: NCI Investigational New Drug (IND) Application.
MS Word format and html format.
Table 3,4 and 5: Costs of Clinical Trials on Drugs
Qualifying for Orphan Drug Tax Credit, DiMasi, et al's 1991 Estimates of the
Costs of Drug Development, and DiMasi et al 1991 estimates:
out of pocket and capital costs compared. MS Word format
and html format.
Table 6: Expenditures on Clinical Trials, Per Approval.
MS Word format and html format.
Table 7: US FDA Orphan Drug Approvals, 1999. MS Word format
and html format.
Table 8: OTA estimates of Mean Enrollment in Clinical Trials Prior to NDA.
MS Word format and html format.
Table 9: Number of patients referenced in FDA NDA.
MS Word format and html format.
Table 10: Cost of Trials referenced in FDA NDA. MS Word format
and html format.
Table 11: Background Information on FDA Approved HIV/AIDS drugs.
MS Word format and html format.
Table 12: Notes on government role in the development of HIV/AIDS drugs.
MS Word format and html format.
Table 13: Illustrations of US government role in supporting development of
new health care inventions. MS Word format and
html format.
Table 14. Competitive Prices for active ingredients for four HIV drugs.
MS Word format and html format.