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Bibliography and References

Alexander, G. J. M.; Brahm, J.; Fagan, E. A.; Smith, H. M.; Daniels, H. M.; Eddleston, A.L.; Williams, R. 1987. Loss of HBsAg with interferon therapy in chronic hepatitis B virus infection. Lancet; 66-69.

Alexander, G. J. M.; Williams, R. 1988. Natural history and therapy of chronic hepatitis B virus infection. American Journal of Medicine; 85: 143-146.

Altman, L. K. 1993. The doctor's world. The New York Times. New York, NY; October 5; Science(C3).

Aranha, G. V.; Sontag, S. J.; Greenlee, H. B. 1982. Cholecystectomy in cirrhotic patients: A formidable operation. American Journal of Surgery; 143: 55-60.


Balfour, H. H. Jr.; Chace, B. A.; Stapleton, J. T.; Simmons, R. L.; Fryd, D. S. 1989. A randomized placebo-control trial oral acyclovir for the reduction of cytomegalovirus disease in recipients of renal allografts. The New England Journal of Medicine; 320: 1381-1387.

Bassendine, M. F.; Chadwick, R. G.; Salmeron, J.; Shipton, U.; Thomas, H. C.; Sherlock, S. 1981. Adenine arabinoside therapy in HBsAg positive chronic liver disease: A controlled study. Gastroenterology; 80: 1018-1022.

Beasley, R. P.; Hwang, L. W.; Lin, C. C.; Chien, C. S. 1981. Hepatocellular carcinoma and hepatitis B virus. A prospective study of 22,707 men in Taiwan. Lancet; 2:1129-1133.

Bloch, R. S.; Jacobs, L. A.; Lewis, L. S.; Bernys, C. F. 1985. Cholecystectomy in patients with cirrhosis. A surgical challenge. Archives of Surgery; 120: 669-672.

Bowsher, R. R.; Compton, J. A.; Kirkwood, J. A.; Place, G. D.; Jones, C. D.; Mabry, T. E.; Hyslop, D. L.; Hatcher, B.L.; DeSante, K. A. 1994. Sensitive and specific radioimmunoassay for fialuridine: Initial assessment of pharmacokinetics after single oral doses to healthy volunteers. Antimicrobial Agents and Chemotherapy; September; 38(9): 2134-2142.

Breslow, N. E.; Day, D. E. 1987. Statistical Methods in Cancer Research (Vol. II: The analysis of cohort studies). New York, NY: Oxford University Press.

Browne, M. J.; Mayer, K. H.; Chafee, S. B.; Dudley, M. N.; Posner, M. R.; Steinberg, S. M.; Graham, K. K.; Geletko, S. M.; Zinner, S. H.; Denman, S. L.; et al. 1993. 2', 3'-didehydro-3'-deoxythymidine (d4T) in patients with AIDS or AIDS-related complex: A phase I trial. Journal of Infectious Disease; 167: 21-29.



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Review of the Fialuridine (FIAU) Clinical Trials B Bibliography and References Alexander, G. J. M.; Brahm, J.; Fagan, E. A.; Smith, H. M.; Daniels, H. M.; Eddleston, A.L.; Williams, R. 1987. Loss of HBsAg with interferon therapy in chronic hepatitis B virus infection. Lancet; 66-69. Alexander, G. J. M.; Williams, R. 1988. Natural history and therapy of chronic hepatitis B virus infection. American Journal of Medicine; 85: 143-146. Altman, L. K. 1993. The doctor's world. The New York Times. New York, NY; October 5; Science(C3). Aranha, G. V.; Sontag, S. J.; Greenlee, H. B. 1982. Cholecystectomy in cirrhotic patients: A formidable operation. American Journal of Surgery; 143: 55-60. Balfour, H. H. Jr.; Chace, B. A.; Stapleton, J. T.; Simmons, R. L.; Fryd, D. S. 1989. A randomized placebo-control trial oral acyclovir for the reduction of cytomegalovirus disease in recipients of renal allografts. The New England Journal of Medicine; 320: 1381-1387. Bassendine, M. F.; Chadwick, R. G.; Salmeron, J.; Shipton, U.; Thomas, H. C.; Sherlock, S. 1981. Adenine arabinoside therapy in HBsAg positive chronic liver disease: A controlled study. Gastroenterology; 80: 1018-1022. Beasley, R. P.; Hwang, L. W.; Lin, C. C.; Chien, C. S. 1981. Hepatocellular carcinoma and hepatitis B virus. A prospective study of 22,707 men in Taiwan. Lancet; 2:1129-1133. Bloch, R. S.; Jacobs, L. A.; Lewis, L. S.; Bernys, C. F. 1985. Cholecystectomy in patients with cirrhosis. A surgical challenge. Archives of Surgery; 120: 669-672. Bowsher, R. R.; Compton, J. A.; Kirkwood, J. A.; Place, G. D.; Jones, C. D.; Mabry, T. E.; Hyslop, D. L.; Hatcher, B.L.; DeSante, K. A. 1994. Sensitive and specific radioimmunoassay for fialuridine: Initial assessment of pharmacokinetics after single oral doses to healthy volunteers. Antimicrobial Agents and Chemotherapy; September; 38(9): 2134-2142. Breslow, N. E.; Day, D. E. 1987. Statistical Methods in Cancer Research (Vol. II: The analysis of cohort studies). New York, NY: Oxford University Press. Browne, M. J.; Mayer, K. H.; Chafee, S. B.; Dudley, M. N.; Posner, M. R.; Steinberg, S. M.; Graham, K. K.; Geletko, S. M.; Zinner, S. H.; Denman, S. L.; et al. 1993. 2', 3'-didehydro-3'-deoxythymidine (d4T) in patients with AIDS or AIDS-related complex: A phase I trial. Journal of Infectious Disease; 167: 21-29.

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Review of the Fialuridine (FIAU) Clinical Trials Capalbo, M.; Actis, C.; Maurizia, R.; Brunetto, R.; Poli, G.; Baldi, M.; Palmisano, L.; Verme, G.; Bonino, F. 1992. Treatment of chronic hepatitis B with beta interferon given intramuscularly: A pilot study. Italian Journal of Gastroenterology; 24: 203-205. Cardon, P. V.; Dommel, F. W.; Trumble, R. R. 1976. Injuries to research subjects: A survey of investigators. The New England Journal of Medicine; 295: 650-654. Caselmann, W. H. 1989. Beta- and gamma- interferon in chronic active hepatitis B. Gastro enterology; 96: 449-455. Chalmers, I.; Hetherington, J.; Newdick, M.; Mutch, L.; Grant, A.; Enkin, M.; Enkin, E. 1986. The Oxford database of perinatal trials: Developing a register of published reports of controlled trials. Controlled Clinical Trials; 7: 306-324. Chattha, G.; Arieff, A. I.; Cummings, C.; Tierney, L. M., Jr. 1993. Lactic acidosis complicating the acquired immunodeficiency syndrome. Annals of Internal Medicine; 118: 37-39. Chazouilleres, O.; Wright, T. L. in press. Infectious complications of liver transplantation. In: D. Zakim and T. Boyer, Eds. Hepatology: A Textbook of Liver Diseases. Philadelphia, PA: W.B. Saunders Co. Chen, C-H; Cheng, Y-C. 1989. Delayed cytotoxicity and selective loss of mitochondrial DNA in cells treated with the anti-human immunodeficiency virus compound 2',3'-dideoxycytidine. The Journal of Biological Chemistry; July 15; 264(20): 11934-11937. Chen, C-H; Vazquez-Padua, M.; Cheng, Y-C. 1991. Effect of anti-human immunodeficiency virus nucleoside analogs on mitochondrial DNA and its implication for delayed toxicity. Molecular Pharmacology; 39: 625-628. Code of Federal Regulations 21, parts 300 to 499. 1992. Washington, DC : Office of the Federal Register, National Archives and Records Administration; Revised 1 April. Colacino, J. M.; Malcom, S. K.; Jaskunas, S. R. 1994. Effect of fialuridine on replication of mitochondrial DNA in CEM cells and in human hepatoblastoma cells in culture. Antimicrobial Agents and Chemotherapy; 38(9): 1997-2002. Colburn, W. A. 1990. Controversy V: Phase I, First time in man studies. Journal of Clinical Pharmacology; 30: 210-222. Congress of the United States, House of Representatives (Committee on Government Operations). 1994. Towns says lethal science fiction used in the death of FIAU patients—pledges to expedite subcommittee investigation. Washington, DC: News Release; May 13. Conte, D.; Barisani, D.; Mandelli, C.; Bodini, P.; Borzio, M.; Pistoso, S.; Segala. M.; Aimo, G. P.; Fraquelli, M.; Bianchi, P. A. 1991. Cholelithiasis in cirrhosis: Analysis of 500 cases. American Journal of Gastroenterology; 86:1629-1632. Corey, L. 1994. [Letter to FDA. Response letter and appendices to FDA Warning Letter]; June 29. Cox, D. R. 1972. Regression models and life-tables. Journal of the Royal Statistical Society ; 34:187-220. Coyle, T. 1993. Letter to the Editor: Response to Chattha et al., Ann Intern Med, 1993;118: 37-39. Annals of Internal Medicine; August 15; 119(4): 344. Cryer, H. M.; Howard, D. A.; Garrison, R. N. 1985. Liver cirrhosis and biliary surgery: Assessment of risk. Southern Medical Journal; 78: 138-141.

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Review of the Fialuridine (FIAU) Clinical Trials DHEW Secretary's Task Force on the Compensation of Injured Research Subjects. 1977. DHEW Publication No. (OS) 77-003, Appendix A, DHEW Publication No. (OS) 77-004, Appendix B, DHEW Publication No. (OS) 7-005. Washington, DC. Di Bisceglie, A.M.; Waggoner, J. G.; Hoofnagle, J. H. 1987. Hepatitis B virus deoxyribonucleic acid in liver of chronic carriers. Correlation with serum markers and changes associated with loss of hepatitis B e antigen after antiviral therapy. Gastroenterology; 93: 1236-1241. Dickersin, K. 1988. Report from the panel on the case for registers of clinical trials. Controlled Clinical Trials; 9: 76-81. Dickson, R. C.; Porayko, M. K.; Keating, M. R.; et al. 1992. Cytomegalovirus (CMV) prophylaxis following liver transplantation (Ltx) (abstract). Hepatology; 16: 277A. Dienstag, J. L.; Perrillo, R. P.; Schiff, E. R.; Bartholomew, M.; Vicary, C.; Rubin, M. 1994. Double-blind, randomized, three-month, dose-ranging trial of lamivudine for chronic hepatitis B (abstract). Hepatology; 20(4): 199A. Doberneck, R. C.; Sterling, W. A. Jr.; Allison, D.C. 1983. Morbidity and mortality after operation in nonbleeding cirrhotic patients. American Journal of Surgery; 146: 306-309. Donaldson, N.; Donaldson, B. 1980. How did they die? New York: St. Martins Press. Dunnington, G.; Alfrey, E.; Sampliner, R.; Kogan, F.; Putnam, C. 1987. Natural history of cholelithiasis in patients with alcoholic cirrhosis (cholelithiasis in cirrhotic patients). Annals of Surgery; 205: 226-229. Dusheiko, G.; Di Bisceglie, A.; Bowyer, S.; Sachs, E.; Ritchie, M.; Schoub, B.; Kew, M. 1985. Recombinant leukocyte interferon treatment of chronic hepatitis B. Hepatology; 5: 556-560. Elder, G. A.; Sever, J. L. 1988. Neurologic disorders associated with AIDS retroviral infection. Review of Infectious Disease; 10: 286-302. Eli Lilly and Company. 1993. Good Clinical Practices: Worldwide Guidelines and Regulations—U.S. and E.C. Indianapolis, IN: Eli Lilly and Company; January; Book 1. Eli Lilly and Company. 1994. [Letter to FDA. Response letter and appendices to FDA Warning Letter]; June 28. Emmerson, J. 1994. Presentation to the IOM Committee to Review the FIAU/FIAC Clinical Trials. Washington, DC: Institute of Medicine; July 26. Engelhardt, J. A. 1994. A toxicity study in Fischer 344 rats given fialuridine (FIAU, LY303256) three times daily by gavage for 10 weeks. Eli Lilly and Company. Toxicology Report No. 41; July; volumes 1 and 2. Erice, A.; Jordan, M. C.; Chace, B. A.; Fletcher, C.; Chinnock, B. J.; Balfour Jr., H. H. 1987. Ganciclovir treatment of cytomegalovirus disease in transplant recipients and other immunocompromised hosts. Journal of the American Medical Association; 257: 3082-3087. Fanucchi, M.; Leyland-Jones, B.; Young, C. W.; Burchenal, J. H.; Watanabe, K. A.; Fox, J. J. 1984. Phase I evaluation of oral 2'fluoro-5-iodo-1-beta-D-arabinofuranosylcytosine (FIAC) in immunosuppressed patients with herpes zoster. American Society of Clinical Oncology Proceedings; 3: 96.

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Review of the Fialuridine (FIAU) Clinical Trials FDA (Food and Drug Administration). 1993a. Center for Drug Evaluation and Research. Antiviral Drugs Advisory Committee: Mitochondrial Damage Associated with Nucleoside Analogues; September 20 and 21; Rockville, MD. FDA (Food and Drug Administration). 1993b. Report of an FDA Task Force. Fialuridine: Hepatic and Pancreatic Toxicity: FDA; November 12. FDA (Food and Drug Administration). 1993c. Almanac FY 1993. Rockville, MD: Office of Public Affairs, DHHS Publication No. (FDA) 93-1193. FDA (Food and Drug Administration). 1994a. Adverse experience reporting requirements for human drug and licensed biological products: proposed rules; 21 CFR Part 20, et al. Federal Register 59:54,046-54,064; 27 October. FDA (Food and Drug Administration). 1994b. Warning letters to Drs. Hoofnagle, Richman, Corey, Eli Lilly and Company, and Oclassen Pharmaceuticals; May 11. Federal Register. 1994. Adverse Experience Reporting Requirements for Human Drug and Licensed Biological Products. draft. Note: proposed change in 21 CFR regulations. Feigel, D. 1994. Presentation to the IOM Committee to Review the FIAU/FIAC Clinical Trials. Washington, DC: Institute of Medicine; September 8. Fourel, I.; Hantz, O.; Watanabe, K. A.; Jacquet, C.; Chromel, B.; Fox, J. J.; Trepo, C. 1990. Inhibitory effects of 2'-fluorinated arabinosyl-pyrimidine nucleosides on woodchuck hepatitis virus replication in chronically infected woodchucks. Antimicrobial Agents and Chemotherapy; 34: 473-475. Freiman, K. P.; Helfert, K. E.; Hamrell, M. R.; Stein, D. S. 1993. Hepatomegaly with severe steatosis in HIV-seropositive patients. AIDS; 7: 379-385. Freise, C. E.; Pons, V.; Lake, J.; Burke, E.; Ascher, N. L.; Roberts, J.P. 1991. Comparison of three regimens for cytomegalovirus prophylaxis in 147 liver transplant recipients. Transplant Proceedings; 23: 1498-1500. Garcia, G.; Smith, C. I.; Weissberg, J. I.; Eisenberg, M.; Bissett, J.; Nair, P. V.; Mastre, B.; Rosno, S.; Roskamp, D.; Waterman, K.; et al. 1987. Adenine arabinoside monophosphate (vidarabine phosphate) in combination with human leukocyte interferon in the treatment of chronic hepatitis B. Annals of Internal Medicine; 107: 278-285. Gilbert, D. N. 1987. Guidelines for evaluating new antimicrobial agents. Journal of Infectious Disease; 156: 934. Glendon, M. A. 1991. Rights Talk: The Impoverishment of Political Discourse. New York, NY: New York Free Press; 2. Gold, J.; Leyland-Jones, B.; Urmacher, C.; Armstrong, D. 1984. Pulmonary and neurological complication of treatment with FIAC (2'fluoro-5-iodo-aracytosine) in patients with acquired immune deficiency syndrome (AIDS). AIDS Research; 1: 243. Gonzales, M. F.; Davis, R. L. 1988. Neuropathology of acquired immunodeficiency syndrome. Neuropathy and Applied neurobiology; 14: 345-363. Grasela, T. H.; Walawander, C. A.; Beltangady, M.; Knupp, C. A.; Martin, R. R.; Dunkle, L. M.; Barbhaiya, R. H.; Pittman, K. A. 1994. Analysis of potential risk factors associated with the development of pancreatitis in Phase I patients with AIDS or AIDS-related complex receiving didanosine. Journal of Infectious Diseases; 169: 1250-1255. Greenberg, H. B.; Pollard, R. B.; Lutwick, L. I.; Gregory, P. B.; Robinson, W. S.; Merigan, T. C. 1976. Effect of human leukocyte interferon on hepatitis B virus infection in

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Review of the Fialuridine (FIAU) Clinical Trials patients with chronic active hepatitis. The New England Journal of Medicine; 295: 517-522. Groves, J. E. 1978. Taking Care of the Hateful Patient. The New England Journal of Medicine; 298: 883-887. Hantz, O.; Allaudeen, H. S.; Ooka, T.; De Clercq, E.; Trepo, C. 1984. Inhibition of human and woodchuck hepatitis virus DNA polymerase by the triphosphates of acyclovir, 1-(2'deoxy-2'fluoro-ß-D-arabinofuranosyl)-5-iodocytosine and E-5-(2-bromovinyl)-2'deoxynridine. Antiviral Research; 4: 187. Harry, J. D. 1987. Research on healthy volunteers-a report of the Royal College of Physicians. British Journal of Clinical Pharmacology; 23: 379-381. Hashida, T.; Sawada, T.; Esumi, N.; Kinugasa, A.; Kusunoki, T.; Kishida, T. 1985. Therapeutic effects of human leukocyte interferon on chronic active hepatitis B in children. Journal of Pediatric Gastroenterology and Nutrition; 4: 20-26. Hilts, P. J. 1994. Speed of FDA Action on Rules for Drug Tests is Questioned. The New York Times. New York; October 29; National 10. Hoofnagle, J. H. 1994a. [Letter to FDA. Response letter and appendices to FDA Warning Letter]; July 6. Hoofnagle, J. H. 1994b. Presentation to the IOM Committee to Review the FIAU/FIAC Clinical Trials. Washington, DC: Institute of Medicine; July 25. Hoofnagle, J. H. 1994c. Statement on FIAU; January 3. Hoofnagle, J.H.; Di Bisceglie, A.M. 1990. Antiviral therapy of viral hepatitis. Antiviral Agents and Viral Diseases of Man, 3rd ed.; 415-459. Hoofnagle, J. H.; Straus, S. 1994. Lessons From the Studies of FIAU; February, 14. Note: written in response to a question from the DAC on how to avoid such episodes in the future. Hoofnagle, J. H.; Dusheiko, G. M.; Seeff, L. B.; Jones, E. A.; Waggoner, J. G.; Bales, Z. B. 1981. Seroconversion from hepatitis B e antigen to antibody in chronic type B hepatitis. Annals of Internal Medicine; (94): 744-748. Hoofnagle, J. H.; Hanson, R. G.; Minuk, G. Y.; Pappas, S.C.; Schafer, D. F. ; Dusheiko, G. M.; Straus, S. E.; Popper, H.; Jones, E. A. 1984. Randomized controlled trial of adenine arabinoside monophosphate for chronic type B hepatitis. Gastroenterology; 86:150-157. Hoofnagle, J. H.; Shafritz, D. A.; Popper, H. 1987. Chronic type B hepatitis and the ''healthy" HBsAg carrier state. Hepatology; 7: 758-768. Hoofnagle, J. H.; Peters, M.; Mullen, K. D.; Jones, D. B.; Rustgi, V.; Di Bisceglie, A.; Hallahan, C. 1988. Randomized controlled trial of recombinant human alpha-interferon in patients with chronic hepatitis B. Gastroenterology; 95:1318-1325. Hutt, P. B. 1983a. Investigations and reports respecting FDA regulation of new drugs (Part I). Clinical Pharmacology and Therapeutics; 33(4): 537-548. Hutt, P. B. 1983b. Investigations and reports respecting FDA regulation of new drugs (Part II). Clinical Pharmacology and Therapeutics; 33(5): 674-687. Hutt, P. B. 1994. Presentation to the IOM Committee to Review the FIAU/FIAC Clinical Trials. Washington, DC: Institute of Medicine; September 9. IMS America Ltd. 1990. U.S. pharmaceutical market. Plymouth, PA: IMS America Ltd.

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