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.
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.
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.
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
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.
Jonas, H. 1970. Philosophical reflections on experimenting with human subjects. In: R. A. Freund, Ed. Experimentation with Human Subjects. New York, New York: George Braziller; 1-31.
Kalbfleisch, J. D.; Prentice, R. L. 1980. The Statistical Analysis of Failure Time Data. New York, NY: John Wiley and Sons.
Kaplan, M. 1993. The Institutional Review Board document: Patient data from PPPA study. New England Medical Center; November 11.
Kassianides, C.; Hoofnagle, J. H.; Miller, R. H.; Doo, E.; Ford, H.; Broder, S.; Mitsuya, H. 1989. Inhibition of duck hepatitis B virus replication by 2',3'-dideoxycytidine. Gastroenterology; 97: 1275-1280.
Kizilisik, T. A.; Preiksaitis, J. K.; Kneteman, N. M. 1993. Cytomegalovirus disease in liver transplant recipients: Impact of acyclovir prophylaxis. Transplant Proceedings; 25: 2282-2283.
Knox, J. H. M., Jr. 1933. The Medical History of George Washington, His Physicians, Friends and Advisors. Bulletin of the Institute of Historical Medicine; 1: 174-191.
Korenman, J.; Baker, B.; Waggoner, J.; Everhart, J. E.; Di Bisceglie, A. M.; Hoofnagle, J. H. 1991. Long-term remission of chronic hepatitis B after alpha-interferon therapy. Annals of Internal Medicine; 114: 629-634.
Lai, K. K.; Gang, D. L.; Zawacki, J. K.; Cooley, T. P. 1991. Fulminant hepatic failure associated with 2', 3'-Dideoxyinosine (ddI). Annals of Internal Medicine; August 15; 115(4): 283-284.
Lau, D.; Mostowski, H.; Hoofnagle, J. H.; Sallie, R. 1994. Nucleoside analogue toxicity and mitochondria. Hepatology; 20(4).
Levine, J. M.; Colacino, J. M.; Bowsher, R. R.; Sallie, R.; Lewis, W. 1994. FIAU incorporates into DNA from human liver and from human hepatoblastoma cells. Hepatology; 20(4): 189A.
Levine, R. J. 1986. Ethics and Regulation of Clinical Research. 2nd Edition. Baltimore, MD: Urban & Schwarzenberg; c1981.
Levine, R. J. 1991. AIDS and the doctor-patient relationship. In: F. G. Reamer, Ed. AIDS and Ethics. New York, NY: Columbia University Press; 188-214.
Levy, R. M.; Bredesen, D. E. 1988. Central nervous system dysfunction in acquired immunodeficiency syndrome. Journal of Acquired Immune Deficiency Syndromes; 1: 41-64.
Lewis, W.; Papoian, T.; Gonzalez, B.; Louie, H.; Kelly, D. P.; Payne, R. M.; Grody, W. W. 1991. Mitochondrial ultrastructural and molecular changes induced by zidovudine in rat hearts. Laboratory Investigation; 65(2): 228-236.
Lewis, W.; Gonzalez, B.; Chomyn, A.; Papoian, T. 1992. Zidovudine induces molecular, biochemical, and ultrastructural changes in rat skeletal muscle mitochondria. Journal of Clinical Investigation; 89: 1354-1360.
Lewis, W.; Simpson, J. F.; Meyer, R. R. 1994. Cardiac mitochondrial DNA polymerase-gamma is inhibited competitively and noncompetitively by phosphorylated zidovudine . Circulation Research; 74(2):344-348.
Lewis, W.; Meyer, R. R.; Simpson, J. F.; Colacino, J. M.; Perrino, F. W. in press. Mammalian DNA polymerases alpha, beta, gamma, delta and epsilon incorporate fialuridine (FIAU)
monophosphate into DNA and are inhibited competitively by FIAU triphosphate. Biochemistry.
Leyland-Jones, B.; Donnelly, H.; Groshen, S.; Myskowski, P.; Donner, A. L.; Fanucchi, M.; Fox, J. 1986. 2'-fluoro-5-iodo-arabinosylcytosine, a new potent antiviral agent: Efficacy in immunosuppressed individuals with herpes zoster. Journal of Infectious Diseases; 154: 430.
Liaw, Y.-F.; Chu, C. M.; Su, I. J.; Huang, M. J. 1983. Clinical and histological events preceding hepatitits B e antigen seroconversion in chronic type B hepatitis. Gastroenterology; 84:216-219.
Lilly Laboratory for Clinical Research. 1993. Fialuridine (LY303256): Bioequivalence of Syrup and Tablet Formulations, and Influence of Timing of Meals on Pharmacokinetic Variables; 1993, February. IND Number 34,973, Protocol H3X-LC-PPPG(a).
Lilly-NIH FIAU meeting. 1994. FIAU Symposium. Gaithersburg Marriott Washingtonian Center; April 28.
Lilly Research Laboratories. 1993a. Attachments PPPA. I: Protocol H3X-MC-PPPA(c) and Amendments a, b, c, and d; May.
Lilly Research Laboratories. 1993b. Clinical Investigation Brochure: Fialuridine LY303256. Indianapolis, IN: Eli Lilly and Company; February.
Lilly Research Laboratories. 1993c. Fialuridine (FIAU) vs. Placebo in the treatment of patients with compensated chronic hepatitis B, Protocol H3X-MC-PPPB, at 15; February 17.
Lilly Research Laboratories. 1993d. Fialuridine (FIAU): Pharmacokinetic/Pharmacodynamic Dosing Regimen Study in Patients with Compensated Chronic Hepatitis B; May. Note: IND Number 34,973, Protocol H3X-MC-PPPA(c).
Lilly Research Laboratories. 1994a. Clinical Report Synopsis: Study H3X-MC-PPPA. Indianapolis, IN: Lilly Research Laboratories; August 22.
Lilly Research Laboratories. 1994b. Revised FIAU Nonclinical General Pharmacology and Toxicology Sections and Complication of Study Summaries Described in Clinical Investigator's Brochure; June.
Lipsett, M. B.; Fletcher, J. C.; Secundy, M. 1979. Research Review at NIH. Hastings Center Report 9; February; No. 1: 18-21.
Lopez, C.; Watanabe, K. A.; Fox, J. J. 1980. 2'fluoro-5-iodo-aracytosine, a potent and selective anti-herpes virus agent. Antimicrobial Agents Chemotherapy; 7: 803.
Lorber, J. 1975. Good patients and problem patients: Conformity and deviance in a general hospital. Journal of Health and Social Behavior; 16: 213-225.
Lumbreras, C.; Otero, J. R.; Herrero, J. A.; Gomez, R.; Lizasoain, M.; Aguado, J. M.; Colina, F.; Garcia, I.; Morena, E.; Noriega, A. R. 1993. Ganciclovir prophylaxis decreases frequency and severity of cytomegalovirus disease in seropositive liver transplant recipients treated with OKT3 monoclonal antibodies. Antimicrobial Agents and Chemotherapy; 37: 2490-2492.
Matthews, T.; Boehme, R. 1988. Anti-viral activity and mechanism of action of ganciclovir. Review of Infectious Disease; 10: S490-S494.
Maxson, C. J.; Greenfield, S. M.; Turner, J. L. 1992. Acute pancreatitis as a common complication of 2', 3'-dideoxyinosine therapy in the acquired immunodeficiency syndrome. American Journal of Gastroenterology; 87: 708-713.
Medina, D. J.; Tsai, C.-H.; Hsiung, G. D.; Cheng, Y.-C. 1994. Comparison of mitochondrial morphology, mitochondrial DNA content, and cell viability in cultured cells treated with three anti-human immunodeficiency virus dideoxynucleosides. Antimicrobial Agents and Chemotherapy; 38(8): 1824-1828.
Meinert, C. L. 1988. Toward prospective registration of clinical trials (editorial). Controlled Clinical Trials; 9: 1-5.
Mizrahi, T. 1986. Getting Rid of Patients. New Brunswick, N J: Rutgers University Press. Mollison, L. C.; Richards, M. J.; Johnson, P. D.; Hayes, K.; Munckhof, W. J.; Jones, R. M.; Dabkowski, P. D.; Angus, P. W. 1993. High dose oral acyclovir reduces the incidence of cytomegalovirus infection in liver transplant recipients. Journal of Infectious Disease; 168: 721-724.
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1976. Research Involving Prisoners: Report and Recommendations. Washington, DC; DHEW Publication No. (OS) 76-131.
Nelson, M. R.; Moyle, G. J.; Gazzard, B. G. 1993. Use of didanosine in zidovudine-intolerant patients infected with human immunodeficiency virus. CID; 16 (suppl 1): S59-S62.
Neu, H. 1992. The crisis in antibiotic resistance. Science; 257: 1064. NIH (National Institutes of Health). 1994a. Draft addendum to the ACD Subcommittee Report on Review of FIAU Studies; May 26. Note: prepared in response to the FDA Warning Letter to Dr. Jay Hoofnagle.
NIH (National Institutes of Health). 1994b. Draft report of the ACD Subcommittee on Review of FIAU Studies; April 29. Note: transmittal memo from Drs. Challoner and Kipnis.
NIH (National Institutes of Health). 1994c. List of References Available to the NIH Subcommittee to Review FIAU Studies; April 29. Appendix A to ACD Report.
Nordback, I. H.; Olson, J. L.; Chaisson, R. E.; Cameron, J. L. 1992. Acute effects of a nucleoside analog dideoxyinosine (DDI) on the pancreas. Journal of Surgical Research; 53: 610-614.
Norman, J. E.; Beebe, G. W.; Hoofnagle, J. H.; Seeff, L. B. 1993. Mortality follow-up of the 1942 epidemic of hepatitis B in the U.S. Army. Hepatology; 18: 790-797.
Oates, J. A. 1972. A scientific rationale for choosing patients rather than normal subjects for Phase I studies. Clinical Pharmacology and Therapeutics; 13(5): 809-811.
Oclassen Pharmaceuticals, Inc. 1989. Confidential Investigator's Brochure: FIAC. San Rafael, CA; August 31.
Oclassen Pharmaceuticals, Inc. 1990. Confidential Investigator's Brochure: FIAU. San Rafael, CA; May 31. Note: Appendix B.
Oclassen Pharmaceuticals, Inc. 1991a. Patient Summary Sheets; July 10.
Oclassen Pharmaceuticals, Inc. 1991b. Patient Summary Sheets; July 25.
Oclassen Pharmaceuticals, Inc. 1991c. Patient Summary Sheets; September 9.
Oclassen Pharmaceuticals, Inc. 1991d. Patient Summary Sheets; November 13.
Oclassen Pharmaceuticals, Inc. 1991e. Patient Summary Sheets; December 5.
Oclassen Pharmaceuticals, Inc. 1992. Patient Summary Sheets; January 3.
Oclassen Pharmaceuticals, Inc. 1994. [Letter to FDA. Response letter and appendices to FDA Warning Letter]; June 28.
Packard, F. R. 1921. Life and times of Ambrose Paré, 1510-1590. New York, NY: Paul B. Hoeber.
Pan, S. H.; Rosenthal, P.; Howard, T. K.; Podesta, L. G.; Sher, L.; Makowka, L. 1992. Evaluation of three cytomegalovirus infection prophylactic regimens in liver transplant recipients. Transplant Proceedings; 24: 1466-1467.
Perrillo, R. P. 1992. Antiviral agents in the treatment of chronic viral hepatitis. Progress in Liver Diseases; X: 283-309.
Perrillo, R. P.; Brunt, E. M. 1991. Hepatic histologic and immunohistochemical changes in chronic hepatitis B after prolonged clearance of hepatitis B e antigen and hepatitis B surface antigen. Annals of Internal Medicine; 115: 113-115.
Perrillo, R. P.; Campbell, C. R.; Sanders, G. E.; Regenstein, F. G.; Bodicky, C. J. 1984. Spontaneous clearance and reactivation of hepatitis B virus infection among male homosexuals with chronic type B hepatitis. Annals of Internal Medicine; 100: 43-46.
Perrillo, R. P.; Regenstein, F. G.; Bodicky, C. J.; Campbell, C. R.; Sanders, G. E.; Sunwoo, Y. C. 1985. Comparative efficacy of adenine arabinoside 5' monophosphate and prednisone withdrawal followed by adenine arabinoside 5' monophosphate in the treatment of chronic active hepatitis B. Gastroenterology; 88: 780-786.
Perrillo, R. P.; Regenstein, F. G.; Peters, M. G.; DeSchryver-Kecskemeti, K.; Bodicky, C. J.; Campbell, C. R.; Kuhns, M. C. 1988. Prednisone withdrawal followed by recombinant alpha interferon in the treatment of chronic type B hepatitis. A randomized, controlled trial. Annals of Internal Medicine; 109: 95-100.
Perrillo, R. P.; Schiff, E. R.; Davis, G. L.; Bodenheimer, H. C. Jr.; Lindsay, K.; Payne, J.; Dienstag, J. L.; O'Brien, C.; Tamburro, C.; Jacobson, I. M.; et al. 1990. A randomized controlled trial of interferon alfa-2b alone and after prednisone withdrawal for the treatment of chronic hepatitis B. The New England Journal of Medicine; 323: 295-301.
Physicians' Desk Reference. 1994. Videx.
Pierce, R. P. 1994. Presentation to the IOM Committee to Review the FIAU/FIAC Clinical Trials. Washington, DC: Institute of Medicine; July 25.
Posvar, E. L.; Sedman, A. J. 1989. New drugs: First time in man. Journal of Clinical Pharmacology; 29: 961-966.
Powell, J. R. 1986. Healthy volunteers, risk, and research. Drug Intelligence and Clinical Pharmacology; October; 20: 776-777.
The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. 1982. Compensating for Research Injuries: The Ethical and Legal Implications of Programs to Redress Injured Subjects. Washington, DC: US Government Printing Office; Stock No. 040-000-00455-6.
Richardson, F. C.; Engelhardt, J. A.; Bowsher, R. R. in press. Fialuridine (FIAU) accumulates in DNA of dogs, monkeys, and rats following long-term oral administration.
Richardson, M. L. 1994a. (FDA, Office of Compliance, CDER). [Letter to Frederick Manning]; The letter contains a series of attachments that provide further information about the FDA inspection of the four investigative sites and two sponsors involved with the clinical studies of FIAU. November 15.
Richardson, M. L. 1994b. Presentation to the IOM Committee to Review the FIAU/FIAC Clinical Trials. Washington, DC: Institute of Medicine; July 25.
Richman, D. D. 1989a. Experimental Subject's Bill of Rights. University of California, San Diego. Note: Appendix III.
Richman, D. D. 1989b. UCSD Treatment Center Policy for Reporting Adverse Events and UCSD Research Subject Injury Report. Note: Appendix IV.
Richman, D. D. 1989c. University of California, San Diego Institutional Review Board Guidelines. Note: Appendix V. Richman, D. D. 1990. Data Flowsheets of Lab Values and Adverse Experiences for Study R 89-001 (FIAC). Note: Appendix I.
Richman, D. D. 1994. [Letter to FDA. Response letter and appendices to FDA Warning Letter]; May 26.
Royle, J. M.; Snell, E. S. 1986. Medical research on normal volunteers. British Journal of Clinical Pharmacology; 21: 548-549.
Saliba, F.; Eyraud, D.; Samuel D.; David, M. F.; Arulnaden, J. L.; Dussaix, E.; Mathieu, D.; Bismuth, H. 1993. Randomized controlled trial of acyclovir for the prevention of cytomegalovirus infection and disease in liver transplant recipients. Transplant Proceedings; 25: 1444-1445.
Sallie, R.; Kleiner, D.; Richardson, F.; Conjeevaram, H.; Zullo, S.; Mutimer, D.; Hoover, S.; Fox, C.; Hoofnagle, J. H. 1994. Mechanisms of FIAU induced hepatotoxicity (abstract). Hepatology; 20(4):209A.
Saracco, G.; Mazzella, G.; Rosina, F.; Cancellieri, C.; Lattore, V.; Raise, E.; Rocca, G.; Giorda, L.; Verme, G.; Gasbarrini, G.; et al. 1989. A controlled trial of human lymphoblastoid interferon in chronic hepatitis B in Italy. Hepatology; 10: 336-341.
Schwartz, J. 1993. Researchers seek lessons from drug study deaths: Hepatitis tragedy leaves doctors solemnly contemplating risks of their own projects. The Washington Post. Washington, DC; September 28, Health: 9.
Schwartz, J. 1994. FDA Moves to Improve Safety of New Drug Trials. The Washington Post. Washington, DC; October 28; A10.
Schwartz, S. I. 1981. Biliary tract surgery and cirrhosis: A critical combination. Surgery; 90: 577-583.
Scullard, G. H.; Pollard, R. B.; Smith, J. L.; Sacks, S. L.; Gregory, P. B.; Robinson, W. S.; Merigan T. C. 1981. Antiviral treatment of chronic hepatitis B virus infection I. Changes in viral markers associated with interferon associated with adenine arabinoside. Journal of Infectious Disease; 143: 772-783.
Seeff, L. B.; Beebe, G. W.; Hoofnagle, J. H.; Norman, J. E.; Buskell-Bales, Z.; Waggoner, J. G.; Kaplowitz, N.; Koff, R. S.; Petrini, J. L., Jr.; Schiff, E. R.; et al. 1987. A serologic follow-up of the 1942 epidemic of post-vaccination hepatitis in the United States Army. The New England Journal of Medicine; 316: 965-970.
Selzer, R. 1992. Postoperative refractory ascites- division of hepatic lymphatics? Hepatology; 16(4, pt. 2): 252A.
Simes, R. J. 1986. Publication bias: The case for an international registry of clinical trials. Journal of Clinical Oncology; 4: 1529-1541.
Smith, M. A.; Brennessel, D. J. 1994. Cytomegalovirus. Infectious Disease Clinics of North America; 8: 427-438.
Staschke, K. A.; Colacino, J. M.; Mabry, T. E.; Jones, C. D. 1994. The in vitro anti-hepatitis B activity of FIAU [1-(2'-deoxy-2'fluro-1-ß-D-arabinofuranosyl-5-iodo) uracil] is
selective, reversible, and determined at least in part, by the host cell. Antiviral Research; 23: 45-61.
Staschke, K. A.; Colacino, J.M. in press. Priming of duck hepatitis B virus reverse transcription in vitro: Premature termination of primer DNA induced by the 5'-triphosphate of fialuridine. Journal of Virology.
Stevens, C. E.; Beasley, R. P.; Tsui, J.; Lee, W. C. 1975. Vertical transmission of hepatitis B antigen in Taiwan. The New England Journal of Medicine; 292: 771-774.
Straus, S. 1992a. Draft Manuscript of FIAU Treatment in HIV-Infected Patients.
Straus, S. 1992b. Information provided to FDA at meeting 10/28/92 at which the plan to proceed with long-term FIAU was discussed and then permitted. Appendix to FDA response letter.
Straus, S. 1992c. NIAID FIAC/FIAU Studies: Monitoring by Oclassen and Investigators Meetings. Appendix to FDA response letter.
Straus, S. 1993a. [Letter to NIH. Outline of Presentation to NIH DAC]; December 20.
Straus, S. 1993b. Bibliography of Literature Documenting the Transient Rise in Liver Enzymes ('Flare') During Spontaneous or Drug-Induced Clearance of HBV.
Straus, S. 1993c. Case Summaries: All Participants in 91-I-31 NIAID's Part of ACTG 122. Appendix to FDA response letter.
Straus, S. 1993d. Documentation of Formal Presentation to NIAID Clinical Director & Clinical Staff Regarding FIAC/FIAU. Appendix to FDA response letter.
Straus, S. 1993e. Narrative Summary of NIAID Studies of FIAU for Chronic Hepatitis B Virus Infection; December. Note: Contains Dr. Straus' CV, Selected Documents Available to NIAID from Oclassen.
Straus, S. 1994a. [Letter to FDA. Response letter and appendices to FDA. Warning letter of May 11, 1994]; June 21.
Straus, S. 1994b. Presentation to the IOM Committee to Provide Review of FIAU/FIAC Clinical Trials. Washington, DC: Institute of Medicine; July 26.
Straus, S.; Smiles, K. 1991. Interim Status Report: Tolerance of HIV-infected Patients to Oral FIAU and its Effect on Hepatitis-B. San Rafael, CA: Oclassen; September 27; Oclassen Clinical Study R90-001. Appendix to FDA response letter.
Tennant, B. C. 1994. (Cornell University College of Veterinary Medicine). [Letter to Teresa Wright]; November 16. Re: Two studies with FIAU have been conducted using the woodchuck model of hepatitis B virus infection.
Tennant, B. C.; Gerin, J. L. 1994. The woodchuck model of hepatitis B virus infection. In: I. M. Arias, J. I. Boyer, N. Fausto, W. B. Jakoby, D. A. Schachter, and D. A. Shafritz, Eds. The Liver: Biology and Pathobiology. 3rd ed. New York, New York: Raven Press, Ltd.
Therasse, D. 1993a. (Eli Lilly and Company). [Letter to R. Williams, FDA]; November 1; Attachment 3, Lilly papers.
Therasse, D. 1993b. (Eli Lilly and Company). [Letter to R. Williams, FDA]; December 2; Attachment 3, Lilly papers.
Tong, M.; Huang, S. J.; Lefkowitz, M.; Lee, S. D.; Co, R. L.; Lo, K. J. in press. A pilot open-labeled Phase II study using oral ribavirin in the treatment of patients with chronic active hepatitis B. Clinical and Diagnostic Virology.
Toulmin, S. 1981. The tyranny of principles. Hastings Center Report; 11(No. 6): 31-39.
Treem, W. R.; Rinaldo, P.; Hale, D. E.; Stanley, C. A.; Millington, D. S.; Hyams, J. S.; Jackson, S.; Turnbull, D. M. 1994. Acute fatty liver of pregnancy and long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency. Hepatology; 19(2): 339-345.
Twentieth Century Fund Task Force on the Commercialization of Scientific Research. 1984. The Science Business. New York, NY: Priority Press.
Van Landingham, S. B. 1984. Cholecystectomy in cirrhotic patients. Southern Medical Journal; 77: 38-40.
Venning, G. R. 1983a. Identification of adverse reactions to new drugs. I: What have been the important adverse reactions since thalidomide? British Medical Journal; January 15; 286: 199-202.
Venning, G. R. 1983b. Identification of adverse reactions to new drugs. II- How were 18 important adverse reactions discovered and with what delays? British Medical Journal; January 22; 286: 289-292.
Venning, G. R. 1983c. Identification of adverse reactions to new drugs. II (continued): How were 18 important adverse reactions discovered and with what delays? British Medical Journal; January 29; 286: 365-368.
Venning, G. R. 1983d. Identification of adverse reactions to new drugs. III: Alerting processes and early warning systems. British Medical Journal; February 5; 286: 458-460.
Venning, G. R. 1983e. Identification of adverse reactions to new drugs. IV- Verification of suspected adverse reactions. British Medical Journal; February 12; 286: 544-547.
von Einsiedel, R. W.: Fife, T. D.; Aksamit, A. J.; Cornford, M. E.; Secor, D. L.; Tomiyasu, U.; Itabashi, H. H.; Vinters, H. V. 1993. Progressive multifocal leukoencephalopathy in AIDS: A clinicopathologic study and review of the literature. Journal of Neurology; 240: 391-406.
Weinstein, A. 1994. Presentation to the IOM Committee; July 26; Washington, DC. Institute of Medicine.
Weissberg, J. I.; Andres, L. L.; Smith, C. I.; Weick, S.; Nichols, J. E.; Garcia, G.; Robinson, W. S.; Merigan, T. C.; Gregory, P. B. 1984. Survival in chronic hepatitis B. Annals of Internal Medicine; 101: 613-616.
Weller, I. V. D.; Bassendine, M. F.; Craxi, A.; Fowler, M. J.; Monjardino, J.; Thomas, H. C.; Sherlock, S. 1982. Successful treatment of HBsAg and HBeAg positive chronic liver disease: Prolonged inhibition of viral replication by highly soluble adenine arabinoside 5' monophosphate (ARA-AMP). Gut; 23: 717-723.
Williams, R. (FDA). 1993. [Letter to D. Therasse, Lilly]; November 22; Attachment 3, Lilly papers.
Williams, R. L. 1990. Controversy V: Phase I, first in man studies: An academic perspective. Journal of Clinical Pharmacology; 30: 210-222.
Wolfe, S. M.; Reid, R. 1993. (Public Citizen's Health Research Group). [Letter to David Kessler, Commissioner, Food and Drug Administration]. Washington, DC; December 9.
Wright, T. L.; Venock, A. P.; Millward-Sadler, G. H. 1992. Hepatic tumors. In: G. H. Millward-Sadler, T. Wright, Arthur, Eds. Wright's Liver and Biliary Disease. Philadelphia, PA: W.B. Saunders Co.
Young, C. W.; Schneider, R.; Leyland-Jones, B.; Armstrong, D.; Tan, C. T.; Lopez, C.; Watanabe, K. A.; Fox, J. J.; Philips, F. S. 1983. Phase 1 evaluation of 2'fluoro-5-iodo-1-beta-D-arabinofuranosylcytosine in immunosuppressed patients with herpes virus infection. Cancer Research; 43: 5006.
Zarafonetis, C. J. D.; Riley, P. A.; Willis, P. W.; Power, L. H.; Werbelow, J.; Farhat, L.; Beckwith, W.; Marks, B. H. 1978. Clinically significant adverse effects in a Phase I testing program. Clinical Pharmacology and Therapeutics; 24(2): 127-132.