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Review of the Fialuridine (FIAU) Clinical Trials
escalated sharply when the tragic events of the PPPC trial unfolded. The patient felt that the trial should never have been undertaken in view of his neuropathy and adverse effects noted in other patients during and after the previous trials. The doctor-patient relationship finally ruptured with the patient's very strongly worded testimony to this effect to the FDA Antiviral Advisory Committee in September of 1993 and a subsequent letter to him from Hoofnagle informing him that in view of those remarks he did not think it appropriate for NIH to continue providing medical care or advice. Upon appeal to the Acting Director of NIH the patient was extended a formal apology, assured that he would receive the same opportunities for assistance as other former trial participants, and given a new point of contact at NIH, the Clinical Director of NIDDK. He subsequently received a thorough clinical evaluation which included assays for FIAU in blood and urine (negative). He has declined to participate in a formal long-term study of FIAU patients at NIH.
The committee cannot and does not see it within its charge to make judgments on the veracity of every patient's complaint. Accordingly, the unhappiness of these three patients may be completely justifiable. The overall pattern of response by the interview subjects, however, suggests that the studies on the whole were characterized by good to excellent rapport between patients and staff, frank discussion of potential risks, close attention to signs of FIAU toxicity, prompt action when it seemed indicated (leaving aside the question of whether the investigators should have known more than they did about toxicity at the time), and a general feeling by the patients that although they would certainly never have volunteered for a study that they believed involved a serious risk of death or permanent injury, they felt that they had been informed to the best of the investigators' abilities and had been treated conscientiously throughout the trials.