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Review of the Fialuridine (FIAU) Clinical Trials
that they were free to withdraw at any time (although two subjects also reported that it was made clear that they were lucky to be accepted and should be very grateful; no one interviewed ever considered dropping out of the study). Surprising, only four subjects sought advice from another physician once they had the consent form or protocol in hand (all four were encouraged, to a greater or lesser degree, to sign the form).
All of the interview subjects reported that the study staff had been very attentive to their reports of side effects at every appointment, pointing out that they were always quizzed not only on the symptoms from a long written list but about any other changes in their health of any sort. When they reported new symptoms or increased severity of previously reported symptoms to nonphysician staff, the latter were quick to call in a physician. Four of the 19 patients (3 with current injuries they attribute to FIAU) interviewed reported that they would not consider volunteering for further drug trials with their previous investigators under any circumstances.
An important commonality among the six patients in the PPPC trial was their universal recall of discussion during the informed consent process about the death of one of the patients in the PPPC trial 4 months after completing FIAU therapy, following surgical removal of his gallbladder. Although the PPPC protocol discussed the death in some detail, along with the rationale behind the investigators' judgment that the death was not FIAU related, the ICD actually given to the subjects for signature contained none of this information. All of the subjects interviewed recalled being told about this patient, as well as another patient in the R91 trial who developed peripheral neuropathy some months after his course of FIAU treatment. All of them also recalled, in varying detail, that the investigators did not believe that FIAU was responsible for the death and that nerve conduction tests had been added to detect neuropathies. The Boston/Galveston (PPPA) trial, which began at roughly the same time as the PPPC trial, did not include such a discussion, and as a result one of the patients from that trial, who was otherwise quite satisfied with his treatment by the study staff expressed disappointment that he "didn't get full disclosure." As he put it, "Even if they thought it was irrelevant it should have been my call." This patient was one of the four who told the interviewer that they would not volunteer for another drug trial (in this subjects' case, ''anywhere'').
Perhaps the most important generalization that can be deduced from this small sample of 19 interviews is that the subject's reports of the informed consent process and their satisfaction with their treatment by the study staff are closely associated with their current health. The three subjects interviewed who reported currently suffering from peripheral neuropathy, although two were in the R91 trial and the other was in the PPPA trial, were insistent that the risk of side effects had been minimized in their discussion of the ICD. One reported being satisfied with the answers to his many questions at the time, but he now feels that significant pieces of information were withheld or denied; the second reports that his only question, directed at one of the associate principal investigators sometime after signing the ICD, earned him a scolding for his lack of faith. The third patient reported a painful neuropathy that developed, like that of the others, sometime after halting FIAU and complained of indifference or disbelief by the study staff (see chapter 7 above). Although NIH continued to provide evaluation and consultation to the patient's private physician (the patient had moved to the Far West in the interim), relations became increasingly adversarial. Difficulties initially centered upon the apparent reluctance or inability of NIH to provide for pain treatment, but