Human experimentation in medicine -- Fiction; Suspense fiction
He went back and clicked on STUDY PROCEDURES. This section explained how
the reporting was structured. He still held out hope that the names of
the discharged patients in the clinical trials could be accessed
somehow. In the past, when the FDA tested drugs, it often happened that
the names of the participants were not revealed to the monitor, or to
anybody. The policy was intended to preserve the privacy of study
participants. But lately it had been under review. All that secrecy and
non-accountability had permitted some spectacular fabrication of test
data.
Surely the NIH had taken this into consideration by now and come up
with a system whereby the identities of the participants could be
checked and verified. That information had to be stored somewhere.
No such luck. It appeared the NIH had begun using a modified version of
the new FDA sunshine policy. NIH clinical trials had a "one week of
sunshine" provision, during which the suitability of test subjects
could be evaluated by a review procedure. During that time, their real
identity was in the database. But after that, the identity information
of any patient actually selected for inclusion in the clinical trials
was encoded--where thenceforth it could only be accessed through a
lengthy legal process.
Screwed again.
At this late date, the Gerex Corporation surely was not going to be
adding any new names and giving them that week of sunshine. According
to press releases at the beginning of the clinical trials, when Gerex
was a lot more communicative, at this date the entire study should be
just days away from being wrapped up.
He went back to the patient files one last time, out of frustration. As
he continued to scroll, he noticed that although the identities of
patients and crucial personal data were encrypted, the dates on which
they entered and finished the trials were all supplied.
Hmmm. It was actually more detailed than that. There were dates for
when a patient entered each stage of the procedure: Screening, Initial
Evaluation, Admitted into Program, Procedure Under Way, Procedure
Monitoring, Results Evaluation, Patient Release, Patient Follow-up.
The time between screening and patient release averaged around five
weeks, six weeks at most
Looking at the time-sequenced data, you couldn't avoid the conclusion
that the clinical trials had been a spectacular success. No doubt the
specific data would reveal whether there had been any adverse
reactions, but as clinical trials go, these seemed to have been without
major incident. He had a nose for trouble, and these looked as rigorous
as clockwork. . . .
Hold on a second. . . . _That's_ odd.
What the data structure did not have was a category for Termination.
Yet one of the patients had been listed with dates leading up to and
including Procedure Under Way, but after that the patient was noted
parenthetically as having been "terminated." That was all the
information given.
What could that mean?
Public-domain text, read in full here on John Shaqi.
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