Syndrome Part 27

But first things first He had gone to the section that described the many and varied clinical trials the NIH had under way. Then he used "scrambled eggs," the entry protocol given to him by Dale Coverton, to circ.u.mvent security on the site and get him into the second-level NIH data files. He was hoping to find the names of patients who had gone through the Gerex stem cell procedure and could be interviewed.

It really wasn't all that difficult, or even--he told himself--unethical to get in this far. No big deal. Entry protocols were available to any high-level NIH employee who had the right security grade. Now he was poking through the reams of proprietary data that the Gerex Corporation had submitted to initiate the clinical trials.

It was one of the more ambitious studies he'd ever seen, not in numbers of patients necessarily but certainly in scope. They were indeed running stage-three clinical trials of their stem cell procedure on a variety of maladies. There was no double-blind placebo. You either were cured or you were not.

Jesus, it was incredible. They were shooting for nothing less than the unified field theory of medicine, aiming not just to patch some failing element of the human body but to regenerate entire organs. Among their stated objectives were building pancreatic islets, reconstructing the ventricles of the heart, reconst.i.tuting the damaged livers of individuals with advanced cirrhosis. They were also accepting patients with Alzheimer's and Parkinson's.

"Christ," he said, scrolling past page after page, "how come they're suddenly so secretive about this?"

If Van de Vliet had achieved results in just a fraction of those trials, it would herald the beginning of a new age in medicine.

The NIH monitor for the Gerex trials was Cheryl Gates, just as Dale had said. Her photo was featured along with the introductory description of the trials. Nice-looking, he thought, probably late thirties, dark hair, dark-rimmed gla.s.ses. She wasn't wearing much makeup in the photo, probably to emphasize how serious she was. Sooner or later, he told himself, he had to find a way to meet her... .

He stared at his IBM Aptiva screen a moment longer, overwhelmed at what he was seeing, then got up and walked into the kitchen and made a peanut b.u.t.ter sandwich, whole wheat. It was a rehearsal for the possibly hard times to come. Then he retrieved a Brooklyn Lager from the fridge. It was his day off and the sun was over the yardarm.

He lived on the fourth floor of a brownstone in Yorkville, in New York's East Eighties. The apartment was small, but it was rent stabilized which meant he was paying well under market value--$1,128 a month on a place that probably could go for close to twice that on the open market. He'd lucked into it after he and Jane split--even though they weren't married they'd bought a condo in the West Fifties, and at the breakup they'd switched the mortgage to her name--but the problem now was, how was he going to pay even this piddling rent (not to mention child support for Amy) after he got fired from the Sentinel?

That day, he sensed was fast approaching. And if it happened before the book was finished he was just three months away from going back to freelancing. That was how long his "nest egg" would last.

Carrying the sandwich and beer, he walked back to his "office," a corner of the cramped living room that had an Early American desk, and sat down at the frayed chair in front of his IBM.

So here he was, past the first level of security of the NIH site, zeroed in on the Gerex clinical trials. Somewhere here had to be all the data about the patients who had been, and currently were, partic.i.p.ating.

He moved on to the results section and opened the first page. Yes.

Then he looked more closely.

h.e.l.lo, we've got a problem. The patient data he was looking at had only code numbers for names. The categories of trials also were just numbers. Without a key, there was no way to get a single patient name or differentiate Alzheimer's from fallen arches. Then he saw the notice at the top of the page: As part of the NIH policy on privacy, all patient data are aggregated and anonymous.

s.h.i.t.

This was as far as "scrambled eggs" would take him. He needed a higher security protocol to get into individual-case data. Dale either didn't have it or didn't dare give it out.

Well, he thought, at least I've got information on the structure of the clinical trials. I should print that before the system realizes it's been hacked. He clicked on the print icon. Let the games begin.

His real objective was to try to w.a.n.gle an interview with Karl Van de Vliet, an interview that would have to be approved by Winston Bartlett.

Maybe what could be gleaned from this level of the NIH site would be enough to bluff Bartlett into thinking he knew more than he really did.

In truth, interviewing discharged patients would have meant anecdotal information, probably not rigorous enough for use in a definitive book.

But at the moment, that would have been a start.

He lifted the first printed page and studied it.

Stone Aimes had seen enough clinical trials over the years to know that the data were reported according to an established schedule. Obviously, the schedule was always adapted to fit the nature of the trials under way, but studies that produce the kind of short-term results Gerex hinted at in their early press releases--before they clammed up--would probably have a tight reporting schedule, possibly even weekly.

He stared at the page for a moment, then lifted out another. He wasn't sure just yet what it all meant, but he might be able to infer something. He was still puzzling over the columns of numbers as the data finished printing.

What was it telling him?

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 partic.i.p.ants were not revealed to the monitor, or to anybody. The policy was intended to preserve the privacy of study partic.i.p.ants. 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 ident.i.ties of the partic.i.p.ants 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 ident.i.ty was in the database. But after that, the ident.i.ty 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 ident.i.ties 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?

He leaned back with a sigh and pulled on his Brooklyn Lager. Okay, patients frequently got dropped from clinical trials because some underlying condition suddenly manifested itself and made them unsuitable trial subjects. In fact, that was preferable to keeping them in a study when they were no longer appropriate. But the thing about clinical trials was, there always had to be a compelling, fully explained reason for terminating a test subject. Otherwise you could just "terminate" non-responsive partic.i.p.ants and skew the results. No reason was given here.

He thought again about the "one week of sunshine," and as a long shot checked to see if anyone had been admitted this week.

Nada, but again that was reasonable. The entire study was wrapping up.

Which meant, in short, that he had nothing to work with in terms of people. All he had were dates and encrypted names.

What now?

He finished the beer and was preparing to go off-line when a drop-down screen flickered NEW DATA.

He was being directed to the new applicants' "sunshine" page.

He clicked back, then stared at the screen.

A name had appeared.

He couldn't believe his luck. For some unknown reason,

they must still be adding new test subjects at this late date in the trials.

NINA HAMPTON.

Finally he had a name. This was an incredible stroke of...

Wait. A second name was appearing now, the letters popping up one by one as they were being typed in.