medical charts were meticulously kept by the nursing staff.”
“You mean a separate and hidden set.”
“Yes, but the trial data wasn’t kept from those who need to know at the FDA.”
“That still doesn’t explain why there are no nurses’ reports of the trials in my records or the alleged improvement of patients’ behavior and functionality. Or why I wasn’t told.” Because her job centered mostly on paperwork, she had only minimal contact with nursing home residents—something she hoped to change as time passed. Therefore, she could not personally have witnessed any actual improvements in the behavior of these trial subjects. Nonetheless, nurses and other staffers at her homes often talked about patients’ health, behavior, affect, the funny things they may have said. Yet, remarkably, nobody had uttered a word about the extraordinary changes in Clara Devine or any other patients in these trials.
“Well, I’m telling you now.”
“But only because Clara Devine eloped and murdered someone.”
His face darkened. “That was unfortunate.”
“Doctor Carr, this isn’t a blinded study, it’s a concealed one.”
He stared at her for a moment, then shrugged. “If you wish.”
He was trying to disarm her with a concession because he knew that she
could report him. As an employee of CommCare, she was an outsider to the nursing home and bound by state and FDA regulations. And they both knew that she could lose her job were she not to report a secret clinical trial. “Doctor, you’re not answering my question: Why was I kept in the dark?”
“It was nothing personal. Even the nursing staff didn’t know what the subjects were on, though they were aware they’d been enrolled in trial of a dementia drug.”
“That still doesn’t answer my question.”
He drained his wineglass. “Because GEM Tech did not want to risk the competition getting wind of what we have. Period.”
The we floated like a lazy feather in the air. “They’re really worried some other drug company’s going to whip up a me-too compound?”
“In a word, yes. They don’t want somebody else beating them to the market. You know what a rat race the pharmaceutical industry is. Somebody invents a Ford, and a Chevy is right on its bumper.” He lowered his voice to a conspiratorial whisper. “René, we’re talking about a supreme blockbuster drug here—a fifty- billion -dollar pill.”
The waiter arrived to clear their dishes. When he left, Carr said, “I know it’s premature, but the FDA is very excited about this, very. And I won’t be surprised if they fast-track its approval.”
That still didn’t justify burying data. But the more he talked about the miraculous results, the more she became self-conscious about raising niggling issues of policy regulations. Here was a celebrated senior neurologist sharing with her what might be the greatest breakthrough in medicine since penicillin, and two months on the job and little Polly Protocol was souring the air with fumes. “I can imagine.”
“In four months we’ll be submitting trial reports to the Institutional Review Board—all the data and documentation thus far, everything with all the Ts crossed and Is dotted as required by the FDA, to be followed by the necessary publications, which will no doubt make the press. This is going to be huge.”
“You’re talking as if you’re the principal investigator.”
“Actually, I’m one of them. A chief has yet to be named.”
The chief principal investigator on any clinical trial occupied a post heavy with responsibility and prestige, especially if the compound tested showed promise. That Jordan Carr was a prime candidate was evident. So was his yearning.
“So, what about Clara killing a man? How is that being explained?”
“That was unexpected, of course. And we’ll have to make the best of it. Thankfully, patient confidentiality protects us. Meanwhile, she’s at McLean for observation.”
She remembered
“You mean a separate and hidden set.”
“Yes, but the trial data wasn’t kept from those who need to know at the FDA.”
“That still doesn’t explain why there are no nurses’ reports of the trials in my records or the alleged improvement of patients’ behavior and functionality. Or why I wasn’t told.” Because her job centered mostly on paperwork, she had only minimal contact with nursing home residents—something she hoped to change as time passed. Therefore, she could not personally have witnessed any actual improvements in the behavior of these trial subjects. Nonetheless, nurses and other staffers at her homes often talked about patients’ health, behavior, affect, the funny things they may have said. Yet, remarkably, nobody had uttered a word about the extraordinary changes in Clara Devine or any other patients in these trials.
“Well, I’m telling you now.”
“But only because Clara Devine eloped and murdered someone.”
His face darkened. “That was unfortunate.”
“Doctor Carr, this isn’t a blinded study, it’s a concealed one.”
He stared at her for a moment, then shrugged. “If you wish.”
He was trying to disarm her with a concession because he knew that she
could report him. As an employee of CommCare, she was an outsider to the nursing home and bound by state and FDA regulations. And they both knew that she could lose her job were she not to report a secret clinical trial. “Doctor, you’re not answering my question: Why was I kept in the dark?”
“It was nothing personal. Even the nursing staff didn’t know what the subjects were on, though they were aware they’d been enrolled in trial of a dementia drug.”
“That still doesn’t answer my question.”
He drained his wineglass. “Because GEM Tech did not want to risk the competition getting wind of what we have. Period.”
The we floated like a lazy feather in the air. “They’re really worried some other drug company’s going to whip up a me-too compound?”
“In a word, yes. They don’t want somebody else beating them to the market. You know what a rat race the pharmaceutical industry is. Somebody invents a Ford, and a Chevy is right on its bumper.” He lowered his voice to a conspiratorial whisper. “René, we’re talking about a supreme blockbuster drug here—a fifty- billion -dollar pill.”
The waiter arrived to clear their dishes. When he left, Carr said, “I know it’s premature, but the FDA is very excited about this, very. And I won’t be surprised if they fast-track its approval.”
That still didn’t justify burying data. But the more he talked about the miraculous results, the more she became self-conscious about raising niggling issues of policy regulations. Here was a celebrated senior neurologist sharing with her what might be the greatest breakthrough in medicine since penicillin, and two months on the job and little Polly Protocol was souring the air with fumes. “I can imagine.”
“In four months we’ll be submitting trial reports to the Institutional Review Board—all the data and documentation thus far, everything with all the Ts crossed and Is dotted as required by the FDA, to be followed by the necessary publications, which will no doubt make the press. This is going to be huge.”
“You’re talking as if you’re the principal investigator.”
“Actually, I’m one of them. A chief has yet to be named.”
The chief principal investigator on any clinical trial occupied a post heavy with responsibility and prestige, especially if the compound tested showed promise. That Jordan Carr was a prime candidate was evident. So was his yearning.
“So, what about Clara killing a man? How is that being explained?”
“That was unexpected, of course. And we’ll have to make the best of it. Thankfully, patient confidentiality protects us. Meanwhile, she’s at McLean for observation.”
She remembered
Similar Books
