Dr. Frances Aintnoway is staring down the mountain of papers weighing down her tiny, government-issue desk. It's 9 a.m., and she's been up since dawn. Frances gives one particularly scary-looking stack a light push — just to test the law of gravity, she tells herself — and there it goes, off the desk and onto the floor in a blizzard of cheap white paper.
Her nerves are getting the best of her.
Today is D-Day for Frances, the newbie FDA scientist. She's reviewing an application for a new anti-psychotic drug hailed -- by its manufacturer, of course -- as the miracle drug of drugs, one that's shown tremendous promise in curing mental illnesses. She's on the hook for making a do-or-die recommendation on this drug. Is it ready to hit the market, or not?
That is the question.
No pressure. Frances grins. The manufacturer adopted the take-no-prisoners mode of persuasion. That paper burying her desk? She can thank the manufacturer for that. Over the past few weeks, she's plowed through the protocols and amendments that explain the hows and why of the clinical study and how the drug affects study subjects.
Frances flips through a page of one of its reports. "It's a miracle," it says. “Hrumph” is her response. She glances at the clinical study reports, integrated summaries of safety and efficacy. She reads another testimonial: "Of course the drug is safe when we compared the results from the controls and experimentals . . . " Bull-pucky, says Frances. She riffles through module 2 summaries of the Common Technical Document, where everything is explained. Ha, snorts Frances.
The manufacturer isn't totally on the hook for the paper chase. It used eSubmission, as the FDA prefers, to file all the documents electronically but, by golly, can't Frances let herself be a Luddite here and there? She knows she can settle into document review only if she can red-pencil real, live printouts.
Call her compulsive.
Frances is rock-solid in her opinion of her capabilities — hey, she has a PhD in molecular biology from Johns Hopkins. Her scientific instincts tell her that something is a bit off with this miracle drug. She leans over to red-ink another pie chart.
Frances looks up in time to see her colleague, Dr. Ken Showentell, walk into her office clutching a manila envelope. Not all pharma staffers use eSubmission, Frances notes, as Ken rips open the envelope.
"Frances, you are so Miss Suspicious," he says, tossing the envelope onto her chair. "Betcha the miracle drug manufacturer didn't let you in on this little study." Ken tears open the envelope and begins to read: "In sum, this drug effectively alleviates the symptoms of schizo-effective disorders in 95 percent of the patients, but the remaining 5 percent drift into a catatonic stupor."
"Catatonia? Catatonia?" Frances says. "I knew it… I knew this place was burying something."
"Might it be in a footnote?" Ken suggests.
Her phone display blinks again. Thank goodness for caller ID. The manufacturer has been calling at least 10 times a day, pressuring her to OK the drug. Heck, the drug representatives even complained to her boss that she was gumming up the works, depriving people who were suffering and in pain from access to this wonder drug.
"Is this company ready for prime time?" Ken says, raising his eyebrows only just a little.
True, the company was a biotech startup and obviously wasn't used to the byzantine ways of the FDA approval process. Frances is not a happy camper. Greenhorns give her headaches, but she has a job to do. It's time to finish her PowerPoint presentation on the drug.
It'll be thumbs down.
Five hours later, Frances is facing a panel of her peers and superiors. Slide by slide, she explains her reasoning behind her recommendation to deny approval to the anti-psychotic drug.
"Catatonia is a serious possible side effect," Frances solemnly intones. She looks out at her audience. Their eyes are glazed over. Heads are nodding, and not in a good way. They look as if they know catatonia up close and personally. Frances clears her throat and silently curses her decision not to take the "Voice and Speech I for Scientific Presenters" in graduate school. Being an FDA scientist is more than science -- it's talk, talk and more talk.
A soft snore wafts over from the department chief who is sitting in the front row. Frances ramps up her decibel level.
"My recommendation is: HECK NO!" Frances slips off a shoe and bangs it on the lectern.
That gets their attention. Her audience looks at her as if she gone slightly cuckoo.
Maybe she has, but she sure is enjoying herself.
It's 5 p.m. What a great way to end a day at the FDA.