“How could we possibly make such a guarantee?” Calligrafa Corbin asked.  “We are an excellent clinical research organization with a stellar track record.”

“I am sure you are,” said Rupert.  “And so was Hoptuit or whatever they’re called.  Until it wasn’t.  All it took was one rogue technician who fabricated data.” [1]

Calligrafa paled.  “I suppose someone had to be the first one prosecuted under the Good Laboratory Practice Regulations.  We do not intend to be the second.”

Rupert frowned and swiveled in his chair.  He glanced at the walls, at the ceiling tiles, at the untouched bagels and coffee in the corner.  He could not look Calligrafa in the eyes.  “That’s what worries me.  You might settle for third.  Second place might go to a company so bad that it finally went out of business overnight.”

Calligrafa began to tremble.  “Oh.  You mean PRACS?”

“I mean PRACS.  That’s just a renamed Cetero, the lab flagged by the FDA as generating fraudulent results. [2]  What gets me is that when PRACS disappeared, they wiped out maybe 40 studies. Those were run for the big boys.  You know, Merck, Glaxo, Gilead, Ranbaxy.  Much larger than we are.  We can’t afford a fraudulent clinical trial.”

Calligrafa let go of her pen so it would stop tapping frantically.   It skittered across the table and escaped to the floor.

Rupert leaned back in the soft leather chair and gazed at the ceiling.  “I hate being the bad guy, but it seems Eisai has the right idea.  They appointed an enforcer, someone whose job it is to make sure that Phase III trials do not fail.  This enforcer will reach into the CRO actually running the trial.” [3]  He sat up and forced himself to stare at Calligrafa.  “So will we.  We don’t like failure either.  For any reason.  Not during the trial, and not after.”

Calligrafa gulped and jammed her hands together.

Rupert swiveled to stare out the window of the conference room.  “I do not intend to end up showing preposterous so-called data that show our superdrug for muscular dystrophy is no better than placebo.  I don’t intend to dress up the statistics just to fool the rubes.” [4]

“That puts us in an impossible position,” Calligrafa said.  “You want all of your drug trials to succeed but you of course want no fraud.  We can fight fraud with the strictest enforcement, but how can we guarantee every trial succeeds?”

“Well, there’s that,” Rupert said.  “Oh, look at the time.  I really must run.  We will speak further of this.”  He stood up and strode out of the room.

~~~~~~~~~~~

That evening at the charity ball, Betty Lidalot felt a tingling sensation that alerted her to an approaching threat.  She whirled away from a very surprised movie star in mid-sentence to face Rupert still three feet away.  When she saw his shocked expression, she carefully lowered her karate stance.

“Rupert, so good to see you,” she said.  “My new SpiderSense gown, do you like it?  I had it made specially by Victor Mateevitsi.”

“Um, it looks very, um, technical,” Rupert said.  He rubbed his chin.  “Who is Victor Macchiavelli?”

“Mateevitsi.  He’s an engineer so I hooked him up with the finest fashion talent.  Now women can sense approaching danger as well as Spiderman can.”

“But Spiderman is a fictitious character.  He senses danger only when the author tells him to.”

“Rupert, you are such a bore.  Now can you tell me how the CRO meeting went?”

Rupert’s face brightened.  “It went very well.  I had them sweating and quaking in their shoes.  You would have been proud of me!  We don’t need any fraudulent results discovered after our drugs are on the market.”

Betty’s smiled and held up her wineglass.  “That’s wonderful news!  So there will be no more failed clinical trials?”

Rupert picked at something in his eye.  “Um, yes.  About that.  Well, I really must be going.  Way past my bedtime.”

“Rupert Madasheck, what is this all about?” Betty hissed.  Several ballroom dancers skirted away to clear a space around them.

“First there were placebos,” Rupert moaned.  “Now we have nocebos.”[5]

Betty frowned angrily.  “What is a nocebo?”

“We have to warn people in the trial of the possible side effects.  That seems to make people feel those side effects.  Even if we give them sugar pills.”

Tune in again when we ask:

• Can giant error bars be ignored as long as the drug treatment line appears better than the placebo line?  Even if those error bars overlap?
• Can Eisai’s enforcer guarantee no Phase III trial failures?
• Can Calligrafa guarantee her CRO will never compromise results?
• Will Betty’s SpiderSense threat-detecting gown catch on in fashionable