Tag Archives: FDA

Placebo Takes The Heat

“I hate providing quotes for press releases,” said Rupert.

“Every company CEO needs to say something profound when the company makes headlines,” Betty said.  “Especially two headlines in one day.  Don’t worry, your Marketing VP, what was his name?”

“Marky Marketeer,” Rupert said as he stared at the ground.  “I hope he changes his name soon.”

“Marky.  Yes.  Don’t worry, he can create a quote for you.  It’s not like anyone ever actually said that stuff in the news.”

“Yes, but this isn’t my fault,” said Rupert.

“Oh, Rupert, placebo effects are nobody’s fault.  They just…happen.  Do you know how you are going to spin this one?”

“Well, you have to wonder why someone would keep taking a drug for three whole years if there’s no improvement.  Calmidizole and all those anti-depressants take a while to act, but not that long.”

Betty gasped.  “Three years?  If it doesn’t help, what doctor would keep prescribing it?  Whatever it is.  And it’s already FDA approved, so what is the lawsuit?”

“Oh, some dumb broad thinks -”

“Rupert!”  Betty glared with fierce, burning eyes.

Rupert looked around, checked his zipper, then glanced back at Betty.  “What?”

“What was that sensitivity training lecture I gave you this morning?”

Rupert’s eyes focused.  “Oh.  That.  Sorry, and I will never use the word ‘sideboob’ again.”  He inhaled deeply.  “Anyway.  So she claims the drug should be off the market because it didn’t help her personally.  If that is OK, then who needs an FDA?  Every drug will fail with somebody, so there’d be no drugs.  We think the court will toss it out.”

“It just better,” said Betty.  “Now.  What happened with your clinical trial?  You know, the cancer one.”

“Prostate cancer is nasty,” Rupert said.  “Just about any drug helps only a small percent, and ThermoNu-Q-LRx should do just that.  It just helped a smaller percent than normal – and the placebo helped a larger percent than normal.”  He moaned for the tenth time that hour.  “Our stock dropped 97% to a buck, and Rotten Capital downgraded our stock.”

He moaned yet again.  “What kind of quote do I give?  Something like, ‘Sorry to waste all our investors’ funds, it doesn’t work’ or what?”

Betty grabbed him by the shoulders and shook him.  “First, quit whining.  Second, try something like ‘We notice this subset of patients did improve, and we intend to discuss this with the FDA.’  Never give up.  Never.”

Rupert’s eyes focused.  “I’m not giving up. ThermoNu-Q-LRx needs to be activated by radiation, and that seems to work.  All of the treatment patients had brighter teeth, even if they still had cancer.  When we started developing the drug, we put patients in front of a color TV.  Now we need to point the radioactivity at the patient bone metastases.  You know, those painful little arrowheads that show up on elbows and knees.”

Betty gasped again and covered her mouth.  “You pointed radioactivity at their bones?  Rupert, did you give these patients bone cancer?”  She twisted her face into a sarcastic smirk.  “I’m sure that will send your stock into outer space.”

“Oh,” said Rupert.  “Um…could I quote you on that?”


Sources of inspiration:

  1. http://www.pharmalot.com/2013/02/pfizer-zoloft-and-the-vexing-placebo-effect/
  2. http://www.bioworld.com/content/celsion-out-cold-following-heat-failure-thermodox-0
  3. http://seekingalpha.com/article/1283871-celsion-s-thermodox-may-be-back-in-play?source=yahoo

Episode 25: Elevator Pitch Goes Foul

As a CEO in the Candybar Building, Rupert Madasheck had privileged access to the secret Executive’s Elevator. He stepped inside the elevator car and noticed on its display that one other exec would join him. He poured himself a glass of 1995 Araujo cabernet from the cache and settled into his favorite stuffed chair. Glancing at the keypad on the chair’s arm, he entered his floor number.

As he swirled and sipped his wine, the door opened and an elderly gentleman stepped in. The new arrival opened the 15th Century globe and poured himself a snifter of brandy. To Rupert’s surprise, the man gulped the brandy and poured more. Shutting the globe, the man sat down and entered his own floor number.

Rupert spoke first. “Rupert Madasheck, Cappuccino Pharmaceuticals.”

The other man raised his eyebrows and said, “Gary Cortescu, Pfuztercluck Pharmaceutics. Glad to share a ride with you.” The elevator began to move with a barely perceptible bump.

Gary inhaled the aroma of the brandy with a studied sniff, eyes closed. “Ah, delightful. I hate rushing these things.”

“But you did,” Rupert said. “We’re here to relax for a while, aren’t we?”

Gary sighed heavily and sipped. “Oh, yes, of course. I haven’t belted down a shot since the last disaster. Doubtless you’ve heard the news.”

“Your donations to the Heartless Institute? I won’t feign total ignorance.”

Gary sighed again. Is he going to do that a lot? Rupert wondered.

The elevator hummed softly and the walls glowed and pulsed with warm swirls of color. Gary stared at his glass and sighed again. Finally he said, “I suppose it’s my own fault. We did want to make some corporate charitable donations and I was willing to overlook some of their more controversial positions.”

“They believe global warming is a hoax, as I recall,” Rupert said.

“Well, of course it is. But that is irrelevant to us. Let the energy sector worry about that. Our industry has its own issues.”

“Don’t they oppose evolution to the point that they think bacteria don’t evolve?” Rupert asked.

“Oh. Um, well, yes. But leave that to the education sector to worry about.”

“Remind me how they explain bugs mutating around antibiotics.”

Gary rubbed his chin. “I believe it’s cosmic rays according to one statement.”

“Which don’t exist, according to another.” Rupert sipped his wine and recalled a recent news flap. “Didn’t they declare that the Higgs Boson was also based on junk science?”

Gary chugged the rest of his brandy and coughed. “I’d almost forgotten that. But again, education sector. Not my department.” He stood up shakily and moved back to the globe. “Let us not dwell on these things. We are here to relax for a brief moment on our rush through an unrelentingly hostile world, are we not?”

Rupert sipped his wine and let the taste linger. He wished the elevator would never arrive at his floor. Yet he could not let go of the topic without asking. “But why did Pfuztercluck donate to the Heartless Institute at all?”

“Like any sensible business, we agree with their push to eliminate price controls and reduce regulation.”

“You know that they also want to eliminate corporate subsidies,” Rupert said. “Wouldn’t that include research grants?”

Gary looked thoughtful. “I’m not sure we need research grants, do we? That’s for the small companies. Our competition, so to speak.”

Rupert set his glass down and leaned forward. “We often rely on those small companies to invent. Then we license what looks promising. I don’t understand why, but the startups are where innovation happens. So isn’t Heartless working against your own interests?”

Gary sat down and delicately sipped his third snifter of brandy. “Ah, my lad, you are young indeed. We support only the one advocacy arm of theirs that supports us.”

“Of course, of course.” Rupert took another leisurely sip. “But what is that?”

“Why of course they believe that all FDA rejections are based on junk science. Now, outside this elevator I could never admit that we support their ‘Freedom to Pick Your Meds’ initiative.” Gary leaned back in his chair and sighed yet again. “Ah, what a world it would be if people could decide what medicine worked for them without any government stooges getting in the way.”

Rupert was aghast. “Are you suggesting we do away with the FDA altogether?”

Gary closed his eyes and smiled. “Ah, you may say I’m a dreamer…” His voice trailed off. Rupert sipped his wine. The elevator hummed softly and the colors swirled.

The door opened and they both looked up. “Good to meet you, Gary. This is my floor.” Rupert put his glass in the collection grip and walked out to the hallway and his day’s destiny.

That evening, Betty and Rupert met at a single malt tasting room and chose suitably snooty single malts. Betty said, “I got a letter addressed to the Chair of Cappuccino Pharmaceuticals today.”

Rupert said, “That would be fitting since you are indeed the Board Chair.”

“It was from a group of investors concerned about contributions to one entity known as the Heartless Institute. What do you know about them?”

Rupert downed his single malt in one gulp and gasped for breath. “Never heard of them.”

Copyright ©2013 Bixogen, Inc. All rights reserved. Used by permission.
No part of this work may be reproduced or transmitted in any form or by any process without prior written permission. Continue reading

Episode 23: What’s In a Name?

Rupert Madasheck was not the only CEO in the club’s cherrywood paneled room that day.  Gazing up into the distance at the crystal chandeliers, he eased himself into an overstuffed chair next to fellow CEO Gjioughneh Kqueuerillieux.  As he glanced around the room at the executives lounging at the Jonathan Club, Rupert asked Gjioughneh how things were going.

“Terrible,” Gjioughneh said.  “We were just informed that the PMA for our OctoPlex gel was rejected.”  Gjioughneh stared down at his folded hands and sighed.  “I just don’t understand it.  You can’t ask for better clinical trial outcomes.   It’s been on the market outside the US for a decade.  The manufacturing profile is top notch.  What else do they want?”  His fingers gnarled around each other in a knot.

“What exactly does this, um, this Octomom do?” Rupert asked.

“OctoPlex, not Octomom,” Gjioughneh said without looking up.  “It lessens the pain from failed surgery, particularly botched jobs to relieve Restless Third Leg Syndrome.”

“Oh, yes,” said Rupert.  “The syndrome that’s not just for congressmen anymore.  There’s surgery for that?”

“As a last resort,” Gjioughneh said.  “The drugs available for it just can’t stop all the scandals, so people need to take drastic surgical measures.  But surgery has a lot of problems and high chance of lifelong pain.  Too bad there’s a political angle.”

At the word ‘political,’ Rupert hunched his shoulders as if leaning into a rainstorm.   He remembered the never-ending stream of politicians sending lewd photos of themselves to would-be mistresses.  “Don’t tell me Congress wants your gel all to themselves.”

“No, it’s worse.  Congress wants to save money by cutting funding to the FDA.  So they are retaliating to make the House of Reprehensibles feel the pain.  We really believe the rejection is bull,” Gjioughneh said. “I’ve decided we’ll file a petition for reconsideration.”

Rupert looked up with a startled expression.  “You could do that?  Won’t it just annoy them?”

“We’re going with the ‘creates jobs in the US’ angle.  Once we get approval we can put a dent in the unemployment rate.”  Gjioughneh’s eyes glazed suddenly in rapt attention and he pulled out his vibrating YouPhone.  After fumbling for a second, he held it to his ear and said, “Gjioughneh here.”

Knowing that cell phone use is frowned upon at the Jonathan Club, Rupert looked away and twiddled his thumbs patiently while Gjioughneh listened to his call.  Should he edge away and leave Gjioughneh in peace?  Should he pull his own phone out for a quick game of Sudoku while pretending to work?  Would Gjioughneh be escorted to the floor with the phone booths?  Before Rupert could decide, Gjioughneh put the phone down.

“Rupert, I want to get out of this business,” Gjioughneh said.  “Turns out the FDA denial was based on the fact that no one at FDA could figure out how to pronounce the name of our company.”

Rupert’s eyebrows shot up.  “They couldn’t pronounce ‘FzGnque’ so they rejected Octomom?  I can’t believe that.”

“OctoPlex.”  Gjioughneh shook his head sadly.  “You’re close.  It’s pronounced ‘FzGnque.’  But it’s true.  They were too embarrassed to contact us.”  He frowned and looked around the room.  “We can change our name to FrzeuQ if they want.  And who are they to complain anyway?” he added.  “Is it ‘FDA’ or the FDA?”

Yes, this story was inspired by an actual news article.  Brownie points for finding the original source! –      The BixoBrat

Copyright ©2013 Bixogen, Inc. All rights reserved. Used by permission.  No part of this work may be reproduced or transmitted in any form or by any process without prior written permission.