Robin Cook - Acceptable Risk

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With billions of dollars at stake, every scientist in America is fighting to discover the next Prozac, the latest "feel good" drug. Using bacterial mould first uncovered during the Salem witch trials, Edward Armstrong isolates a stunningly effective anti-depressant.

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“Where did it come from?” Candice asked.

Edward summarized the story by explaining the association between Kim’s forebear, the Salem witch trials, and the theory the accusers in Salem had been poisoned by a mold.

“It was Kim’s question whether the poison theory could be proved which got me to take some samples of dirt,” Edward said.

“I don’t deserve any credit,” Kim said.

“But you do,” Edward said. “You and Elizabeth.”

“Such irony,” Candice said. “Finding a useful drug in a dirt sample.”

“Not really,” Edward said. “Many important drugs have been found in dirt like cephalosporins or cyclosporine. In this case the irony is the drug is coming from the devil.”

“Don’t say that,” Kim said. “It gives me the creeps.”

Edward laughed teasingly. He hooked his thumb at Kim and told the others that she was wont to have occasional attacks of superstition.

“I don’t think I like the association either,” Stanton said. “I’d rather consider it a drug from heaven.”

“The association with the witch frenzy doesn’t bother me at all,” Edward said. “In fact I like it. Although finding this drug can’t justify the death o£, twenty people, at least it might give their sacrifice some meaning.”

“Twenty-one deaths,” Kim corrected. She explained to the others that Elizabeth’s execution had been overlooked by the historians.

“I wouldn’t care if the drug were related to the biblical flood,” Stanton said. “It sounds like an extraordinary discovery.” Then, looking at Edward, he asked, “What are you going to do?”

“That’s why I wanted to see you,” Edward said. “What do you think I should do?”

“Exactly what I already told you,” Stanton said. “We should form a company and patent the drug and as many clones as possible.”

“You really think this could be a billion-dollar situation?” Edward asked.

“I know what I’m talking about,” Stanton said. “This is my area of expertise.”

“Then let’s do it,” Edward said. “Let’s form a company and go for it.”

Stanton stared into Edward’s face for a beat. “I think you are serious,” he said.

“You bet I’m serious,” Edward said.

“All right, first we need some names,” Stanton said. He took out a small notebook and pen from his jacket pocket. “We need a name for the drug and a name for the company itself. Maybe we should call the drug Soma for the literary set.”

“There’s already a drug called Soma,” Edward said. “How about Omni, in keeping with its potentially wide range of clinical applications?”

“Omni just doesn’t sound like a drug,” Stanton said. “In fact it sounds more like a company. We could call it Omni Pharmaceuticals.”

“I like it,” Edward said.

“How about ‘Ultra’ for the drug,” Stanton said. “I can see that working well for advertising.”

“Sounds good,” Edward said.

The men looked at the women for their reaction. Candice hadn’t been listening, so Stanton had to repeat the names. After he did she said they were fine. Kim had been listening, but she didn’t have an opinion; she was a bit taken aback by the discussion. Edward had shown no awkwardness in this sudden and unexpected interest in business.

“How much money can you raise?” Edward asked.

“How long would you estimate it would take before you were ready to market this new drug?” Stanton asked.

“I don’t think I can answer that question,” Edward said. “Obviously I can’t even be one hundred percent sure it will ever be marketable.”

“I know that,” Stanton said. “I’m just looking for a best-guess estimate. I know that the average duration from discovery of a potential drug to its FDA approval and marketing is about twelve years, and the average cost is somewhere around two hundred million dollars.”

“I wouldn’t need twelve years,” Edward said. “And I wouldn’t need anywhere near two hundred million dollars to do it.”

“Obviously the shorter the development time and the less money needed means more equity we can keep for ourselves.”

“I understand,” Edward said. “Frankly I’m not interested in giving away much equity at all.”

“How much money do you think you would need?” Stanton asked.

“I’d have to set up a state-of-the-art lab,” Edward said, beginning to think out loud.

“What’s the matter with the lab you already have?” Stanton asked.

“The lab belongs to Harvard,” Edward said. “I have to get the Ultra project away from Harvard because of a participation agreement I signed when I accepted my position.”

“Is this going to cause us some problems?” Stanton asked.

“No, I don’t think so,” Edward said. “The agreement concerns discoveries made on company time using company equipment. I’ll argue that I discovered Ultra on my own time, which is technically correct although I’ve done the preliminary separation and synthesis on company time. Anyway, the bottom line is that I’m not afraid of some legal harassment. After all, Harvard doesn’t own me.”

“How about the development period?” Stanton asked. “How much shorter do you think you could make that?”

“A lot,” Edward said. “One of the things about Ultra that has impressed me is how unbelievably nontoxic it appears to be. I believe this fact alone will make FDA approval a breeze since characterizing specific toxicities is what takes so damn much time.”

“So you’re talking about getting FDA approval years sooner than the average,” Stanton said.

“Without doubt,” Edward said. “Animal studies will be accelerated if there’s no toxicity to worry about, and the clinical portion can be collapsed by combining phase II and phase III with the FDA’s expedited schedule.”

“The expedited plan is for drugs targeted for life-threatening diseases,” Kim said. From her experience in the SICU she knew something about experimental drug testing.

“If Ultra is as efficacious for depression as I think it will prove to be,” Edward said, “I’m confident we can make a case for it in relation to some serious illness.”

“What about western Europe and Asia?” Stanton asked. “FDA approval is not needed to market a drug in those areas.”

“Very true,” Edward said. “The USA is not the only pharmaceutical market.”

“I’ll tell you what,” Stanton said. “I can easily raise four to five million without having to give up more than a token amount of equity since most of it would come from my own resources. How does that sound?”

“It sounds fantastic,” Edward said. “When can you start?”

“Tomorrow,” Stanton said. “I’ll start raising the money and organizing the legal work to set up the corporation as well as to start the patent applications.”

“Do you know if we can patent the core of the molecule?” Edward asked. “I’d love the patent to cover any drug formulated with the core.”

“I don’t know, but I can find out,” Stanton said.

“While you’re seeing to the financial and legal aspects,” Edward said, “I’ll start the process of setting up the lab. The first question will be where to site it. I’d like to have it someplace handy because I’ll be spending a lot of time there.”

“Cambridge is a good location,” Stanton said.

“I want it away from Harvard,” Edward said.

“How about the Kendall Square area?” Stanton suggested. “It’s far enough away from Harvard and yet close enough to your apartment.”

Edward turned to Kim and their eyes met. Kim guessed what he was thinking so she nodded. It was a gesture imperceptible to the Lewises.

“Actually I’m moving out of Cambridge at the end of August,” Edward said. “I’m moving to Salem.”

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