by Rene Fomby
“Without going into the exact chemistry of the manufacturing process for Allurea—a topic that would likely keep us here for weeks—I want to focus on one building block molecule in particular, one Lego, the nonpolar, aliphatic amino acid Alanine, part of a larger molecule we sourced out of a pharmaceutical manufacturing facility just outside of Beijing. Working our way back through our supply chain, it appears that something happened during the manufacture of one particular batch of Alanine to flip the molecule from the left handed version, L-Alanine, one of the most common amino acids in nature, to the right handed version, D-Alanine. This most likely occurred when the Alanine was first synthesized by the reductive amination of the alpha-keto acid pyruvate, probably due to some type of contamination in the pharmaceutical vats at the plant. As it turns out, the very next step in the manufacturing process involves linking this molecule to another building block, and that’s where everything suddenly went haywire with the process, with the problems starting to cascade. And thus, by the end of the manufacturing process, you ended up with a final molecule that was almost identical to Allurea, but with one important little twist.”
Once again, McCarren advanced the slides. “So, here you have good Allurea and evil Allurea. Almost identical twins, sitting side-by-side in the bottle. By itself, that tiny bit of difference would normally be pretty neutral, and the modified version of Allurea would probably be just a somewhat less effective form of the drug. But the human body has other plans. It appears that when evil Allurea is metabolized by the human body, it cleaves into two separate molecules that are vastly different from the metabolized version of good Allurea.”
He clicked to one final slide. “The right side half-molecule is a type of complex sugar, and has no real impact on anything. But the molecule on the left side is a very dangerous toxin that has a specific preference for cardiovascular muscle tissue. In small amounts it can cause severe arrythmia, and in larger quantities it can cause the heart to stop altogether. And that, ladies and gentlemen, is the killer molecule we’ve been searching for since all of this first popped up.” McCarren’s eyes swept across the sea of upraised hands. “Yes, Michael Kirkpatrick.”
Kirkpatrick glanced down at his notes, then quickly back up. “Josh, my understanding is that this drug was taken by several million people that morning. But only a few thousand actually died. Why is that?”
McCarren nodded. “Right, Larry. Well, there are two reasons for that. And by the way, I think all of us in this room, and in this company, are very grateful that so few people were actually affected by any of this. It could have been a lot worse. Much, much worse. But, first, thankfully, only one particular batch of Allurea was impacted, so only those patients who had just received a bottle from that batch were exposed to the contaminated drug. Second, it appears that only a specific genetic subsection of the population metabolizes the drug in this particular way. Everyone else either produces two inert proteins, or at the worse a less toxic version of the killer protein. That second group probably composed the larger number of patients who got sick but quickly recovered. Helen?”
“Helen Angleton, USA Today. So, now that you know what happened, what’s next? What are you going to do about all of this?”
“Yes, Helen. Glad you asked that.” McCarren took another sip of water and consulted his notes. “First off, we are putting a new quality control process in place to make sure that nothing like this ever happens again. We won’t ship a single bottle of Allurea until we are absolutely certain the product is completely safe and effective. Second, even though, from a legal perspective, I’m told that Labarum itself has no liability for what happened, the company has decided to step up and create a fund for the victims of this disaster. Acting Vice President of R&D Claire Johnson herself will be heading up that effort. More details to follow.”
The room immediately exploded with sound. Grant Edam was closest and managed to get his question heard. “What do you mean, acting vice president? What happened to Robert Kelley? Was he fired over all of this?”
McCarren drew a deep breath. This was a topic he would have desperately liked to avoid, but now he had to pay the price for his accidental slip-up. “No, unfortunately, Dr. Johnson is taking over temporary responsibility for R&D because Dr. Kelley was found dead at his home yesterday morning, the victim of an apparent suicide. He had reportedly been dealing with problems at home with his marriage, and that, coupled with the stress from all of this, must have taken its toll. Needless to say, all of us here at Labarum are deeply saddened by our loss, and we wish his family, particularly his daughter Melissa—who walked in and discovered the body—all of our prayers and support in the days and months going forward.”
That admission seemed to suck all of the air out of the room, and McCarren took that as an opportunity to close up his notes and slip quietly out the side door.
14
Houston
Alden Lantanna had just finished watching the Labarum press conference for the third time, and finally shut it off, throwing his television remote down on his desk with disgust. “So, Larry, where does all this leave us with the case?”
Larry Bowser shook his head slowly. “Boy, I wish I could tell you otherwise, Alden, but I think this case has about as much chance of slipping past a defendant’s summary judgment as a cat has hissing at a dog convention. Maybe less.”
“Yeah, I’m with you on that. Particularly now that the Chinese company has come forward with the mea culpa. We can’t really sue them in China, and the Chinese government adamantly refuses to honor judgments from the US courts. So we can’t win in their court, and we can’t collect in our court. That leaves us with one helluva case but no way to get paid.”
“Plus, the Chinese company doesn’t have two nickels to rub together—or whatever passes for nickels out there—so even if we could get to them, it’s gonna be just sucking on a dry hole,” Bowser noted. “You sure we can’t still go after Labarum?”
Lantanna rubbed a hand slowly across the top of his thinning scalp, anger and frustration showing clearly on his face. “Nope, I’m afraid not. Not unless we’ve got something that proves they knew about the problem, or should have known to look for the contaminated product in the first place.” Lantanna picked up the Labarum file and tossed it into his out basket. “And that, my friend, is something any pharma company worth its salt knows how to avoid, just in case. They built themselves a Chinese wall, pardon my pun. So it’s kinda like the situation with the car companies and the faulty airbags. People get themselves seriously injured, and the victims just wind up getting victimized once again by the system. Thank you, Lady Justice. You are quite blind, indeed. Blinded by all the money, unfortunately. Same old song, just a different verse.”
“So what’s our next move, boss?”
“I don’t see that we have any real choice in the matter, to be honest. We’ll have to do our due diligence, of course, just to be sure. But in the end, we’ll probably just send out a letter to all of the feeder attorneys who forwarded us their cases, saying thanks but no thanks, we’ll see you around. I’ll get Bonnie to put together a press release explaining why we’re backing out of the lawsuit. And, by the way, let’s make sure to give Big Pharma a black eye over this whole mess while we’re at it.” He looked down dejectedly, playing absentmindedly with a silver pen lying on the desk before him. “Then, I hate to say it, I guess our next move is to lay off a bunch of people and hunker down for the next big thing. Unless we can somehow get some traction out of that Russian knee replacement case.”
“Well, Alden, it’s been great while it lasted,” Bowser said as he grabbed the file off the top of the out basket to give to an assistant to file away. “There’s always next time.”
“That’s the great thing about this business, Lar,” Lantanna agreed. “No matter what happens, there’s always a next time.” He wadded up a sheet of paper containing his notes from the press conference and tossed it at a waste basket across the room, just mi
ssing. “Of course, all that’s assuming you can manage to keep the lights on while you’re waiting. So I guess that brings us back around to the subject of layoffs.”
15
La Jolla
Acting R&D Vice President Claire Johnson had no idea why Peter Boucher had called and ordered her to his office. Immediately, he said. A new distraction she really didn’t need, given the fact that she barely had enough time in her day to eat or sleep. Now that the source of the contamination of Allurea had been located, her people were still pulling double shifts to sign off on the purity of every single batch that left manufacturing. And given the fact that so much of the product had already been sidelined and subsequently destroyed by the recall, that meant a lot of new batches.
But, considering all that had taken place over the last few weeks, events that had pushed her predecessor into taking his own life, she could be forgiven for being just a little wary of her boss. And the unstated reason for this meeting. As she stepped into his office, urged forward by his assistant outside, Boucher stood and impatiently waved for her to close the door, pointing to a seat in front of his desk.
“So, Johnson, what do you know about LP386?” he asked, seemingly out of the blue.
“Just the general info,” she answered, suddenly confused. “It was developed as an anti-anxiety drug, with some potential to also address schizophrenia, but it wound up being far too potent. Even when we titrated it down, the side effects far outweighed any clinical benefit patients could get from the drug. So now it seems to be permanently stuck in Phase I. There’s just not a market out there for the drug that justifies the cost of full-scale Phase II clinical trials.”
“Yeah, well, that’s right, as far as it goes,” he agreed. “But there may be some applications for the molecule that work well outside of the normal clinical box, applications that I’m currently exploring with several, let’s say, government agencies. And that means I’m going to need you to round up our entire clinical supply from our Phase I stocks, as much as you can lay your hands on. Plus a smaller sample of, say, ten to twenty capsules, stuffed in a pill bottle. You can have that bottle sent straight up to my office, and have the rest waiting down at the docks for pickup.” He looked away from her, studying a piece of paper on his desk. “I’m afraid I’m going to need all that done by the end of the day. I’m heading out first thing tomorrow morning for a meeting in Washington, then I have to spend a few days at a pharmaceutical conference in Vegas. Where I’ll be joining up with some folks who’ve indicated a pretty strong interest in moving forward with the drug.”
“But—I’m afraid I can’t do that, sir,” she protested. “Releasing clinical trial samples like that is highly irregular. FDA would be on us in a heartbeat, wanting to know what we did with it. And wanting to see the prescription or physician sign-off that backed up its release.”
Boucher scowled and sat back in his chair, staring at her for a long moment. “The FDA isn’t a problem here, Johnson. Let’s just say there are parties involved that trump FDA’s authority over whatever happens with the drug.”
“But sir,” Johnson said. “In its current clinical state, the drug is functionally useless. The side effects, the nausea and vomiting, not to mention the headaches and memory loss, they’re far too dangerous to risk in any Phase II trials. And the dosing—just one tablet would render a patient almost comatose, and an overdose could very easily be fatal. Plus, as you know, our test subjects became dangerously compliant to suggestions after being dosed with only half a tablet, almost as if they had been hypnotized, and then woke up the next day with absolutely no memory of what had happ—” She stopped, suddenly aware of what he was suggesting. “You don’t want to use the drug for patients at all. You want it for—other purposes.”
“What I want it for is none of your business, Johnson,” Boucher growled. “And if you know what’s best for you, you’ll keep it that way. Just get me the damned bottles by the end of the day. Or find new employment. It’s as simple as that.”
Still, Johnson hesitated. The rules set in place by FDA for monitoring the use of experimental drugs were unyielding. Every single tablet had to be accounted for, and the penalties for ignoring those rules could be career defining. She stared at her boss for several seconds, uncertain of what to say, what to do.
“Johnson, unless you have something more you want to add, then get the hell out of my office,” he snarled, fixing her with a piercing, visceral glare. “And I expect to see that bottle in my office by mid-afternoon, and the rest of the lots on the loading dock, or I’ll come down to R&D and fire every damned one of you until I find someone who will make that happen. It’s your funeral, Johnson. And if that’s what it takes, I’m not going to be shedding any tears over your grave. Now get out.”
Funeral. Grave. Suddenly it all made perfect sense to her. Robert Kelley. He hadn’t committed suicide, after all. She’d seen him, talked to him that very same day when she showed him the book, and even though he was clearly upset about something, she knew him far too well to think that he was ready to kill himself. No, angry people might wind up killing someone, but rarely is it ever themselves. At least not at first. And when Kelley had left her office, he was headed in this direction …
She spun on her heels as quickly as she could and strode briskly out the door, not slowing down until she was well past the outer office and halfway down the hall.
Maybe she was imagining it. Maybe Robert Kelley really had gone home and taken a lethal dose of a neurotoxin he had somehow managed to sneak out of the lab.
But no. The pieces—some of them just didn’t fit. After all, why had he checked out the neurotoxin several days before he was found dead? And all that nonsense at the press conference about marital problems. No way that was true. All he ever talked about at the labs were his plans for the coming weekend with Anne, or the next trip they were taking together.
She could go to the police. She should go to the police. But all she had was speculation. There was absolutely no evidence to back up what she knew in her gut had to be the naked truth. And then she thought about Robert. Her friend. And the fact that, whatever had happened between Robert and Boucher, he had almost certainly been killed just to get him out of the way. To shut him up for good. Maybe because of the DVD he had slipped her just before he died. And if she wasn’t very, very careful right now, she might be the next in line.
The hallway was empty, and nobody had witnessed her storm out of Boucher’s office and race down the hall. Even Boucher’s assistant had been out of the office, apparently off running some kind of errand. She leaned back against the wall, catching her breath, steeling herself. She had to get back to the lab. Back to her job. And start looking for a new job right away.
But first, she had to sign God knows how many hundred-count bottles of LP386 out of Labarum’s clinical inventories. Xenophant. A date rape drug on steroids. A drug the CIA and FBI had clearly been wet dreaming about for years. One small dose and in minutes their target would be singing like a canary, then promptly pass out and remember nothing at all about the interrogation the next day. What did they care about side effects, when they were every bit as willing to waterboard their targets, or stick electrodes to their testicles? The end justifies the means. And now, ethically, she was little better than they were. She had signed off on the Hippocratic Oath when she graduated from medical school, and now she had to sign off on handing over this drug to a heartless band of criminals with absolutely no sense of right and wrong. But with bright, shiny badges that nonetheless made it all right and proper under the law.
Johnson had worked for Boucher long enough to know he wasn’t bluffing. About firing everyone, one by one, until someone agreed to release the drug. And probably, in the end, not shedding a tear over her freshly dug grave. Any more than the crocodile tears he shed when Robert turned up dead.
She stood up straight, took a deep breath, and took one small step toward her office. And then another. With each step
, her path became a little clearer. She had a husband. She had children. She had a mortgage, a mortgage that right now was upside down, ever since the SoCal real estate crash of 2008. She had bigger fish to fry than fretting over the rights of terrorists in Guantanamo. Like it or not, she had a job to do. She just needed to cover her tracks very well when she did it.
the partnership
16
Siena, Italy
Picking up and moving all the way from Central Texas to Central Italy at the drop of a hat wouldn’t ordinarily have been at the top of Samantha Tulley’s to-do list, but with her baby daughter becoming a billionaire almost overnight—and with all that money at great risk of evaporating into thin air, thanks to her father-in-law’s treachery—Sam found herself left with very few good options. The worst part of it was she had been forced to leave everything she knew and every friend she ever had way back in Texas—a life most of which was now reduced to nothing but ashes. Literally. And now, that meant the only real people she had left to talk to in Siena were her baby daughter and her dead husband’s well-meaning but overly-pampered mother. And once a week, a third-year law student back at Baylor University.
Drumming her fingers lightly on the desktop in front of her, Samantha Tulley checked her watch for the third time. Five minutes till. She glanced impatiently at the grape vines spreading across the Tuscan hills just outside her window, still several months away from harvest. A sight that used to bring her peace, a feeling that was becoming all too rare lately.
