by Rene Fomby
The handling of the Tylenol scare had long been the gold standard for crisis management. In October of 1982, seven people in Chicago fell dead after taking extra-strength Tylenol capsules. Some unknown person had tampered with bottles of Tylenol sitting on store shelves, replacing them with bottles laced with deadly cyanide. The maker of Tylenol, Johnson and Johnson, ordered an immediate nationwide recall of the drug, at a total cost of over one hundred million dollars. Even after determining that the cause of the deaths had nothing to do with their drug, J&J relaunched Tylenol with substantial retail discounts and a new triple-sealed tamper resistant package. J&J’s quick action not only saved Tylenol, but it also established the company as one of the most trustworthy firms in America.
“Well at least someone in this company has the balls to get something done for a change!” Boucher roared. “Good work, Wommack.”
“Yes, sir,” Wommack said, relief sounding in his voice. “Oh, and one other thing. We had the reps go to the victims’ homes and collect the bottles of tainted pills. They labeled each bottle separately and FedExed them back here to R&D. I’m told the labs are going over them right now to try and identify what might be wrong with the product.”
Boucher spun sharply to his left to glare at Robert Kelley. “And I get to hear that from Sales? Don’t you think that would have been an interesting little tidbit to share with us a little earlier?”
Kelly shrunk back like he had been physically hit. “Uh, sorry, sir. I was going to say something, but you cut me off when—”
“No more goddamn excuses out of you, Kelley. One more goddamn excuse and you’re walking. Do you get that?”
Kelley swallowed visibly and stepped back a little further, his legs pressing hard against the seat behind him. “Yes, sir. Sorry sir. And—as far as the returned bottles go, we ran a first round of assays with no results. The product looks perfectly normal on all of our lab tests, with trace impurities but nothing that should be causing the arrhythmias.” He looked down at some papers he was tightly clutching. “We’ve also taken a hard look at the manufacturing and packaging lots. It appears that all of the problem material is fairly new, manufactured approximately one month ago. Of course, given normal wholesaler stocking and stock rotation, that would make sense. It’s product that is just now hitting retailer shelves. Our next step along those lines is to check the newer lots still at the wholesalers to see if the problem was a one-off, or whether it’s ongoing. But until we actually know what to look for, what’s really causing the problem, running assays on the wholesaler inventories would be useless. That means the people at the point of the spear in this investigation are the lab rats.”
“Then you stay on ‘em night and day, Kelley. Double up the staff if you need to. I want the answer to all this on my desk like yesterday. You got that? Yesterday!”
Kelley nodded curtly, still pressed tightly against the seat behind him. “Yes, sir, I’ll put every person I’ve got on it. I assure you, it’s my top priority.”
“Then what the hell are you still doing here?” Boucher threw his pen across the room violently, where it buried its point in the wall for a second, then fell clattering to the floor. “For that matter, if none of you incompetent assholes have anything more to contribute to this discussion, then get the hell out of my face!” The entire room moved instantly to gather up their notepads and beat a hasty retreat. But Boucher wasn’t finished yet. “McCarren! My office, now! We need to put together a statement to hand out to the media to see if we can somehow pull this shit out of the fan.”
4
La Jolla
The unexpected phone call had him suddenly unnerved. Peter Boucher punched the button on his intercom. “Tell him I’ll be right with him.” He subconsciously adjusted his tie out of old habit, then drew a deep breath and picked up the receiver. “This is Peter.”
“What the hell are you trying to pull out there?” yelled the voice on the other end. “Was I not perfectly clear about all this? Are you intentionally trying to screw this whole thing up? Right now, when all the pieces are finally starting to fall into place?”
Boucher swallowed hard, working to calm himself. This was not a man who tolerated alternative opinions. “Sir, I thought my email was quite clear. This is just a situation that came up. I didn’t cause it, but I do have to control it.”
“Sounds like it’s got control of you,” the voice bellowed. “Sounds from this end that it’s got you by the balls, Boucher. Assuming you still have any.”
“Look, sir, I’ve got everyone working overtime to put a lid on all of this. Give me a week, and everything will be back to business as usual again. That I can promise you.”
“I don’t need promises, Boucher, I need to know that you’re well off camera by the time we hit our launch date. And I don’t care who you have to maim or kill to make that happen. Just get it done, or I’ll be personally handing your replacement a plate with your head on it. You got that?”
“Yes, sir, I understand.” Boucher wiped a hand nervously across his brow. “But might I add that this company has already poured almost a billion dollars into the project? And that almost every penny of that has been thanks to Allurea?”
“And every penny of that has been repayment for all the money I poured into buying that rathole of yours. So don’t give me any of that crap about what you’ve done for me. I don’t give a shit about any of that, Boucher, and you know it. Money isn’t gonna help us one bit if word gets out before we’re ready. If the press gets just one whiff of what we’re planning, then we’re done for, dead in the water. And you’ve got just about every news camera in the world trained right on your dick at the moment. So, I need you for once to keep everything zipped up and out of sight. You hear me? Get it locked down. Now!”
“Loud and clear, sir.” Asshole.
“And tell me you’ve at least got the pills ready. And you’ve got something lined up to get me those codes. Without access to those bank accounts, we’re left running on fumes.”
“That’s not going to be a problem. Everything will be ready by the end of the week,” Boucher assured him. “And one way or another, so will the Allurea mess. I’ll be packed up and out of here as scheduled.”
“Good. Then don’t screw this up. We’re coming up on our launch date, just a little over two months away now, and we can’t afford any more delays. For any reason.”
“I won’t let you down, Your Grace,” Boucher promised, getting no other response than a distinctive click on the other end as the caller abruptly hung up.
Boucher sat in thoughtful silence for a minute, his head sunk into his hands, when suddenly his phone rang again. Robert Kelley. He considered for a second just letting it go to voicemail. But it might actually be good news for a change. The idiot just might have figured it out, after all. He grabbed the receiver.
“Boucher here. What you got?”
“Yeah, Peter, this is Robert. My guys are all hard at work trying to figure out what went wrong, but we still haven’t made any progress. So I got to thinking, why not go back and take another look at the Phase IIs? See if we can isolate what may have caused the arrhythmia issues back then? Or even dig into the Phase IIIs? It’s worth a shot.”
Shit. Kelley was an even bigger idiot than Boucher had pegged him for. This had to be nipped in the bud. And now. “Listen up, Kelley. I need you to stay focused on the issue right in front of you, and not go chasing off down some rabbit hole looking for answers that aren’t there.”
“But … I’ve already located the backup files. We digitized them for the FDA submission, so it’s just a small matter for IT to pull them up out of data storage and—”
“NO!” Boucher had to fight the urge to throw his phone across the room. “Drop it, and I mean NOW!”
“But, Peter—”
“If you want another job somewhere else, then just say another word that isn’t ‘yes sir.’ You got that?”
There was a slight pause on
the other end. Then, in a voice that suggested Kelley wasn’t entirely convinced of just why he needed to drop that particular angle on the investigation, he relented. “Yes, sir. I’ll tell IT to cancel the request.”
“Good. Now get back to work. To the real work, for a change. And let me know the instant you find something.” Boucher reached over and hung up the receiver, hard and loud. This was a dangerous new development. He had pegged Robert Kelley in the past as a pretty bright and compliant guy, but now he was being forced to reconsider. No matter how many hints he dropped, Kelley just never seemed to catch on. And time was clearly running out on all this—the Allurea fiasco needed to be put to bed like last night. And now—taking another look at the Phase IIIs. A really bad idea. Some secrets just needed to stay buried.
5
Houston
Alden Lantanna had his palms pressed hard to the floor-to-ceiling window that made up one entire wall of his office. Off to the east of the city, he could see the last remnants of the thunderstorm that had dumped several inches of rain on the crowded streets below. Now that the storm had moved out over the gulf, most of the lightning was confined to the clouds themselves, lighting them up with sudden streaks of yellow and a persistent wet green glow.
“Okay, Larry. Labarum. What’s the story on them?”
“Not a whole lot to tell, boss. They’re privately held, so not much in the way of public filings to lean on. And even their ownership is a little murky.” Larry Bowser was standing across from Lantanna’s desk, flipping through a tan manila folder. “Seems they were originally out of Boston. A couple of Harvard Med doctors came up with a novel way to attack certain cancers, so they created a company to commercialize it. Which they named New England Pharmaceuticals.”
Lantanna snorted. “Not very original.”
“No, but of course, they’re doctors, not marketing geniuses. Anyway, they got to Phase IIs and ran short on money. That’s when a private pharma consortium named Crimson something or other out of Europe swooped in and bought them up. Moved the company to La Jolla and renamed it Labarum Pharmaceuticals.”
“Why La Jolla?” Lantanna asked, turning away from the window to face his second in command.
“Not sure, but there’s apparently a lot more traction these days in the Biotech Beach area of San Diego than back in Massachusetts. A ton of biotech brainpower had flocked to La Jolla, with all kinds of useful skill sets. One company in particular had just been bought up by Pfizer, and some of their scientists chose to stay put in California rather than pack up their families and move out to the East Coast. As it turned out, those scientists were some of the world’s top specialists in X-ray crystallography, and Labarum’s new owners needed that particular skill set to design their next generation of drugs.”
“X-ray crystallography?” Lantanna looked confused, a rare moment for him. “Catch me up on that, Lar. Isn’t that all about building molecules out of organic Legos?”
“Yeah, kinda sorta. The idea behind that technology was to bounce X-rays off an organic molecule—say, a virus you want to block—and use that to build a 3D model of the molecule. Using really powerful computers to do the number crunching. So Labarum thought they could improve on the potency of the anti-cancer agents they had bought from the Harvard doctors by fine tuning them at the molecular level.”
“And how did that work out? My understanding is that X-ray crystallography generally turned out to be a hit-or-miss proposition. Mostly miss.”
“You’re right,” Bowser agreed. “It was a terrific gimmick for convincing a group of unsophisticated investors to buy in on emerging biotechs, especially when they slipped on the 3D headsets and you walked them through how your drug might interact with a virus at the atomic level. But in the end, there were very few breakthroughs with that, and the cancer drugs Labarum bought wound up being no exception to the rule.”
“So, did they get a chance to launch them?”
“Not exactly.” Bowser examined his notes. “They got the drugs through Phase IIs, but it appeared they had little in the way of blockbuster potential. Nothing broad-spectrum, no multi-billion-dollar answers to pancreatic or colon cancer. Just another me-too drug that got thrown into the mix for the chemotherapeutic cocktail du jour.”
“So, sixty, seventy million dollars a year, tops.” Lantanna turned back again to watching the dwindling lightning display.
“Right. At best. So not even enough to cover the care and feeding of an oncology sales force. In the end, they were forced to out-license the drugs themselves to another oncology biotech.”
“So where did Allurea come out of all this?” Lantanna asked, running a hand through his hair.
“It seems Allurea was just a welcome mistake, boss. One of the cancer targets was designed to substantially increase the body’s natural immune response, to cause it to develop antibodies that were specific to the cancer cell they wanted to attack. But it wasn’t working all that well, so the designers at Labarum tweaked it to see if they could add a slight modification, a modification that wound up being very similar biologically to the anti-inflammatory mechanisms of several existing allergy drugs. As it turned out, that tweak was amazingly effective at shutting down the Immunoglobulin E production that causes the itching and swelling we associate with allergies. And it did so with a safety profile even more benign than existing drugs like Claritin.”
“Hmm. Same old song, different verse. Try to cure male pattern baldness, wind up with Viagra. Which, by the way, was very effective in taking men’s minds off their male pattern baldness.”
Bowser laughed softly at his boss’s observation. “Exactly. For all of the crowing we do about mankind’s brilliance, in the end almost all of our progress comes down to blind, stupid luck. What Edison called ‘one percent inspiration, ninety-nine percent perspiration.’”
“Right.” Lantanna walked across the room, stopping at a whiteboard. He picked up a blue market and wrote ‘Allurea’ on the board, underlining it several times. “I assume they cleaned up the molecule and took it through Phase IIs and IIIs, with no major hiccups.”
Bowser nodded, once again consulting his notes. “No hiccups that we could discover, at least. But you know how clinical trials are run these days. Hardly any of the lesser pharma companies wants to run a trial in the U.S. or Europe. Too much regulation and way too much visibility. So they ship the trials out to little backwater countries, countries whose governments are more than willing to be a little more flexible, as long as the money is good.”
“And if a trial starts to go south, showing safety concerns or low efficacy, they can simply declare a breach of clinical protocol and shut down the trial before any news of the problems leaks out.” Lantanna scribbled ‘monitoring’ on the whiteboard.
“Mm-hmm. That’s exactly what happens, all too often. They bury the evidence that the drug has problems, and only submit the studies with positive results. That almost never happens with Big Pharma—they have way too much to lose to play that game, and they have way too many good candidates in the pipeline to waste time on the losers—but with smaller companies like Labarum, there’s a lot of pressure to make every drug candidate a blockbuster. The alternative is to go bust themselves.”
“So tell me, Lar, why doesn’t FDA or the World Health Organization ride herd on any of this?”
Bowser rubbed the back of his neck lightly. “I think they honestly want to, boss, but the political pressure to produce cures for major diseases like cancer are just too great. As a result, the U.S. and Europe are continuously engaged in a relentless race to the bottom, to see who can deregulate the clinical trial process the fastest. As you well know, there was almost zero regulation of the industry before the Thalidomide disaster, and for a long while after that, FDA kinda operated on a cover-your-butt approach to drug approvals. Better to delay a drug’s approval than to let a mistake work its way through their little safety net. But pretty soon, Europe started approving a long list of drugs that h
ad been backlogged in the U.S., and then the domestic pharma industry applied not a small amount of pressure on Congress to cut through all the delays and expense of the so-called red tape at FDA. And all that resulted in the current sorry scenario, clinical trials being conducted in third world countries with little to no regulatory oversight.”
Lantanna listened to all that while nodding his head and tossing the blue marker lightly in his left hand. Finally, after a short pause, he looked up, apparently having made up his mind about something. “But in the end, Allurea has been subjected to the best clinical trial of all. Labarum has managed to do the impossible, launch a brand new drug into a crowded marketplace, and climb to a forty percent market share almost overnight. And that means tens of millions of people taking the drug every day, with precisely zero side effects up to this point. So what changed?”
“I guess that’s the million dollar question boss,” Bowser answered. “Or, more precisely from our perspective, the ten billion dollar question.”
6
La Jolla
The last week had been the longest of Robert Kelley’s life. He had doubled the staffing in the labs and had them up and running twenty-four hours a day, but they still didn’t have a clue as to what had caused all the deaths. Seven hundred at last count. And climbing.
It was well past eleven when he finally arrived home. The lights were off, except for the under-cabinet lights in the kitchen and a night light they kept on in the upstairs hallway. After making sure that all the doors were locked and deadbolted, he decided to undress in the kitchen before making his way carefully up the stairs and down the hall to the bedroom. His wife, Anne, was already dead asleep, and he could just hear the soft rattling of her faint snores, a sound he had hated when they were first married but had come to adore over the last thirty-one years.
