by Thomas Locke
The congresswoman rewarded her with an approving look. “I am sorry I did not have you for freshman biology, Dr. Givens. I think I would have enjoyed it a great deal more than I did.”
When the room quieted once more, Congressman Larson pointed with his gavel to the dais’ opposite end and said, “The chair now recognizes the distinguished representative from Ohio.”
“Dr. Givens,” the florid-faced congressman boomed, “did I correctly hear you state that you do not know how your drug works?”
“That is correct.”
“Forgive my ignorance, Dr. Givens, but doesn’t that bother you? I mean, if I were to take a drug, I would most certainly like to know why.”
“Sometimes it’s just not all that necessary to know how a particular result is achieved. That it works at all, and works well, is enough for the moment,” Deborah replied. “For example, there are three new epilepsy drugs out—felbemate, camotrigine and gabapentin. We think the first blocks chemical-electrical brain signals, and we think the other two stimulate production of natural chemicals that calm brain activity. But we don’t know. All we know is that they work incredibly well, and work for patients who have been unresponsive to previous treatment. For the moment, that is enough.”
“And the same is true for your drug?”
“In a sense, yes. Great chasms exist between what is known and what is not known about the immune system. Even greater problems exist in identifying and attacking specific viruses. Perhaps by identifying these compounds that appear to strengthen the body against the viral attack, we will come to understand both better. In time, anyway.”
“Thank you, Dr. Givens,” Congressman Larson intervened. He glanced at the wall clock, then pulled the slip of paper from his pocket and said, “Before we recess for lunch, I would like to pose one question myself.” He unfolded the paper and said, “Dr. Givens, in your opinion, has the FDA’s ever-growing hunger for more and more paperwork hampered your company from delivering this most important new product to the sick and dying of our nation?”
Deborah did not know which startled her more—that the question was asked at all, or that it had been asked at the apparent request of Whitehurst. “Naturally, I would like to have our products released as swiftly as possible. But we are still in the very early stages—”
The gavel’s rap was so unexpectedly loud that Deborah actually jumped. “Thank you, Dr. Givens, for a most erudite discussion. This hearing is now adjourned until two o’clock.”
9
“None of this makes sense,” Ralph Summers declared when Cliff finished describing the subcommittee hearing. “Why on earth would Larson begin baiting us on this one now?”
It was nine o’clock Friday morning. The three of them—Sandra, Cliff, and Summers—were seated in the small conference room adjoining the director’s office. Sandra offered, “Maybe they wanted to start preparing the groundwork for a major assault.”
“I don’t see how,” Cliff declared. “Pharmacon is at least a year away from starting phase-three testing. That makes it another two, maybe even three years before approval. By that time whatever happens now is going to be long forgotten.”
Sandra responded to Cliff’s observation with a smoldering gaze. Cliff offered a small smile, which inflamed her further. He wondered once more if he had made a mistake in not telling Summers the real reason behind Sandra’s attitude.
Sandra had never been married. She claimed to like playing the field too much to settle down. And Sandra was proud of her ability with men. So proud, in fact, that she relished Mondays as the day to impress the girls in her office clique. Sandra liked to saunter into the offices after a weekend and respond to her friends’ questions with exaggerated sighs and lots of eye rolling.
A certain type of man, Cliff was sure, would find Sandra at least challenging and possibly attractive. But not him. And that was the genesis of the problem.
During Cliff’s first week at the office, Sandra had smilingly propositioned him. Cliff had responded politely. The second week, she had put it more bluntly. Cliff had held himself in check and given the same polite response.
The third time he had snapped back that he was not interested. Not then, not next week, not ever. The hostility had begun that same afternoon and never let up.
Cliff had often thought of going over Sandra’s head and claiming sexual harassment, but was stopped by the utter foolishness of it. For one, who would believe him? A woman could claim it, sure; harassment charges were part of the modern-day office culture. But a guy?
He could just hear the cafeteria chatter now. Hey, why didn’t he just go with the flow, take advantage of a good thing? Principles? Did he really say it was principles? Hey, let me borrow your dictionary, I got to see what this guy is talking about.
Ralph Summers remained bent over a notepad doodling, his brow furrowed, and missed the exchange. “No, I’d have to agree it is highly unlikely that they would open an attack this early. Unless, of course, they have been carrying on further tests we don’t know about.”
“Not a chance,” Cliff said. “Debs would have told me. They’ve got clinical trials on a grand total of fifty-six patients.”
“You’re so close to this friend,” Sandra sneered, twisting the last word, “that you can take her word on something like this?”
“Yes,” Cliff replied calmly. “I am.”
Summers raised his head, looked from one to the other, and started to say something, then simply shook his head and returned to his doodling. “How about a sideswipe? Are you working on anything controversial?”
“Nothing more than usual.”
“Any contested holdups?”
Cliff mentally ran through his list of projects, decided, “Nothing that they could sensibly make an issue of.”
“What about you, Sandra? Been anywhere close to the vitamin problem lately?”
“No,” Sandra answered. “I leave it to Cliff to stick his nose where he doesn’t belong.”
Summers slapped down his pen. “Is there any reason why you two can’t get along?”
“Not from my side,” Cliff said.
“I prefer to spend my time working with professionals,” Sandra snapped.
“All right, that’s enough.” Summers rose to his feet. “I’ll have to pass this along upstairs, see if they can make anything of it. Are you talking with Dr. Givens anytime soon?”
“I was planning to go back down to North Carolina this weekend.”
“Bad idea,” Sandra threatened. “Very bad.”
Cliff addressed his words to the director. “It seems to me that further contact at this point could only help. If we’re going to stay on top of this, we need up-to-date information.”
“I tend to agree,” Summers replied.
Sandra slammed her notebook closed, gathered her papers, and stormed from the room.
His eyes on the door, Summers said, “You know, I can’t help you if you won’t talk to me about whatever it is that’s going on here.”
“I’ll think about it,” Cliff said weakly and left.
He walked the hall arguing with himself, only to come up time and again with the one undeniable fact. He was ashamed of the whole thing. And going public would only make it worse. Much worse.
Cliff was almost to his office before he realized he had forgotten to mention Tuesday’s other curiosity. He debated going back, then shrugged and walked on.
As he had left the subcommittee hearing room after Deborah’s presentation, a tall scrawny man with a rooster’s comb of red hair had come up and declared, “Hey, this is great, you just saved me a trip to Rockville.”
“I’m sorry,” Cliff said, searching the corridor for Deborah and seeing only strange faces milling about. “I don’t—”
“Dr. Wendell Cooper,” the man offered. “President of the Health and Medicine Advisory Council. And I believe you are Cliff Devon of the FDA.” He stuck out his hand. “A great pleasure to meet you, Cliff.”
“Likew
ise,” he mumbled. Deborah was nowhere in sight. She must have left before he could escape through the crowd pushing for the chamber’s single door.
“Yeah, I had planned a special trip up to Rockville this very week just to have the pleasure of making your acquaintance, and look what happens. Here, let me give you my card.”
“Thanks,” Cliff said. “I’m afraid I don’t—”
“No problem. I already know who you are. Yeah, I got your name from a mutual friend. The infamous Tweedie.”
Cliff looked up. “Horace Tweedie?”
“Hey, could there really be two guys with a name like that?” The man’s laughter rang up and down the corridor. Attention turned their way. When their faces were not recognized, focus drifted elsewhere. “Anyway, we’re a new advocacy group working with concerned citizens on health care related issues.”
“Uh-huh.” Since health care reform had surfaced as a hot topic, the number of lobbyists working the issue had exploded.
“Hey, I know what you’re thinking. Listen, we’re not like the others. No, really. We’re mostly scientists. We’ve set up our own labs, and we’re working on concerns that parallel your own.”
An advocacy group that did medical research was a new one. “Where do you get your funding, from the AMA?”
“Sure, sure, we’ve got backing from every place under the sun,” he replied cheerfully. “What I wanted to say was, if you ever run across something that really raises the red flag, we’d be happy to check it out for you. Confidentiality guaranteed, and no strings attached.”
“The FDA does no research of its own,” Cliff pointed out.
“Right. That’s why we’re not in conflict, see? We’d just like to be in on any major concerns that pop up.”
“I don’t think I’ve ever heard of the FDA working with an outside organization not actually connected to drug development.”
“Great, great, we can call this a major breakthrough, then.” The tall man stuck his hand out a second time. “Just remember to give me a call if anything happens to come up, okay?”
* * *
Cliff barely made it in the door before Madge said, “Call just came in for you. Line one.”
“I’ll take it in my office.” He walked in, shrugged off his coat and tossed it in the general direction of a free chair, picked up the phone. “Devon.”
“Isn’t it great to have a friend to call,” the voice on the other end said, “when the world starts falling apart?”
“Hey, Debs.” He reached over and kicked the door closed. “Great timing. I needed a little cheering up.”
“Then maybe I better call back later.”
“Why, what’s the matter?”
“Things are bad, Junior.”
“How so?”
“‘B’ as in beastly, ‘A’ as in awful, ‘D’ as in disastrous. Real bad. Can you get down to Edenton?”
“I assume I should treat this as an emergency.”
“I would say,” Deborah said, “that just about sums it all up.”
Cliff checked his calendar and said, “I’ve got a relatively clear day and plenty of leave coming. No reason I couldn’t take off now.”
“It would help a lot to have you around,” she said.
“Then I’m on my way,” Cliff replied.
“If you can get down before six, come straight to the lab. And Junior—”
“Yes?”
“If anybody up there asks where you’re going,” Deborah told him. “Lie.”
“Too late,” Cliff said. “I’ve already mentioned where I was headed.”
“Then just come, okay? And hurry.”
* * *
James Whitehurst strode into Harvey Cofield’s outer office. Normally he took time for a verbal pass at Blair, something to the effect that the environment in his office was much more stimulating now that she was working here. Blair Collins was one trophy he had no intention of allowing Harvey Cofield to keep. But today all he said was, “He in?”
“All by his lonesome,” Blair replied, not looking up from her console.
Whitehurst pushed through the door and said, “This friendship between Devon and Givens is growing very dangerous.”
Cofield’s eyes narrowed. “What are you talking about?”
“He’s coming down here again today, for the third weekend in a row.” Whitehurst flung himself down in a chair and scowled. “I didn’t even hear it from her. I’ve just spoken to Devon’s superior, a woman by the name of Sandra Walters. She’s no happier about it than I am. Devon simply took a day’s vacation. I checked with Givens. She confirmed he was expected here later this afternoon. She said she saw no need to inform us, since we had okayed his first visit. Did you know he had returned last weekend as well?”
“No.” Cofield’s eyes narrowed. This was all news, and dangerous news at that. Scientists were notorious for throwing roadblocks in the way of bringing new products to market. Their ears were deaf to the ticking of the profit clock. “Have you asked her why?”
“Yes,” Whitehurst sniffed. “She said they were just two friends getting together and it had nothing to do with Devon’s regulatory work.”
“I don’t believe that for an instant,” Cofield snarled.
“Nor I.” Whitehurst was on his feet again, pacing the carpeted expanse. He stopped abruptly. “On second thought, perhaps we should allow this visit to go ahead.”
“But this is highly irregular,” Cofield protested. “What if she passes over information that we don’t want the FDA to have?”
“The time is almost ripe,” Whitehurst replied. “Why not turn this to our advantage and strike now?”
* * *
There was no levity when Deborah met him at the entrance door to Pharmacon’s lab. “Thank goodness you’ve arrived.”
“What’s the matter?”
“No time, no time.” She led him through the first pair of automatic doors and said to the guard, “You remember Cliff Devon. He’ll need another three-day pass.”
“Sure, he’s down okay. Have to ask you to go through the routine again, sir.”
“No problem,” Cliff said, sobered by Deborah’s mood. He placed his hand on the scanner, repeated the voice identification sentence, accepted the card, and followed her into the hall. “What’s the matter?”
“Somehow Whitehurst caught wind of your visit and insisted on this meeting,” she replied, leading him urgently down the hall, her voice tight, “For both our sakes, whatever it is they say, answer yes.”
“Cliff Devon!” James Whitehurst rose from the conference table and walked forward, smile and hand extended. “How great to see you again.”
“Likewise,” Cliff said, trying hard to match the man’s false friendliness. “How are things?”
“Couldn’t be better. Come on, have a seat right here. That’s it. Get you anything?”
“I’m fine, thanks.”
“Hey, that’s swell. What say we get right down to business?”
“Fine.”
“Splendid, splendid. Look, Cliff, we’re growing concerned with the holdup over the echin drug approval.” His gaze turned sorrowful. “We feel like we’ve gone out of our way to supply everything your people have requested, and yet we’re not receiving very much in return.”
“A great big zip,” Harvey Cofield growled. “And it’s getting under our skin. Seems to me like it’s about time—”
“Harvey, please,” Whitehurst soothed, “Devon here is on our side, I’m sure. Aren’t you, son.”
Cliff was far too baffled to be angry. He opened his mouth to ask, approval for what? Then he caught sight of Deborah’s worried frown across the table, and changed his reply to, “I’d certainly like to be.”
“Hey, didn’t I tell you?” Whitehurst beamed at all and sundry. “Devon here is willing to play ball. And let me tell you, son, we don’t forget our friends. Nossir, not us. Pharmacon always has room at the top for a bright young man in a hurry. Why, you just say the word and I’ll
have you flown up to New York to meet our chairman. He’s looking for a new assistant right this minute.”
“Just what exactly is it you need, Mr. Whitehurst?” Cliff asked.
Harvey Cofield barked, “An end to this bureaucratic stalling.”
“But we’ve just received the first preliminary trial data,” Cliff protested. “You can’t be thinking—”
“We’re under considerable pressure here, son,” Whitehurst said around his semi-permanent smile, “and it’s mounting every day. Between the press and these pressure groups representing the various ailments who want to start using our drug, why, it’s a wonder I get any sleep at all.”
“If you ask me,” Cofield snapped, “it’s time to go back up to Washington and light a few fires of our own.”
Cliff decided they had the good-cop, bad-cop routine down perfectly. “But you’re looking at two, maybe three years of testing before we can even think about granting full approval. Do you want to apply for a restricted license?”
“We want action,” Cofield demanded.
“Exactly,” Whitehurst soothed. “And we are delighted to give the FDA anything they require in order to have them act swiftly, aren’t we?”
Cofield muttered something to the effect that there was something else he wanted to give them.
“But what we don’t understand,” Whitehurst went on, “is why a tentative approval can’t be given while more clinical data is collected.”
“You did it with AZT,” Cofield snapped. “You can do it for us. And fast.”
“AZT was a drug dealing with one limited group,” Cliff pointed out, speaking as mildly as he knew how. “HIV positive patients were faced with the prospect of either trying this drug or dying. Echiniacin, on the other hand, is a product that will potentially be used by millions of patients—”
