The Delta Factor (15 page)

“I think I see,” the congresswoman said, raising her half-moon eyeglass and inspecting a page of notes on the table before her. “One further question, please. You stated that you considered your product to be a possible alternative to monoclonal antibodies. Could you please elaborate?”

“Sure. Monoclonal antibodies are on the leading edge of antiviral research,” Deborah said, warming to her discussion. “Mono means single; monoclonal means cloned from a single cell. Viruses themselves have DNA or RNA cores. Then they usually have protein shells surrounding this, but not always. They may have lipid layers. They may be round or square or triangular or octagonal. They are incredibly diverse. The molecular shape of these cores and exterior shells can usually be identified by a specific antibody. These identifiable shapes are called antigens. When we make a monoclonal antibody, we are fashioning a molecule that will go in, identify a specific antigen from a specific virus, and attach itself to it. Then the antibody is absorbed by the virus and destroys it.”

The congresswoman was nodding and taking notes. Deborah felt more in her element. There was nothing that got her going quite like a student who truly wanted to learn. “In monoclonal work, every time a new virus is identified, a specific antibody is designed to combat that particular ailment. Specific to the point of designing new molecular chains and adapting genes inside the body's immune system to identify that new danger. But there are problems.”

The congresswoman looked up from her note-taking. “The more specific you become, the greater the risk that something will do an end run.”

“Exactly,” Deborah agreed. “This is the problem with AIDS, and we think with a lot of other viruses. They adapt themselves to the body, and they
change
. So the immune system is taught by these new monoclonal antibodies to attack something that then masks itself by changing its molecular shape. And there is the additional problem of very severe contraindications, or possible adverse reactions when taken.”

“And those are?”

“The majority of these new drugs have a slew of contrandications,” Deborah explained. “The list of cautions and warning statements included with their packaging may be several pages long. Interleukin-2, for example, is a drug known to actually kill about four percent of the people who take it. But this is the only known treatment for several terminal cancers. So the drug was licensed for limited use. The majority of these new monoclonal antibodies are very toxic in their own right. Thus the research on these new molecular shapes has been limited to the deadliest of diseases, where any progress is welcome, no matter how risky.” She shook her head. “I decided to go in a different direction.”

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.”

“Likewise,” 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.