by Thomas Locke
“Of course I have,” she said tenderly. “We’re friends, aren’t we?”
Another sigh. He lifted his head, spotted Cochise waiting patiently behind them, and said, “Get rid of the Injun. I got something to tell you.”
Deborah turned and said, “I’ll meet you in the lab.” Once Cochise had ambled off, she said, “Tell me what it is, Tom.”
“Let’s go outside,” the old man replied and pushed himself from the chair.
The air was blistering hot, the humidity bordering on 100 percent. Deborah followed Tom over to the shaded alcove by the entrance ramp and waited while the old man settled himself. He appeared in no hurry to speak. Despite her cloud of fatigue and the sweat that was already plastering the blouse to her skin, she forced herself to be patient.
“Done something I ain’t proud of,” Tom said finally.
She tried to make light of it. “Making mistakes is what keeps us human, Tom.”
But he wasn’t having any of it. “You ‘member the last time you was here? Went flying off in a chopper.”
“Of course I remember. You helped me with my chair.”
Tom squared his shoulders. “I took money from a feller. I’m broke, plain and simple. Owe money to just about everybody. Ain’t no way to grow old, sick and broke. This feller showed up and offered me money, and I took it, and that’s all there is to it.”
Deborah searched the old man’s face, a knot growing in her gut. “I don’t understand, Tom. What was it they were after?”
“Was a him, not a them. One man. Foreign feller. Don’t ask me where from, ’cause I don’t know. Never had much time for any of ’em. Wisht I hadn’t of this time. But what’s done is done.” The old man blew out his cheeks. “Told him what he wanted to know, sure enough. But I never said I wouldn’t tell nobody else.”
“Tell what, Tom,” Deborah pressed. “What were they after?”
Tom faced her, pain crying from his rheumy old eyes. He replied, “He was after you.”
* * *
“I’m still not sure it was a good idea to bring that Givens woman along,” Owen MacKenzie said when Whitehurst had rejoined him.
“I understand,” Whitehurst agreed. He turned his back to the throng and allowed his smile to slip away. “But you should hear Cofield make a presentation.”
“Not good?”
“Hopeless. He slips into this superman-scientist role and talks down to the world.”
“Not the image we need here,” the chairman agreed.
“Word is already out through the scientific community,” Whitehurst went on. “I’ve been checking. This kind of news spreads like wildfire. Everybody who’s anybody knows that Givens was behind the research. If we showed up here in public without her, we’d be tarred and feathered.”
“What about this friend of hers, the guy from the FDA?”
“Cliff Devon. Nothing to worry about. He’s barely a midlevel bureaucrat. Takes himself and his job far too seriously.” Whitehurst permitted a glint of steel to show through. “When we pop the lid on this one, there won’t be anything left of Devon but a greasy stain on the sidewalk.”
* * *
Cliff took Rockville Pike southbound to where it became Wisconsin Avenue, and fought traffic the entire way. The little stretch of road that joined Wisconsin to Massachusetts was a snarling tangle that took a good twenty minutes to navigate. Cliff gave himself two pats on the back, one for leaving enough time for the Washington passage, and two for driving his Plymouth—the Jag tended to become surly in traffic. Cliff bided his time by replaying the Saturday evening he had spent with Blair.
For some reason, her defensive barriers still had not bothered him. He barely knew her, and yet had shown her a depth and honesty rare for him. Very rare.
After dinner they had taken a walk along the bay, then returned to sit on the porch. Blair’s Aunt Sadie had long since gone to bed. They had sat in silence for a time, the rockers creaking a comfortable conversation for them. The night had soothed and caressed and invited warm intimacies.
After a time she had asked, “Do you like city living, Cliff?”
“It’s where I need to be to do my job. If I had my choice, I think I’d rather be here.”
That gave her pause. Then, “Do you love your work that much?”
“I feel like I’m doing something important. I feel like I’m good at it. As for the rest,” he shrugged. “I’ve made peace with myself a long time ago. It’s a shame that some others haven’t.”
“Like who, for instance?”
“Oh, my dad, for one. He’s a surgeon. Top digger at a big hospital in Chicago. It was always expected that I’d follow in his footsteps. Then when I got to college I realized there was more to life than boning for grades. These days, most of the people who make it to med school basically live for that and nothing else. I felt like life had a lot of other things to offer—puttering around with the Jag, making friends, enjoying life.”
Blair rewarded his honesty by reaching over and slipping her hand into his. Her fingers were cool, her touch as light as the breeze. “Was that tough for your father to accept?”
“Oh, Dad’s okay,” Cliff replied, achingly aware of her touch, yearning for more. “He just doesn’t have room for anything else in his world besides medicine. My kid brother’s just started his surgical residency. He has all the brains in the family. They get along great. But when I’m around, well, you can see both of them kind of floundering, trying to find something to talk about. Like, here’s good old stumblebum Cliff. Let’s be polite.”
“Stop that.”
“It’s true, I tell you. Silence descends on the room, and they make these awful comments about the weather or something equally warm and congenial, until I feel like I’ll explode if I stay there another minute. So I leave, and thirty seconds later they’re deep in discussion, as though I had never even been there.” He shook his head. “Yeah, going home is all laughs and good times for old Cliff.”
“Family,” Blair sighed to the night. “How can we love each other so much and still cause so much pain?”
Cliff turned. Streetlights gave her features a soft silver cast. He asked softly, “Who hurt you, Blair?”
There was a stiffening, a drawing away, before she forced herself to relax. The hand in his became cold. “Life,” she said, her voice flat. She stood up abruptly, turned, and gazed down on him with eyes that saw nothing but what she refused to reveal. “I think it’s time you were going, Cliff. Thank you for a lovely evening.”
* * *
“Debs!” Seeing her seated in the wheelchair gave him a lance of worry. “How are you doing?”
“Not near as well as I will be when this is over,” she replied. “But better now that you’re here. Thanks for coming.”
“No problem,” he replied, and covered the upsurge of emotions by examining the hall. “Would you get a look at this circus.”
Close to a hundred people swarmed the corridor outside the hearing rooms. Lobbyists buttonholed everyone in sight or stood in clusters and muttered among themselves. Journalists vied with one another to pressure incoming and outgoing congressmen and aides. The scene rang with self-importance. “It’s easy to tell which ones are here to testify,” Deborah said. “They’re the ones wearing lost expressions and wishing they were somewhere else.”
Cliff pointed to a group farther down the hall. “Who is that giving us the eye?”
“Don’t point. That’s my chairman.”
“The chairman of Pharmacon is here?”
She looked up at him. “I agree. A month into phase two and they’re already out in force. It’s strange. All of this is strange.”
Obtaining FDA approval for a new drug was a multiphase process. Including pretrial testing and development that had to take place before initial application, the procedure lasted well over five years.
After the initial analysis and synthesis, the new drug had to be tested in animals. A safe dosage for humans had to be worked out. I
nitial claims for benefits had to be developed and possible side effects—known as contraindications—established. And then a representative like Harvey Cofield would appear at the FDA offices, present reams of preliminary documents, and make the Investigational New Drug application. Only after the IND was approved could clinical trials on humans—and the actual FDA approval process—begin.
Phase one of the clinical trials usually involved between twenty and one hundred human subjects. This normally occurred over a three- to six-month period and concentrated upon safety. During this time, the medical doctor on the FDA team would conduct a safety review.
Phase two involved the first tests upon human subjects actually suffering from the ailment which the drug claimed to treat. This was where the detailed case studies began. Phase-two testing usually involved between one and three hundred patients and took something over one year. Phase three followed, with more than a thousand patients treated, and if the drug passed this hurdle it was approved.
On average, research and development and application for a new drug cost more than two hundred million dollars. For every drug that won FDA approval, nine were turned down. For the drugs that were approved, however, the payoff could be mind boggling.
Newly approved drugs had on average seven years left to run on their original patent. For those seven years, no other company was allowed to produce that drug, and prices could be set as high as the market would bear. For ground-breaking new medicine, the market could bear an enormous amount.
A new ulcer drug recorded first-year revenues of seven hundred million dollars. A new migraine drug cost seventy dollars for two doses and was expected to earn almost two billion dollars in the first eighteen months of its release. And so on.
Political and media pressure to accelerate FDA approval was commonly exerted, but usually not before phase-three testing had been underway for at least a year. Approval prior to this time was simply too dangerous. Until a drug had been tested on a large number of patients over a substantial period, there was too much risk of something going wrong, of some unforeseen side effect appearing. No drug company could afford to take such a chance.
To have political pressure applied so early in the approval process was unheard of. Yet there was no other reason for Pharmacon to appear before the subcommittee.
Cliff asked, “Can we get together after this is over?”
“Doubtful. They’ve got plans to sweep us away someplace or another as soon as we’re done.” Deborah motioned him closer. “There’s something I have to tell you.” Swiftly she related the conversation with Tom.
Cliff grew more alarmed with each word. “Foreign industrial spies?”
“It sounds that way.”
“Have you told the others?”
“I’ve tried. But right now they can’t think any further than being the next act in line here.” Out of the corner of her eye, Deborah saw a group of three congressmen exit the hearing room. She was scheduled to speak immediately after the morning break. Her heart rate accelerated. “I’ll pin them down this afternoon and lay it out.”
“You’ve got to be careful, Debs.”
“Are you kidding? Our building is tighter than a bank vault.”
“Yeah, but you don’t live there all the time.”
One of the congressmen, a handsome gray-haired man she recognized from somewhere, strode directly toward where Whitehurst and MacKenzie stood talking. Two aides were kept busy holding the journalists at bay. Whitehurst reached into his pocket and handed the congressman a note.
“Junior,” Deborah asked, “who’s that congressman over there talking with the suits?”
Cliff raised his head and snorted. “Larson. Congressman from Utah and head of the subcommittee you’ll be addressing. He’s no friend of ours. The FDA, I mean.”
The congressman read the note, kept nodding as Whitehurst bent his ear with a whispered discourse. For once, the VP was not wearing his smile. “Why isn’t he your friend?”
“Oh, his state contains a large number of vitamin manufacturers. Vitamins aren’t covered by the FDA, and they’re lobbying like crazy to keep it that way. Larson uses every chance he gets to toss grenades our way.”
“That’s right, I remember reading something about it.”
The congressman said something, to which Whitehurst replied by pointing in Deborah’s direction. She felt a chill rise as the three men started toward her. Larson called to an aide, who scampered over. The journalists saw the focus of their attention and realized there was someone potentially important in their midst.
“Looks like showtime, Junior. I’ll call you when I get back to the hotel tonight.”
“Debs—” Cliff was stopped by the descending swarm. They jammed around Deborah’s wheelchair, completely blocking him out. Cameras flashed continually as the congressman bent over and shook Deborah’s hand.
Cliff heard one journalist ask another in a whisper laced with whiskey and cynicism, “Who’s the crip?”
“Dunno,” came the muttered reply. “But if she brought Larson out of chambers, tomorrow she’s probably gonna be news.”
* * *
Despite her years of lecturing to classes far larger than this gathering, Deborah’s opening comments were delivered in a voice so shaky she doubted anyone could understand her.
Nothing could have prepared her for the pressure she felt as she addressed the subcommittee. The congressmen sat on a raised dais in front of her, their semicircular desk sweeping out and around the witness table. Congressman Larson occupied the central seat. Behind them, aides sat, stood, wrote, came and went, leaned over and spoke into the ears of the congressmen. Behind Deborah rose tier after tier of seats, all of them occupied.
By the time she completed her overview of the drug and the initial clinical trial data, she felt her heart begin to descend from her throat. Congressman Larson smiled. “Thank you for your remarks, Dr. Givens. I wish all of our experts could be as brief and succinct in their talks.” He paused as the audience tittered appreciatively. “I am sure several of my colleagues will want to take advantage of your clarity.” He looked to his left, nodded to a middle-aged congresswoman, and said, “The chair now yields to my distinguished colleague from Illinois.”
“Dr. Givens,” the congresswoman began, “I was wondering if I might ask you about some of the terms you used in your talk.”
“Sure.” Deborah found herself calming, steadying. She had spent most of her adult life dealing with students who did not understand.
“You mentioned that your compounds were naturally occurring, rather than biosynthetic, as though that were a problem. Did I understand you correctly, and if so, why is this an issue?”
“Biosynthetic drugs are manufactured in the laboratory,” Deborah explained. “Naturally occurring drugs are derived from materials found in the physical world. Pharmaceutical companies prefer to work with biosynthetic drugs. Aspirin, for example, was discovered first in the natural world, then eventually a means was found to manufacture it in the lab.”
“Why is that so important?”
“Because it’s easier, and eventually cheaper. With naturally occurring drugs, we have to find methods of purification to remove any harmful substances in the final product. Then we have to prove that we will obtain the same pharmacological response every time.”
“I beg your pardon?”
Deborah shifted to a lower mental gear. “We have to prove that the dose from this batch of plants will have exactly the same effect as the one from the next batch. We call it validation of the process, where every batch has the same purity and potency, time after time.”
“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,” D
eborah 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.”