After Levine and company had left the conference room, Harper sat down in the chair across from Morgan’s desk. She was puzzled by the whole situation, and she had to admit she didn’t know much about the actual procedure to bring a new drug to market. The research she had done for the antitrust litigation had really not gone in that direction.
Morgan picked up a binder with the protocols and test results from the Maxprotem trials and started to leaf through it. “I just don’t get this. There should be some results, but none of the subjects show any change in their blood work at all.”
“Explain the procedure to me—layman’s terms, please, just an overview.”
“Okay. Clinical Trial 101. Maxprotem is a drug currently in Phase II clinical trials. It’s a new drug that our researchers are testing for use in treating diabetes. We are hopeful that eventually it will be especially useful in treating children. In Phase I, it was tested on a small group of eighty healthy older individuals for the first time. In that phase it’s more about safety of the drug than the efficacy. We’re trying to determine the best way to administer the drug. Should it be injected or taken orally or topically? We also want to determine safe dosage ranges and identify side effects, drug interactions, and possibly allergic reactions. In Phase II of the trial, which we’re currently in, the drug is given to another small group of about one hundred older individuals that actually have the disease. The idea is to confirm the results of the Phase I trials and to evaluate optimum dosages. If the drug has been found to be relatively safe and seems to be effective, then we proceed with Phase III. The drug is given to a larger group of people, usually numbering in the thousands, to confirm the results of the Phase I and II tests to see if the results hold steady over a larger demographic and to see how it compares to other commonly used treatments. We want to collect more information about the drug’s risks and benefits, its effectiveness, safety, and side effects. Finally in Phase IV, continued studies are done after market to confirm the effects of the drug in different populations, and to monitor side effects linked to long-term use. Doctors and patients report any adverse symptoms or effects over time.”
“That could take years, right? And your company has to bear the burden of paying the cost of the studies, all the personnel, and other expenses involved.”
“That’s right. It can take up to fifteen years to get a new drug to market, including clinical trials that can last up to five years. There is currently some legislation that we are hopeful will streamline the procedure. In the event the trial is larger than we can handle in-house, we might outsource the trial to a contract research organization or a clinical trials unit at a medical school or university. I personally don’t like to do that unless it’s absolutely necessary, because we lose a measure of control once the trials go off the reservation.”
“And after all of that, the drug might still not be approved by the Food and Drug Administration. That’s a huge investment of time and money.”
“Yes, but when a drug makes it big, the rewards are also large, both in terms of eliminating human suffering and reaping financial rewards, that then go to fund more new research and more new drugs. It’s a cycle. We currently have several different drugs in our pipeline in various stages of research and development, as well as in clinical trials. We don’t like to have all of our eggs in one basket, so to speak. The biotech industry is very competitive—cutthroat actually.”
“So, what do you do before Phase I trials begin?”
“We put together the original research, diagnostics, therapy protocols, and animal trials—I know that concept is unpopular, but if your kid has diabetes or leukemia, the idea of animal trials is a lot more palatable. If the initial research is satisfactory regarding nonclinical safety, approval is sought from a regulatory committee of the FDA to begin human testing. The big argument right now is whether or not Phase II and higher participants should be given placebos or other drugs currently in use versus the new drug being tested. Some argue that the patients receiving placebos are at risk because they are not actually receiving any treatment for the disease in question. Others argue that giving drugs currently in use doesn’t give a clear picture of the effectiveness of the new drug.”
“Is this particular trial being conducted by Court Industries or by an outsourced provider, and is it placebo based?”
“In this instance, since we have several other trials ongoing at the present time, we outsourced the trial to a contract research organization. Some participants are receiving Maxprotem, and some are receiving placebos.”
Harper could already see some areas she would want to investigate in this scenario, but she had to think about it before making any suggestions to Morgan.
Chapter Twenty-One
Conference Room of Court Industries, New York City, Friday, November 22, 2013, 3:30 p.m.
Harper and Morgan had spent the remainder of Thursday and Friday immersed in drug protocols and clinical results reports. She had camped out in the conference room next to his office. So far nothing but the spectacular lack of results stood out to either of them.
Harper walked into Morgan’s office. “Do you think we could take a tour of the research facility actually conducting the trials? I would really like to see what goes on for myself.” She could see that Morgan looked even more upset than usual. “What’s wrong? You look…”
“Someone leaked a rumor to one of the trade magazines that Court Industries’ new diabetes drug currently in testing is not performing well in Phase II clinical trials. And some more insinuations along the lines that we are trying to put a substandard or ineffective drug out on the market—that the drug is actually making some of the participants sick.”
“Is it standard operating procedure to release that type of information so early in the trials? Have they contacted you for a comment? Can they publish that without substantiation?”
“No, that’s how I heard about it. I told them that Phase II is in its early stages, and nothing definitive has been determined yet. I let them know I wouldn’t be happy to read unsubstantiated allegations in the magazine and that my legal department would be all over it. It’s a cutthroat business. If a competitor can plant seeds of doubt that a drug is ineffective or unsafe, the rumors can kill its marketability or chances for FDA approval. I don’t know how anyone would come by that information at this stage in any event. This is all highly confidential information. No one should have access to anything like that at this point.”
“Then I definitely think a field trip is in order. What do you say?”
“The testing facility is out on Long Island. I think we should spend the weekend at my house in East Hampton, make a surprise visit to the lab tomorrow morning, and maybe spend some quality time at the stables. I haven’t seen Shadow and Ollie in weeks. My sister and the girls will probably be there as well, and you can meet some of my family.”
“That sounds good. Let’s plan on it. I’ll go home tonight when we’re done here and pack a few things.”
Morgan grinned for the first time in two days. “A few things? I’d like to see that.”
“Listen, wise guy….”
* * * *
Despite the worries currently clouding his mind, Morgan had to admit that having Harper at his side was a situation he thought he might want to make permanent. It was a pleasure to watch the workings of her clear thinking and analytical mind, and he could see that she might really be helpful in this situation.
Chapter Twenty-Two
Morgan Court’s Beach House, East Hampton, New York, Friday Evening, November 22, 2013
Morgan and Harper drove out to the island on Friday night. They arrived late, and after opening the house they had a glass of wine and went to bed. On Saturday morning, Morgan woke early, as had been his habit on board the Golden Dolphin. He pulled on a robe and walked out onto the deck off the master bedroom. The sun was just coming up. The pounding surf and the cold wind off the water were bracing. He padded barefoot downstairs to the kitc
hen, put on a pot of coffee, and took bagels out of the freezer. His housekeeper didn’t usually keep the refrigerator stocked during the cold months because of the likelihood of power outages during winter storms.
When the coffee had brewed, he carried a tray up to the bedroom. Harper was still asleep, and he took the opportunity to just watch her for a few moments. She was curled on her side with the blankets pulled tight to her chin. Her midnight-black hair was spread over the pillow and covering her face. He smiled. Sometimes she was like a little kid, and other times she was like a lioness. He was amazed at how much she had come to mean to him. The emotions just seemed to be wrapped around his heart, squeezing it tight. Love is a strange thing. It comes along at the oddest times—when you’re not looking for it and when you least expect it. He had been attracted to her and interested in her for a long time, but now he knew he was in love with her. With all the problems currently on his plate, this was not an opportune time to fall in love with a complicated woman like Harper, but he knew it was totally out of his hands. It was already too late. He had fallen, and he had fallen hard.
After putting the tray down on a table, he sat on the side of the bed and leaned over her. He brushed the hair out of her eyes and kissed her lips softly. She sighed and rolled over. Her eyes opened slowly, and she gazed up at him, looking slightly confused as to where she was. In the last few days they had slept on the ship, in his apartment in the city, and now his house at the beach. It was no wonder she was confused. “Hey, beautiful. I have coffee. Can I tempt you to get up? We’ve got bagels and not much else for breakfast. We’ll stop at the market in the village for provisions later.”
“Coffee is about the only thing that could get me out of this warm bed.” He handed her a robe as she sat up. She pulled it around herself before she stuck her feet out into the cool air. “Morgan, the door to the deck is wide open. No wonder I’m freezing.” She took the cup he offered her and gulped down a swallow with evident delight. He knew he had fixed it just the way she liked it. “Oh, good…coffee. You made it yourself?”
“Yes, I made it myself. I’m not totally incompetent, you know. I’m sorry about the draft. I was just watching the sun come up on the deck before I went down to make coffee. It looks like it’s going to be a beautiful day. Why don’t you dress for the barn—jeans, sweater, short jacket, and boots. It will make our unannounced trip to the lab seem more casual and nonthreatening. After we poke around a bit, we can go out and visit the guys, take a ride, maybe take Melanie and the girls to lunch.”
“Sounds like a plan. Care to join me in the shower?”
“Now that sounds like a plan.” He grabbed her wrist and pulled her off the bed and down the short hall to the master bathroom.
* * * *
Harper looked around casually. She hadn’t gotten a good look at the house the night before. She had the impression it was a big, rambling open-plan contemporary with high-ceilinged rooms. It had an earth-toned color scheme, mostly bare, highly polished wood floors, comfortable furniture, and some excellent art on the walls. It was elegant without being stuffy or overcrowded. It seemed to suit Morgan’s personality. She could see the gray-painted clapboard walls outside the glass doors overlooking the sea grass and sand dunes, and the pristine white trim of the deck railings. It looked beachy and lived-in.
The bathroom was a marvel of high-tech fixtures with floor-to-ceiling glass walls looking out onto the beach. The walls had privacy blinds sandwiched in between the sheets of glass. The shower was tiled in dark blue-green colored glass tiles with a mosaic design of a seahorse on the back wall that looked like it was made of tumbled beach glass. It was gorgeous. The floors were a mottled, sandy-colored tile that was heated from beneath. There was an enormous spa tub in the middle of the room that was raised up and accessed by two steps.
“Okay. See you when it’s time to go back to the city. I don’t think I’ll leave the bathroom all weekend.”
“How much detecting can you do from the tub?”
“You would be surprised.” She laughed as he pulled her robe off and yanked her into the shower. The water came on automatically at just the right steaming temperature. He obviously had it programmed to his preference for very hot water. “Morgan! You’re going to cook me.”
He kissed her deeply, parting her lips as the water crashed down on them like a waterfall from the ceiling, and she forgot about the hot water. She held her breath as he plundered her mouth. Finally she had to gulp in some air. His lips grazed her neck and coasted down over her breasts to her stomach. He boosted her up until her legs were wrapped around his waist, and she was braced back against the shower wall. He looked into her eyes as he entered her. The look on his face reminded her of a warrior about to take what he wanted—but no prisoners. His steel-hard erection pierced her like a hot knife through butter as he plunged deep, and she moaned her acceptance. He began to pump slow and easy as she met him stroke for stroke.
“Harder, Morgan. Faster.”
“You’re always in such a hurry, baby. I’m going to make this last.” The hot water continued to drench them as he pounded into her, gradually increasing his pace. She clenched around him, and her inner muscles milked his hard shaft. Finally, when she could not wait another minute, her orgasm washed over her like the rhythmic sound of the surf she could hear on the beach. He followed, and they both rode the crest of the wave to completion. She rested her forehead against his neck as her heartbeat steadied, and her breath came back to normal. He stayed in her tight sheath while waves of sensation continued to course through their bodies. Finally he let her feet come back to the floor. When she could stand on her own, he began to soap her body and shampoo her hair, paying particular attention to her aching breasts and singing pussy. She did the same for him, but was afraid they would never leave the shower if she gave his body the loving attention he was showering on her. She grazed over his still-hard cock as she looked into his eyes, and she ached to take him into her mouth. She now saw the tenderness in his expression. The warrior was gone, and her heart clenched. She saw love there. She just knew she did, and her heart opened to him. She knew she had to think about the feelings that were blossoming inside her.
After a few more minutes of basking in the afterglow, she said, “Babe, we’re getting pruny, and I have to blow-dry my hair. If we are going to get to everything we want to do today, we had better get out of this shower soon, or I’m not going to be willing to leave.”
“You’re the one who said you weren’t going to leave the bathroom…”
“Come on. Out.”
He just laughed at her as he said, “Half temp, water off.” She yelped as the water coming from the ceiling was suddenly cool and then shut off.
She shivered. “I will get you for that…when you least expect it.”
* * * *
Harmon Burke had spent the last several days following Court and Cameron back and forth from Morgan Court’s apartment building to his office building. He had been unable to gain entry at either location, and the doorman at the apartment building wouldn’t give him the time of day, nevermind the security guys who had threatened him with bodily harm if he didn’t make himself scarce. Now he had spent the cold and blustery night in his car parked down the road from Court’s beach house. He’d had to move the car numerous times to avoid the notice of the local police who patrolled the beach road. The pricey beach “cottages” were apparently watched very carefully by the local cops. It wouldn’t do to get picked up for vagrancy or because he looked like he was casing the house to break in—not that he wouldn’t break in if he got the chance. By the looks of the joint, that wouldn’t be likely. He was sure Court had a top-of-the-line security system. He knew he had to come up with something soon. Maurie was getting impatient, and he could feel the breath of another young, eager reporter breathing down his neck for this story. It was only a matter of time. He had way too much invested at this point to let it get away from him a second time. He was getting desperate.
/> * * * *
Morgan and Harper got dressed, took go-cups of coffee, and went for an early morning walk on the beach. It was far too early to visit either the lab or the barn. While he knew Shadow and Ollie would be glad to see him no matter the time because of the pocketful of sugar cubes and the offering of many carrots he always brought, he didn’t want to disrupt the barn staff’s morning routine. It made no difference to them whether it was the weekend or not. Horses had to be fed, groomed, turned out for exercise, and stalls had to be cleaned. He doubted anyone would be in early at the lab on a Saturday, though.
The crashing sound of the waves and screeching of the gulls was music to his ears, and he always loved to watch the sandpipers skitter back from the breaking surf as they hunted for small crustaceans and other delectable morsels in the sand. Morgan and Harper trekked up to the point and back before he thought they could reasonably leave for the Eastern Shore Research Laboratory, which was about an hour or so back toward the city.
When they arrived at the lab at nine thirty, Morgan had no problem entering the fenced parking lot since his name was on security’s clearance list, but getting into the building proved more difficult. There were only two cars in the parking lot. When Morgan rang the bell at the back entrance, they were greeted by a young man with long hair and a beard wearing ripped jeans and a lab coat, who looked like a student working a weekend job. He was not anxious to let strangers inside. Morgan had to do some fast talking and show the lab assistant his identification before they were allowed to enter the facility.
“Look, man, I could lose my job for letting someone in here.”
Harper's Submission [Golden Dolphin 2] (Siren Publishing Classic) Page 11