Harper's Submission [Golden Dolphin 2] (Siren Publishing Classic) (14 page)

“I understand, Morgan. It would be a shame to miss the rest of the cruise, but at least we’ve had the first half, eleven glorious days. I’m ready to go home if we have to.”

“No, babe. If I have to leave early I’d want you to stay. Your steward can move your things into the master suite, and you can relax up here for the rest of the cruise. At least one of us should enjoy it.”

“I wouldn’t feel right about staying if you have to leave early. That wouldn’t be right. Besides, I’m your attorney. You may need me there.”

“If I do, I can send the jet to pick you up. Let’s see what I hear tonight. In the meantime, let’s enjoy the day. Montréal awaits.”

* * * *

Harper was worried. She didn’t know exactly how much money, as well as credibility for Morgan’s company, was on the line, but she knew it was substantial. She understood that he might very well have no choice but to return to New York and oversee this problem himself. She knew she would be disappointed to have their trip interrupted just when she was beginning to make progress herself.
Isn’t that always the way? Stuff happens at the worst possible times
. She hated to seem selfish, and she hated to see him worried.

They took a romantic horse-drawn carriage ride through
Vieux-Montréal,
which, according to her ever-present guidebook, contained the largest collection of historic buildings in North America.

“I think he should let me drive.” Morgan grinned at her.

“I don’t know if I’m ready for that. With your tendency to go from zero to sixty…”

“This horse is not capable of sixty, so no need to worry.”

They spent the day enjoying the wonderful French culture that was the heart of Montréal. They explored only a small part of the nineteen miles of neon-lit shops and boutiques in the underground city and made a brief stop at the
Musée des Beaux Artes
, but there was only so much one could do in one day. They were disappointed to miss the
Jardin Botanique
, the largest Chinese gardens in North America, but it was really too cold, and the gardens were far past their peak in any event. Harper carefully watched Morgan, and she could see the worry underlying his cheerful disposition. She decided then and there that he was not leaving the cruise without her. If he went, she would go as well.

Over a late lunch at a café in
Vieux-Montréal
she said, “Morgan, I can see you’re worried. Why don’t we cut the trip short here? We can catch a flight back to New York tonight, and you can be in your office tomorrow morning. You can do what you need to do, and then maybe we can come back. If not, there’s always another trip.”

“I’m sure Casey can get us flights, but we won’t have time to pack up or anything.”

“Our steward can arrange to have our things packed and delivered when they get back to New York. I really don’t need anything but my laptop and my handbag. In any case, don’t even think you’re going back without me.”

“Harper, there’s no reason for both of us to miss out on the rest of the cruise.”

“Yes, there is. It just wouldn’t be any fun without you. I’m not going to change my mind—if you have to go back, we’ll both go back. Besides, you may need your attorney.”

“Are you sure? I hate to cut our trip short, but you’re right. My mind is just not on it. I need to be in New York. I don’t know what I can do that the scientists running the trial can’t, but I have to see for myself. Maybe fresh eyes…”

Casey Campbell got them on a flight to New York that night. She assured them that their suites would be waiting if they could rejoin the cruise, and if they could not, she would have their belongings packed and delivered to them in New York. Harper was amazed at the level of service provided aboard the
Golden Dolphin
. She knew she would always treasure the memories of this trip and hoped she and Morgan would be making many more great memories in the future. But right now, she needed to support him. She was wracking her brain to see if she could come up with any ideas. She wasn’t a scientist or chemist, but she had a legal mind like a steel trap and just as deadly. She planned to be in Morgan’s office with him in the morning.

Offices of Court Industries, New York City, Thursday, November 21, 2013, 8:30 a.m.

Harper poured cups of coffee from the carafe on Morgan’s credenza as she watched him start to sift through the mail, reports, and miscellaneous items that had piled up on his desk during the past eleven days.

“I haven’t been away from this desk for that long in years. It feels strange to be back. I keep thinking I should take my coffee out on the deck.”

“I know what you mean. I wish we were still cuddled up in bed watching the snow accumulate on the deck railing. What is your plan for the day?”

“First, I’m going to have Joe Levine and his team in for a little sit-down. I want a blow-by-blow of what they’ve done to look into this matter. I want to review the animal tests again and the records of the human participants in the clinical trial and see if anything jumps up and bites me. Levine and his crew will be here at ten o’clock, and I’ll see what they have to say. Don’t you need to get back to your office?”

“They’re not expecting me back in town until November 25, and I’m not scheduled to be back in the office until December 2. Thanksgiving is the twenty-eighth, so that gives us eighteen days to spend together and for me to try to help you here. I haven’t decided if I’m going to give notice and move over to another firm or start my own firm. I’ve been considering both options. I don’t think I’m interested in a partnership at my current firm. It might be time to move on.”

“You could be right about that. I think they’re too accustomed to taking you and your talents for granted for a partnership to make much difference in your quality of life. Any increase in salary would be at least partially offset by your share of responsibility for the firm’s debts and profitability.”

“I agree. I just have to decide which way to go.”

* * * *

Harper looked around the conference table at the worried faces of Joe Levine’s team. The meeting had not gone well, and nothing new had come to light.

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.

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.”