She looked up at him in the dark, expectantly.
“I really like you. I come to town pretty regularly for this client. They are important to the firm. I don’t want to do this unless I can see you again.”
“I’d love to see you again.”
* * *
Odd how you can sleep with only one man for fifteen years and then one night find yourself with a stranger, Kathryn thought when it was all over. Dan was a thoughtful, gentle lover. Much better than she had expected from a random meeting in a bar, but she burst into tears the minute they finished.
“Hey, hey, what’s wrong?” He pulled her close as he turned on the light by the bed. “Did I hurt you?”
“No, oh, no. I am so sorry, I never expected this.”
“It’s okay. It’s your first time after–”
“Yes, but don’t say it. It’s not your fault. I’m just a little upset and confused right now. But it has nothing to do with you.”
“Why don’t you tell me about it?”
She settled back into his arms and narrated the whole story of Tom, Paul, and Steve and Shannon. He listened thoughtfully, tightening his arms around her gently when she gulped back tears.
“Do you want to know what I think?”
She looked up into his kind, dark eyes through her tears. “Yes.”
“I think your friend Paul is right. Your husband may have been temporarily confused, but he never intended to leave you. You are an amazing woman. He would never have wanted to give you up.”
His words were balm poured into her wounds of grief, loss, and betrayal.
“Thank you.”
“I mean it. And I’m going to count the days until I’m back in San Diego. Now, let’s get some sleep.”
* * *
But he was gone when she woke without any sign he’d been there except for the crease in the pillowcase on the other side of her bed. And he left nothing, not even a business card, to tell her how to contact him. At first she thought he had been only a figment of her alcohol-fueled imagination. But then she found the note he’d left stuck in the frame of the mirror on the coat rack in the hall. “Can’t wait to see you again. Dan.”
THE INVESTIGATION,
PART TWO
CHAPTER TWENTY-FIVE
Tuesday, October 21, 2014, First Class Cabin, San Diego to Dulles International Airport
Hugh had chivalrously offered Kathryn the aisle seat in their row in the first class cabin. Mark and Rick Peyton were in the row behind them. They were on their way to interview the Food and Drug Administration team that had approved Myrabin. The big United jet sped eastward as they settled themselves for the flight. Hugh was drinking scotch and checking messages on his iPad. Kathryn was sipping red wine and trying not to think that a month had gone by, and she’d heard nothing from Dan Ayers. She knew she’d only intended a hookup, but it had seemed like so much more.
“Tomorrow should be very interesting,” Hugh said as he closed his iPad. “I can’t wait to hear what they have to say about Dr. Vannier’s research.”
“Do you think they will actually address his conclusions?”
“They’ll have to. When Wycliffe sought approval for Myrabin, the company had to first submit what’s called an ‘IND’ or ‘Investigational New Drug’ application to the FDA’s Center for Drug Evaluation and Research. The IND had to be based on laboratory work from Wycliffe that demonstrated the proposed drug showed promise and was safe to put into clinical trials. No matter what Wycliffe sent as its own laboratory data, Vannier’s work should have caused the FDA to prevent Wycliffe from initiating clinical trials.”
“But it didn’t.”
“Right, and I can’t wait to hear them explain why they didn’t stop the clinical trials as soon as they saw Dr. Vannier’s research.”
Kathryn listened to the jet engines hum and tried not to think about Dan Ayers’ silence.
“I’m glad you wanted to come on this trip,” Hugh said. “I thought you might say no because it would stir up too many painful memories.”
“It’s deposition preparation that stirs up the memories.”
“I know, and I’m sorry. I was able to postpone it, so we could meet with the FDA, but the December first date is now set in stone because we’ve postponed twice already. Mark and Patty will take good care of you.”
* * *
Wednesday, October 22, 2014, The FDA’s Center For Drug Evaluation, Silver Spring, Maryland
Next morning, Kathryn followed Hugh, Mark, and Rick Peyton into the modern, angular glass and brick tower of Building 51 in Silver Spring, Maryland, the headquarters of the FDA’s Center for Drug Evaluation and Research. Even on an October rainy day, the glass walls made the lobby light and bright. While Mark and Hugh dealt with the security arrangements for entry, Kathryn looked up at the offices visible through the large windows above her that faced the lobby. In addition to offices, she could see conference rooms on every floor with long, polished shiny wooden tables that looked sterile enough for surgery. People in this ultramodern glass and brick box had set in motion the chain of events that had cost her Tom. Unexpectedly, she felt tears in her eyes and reached up to wipe them away, hoping no one saw.
The members of the team who had approved Myrabin’s New Drug Application in 2006 were already waiting for them in the conference room on the third floor that overlooked the lobby below. Through discovery, Kathryn already knew who they were. Dr. Fred Butler, round and bald, an M.D. in his early fifties, wearing a light blue shirt and gray cardigan sweater, sat at the head of the table. Mary Lancaster, an elegant brunette in her forties with a Ph.D. in pharmacology, wearing a simple wool skirt and black sweater, sat in the chair to his left. Frank Reynolds and Harrison O’Connor, both Ph.D. organic chemists in their late forties wearing plaid shirts and v-neck pullovers, sat to Dr. Butler’s right. Their casual dress and the way they all leaned back comfortably in their chairs told Kathryn they were confident there were no holes in their story. Myabin was safe, and the FDA had been right to approve it.
In contrast to government-confident-casual, Hugh and Mark had adopted an aggressive-conservative look. They had dressed one notch down from power suits in well-tailored navy blazers and gray or black pants. Rick Peyton’s lanky frame, on the other hand, in his ill-fitting gray suit did not convey the same air of power and assurance.
Ever concerned about looking the part of lawyer and client, Kathryn had splurged on a new dark gray dress and black blazer from Anne Taylor. She thought it gave her the Patty E. Fox Harvard Brahmin look.
“Thank you for meeting with us this morning,” Hugh began after the initial round of handshakes and introductions.
“We’re glad to answer any questions you have,” Dr. Butler smiled. “As a preliminary matter, I should make sure that you received everything you requested from us.”
Hugh glanced over at Rick, who had told Logan how to write the Freedom of Information Act Request. “Yes, thank you.”
“Good.” Dr. Butler glanced around the table at his staff, who smiled back. Their demeanor said this meeting is going to be easy.
“Why don’t you start by walking us through the chronology of the approval process for Myrabin,” Hugh began.
Dr. Butler’s eyes went to Dr. Lancaster, who opened a folder in front of her. “Let’s see. Wycliffe Pharmaceutical filed their IND in November 1997. We gave them approval for clinical trials a month later. Phase I trials began in January 1998 with fifty volunteers. The trials lasted one year. Phase II trials with two hundred and fifty patients began in January 2000. Phase II lasted two years. Phase III trials with two thousand patients began in January 2002 and went on for three years. Following Phase III, Wycliffe filed its New Drug Application on January 15, 2006. We reviewed it, and based on the strength of the data, we gave it expedited status. We approved the NDA for Myrabin six months later. The drug officially went on sale in January 2007.”
“And what were the adverse effects reported during the trials?” Hugh asked.
Dr. Lancaster looked down at her notes. “Not much. Skin rashes, primarily. Some patients developed a cough.”
“Were there any deaths?” Rick Peyton spoke up.
“Of course not. You know that we would have halted clinical trials if there had been.”
“Dr. Vannier told us that Myrabin would necessarily have caused deaths,” Hugh insisted.
“Well, I’m sure he said that, but he’s wrong. His conclusion that the drug was not safe cost Suchet billions of dollars. Myrabin is one of the top-performing hypertension drugs in the world.” Dr. Butler looked directly at Kathryn as he continued, “We’re sorry for the loss of your husband, Mrs. Andrews, but we feel confident that Myrabin wasn’t the cause of his death. Did his doctors consider outside factors like alcohol or hepatitis or recreational drug abuse?”
Kathryn wanted to slug his smug oiliness. She clenched the arms of her chair to avoid the temptation. In her best courtroom defense-lawyer disparaging tone she put him in his place. “Those were all ruled out. Tom’s treating cardiologist felt strongly that Myrabin caused his liver to fail.”
“How did you factor Suchet’s laboratory work on the drug into your approval process?” Hugh asked.
Dr. Lancaster was quick to respond. “We didn’t. The application was from Wycliffe. We relied on their lab work to initiate clinical trials.”
“But back at the Investigational New Drug or IND stage, you were obligated to look at all the laboratory data surrounding the development of the drug. Suchet originally formulated and tested Myrabin.”
“True,” Dr. Butler agreed. “But Wycliffe bought the rights from Suchet in 1994 and worked on it in their laboratories for three years before they submitted an IND. We only looked at Wycliffe’s research.”
Hugh and Mark exchanged looks, and Kathryn realized Hugh was cuing Mark to ask the next question.
“We interviewed Dr. Maurice Vannier who was head of the development team for Myrabin at Suchet from 1991-1993.”
“Of course, we know Dr. Vannier,” Dr. Butler conceded.
“He gave us copies of his team’s work on Myrabin.”
“That’s fine, but they are irrelevant to Wycliffe’s application,” Dr. Butler insisted.
“No, they are relevant. Very, very relevant.” Hugh insisted. “Dr. Vannier’s lab work showed that Myrabin was toxic.”
Dr. Lancaster chimed in, “Wycliffe’s scientists reformulated Myrabin to make it effective and safe. There have been no deaths from Myrabin.”
Hugh had his head down, writing furiously on his legal tablet. Kathryn had the sense he was again cuing Mark, who spoke up.
“Did the FDA ever compare the Suchet version of Myrabin to the Wycliffe version to determine how Wycliffe modified the drug?”
Dr. Lancaster shook her head. “We never saw Dr. Vannier’s work. Our focus was on our applicant, Wycliffe. Their clinical trials showed the drug was safe. There were no deaths linked to the drug. That was all we needed for approval.”
Hugh looked up from his legal pad. “So you are certain no one at the FDA ever saw Dr. Vannier’s work? He never sent it to you himself?”
“Never,” Dr. Butler smiled benignly at everyone at the table.
* * *
Wednesday night, October 22, 2014, The Lounge at Bourbon Steak, The Four Seasons, Washington, D.C.
Around nine-thirty, Kathryn grew restless in her impressively expensive Georgetown Four Seasons room and wandered down to the bar, hoping she might run into Mark Kelly as she had on their last night in Paris. Instead, she found The Lounge empty except for Hugh on one of the stools at the most distant end of the bar, nursing his perpetual scotch. His back was toward her, so she could not see his face. But his big lanky frame folded awkwardly over the stool projected an aura of profound sadness and loneliness into the dimly lit, empty week-night bar.
He turned and smiled and gestured for her to join him, and she realized he had seen her reflection in the mirror behind the bar when she walked in.
As she slid onto the stool next to his, he summoned the bartender, who hurried over.
“Scotch?” Hugh invited, shaking the ice cubes in his own drink.
“No, thanks. Red wine; a merlot is fine.” Kathryn told the hovering attendant.
“Don’t worry about today,” Hugh began.
“It wasn’t what we were expecting, though.”
He heaved his massive shoulders in a shrug. “They’re lying. I’m never surprised when the other side lies.”
“So you see the FDA as aligned with Wycliffe? They aren’t neutral?”
“Ha!” Hugh shook his big head. She could tell he had moved from lonely to enjoying himself as he interpreted the facts for her. “They can’t be neutral. They approved Myrabin. They have almost the same stake Wycliffe has in proving Myrabin didn’t kill your husband. Even if the FDA is not on the hook for wrongful death damages, it still doesn’t want the public to know that unsafe drugs make it through their review process.”
Out of the corner of her eye, Kathryn saw a man enter the bar. At almost the same second, she realized Hugh had seen him, too. They couldn’t discuss the case with a stranger present unless he settled himself at the far end, away from them.
But the man walked toward them; and as he did, Kathryn had a momentary shock of recognition. This man looked exactly like Harrison O’Connor, the organic chemist they’d met at the FDA that morning.
The man continued over to Hugh and sat down on the empty stool beside him. He handed Hugh a business card. Kathryn could see the name: Harrison O’Connor, Ph.D.
“Let me buy you a drink,” Hugh said.
“No. I need to talk to you, but not in public.”
“Let’s go up to my suite.” Hugh picked up his scotch and headed for the elevator with Harrison. Kathryn followed closely behind. Although Hugh seemed completely unfazed by the sudden appearance of the FDA’s organic chemist, Kathryn’s heart was pounding.
Once the elevator doors had closed behind them, Hugh dialed Mark’s cell.
“Someone has come to talk to us, and you’re going to want to hear what he has to say. Get Rick and meet us in my suite in five minutes.”
Mark and Rick were standing at the door of Hugh’s West Wing Presidential suite when they arrived. They all went inside and settled on the soft yellow brocade couches in the living room. Harrison declined Hugh’s offer to order something from room service.
“I can’t stay long. I’m worried I was seen coming here.”
“How did you know where to find us?”
“I called your office here in D.C. after you left.”
“Why are you worried about being followed?”
“Because I’ve been pretty sure someone has been watching me since you set up the meeting on Myrabin. And someone is also following Mary Lancaster and Frank Reynolds.”
“Did Mary and Frank tell you they thought they were being followed?”
Harrison nodded.
“Why would someone surveil three FDA research scientists?” Hugh asked.
“Because we worked on Myrabin. And because you guys are now coming around asking about the approval process.”
“So I take it the approval process was not strictly by the book as we were led to believe today?” Hugh polished off his drink and set it on the table, waiting expectantly for the answer to his question.
“That’s right. It wasn’t by the book at all. We did receive a packet from Maurice Vannier. I opened it and studied it. And, as you said, Dr. Vannier and his team found the drug caused liver failure in rats. Sometimes rapidly, sometimes more slowly. But it was not a safe drug.”
“Then why did Dr. Butler lie to us today?” Mark Kelly spoke for the first time.
“Because he was instructed to ignore Dr. Vannier’s materials.”
“Who told Dr. Butler to do that?”
“Charles Lawson, who was head of the FDA at the time. Lawson also instructed him not to shut down Wycliffe’s clinical trials after two people di
ed from liver failure, one in Phase One and the other in Phase Three.”
“So there were deaths!” Rick said.
“Absolutely,” Harrison O’Connor said. “But we were not allowed to investigate them. Mary, Frank, and I resisted. By law we can’t ignore deaths in clinical trials. But Dr. Butler said that if we wanted to keep our jobs, we’d accept those deaths as alcohol-related and not recommend suspending the trials.”
“Why did you come to us?” Mark asked.
“Because I’m worried about the people who are taking the drug. When I met Mrs. Andrews today, it was the first time I’d met a person who’d lost a loved one because of what Mary, Frank, and I did to keep our jobs. I felt so guilty that I decided to come and tell you the truth.”
“How many deaths have been reported since Myrabin’s approval?” Hugh asked.
“I have no idea. Mary, Frank, and I receive reports, and we input them into our database, but they never show up after that.”
“Do you know why that happens?”
“No idea. I just know it allows the FDA to go on saying there have been no reported deaths. Listen, I’ve told you all I know. I need to get going.”
Hugh nodded. “Mark will walk you out. Thanks for coming. Would you be willing to testify at trial?”
“No, I’m sorry. I don’t want to lose my job, and I would if I told the truth about Myrabin. And, since people are following me, there’s a good chance I wouldn’t survive if I testified.”
CHAPTER TWENTY-SIX
October 23, 2014, The Amtrak Morning Train to New York From Washington, D.C.
Next morning, Hugh chose Amtrak’s 2154 Acela Express for their three-hour trip to New York. He had used his Craig, Lewis, and Weller connections to get them an appointment with Charles Lawson. Hugh sat with Rick Peyton in the larger business class seats, using the time to decide how they would pose questions to Lawson. Mark and Kathryn sat behind them.
Yesterday’s rain was still with them. Kathryn sipped coffee and watched the drops hit the windows as the early morning world sped past. The drops smashed themselves against the glass, spreading into long tears that slipped down the window. She thought about Tom and those last awful, agonizing days, and a tear of her own betrayed her.
The Death of Distant Stars, A Legal Thriller Page 17