Senate Cloakroom Cabal (13 page)

“Look her up, see how good a writer she is.”

“You're in for a lot of reading. She's the one who solved the serial killer case in DC last year.”

His face lit up. “Aha! Now I can find her all by myself.”

“Wolfe. Her name is Laura Wolfe.”

31

M
ichael and I met at Union Station and took the 6:30 morning Metroliner to Newark, New Jersey.

He provided me with more papers on the FDA than I could ever M get through in a day, much less in a three-hour train ride. I did my best to scan and highlight.

In Newark, we were met by a man holding a small sign with Michael's alias,
Mr. Howard
, on it. We soon were out of the city in our mini limo and into heavily wooded, hilly terrain. Michael and I both read during the half-hour trip to Morris Plains. I had no idea what nuggets we might mine, but Michael was confident we'd learn something.

We were politely ushered into a very comfortable room along the lines of a large paneled library in an opulent mansion: plush leather, mahogany desks and trim, oriental rugs, a mounted animal's head, and Renaissance paintings. It was a man's room, solid and visceral.

The soft lighting highlighted the very large windows that looked out over the campus-like grounds, resplendent with great sweeps of lawn, copses of trees, and a pond with a fountain in the middle. It was regal and serene.

A door opened and two men entered, one elderly, the other middle-aged. Both were dapper and in excellent physical shape. The younger was in a dark suit, while the older wore a dark blue blazer and grey slacks. The door was closed behind them.

“Mr. Horne, Ms. Wood, so good of you to make the trip. I am Harley Rogers, and this is my son and company president, Sherman.”

We did the handshakes and salutations. I'd already forgotten about the aliases. Michael was Horne inside and howard in the outside world.

“Please, let us sit over here, where we can take advantage of the view. Sherman won't be with us long, but he wanted to meet you. It has not been often, if ever,” and he looked at Sherman, “that we've had someone from the United States Senate, other than our own two, visit us.”

Michael took the lead. “Senator Dalton sends her regards and asked me to convey to you her deepest respect for you and your company.”

“You are the senator's administrative assistant?” Sherman asked.

Michael nodded.

“And Ms. Wood?” the son asked.

“Administrative aide in charge of research,” Michael said.

Harley nodded. “Ah, research.”

I took up the baton. “Yes, and I'm afraid I'm all FDA'd out.”

The senior Rogers chuckled. “This is your first experience with an FDA case?”

“Yes sir.”

Harley smiled. “Well, we'll see if we can enlighten you and lighten your reading load at the same time.”

I returned his smile. “I'd appreciate that, sir.”

“Well,” Sherman said. “I have some things to see about in the lab.”

“Would that something be Tutoxtamen, sir?” I asked.

The younger Rogers gave me a forced smile. “We produce many drugs here. As much as we wished Tutox was among them today, we still have a large operation to run.”

“Yes sir,” Michael jumped in with what I perceived as a little anxiety. “We appreciate meeting you and look forward to visiting in the future.”

“I'm planning to join you at lunch. But if I don't make it, please give my regards to Senator Dalton.” He extended his hand to Michael. “Thank you for coming and caring, Mr. Horne.” He looked at me. “Ms. Wood.”

He didn't extend his hand to me. He nodded to his father and left.

“Come now, please let's sit,” Harley offered. “We have light refreshments. I hope you'll be staying for lunch. I'd like the time to show you around our facility.”

“That would be very nice, sir,” Michael said.

The octogenarian took a large chair, Michael and I shared the large sofa. I took out my notebook. Michael maintained his stature as the senator's number one.

Harley spoke first. “You needn't worry about your senator's prior actions regarding me. There was nothing else she could do, then. With your presence here today, I am assured of her position regarding Tutox and am grateful for her support. Although I don't know how a minority of senators could be effective facing the powerful pharmaceutical juggernaut.”

Michael looked pleased. “I will convey your kind comments to the senator.”

“What we need, sir,” I piped up, “is assurance that there really are no deadly side effects to Tutox and how we can corroborate what you tell us. We don't doubt your veracity, but we need irrefutable proof if we are to curry support from other senators.”

There was a deafening silence. I didn't know how what I'd just said affected Michael, but I'd been in this position before. If I'm not up front at the very beginning, the rest could all be a huge waste of time.

“I don't, for a minute, doubt your reasons, Ms. Wood. In fact, I admire your gumption. We can corroborate everything we tell you. Several independent groups have worked with us on phases I, II, and III. We even went beyond the FDA's requirements, studying many more people with other diseases, using our drug in combination with other drugs.”

Michael jumped in. “Were these reports given to the FDA?”

Harley leaned forward. “Phases I, II, and III were provided to the FDA over a year ago, but we continued testing, ironically, against the same negative side effects they have used against us: the problems with heart patients. We went out and explored new populations to use with Tutox in combinations with other drugs to see if they compromised the primary curing qualities of our drug.”

He eased back in his seat. “Will there be heart patients that may not be able to take Tutox? Unfortunately, yes. Nevertheless, we are working with those anomalies and hope to come up with an answer. It may be possible that the heart treatment can be altered, allowing a patient to take Tutox. However, that's all up to the patient's doctor,” Harley said caringly.

“What was the FDA's reason for not approving Tutox, in your opinion,” I asked.

“You know their official reason?” Harley asked.

“Side effects,” Michael jumped in. “A combination of safety issues. You were given the designation of ‘not approvable' because additional studies needed to be conducted on more different people for a longer period of time.”

He nodded at Michael. “You've done your homework, son. I admire that.”

Michael blushed, but recovered. “Your opinion of that matter, sir?”

“The FDA will choose their language carefully, citing many intangibles that will force us into more studies. Even after we prove Tutox is everything, if not more, we say it is, quality control issues will then have to demonstrate Tutox still contains the same curing elements that were in the earlier tests.

“If in the upcoming process, we discover something new to add, not because there is anything wrong with Tutox, which there isn't, but because we have discovered something new and better, we couldn't . . . we're not allowed to. The tiniest modification to the drug would require testing to start from the very beginning.”

I was completely engrossed with this elderly man's acumen.

“We have to play the game very carefully. We've received the FDA's action letter. CDER will give us an opportunity to meet with the agency officials to discuss the so-called deficiencies.” Harley sat back.

“CDER?” I asked.

“Center for Drug Evaluation and Research,” he answered. “The FDA had fully reviewed our NDA, eh, New Drug Application. It included all animal and human data, analysis of that data, as well as information about how the drug behaves in the body, as I mentioned earlier.”

I nodded that I understood. “I've read that some new drugs for life-threatening illnesses like cancer are given accelerated approval that would allow, say Tutox, to be approved before some measures required for approval were available.”

“Surrogate endpoints,” Harley clarified. “But we didn't seek that. We wanted all the details—the measurements of how a patient feels, functions, their chance of survival—everything on the table. We're considerably beyond phase III in our studies.”

“Someone in the FDA said that they thought all the information they needed had been provided and that the real problem seemed to be with clinical trials.”

“Balderdash! We went overboard to detail every phase of safety and effectiveness, and the studies of different populations . . . everything imaginable.”

“Then how can they justify their
not approvable
classification?”

“They don't have to. They could move fast on this, but they won't. They'll take two to three years. I may not live long enough to see the miracles this drug can perform.”

“You believe that Tutox will eventually be approved?”

“There are no guarantees that it will.”

That rang out like a death warrant, but the vibes I was receiving from Harley Rogers were not those of a defeated man. Michael had listened emotionless in rapt attention. I couldn't read his true feelings. Could Harley have an ace up his sleeve? Faking out his enemy, while secretly . . . no, that was too conspiratorial.

He suddenly stood, taking us by surprise. “How about a tour of the grounds and the labs before we have lunch?”

We both rose. “That would be very nice,” Michael said distractedly.

I couldn't understand why Harley wasn't outraged. He had the well-known reputation of being a fighter. There was more here than met the eye, and I was beginning to think that my earlier feelings were not as conspiratorial as I thought.

I'll have to dig deeper into Rogers Pharmaceuticals and its founder.

32

“I
found it strange Rogers didn't ask us any questions about the senator,” I said to Michael, as the Metroliner train to Washington was pulling out of Newark station.

“Why?”

“Because we were representing her. I did think he overreacted when I walked toward what appeared to be another lab.”

“Maybe some secret . . .”

“Maybe. He sure rushed us through the rest of the tour.”

I took out my notepad.

“It could be another miracle drug,” he said offhandedly.

I didn't care for his aloofness. “I'm no threat. I don't know a bacterium from a virus.”

Michael uncharacteristically slouched. “Where do we go from here?”

“How ‘bout neither Rogers appearing traumatized by their drug being turned down.”

“What? How can you say that?” he said intensely, sitting up and turning to me. “They certainly have no love for the FDA.”

Finally, he was out of his lethargy.

“I'm talking about attitude,” I explained. “Harley Rogers talked angry, but didn't act angry.”

“So?” Michael snapped at me, clearly irritated.

“What? You think I'm being skeptical? I'm looking for ideas here. Give and take. I do it with my husband and Max Walsh all the time.”

Michael turned sharply to me. “Walsh? The homicide captain? You are friends with a homicide cop?”

“Very much so.” It dawned on me that Michael knew little or nothing about me.

He went on. “After I was mugged, I was interviewed by a homicide detective.”

“That was probably Hayes. But Max knows all about your case.”

Michael was on the edge of his seat. “He told you?”

“When you were found, no one knew your exact condition. You were lucky that a neighbor saw the mugging and called it in. Max answered the call along with the Capitol Hill police. He saw that you worked for Senator Dalton, whom he didn't know. He looked up both of your bios.”

Michael frowned. “Is that good or bad?”

“Not bad. He's just very thorough. If you had been killed, you would have been his case. He followed up anyway. He found it odd that you'd been mugged at your front door. It's rare there's a homicide or vandalism in that neighborhood.”

“That's amazing. I wouldn't have—”

“Little things are important. They sometimes create big things,” I said easily.

“Like with Rogers. I'm impressed with your observations. I saw and heard the same things you did, but you came away with a very different picture than I did.”

“I look at people's attitudes, their reactions and body language, and their eyes. They all tell a story.”

“Did you learn that in journalism school or just pick it up?”

“I wish they had taught it. I learned it on my own. I'm always learning.”

The train slowed for Trenton. Michael said he was going to the dining car and asked if I wanted anything.

“A Diet Pepsi and a bag of peanuts would be great.” I reached for my bag.

“That won't be necessary; it's on me.” He went up the aisle.

I took out my cell and called Jerry's private line. He didn't answer. I called Anna's cell. She told me, “Tyler, he nap, not too hungry, some, eh fussy.” Anna had picked up
fussy
from me. She said she liked the word because “it say much.”

A guy who had gotten on the train wanted Michael's seat. He acted as though he didn't believe me when I said it was occupied. Maybe his disbelief was because I was passing the wonderful opportunity of his company. His ego sealed it when he asked me whose seat it was. I gave him my sternest look. “Believe me, it's occupied.” He reluctantly moved on.

Michael returned. The Diet Pepsi and peanuts hit the spot. “You know, Michael, there's nothing like a bag of salted nuts . . . and a soda,” I quickly added. “I was up in your neighborhood yesterday,” I said, wanting to get back to business.

“Oh? For anything in particular?”

“Yes and no. I wanted to familiarize myself with the Senate office buildings. I was also curious about what Senate committee had oversight of the FDA.”