Two days later, UPS delivered the three-inch package from People for Alternative Treatment, Inc.
The PAT0035 protocol was forty pages long. It defined the selection criteria for the study, the assessment steps necessary prior to initiation of treatment, and the strict follow-up requirements. The clinical forms were complex as were the informed consent documents. Most of the packet was supporting publications from the scientific literature and the details of Andre Keller’s studies. These studies included the specific details of creation of the PAT0035 vector, its testing on animals, and early human safety testing. The data tables were extensive as were the statistical analyses supporting their reported results.
I’ve had some exposure to statistical analysis while in medical school, Harmony thought, but I’ll never understand the significance of this tabulated data. I’m no statistician. Just like most physicians involved in clinical trials, I have no choice but to trust the integrity of PAT, Andre Keller, and the peer reviewed research process.
Over the first month, Harmony enrolled five patients into the study. Her enthusiasm and sincere commitment to her patients’ welfare assuaged their reservations. Harmony and Shelley Stillwell completed the multipage forms, described the patients’ conditions, and recorded their blood test results.
Within three weeks, patients were reporting remarkable results. “My rash is fading. My joints have never felt this good. I feel just wonderful.”
As this was not a placebo-controlled study, each patient served as her own control (the effects measured against themselves before and after treatment). Harmony at first suspected that they were seeing some kind of potent placebo effect.
Maybe I oversold the treatment.
Soon the standard laboratory and the specific clinical data showed that the effects were real and significant.
It didn’t take much time for the drug’s remarkable effects to leak to on-line interest groups. Patient support groups for difficult diseases like lupus, fibromyalgia, and chronic fatigue syndrome have served as important resources for information. Initially, these groups functioned in loose networks by phone, newsletter, and periodic meetings. Today, with the Internet, patients had immediate access to the whole range of information about their disease and the many forums provided an outlet for sharing information, experiences, and suggestions for treatment. The latter, however, ran the gamut from reliable and useful, to extraterrestrial, with every wacko idea having free reign and every kook having her say. Many had asked Harmony to participate in several on-line chats where she shared her experience and made general recommendations. She rebuffed all questions about the PAT study.
When the early PAT study results somehow found their way onto the net, lupus patients flooded them with requests to consult with Harmony. Many asked to transfer their care to her practice.
Jeanette Brooks, one of Harmony’s new patients sat on the examination table. “My doctor’s pissed. He said you were a quack and a kook, and that I’d better be careful. Can doctors really say things like that about each other?”
This was the fourth or fifth time Harmony had heard herself disparaged in this way.
I should have expected this once I strayed off the straight and narrow. I shouldn’t take it personally, but I do, and it hurts.
The first time Harmony heard it, she raged on for hours. Now she had become sanguine about it.
“Doctors don’t like to lose patients to another physician, and most physicians are conservative and resist new treatments for as long as possible. That’s admirable because it puts safety first, but it sometimes deprives patients of better and more effective treatments.”
Even physicians dedicated to their patients’ welfare found difficulty in the success of other doctors. It was one thing to refer a patient to an expert at the university or the Mayo Clinic; no physician could be a world-class expert in everything. It was another thing to find your patients doing well in the hands of a quack or kook. Everyone knew the virtue of the sympathetic ear, the hugs, and the extended time afforded a patient, but most busy physicians didn’t have the time or the psychological predisposition for the rest. It had to be more than that, they thought, for many of the most refractory, and some of the most obnoxious patients that they’d dumped on Harmony were, to their dismay, doing better.
They kept asking each other, “How is that possible?”
As news of Harmony’s study activities spread, she noted a subtle change in how Brier physicians responded to her. She tried to avoid reading much into the furtive looks that greeted her.
Was it envy, respect, disdain, or anger? She wondered.
Several physicians had pulled her aside and asked or cross-examined her about the study, and whether they could participate with their own patients. She referred them to Andre Keller. Harmony tried to maintain her perspective and her sense of humor over these encounters, but it was difficult, and sometimes impossible.
The human element in clinical research was unfortunate—humans had a way of, well—being human. That always made studies difficult to perform and analyze. One of the newest patients to join the study was Patricia Martinez. She was so anxious to participate, that between the initial evaluation for acceptability and the start of treatment with PAT0035, she failed to tell Harmony or Shelley that she had an infected ingrown toenail, a problem that would have excluded her from the study. When she returned after one week she said, “I don’t know if it’s important or not, but I had a bad infection in my foot last week?”
“Why didn’t you tell us?”
“I didn’t want to screw things up, you know with the study.”
Harmony untied her shoes. “Let me look at your feet. I’m really concerned.”
“Sure Doctor, but you won’t see anything. Twenty four hours after you gave me the new medicine, the infection disappeared.”
This wasn’t the first time she’d heard of such an effect in her patients. Andre’s experimental animals had shown similar responses.
This stuff’s incredible, Harmony thought.
Andre was riding high at PAT. His clinical and research studies were doing well.
They held the monthly research review meeting in PAT’s large modern conference room next to Greg Wincott’s office. Each research section manager presented their most recent results and plans for future investigations.
Andre sat with Raymond Ames. Both smiled in the sunshine of the applause that followed their presentation.
Greg turned to Andre. “What’s the next step?”
“We’ll complete Phase II soon on PAT0035, and then move into Phase III. We have preclinical testing done on two more DNA virus vectors, one PAT0075, is an active virus that looks promising.”
Following the meeting, Raymond approached Andre at his desk. Ray had become increasingly concerned with the integrity of the data. Andre had shown a cavalier attitude to data analysis in the past, but now that they were in the clinical phase, Ray had become uneasy. At several of their last data analysis meetings, Andre had taken his yellow highlighter in hand and had crossed out large pieces of data that “didn’t fit” with the overall results. Ray recalled commiserating with Roy Ostrow, one of Andre’s Ph.D. candidates, over similar data omissions.
“We have to include some of our late findings, Dr. Keller.”
“We’ve been through this before. Erroneous information will only serve to weaken our finding unnecessarily.”
“Respectfully, sir, I disagree. The results are so overwhelmingly positive that this small amount of data will not significantly change the thrust of our findings. Moreover, if findings are too good, people get suspicious.”
“I don’t give a damn what people think.”
Ray tightened his fists. “More important to me, sir, is now that PAT0035 is in clinical study, I think that we and our clinical investigators should be on the alert for the reversals we’ve seen in some mice.”
“Don’t be ridiculous! I’m not going to foul up our findings with such spurious results. Yo
u’ve seen the findings and the mass of the data overwhelmingly supports our conclusions. ”
Andre changed subjects. “I want you to crank it up on the preclinical studies on PAT0075. I’d like to get into Phase II ASAP.”
That evening sitting at the dinner table, Shirley, Ray’s wife noted that he was unusually quiet.
“What’s wrong? Your mind’s somewhere else tonight.”
“I’m sorry we got into this thing with PAT and Andre. The guy’s brilliant, but he doesn’t have a soul. He’s so single-minded in his work that he refuses to acknowledge problems that are right there in our data.”
“Every researcher tries to put the best spin on their data, Ray. What’s so different here?”
“I’m concerned about two areas. First, he routinely discards actual data, although the overall impact on our findings and conclusions are minimal. The scientists who evaluate our results need to see and assess all the data, not just those that Andre chose for them. Second, we’ve gone from the lab where adverse effects on mice generate a report, to human trials where untoward effects can lead to catastrophe.”
“What kind of catastrophe?”
“God knows.”
“What are you going to do?”
“I’m not sure. It’s too soon and maybe nothing’s wrong. Unknown to Andre, I’m keeping a second set of data books with all the experimental findings, and I’ll follow all the animals right through to their deaths. I hope I’m just being too compulsive, too cautious.”
Chapter Twenty-Five
As Jack stared at Rachel’s chart, he thought, So much for my prediction that Rachel Palmer’s situation would be resolved one way.
Two more weeks had passed and her condition remained unchanged. The pressure, however, to do something—do anything, had become dispiriting. The human element again, constantly screwing everything up.
Jack didn’t think he was paranoid, but gradually those involved in Rachel’s care, had become reserved around him. He’d seen heads shaking, overheard less than flattering comments, and a few conspicuously avoided the subject. He checked his breath and felt his pants to be sure he’d zippered his fly.
Beth understood Jack better than anyone and she chose to avoid the subject. He didn’t know if she agreed with his decisions or not, and he didn’t care. She was there for him and they talked about Rachel only when Jack raised the subject.
The staff met several times about Rachel’s care. They helped to relieve built up tensions, but only temporarily.
Finally, one of Rachel’s nurses couldn’t resist. “How can you do this to Rachel and her family? It’s just so wrong, Dr. Byrnes.”
Jack had been more than patient, and almost saintly in his forbearance of suggestions about how to care for Rachel. He turned to the nurse and handed her his pen. “Okay. You go in there, grab her chart, and write the orders to discontinue treatment. I’ll countersign them and we’ll be through with this.”
She stared at Jack in shock and wept.
Jack felt like a shit. He scanned the group’s faces. “I don’t like what’s happening any more than you do, but let’s be careful about who’s running out of gas here, the patient, the family, or the doctors and nurses taking care of her.”
Jack entered Rachel’s room. Tom and Maxine sat in their usual places.
“How are you doing this morning, Rachel?”
She slowly opened her eyes and when she’d finally fixed her eyes on Jack, she smiled. Her voice was barely a whisper. “I’m so tired. It’s even an effort to breathe.”
He turned to Tom. “Have you guys talked?”
Tom turned his head away and remained silent.
As Jack was leaving, Maxine stood. “We’d like a moment with you, Doctor.”
“Of course. Let’s use the nurses’ lounge.”
The two nurses in the lounge left when they entered.
“What’s up Maxine?”
“Don’t take anything we say as a criticism. We appreciate everything you’ve done. We understand that what happened to Rachel after the first episode of peritonitis was unavoidable. We also understand,” she said, looking at Tom for support, “that she’s had the best modern medicine has to offer, that you’ve done all you can.”
They’re going to pull the plug, Jack thought.
“Nevertheless,” Maxine continued, “it hasn’t been enough.” She turned to Tom and said, “Tom!”
“Jack, we’re going to ask Harmony Lane to consult on Rachel’s case. We’ve asked around. She’s had some incredible success with her patients and even has access to an experimental treatment which could help Rachel, maybe even be a miracle.”
Harmony Lane? Jack’s eyes widened. “I know Dr. Lane, but she’s a family practitioner who has little or no experience in treating Rachel’s problems. I can’t see what she could offer. As far as experimental treatment, I don’t know of anything that’s available even in a preliminary stage which would be suitable for use at Brier Hospital.”
“Dr. Byrnes,” Maxine said, “Dr. Lane will be in this afternoon to see Rachel. This is our wish. Please respect it. She promised to discuss her opinion with you after she’s completed her evaluation.”
They’d left Jack no room to say anything else about this decision, so he rose to leave. “I hope she has something because I’m fresh out of miracles.”
Harmony appeared later that afternoon at Jack’s office. “Can we talk?”
“Come in and have a seat.”
She sat across from his desk, crossed her legs, and gave Jack a subtle smile. “I know I’m the last one you wanted on Rachel’s case…”
“Please, Harmony, you’re a good person and a good doc, so don’t take any of this personally.”
Harmony smiled. “I was about to say the same thing to you, Jack. I’ve been through the chart, all of it, every note, consultation, opinion. It’s heartbreaking, but if I ever get this sick, I want you there treating me. You’ve been great. I don’t know how you do it—care for these ICU patients, maintain your intensity, determination, and optimism. I couldn’t do it.”
“I appreciate that, but I don’t know what more I can do for Rachel.”
“You’ve probably heard that I’ve been working with People for Alternative Treatment doing clinical trials on lupus patients. We’ve had some incredible success with a DNA vector, an adenovirus which can control the immune system’s attack on the body, and is also a potent stimulator of cellular growth factors, and a fighter against active infection.”
“You’re not thinking of trying that on Rachel, are you? She couldn’t possibly fit the protocol for any clinical trial. PAT would probably blow their cork, and Brier Hospital would never permit the use of such a treatment under these circumstances.”
“I know, Jack, and I’ll tell that to Tom and Maxine. But truth-be-told, since there’s no downside, except that it might not work, I’d love the opportunity to try it.”
“Don’t even think of it, Harmony. It could cost you your license and a lot more.”
Harmony returned to ICU. After a ninety-minute discussion where she outlined the problems and limitations of experimental treatment, she faced Tom and Maxine. “I’m sorry. I can’t possibly consider using these unproven medications.”
Maxine was determined. “Please don’t make a final decision. Sleep on it and we’ll talk tomorrow.”
Harmony didn’t sleep well that night. Her decision about Rachel Palmer troubled her.
I really don’t have a choice, do I?
When the elevator door opened on her floor, Tom and Maxine were standing at her office door.
“Just a few minutes of your time, Dr. Lane,” Tom pleaded, “we just want to talk.”
Not again, she thought. These people never give up.
Harmony unlocked her door, picked up the mail spread across the floor, and walked them into her office.
“I’ll make coffee.”
Minutes later, she sat behind her desk sipping coffee when Maxine made her pitch. “
We’d like you to reconsider your decision, Doctor. Everything else has failed, Rachel’s just wasting away, and eventually some additional complication will strike and end it all.”
“I thought I made my position clear yesterday. There’s no way that anyone involved in these studies will allow me to use these preparations in a patient like Rachel.”
Tom stared at Harmony. “I’m not a mind reader, Doctor, but I’m willing to bet that absent these constraints, and under these specific circumstances, you’d choose to treat Rachel.”
“Maybe so, but this is the world in which we live. I can’t change that, and I’m not about to risk my career.”
“We’d absolve you of all responsibility. We’ll sign any paper—do anything if you’ll just agree to treat my daughter. How can you let the bureaucracy stand between you and your patient? We accept your warning that it may not help, but you’ve said that there’s no proven risk, so I can’t see how you can deny Rachel what may be her last chance.”
“How is the treatment administered?” Tom asked. “Would anyone have to know?”
Harmony’s mind was spinning. I’ve spent my life in dedication to helping my patients. How can I stand by and let Rachel die without even trying? What’s stopping me? Is it just fear, or maybe I don’t really have the courage of my convictions?
“The treatment is simple and safe. Just an injection of the preparation into Rachel’s IV line is all that it takes.”
Tom sat on the edge of the chair. “You’ll do it?”
Harmony nodded slowly.
Later that day, while Maxine stood guard at the door of Rachel’s room, Harmony wiped the injection port of Rachel’s IV with alcohol, said a short prayer, and injected the PAT0035.
Chapter Twenty-Six
Jack and Beth had seen Sandy and Marty Greer socially several times since Beth had run into her at the market. The women renewed their intimacy as if they’d never parted. Beth had many close women friends, but something about old friendships were unique.
The Plague Within (Brier Hospital Series) Page 14
