Chasing Medical Miracles: The Promise and Perils of Clinical Trials
272
Chasing Medical Miracles: The Promise and Perils of Clinical Trials
272Paperback
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Overview
Product Details
| ISBN-13: | 9780802719904 |
|---|---|
| Publisher: | Bloomsbury USA |
| Publication date: | 05/25/2010 |
| Pages: | 272 |
| Product dimensions: | 8.32(w) x 5.64(h) x 0.73(d) |
About the Author
Read an Excerpt
Chasing Medical Miracles
The Promise and Perils of Clinical TrialsBy Alex O'Meara
Walker & Company
Copyright © 2009 Alex O'MearaAll right reserved.
ISBN: 978-0-8027-1696-5
Chapter One
ENTERING THE RISKY WORLD OF CLINICAL TRIALS
I never went looking for a clinical trial. Instead one found me when my insulin pump broke. When it happened I immediately threw myself a good and fairly sizable tantrum for a thirty-eight-year-old man because the pump delivered insulin into my body like a mechanical pancreas, keeping me alive. I called MiniMed, the company that made the pump, to see if they could fix it. They sent a technician named Celeste to my house. While working out the problems with my pump Celeste told my wife and me that doctors at the University of Virginia were looking to enroll qualified volunteers in a clinical trial to cure diabetes. The experimental procedure replaces the insulin-producing cells that have died in a diabetic's pancreas with living, healthy, insulin-producing cells. Because the cells are located in a part of the pancreas called the Isle of Langerhans, the cells are called islet (eye-let) cells.
Those islet cells are taken, or harvested, from a recently deceased organ donor and infused through a tube into a person's portal vein, which leads to the liver. The idea was that once in the liver, the islet cells would nestle in and produce insulin as if they were in a pancreas. It's an amazing idea. Even more amazing, according to Celeste, was that the protocol for the study stipulated that the subjects had to be completely free of diabetic complications except for hypoglycemic unawareness. They were looking for people like me.
I, however, wasn't looking for them. Like a man sentenced to life in prison who, in order to keep sane, stops thinking about the outside world, I never considered the possibility of a cure for diabetes. I had had the disease for almost thirty years. During that time many people told me about "cures" and about how some day scientists would solve the riddle of diabetes and set me free. I would listen politely then immediately put whatever they said out of my mind. I couldn't afford to think about a cure because if I did I might start resenting all the work I had to do each day managing my diabetes.
Every day I took two or more shots of insulin, tested my blood sugar four or five times, counted the carbs and calories for every scrap of food I ate, calibrated the impact of exercise on my blood sugar, and tried to avoid seizures and comas. I had spent twenty-seven years—almost ten thousand days—dealing successfully with that narrow and rigorous reality. I was raised through high school in extreme poverty, often going without food and sometimes even without medication. I rarely saw a doctor. That upbringing forced me to become my own doctor, in a way. By the time I was putting myself through college I was a pro at controlling my diabetes. Aside from the unfortunate glasses-eating incident, the only diabetes-related drama in college I suffered was the time my college roommate saw a syringe on my desk and thought he was rooming with a heroin addict.
After graduation I became a journalist in New York, Chicago, Washington, D.C., Hartford, and Tucson, Arizona. Then I embarked on a business career and was successful in marketing, which was what I was working at when I moved across the country from Arizona to Richmond, Virginia. Although I was a diabetic I had also run four marathons and was deliriously happy in my marriage. I was doing a good job with my life, and I wasn't looking to jeopardize the good health I had worked hard to attain, and maintain, by enrolling in some experiment. Plus, I didn't want to get let down chasing some miracle that was a remote possibility at best. I just wasn't in the market for a cure.
My wife thought I should be. Once Celeste solved the problem with my insulin pump and left, Traci went to work convincing me to at least call the University of Virginia and ask about the trial. "What harm could it do?" she asked. A lot, I thought. The idea of putting insulin-producing cells from a dead person's pancreas into my liver, then expecting the cells to work, sounded too much like science fiction and not enough like science. She was unrelentingly positive, however, so I said I would call and find out more about the trial.
A few days later I spoke to Winsor, the patient coordinator for the clinical trial at UVA. She said she had received inquiries from people across the country seeking to enroll and that there was a backlog of people who had yet to go through the rigorous initial screening. Only one patient had gone far enough along in the trial to be on the list to receive a transplant.
She explained that the procedure originated in Edmonton, Alberta, Canada. More than three hundred people in Canada and the United States had so far received the transplant and, although it was early in a Phase I clinical trial, the success rate was promising. She said that 20 percent of the subjects had stopped taking insulin entirely. And 50 percent had significantly reduced their insulin. This was promising. It meant it wasn't some quack cure.
If I wanted to be considered for the study, Winsor said, I should send her my medical records confirming I had hypoglycemic unawareness. Then I would have to undergo a slew of tests, at my own expense, to demonstrate that I met the protocol criteria for the study. They were tests that I routinely had done anyway as part of my standard health-care regime. They included an eye exam for retinopathy, a degeneration of blood vessels in the eye that causes blindness; blood tests for tissue typing, cholesterol levels, and to measure the amount of protein in my urine, which was an early indicator of kidney failure; an EKG; a dental exam; and a chest x-ray.
If the results of those tests were in acceptable ranges I would stay at the University of Virginia Medical Center for an overnight evaluation where they would run more definitive tests. If I passed the evaluation, my name would be added to the national waiting list for a pancreas from a deceased donor to be used for the islet cell transplant. Once a donor match was found, I would be infused with the islet cells and placed on antirejection drugs to suppress my immune system, just like any other transplant patient. She said I would have to take the immunosuppressants for the rest of my life. Even though it sounded daunting, I was intrigued. Winsor said she would send me details about the tests and the formal protocol for the study.
That night I had second thoughts. I told Traci that the whole thing seemed like a long, involved process and that she shouldn't get too excited because I might not pass all the tests. Besides, I said, the tests would probably be really expensive. With Traci in grad school and money tight, they might be more than we could afford. Traci said we had great health insurance through my job and the tests might be covered. She said I should at least find out. Once I did, and if they were affordable, I should get the tests done and go from there. "What harm could it do?" she said. I said I would look into getting the tests.
Sometimes subjects have to take on a level of financial commitment in their clinical trial. I had paid for the cost of the initial tests but they were tests I would have had anyway as part of taking care of my diabetes, so that wasn't a burden. I was also told I would have to pay for the lifelong antirejection drugs after the transplant and that those could run me hundreds of dollars a month if they weren't covered by my insurance. I was fine with those financial possibilities.
It turned out we had exceptional insurance. I spent the next six weeks going around Richmond visiting various doctors, getting numerous tests, and sending the results to Winsor at UVA. Every doctor and nurse I told about the clinical trial was thoroughly impressed with the technology and creativity of the procedure and with the cutting-edge medicine being performed at UVA. Some, like my general care physician, said they were even impressed with me for having the courage to pursue this. I thought that was funny. If I passed the evaluation, I wouldn't be doing much. The team at UVA would be doing most of the work. But the sentiment pumped me up. It made me think I was part of something unique. For the first time, I had the idea that a cure was not only possible, it might be possible for me. Then, with only the chest x-ray needed to complete my round of tests, everything came to a screeching halt.
Winsor called to tell me there was a change in the funding for the clinical trial. A private donor whose two children had diabetes significantly funded the study. It was his desire to help eradicate the disease. However, it apparently was not his wish at that time to pay for every aspect of accomplishing this extremely expensive goal. I was told I might need to come up with as much as ten thousand dollars for post-transplant infusions of antirejection medication. On an outpatient basis I would receive an IV of immunosuppressive drugs, and each of those sessions cost two thousand dollars. All told, I might require up to five transfusions after the transplant.
I didn't have a spare ten thousand dollars, and I didn't expect to be laying my eyes or hands on that kind of money anytime soon. I told Winsor I would call her back.
Traci and I discussed it. We talked about getting loans. We talked about Traci delaying grad school and working. I suggested we could sell some things, like perhaps our cars. In the end we admitted that even if we were able to scrape up ten thousand dollars, it was a lot to invest in an experimental treatment that might not even work. I explained all this to Winsor. She said it was understandable but that I should have the chest x-ray taken so at least all the prescreening tests would be completed in case things eventually ended up moving forward. She would send me the consent form to study so I could become familiar with it. Things might change, she said. Grant money might come through. She would let me know.
I got the chest x-ray. Then I went hunting for another clinical trial also doing islet cell transplants that might not be as cost prohibitive. It turned out there were hundreds of people already in line at a few other hospitals conducting clinical trials in order to establish their own islet cell transplant capability. The few hospitals that were recruiting subjects, however, were for me too far away from Richmond to be practical. It became obvious that the trial at UVA, a long shot to be successful even if I received the transplant, was one of those once-in-a-lifetime opportunities. It was a chance I came close to, but one that I missed. After a week trying to locate an alternative to UVA, I hit a wall. I would not be a subject in a clinical trial attempting to cure diabetes. It was a letdown. Then it got worse.
The chest x-ray revealed a lump in the lower lobe of my right lung. It was 1.5 centimeters. The word that hit hardest was the one my doctor didn't say: "Cancer." That word, even though it was not uttered, sucked every thought out of my head. Sure, diabetes is a serious, life-threatening disease. It's a top-ten killer. Cancer, though, is a step up. That's a destroyer.
I was referred to a pulmonologist. I asked him if my past history of smoking might have given me cancer. He said it was too early to even start down that road. He said I should get a CT scan and an MRI. On the way out of his office he gave me a pat on the shoulder and said not to worry.
Those tests, and others, didn't clearly define what was going on with the nodule. The pulmonologist said the best thing was to take more images of the lump in six months to see if it grew or changed. If not, then his initial impression that it was benign would stand. If it was benign then we would just keep an eye on it with tests every two years or so to make sure it stayed that way. I left his office comforted by the results but bothered to be walking away with what looked like yet another chronic condition.
A week later I celebrated my thirty-ninth birthday. I took stock. I hadn't been thinking about the clinical trial for days. As far as I was concerned, it was in the past. My next "cancer" checkup was a while off so that got shoved to the back of my mind. It was the first time in months I didn't have a test to schedule, go to, or go through. I went to my job as a communications specialist at Capital One. I spent some time writing a proposal and editing the first chapters for a book my agent was hopeful about. I also started rewriting a novel so I could send out chapters to friends for feedback. I went for a run and thought about running my third New York City Marathon in November. (I was forced to stop when I popped a chunk of cartilage out from the underside of my right knee and had to settle for limping through a half marathon before getting arthroscopic knee surgery.) Some weeks went by. I relaxed. Then in late October the phone rang. It was Winsor. Funding for the postoperative immunosuppression had come through. The clinical trial was back on.
Winsor made sure I had studied the consent form, then asked if I could come in for an overnight evaluation. She said I was their most promising candidate. They wanted to get moving as soon as possible. How does early November sound? she asked.
Traci asked if she should be there for the evaluation. By that time I was an old hand at being in hospitals, whether for tests or disasters. I told her it would probably be best if she stayed home and dealt with school.
On a crisp early November day in 2004 I drove an hour to Charlottesville from Richmond and rode the elevator to the General Clinical Research Center (GCRC) on the eighth floor of the UVA Medical Center. I walked down a plushly carpeted hallway to the nurses' station where I found four nurses—three brunettes and one blonde. They all smiled at me.
I said hello and they greeted me warmly, like I was an old friend or a VIP.
A doctor walked up and asked, "Who do we have here?"
"This is Mr. O'Meara," one nurse said. "Our transplant candidate."
"Excellent!" he said beaming. "Excellent. Welcome."
I'd been in hospitals in five states and I'd never been treated like this. It was like I was being greeted at an airport courtesy lounge in Japan.
One nurse, who introduced herself as Emelita, led me to my room.
The walls of the hallway were oak paneled, and instead of the standard hospital interrogation-style fluorescent lights the place was illuminated by muted, soft recessed lighting. The deep carpeting and the wood muffled the sounds of voices and hospital machinery until it became a soothing background hum.
Where was the linoleum? What about the institutional green hospital walls? Where were the harsh white lights that gave you an instant headache? Where was the expert, tough, and taciturn staff? Were these people for real?
Once in my room I put my bag on the bed by the window. I had a gorgeous view of the UVA campus. I could see the University of Virginia Rotunda designed by Thomas Jefferson, and the east wing of the medical center.
I changed into shorts and a T-shirt, sat on the edge of the bed, and thought about what might happen over the next two days. I imagined undergoing a barrage of tests. Nurses would draw and centrifuge my blood. They would collect my fluids and measure them in test tubes. Numbers, reports, graphs, trends, and microgram comparisons of what happened in my body would be generated and evaluated by doctors. Information about me would be noted and debated by medical experts to see if I was a good candidate for a risky transplant that could cure diabetes.
I sat there thinking about everything that would be coming up and it suddenly freaked me out. Was I worthy of all this attention and effort? The cost of the transplant alone had to be staggering, and I wouldn't be paying a dime for it. While I was very healthy, my diabetic lifestyle hadn't been exemplary. I had downed my share of beer and pizza. Did those transgressions reveal a dark flaw in my character that made me a less-than-perfect specimen for scientific study?
(Continues...)
Excerpted from Chasing Medical Miracles by Alex O'Meara Copyright © 2009 by Alex O'Meara. Excerpted by permission of Walker & Company. All rights reserved. No part of this excerpt may be reproduced or reprinted without permission in writing from the publisher.
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Table of Contents
Preface vi
Introduction 1
Chapter 1 Entering the Risky World of Clinical Trials 7
Chapter 2 The Right and Wrong of Clinical Trials 20
Chapter 3 Money Makes the Trial Go 'Round 54
Chapter 4 Legal Trials 85
Chapter 5 There's a Subject Born Every Minute 97
Chapter 6 Going Global 122
Chapter 7 The Perfect Laboratory for Clinical Trials 150
Chapter 8 The Stories Behind the Subjects 172
Chapter 9 Transplanted 198
Afterword: Volunteering for a Clinical Trial 218
Acknowledgments 225
Notes 226
Index 256