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Human Trials: Scientists, Investors, and Patients in the Quest for a Cure

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"In the never-ending war between science and disease, the heroes are many, the victories few. Human Trials is the gripping story of one of the battles in that war, an attack on autoimmune disease, and of the brave and hopeful patients, dedicated scientists, and bold venture capitalists who become allied in the struggle." "Susan Quinn's story takes the reader into the closed world of experimental drug trials in which new drugs are developed: Her account is told from inside, from the lead investigator's diaries, the closed-door meetings with
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Scranton, Pennsylvania, U.S.A. 2001 New 0738201820. 320 pages----Choose us, for the information you need, with personal service--DESCRIPTION: --"In the never-ending war between ... science and disease, the heroes are many, the victories few. Human Trials is the gripping story of one of the battles in that war, an attack on autoimmune disease, and of the brave and hopeful patients, dedicated scientists, and bold venture capitalists who become allied in the struggle. " "Susan Quinn's story takes the reader into the closed world of experimental drug trials in which new drugs are developed: Her account is told from inside, from the lead investigator's diaries, the closed-door meetings with investors, and the hopeful or heartrending encounters in doctor's offices. The target of these particular "human trials" is autoimmune disease-the set of major incurable afflictions, affecting over 50 million people, which include multiple sclerosis, arthritis, lupus and diabetes-in which the body attacks its own tissue. "-- Read more Show Less

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Overview

"In the never-ending war between science and disease, the heroes are many, the victories few. Human Trials is the gripping story of one of the battles in that war, an attack on autoimmune disease, and of the brave and hopeful patients, dedicated scientists, and bold venture capitalists who become allied in the struggle." "Susan Quinn's story takes the reader into the closed world of experimental drug trials in which new drugs are developed: Her account is told from inside, from the lead investigator's diaries, the closed-door meetings with investors, and the hopeful or heartrending encounters in doctor's offices. The target of these particular "human trials" is autoimmune disease - the set of major incurable afflictions, affecting over 50 million people, which include multiple sclerosis, arthritis, lupus and diabetes - in which the body attacks its own tissue."--BOOK JACKET.
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Editorial Reviews

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The Barnes & Noble Review
We are living in the age of clinical trials, where millions of dollars are spent on research for the prevention, cure, or amelioration of a host of diseases. It's a complicated interaction that involves clinical research teams, whose passion for science comes in conflict with the realities of the massive expenses required to maintain research labs; pharmaceutical companies, whose eagerness to collaborate with researchers rests on potential giant financial gains; and patients, whose only hope for cures may lie in the unproven medications (or placebos) they will take.

Human Trials describes in fascinating detail the high stakes universe of clinical science. The author, Susan Quinn, follows one Harvard University physician, Howard Weiner, whose results with lab mice show the potential for bringing multiple sclerosis patients into long-term remission. We are introduced to a crew of dedicated scientists who shared his early successes and to the subsequent roller coaster ride, involving everything from the struggle to find the optimal dose -- how much of the drug can they give before the side effects outweigh the benefits -- to the issues of physicians faking records ("dry-labbing"), to the heartbreaking news that the placebo in a trial works as well as the experimental drug, which also seems to work quite well.

The heart of the book is an ongoing exploration of the profound contradiction that exists between research and business. The author examines what happens when academic ethics, which mandate that knowledge be shared, and the proprietary mentality of the profit sector, which insists that information be held back for the sake of future profits, are brought together in a state of mutual dependency. This is a gracefully written, accessible, informative, and thought-provoking book that illuminates the brave new world of medical science and commerce. (Judith Estrine)

Nature
A readable and authoritatively written insight into what is at stake when a determined and talented scientist puts his ideas on the line...
Nature Biotechnology
Eminently readable.
Nature Medicine
A well-told story, with a lucid, linear narrative. For laypeople unfamiliar with clinical trials, it serves as an intelligible introduction.
Pharos
Quinn captures and holds the reader even when the characters are not admirable. (The Pharos - Alpha Omega Alpha Honor Medical Society)
New Scientist
Read this modern American tale...Human Trials gives valuable insight into how science gets from the lab to the clinic via the stock market.
Journal of Social Work Education
Provides a window into a world with which few people are familiar.
Washington Monthly
A sobering view of why the search for medical miracles involves enormous risk.
Inside MS
Quinn presents brilliantly the complex choices made by scientists constructing clinical trials and the way results are interpreted...A gripping narrative.
Key Reporter (Phi Beta Kappa)
[Quinn] eloquently presents issues related to clinical trials, including ethical aspects and the nagging problem of the placebo effect.
Oncology Times
[A] compelling story...an entertaining look at several phenomena of the scientific world...a human drama of pain, triumph, loss, and hope.
Business Week
Packed with valuable information...should be required reading for doctors, investors-and for patients deciding whether or not to participate in a clinical trial.
Bookwatch
Draws unusual and important connections between scientists, investors, and how drug trials are financed and conducted.
Choice
Clearly written...a compelling description of our current engagement with an incorrigible disease.
Roanoke Times
Illustrates some of the unrecognized factors of medical research. This meticulous analysis highlights the many aspects of the journey.
Institutional Investor
[Quinn] does an impressive job of explaining complicated science and the politics of lab research. A fine writer.
New York Daily News
Quinn offers readers a real-life thriller.
Medscape.com
Gives the reader a Paul Harvey-esque 'here's the rest of the story' look at clinical research...a very readable accounting.
Salon.com
An important read...a revealing inside look at the drama and frailty of our system of human experimentation.
Library Journal
How are new drugs conceived and tested? Quinn (Marie Curie: A Life) attempts to answer that question as she follows the quest of Harvard neurologist Howard Weiner. Using observations from Weiner's personal journals along with interviews and videotapes of key events, Quinn portrays the personal hopes and frustrations that are part of the drug trial process. Weiner's team strives to produce safe, easy-to-ingest drugs for individuals with autoimmune diseases such as multiple sclerosis and rheumatoid arthritis. Quinn's absorbing book follows the formulation of the drugs from the basic biological theory to fund-raising efforts and, finally, the formulation and execution of the trials. The human aspects of the process are very evident as the reader is introduced to the researchers, investors, doctors, and, most importantly, patients involved in the trial. Lacking both an index and a bibliography, this volume is aimed at general readers. Recommended for public libraries. Tina Neville, Univ. of South Florida Lib., St. Petersburg Copyright 2001 Cahners Business Information.
Booknews
Quinn (a biographer) has written a case study of a lengthy trial led by Howard Weiner, director of the Multiple Sclerosis Center at Brigham and Women's Hospital in Boston, to invent a new drug for MS. She has written this narrative for the non-specialist reader, describing the deliberations with the drug company, the expectations of the scientists, the hopes of the patients who took part in the clinical trials, and the role of the venture capitalists who financed the study. Her research was drawn from interviews, her observations of events, tapes and video recordings, and Weiner's journals. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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Product Details

  • ISBN-13: 9780738201825
  • Publisher: Da Capo Press
  • Publication date: 5/15/2001
  • Edition number: 1
  • Pages: 320
  • Lexile: 1120L (what's this?)

Meet the Author

Susan Quinn is the author of two highly praised biographies: A Mind of Her Own: The Life of Karen Horney and Marie Curie: A Life. She lives in Brookline, Massachusetts.

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Read an Excerpt


Chapter One


The Clinic


Most of neurologist Howard Weiner's days are spent in his laboratory or on the road, talking at conferences. But on Tuesdays, he takes the white coat, size 42 long, down from his office door, pulls it on over his blazer, and walks from his lab to the multiple sclerosis clinic at Brigham and Women's, a Harvard teaching hospital in Boston.

    On this particular Tuesday, it's windy and cold as he heads across the mall of Harvard Medical School, his white coat flapping, at a walk that verges on a trot. Inside the hospital, he swings by the coffee shop and picks up juice and a blueberry muffin to be consumed between consultations, and hurries down the long corridor everyone calls "the Pike."

    On the Pike, which connects the old and new Brigham hospital buildings that have accumulated over a century, Weiner slows momentarily to meet and greet other white coats moving in the opposite direction. Then he hurries across the grand hospital lobby and through the neurology waiting area to the doctors' room, where he scans the roster of multiple sclerosis patients he will see that morning. As usual, he recognizes most of the names on the list: Many of them are long-term patients, and most of them are not doing very well. "There are some very sick people coming in today," he says softly.

    Howard Weiner is a fit six-footer with thick glasses that can make his eyes look wild. His hair used to be abundant and curly, but now that he's in his fifties, it's slicked down and thinning on top, adding prominence to hisnose. He has a gleaming smile that flashes often, but he is incapable of irony or sarcasm. Because of his deep bass voice and his earnestness, one of his poker buddies thinks he would have made a good rabbi. Weiner, however, has chosen to devote himself to another mission: finding a cure for multiple sclerosis. Even after thirty years of searching, including many setbacks and frustrations, his zeal is undiminished.

    Weiner has always been an activist when it comes to treating multiple sclerosis. "I think you've got to be doing something," he frequently declares. To buttress his argument, he sometimes quotes a line from King Lear: "Nothing will come of nothing." But the truth is that, much of the time, multiple sclerosis defeats his interventions. That's why, on Tuesday evenings, he so often writes in his journal about how "tough" his day in the clinic has been. He doesn't like seeing people getting worse.

    The first patient on the roster this Tuesday morning is new to him. She is Harriet M., a forty-three-year-old from New Hampshire who is experiencing numbness in one arm and has come to get a second opinion. Harriet is a small woman with curly, bleached hair that creates a halo around her face. She is wearing comfortable knit pants, which accommodate her slender waist and full, low hips, and a short T-top reveals a little of her firm midriff. Her eyes look puffy and tired, but her skin is smooth and youthful, and her arms look strong. She lifts weights, she tells Weiner, takes care of herself.

    There are two children—a son out in Las Vegas, "sowing his oats" working as a blackjack dealer, and a fifteen-year-old daughter still at home. And there is a husband, sitting there next to her with his arms folded across his round belly, outwardly calm. The neurologist in the small town where they live wasn't entirely sure whether she had MS or not, she explains to Weiner, and wanted to wait a couple of months before starting any treatment. Their son, worrying on the phone from Las Vegas, said he thought that the doctor was too nonchalant. So the two of them took the day off from work—she has a clerical job, he runs a news distribution service—and started out for Boston before dawn on this brisk November morning for an appointment with Howard Weiner, an expert who can clear things up, for better or for worse.

    Weiner listens to Harriet's story, a variation on hundreds of others he has heard in the MS clinic over the past twenty-five years. Eight years ago, she had a cold that resulted in dizziness and numbness on one side of her face. Her doctor referred her to an ear specialist, guessing that she probably had an inner ear disturbance related to the infection. But for two years after that, when she looked at her feet, she got a strange sensation in her back. When her left arm began to get numb recently, she thought it might be because she had carpal tunnel syndrome from her job. That was when her doctor mentioned MS as a possibility.

    The story has revealed a lot to Weiner. Probably, the facial numbness eight years ago was a first MS attack. Most telling is the report that Harriet has been feeling shocks down her spine for the last two years when looking at her feet. This was probably the "Lhermitte's sign," caused by a lesion in the spinal cord that increases pressure when the neck is bent forward and down. It is a classic symptom of multiple sclerosis. So far, though, Weiner is going only on the patient's history. Now he asks her to sit on the end of the examining table so that he can run through the neurologic exam.

    Howard Weiner likes to come prepared: His family teases him that he never comes home to Colorado without a set of clothes for every kind of weather. He always carries an extra laser pointer with him when he's giving a talk, just in case. Similarly, Weiner keeps his white coat fully equipped for clinic days. On one breast pocket is the white plastic tag bearing the wavy crest of "the Brigham," next to the words "Howard Weiner, M.D., Neurology" and inside there's a plastic eye chart and a tuning fork for testing sensations. A black rubber reflex hammer and stethoscope weigh down the lower right pocket and there's a prescription pad, lower left. His car keys, also essential, are dropped in at the last minute.

    Now he taps Harriet's knee with his reflex hammer. He runs his car keys along the arches of her feet, noticing that her right big toe turns up instead of down, as it would in a normal subject. He asks her to follow his finger with her eyes, looking for "disconjugate eye movements," which indicate that the brain stem has been affected. Finally, Weiner watches Harriet walk, a slight bit unevenly, from one end of the corridor at the Brigham clinic to the other.

    By the time he's finished the neurologic exam, he strongly suspects that Harriet has an MS lesion affecting the left side of her body. But he won't say anything until he's taken a look at the films she brought along. He carries the giant manila envelope down to the doctors' room and throws the stiff films up, two at a time, onto the view box. Very quickly he finds a white spot on the vertical ropes of gray that tells him she has a lesion on the left side of her spinal cord, in the neck area, then two other lesions in the brain. To Weiner, the conclusion is now unavoidable: This woman has multiple sclerosis.

    Diagnosing MS is tricky, because the symptoms are various, and they come and go. But for a long time, diagnosis was about the only thing neurologists could do. "For a neurologist," writer and MS patient Nancy Mairs wrote in 1989, "MS must be the worst possible fate, worse even than a brain tumor," which offers a "chance for heroic rescue.... With MS, they stare powerlessly, sometimes for decades, at inexorable degeneration."

    Until the 1990s, there were no drugs specifically designed to treat MS, and very few that helped. Steroids could be given to calm inflammation, but they had no effect on the progress of the disease. "Neurologists described patients and diseases and wrote atlases about them," says neurologist Larry Levitt, "But they didn't do much. They were very nihilistic about multiple sclerosis—they'd say come back in six months and I'll recheck to see if you have even further trouble walking."

    Levitt, who practices now in Allentown, Pennsylvania, was Howard Weiner's chief resident when the two of them trained at Harvard. He has watched his old friend Weiner challenge this nihilistic attitude about MS in his research and treatment, sometimes incurring harsh criticism from colleagues. When Weiner initiated an MS trial of a drug previously used in cancer treatment, back in the late seventies, many in the field faulted him because the underlying mechanisms that caused the disease were unknown. "He recognized and admitted the fact that it wasn't the best way to do it," Levitt says, "but it offered hope and was effective in some cases."

    In recent years, Weiner has had a lot of company, as neurology has moved from passive observation to active intervention. MS trials abound, even though the disease mechanism is still only partially understood. When the American Academy of Neurology gathered in Boston in 1997, the meeting had a title that reflected this change. "Revolution in Neurology" appeared in bold letters on the thick program, with the R doing double duty in the symbol Rx. By 2000, there were about 100 clinical trials planned, in progress, or recently completed.

    Some successes have emerged from all this activity.

    There are three drugs on the market that target MS: Avonex, Betaseron, and Copaxone. The ABC drugs, as they are called in MS circles, have given new hope to patients, but they are not the cure. The drugs can reduce the MS attack rate by only about 30 percent, and they don't work in all cases. All three must be given by injection on a frequent basis, and there are sometimes side effects. In addition to the ABC drugs, chemotherapy agents are gaining acceptance for the treatment of certain forms of rapidly advancing MS. But these, although sometimes dramatically effective, have worse side effects than the ABC drugs.

    About fifteen years ago, Howard Weiner got an idea for an entirely new and potentially revolutionary approach to multiple sclerosis. This approach, if successful, could result in a safe, oral treatment not only for MS but also for other diseases with similar autoimmune characteristics. From the moment he discovered that the approach worked in animals, he believed its development was going to be his crowning scientific achievement. The idea, called "oral tolerance," was ridiculed in the beginning, but it has since become the focus of research in laboratories all over the world. So far no one has been able to show conclusively that it works in treating human disease. "Sooner or later," Weiner insists, "it has to work. When that happens, I'll be a happy man."

    For the New Hampshire couple who have come to see him on this Tuesday, however, such dreams of future breakthroughs are no comfort. Weiner enters the room where Harriet and her husband are waiting and hoists himself onto a swivel stool. With his hands clasped around one knee, he turns to face the couple. When you have only one symptom, he begins in his low, ponderous voice, then it's difficult to know if it's MS. But when a number of symptoms point in the same direction, as in this case, it becomes possible to make a diagnosis. Then, incongruously, Weiner offers the New Hampshire couple a big-city analogy: When you see the Empire State Building and Central Park and Madison Square Garden, he tells them, you know you're in New York.

    Neither of them smiles, or even seems to hear what Weiner has just said. But then, as he starts to speak again, the woman stops him. "Wait a minute," she says in a trembling voice. "You say you think I have MS. It's not for sure?"

    "No," Weiner answers firmly. "It is MS. I have no doubt."

    He continues. "MS is an autoimmune disease of the nervous system in which some of your cells attack your own tissue. You probably had a first attack eight years ago, and that's lucky, because there has been a long interval between attacks. But with MS, it's impossible to know the future. It's a little tike being in a boxing ring where you keep getting hit by an invisible opponent. You may be in the ring with a five-year-old who doesn't hit too hard. Or you may be in there with a pro who does."

    None of this is registering with the patient, and only a little with her husband. "Do you understand?" Weiner asks. "Well, right now I ..." her voice trails off. She is staring at the floor, about to cry. Understanding will be a long and complicated process.

    Back in the doctors' room, Weiner picks distractedly at the dome of his blueberry muffin and washes it down with juice as he dictates his orders into a small recorder. He recommends that Harriet start immediately on a course of injections of one of the ABC drugs, combined with a course of intravenous steroids to calm the current inflammation. Before he moves on, he tells MS clinic nurse Lynn Stazzone that the patient is "scared" and needs to talk more about what she is facing.

    In his research Howard Weiner accepts, reluctantly, the slow pace of progress. But when a meeting goes on too long he can be seen glancing at his watch. When it comes to sitting with patients in distress, he relies on Lynn Stazzone. Lynn is famous for taking as much time as necessary. One of her patients confides that she sometimes tires of waiting for Lynn, who is often late, but then her turn comes, and she knows Lynn is completely available to her for as long as she needs her. Then she forgives her.

    Before she leaves on this day, Harriet will talk over the meaning of her diagnosis with Lynn Stazzone and she will be loaded down with literature. After she leaves, if she is like most MS patients, she will continue to investigate with a fury. She will do what one patient called "going to Dr. Library." She will contact the MS Society, which provides information about support groups and MS walks. She may well log on to the chat rooms on the Internet, where hours are spent comparing symptoms, treatments, and strategies. In the end, she will be forced to conclude that MS is a frightening and capricious disease.

    MS is rarely fatal. But future attacks may result in vision problems, speech impairments, and incontinence, and occasional diminished intellectual capacity, as well as disabling paralysis that can affect arms as well as legs. Walking is likely to become difficult as the disease progresses, and she could eventually end up in a wheelchair, unable to use her legs at all.

    Of all the afflictions of multiple sclerosis, the most difficult may well be the disease's unpredictability. In Harriet's case, as Weiner noted, it is a good sign that she had her first attack eight years before. On the other hand, the eight-year interval is no guarantee of anything. Many patients whose disease has been mild for years take a sudden turn for the worse, and end up with paralysis and other distressing symptoms. In medical parlance, a disease that is "relapsing and remitting" can become, for no apparent reason, "progressive." So when the patient asks that most important question, "What's going to happen to me?" the doctor can only answer, "I don't know."

    Sometimes there are happy surprises, as inexplicable as the unhappy ones. Waiting for Weiner in another examining room is Natalie H., a sixty-five-year-old with the mildest possible MS. Coming to see Weiner, as she has for many years, means taking a break from a life of travel. Natalie is trim, tanned, well coiffed. Her hands are manicured and adorned with gold bracelets. As Weiner goes through the motions of the neurological exam, she talks about her golf game: She still walks well enough to keep it up, she tells him, though she has some numbness in her hands, which affects her putting. She treats Weiner as the young doctor he was when their relationship began. She teases and he teases back. Weiner is grinning as he leaves her.

    The rest of the patients Weiner sees this day are not so lucky. Carol S., a woman of about sixty, transfers her weight from a wheelchair to a walker and makes her way, with great effort, along the corridor. Given a choice, Weiner himself always walks very fast. So it is ironic that he is the inventor of something called the "ambulation index," which measures the often slow pace of MS patients. The index allows him to assess changes in walking ability, from one appointment to the next. On clinic day his father's Rolex, which usually moves him briskly through his daily printout of appointments, is put to a different use—timing patients as they walk, slowly and often with great difficulty, the length of the clinic corridor. The ceiling panels above serve as his unit of measurement. Carol S. seems to think she's moving better than last time, but Weiner, glancing from his watch to the ceiling panels, has a slightly pained, doubtful look on his face. Both doctor and patient know there isn't very much that conventional medicine can do for her anymore.

    But Carol has brought a sheaf of papers describing a nutritional program that she hopes will help. It has to do with someone's complicated theory about the connection between MS and allergens and the blood-brain barrier, and it requires a number of unusual lab tests. Weiner agrees to look into it. In fact, this will be yet another task for the MS clinic nurse, Lynn Stazzone. Minutes later, she is on the phone with the lab people, trying to explain her reasons for needing tests the lab has never heard of.

    "I think you have to do everything you can to support people," Weiner says. "Many of them are trying to put some order onto their life, onto their disease, trying to find some way to help themselves. I never ridicule them for crazy things." But the fact that so many patients are seeking alternatives is yet more evidence that Western medicine has weak answers when it comes to multiple sclerosis.

    Women are twice as likely as men to get MS. So it is not surprising that there is only one man on Weiner's roster this morning. He is a doctor, an anesthesiologist whose disability has made it impossible for him to work at his specialty. He attempts the ambulation test with a walker, but it's so belabored that Weiner stops him. He is only fifty, but he looks older, pale, and unwell, sitting in his wheelchair. He agrees to a new treatment, hoping that it will work better than the ones he's tried so far. "I think he was going down like this," Weiner say's, bending his hand toward the floor, "and we maybe changed the angle of his decline a little bit. Dramatic impact we haven't had."

    The last patient of the morning is the most desperate. There isn't any chance this woman, who is in her late forties, could take the ambulation test. Her legs are pencil-thin from disuse, her head is fixed to one side, and there are hesitations in her speech. She is wearing nice clothes: a matching sea-green skirt and blouse and a little black jacket. But everything in her life seems to be going from bad to worse. She's battling incontinence (an MS symptom) and she smells of urine. She has had an infection that put her in the hospital with something close to toxic shock. She took a leave from her job two months earlier without pay. Yet she still hopes to go back to work, and she asks Weiner over and over about new drugs she could possibly take. Most of them aren't possible, as Weiner explains with studied patience. Weiner agrees to try a low dose of methotrexate, an immune suppressant, but only after a liver test determines she can handle the side effects. "I'd like to try something," she tells him, the tears welling up, "because I'm definitely getting worse."

    Outside the examining room, Weiner admits that the methotrexate probably won't help this woman. Once someone has been in a wheelchair for a while, it's too late to do much. The earlier you treat the disease process, the more likely you are to have an effect. But even among those in the early stages of MS, there are responders and nonresponders.

    The same unpredictability that makes MS so hard to treat makes it difficult to study. There is simply no usual course for the disease: Some cases are mild, some severe, some progress rapidly, and in some there are long lapses between attacks. How is it possible to measure the effectiveness of a treatment, if every MS patient's disease behaves differently? The difficulty of this task is one of the reasons a highly effective treatment for MS has been so elusive. But then, as Howard Weiner points out, none of the diseases that still confound biological science are easy or uncomplicated. "The low-hanging fruit has been picked."

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Table of Contents

Acknowledgments ix
Note to Reader xi
Chapter 1 The Clinic 1
Chapter 2 The Disease 13
Chapter 3 The Lab Director 21
Chapter 4 The Researchers 41
Chapter 5 The Big Idea 53
Chapter 6 The Capitalists 65
Chapter 7 Off and Running 87
Chapter 8 The Road Show 107
Chapter 9 The Investigators 121
Chapter 10 The Next Question 139
Chapter 11 Results 157
Chapter 12 Not the Last Supper 183
Chapter 13 The Rheumatologists 209
Chapter 14 Two Meetings 227
Chapter 15 Human Trials 247
Chapter 16 The End 265
Chapter 17 The Beginning 277
About the Author 297
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