Human Trials: Scientists, Investors, And Patients In The Quest For A Cure. (Books).Ever wonder, when you read about this or that drug for MS that's in "Phase I" or "Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA " trials, what all that looks like in the lab? Or perhaps you're disappointed when a particular drug, which your doctor told you sounded promising, turns out not to have been as effective in trials as you'd hoped. Ever wonder what the scientists working on that drug feel, after they've poured years of their lives into it? In Human Trials, Susan Quinn explores the work of Dr. Howard Weiner, now a professor at Harvard University Harvard University, mainly at Cambridge, Mass., including Harvard College, the oldest American college. Harvard College Harvard College, originally for men, was founded in 1636 with a grant from the General Court of the Massachusetts Bay Colony. , who's been intrigued by multiple sclerosis since he was a neurology neurology (n rŏl`əjē, ny –), study of the morphology, physiology, and pathology of the human nervous system. resident in 1971. (Dr. Weiner was recently inducted into the National MS Society Hall of Fame for his years of volunteer work for the Society.) As a researcher, he became intrigued by the concept of "oral tolerance"--the idea that eating a small dose of an immune system immune systemCells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. target, or antigen, would turn off the immune system's attack against that antigen. In 1986, Weiner embarked on a nearly 15-year effort to apply this principle to the treatment of MS. In the process, he founded a biotechnology company called AutoImmune autoimmune /au·to·im·mune/ (-i-mun´) directed against the body's own tissue; see under disease and response. au·to·im·mune adj. , which conducted trials for Myloral, or oral myelin basic protein Myelin basic protein (MBP) is a protein believed to be important in the process of myelination of nerves in the central nervous system (CNS). MBP was initially sequenced in 1979 after isolation from myelin membranes [1] , for people with MS, as well as similar substances for diabetes and rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. . None of AutoImmune's trials showed a better response than for a placebo. But Weiner hasn't given up on the concept of oral tolerance. Human Trials is framed for the most part around the life cycle of AutoImmune, Inc. In so doing, Quinn gives us perhaps the most cogent COGENT - COmpiler and GENeralized Translator one-chapter history of MS ever written, and makes vivid and real the portraits of patients, researchers, and scientists along the spectrum, from Weiner himself to his employees. Quinn presents brilliantly the complex matrix of choices made by scientists constructing clinical trials and the way results are interpreted (what does the placebo effect placebo effect n. A beneficial effect in a patient following a particular treatment that arises from the patient's expectations concerning the treatment rather than from the treatment itself. mean, for example?). She makes us care about all the scientists, investors, and patients with their hearts set on Myloral's success. One might wish she'd been a little more explicit in highlighting the tensions between science and commerce. The book does not discuss the possible conflicts between a company's need to encourage its investors and the need of researchers to share information freely. In the absence of explicit discussion of such issues, this reader could have done without the several chapters devoted to the building of AutoImmune, Inc. None of this detracts from Quinn's major accomplishment--creating a gripping narrative of the Myloral drama, with vivid characters and a definite dramatic arc. Reading Human Trials also makes a person with MS feel like a part of the international conversation that is medical research--the conversation that's ongoing, and necessary, for any successful treatment of complex diseases like MS. Perseus Publishing, 2001, 320 pp., $26. Tollfree: 800-386-5656; e-mail: <westview.orders@ perseuspublishing.com>; Web site: <www.perseus publishing.com>. Reviewed by Chris Lombardi, who wrote the feature on the Winter 2002 Paralympics on page 20. |
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