What the Doctor Didnt Say: The Hidden Truth about Medical Research

Hardcover | August 15, 2006

byJerry Menikoff, Edward P. Richards

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Millions of people each year decide to participate in clinical trials--medical research studies involving an innovative treatment for a medical problem. For the patient, such participation can sometimes be a life-saving choice. But it can also be just the opposite. Our country years agoadopted rules designed to assure that people are making informed choices about participation. This book explains the reality behind those rules: that our current system of clinical trials hides much of the information patients need to make the right choices. Witness the following scenarios: -Hundreds of patients with colon cancer undergo a new form of keyhole surgery at leading cancer centers--never being told that 85% of colorectal surgeons, worried that it increases the risk of the cancer returning, would not themselves undergo that procedure. -Tens of thousands of women at high risk of developing breast cancer are asked to participate in a major research study. They are told about the option of having both breasts surgically removed--but not told about the option of taking a standard osteoporosis pill that might cut the risk of gettingbreast cancer by one-half or more. What The Doctor Didn't Say, principally written by a nationally prominent expert, is the first book to reveal many heretofore hidden aspects about the true nature of participation in clinical trials. It shows why options not commonly known--including getting a new treatment outside of a researchstudy--can often be the best choice. It explains how patients can make good decisions even if there is only limited information about a treatment's effect. And it does this through the eye-opening stories of what is happening daily to thousands of people. This book ends up confronting the fundamental dilemma of medical research: Participation in clinical trials plays a vital role in advancing knowledge, and many experts fear that if the information provided herein became widely known, fewer people would participate. But the authors demonstrate thatthere is no need to deceive people into participating in research. We can have a system that promotes participation while still providing truthful information to participants.

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Millions of people each year decide to participate in clinical trials--medical research studies involving an innovative treatment for a medical problem. For the patient, such participation can sometimes be a life-saving choice. But it can also be just the opposite. Our country years agoadopted rules designed to assure that people are m...

Jerry Menikoff is Associate Professor of Law, Ethics and Medicine at the University of Kansas School of Medicine, where he is also Director of the Institute for Bioethics, Law and Public Policy and chair of the Human Subjects Committee. He is also Associate Professor of Law at the University of Kansas School of Law. He is the author o...
Format:HardcoverDimensions:336 pages, 6.3 × 9.29 × 0.79 inPublished:August 15, 2006Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0195147979

ISBN - 13:9780195147971

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Table of Contents

1. The Dilemma of Human ResearchPart I: How Good Studies Can Be Bad Choices2. The Nature of Research3. A Case Study: The Difference Between Being a Patient and Being a Research Subject4. How the Law Protects Patients Who Get Non-Standard Care5. The Weakened Legal Protections Given to Research Subjects6. How Bad for the Subjects Can the Study Be?Part II: Consent: What Are Subjects Told?7. What Informed Consent Requires8. The Anatomy of a Consent Form9. The Good, the Bad, and the Ugly Research Study: From Consent to Choice10. The Hidden AlternativePart III: When Consent Can't Be Obtained11. Incompetent Adults12. Emergency Research13. Children in Research: The Basic Rules14. Can Children Be Enrolled in Studies That Are Bad for Them?15. Research and ReproductionPart IV: The Role of Money16. Should Research Subjects be Paid?17. Compensating Researchers: Dealing with Conflicts of InterestPart V: The Challenge for the Future18. Where Do We Go From Here: The Paradox of Pediatric Oncology ResearchIndex

Editorial Reviews

"His observations regarding clinical trials in the way they are typically conducted are striking...Insightful and sometimes painfully honest book."--Journal of Legal Medicine