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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 ago adopted rules designed to make 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 getting breast 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 research study--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 whatis 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 k
Jerry Menikoff is Associate Professor of Law, Ethics & Medicine at the University of Kansas School of Medicine, where he is also Director of the Institute for Bioethics, Law & 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 of a leading textbook on law and bioethics and co-author of a textbook on the ethics and regulation of research with human subjects. He has on a number of occasions served as a consultant to the federal government on issues relating to protecting research subjects.
Edward P. Richards is Harvey A. Peltier Professor of Law at the Louisiana State University, where he directs the program in Law, Science, and Public Health. He has published several books and more than 100 articles on health and public health policy, and has consulted with state and federal agencies on public health and policy. He worked in medical research before becoming a law professor and has taught both FDA and biotechnology law.
1: The Dilemma of Human Research
Part I: How Good Studies Can Be Bad Choices
2: The Nature of Research
3: A Case Study: The Difference Between Being a Patient and Being a Research Subject
4: How the Law Protects Patients Who Get Nonstandard Care
5: The Weakened Legal Protections Given to Research Subjects
6: How Bad for the Subjects Can a Study Be?
Part II: Consent: What Are Subjects Told?
7: What Informed Consent Requires
8: The Anatomy of a Consent Form
9: The Good, the Bad, and the Ugly Research Study: From Consent to Choice
10: The Hidden Alternative
Part III: When Consent Can't Be Obtained
11: Incompetent Adults
12: Emergency Research
13: Children in Research: The Basic Rules
14: Can Children Be Enrolled in Studies That Are Bad for Them?
15: Research and Reproduction
Part IV: The Role of Money
16: Should Research Subjects Be Paid?
17: Compensating Researchers: Dealing with Conflicts of Interest
Part V: The Challenge for the Future
18: Where Do We Go From Here: The Paradox of Pediatric Cancer Research
