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You are here > Home > Reading Lists > Healthcare Policy & Politics > What the Doctor Didn't Say: The Hidden Truth about Medical Research

What the Doctor Didn't Say: The Hidden Truth about Medical Research
Jerry Menikoff, Edward P. Richards

Hardcover: 336 pages
ISBN 0195147979
9780195147971
Oxford University Press, USA
September 2006
Price $29.95

 

Patients at Risk helps to empower patients to survive in a world of medical uncertainty, and makes positive recommendations for systemic reform.

Most people know precious little about the risks and benefits of participating in a clinical trial - a medical research study involving some innovative treatment for a medical problem. Yet millions of people each year participate anyway.

Patients at Risk explains the reality: that our current system intentionally hides much of the information people need to make the right choice about whether to participate. For example, 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.

Patients at Risk, written by two nationally prominent experts, is the first book to reveal the secrets that many in the research establishment have fought long and hard to keep from patients. 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 treatments effect. And it does this through the eye-opening stories of what is happening daily to thousands of people. Day after day, we are learning how little we know about what really works. Headlines regularly announce that a previously unquestioned treatment hormone replacement therapy, drugs such as Vioxx or Celebrex may now be much riskier than we thought. These are the book's chapters:

  • The dilemma of human research
  • The nature of research
  • A case study: the difference between being a patient and being a research subject
  • How the law protects patients who get nonstandard care
  • The weakened legal protections given to research subjects
  • How bad for the subjects can a study be?
  • What informed consent requires
  • The anatomy of a consent form
  • The good, the bad, and the ugly research study : from consent to choice
  • The hidden alternative
  • Incompetent adults
  • Emergency research
  • Children in research: the basic rules
  • Can children be enrolled in studies that are bad for them?
  • Research and reproduction
  • Should research subjects be paid?
  • Compensating researchers: dealing with conflicts of interest
  • The paradox of pediatric cancer research
  • Where do we go from here?

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 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. 

"Take my advice: study carefully this deftly written account of the hackneyed myths and jarring realities of human subjects experimentation." --Jerome P. Kassirer, M.D., Distinguished Professor, Tufts University School of Medicine, Editor-in-Chief Emeritus, New England Journal of Medicine

"A very good book, precisely because it is so disturbing. All of us tend to think that medical research will continue to progress in linear fashion. Yet as Jerry Menikoff's comprehensive and insightful book reveals, many hidden obstacles lie along the path to medical improvements. Most patients enroll in clinical trials because they are desperately ill, and rightly concerned with their own health and welfare. Menikoff highlights the genuine conflicts of interest between care for the patient and the advancement of science that cannot, and should not, be swept under the rug." -Richard A. Epstein, James Parker Hall Distinguished Service Professor of Law, University of Chicago

"Finally! A book for the layperson that explodes the myths, unpacks the mysteries and tells the truth about medical research. It should be required reading for anyone thinking of entering a clinical trial. Menikoff has done the public a great service." --Mary Faith Marshall, Ph.D., Professor, Center for Bioethics and Associate Dean, University of Minnesota Medical School

"What the Doctor Didn't Say combines depth of scholarship and clear writing with wisdom, experience and sound judgment to create a volume that is essential for understanding the rights and interests of patients and the obligations of providers in the dance of medicine called informed consent. It provides the gold standard of understanding that should be the starting point for discussion and future research." --Nancy Neveloff Dubler, Director, Division of Bioethics, Montefiore Medical Center, and Professor of Epidemiology and Population Health, Albert Einstein College of Medicine

If you are interested in policy or books about health care reform, please see our up-to-date collection here: Politics, Policy & Reform.

(information provided by the publisher)

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