The Truth About Research
Unbiased Information to Help You Make the Right Decision about Clinical Trials
You have probably noticed that when you search the web for information to help you make a good decision, you end up finding mainly groups that have a strong interest in convincing you to participate in studies. Google the term "clinical trials" and you'll see what we mean. The search leads to many private and governmental groups that are in the business of conducting research studies. These group have tens or even hundreds of millions of dollars at stake in making sure that they get enough research subjects. And even the "independent" information sites often do not seem totally independent. Sometimes they might be run by a company that also provides services to many of the people in the medical research industry.
Unfortunately, you cannot assume that you are going to get all the information you need from the doctors or other people who might be asking you to be in a study. All too often, even they will not be giving you the information that lets you determine if a particular study is the best way to treat your medical problem. But now there is a book that gives patients the inside information they need to make the right decisions about being in a clinical trial.
And this book discusses the issues that are showing up regularly in headlines in the New York Times, the Washington Post, and the Wall Street Journal. Do you know the story about Abigail Burroughs, the Abigail Alliance that her father Frank created, and the subsequent lawsuit against the FDA, Abigail Alliance v. Eschenbach? What issues are behind the death of Jolee Mohr, a young woman with arthritis, who died after participating in a gene therapy experiment? Why was 4-year-old Penelope London, as reported in the Wall Street Journal, unable to receive from Neotropix Inc. the experimental cancer drug that might have helped her? How was it that Kianna Karnes, as described in a New Yorker article by Dr. Jerome Groopman, wasn't able to get the drug Gleevec that might have cured her Kidney cancer? Only one book will give you the complete background behind these types of events, arming you with the information that might help prevent something similar from happening to you or a loved one.
This new book from Oxford University Press, whose main author is a medical and law school professor who has spent nearly a decade in helping to protect the interests of research subjects, reveals the information that others may try to hide from you. Here is what some prominent people have already said about the book:
"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 and Editor-in-Chief-Emeritus, New England Journal of Medicine
"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
Among the things that you will learn in this book are:
How research subjects are given weaker legal protections than patients. A doctor can do things to a research subject that she could not do to a patient--and that might even constitute malpractice if it were done outside of a research study.
Exactly how bad for the subjects can a study be.
What researchers should be telling subjects in order to allow them to make enlightened decisions about whether or not to be in a study--but in many and even most instances are not telling them.
How to go through a consent form and understand which parts of it are likely to not be revealing the full truth.
What specific pieces of information you need to find out about a study that will probably not be disclosed in the consent form.
How to find out about the financial conflicts of interest that may be playing a major role in encouraging your doctor to try to enroll you in a clinical trial--and that you probably will not be told about.
The special rules that apply to children, and what you'll need to know in deciding if being in a research study is in your child's best interests.
The special rules that apply to incompetent adults and to research studies that take place in "emergency" settings when consent cannot be obtained.
These points are illustrated by numerous examples of recent clinical trials:
- The federally funded study to determine whether the drug raloxifene, already being used by millions of women to treat their osteoporosis, might be able to work as well as the drug tamoxifen to prevent breast cancer from developing. Tens of thousands of women were enrolled, and were told that instead of being in the study, they could choose to have surgery to remove both breasts (even though they did not yet have breast cancer). They were not, however, told that they could easily choose to have a doctor treat them with raloxifene instead of participating in the study (and not even knowing what drug they would be getting) for five years.
- The studies of brand new drugs, to see how high a dose a person could be given before they have unacceptable side effects, in which patients were told merely that they "might" benefit from participation instead of being given the more truthful information that their chances of benefiting were very close to zero.
- How most children with cancer get treated in clinical trials--even though there is another treatment option that their parents would have preferred (and that in their view might have given the child a better chance at a cure), but were not told about.
- The clinical trial conducted at the Cleveland Clinic, in which a patient had told the doctors that he wanted to get the new chemotherapy that was being studied to treat his form of head and neck cancer. He was instead talked into participating in a randomized study, and ended up being assigned to not get the chemotherapy. He died several years later--and had he gotten the chemotherapy he wanted, he likely would have been cured. He had never been told that there were doctors in Cleveland who would have happily treated him with the chemotherapy that he wanted. The lawsuit brought against the doctors was quietly settled.
- The study comparing small incision (keyhole) surgery to the standard large incision surgery for colon cancer. Hundreds of patients were enrolled in this study, not being told that very few of the surgeons putting them in the study would have chosen to undergo the keyhole surgery, if they themselves ever developed colon cancer. Nor were they told that the procedure was considered so risky that the professional society for those surgeons had determined that no surgeon should perform it on a patient outside of a research study.
Primary author Jerry Menikoff, M.D., J.D., is Associate Professor of Law, Ethics & Medicine at the University of Kansas School of Medicine (in the Department of History and Philosophy of Medicine), and Associate Professor of Law at that university's law school. He received three degrees from Harvard University (A.B., magna cum laude, and Phi Beta Kappa; J.D., magna cum laude, and Editor and Officer of the Harvard Law Review; and M.P.P. (public policy) from the Kennedy School of Government). His medical degree is from Washington University in St. Louis, where he was elected to Alpha Omega Alpha. He has been a fellow at Harvard's Edmond J. Safra Foundation Center for Ethics and at the University of Chicago's MacLean Center for Clinical Medical Ethics, where he taught the health law class at its law school. In recent years he has regularly served as an adviser to the federal government on issues relating to protecting research subjects, both for the Office for Human Research Protections, and as one of the initial members of the Environmental Protection Agency's newly created Human Studies Review Board. He is the author of the textbook Law and Bioethics: An Introduction (Georgetown University Press), and co-author of the textbook The Ethics and Regulation of Research with Human Subjects (LexisNexis).
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.
Questions or comments about the book are very welcome! You can contact Jerry Menikoff at firstname.lastname@example.org.