Its Great! Oops, No It Isnt

This book dissects the methods behind the triumphs and tragedies of medical research to fully explore why doctors and researchers are so often wrong. Written for the lay person, it pays particular attention to the "clinical trial" and its seven fatal flaws.

The truth is, few people know the first thing about clinical research. The public reads about a medical research project that announces unbelievable results for a miraculous drug. Some years later, another investigation completely wipes out those initial favorable findings. Hormones Cut Women's Risk of Heart Disease (San Francisco Chronicle, 1994) Hormones Don't Protect Women from Heart Disease, Study Says (Washington Post, 2001) The people are confused because we do not understand the process behind these conflicting results. Our health, and in fact, our very lives are dependent on clinical trials, but we know little about them. This book explains the issues the public needs to be aware of when it comes to clinical research. It uncovers the problems in medical investigations that can not be overcome no matter how much care and diligence medical researchers bring to a research project. The basic premise that drives the writing is that it is impossible for medical researchers to guarantee that they can get all the right answers from a single study. No matter how good the investigators are, no matter how well a study is planned, no matter how carefully the plans are executed and no matter how conscientiously the results are analyzed and interpreted the answer may still be wrong. The deck is stacked against medical researchers and the public you should be skeptical of the results no matter how impressive they seem on the surface.

Tells consumers precisely why medical researchers can't promise that their investigations produced a correct finding by exposing sources of errors that go beyond the researcher's control Explains why the path drugs must travel as they make their way through the development phase and onto the market is flawed Describes the pitfalls that occur when publishing and communicating medical research results to the medical profession and the public Offers ways to improve the current systems of approving and monitoring drugs Provides the information patients, physicians and healthcare professionals need so their interests and concerns are heard by the medical research community

Inhalt
Medical Research Explained.- Medical Research Searching for Answers.- The Case-Control Method Looking Backwards.- The Cohort Study Watchful Waiting.- The Clinical Trial The Gold Standard.- Comparing the Methods Qualitative Differences.- Understanding the Clinical Trial.- The Protocol The Guiding Light.- The Control Group Leveling the Playing Field.- Measurements They'ever Exact.- Bias Control A Closer Look at Blinding and Randomization.- Utility Are Clinical Trial Results Useful?.- Research Discrimination Inadequately Tested Populations.- Seven Deadly Flaws The Clinical Trials' Achilles' Heel.- Tools of the Trade.- Statistics Was the Finding Significant?.- Analysis Issues A Lot of Choices.- Meta Analysis An Alternative to Large Trials.- The Real World.- Research Results That Clashed What's the Right Answer?.- Hormone Replacement Therapy The Silver Bullet That Misfired.- Publishing Getting the Word Out to Doctors.- The Public Forum Sharing the News with the Public.- Product Development Getting Discoveries to the Market.- Medical Innovations Regulators, Resources and Results.- Science and Politics A Troubling Mixture.- Research Misconduct Irresistible Temptation.- Postmarketing Surveillance An Imperfect System.- Regulatory Reform Changes Needed.- Journey's End A Call for Action.