Free To Choose Medicine: Better Drugs Sooner at Lower Cost: 3rd Edition - Softcover

Bartley J. Madden

Softcover

ISBN 10: 1934791679 ISBN 13: 9781934791677

Publisher: Heartland Institute, 2018

Synopsis

Would you support a reform that would make prescription drugs better, available sooner, at lower cost?

If you answer yes to this question, then you should support Free To Choose Medicine. Free To Choose Medicine, or FTCM for short, would be implemented through federal legislation authorizing four things:

1. Creation of a Free To Choose track, outside the control of the FDA, for patients and their doctors who want early access to promising new drugs;

2. Creation of a Tradeoff Evaluation Drug Database (TEDD) that would make real-time data about the treatment results and side effects of early-access drugs available to the public on the Internet;

3. Creation of a new type of FDA new drug approval based on observational data, rather than randomized controlled trials, utilizing assessments of safety and effectiveness from drug use by patients on the Free To Choose track; and

4. Legal liability reform, so patients are legally able to take responsibility for choosing a drug that might pose risks to their health and drug companies are not held liable for side effects that aren't due to incompetence or neglect.

Why is FTCM needed?

* People are suffering and dying because they are denied timely access to new drugs stuck in the FDA new drug approval pipeline. There is an enormous invisible graveyard of patients who were denied access to drugs that could have saved their lives.

* The purpose of the drugs-to-patients system should be to deliver better drugs, sooner, at lower cost, not to chase after the impossible goal of zero risk.

* The FDA is unnecessarily delaying the approval of new drugs by many years as well as stifling innovation. It refuses to change.

* The essential ingredients of reform are increasing patient and doctor choices, reducing regulatory costs and delays, increasing innovation, increasing competition and consumer choice, and reducing drug prices.

This third edition of Bartley J. Madden's book Free To Choose Medicine describes how we can achieve this defining moment for America--a directional change from today's trend of increasing litigation and regulation as well as a stake in the ground anchoring the undeniable truth that control of medical decisions belongs, first and foremost, with individual patients and doctors, not the government.

About this title

About the Author

Bartley J. Madden is currently an independent researcher and a policy advisor for The Heartland Institute. His research focuses on knowledge building and wealth creation as opposite sides of the same coin. His latest book, Value Creation Thinking, focuses on how the creation of long-term value by business firms begins with clarity about the purpose of the firm while emphasizing the overriding importance of a knowledge-building culture.

Madden retired as a managing director of Credit Suisse Holt after a career in money management and investment research that included the founding of Callard Madden & Associates. His early research was instrumental in the development of the cash-flow return on investment (CFROI) valuation framework that is used today by money management firms worldwide.

Knowledge building is the topic of his book, Reconstructing Your Worldview: The Four Core Beliefs You Need to Solve Complex Business Problems, in which he discusses a systems mindset to identify and fix the key constraint that degrades overall system performance. His work in public policy has resulted in the Free To Choose Medicine plan, which was developed in journal articles published in Regulation, Cancer Biotherapy & Radiopharmaceuticals, Medical Hypotheses, and Engage.

For further background and details about Madden's research, see his website at LearningWhatWorks.

Review

Breakthrough, transformative ideas are all too rare in politics, but this proposal is exactly that. By empowering America's patients, doctors, and entrepreneurs, Madden outlines a free-market, bipartisan solution that could unleash a long-overdue wave of innovation in an American pharmaceutical industry long plagued by government control, industry bureaucracy, and high prices.
--Hon. Tim Huelskamp, Ph.D.
President and CEO
The Heartland Institute

Bart Madden brings to his task a thorough knowledge of the issues that must be confronted and a deep concern for improving the rules that govern FDA processes. It's about defining an FDA track that empowers the patients and physicians who have the relevant knowledge and need the freedom to choose to use that knowledge without harming others. This is a book that can be studied fruitfully by all who have a concern for these problems. It is fundamentally bipartisan and should be read in that spirit.
--Professor Vernon L. Smith
Economic Science Institute
Chapman University
Nobel Laureate in Economics, 2002

Madden's book is an excellent summary of the arguments many of us have made to suggest the need for change in the hidebound FDA-regulated drug development system. Dual Tracking and Freedom to Choose are specific proposals of real interest. Unfortunately, in addressing the problems in our drug development system for over 25 years, I have seen no credible evidence that the FDA has any interest in substantial change. The FDA responds (if they do at all) to critics with lip service, obfuscation, or intimidation. I hope Bart Madden's book will elicit a real response and debate leading to substantial change that will benefit patients.
--Robert K. Oldham, M.D.
Cancer Cellular Therapeutics, Inc.

About this edition

• Publisher: Heartland Institute
• Publication date: 2018
• ISBN 10: 1934791679
• ISBN 13: 9781934791677
• Binding: Paperback
• Edition number: 3
• Number of pages: 103