A Roadmap for Curing Cancer, Alzheimer's, and Cardiovascular Disease

Cancer, dementia, and cardiovascular disease are responsible for almost two million deaths each year in the United States alone and represent the largest immediate threat to humanity. Over the last century, we have made spectacular advances that have transformed our society – splitting the atom, space travel, telecommunications, and the Internet – but with medical research focused mostly on science for the sake of science, it has yielded precious few cures.

A Roadmap for Curing Cancer, Alzheimer’s, and Cardiovascular Disease represents a "first of its kind" effort to address both the reasons for this and to posit solutions to fix our broken system, in an effort to finally end this cure crisis. Dr. Marangos draws on 45 years of experience in every aspect of the biomedical R&D field, from basic drug discovery research at the NIH to the co-founding of five drug companies. He has published 252 research papers and edited four books on drug discovery, is co-inventor on 14 patents, and founded "The Journal of Molecular Neuroscience". He argues that from a development perspective, the regulatory, patent, and legal hurdles that force industry to pursue so-called "me-too" drugs rather than cures for terminal diseases must be re-thought. Leadership accountability, strategy, focus, and urgency need to be re-evaluated, and major reforms to the NIH, FDA, and patent codes are proposed.to remedy these impediments to cures. Written for anyone frustrated with the seemingly endless threat of terminal disease, this book seeks to inform, energize, and provide the rationale for the public and industry stakeholders, as well as clinicians and researchers, to resurrect the physician-patient relationship and demand that we get serious about ridding society of this scourge on humanity.

This work contains the views and opinions of the author and are in no way intended to harm the reputation of any person, agency, organization, or commercial entity discussed herein.

• First comprehensive analysis of the failures in curing cancer, Alzheimer’s, and cardiovascular disease with solutions proposed
• Defines deficiencies in academic life science research, including conflicting incentives, QA/QC issues, and how to fix them
• Provides a rationale for FDA reform especially as it relates to terminal disease drugs
• Details how a reformed NIH, regulators, and industry can partner to form a NASA-type effort to speed cures of terminal diseases
• Provides the first detailed roadmap for life science researchers to conquer terminal disease

Anyone concerned about curing terminal disease. The general public and Alzheimer’s researchers, cancer, and cardiovascular researchers. Healthcare stakeholders such as insurance companies, payers, drug industry, universities, institutes, charities, and the legal community, federal and state government policy makers. Anyone who has experienced either directly or indirectly the agony of terminal disease.

Part A. The Reasons for Failure

Chapter 1. The Medical R&D Fiasco

• The Most Serious Humanitarian Crisis
• The Magnitude of the Problem
• My Journey Through the Quagmire
• Where to Begin
• Cancer: Fifty Years of the Same Toxic Drugs
• Neurodegenerative Disease: Criminal Negligence
• Cardiovascular Disease: Treating the Symptoms
• Time to Get Serious

Chapter 2. Academia Is Marching to the Wrong Drummer

• Science for Its Own Sake
• Chaotic Poor-Quality Science
• Universities: Where Is the Accountability?
• Technology Transfer, Why Bother?
• The Collaboration Myth
• Thought Leaders: Blessing or Curse?
• The National Institutes of Health: Where Is the Beef?
• Strategy, Accountability, and Urgency: The Missing Links

Chapter 3. Mavericks Versus the Establishment

• Medical Research 101
• Established Science Is Being Wasted
• Maverick Science, Our Best Hope?
• Old Drugs for New Uses and Mavericks
• Getting Physicians Back in the Game
• Natural Agents Are Being Overlooked
• Charities: An Insult to the Cure Quest
• The Bottom Line on the Research Enterprise

Chapter 4. The Strangled Unincentivized Drug Industry

• Biotechnology Versus Pharmaceuticals, Macro Versus Micro
• Biologics: Great Targets but Terrible Drugs
• Biologicals: Super Expense for Marginal Benefit
• Gene Therapy and Stem Cell Therapy: Hype Versus Substance?
• The Biotechnology Report Card
• Start-Up Companies and Why They Fail
• Venture Capital: Selling Science for Profit
• Pharmaceuticals: Where Is the Beef?
• Corporate Partnering, Oil, and Water

Chapter 5. The FDA Roadblock to Cures

• Evolution of a Monster
• The Rocky Road to Drug Approval
• Clinical Trials: A Very Inexact Science
• Phase III: The Mother of All Clinical Trials
• Must We Be so Timid for All Drugs?
• Terminal Disease Patients Condemned to Death
• The Mistake That Created the Monster
• Surgery, an Example of What Fewer Regulations Can Produce
• Regulation and the Patient–Physician Relationship

Chapter 6. The Liability Barrier

• Everyone Responds to Drugs Differently
• Where Does Liability Begin?
• Medical Class Action Lawsuits: A Litigator’s Dream
• Should We Trust the Drug Companies?
• Malpractice Madness; Who Wins?
• The Risk–Benefit Conundrum
• Liability for Failed Clinical Trials

Part B. Towards Solutions

Chapter 7. Cleaning Up the Academic Research Quagmire

• Rebuilding the National Institutes of Health: NASA for Cures
• What to Do With Academia and Indirect Costs?
• Charities: You Have to Be Kidding!
• Quality Control in Research
• Injecting Strategy and Management Into Medical Research
• Fewer Thought Leaders and More Mavericks
• The Public Rip Off

Chapter 8. Reforming the FDA

• The Evolution of Drug Regulation
• Rethinking the FDA
• Some Common FDA Horror Stories
• Academic Purism Versus Right to Life
• Placebo-Controlled Trials for Terminal Disease Drugs
• A Regulatory–Industry–Research Partnership

Chapter 9. Enabling the Drug Industry

• Treating Is More Profitable Than Curing
• Ending Me-Too Drugs
• Mavericks Are Needed in the Industry Too
• The Venture Capital Fiasco
• Do Start-Ups Make Sense?
• Corporate Partnerships, Why Bother?
• Incentivizing Industry to Focus on Cures
• Where Is the Consumer?

Chapter 10. Patent and Liability Reform

• Speeding Up Patents
• Opening the Floodgates: Patenting Existing Science
• Born Again Patents and the Terminal Disease Exclusivity Act
• Immunity and Indemnification
• Reigning in the Medical Tort System

Chapter 11. The Public Will Make It Happen

• Taking Back Control of Our Lives With Health Savings Account
• Knowledge Is Power
• The AIDS Strategy
• The Roadmap