Tuesday, April 3, 2012


Some people who know me know that I was a practicing pharmacist and a practicing attorney in my years before retirement. During those early years I worked as a retail and hospital pharmacist, as a marketing legal counsel drug manufacturer, as an executive and legal counsel for the association of schools of pharmacy, legal counsel and congressional liaison for the United States Pharmacopeia, and for an assortment of hundreds of individual clients. I am still a member of pharmacy and bar associations and keep up in some of those areas. Many people do not know that for the last 15 years I have published a newsletter concerning the laws and regulations of dietary supplements, botanical and herbal products plus the emerging science about these products. So I am very well acquainted with the market conditions and possibilities these products can offer to reduce the cost of illness and prevent disease.

  As I have been thinking about the immense Federal government debt in recent months, I have come across some ideas that may provide a way to stop the entitlement creep in the health care area, most specifically in the area of prescription drugs and other similar products. The entitlements that Congress has created to help get themselves reelected are now set to take over all of the discretionary spending of the Federal government.

  Currently we see commentators write about the $15 to 16 Trillion in Federal government debt, made up of $11 Trillion or so of deficit spending and about $5 Trillion of debt to various Trust Funds like the Social Security Trust Fund, the Highway Trust Fund and other federally established Trust Funds. Few people however write about or even understand that these two numbers do not include the amount needed to fund all of the promises the Congress and past Administrations have made for Social Security, Medicare and Medicaid plus pensions for Federal employees and a few other items. If the cost of providing what the law has promised to future generations is calculated to give the present day cost of those programs there may be another $105 to $120 Trillion promised that we do not have in the bank or anywhere else.

  This has led Michael D. Tanner, speaking to the Cato Institute recently on the True State of the Union to say that “We are broke. And we cannot pay it back.!”

  If we are to fix this debt problem, large and bold plans must be developed that will change the way we forward fund all of our luxuries onto future generations. It is not fair of us in 2012 to borrow forty cents of every dollar we spend from China and expect the unborn to be saddled with the bill. Politicians will tell you we can get by one more election, then we can take care of the problem. I say we must start now, not later, to get our Federal spending in order.

  For a number of years I have been a member of the Life Extension Foundation, located in Ft. Lauderdale. The organization has a pharmacy, mail order operation, diagnostic labs and a magazine titled Life Extension®. Every issue contains an article about a conflict or road block that the Food and Drug Administration has put up to stop the sale of some product or to demand more proof of effectiveness and safety for drugs that might help some very sick people.

  Now these articles have been collected into a book titled, Pharmocracy, How Corrupt Deals and Misguided Medical Regulations are Bankrupting America – And What To Do About It, by William Faloon. The book (ISBN 978-1-60766-011-8) is available from www.lef.org and Praktikos Books info@praktikosbooks.com. Members of the Foundation can purchase it at a discounted price.

  The book contains information advanced by Faloon since 1998 through 2011. Over the years he has generated several attempts to get Congress to change laws related to FDA controls over pharmaceuticals to a free market system. But success has come bite by bite, not all at once.

  I am blogging about this book because it contains a treasure trove of background information and solutions to problems that have created our growing debt for healthcare. The ideas in the book are not the only solutions out there, but the book needs to be included in the thinking of policy planners and decision makers. We have reinvented too many wheels recently when some answers are staring us in the face.

  What does the free market system look like in the eyes of Faloon?

  In the Preface, he writes: “Pharmocracy provides an irrefutable and rational basis to remove the suffocating compulsory aspect of healthcare regulation and allow free-market forces to compete against government-sanctioned medicine.”

  “This book documents how the free market can provide superior healthcare at far lower prices while better protecting consumers.

  “I fear that disregard of the obvious problems revealed in this book will condemn the United States to a downward spiral with little improvement in human longevity.”

  One explanation of Faloon’s free market system is “Our longstanding proposal has been to change the law so that anyone can opt out of the FDA’s umbrella of ‘protection.’ This approach will allow companies to sell drugs that have demonstrated safety and a reasonable likelihood of effectiveness, which are clearly labeled ‘Not Approved by the FDA.’ Patients who wish can still use only FDA-approved drugs, while those willing to take a risk, in consultation with their doctors, will be allowed to try drugs shown to be safe that are still not approved.”

  “We believe this initiative will result in a renaissance in the practice of medicine similar to the computer technology revolution of the past three decades. In the liberated environment we propose, many lethal diseases will succumb to cures that are less expensive that is presently the case. And greater competition will help eliminate the healthcare costs crisis that exists today.” p. 85.

  Faloon says the main reasons we have a less than effective free market, is that “For more than a century, consumers have been misled into believing the FDA protected them against dangerous drugs. The harsh reality is that the FDA functions to protect the economic interests of the pharmaceutical establishment, while trampling on the rights of Americans to access safer and more effective natural therapies.” P. 99

  The Faloon system would rely heavily on trial lawyers to stop companies from selling drugs making fraudulent claims. The Federal Trade Commission would be given authority over drug claims that it does not have now. The FDA would no longer be an impediment to seriously sick people from getting the latest, even if unapproved, treatment for their problems. Faloon says, “So we have a system in place today in which progressive doctors are persecuted, while those who sell dangerous and often ineffective therapies receive protection and payment from the federal government. People without the financial wherewithal have no choice, since Medicate will only pay what the FDA claims is safe and effective. Conventional medicine’s goldmine will end when Medicare exhausts its ability to pay.” P. 124

  At the end of this 364 page book is a summary of the seven regulatory restructuring changes required to reap the rewards of the free market. “Congress must pass laws that prohibit regulatory agencies (both federal and state) from taking enforcement action that impedes competition, drives up costs, stifles innovation, chills free speech, grants privileges to certain groups that are denied to others, mandates government approval or licensing, and creates wasteful and corrupt bureaucracy.” p. 361.

  This is a lot to do. And there are some problems in my mind with Congress telling the States what they cannot prohibit, since the FDA is based on the Commerce Clause and the 10th Amendment is coming back to life. But the seven areas Faloon mentions are worthy as an outline for what needs to be considered.

  The problem right now is what Faloon recognizes in his Epilogue. He says, “Our government has no idea what’s destroying America’s healthcare system. I doubt any elected official understands more than five percent of what you have just learned in this book.”

  “One reason our political leaders wallow in blind ignorance is that healthcare is only one of hundreds of different issues they are responsible for.”

  We would all be well to elect only Representatives and Senators, as well as a President, who now understand what is explained in this book or pledges to undertake to read it and ask why the healthcare system must remain under all of the current regulation.