“I have sworn upon the altar of God eternal hostility against every form of tyranny over the mind of man.”
—Thomas Jefferson, September 23, 1800
When Congress created the U.S. Food and Drug Administration (FDA) in 1906, it was intended that this vital agency would operate under principles of our Constitution. It was not the intention of Congress to create an agency that would encumber the health of our nation.
While there are divisions within the FDA that are indeed carrying out the intent of Congress, there are “old guard” branches within the FDA that do more harm than good because they act more to protect the interests of the pharmaceutical industry than to help our citizens achieve optimal health. Unfortunately, these few branches undermine the efforts of the entire FDA and they negatively impact the health of our people. The FDA “old guard” establishes and enforces the legal tyranny (unjust use of power) of the FDA.
You and I have to deal with the tyranny of the FDA every day. You are prohibited from telling customers about scientific truths concerning any relationship between a nutrient and a disease. The FDA prevents this dissemination of truth under the cloak of FDA’s arbitrary definition that they are no longer nutrients, but rather illegal, unproven drug products if you mention a disease.
Please keep in mind that I recognize the need for a legal, scientific and active regulator of the health food industry. I am a strong advocate for an intelligent and responsible FDA. What I am opposed to is unscientific bias, suppression of constitutional rights and corruption. What needs to be done is to have the regulatory agency become scientific, lawful and non-corrupt, and to properly enforce the legal powers that it already has.
We have seen several aspects of the FDA’s tyranny in past columns. We have discussed the FDA’s injustices to the health food industry in this column with Frank Murray in July and August of 2005. We discussed several instances where it seems that the goal of the FDA has not been to regulate, but to destroy the industry while disregarding the Constitution of the United States. (Please see http://www.drpasswater.com/nutrition_library/Nov_05/Murray_FDA_part_1_final.html and http://www.drpasswater.com/nutrition_library/Nov_05/Murray_FDA_Struggle_final.html.)
We also have discussed “Bringing the FDA into Compliance” in a two-part interview with constitutional Attorney Jonathan W. Emord in the September and October 2003 columns. (Please see http://www.drpasswater.com/nutrition_library/Bringing_FDA_Compliance_Part_1.html.)
Attorney Emord is helping to bring the FDA into compliance with the Constitution, and hopefully, his efforts will help establish the credibility that the FDA needs to be effective. Recent events are indicating that the FDA “old guard” has finally realized that its agency can’t survive if it continues to pursue arbitrary and capricious unconstitutional ways of illegal censorship of scientific truth. The FDA is its own judge and jury as it creates rules, enforces them and judges their alleged violations. The courts have even given the FDA civil forfeiture powers to boot. The FDA must be brought to obey the Constitution. Congress must pass additional laws to make the FDA more responsive to the health needs of our citizens and more cases must be brought against the FDA to fine-tune and firmly establish our constitutional rights, and this is what Attorney Emord is doing.
The current emphasis is on freedom of truthful information. The Health Freedom Protection Act (H.R. 2117) was introduced by Congressman Ron Paul in the House of Representative on May 2, 2007. Congressman Paul is a staunch believer in our constitutional rights. It is also interesting to keep in mind that Congressman Paul is a physician who is very concerned about our health. Congressman Paul asked Attorney Emord to write the Congressional bill. In the introduction to the bill, Congressman Paul states in part:
“This bill restores the First Amendment rights of consumers to receive truthful information regarding the benefits of foods and dietary supplements by codifying the First Amendment standards used by Federal courts to strike down the Food and Drug Administration (FDA) efforts to censor truthful health claims. The Health Freedom Protection Act also stops the Federal Trade Commission (FTC) from censoring truthful health care claims. The American people have made it clear they do not want the Federal government to interfere with their access to dietary supplements, yet the FDA and the FTC continue to engage in heavy-handed attempts to restrict such access. The FDA continues to frustrate consumers’ efforts to learn how they can improve their health even after Congress, responding to a record number of constituents’ comments, passed the Dietary Supplement and Health and Education Act of 1994 (DSHEA). FDA bureaucrats are so determined to frustrate consumers’ access to truthful information that they are even evading their duty to comply with four Federal court decisions vindicating consumers’ First Amendment rights to discover the health benefits of foods and dietary supplements. FDA bureaucrats have even refused to abide by the DSHEA section allowing the public to have access to scientific articles and publications regarding the role of nutrients in protecting against diseases by claiming that every article concerning this topic is evidence of intent to sell a drug. Because of the FDA’s censorship of truthful health claims, millions of Americans may suffer with diseases and other health care problems they may have avoided by using dietary supplements. For example, the FDA prohibited consumers from learning how folic acid reduces the risk of neural tube defects for 4 years after the Centers for Disease Control and Prevention recommended every woman of childbearing age take folic acid supplements to reduce neural tube defects. This FDA action contributed to an estimated 10,000 cases of preventable neutral tube defects! The FDA also continues to prohibit consumers from learning about the scientific evidence that glucosamine and chondroitin sulfate are effective in the treatment of osteoarthritis; that omega-3 fatty acids may reduce the risk of sudden death heart attack; and that calcium may reduce the risk of bone fractures. The Health Freedom Protection Act will force the FDA to at last comply with the commands of Congress, the First Amendment, and the American people by codifying the First Amendment standards adopted by the Federal courts. Specifically, the Health Freedom Protection Act stops the FDA from censoring truthful claims about the curative, mitigative, or preventative effects of dietary supplements, and adopts the Federal court’s suggested use of disclaimers as an alternative to censorship. The Health Freedom Protection Act also stops the FDA from prohibiting the distribution of scientific articles and publications regarding the role of nutrients in protecting against disease. This legislation also addresses the FTC’s violations of the First Amendment. Under traditional First Amendment jurisprudence, the Federal government bears the burden of proving an advertising statement false before censoring that statement. However, the FTC has reversed the standard in the case of dietary supplements by requiring supplement manufactures to satisfy an unobtainable standard of proof that their statement is true. The FTC’s standards are blocking innovation in the marketplace.”
The two freedom health fighters worked together to also craft the “Congressional Responsibility and Accountability Act” (H.R. 3302), which was introduced on August 1, 2007. This is a powerful and historic bill that, if passed, would restore the system of separation of powers and checks and balances that defines the original Constitution. As noted by Congressman Paul in his introduction, “Today, three quarters of all federal laws are not created by the peoples’ elected representatives but are regulations promulgated by unelected officials in the federal agencies. Those agencies are largely unaccountable for their actions to the Congress, the Courts, and the President.”
Attorney Emord had called for this Bill in his book, The Ultimate Price, in which he noted, “They (the agencies) possess tremendous autonomy and expansive executive, legislative, and judicial powers that the Founding Fathers warned should never be vested in single hands if liberty was to be preserved.”
Now Attorney Emord has written a new book, The Rise of Tyranny (www.sentinelpressshop.com) intended to help correct the tyranny of the FDA.
I have had the honor and privilege of working with Attorney Emord on a petition to the FDA to protect the health claims allowed for selenium against some forms of cancer and to expand these health claims to pertain to specified cancers. Attorney Emord is working in many ways to protect the health of our citizens.
Attorney Emord has been practicing constitutional and administrative law before the federal courts and agencies since 1985. Having begun his career as an attorney in the Federal Communications
Commission during the administration of President Ronald Reagan, Attorney Emord has maintained an abiding conviction to achieve full First Amendment protection for the freedoms of speech and press. In 1991, he authored the critically acclaimed Freedom, Technology, and the First Amendment, in which he chronicled the intellectual foundations of the First Amendment and advocated replacing government control over the airwaves with a title registry, private property rights approach. Attorney Emord has practiced law for a number of well-respected firms, including Wiley, Rein & Fielding, and served as a Cato Institute Vice-President.
He practices food and drug law, deceptive advertising law, and libel law, and he served as lead counsel in the Pearson v. Shalala (D.C. Cir. 1999); Pearson v. Shalala (D.C.D.C. 2001); Pearson v. Thompson (D.C.D.C. 2001); and Whitaker v. Thompson (D.C.D.C. 2002) cases, holding FDA censorship of nutrient-disease relationship claims unconstitutional. He also served as lead counsel in the Nutraceutical Corp. v. Crawford (D.Ut.2005). Attorney Emord is admitted to practice in the states of Illinois, Virginia, and the District of Columbia. He is admitted to practice before the United States Supreme Court; the United States Courts of Appeal for the D.C., Fourth, Seventh, Ninth, and Tenth Circuits; the United States Court of International Trade; and the United States District Courts for the District of Columbia, Eastern District of Virginia, Northern District of Illinois, and Western District of Wisconsin. He is a member of the Governing Council of the International Society of Regulatory Toxicology and Pharmacology. He is a 1982 graduate (B.A., Political Science and History) of the University of Illinois, where he was an Edmund J. James Scholar and a 1985 graduate (J.D.) of DePaul University.
Attorney Emord’s professional publications include Freedom, Technology, and the First Amendment (1991), “The First Amendment Invalidity of FCC Ownership Regulations” (Catholic University Law Review, 1989), “Contrived Distinctions: The Doctrine of Commercial Speech in First Amendment Jurisprudence” (Cato Institute Policy Analysis, 1991), “The First Amendment Invalidity of FCC Content Regulations” (Notre Dame Journal of Law, Ethics & Public Policy, 1992), “Murder by Medicare: The Demise of Solo and Small Group Medical Practices” (Regulation, 1998), and “Pearson v. Shalala: The Beginning of the End for FDA Speech Suppression” (Journal of Public Policy & Marketing, 2000).
Passwater: Why did you decide to practice constitutional law?
Emord: When I was four years old and lived in England at Lakenheath and Alconbury air force bases, I used to enjoy watching the garbage men (called “dust bin men” by the English) do their work. I would wake up early in the morning to see them. I marveled at their strength and service. They wore white gloves at the time, and I thought they were very dapper. At the age of five, upon my family’s return to the United States (Chanute Air Force Base in Rantoul, Illinois), I became familiar with the television program Perry Mason and thought the court room drama intriguing. I then told my mother that when I grew up I wanted either to be a dust bin man or a lawyer. She complimented my choices. Over time I gave up the idea of retrieving trash in favor of the idea of ending the trashing of the framers’ Constitution, and so became a lawyer with that latter pursuit in mind. To answer your specific question, I decided to practice law at about the age of five and to practice constitutional law in my early teens. In my early teens I read a number of great works that affected my thinking, including, among others, Philip M. Crane’s The Sum of Good Government; Henry Hazlitt’s Economics in One Lesson and The Failure of the New Economics; Albert Jay Noch’s Jefferson and Our Enemy the State; Ayn Rand’s Atlas Shrugged; John Marshall’s Life of Washington; much of Dumas Malone’s Jefferson biography series; and The Freeman and National Review magazines—all variously helping to convince me that the growth of the regulatory state posed the greatest threat to the preservation of constitutional government. Those sentiments in favor of practicing constitutional law were reinforced in law school and, after, in actual legal practice, first at the Federal Communications Commission during the Reagan Administration and then at the flag ship Washington, D.C. regulatory firm, Wiley, Rein & Fielding (now Wiley Rein).
Emord: Unlike many other regulatory agencies, decisions made by the FDA Commissioner can determine whether people live or die. The consequences of FDA corruption and abuse of power are not only dire for the economy, they are grave for our health. Thus, when Durk Pearson and Sandy Shaw first asked me to examine FDA regulation of foods, dietary supplements and drugs, I became acutely aware that FDA was generating a real life horror show that good people really needed to stop.
When, for example, the FDA Commissioner approved the marketing of Vioxx over the repeated safety objections of FDA medical reviewers (who forewarned the Commissioner of a three to five-fold increased risk of heart attack from the drug), the Commissioner chose to favor the economic interests of Merck over the lives of the American people. To protect those economic interests, the Commissioner stood by as approximately 140,000 Americans suffered heart attacks from Vioxx, and approximately 60,000 of those died. As FDA Associate Director of the Office of Drug Safety David Graham testified before Senator Charles Grassley’s Finance Committee, that number is comparable to the number of American soldiers who died in the Vietnam War. Although the FDA Commissioner is directly to blame for those injuries and deaths, the law shields him from liability and Congress looks the other way (as it accepts generous campaign contributions from the pharmaceutical industry’s associations and PACs). Also, I will never forget FDA Commissioner David Kessler refusing to allow a health claim associating folic acid with a reduction in the risk of neural tube defect births. Kessler, a pediatrician by training, stood in the way of women of childbearing age receiving that vital, protective information. He did that because allowing the claim would mean that the drug industry would lose its monopoly on the right to convey therapeutic information to consumers. It would open consumers’ minds to the idea that certain nutrients can prevent, and even treat, disease. For each of the seven years the FDA Commissioner blocked the claim, an estimated 2,500 preventable neural tube defect births occurred and countless related abortions also occurred. Indeed, the censorship of the folic acid-neural tube defect claim affected many Americans and has left a legacy of life-long, costly medical care for the children and families affected. We have Commissioner Kessler to blame for that outrage.
I knew from the vast regulatory powers wielded by FDA with virtually no check from the courts or the Congress that if I devoted my energies to guarding the Constitution against FDA abuses, I would be achieving not only a victory for constitutional governance but also for the lives of Americans. That is why I have made FDA law a centerpiece of my firm’s practice.
Passwater: Have you had success in protecting us before?
Emord: Thanks to erudition from the bench, coming from United States Court of Appeals for the D.C. Circuit Judges Laurence H. Silberman, Patricia M. Wald and Merrick B. Garland, we were able to win the landmark Pearson v. Shalala case (holding FDA censorship of the antioxidant vitamin-cancer risk reduction; fiber-cancer risk reduction; folic acid-neural tube defect risk reduction; and omega-3 fatty acids-coronary heart disease risk reduction claims unconstitutionally suppressed). United States District Court for the District of Columbia Judge Gladys Kessler also gave us additional victories over FDA censorship of health claims in Pearson v. Shalala II, Pearson v. Shalala III and Whitaker v. Thompson I and Judge Paul Friedman gave us a victory in Whitaker v. Thompson II—all to the great benefit of American consumers. Although FDA is so prideful and fulsome with its combined legislative, executive and judicial powers that it has refused to implement the constitutional mandates of the D.C. Circuit and District Courts (the mandate stemming from Pearson v. Shalala that it favor disclosure of health claims over their suppression), the precedent is there for future challenges and as a constitutional stick that can help whip FDA into shape.
Passwater: Why did you decide to write The Rise of Tyranny? What do you hope it will accomplish?
Emord: I have been a close witness to corruption and abuse of power at the FDA. I wanted to expose that corruption and abuse of power to the general public in the hope of, at a minimum, leaving a historic marker for future generations to use in restoring constitutional government to America, or, at a maximum, helping Americans rally behind a set of legislative reforms designed to defang FDA. I wanted to show that FDA is a classic example of industry capture wherein the pharmaceutical industry has such influence over FDA’s political appointees (from the Commissioner on down) that it causes drugs that are too unsafe to enter the market to be approved by FDA nonetheless, resulting in serious injuries and deaths. I wanted to reveal that FDA has so much power and no real check on its exercise that it operates outside the Constitution, unanswerable to the courts, the Congress and the American people. I wanted to give specific examples, demonstrating that FDA political management had overruled its medical reviewers safety objections and had authorized the introduction into the market of over a dozen drugs that have caused serious injury including, among others, Redux, Rezulin, Avandia, Vioxx, Ketek, Paxil, Zoloft, Effexor, Omniflox, Trovan, Baycol, Bextra, Seldane, Propulsid, Accutane, Arava, Crestor, Meridia and Serevent.
Passwater: Your book reveals some startling details about FDA’s knowing approval of unsafe drugs. How does Congress let that happen?
Emord: The Rise of Tyranny also tells the story of how the drug industry came to exercise extraordinary influence not only over FDA, but also over Congress, medical school education, medical journal publication and physician prescription practices. I explain in some detail, with many thanks to the brilliant reporting of CBS News correspondent Steve Kroft, how the drug industry achieved the approval of the prescription drug bill. That story of influence peddling, corruption within Congress and the administration, and paybacks by the industry for members and staffers instrumental in the passage of that bill is an eye-opening history. No one familiar with it could seriously doubt the degree of control the drug industry has over the Congress of the United States. Congress holds many hearings and permits FDA whistleblowers to testify of the horrors taking place at the agency. Yet when it comes to taking serious actions to arrest the abusers, Congress never acts. The truth lies in the ultimate outcomes. The drug industry has acquired effective control over a majority of the members of the House and Senate. Bills against the interests of that industry have little chance of success. That is something that we have got to change by voting the rascals out of office at every turn. These congressional sell-outs are in reality selling the Constitution, and the economic viability of America, down the river for their own future nest eggs. They are as despicable as those within the bureaucracy responsible for the approval of drugs, like Vioxx and Ketek, that kill people.
Passwater: Your book offers specific solutions to the problems you identify. What are those solutions?
Emord: In The Rise of Tyranny, I explain in detail legislative reforms designed to end the government tyranny that sacrifices our lives, liberties and property. In sum, I advocate (1) voting members of Congress out of office who have voted in favor of bills that give enormous regulatory powers to the federal agencies, including the FDA; (2) enacting legislation, the Congressional Responsibility and Accountability Act that I wrote for Congressman Ron Paul (introduced by him this last term), to prevent the enactment of regulations by the independent agencies that have a measurable economic impact without Congress passing the law in the constitutional way; (3) enacting legislation to end FDA’s prior restraint on health claims, (4) enacting legislation to prevent industry capture, such as the drug industry’s take-over of the FDA; (5) enacting legislation to require meaningful federal judicial review of agency actions; (6) enacting legislation to punish appointed officials who violate the Constitution or who violate agency regulations or Commission enabling statutes for personal financial gain; and (7) enacting legislation to remove the drug review and approval power from FDA through the creation of a novel university-based system of blinded drug applications and reviews.
Passwater: Who should read your book? Is it written for the lay public or the legal community?
Emord: I think anyone who loves this country and seeks a return to constitutional government should read it. I think anyone who wants to know how FDA came to be controlled by the drug industry and how that control has led to corruption, abuse of power and the approval of unsafe drugs should read it. I think anyone who wants to understand real examples of industry take-over of regulatory authorities, who wants to understand how the current regulatory state violates fundamental constitutional principles of separation of powers and non-delegation of core constitutional functions ought to read it. I have written it in a way that is broadly accessible. Lawyers are certainly in the audience, but the audience for the book is much larger than just lawyers. It’s for the every concerned citizen.
Passwater: How can readers acquire a copy of the book?
Emord: They can purchase the book online from the publisher at www.sentinelpressshop.com or from my office at 202-466-6937. It is $24.95 (US) and $33.95 (Canada).
Passwater: Thank you for taking the time out of your busy schedule to chat with us and for your outstanding and untiring efforts to protect the health of our people. WF
Dr. Richard Passwater is the author of more than 40 books and 500 articles on nutrition. He is the director of research and development for Solgar Vitamin and Herb, Inc. Dr. Passwater has been WholeFoods Magazine’s science editor and author of this column since 1985. More information is available on his Web site, www.drpasswater.com.
Published in WholeFoods Magazine, October 2008