Victory Over the FDA: Durk Pearson and Sandy Shaw Win Lawsuit Against FDA

Victory Over the FDA

Pearson & Shaw Legislative Update - September 2001

The Food and Drug Administration (FDA) would have us believe that they are our protectors and that it is their mandate to prevent the mercenary world of business from taking advantage of us. With this assumption, the FDA has asserted that the Bill of Rights - specifically, the First Amendment (the right to free speech) - of the United States Constitution does not apply to commerce. Thus, the entire healthcare industry is at their mercy and is assumed guilty until proven innocent for expressing any conclusions not explicitly endorsed or permitted by the FDA.

AN END TO FREE-SPEECH TYRANNY

Now, with the availability of The Pearson v. Shalala and Bulwark of Liberty Awards videotape, you can learn the truth about the suppression of biomedical information in the United States, and how a small but exceedingly brave group of individuals is successfully challenging the information tyranny of the FDA.Background ColorMomentous First Amendment Victory

Internationally renowned authors and scientists known for their research in nutrition and longevity, Durk Pearson and Sandy Shaw originally designed the Designer Food nutritional formulations for their own personal use. Life Priority Inc. is proud to be providing these wonderful nutritional formulations and supplements to the general public. Our focus on quality is as true today as it was when we first started selling Durk and Sandy's products more than 20 years ago. Buy the quality supplements here.

Life extension scientists Durk Pearson and Sandy Shaw, along with alternative physician Dr. Julian Whitaker and constitutional lawyer Jonathan Emord, fervently disagree with the FDA's belief that the First Amendment is void where prohibited by its edicts. It is the indomitable conviction of Pearson, Shaw, et al. that the FDA must obey the supreme law of the land. They are saying, "We aren't going to take this anymore!"

While there are many who speak out against bureaucratic tyranny, few are courageous enough to take action - and actions speak louder than words. This is especially true when the actions are a reasoned and impassioned response to the prohibition of free speech about life-saving health information. Then, actions can roar like a rocket at liftoff.

Although the regulators at the FDA do not believe that advertising is protected by the First Amendment, this was not the belief of the Founding Fathers - many of whom were involved in some kind of commerce - nor is it the belief of Pearson, Shaw, Whitaker, Emord, and a band of others (including us at Life Enhancement Products) who support their efforts to take this matter all the way to the United States Supreme Court. We believe that commercial speech is as deserving of constitutional protection as noncommercial speech, regardless of whether or not it is "truthful and not misleading."*

*In today's political climate, being "truthful and not misleading" is considered to make something more worthy of protection under the First Amendment. Yet the Founding Fathers had no such qualification in mind and are undoubtedly spinning in their graves over the political need to justify free speech.

BOMBS BURSTING IN AIR

The Pearson v. Shalala and Bulwark of Liberty Awards videotape opens with a rousing rendition of the "Battle Hymn of the Republic" by gospel singer Alma Randolph, setting the stage for the "rockets' red glare" - the political fireworks that are to follow. The one-hour-and-twelve-minute video (VHS format) celebrates the victory of a small group of patriotic Americans who stood up against the FDA Goliath for the cause of free speech and the right to air important biomedical ideas - and won!

In their acceptance speech, Durk and Sandy - who initiated the lawsuit that is bringing the giant regulatory agency to its knees - declare that the stakes are far greater than anyone had imagined. When you tally, says Durk, the lives that have been needlessly lost since their lawsuit began - 10,000 lives taken by neural tube defects (preventable with the use of folic acid), 350,000 lives lost due to homocysteinemia (preventable with the use of vitamins B6 and B12 and folic acid), and 1,000,0000 lives lost due to coronary heart disease (preventable with the use ofomega-3 fatty acids in fish oils) - the total number is staggering.

Indeed, this number is greater than that of all the Americans who died in the Spanish-American War, World War I, World War II, the Korean War, the Vietnam War, and the Gulf War combined. When you realize that these preventable losses are attributable to the FDA - which has refused to allow the dissemination of life-saving information by commercial interests - it is plausible to consider that the FDA is the existential equivalent of our wartime enemies.

THE TRIUMPH OF IDEAS

More than anything, the video is a documentary about a group of heroic individuals who hold as their goal the promotion of ideas that could liberate us from premature death and provide us with a new lease on life. While the FDA does not yet comprehend the magnitude of the lawsuits against them, they are beginning to feel the heat. On July 16, 2001, Jonathan Emord, on behalf of the Pearson/Shaw litigants, filed suit against the FDA and three agency officials over whether certain anticancer claims for antioxidant vitamins may be presented on product labeling.

The three top officials of the FDA named in the action are being sued personally. They must worry about the extent of their liability and whether their ability to make a living may be threatened if they continue to impede the free-speech rights of individuals in the healthcare industry.

THE FDA'S LOSS IS OUR WIN - PLEASE CONTRIBUTE TO THE OUTCOME

As you will see, the outcome is not inevitable, and winning will require our dedicated effort and our moral and financial support. When you purchase your copy of The Pearson v. Shalala and Bulwark of Liberty Awards videotape about the activities of modern-day patriots walking in the footsteps of Thomas Jefferson, James Madison, and Patrick Henry, you will be contributing to their legal expenses.

All proceeds will go to the Pearson & Shaw Litigation Fund, to fuel continued constitutional challenges to the excesses of regulatory agencies that threaten free speech and the dissemination of life-saving knowledge that is so crucial to achieving health, longevity, and prosperity in the twenty-first century.

The FDA's stranglehold on the expression of Constitutionally-protected free speech is coming to an end. The FDA's attempts to severely regulate truthful speech has been ruled unconstitutional.

On January 15, 1999, in a decision that is rocking the regulatory world, scientists Durk Pearson & Sandy Shaw, joined by the American Preventative Medical Association and Citizens for Health, pummeled the Food and Drug Administration to the ground in their FDA lawsuit (Pearson vs FDA1). Ruling unanimously in their favor ( a 3-0 decision), the U.S. Court of Appeals for the District of Columbia Circuit decided against the FDA on all issues raised by Durk & Sandy's lawsuit. The issues included the FDA's health claim approval process now declared unconstitutional.

In an article published in The Laissez Faire City Times,2 Durk Pearson & Sandy Shaw vent their indignation that "commercial speech" has been considered less deserving of constitutional protection under the First Amendment than non-commercial speech. This doctrine, they complain, "makes those of us involved in commercial transactions - either as buyers or sellers - into second class citizens." Into this judicial vacuum, the FDA has deeded itself "unprecedented control over the communication of truthful scientific information when it accompanied a product."

By prohibiting the scientific truth to be told about dietary supplements, the FDA's policies have had a disastrous effect on the public's awareness of dietary supplements as well as over-the-counter drugs. Low-dose aspirin is one such example, but only one. As Pearson & Shaw reported in their 1993 book, Freedom of Informed Choice: FDA vs. Nutritional Supplements,a 1989 study established that for previously-healthy men over 50, an aspirin every other day reduced the risk of a first heart attack by about 44 percent.3 Yet ten years later, the FDA still unconstitutionally prohibits aspirin companies from communicating this information to the general public. During this period, hundreds of thousands of people may have died of heart attacks prematurely because they did not know about the value of low-dose aspirin.

Guiding Pearson & Shaw's case against the FDA from its initial filing in 1994 has been lawyer Jonathan Emord, whose skillful work has been instrumental in achieving this long-awaited victory.4 While the FDA may appeal, Durk & Sandy do not expect the FDA will be able to reverse this decision. This lawsuit has been expensive and aside from a lot of their own money, major financial assistance came from Julian Whitaker, M.D. and the American Preventive Medical Association. Additional financial help came from the National Health Federation, Life Enhancement Products, Life Extension Foundation, and Greg and Michelle Pryor of Life Priority, Inc.

Out of their ardent study of the Constitution and "commercial speech," Durk & Sandy grew the idea that a lawsuit "might push the envelope to help restore freedom of speech and help remove constitutional restraints in the area of what is called 'commercial speech.'" And indeed they have achieved this!

In its decision, the Appeals Court logically developed its conclusions from prior U.S. Supreme Court decisions  concerning First Amendment limitations on government censorship, especially with regard to the communication of scientific information as it pertains to "commercial speech."  The beauty of the decision is that it curtails federal governmental regulatory power as "off limits" when it crosses the Constitutional boundaries of freedom of speech as recognized by the Courts.

It is now incumbent on the FDA to define "significant scientific agreement," a phrase not previously defined by the FDA, making it easy for them to disqualify health statements by nutrient companies. The Court also stated that even if a nutrient company's health claim doesn't meet the FDA's criteria, it may be still be  possible to legally make their health claims if proper disclaimers are used.

At one point the FDA argued that any health claims could mislead the public, to which the Court replied that the position was "almost frivolous." Additional winners, those filing amicus (friendly) briefs in support, are Direct AIDS Alternative Information Resources, People Against Cancer, and the Foundation for Advancement of Innovative Medicine. Other losers, those filing an amicus brief supporting FDA restrictions, are the American Cancer Society, the American Heart Association, the Center for Science in the Public Interest, Public Citizen, and the Consumer Federation of America.

Pearson & Shaw conjecture that the FDA will, at first, attempt to propose the same old unconstitutional rules dressed up in new verbiage. "You can be sure we will be filing Public Comments!," retort Durk & Sandy. Feeling happy about the Court's decision, they believe that it is possible to strengthen and "put teeth into the Constitution's limits on federal actions" with enough conviction and care given to choice of issues, court and attorney. It helps to have lots of time and money too. Perhaps some of those making money as a direct result of being allowed to provide truthful information about their product will decide to pitch in. We all have a lot to gain - health freedom is in the opposition's interest too!

Medical researchers Durk Pearson & Sandy Shaw are the authors of Life Extension: A Practical Scientific Approach as well as other books on health and freedom. They are also formulators of the Life Priority Inc.Designer Food Formulas.

References

  • See http://www.ll.georgetown.edu/Fed-Ct/Circuit/dc/opinions/98-5043a.html.
  • Pearson D Shaw S. FDA Loses Landmark First Amendment Case. The Laissez Faire City Times,Vol 3, No 4, Jan. 25, 1999 (http://www.zolatimes.com/v3.4/FDA.htm).
  • Final report on the aspirin component of the ongoing Physicians' Health Study. Steering Committee of the Physicians' Health Study Research Group. N Engl J Med 1989 Jul 20;321(3):129-35.
  • Jonathan Emord may be contacted through his law firm's website at http://www.emord.com/