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A Celebration of First Amendment Victories Against the FDA

April 2002

By Michele G. Morrow, D.O.

Image with Caption
Dr. Julian Whitaker and Dr. Matthias
Rath, with Durk and Sandy

"Since we have been suing the FDA over homocysteine which is a toxic metabolic by-product which causes cardiovascular disease and heart attacks, and which can be easily lowered with folic acid, vitamins B6 and B12, the FDA is responsible for approximately 350,000 premature preventable deaths of Americans. Since we have been suing the FDA over the effects of EPA/DHA, the extra long chain fish oils that help provide protection against cardiovascular disease, the FDA has been responsible for one million preventable deaths" said Durk.

Former Congresswoman from Idaho's First Congressional District, the honorable Helen Chenoweth-Hage, presented the next award to Dr. Julian Whitaker. Mrs. Chenoweth-Hage was an influential critic of the Food and Drug Administration's failure to implement fully and faithfully the Pearson vs. Shalala decision. She repeatedly wrote the then FDA Commissioner Jane Henney urging her to explain the agency's failure to comply with the Court's order.

Dr. Whitaker is the founder and president of the Whitaker Wellness Institute in Newport Beach, California and a worldwide renowned lecturer and writer on alternative medicine. His organization publishes a monthly newsletter, Health & Healing, that reaches more than 500,000 subscribers. He has published eight major books about health and wellness. Dr. Whitaker participated in the Pearson vs. Shalala and was the lead plaintiff in the Whitaker vs. Shalala First Amendment litigation against the Food and Drug Administration. The Whitaker vs. Shalala case against the FDA asked the federal courts to halt the FDA's more recent attempt to avoid compliance with the First Amendment by restricting what type of therapeutic claim can be made about patented drugs.

Dr. Whitaker is a vehement advocate of liberty and freedom of informed choice as it relates to the healthcare marketplace. In 1995, Dr. Whitaker took on a personal challenge by riding a bicycle on a 10-week trip, 5,000 mile bike hike from California to Washington, D.C. He sent FDA Commissioner David Kessler a letter ahead of time, informing the Commissioner that when his bike arrived at the steps of the nation's Capitol, he would hold a press conference during which time he intended to sell dietary supplements which made truthful but FDA unapproved health claims, a violation of FDA rules. He dared the FDA Commissioner to arrest him claiming that he would challenge the arrest in federal court under the First Amendment. The media and a crowd of people showed up and Dr. Whitaker did sell his supplements; however, no FDA enforcement authorities took the bait.

Dr. Whitaker has gone out on a limb in various situations to help persons with special needs for unapproved medical alternatives. He assisted the family of a 10-year-old cancer patient in finding an alternative to a leg amputation in the face of nearly forced surgery due to threats from the Child Protection Services Department. Several years ago, Dr. Whitaker raised over $300,000 to help fight the federal trial that the FDA brought against Dr. Stanislaw Burzynski. Dr. Burzynski is the director of an alternative cancer center in Houston, Texas. The FDA sought to shut down the clinic because he was using an unapproved medication, which was benefitting certain kinds of otherwise fatal cancer patients who were offered no other useful treatment. Today, the clinic still exists and Dr. Burzynski continues to practice medicine. These are just two of several stories with a similar theme. Dr. Whitaker has enlisted the support of his patients and newsletter subscribers for a variety of issues that have to do with access to medical alternatives and FDA censorship of information, and he himself has boldly challenged the legal system about such issues.

During his speech, Dr. Whitaker alluded to the "arbitrary and capricious activity" of the FDA. He discussed a nine-year-old patient who had a malignant brain tumor and was told by the FDA that he could not go to the Burzynski Clinic. "When you lose your freedom, you don't really know it until you need it and it is not there," said Whitaker. He mentioned a study published in the Journal of Epidemiology that found that 1000 mg of vitamin C in a male can cut heart disease by 70% and all-cause mortality by 60%. "It caused the men to live six years longer than average," he said. "It is time for us to realize that gradual erosion of our freedom is far more dangerous than an armed attack. Tyranny installed gradually is far more difficult to cut off than tyranny installed abruptly. I think this country is worth saving. I hope you do as well," said Dr. Whitaker during a powerful and moving speech.

Norman Singleton, the legislative assistant for Congressman Paul of Texas, presented The First Amendment Freedom Award to Pure Encapsulations. Pure Encapsulations, Inc. is a dietary supplement manufacturing company, which markets their products through doctors' offices and is lead by two brothers, Ray and Peter Hamel. They joined in the Pearson vs. Shalala and Whitaker vs. Shalala battles and provided support to finance the extraordinary litigation needed to enforce the decision over the preceding two years. They believe deeply that eternal vigilance is the price of freedom, said Congressman Singleton. A representative from Pure Encapsulations said, "Durk, Sandy, Dr. Whitaker and Jonathan Emord are the combination that created the most modern force in the modern era of commercial free speech and health freedom. Pure Encapsulations salutes you."

Candace Campbell, Executive Director of the American Preventive Medical Association (APMA) and a lobbyist for preventive medicine rights (APMA) accepted the award for the APMA. "Think of this as a call to arms," she said. "If we can accomplish this in such a short time with so little money, think of what we could do if all of you threw your weight behind it as well. I think we could move mountains," said Mrs. Campbell.

XCEL Healthcare also participated in the Pearson vs. Shalala litigation. Its owners, Dr. Richard Kleinberger, Dr. Daniel Gelber and Ronald Gustilo, oppose FDA censorship of truthful health information and believe absence of such information in the market is harmful to patients. XCEL is a multifaceted corporation; the company consists of a healthcare division, a nutraceutical division, a homecare division, a pharmaceutical division and a research division. They continuously make an effort to develop cutting edge treatments to combat conditions that conventional treatments fail to cure or mitigate.

The Bulkwark of Liberty Awards presentation

The Bulwark of Liberty Award recognizes those who have made extraordinary efforts to advance nutrition science, educate the public on the health benefits of nutrients and end government censorship of health information. The National Foundation for Alternative Medicine and the American Preventive Medical Association presented the Bulwark of Liberty Awards to these four highly distinguished and accomplished individuals:

  • The Honorable Berkley Bedell
  • Charles E. Ragus
  • Dr. Mathias Rath
  • Dr. Charles B. Simone

The honorable Berkley Bedell, who was previously mentioned in this article, has worked behind the scenes to advocate for First Amendment rights.