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The following letters were published in The Wall Street Journal, June 23, 1997:

Letters to the Editor: Reform FDA, Help The Critically Ill

In response to Sue Blevins's June 2 editorial-page commentary "Fighting Cancer--and the FDA":

The case of Dr. Stanislaw Burzynski is a prominent example why we need FDA reform. During Dr. Burzynski's trial, his critically ill patients were faced with the loss of access to his experimental drug, antineoplastons. Many of us in Congress found the government's conduct and handling of this case to be heavy-handed and costly. In fact, it is the subject of an ongoing congressional investigation.

Americans should not have to fear that the government will take away their access to alternative therapies. They should not be forced to leave their country to get medical treatment. The current avenues available to Americans to get experimental therapies such as compassionate investigational new drug-use exemptions or treatment exemptions are grossly inadequate and a bureaucratic nightmare. One Burzynski patient endured the pain and suffering of this disease for six weeks while the FDA tried to decide whether or not this individual should have the treatment. I believe, as do millions of Americans, that the ultimate decision whether to pursue a medical treatment, even experimental or unapproved treatments, should be left to the individual and his or her physician.

Most Americans don't realize that they don't have a legal right to the medical treatment of their choice. A bipartisan coalition of members of Congress and I introduced the Access to Medical Treatment Act, so that this right may be restored to the American people while maintaining a role for the FDA to prevent fraud and abuse.

Rep. Peter DeFazio (D., Ore.) Washington

* * * * *

Our 12-year-old son has a brain tumor that has shrunk by 70% in volume over the past two years while on Dr. Burzynski's treatment. Dr. Burzynski's story is an extreme case that highlights everything that is wrong with our government and our medical system. Children with brain tumors die needlessly while the FDA has spent 14 years wasting tax dollars on a legal vendetta. During this process, the FDA was issued a cease-and-desist order from a federal judge to stop distributing false information about Dr. Burzynski, a shameful statement about our government. To those of us who have children leading healthy lives on Dr. Burzynski's antineoplastons while their cancers disappear over time, the FDA's efforts against Dr. Burzynski and us are ugly representations of a system gone sour.

Now we are demanding that the FDA approve antineoplastons once and for all. The FDA has acknowledged that the treatment is safe and that it is effective against brain tumors. This treatment must be fast-tracked for approval and made available as a treatment choice to cancer patients, and especially to parents whose children have brain tumors.

Ted Wadman Corvallis, Ore.

* * * * *

Ms. Blevins's assumption that patients who choose alternativist cancer treatments like antineoplastons are choosing freely is erroneous. Patients don't choose an unapproved treatment unless marketing efforts lead them to believe that it can make them well. But for patients who swallow the unsubstantiated claims of proponents and sellers, free choice has limited utility. The utility of freedom of choice depends on reliable information. It is freedom of informed choice that counts.

There is no evidence from properly controlled clinical trials that antineoplastons have improved anyone's health. Without clinical trials, there is no way to distinguish a patient's response to a treatment from the effects of chance and bias. This poses no problem for antineoplaston promoters. They cite poignant testimonials by patients who claim remissions. While many are offered sincerely, they are subjective and unreliable.

What some patients interpret as an extraordinary recovery may be just a better-than-average outcome, within the normal variation of the disease. Some cancer patients offer testimonials because they are moved by the prestige or personal traits of their doctors.

Ms. Blevins misleads readers by stating, "Cancer patients shouldn't have to break the law in order to use the medical treatment of their choice." Except for laws directed at "controlled substances" like marijuana, there are no laws against patients using unapproved medical treatments. Consumer protection laws are directed at marketing practices that are deceptive, exploitative, and threats to public health.

William M. London Director of Public Health American Council on Science and Health New York

* * * * *

The FDA's case against Dr. Burzynski is irrational. While the agency offers little hope to cancer victims, it is waging an all-out battle against physicians whose treatments offer hope and a promise of recovery. They are prosecuting Dr. Burzynski and suppressing antineoplaston therapy even though top physicians at the National Cancer Institute and the FDA agree that it works.

The FDA has presided over a failed war on cancer at a cost of $35 billion in government-sponsored research, $200 billion in private research and $1 trillion in treatment more than 25 years. Worse yet, there has been no substantial improvement in cancer cure rates over the last several decades. Cancer rates continue to escalate.

According to court testimony from Paul Zimmerman, an FDA project manager in oncology, the FDA had stonewalled approval for Dr. Burzynski's IND (Investigational New Drug) trials for more than six years, far in excess of the usual 30-day hold. In addition, Mr. Zimmerman revealed that the FDA has, incredibly, never approved a drug submitted by an individual.

Henry Kriegel President Kriegel & Associates Bozeman, Mont.

(Kriegel & Associates is a national marketing and public relations firm that represented the Dr. Burzynski Patient Organization.)

Reprinted with permission of The Wall Street Journal. Copyright © 1997, Dow Jones & Company, Inc. All rights reserved.