Chapter 12: The FDA Versus Freedom of Speech

Recent FDA Court Losses

In spite of the dictatorial powers given the FDA by Congress to crush alternative medicine (technically the FDA works for Congress), in recent years the FDA has lost some critical court cases. It seems there are still a few tough judges willing to stand up to Big Brother.

There are two key problems the FDA has run into.

First, is the issue of scientific evidence. There is a growing number of long-term studies which yield high quality, published scientific evidence linking natural substances to health benefits. Natural health vendors have begun to put this information on their labels, literature and web sites. The FDA does not like that.

Linking truth to products is not acceptable to the FDA. They want the product and the truth to be on separate galaxies and they prefer that the truth be totally suppressed.

Second, is that problematic document that Congress routinely ignores called the Constitution. It seems our founding fathers were not paid-off by Big Pharma and they put a clause in the Constitution regarding "Freedom of Speech." In fact, it is the first amendment, so they must have worried that government would abuse freedom of speech once government got big and corrupt. They were right.

Of course for years the FDA has gotten around the freedom of speech issue by pretending to be concerned about the health of the American people. But with the new studies, it seems that there is now significant, high-quality scientific evidence that favors natural substances and some courts have noticed.

So put yourself in the shoes of the FDA and think for a moment. For decades you have successfully ignored the Constitution, but new scientific discoveries are coming out, and are being used in courts. Suddenly your facade of dignity is getting fairly large cracks in it. What are you going to do?

Before reading on, stop reading and ponder and think about how you would overcome this new obstacle (hint: come up with a really profound sounding slogan that has no meaning). Write down your answer...

Well, what did you come up with?

The FDA came up with the slogan: "significant scientific agreement." The concept of "significant scientific agreement" dates back to the Nutrition Labeling and Education Act of 1997 (NLEA), which was partly or completely written by the FDA.

What in the world is "significant scientific agreement?" The first time the FDA tried to use this new term in court, the court wanted to know what it meant (actually, only the appellate court wanted to know). The FDA had no answer and lost the case at the appellate level.

Since that time the FDA has spent a lot of time and money figuring out how to define the term "significant scientific agreement" so that it could be used in court to crush scientific evidence and crush freedom of speech.

Before getting into the nitty-gritty details, let's look at the big picture. What is the intent of the concept of significant scientific agreement? The intent is to give orthodox opinions more credibility than actual scientific studies.

In other words, the FDA wanted some way to negate actual published scientific studies. They cannot refute the statistical data, so they have attempted to use that old standby - orthodox opinions - to negate truth.

Let us think about orthodox opinions. First we must understand that Medical Doctors are trained in medical schools that are largely funded and historically totally controlled (both directly and indirectly) by the pharmaceutical industry.

Thus, anyone with an M.D. behind their name is guaranteed to have several characteristics:
1) They know virtually nothing about nutrition,
2) They know nothing truthful about alternative treatments for cancer,
3) The are totally brainwashing into believing chemotherapy and radiation are actually good for a patient,
4) They hate alternative medicine because it cuts into their profits, and
5) They think all alternative medicine is quackery (i.e. they think God doesn't know anything about chemistry).

Couple this with massive conflicts of interest, such as the Mayo Clinic, and other cancer research organizations, receiving millions of dollars in funding for cancer "research," and you have the sum total of "orthodox opinion."

In other words, "orthodox opinion" is made up of people: who have massive conflicts of interest, who hate the way God does His chemistry (because it is not profitable), who have been brainwashed into believing God is a quack, who want alternative medicine crushed, and so on.

In short "orthodox opinion" is exactly what the FDA wants because its foundation is profits for the medical community. In other words, "significant scientific agreement," "orthodox opinion," and "pharmaceutical profits" all mean exactly the same thing.

Thus, by cleverly morphing the phrase "pharmaceutical profits" into the phrase "significant scientific agreement," the FDA is pitting pharmaceutical profits against scientific evidence.

The Court Case Dealing With "Significant Scientific Agreement"

The key court case in dealing with the concept of "significant scientific agreement" is the case of Pearson vs. Shalala (Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), reh'g, en banc, denied, 172 F.3d 72 (D.C. Cir. 1999)). Actually is was the Life Extension Foundation (LEF) vs. the FDA, but legally it is known as Pearson vs. Shalala.

I quote from the LEF website:

• "Our challenge began when the government refused to allow claims we wished to make on dietary supplements, including such things as "Antioxidant vitamins may reduce the risk of certain cancers" and "Omega-3 fatty acids may reduce the risk of cardiovascular disease". These claims are backed up by scientific evidence, yet the FDA nixed them based on something called "significant scientific agreement". There may be scientific evidence, they argued, but not everyone agrees. This so-called "significant scientific agreement" rule was purely a creation of the FDA, yet the agency could not, or would not, define it. What it boiled down to is the agency had created for itself a stone wall it could throw up at will. Drug companies could claim that their products prevented X based on scientific evidence, but supplement manufacturers could not. We wanted to knock down this wall so that people could have access to information about vitamins and other supplements."
  http://www.lef.org/magazine/mag99/july99-cover.html

First, let's talk about the phrase: "There may be scientific evidence, they argued, but not everyone agrees." Have you ever heard such a ridiculous statement? Yes, I know that virtually all pharmaceutical research on cancer drugs is totally bogus. But yet it seems that "everyone agrees" with their bogus studies because they lead to profitable treatments.

"Everyone agrees" with the ridiculous and bogus studies that compare one toxic chemotherapy drug to another toxic chemotherapy drug. "Everyone agrees" with the unproven (in fact disproven) theory that shrinking a tumor leads to the increase in life span of cancer patients. "Everyone agrees" that chemotherapy does more good than harm (which, of course, is a lie).

Who exactly is "everyone." Surprise, it is the orthodox medicine people who are under the total control of Big Pharma. Who else would the FDA quote?

But when natural substances are tested, suddenly "not everyone agrees." How can someone disagree with a well-done, quality, honest scientific study? How can they ignore overwhelming, repeatable, scientific statistics? Do you see a pattern here?

I have done many experiments myself, and it is well-known that if you don't agree with something, do it yourself. In other words, a good scientific experiment is verifiable and repeatable. You don't "disagree" with a quality, honest experiment that is verifiable and repeatable. Such an experiment is irrefutable.

So why is the FDA talking about "not everyone agrees?" Perhaps they should have said: "not everyone thinks it leads to more profitable techniques."

So, the LEF wanted to tell their customers about scientific experiments that were not profitable to orthodox medicine. We see that the FDA was willing to accept scientific evidence if it benefited and profited the pharmaceutical industry, but when the scientific evidence benefited the public it was not allowed because orthodox medicine (i.e. the pharmaceutical industry) did not consider the scientific evidence to lead to more profits.

I continue the previous quote:

• "We believe that consumers are perfectly capable of judging for themselves whether they want to take a dietary supplement as long as they have truthful information. Fortunately, the Court agreed with us and the FDA's "Father Knows Best" approach was soundly rejected by the Court which apparently found some of the agency's arguments about a person's ability to make their own decision ridiculous. We got a laugh out of the Court's take on some of the FDA's arguments. In responding to the assertion that all claims lacking "significant scientific agreement" (we still don't know what that is) are misleading, the Court wrote:

  'As best we understand the government, its first argument runs along the following lines: that health claims lacking 'significant scientific agreement' are inherently misleading because they have such an awesome impact on consumers as to make it virtually impossible for them to exercise any judgment at the point of sale. It would be as if the consumers were asked to buy something while hypnotized, and therefore they are bound to be misled. We think this contention is almost frivolous.'"
  ibid

Now things get complicated. The issue here is whether a reasonable person should have the right to make their own health decisions or whether Big Brother should make those decisions for them.

But therein lies the paradox. In order for a reasonable person to make a decision they must have information from the people on both sides of the argument. But the FDA does not allow people to hear both sides of the argument, thus how can Big Brother pronounce that it has proven that a reasonable person doesn't know how to think?

In order to make a decision, a person should have the right to the information from the people on both sides of the fence (where have you heard that before?). The concept of "both sides" of an issue is something the FDA is specifically commissioned by Congress and Big Pharma to crush.

The FDA tells people how good chemotherapy is by approving these drugs. Then the FDA tells people how bad natural medicine is by not approving these products. Thus people know what is good about chemotherapy (actually there is nothing good about chemotherapy) and what is bad about natural products. Somehow, this is not telling both sides of the story.

Thus, worrying that the American people might become healthy (and thus not need prescription drugs), and fearing that people are smart enough to come to a logical conclusion, the FDA has long decided that reasonable people should not be presented with both sides of the issue.

The Freedom of Speech Issue

In essence, this is where "Freedom of Speech" enters the picture. Without freedom of speech Big Brother presents its side of all issues to the public and suppresses any conflicting opinions. "Free Speech" means that everyone gets to express their opinion, even if their opinions differ from those in government. In fact, the concept of "free speech" was specifically designed to allow those who disagree with government to speak without being persecuted. Our founding fathers remembered what happened to their ancestors before they came to America.

But of course, the FDA thinks that the Constitution does not apply to them because they are trying to crush the opinions of those people who think God did not flunk his chemistry course. And, of course, when Big Brother crushes free speech it is supposedly in the "best interests" of the nation. Exactly who is supposed to decide what is in the "best interests" of the nation? Our founding fathers specifically did not think that government should be the organization to decide what is in the "best interests" of the nation.

The "government" is made up of people who worship power, who worship money, who worship being able to do things without getting caught, and so on. These are exactly the people who should not be making decisions based on the "best interests" of the nation.

Of course the real reason all tyrants like the FDA crush free speech is because it is a threat to their tyranny. The FDA crushes free speech (i.e. the alternative viewpoint) because it is a threat to the profits of Big Pharma, and more importantly, a threat to the retirement benefits of FDA executives and a threat to the benefits the pharmaceutical industry provides the members of Congress.

Thus, it is in the best interests of the FDA to continue to pretend they care about human life, to continue to suppress the truth about alternative treatments, and above all, to continue to hide behind the corrupt skirts of the orthodox medical community.

• "The welfare of humanity is always the alibi of tyrants."
  Albert Camus

I like these comments by Ralph Moss:

• "In his classic On Liberty, John Stuart Mill wrote that "over himself, over his own body and mind, the individual is sovereign." In 1914, Judge Cardozo ruled that "every human being of adult years and sound mind has a right to determine what shall be done with his own body...."

  In 1987, the Second Circuit U.S. Court of Appeals affirmed: "We see no reason why a patient should not be allowed to make an informed decision to go outside currently approved medical methods in search of an unconventional treatment." In a masterful review, Berkeley law professor Marjorie Shultz concluded: "patient autonomy should be recognized and protected as a distinct legal interest.""
  http://www.ralphmoss.com/html/step.shtml

Thus, according to the constitution, the responsibility of the government should be to allow the presentations of both sides of an issue (e.g. the issue of cancer treatments). Furthermore, they should be proactively enforcing the public's right to hear both sides of any health issue.

In other words, if the FDA were doing its constitutional job, it would be severely persecuting the media (e.g. T.V., radio, printed) for selling-out to Big Pharma and presenting only one side of the cancer treatment issue in the media.

Here is a quote from a legal journal:

• "If a health claim lies in the gray area of science where connections between health and particular nutrients are unclear, legislation and regulation should favor the policy that the healthcare consumer should be provided with more, rather than less, information whenever possible, based on the theory that the individual is the appropriate determiner of his or her own best interest. This theory is consistent with the model of communication in traditional medicine, fully inform the patient of all possible benefits, risks and uncertainties and then leave the final choice to him whenever possible."
  http://www.law2.byu.edu/jpl/volumes/vol15_no1/Spenc12.pdf

In other words, informing the patient about his health options is required in orthodox medicine, but is forbidden in alternative medicine.

As the article states, the FDA should be requiring more information by alternative medicine vendors, not less.

Of course the real problem is not legal or theoretical, but political. The FDA has sold out to the same people the media has sold out to, and is part of the suppression of truth. Some people would call this a conspiracy, but many people don't believe in conspiracies (I guess they still believe the earth is flat).

The purpose of the first amendment is specifically to declare that the government does not have the right to favor one side of a critical issue and to suppress the other side from presenting their view. The amendment is specifically about suppression of free speech (i.e. suppression of a viewpoint).

In other words, the intent of the constitution was that government should not be allowed to define truth. If the government is allowed to define truth, then they are allowed to present only one side of the issue, the side they define as "truth."

A good example of this is the FDA Modernization Act of 1997 (FDAMA). First, read a little about it:

• "A provision in the FDA Modernization Act of 1997 (FDAMA) provided an additional process for manufacturers to use health claims if such claims are based on current, published, authoritative statements from certain federal scientific bodies. These include only those "with official responsibility for public health protection or research relating to human nutrition" such as the National Institutes of Health, the Centers for Disease Control and Prevention and the National Academy of Sciences."
  http://www.eatright.org/Public/GovernmentAffairs/92_adap1099.cfm

The list of acceptable scientific bodys is a "who's who" of scientific corruption. Did you notice something interesting about this paragraph? Only government controlled experiments are allowed to be used as scientific evidence! Talk about blatant control of "truth."

The New Rules For Labels

Is it wrong for the government to make an honest determination and then crush all competing arguments? While this might seem like a good thing, don't forget that government is not honest, but is corrupt and their decisions are generally based on money, power and profit, not on what is best for the public. For this reason, it is the intent of the constitution to limit the authority of a corrupt government. An honest government needs no such restraints.

• "When you get into politics, you find that all your worst nightmares about it turn out to be true, and the people who are attracted to large concentrations of power are precisely the ones who should be kept as far away from it as possible."
  Ken Livingstone, Member of Parliament

When our Constitution was being debated, government was honest and many people did not see the need for the Bill of Rights. Fortunately, Thomas Jefferson and others persuaded the majority that the government would not always be honest, and that the Bill of Rights was necessary.

As a good example of how "honest" our government is (and how much they really care about our health), consider the tobacco industry, a long-time financial friend of Congress. Several hundred thousand American's a year die because of tobacco products. Yet they are legal. These products have not been banned. Their products only require a warning label put on them (which was probably requested by the tobacco industry to avoid lawsuits). The tobacco industry is also allowed to add chemicals to the tobacco to make their products more addictive.

At the same time this is going on, Big Brother wants to ban labels on nutritional products that notify people of published scientific experiments, the knowledge of which may save their life!

In other words, allow a label on a product that kills you, but ban a label on a product that may save your life. Sounds like profitable logic to the FDA.

That is what government corruption does. And it is this corruption that is the target of the first amendment.

• "The Court indicated in its decision that it is poised to allow disclaimers as a way of notifying consumers that not everyone in the scientific community agrees that, for example, antioxidant vitamins reduce the risk of cancer."
  ibid - LEF

While the court's decision is a giant leap forward, the FDA is not about to give up so easily. They are not about to allow disclaimers on labels for natural products that allow the companies to tell the whole truth on that same label. After all, the FDA has an important mission to perform for Congress and Big Pharma - crush the truth.

On September 1, 2003, new rules went into affect regarding the labeling of nutritional supplements. I don't have enough information yet about how these rules will be implemented, so I do not have a specific comment. Based on what I have seen so far, I am not encouraged. It appears that a tobacco-type disclaimer will be required for most nutritional supplements.

In any case, I can say this, the FDA should be totally disbanded. It should be eliminated and replaced with a new organization where alternative medicine experts (who do not make their living as practitioners) should have a huge voice in the new organization.

The new organization should be designed specifically to make sure the news media presents both sides of all health issues. The media should be forced to give equal time to actual alternative medicine experts (who are not practitioners).

Furthermore, chemotherapy drugs, before they are approved, should be proven to extend life (not based on 5 years, but 10 or more years), compared to both refusal of treatment and alternative treatments, before they are approved. Shrinking tumors, comparing one toxic drug to another, etc. should be eliminated as a criteria for approval.

There is an old saying in the Bible, Matthew 9:17:

• "Neither do men put new wine into old bottles: else the bottles break, and the wine runneth out, and the bottles perish: but they put new wine into new bottles, and both are preserved."

The corruption in the FDA cannot be fixed. It is impossible to put a bicycle tire rubber patch on a 5 foot wide hole in the bottom of a ship. The FDA must be eliminated. The top 500 executives in the FDA should not be allowed to even apply for a job in the new organization without substantive proof that they have had a long track-record of supporting alternative medicine research.

Another Application of Freedom of Speech

Let us suppose there are two people, Mike and Alan. Mike goes to medical school and gets his M.D. Alan, on the other hand, after graduating from college, takes many additional classes on nutrition and herbal medicine. All in all, let us suppose that both of them read an equal number of books and spend an equal amount of time studying.

Rather than look at the degrees each holds, let us look at the books each has read. The medical community (i.e. AMA) has been given the legal authority to determine who can "practice medicine." Thus, because Mike read the "medical books," he can "practice medicine." Likewise, because Alan read the "health books," he is not legally allowed to "practice medicine."

Thus, the medical establishment is essentially saying that the ability to "practice medicine" is based on what you read (and what your teacher tells you, which is the same thing). A person who reads the wrong set of books is not allowed to "practice medicine."

Remembering that "freedom of speech" is really "freedom of viewpoint," those with a viewpoint of orthodox medicine can "practice medicine" and those with a viewpoint of alternative medicine cannot "practice medicine." Thus, the government, once again, has taken sides and crushed the opposition.

In reality, the government has an obligation to force medical schools to teach alternative medicine along with orthodox medicine, and then let the doctors and/or patients decide when to use each type of medicine. But as might be expected, neither the doctor, nor the patient, has any valid information on which to make an informed decision.

The government should also allow non-medical doctors, who have substantial training, to practice medicine, since they have a differing viewpoint. Again, the patients should be fully informed of both kinds of medicine so they can make their own decision. Of course orthodox medicine knows that anyone with an IQ above that of a horse, who was fully informed, would choose alternative cancer treatments when first diagnosed. That is not acceptable to those who profit from Big Pharma's bottomless money chest.

It should be up to the patient (and patients give referrals when their doctor heals them) to choose which type of doctor to go to, and which type of treatment they receive. As mentioned above, the patient should be given more information, not less.

Am I endorsing total chaos in the field of medicine? Let's think about that. When a person has cancer, and decides not to go on chemotherapy (by their own choice), where is he or she going to get medical advice? Most likely they are going to ask their friends if they know anything about alternative treatments for cancer. Most likely their friends know more than an M.D. about alternative treatments for cancer, but far too little to give any type of intelligent advice. Thus, we already have chaos in medicine.

There is no simple solution to the problem. Things are so messed up right now there needs to be a total re-evaluation of cancer treatment credentials. The bottom line is that patients should have far more options, and far more information, in choosing a treatment plan for themselves. Congress, the FDA, AMA, etc. have done everything in their power to make sure that never happens.

In fact freedom of speech is all about options and information. Patients have neither, and neither do the medical doctors.

But the real problem goes much deeper than just licenses. Another key is good statistical information about different cancer treatments. This is exactly where the National Institutes of Health (NIH), National Cancer Institute (NCI) and the American Cancer Society (ACS), etc., enter the picture. Their key job is to insure all research money goes to orthodox medicine and that alternative medicine research is crushed.

For example, not even medical doctors have good statistical information about comparing the Brandt Grape Cure (applying discoveries made since she designed her treatment plan) "cure rate" to the chemotherapy "cure rate," for different types of cancer, etc. But even if they did have the information, they couldn't use it.

What I am trying to say is that even if herbalists, chiropractors, etc. started treating cancer patients legally, it wouldn't help much because the statistical information about cancer treatments is not available. That's why I say it is not totally a license issue.

I would not be as severely opposed to the current system if medical doctors had good access to valid and honest (with a big emphasis on the word: honest) statistical information and if they were allowed to practice alternative medicine, as an M.D., without getting thrown in jail and having their license revoked.

The corruption in Congress, the FDA, NIH, NCI, AMA and ACS, to name but a few, not only suppresses accurate, life-saving honest statistical information, but prohibit medical doctors from applying those statistics.

(Note: Yes, I am aware of Naturopaths (N.D.s), who are licensed to do some things in some states, and there are some really good naturopaths who know a lot about treating cancer, but I have some issues with the profession as a whole, which may be more the fault of the legal system, I don't know.)

Freedom of Choice in Medicine

Now that we have had a chance to talk about freedom of speech, we can talk about freedom of choice in medicine, which has been informally discussed above. But first, let's build a base from which to work.

Let us talk some more about Congress and tobacco. As mentioned above, Congress continues to protect the tobacco industry and continues to allow them to sell tobacco products to Americans legally. Thus, people have "freedom of choice to smoke."

The rationale is that virtually everyone knows the dangers of cigarettes, etc., thus they should have the right to kill themselves and smoke if they wish. Thus, people have a legal right to slowly commit suicide by smoking and chewing tobacco, etc.

First of all, it is a big lie. A person cannot comprehend the dangers of smoking until they get emphysema or lung cancer, and then it is too late. If a person had to spend a month in a hospital, handcuffed to the hospital bed of someone dieing of emphysema and lung cancer, then they would comprehend the dangers of smoking. Likewise, because the tobacco industry adds addictive narcotics to tobacco a person really doesn't have the choice to start and stop smoking at will.

In any case, Congress has, at the same time, consistently forbidden Americans from having the choice of letting their medical doctor work with them using alternative treatments. As if that weren't bad enough, the restriction is still in force even after orthodox treatments have totally failed and they have been sent home to die! Congress has also consistently forbidden Americans to be treated for cancer by herbalists, nutritionists, etc., even after being sent home to die.

Thus we come to the following conclusion:
1) Congress allows you to choose which tobacco product you will use to slowly and painfully kill yourself,
2) If you get cancer, Congress forces you to take chemotherapy, which slowly and painfully kills you,
3) If you get cancer, Congress does not allow you to have your medical doctor treat you with alternative medicine, which is painless, builds your immunity system and selectively kills cancer cells,
4) If you get cancer, Congress does not allow you to go to a non-medical doctor for medical treatments for cancer, even though it may save your life,
5) To make things even more absurd, even if you have been given up for dead by the medical community, you still do not have the legal choice to have your M.D. treat you with alternative medicine or go to a non-M.D. to be treated.
6) Congress has allowed the FDA, NIH and NCI to crush all valid statistical information about alternative treatments,
7) etc.

You might conclude from this that Congress wants you to die. Or you might think that Congressmen are stupid. Actually they don't care if you live or die, and they are not stupid, but the list above shows a clear pattern - Congress makes decisions based on what is best for large corporations. The job of Congress is to protect the profits of large corporations. Why would they do that?

Now, let's be logical, who gets most of the profits of large corporations? Stockholders. Thus, Congress is protecting stockholders. But who are the stockholders? Usually very rich people and families control the Boards of Directors of large corporations, directly and indirectly. They also control Congress both directly and indirectly. Congress can best be thought of as puppets. The puppeteer is big business and old money.

• "...the world is governed by very different personages to what is imagined by those who are not themselves behind the scenes."
  Benjamin Disraeli (1801-1884) Prime Minister of Britain

The problem is not IQ, it never is, the problem is corruption. Congress has sold America's soul and kept the proceeds. The majority of members of Congress have gladly and quickly sold their integrity (i.e. sold their souls) to the highest bidder.

President Abraham Lincoln said it best:

• "We may congratulate ourselves that this cruel war [civil war] is nearing its end. It has cost a vast amount of treasure and blood ... It has indeed been a trying hour for the Republic; but I see in the near future a crisis approaching that unnerves me and causes me to tremble for the safety of my country. As a result of war, corporations have been enthroned and an era of corruption in high places will follow, and the money power of the country will endeavor to prolong its reign by working upon the prejudices of the people until all wealth is aggregated in a few hands, and the Republic is destroyed. I feel at this moment more anxiety for the safety of my country than ever before, even in the midst of war. God grant that my suspicions may prove groundless."
  President Abraham Lincoln
  The passage appears in a letter from Lincoln to Col. William F. Elkins, Nov. 21, 1864, Hertz II, 954, in Archer H. Shaw, The Lincoln Encyclopedia (New York: Macmillan, 1950), p. 40

For Further Reading

Freedom of Informed Choice: FDA vs. Nutrient Supplements
Common Sense Press (800) 542-3230

"The Doctrine of Commercial Speech in First Amendment Jurisprudence"
Cato Institute Policy Analysis (Sept. 23, 1991)

"The FDA Knows Best... Or Does It? First Amendment Protection of Health Claims on Dietary Supplements: Pearson v. Shalala"
BYU Journal of Public Law, Volume 15

Copyright (c) 2003 R. Webster Kehr, all rights reserved