The Threat to Health Freedom Now - an Exclusive Interview with Emord...

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The Threat to Health Freedom Now - an Exclusive Interview with

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Opinion by Journalist Rappaport

Monday, October 25, 2010.

As a medical investigative reporter for 28 years, I’ve seen public

interest in health freedom come and go. Right now, in 2010, it is at a low

point.

In the early 1990s, there was a tremendous fervor in America. Millions of

people, perceiving a threat from the federal government, realized they

could be cut off from the right to improve their health according to their own

wishes, judgments, and decisions.

In practical terms, health freedom has come to mean: the right to have

access to the widest possible range of nutritional supplements, health

practitioners, and treatments—with no government obstruction.

Back in 1993, millions of Americans believed in that principle, and sent

letters to Congress. Rallies were held. Celebrities appeared and supported

traditional American liberty.

The final blow was struck with the passage of the Dietary Supplement

Health Act of 1994 (DSHEA). It appeared to promise the results citizens were

looking for. The FDA would not be permitted to limit access to the full

range of nutritional supplements.

Then the furor died down and people went back to their lives. The

internet grew into a giant. Millions of pages discussing health issues

appeared.

More freedom. More access.

But there has been an overall dampening of that spirit of the early 90s.

Many people believe the major battle has been won.

To examine whether this is the case, and whether the DSHEA Law is actually

keeping Americans safe, I interviewed a widely revered lawyer,

Emord.

Emord is one of the nation’s leading free speech attorneys. He has

defeated the Food and Drug Administration a remarkable seven times in federal

court, more times than any other attorney in American history, earning him the

title, **FDA Dragon Slayer.**

He is the 2007 recipient of the Cancer Control Society’s Humanitarian

Award for **winning and preserving our great civil rights to life, to liberty,

and to health freedoms.**

Mr. Emord has practiced constitutional and administrative law in

Washington, D.C. for the past twenty-five years. He is routinely consulted by

industry, Congress, and the media on regulatory issues that affect health

freedom. He is the author of four critically acclaimed books: Freedom,

Technology

and the First Amendment (1991); The Ultimate Price (2007); The Rise of

Tyranny (2008); and Global Censorship of Health Information (2010).

I hoped Mr. Emord would give us real and detailed information on

substantive issues facing Americans today. He responded in kind, and went the

extra

mile. He cleared up a number of popular confusions, and offered several

predictions based on his long experience as an attorney in the field of

health freedom.

One of the most critical points Mr. Emord makes: The laws Congress passes

can be twisted by the federal agencies responsible for overseeing those

laws. For example, the FDA has reinterpreted health law to suit its own

slanted purposes. This is an extreme violation of the Constitution, and it

endangers the American Republic. Federal agencies can, in effect, illegally

become legislators and enforcers.

This is not a brush-off interview. Mr. Emord provides a compelling and

extensive case that should be read, studied, and acted on by other attorneys,

health-freedom advocates, nutritional-company executives, and all citizens

who value their freedom.

JON RAPPOPORT:

DSHEA is a federal law that was passed in 1994 to protect the public’s

right to buy and take a wide range of nutritional supplements. It’s

considered our best bulwark against invasive actions by the FDA. Did DSHEA

really

give us reliable protection? Where do things stand today?

Has the FDA eroded that law over the last 16 years?

Are we in trouble?

JONATHAN EMORD:

DSHEA has not given reliable protection against FDA censorship or FDA

restrictions on access to products. In certain respects the law itself is to

blame because of flaws in its design; in other respects FDA has purposefully

misconstrued the law to defeat its plain and intended meaning. Congress

has been derelict in counteracting the agency’s abuses—in no small measure

because the drug industry benefits from those abuses and has such

influence over the House Energy and Commerce Committee and the Senate Health

Committee that no meaningful reforms ever occur.

I was invited to comment on the bill when it was in draft form. I said

then that certain provisions in the bill would enable the FDA to censor

health information and restrict access to supplements. I opposed inclusion of

those provisions to no avail.

In particular, DSHEA requires supplement companies to file, with the

government, notice of use of structure/function claims [statements about the

positive effects of a nutrient on the structure or function of the body]. At

the time the bill was being debated, I explained that since

structure/function claims were protected speech under the First Amendment,

there was no

sound justification for requiring any company to submit them to the FDA for

review, and that forcing companies to do so would invite FDA mischief. I

explained that inevitably FDA would use structure/function claim review to

redefine claims from the category of structure/function to the category of

prohibited drug claims, thus reducing the quantity of free speech available

for expression. That has happened.

The DSHEA permits the HHS Secretary to adopt good manufacturing practice

guidelines [GMP] for supplements [how supplements should be made in the

lab-factory]. I warned at the time the bill was being debated that this

provision would invite considerable agency mischief, that FDA would use GMP

regulation to put the industry under its thumb and stop the marketing of

supplements on technicalities, thereby ridding the market of any product it did

not like. That is now happening.

We hired Steve Hanke, the Senior Economist on President Reagan’s Council

of Economic Advisors, to evaluate the impact of the GMP rule. He determined

that the cost of compliance per year [to supplement companies] would

exceed the finances of roughly one-third of all dietary supplement

manufacturers, resulting in their elimination from the market. In the GMP

rule, FDA put

the estimate more conservatively, but admitted that it would eliminate

about one-quarter of the market. The evaluation we were provided also

concluded that there would be less variety of product available to consumers

and

that the cost of product would increase. The FDA also admitted these

effects in its GMP Final Rule. FDA is vigorously pursuing its inspection

agenda. Within the next several years we should see the fall-out. FDA has

increased its reliance on direct court action instead of negotiated settlements

of disputes with the industry. That too will result in a loss of companies

and a reduction in consumer offerings.

The DSHEA adulteration provision included language limiting FDA action to

ban supplements to instances where the agency could prove that they

presented a significant or unreasonable risk of illness or injury. Congress

intended for this to be a meaningful barrier to FDA, compelling the agency to

prove supplements capable of causing harm before removing them from the

market. FDA has construed this language to give it virtually unbridled

discretion. In its ephedra ban, for example, FDA in effect rejected the

Paracelsian model for assessing dietary supplement adulteration (i.e., dose

determines toxicity) in favor of the precautionary principle. Under that

[precautionary] principle, if a nutrient causes harm at some dose level (a

universal

fact because everything, including, water, causes injury at some dose

level), it would be presumed adulterated until the industry proved it safe

beyond doubt at another dose level. That shifted the burden of proof from FDA

(where Congress placed it) to the industry (where FDA prefers that it be),

enabling FDA to ban any nutrient it wishes on evidence readily available

that at some dose level [at preposterously high doses] it causes harm.

The DSHEA included a provision to permit dietary supplement companies to

distribute scientific literature on nutrient-disease associations [a

nutrient can help alleviate a disease] to the public, including to their

customers. At the time, I warned that the provision included ambiguous

requirements

that FDA could construe to emasculate the speech-protective intent of

Congress. FDA has in fact gone farther than I had anticipated. FDA completely

eviscerated this provision by taking the position that any scientific

publication that associates a nutrient with a [positive effect on a] disease…

can still be forbidden by FDA because company provision of the literature to

customers would constitute “evidence of an intent to sell the product as an

unapproved new drug.â€

I also opposed the provision that required submission of a new

dietary-ingredient notice to FDA for every nutrient first sold after the date

of

passage of the DSHEA. Under that provision, if FDA does not object to the

notice, the product is legally marketable. I thought that if a product met the

definition of a dietary supplement, FDA should have no power to prevent its

marketing. I warned that FDA could use its discretion to require a degree

of proof for safety that was so high as to make it impossible for any new

dietary ingredient to enter the American market. While FDA has not

construed it to be absolutely prohibited, it has made it very difficult to

market

lawfully any nutrient first introduced to the American market after the

date of passage of DSHEA.

The dietary supplement industry is in trouble because the FDA harbors an

unscientific bias against supplements, principally arising from its desire

to protect the agency’s foremost regulatee, the drug industry. I remember

when folks were arguing that the GMPs were a good idea because industry

leaders had connections with FDA and could assure that the agency would not

abuse its power. The dietary supplement industry has never had a very

effective lobby and is a Lilliputian compared to the Leviathan drug industry.

I

have often used the following metaphor to describe the power triangle at

work. The drug industry is like an enormous elephant, and the FDA is like a

blind jockey atop the elephant incapable of altering the elephant’s course.

The dietary supplement industry is like a flea on the elephant. So long

as the flea does not irritate the elephant, everything proceeds smoothly,

but as soon as the flea causes irritation, the elephant signals its

displeasure and the blind jockey whacks about the surface of the elephant with

his

riding crop until he nails the flea. Some in the trades and in the dietary

supplement industry have an inflated view of their influence over FDA. The

drug industry they are not, and to the drug industry they are entirely

beholden for any regulatory crumb that falls off that industry’s table.

RAPPOPORT:

Many commentaries about Codex have circulated on the Web over the past

decade.

What is Codex and what is its goal, vis-à-vis nutritional supplements?

Are the American people going to be forced to accept the provisions of

Codex? Is this a looming reality?

EMORD:

The Codex Alimentarius Commission is an organization of the United Nations

Food and Agriculture Organization and the World Health Organization. It

is a standard setting body. The standards it adopts each member state is

expected to implement or, if not, to explain why it has chosen not to do so.

If the failure to adopt a standard caused a member state to discriminate

against imports, that state could be challenged for its failure before the

World Trade Organization. More commonly, however, the Codex Commission

serves as a forum for member states to exercise influence over one another in

the adoption of domestic standards governing the availability of dietary

supplements and the dose levels in the market. By adopting a standard, as

Codex has done, recommending that member states determine whether vitamins and

minerals are safe at particular dose levels and ban them at dose levels

not determined safe, the Commission places the onus on members to implement

regulatory regimes based on dose and, implicitly, on the

government-preferred precautionary principle. That has encouraged the

development of

extensive EU prior restraints on the availability of dietary supplements in the

market and has advanced the European attachment to and advocacy for the

precautionary principle as the best means to assess toxicity. In short, Codex

has become a coercive force in favor of restrictions on dietary supplements

and what can be said [what health claims can be made] about them.

The U.S. Food and Drug Administration admires the European system of

controls and can alter its interpretative construction of existing regulations

to “harmonize†the American model more closely with the European model of

regulation. U.S. delegates to Codex should be opposing the movement toward

greater restrictions on supplements and claims. Instead, they quietly

acquiesce in those restrictions and work toward effecting similar restrictions

within the United States through reinterpretation of existing agency rules.

RAPPOPORT:

What can you tell us about the legal status of nutritional supplements in

Europe? Is the EU really destroying the public’s right to buy a wide range

of nutrients? What’s the situation? Are there serious implications for

America?

EMORD:

Under the European Union Directive governing dietary supplements, no

dietary supplement is legal to market without first being found safe and

bioavailable by the European Food Safety Authority [EFSA]. Moreover, no

claim—not

even structure/function claims—concerning health effects of a dietary

supplement may appear on labels, in labeling, or in advertising of a dietary

supplement in Europe without first being approved by EFSA. This massive

system of prior restraint has imposed a nutrition Dark Age on Europe. As the

EFSA determinations continue to be enforced by the EU member states,

hundreds of products that had been safely consumed for decades will be removed

from the market. Also, claims will disappear, leaving Europeans in the dark

as to the potential of nutrients to affect health and disease.

This system is a form of Lysenkoism or state created orthodoxy over

science. It is dumbing down the European market and removing from it health

enhancing substances. In the end, there will be a rise in age-related diseases

for which risk is diminished by supplementation, such as cancer and

cardiovascular disease. EFSA will be responsible for creating a very unhealthy

environment all in the guise of protected European consumers from anything

less than certain science.

In truth almost nothing in science is certain; nearly everything is

inconclusive, yet we make decisions every day based on the inconclusive

science—

based on personal bets on the extent to which we think evidence of

association [is] correctly indicative of ultimate outcome. Remove from us that

evidence of association by force of law and we become incapable of making

informed bets.

EU censorship of all information in the market not proven conclusively

true necessarily censors information on nutrient-disease relationships that

will in time be proven true. That present censorship will cause those who

would bet on the ultimate truths to be denied the opportunity of guessing

right and, thus, they will lose out in potentially fatal ways.

That is precisely what happened to the FDA. We sued the FDA when it

refused to authorize a claim associating folic acid with a reduction in the

risk

of neural tube defects [NTD]. FDA took the position that the association

had not been proven that folic acid containing supplements could reduce NTD

risk. FDA censored the information for some six years, contributing to

over 2,500 preventable NTDs each year and to countless NTD related abortions.

We ultimately defeated FDA’s censorship in Pearson v. Shalala. That then

led in time to FDA allowance of the claims when we beat the agency a

second time for refusing to permit the claims. The result has been a steady

reduction in the incidence of NTDs in the United States as more and more women

of child bearing age learn of the need to take folic acid supplements

containing 400 (and preferably 800) mcgs each day before they become pregnant.

What will the scientists within EFSA think of themselves if five, ten,

twenty, or more years from now proof positive arises that certain nutrients

they have condemned are associated with significant reductions in the risk of

cancer and cardiovascular disease such that tens of thousands of Europeans

could have lived had they been given market access to information

concerning the association years prior?

The EU ban on supplements and supplement claims (unless pre-approved by

EFSA) is now in place. EU depends on its member states for enforcement.

Each state is variously engaged in enforcement with some using more aggressive

methods than others. Over the next several years, however, we can expect

to see crack downs in each of the member states with products being removed

from the market following each crack down.

The present FDA admires the European example of broad censorship and

restrictions on supplement access and is aggressively ridding from the American

market claims and products. We need to replace that administration and put

into law new constraints on the exercise of government power. I have

written for Congressman Ron a bill that would strip FDA of its prior

restraint on claims, leaving the federal government limited to acting against

claims it can prove with clear and convincing evidence to be false. That

bill, the Health Freedom Act, needs public support and would, if passed, usher

in a new era of speech freedom for claims in the United States.

RAPPOPORT:

During the debate and run-up to the passage of ObamaCare, the national

health insurance plan, I heard very little concern expressed in the health

freedom community about the future implications of this bill. It’s obvious

to

me that, with control being vested in the Department of Health and Human

Services, we could eventually see the day when alternative health care and

nutrition are edged out further and further from permitted treatments. And

citizens would be required to accept conventional medical treatments,

whether they want them or not.

Along a similar line, I see very little evidence, these days, of action

being taken by health freedom groups and nutritional companies to keep health

freedom alive. Certainly, we see nothing like the enormous campaign

launched in the early 1990s, when Congress received millions of letters

protesting the actions of the FDA to limit our access to supplements, and

celebrities came out of the woodwork to support health freedom.

What am I missing? Is some back-door deal in place now? Have nutritional

companies been given assurances that, if they keep their heads down and

their mouths shut, they’ll be allowed to do business as usual?

I’m at a loss to explain the eerie silence from groups that should be

continuing to fight VERY VISIBLY for our freedom in this area. I sense a soft

attitude.

I was very active in the health freedom movement of the early 90s. My

approach was to go after the FDA for their ongoing crimes, to attack. At the

time, some people told me to dial it back, we were going to get a good bill

passed in Congress, and aggressive actions could injure our cause. Is

that the prevailing mood now? Is something on the table we don’t know about?

A new bill?

EMORD:

There has been a recurrent pattern by supplement trade groups and certain

leading companies in the industry (epitomized by the industry move to draft

and advocate FDA adoption of GMP rules giving FDA broad discretion) to

engage in self-flagellation. In its nascent, more competitive years, the

industry more stridently opposed FDA regulation. The movement of consumers

away from specialty supplement brands towards less costly generic varieties

combined with bad economic times contributed to consolidation of the

supplement market, and certain industry leaders have for the last several years

moved away from robust contest with FDA to compromise with the agency. There

is an economic motive for this, to be sure. Large [supplement] industry

players believe they benefit from greater FDA regulation because it creates

costly barriers to entry that keep out smaller competitors.

There is also a mistaken view promoted by certain industry trade

associations that if the industry confesses fault to FDA and Congress, even

when no

fault exists, and professes a keen interest in ridding itself of bad

practices, even when those practices are unrepresentative of the industry, it

will curry favor with the powers that be. Instead, it has provided those

powers with more ammunition to use against the industry, compounding the

industry’s problems and creating a major public relations problem.

The fact is dietary supplements with few exceptions are the safest

ingestible products, far safer than foods and far safer than drugs. That is a

remarkable fact that one would think the industry would recite at every turn.

Instead, certain trade associations and industry leaders voice grave

concerns about supplement safety and agree to greater federal regulation on the

notion that greater regulation is either inevitable or will favor the

market position of the leading companies. To listen to what Congressmen Waxman

or Dingell have to say, you would swear that supplements were fissile

materials. It is the rare exception rather than the rule that a dietary

supplement causes harm.

By buying into the self-flagellation argument (the argument of supplement

opponents that there is something inherently wrong with the market that

necessitates extraordinary new regulation lest we all succumb), the industry

is inviting its own demise.

Industry leaders who buy into this on the notion that it will reduce

competition and shore up their market shares are in fact deluded, however,

because, in the end, the FDA is the drug industry’s, not the supplement

industry’

s, to control. In other words, FDA will be pleased to expand its

regulatory power over the supplement industry but not for the benefit of the

supplement industry’s leaders. Rather, FDA will invariably use greater

regulatory power over the supplement industry to aid its favored regulatee, the

drug

industry, not to shore up the market share of large supplement companies.

The drug industry, not the supplement industry, holds almost all the cards

at FDA and in Congress. The supplement industry has relatively little

clout by comparison.

Instead of engaging in self-flagellation, the industry ought to refute

false representations against supplement safety and efficacy and promote

public awareness of the many benefits supplements bring to consumers.

Supplements are rarely the cause of human injury. The science concerning their

health enhancing effects abounds and grows weekly. The potential for nutrients

to reduce the risk of, prevent, and even treat disease is profound.

Science is unraveling truths about human biochemistry that support the

conclusion that our lifestyle choices very much affect our disease risks and

that

healthful living in reliance on organic foods, above levels of certain key

nutrients, reduction in stress, and faith and hope have a profound impact on

our health, our quality of life, and our longevity.

Rather than engage in self-flagellation, the industry should celebrate its

strengths, advertise them continually to the public and the government,

and act to defend on grounds of principle the freedom to market and sell safe

and potentially life-saving and health enhancing supplements.

RAPPOPORT:

I have searched the most popular conservative radio and television shows

and websites and blogs—in other words, the places where one would expect to

find a defense of our freedom to choose whatever means we want to, to

maintain and improve our health—and I come up with a big fat zero. Why do

you

think the silence there on this issue is deafening?

EMORD:

There may be some truth to the notion that because the media are financed

in no small measure from drug ads, there is a natural economic interest in

avoiding communication that attacks drug safety and efficacy. The FDA and

the FTC have not been shy about informing media of regulatory risks

associated with supplement advertising, thus creating a general chilling effect

on the interest of media to present supplement advertising and discuss

supplement health effects. Finally, as with many areas of emerging science,

there is still widespread ignorance in the media on the association between

nutrients and disease. That ignorance is forged into prejudice when negative

press on supplement-disease associations is widely disseminated, but

positive press on those associations is more often than not ignored or given

short shrift.

RAPPOPORT: This past summer, Congress took up a food safety bill (S.510).

What’s its present status? Does its wording really suggest we may be

subject to Codex regulations vis-à-vis the sale of nutritional supplements?

What are the shortcomings of the bill?

EMORD: This bill is a significant threat to the supplement industry. It

contains a provision that permits FDA to charge the hourly cost of its

inspections of [nutritional-supplement] establishments if the agency finds a

violation warranting a re-inspection. That creates an incentive for FDA to

find fault on first inspections and to do re-inspections as a revenue

raiser. The bill also includes a provision that encourages FDA to evaluate

harmonization between domestic and foreign regulation. That invites the agency

to construe its regulations to effect a change in them favoring the EU

model. At a time when the FDA is in great disrepute for abusing its powers

(approving unsafe drugs, failing to force the withdrawal of unsafe drugs form

the market, and censoring health information concerning supplements), the

Congress is about to entrust the agency with yet more vast new regulatory

powers. That is a big mistake. Congress should be moving rapidly in the

other direction, taking away power from this corrupt agency. The problem is

that Congress, too, is quite corrupt. Senator Harry Reid said that he would

not move the bill forward in the Senate until after the election. The

election is likely to result in Republican control of the House and either

Republican control of the Senate or a loss of Democratic dominance in the

Senate. If that happens, S. 510 could become a casualty of an angry electorate

desirous of stopping the regulatory train before it leaves the station.

RAPPOPORT:

In a radio interview we did some months ago, you made a number of points

that need much wider dissemination. I’d like you to expand on two of those

points. First, you said we have a federal government that, actually and

disastrously, is run by and through its regulatory agencies, whose employees

stay on during one administration after another. And two, despite your

string of unprecedented victories in court against the FDA, you have the sense

that the Agency is quite prepared to ignore the court rulings limiting its

illegal intrusions into our affairs—in fact, the Agency fully intends to

carry on without paying one iota of attention to those court rulings…making

it, in my eyes, a rogue Agency.

EMORD:

In my book, The Rise of Tyranny, I explain how our federal government has

been transformed from a limited federal republic into a bureaucratic

oligarchy since the 1930s. Under our Constitution, Congress is vested with the

power to make laws. We have a separation of powers that prevents any one

branch from exercising combined legislative, executive, and judicial powers,

and we have a non-delegation doctrine, that forbids those branches vested

with those powers from delegating them to other entities. In the 1930’s,

the Supreme Court at first held efforts by President Roosevelt to delegate

governing power to bureaucratic agencies unconstitutional. In response,

President Roosevelt advocated the passage of legislation that would have packed

the court, adding a justice for every one sitting who had reached 70 and

one-half years, thus altering the composition of the Court to receive

jurists who would favor the New Deal agencies. The bill was not passed but

caused what the media of the day referred to as “the switch in time that saved

nine.†In 5 to 4 majority decisions, the Court switched from defending the

separation of powers and the non-delegation doctrines to abandoning them.

Since that time, despite the creation of over 183 federal agencies, many

with these combined powers, there has not been a single instance in which the

Supreme Court has held the delegation of governing power outside the [three

basic] constitutional branches to be a violation of the non-delegation

doctrine. As a result, today over ninety percent of all federal law is not

the product of our elected representatives but regulation promulgated by

unelected heads of the bureaucratic agencies. We founded this country on the

notion that no American should be taxed without being represented, and yet

today we are taxed and those who create almost all laws governing us are

unelected. Madison, Jefferson, , Hamilton,

and Washington each stated that if ever our country were to reach a

point where legislative, executive, and judicial powers were combined in

single hands that would be the end of liberty and the birth of tyranny.

Sadly, I believe we are there. A bill I wrote for Ron would restore

constitutional governance by preventing any regulation from having the force of

law until it was passed into law by Congress in the way the Constitution

requires. That bill, the Congressional Responsibility and Accountability Act,

is pending in Congress.

RAPPOPORT:

A more general question: From your experience and training as a

constitutional lawyer, what is your view on what the Constitution put in place,

through word and intent, regarding individual freedom? Constitutionally, what

is the meaning and range of freedom?

EMORD:

Ours is designedly a Constitution of liberty. It is remarkably unique.

The Declaration of Independence perhaps best sums up the legal creed that

underlies the Constitution. Just governments are instituted among men to

protect the rights of the governed. Just governments are derived from the

consent of the governed. When governments become destructive of those rights,

it is the duty of the people to alter or abolish them so as to restore

governance in protection of, rather than derogation of, those rights.

The Constitution is an extraordinary document precisely because it is a

written limit on the power of the state. Before it, no government on earth

had such written limits. Under it, no power rightfully exists in the state

except that which is expressly given to it by the instrument. It

enumerates the powers of Congress; it separates legislative, executive, and

judicial

powers; it makes law-making the province of an elected branch but only for

enumerated purposes; it makes war declaration the province of that same

branch, albeit war prosecution the province of the executive. It makes

treaty negotiation the province of the executive, but reserves consent to the

Senate for treaties negotiated. It makes the individual sovereign by

limiting federal powers, preserving state powers as a check on the federal

ones,

and forbids in the Bill of Rights government from acting beyond the powers

enumerated in the Constitution against the reserved rights of the states and

the people. Those reserved rights create for us a universe of freedom

that is meant to be extremely broad. Its scope is perhaps best conveyed in

Jefferson’s definition of liberty:

**Of liberty I would say that in the whole plenitude of its extent, it is

unobstructed action according to our will. But rightful liberty is

unobstructed action according to our will within limits drawn around us by the

equal rights of others. I do not add ‘within the limits of the law,’

because

law is often but the tyrant’s will, and always so when it violates the

right of an individual.**

That ideal, that scope of freedom, we do not presently have because the

plain and intended meaning of the Constitution is now largely dishonored.

RAPPOPORT:

What is your view of the so-called **living, evolving Constitution**

promoted by many, many judges?

EMORD

I have given much thought to this. My thinking is reflected in my books

Freedom, Technology, and the First Amendment and Global Censorship of Health

Information.

In brief, the Constitution’s words spring from underlying principles.

Those principles are static. Yet, as we progress in science, technology, and

knowledge, we are confronted with new facts. That environment, the life of

the Republic, is dynamic. The Constitution permits amendment through a

precise process prescribed in Article V. Its meaning, i.e., the principles

designedly protected by its words, may not be reasoned out of the document

or altered, except by amendment in the way the document designates.

Consequently, those principles must be preserved in the face of the evolution

of

our Republic, but that is not to say facts arising from that evolution,

because not previously known, justify departure from first principles. To the

contrary, the aim must be to ensure that first principles are upheld

despite the evolution. So, for example, while the electronic media was not

known

to the Founders, it is nevertheless media and therefore should be entitled

to the same full First Amendment protections afforded the print media. We

thus preserve freedom for the message (the aim of the First Amendment)

regardless of the medium.

RAPPOPORT:

When a pharmaceutical company is found guilty of pushing a drug on the

public it knew was dangerous; and when the drug has been shown to have caused

considerable injury and death; when law suits for grievous harm result in

huge money judgments; why aren’t persons in that company prosecuted

criminally and thrown in prison for long sentences? What keeps that from

happening?

EMORD:

You raise an excellent question. I believe those who knowingly introduce

into the market substances that are likely to cause mortal injury, not just

those in industry but also those in government, should be prosecuted

criminally for homicide or, at a minimum, criminal negligence.

RAPPOPORT:

On what Constitutional basis does the federal government pour billons of

dollars into the National Institutes of Health, a federal agency, for

ongoing medical research?

EMORD:

None. Ideally, the federal government should be limited to Justice,

State, Treasury and Defense. The health and safety power was meant to be a

state power, and I think we in this and many other respects have exceeded the

intended bounds of the federal government.

RAPPOPORT:

Could you comment on the legality/illegality of ways in which the

government partners with conventional medicine, making it the preferred method

of

health treatment in all areas.

EMORD:

On the state level, medical boards engage in anti-competitive regulation,

largely designed to deem it a failure of the standard of care for a

physician to innovate in medicine and create a market for the innovation that

would harm the economic interests of those who practice conventionally. On the

federal level, Medicare establishes treatment orthodoxies through its

coverage determinations that bleed into all areas of care and invite charges of

abuse for those physicians who would provide a different degree, nature,

or quality of treatment than is accepted by Medicare. That condition is

destined to worsen as the Health Reform law causes care for all Americans to

be federally scrutinized and subject to a Medicare-type system of

second-guessing of physician services. The FDA contributes to this regime

because

nothing can be used for treatment of disease in the United States unless it

has been approved by the FDA as a drug. Because it costs on average about

$600 million to get a drug approved in the United States, tens of thousands

of potential therapeutic agents are never legally available to treat

patients and, thus, secure a monopoly for drug companies in the treatment of

Americans. FDA is an example of industry capture. The drug industry controls

the agency. The drug industry also largely dictates the content of medical

education and the prescription practices of physicians. Its influence is

pervasive and reinforces allopathic medicine at every turn.

RAPPOPORT:

What do you think our best strategy is, here in America, to head off what

the FDA is going to do?

EMORD:

In my book The Rise of Tyranny I provide a detailed explanation of the

changes needed to restore the Framer’s Republic. In short, I urge people to

vote out of office those who have not supported deregulation and to press

members of Congress to support two of the bills I have written for

Congressman Ron —the Congressional Responsibility and Accountability Act

and the

Health Freedom Act. The former would prevent any regulatory agency from

enforcing any regulation it promulgated until that regulation is passed into

law by Congress in the way in which the Constitution designates. This

would prevent the agencies from exercising unchecked power and would restore

the law-making function to Congress, preventing a lot of abusive regulation

from ever being enforced. The latter bill would disarm FDA of any power

to require advance review of claims for supplements. That system of prior

restraint violates the First Amendment and should be dismantled. Those who

would defraud the public by falsely advertising their products should be

prosecuted after the fact but those who wish to tell the truth should not be

required to convince the FDA before they are allowed to speak. There are

many other reforms we need to institute, including removing from FDA the

drug approval power and vesting in universities, through a blinded system,

drug reviews so that science, rather than politics and favoritism, determines

the outcome of drug evaluations.

JON RAPPOPORT

_www.nomorefakenews.com_ (http://www.nomorefakenews.com)

_qjrconsulting@..._ (mailto:qjrconsulting@...)

EMORD AND ASSOCIATES

_www.emord.com/_ (http://www.emord.com/)

JON RAPPOPORT

_www.nomorefakenews.com_ (http://www.nomorefakenews.com)

Jon Rappoport is the author of a course, LOGIC AND ANALYSIS, for

homeschoolers and adults. To inquire: _qjrconsulting@..._

(mailto:qjrconsulting@...)