U.S. Health Freedom on Verge of Collapse


Richard Moore

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U.S. Health Freedom on Verge of Collapse

This article has been reprinted with permission from Newswithviews.com

Major Expansion of FDA Powers will Target Dietary Supplements

A new attack against health freedom, drug safety, and dietary supplements was 
launched last week by Senator Edward Kennedy (D-MA) with major support from 
Michael Enzi (R-WY).  It is called the Food and Drug Administration 
Revitalization Act (S1082).  This legislation was planned over the past few 
years working hand-in-glove with the FDA¹s dysfunctional management and legal 
team ­ meaning this legislation was written for the profits of Big Pharma and 

S1082 is a Trojan Horse bill that pretends to address safety issues.  
Unbelievably, the bill turns the FDA into a drug development company that will 
expose Americans to new and dangerous biological drugs that have little testing 
to prove safety or effectiveness.  And to top it off, the bill gives broad new 
regulatory powers to the FDA that can be used to frivolously attack dietary 
supplements and forward the FDA management¹s anti-American globalization agenda.

On April 18, 2007, S1082 was approved by the HELP committee (which Kennedy and 
Enzi control) and now moves to the floor of the Senate.  In a slick move, 
Kennedy has attached his long-planned FDA/Big Pharma ³reform² measures to the 
renewal of PDUFA (Prescription Drug User Fee Act).  Current PDUFA law expires 
later this year and must be reviewed by Congress.  PDUFA allows Big Pharma to 
pay the FDA fees to speed the approval of its drugs.  The new Kennedy bill will 
increase these FDA bribes to 380 million dollars in 2008, well over 50% of the 
FDA budget for new drug approvals.  This is like paying the mob for protection.
Kennedy, by replacing the existing PDUFA law with this new bill (S1082), is 
ensuring that his twisted legislation is the one that will be put before the 
Senate for a vote.

The FDA Drug Company, an Agency with New Regulatory Power

It is hard for anyone to comprehend that the agency that is supposed to be in 
charge of drug safety is about to become a drug company.  It is astonishing that
the FDA will now manage a full scale business activity that uses a ³non profit² 
foundation as a shield to avoid international patent problems, protect 
proprietary rights of its commercial drug-development enterprise, and massively 
expands FDA regulatory powers to quickly remove anything from the market that is
competition to its own products and licensing agreements.

This new FDA business enterprise is called the Reagan-Udall Foundation for the 
Food and Drug Administration (see pages 105-125).  In previous versions of the 
Kennedy bill it was going to be an independent drug company within the FDA (the 
Reagan-Udall Institute for Applied Biomedical Research).  In the current bill it
is a ³non profit² collaboration of the FDA, private industry, government 
funding, and private funding.  It is run directly by the FDA even though it 
pretends to not be part of the government.  Under this scam taxpayers will foot 
the bill for drug development and then be charged outrageous prices for the 
drugs.  Furthermore, the new bill seeks to allow a massive expanse of FDA 
regulatory power through this new foundation.  For example, on pages 106-107 the
bill states:

³The purpose of the Foundation is to advance the mission of the Food and Drug 
Administration to modernize medical, veterinary, food, food ingredient, and 
cosmetic product development, accelerate innovation, and enhance product 
safetyŠ.The Foundation shall [take] into consideration the Critical Path reports
and priorities published by the Food and Drug Administration, identify unmet 
needs in the development, manufacture, and evaluation of the safety and 
effectiveness, including post approval, of devices, including diagnostics, 
biologics, and drugs, and the safety of food, food ingredients, and cosmetics.²

Through this foundation the FDA is seeking broad new regulatory power that it 
currently does not possess.  This will include the authority to attack any 
dietary supplement (which are food ingredients) as unsafe based on its use of 
³Critical Path² technology. This means the FDA will use proteomics (the advanced
study of proteins in biological systems) to assess changes in biomarkers (the 
change in the state of a protein at the molecular level) in order to establish 
whatever it wants to consider as a risk.  The FDA can slant this technology, 
based on their own personal opinions, to make anything they want appear as a 
risk ­ including your favorite dietary supplements that you use to stay healthy.

Deceiving the Public

This new bill panders to concerns of Americans regarding the safety of drugs.  
This legitimate worry is used by Kennedy and Enzi to garner support when in 
reality the bill does just the opposite - exposing Americans to almost 
unfathomable new drug risks and dangers while simultaneously making it possible 
to remove super safe, therapeutic, and helpful dietary supplements.  The entire 
Critical Path initiative is a plan to race new and untested powerful biological 
drugs onto the market and experiment on patients all over the country ­ throwing
caution to the wind as far as drug safety is concerned.

While S1082 also pretends to address the issues of drug safety, in reality all 
the needed Big Pharma loopholes are firmly in place.  Additionally, the 
establishment of a clinical trial database as written in this proposed law will 
enable Big Pharma to hide experimental and undesirable side effects.  Instead of
full disclosure we will have a sterilized clinical trial database that will have
the net effect of being used as a tool by Big Pharma to promote off label use of
drugs.  This is a far cry from disclosure that results in safety.

In response to the Kennedy con Charles Grassley (R-IA) immediately attacked the 
legislation on the floor of the Senate:

³The bill [S1082] does not address the outstanding critical problem that the 
office responsible for post-market drug safety lacks the independence, lacks the
authority to promptly identify serious health risks and take necessary steps 
that will protect the public.  As I think we all agree, the FDA is in desperate 
need of major overhaul.²

The problem for Grassley, and all Americans, is that his true safety reform 
measures for the FDA are being held hostage by the HELP committee which is under
the control of Kennedy and Enzi.  His proposed legislation is S. 468: Food and 
Drug Administration Safety Act of 2007 and S. 467: Fair Access to Clinical 
Trials Act of 2007.  As Grassley told the Senate:

³Let me be clear: Big Pharma does not like these bills. FDA management does not 
like these bills. Lobbyists are spending hours upon hours lobbying against these
billsŠWhat is wrong with establishing a separate center within the FDA--not 
outside the FDA, within the FDA--with its only job being that of a watchdog for 
those drugs already in the market?...What is wrong with supporting a clinical 
trial registry and results database that also requires sponsors to reveal their 
negative trials?...I propose there is nothing wrong with any of these 

The situation is rather grave for all Americans.  Kennedy has attached 
repressive legislation to replace the PDUFA funding thereby ensuring that his 
agenda will come before the Senate for a vote.  The only real opposition to the 
legislation is coming from Grassley, who is attacking the weakness in FDA reform
regarding drug safety and clinical trials.  An even greater threat to the public
­ turning the FDA into a drug company and creating new regulatory powers that 
can be used to attack dietary supplements and remove them from the market ­ is 
being ignored by everyone ­ until now.  Kennedy knows he can defeat Grassley and
keep Grassley¹s bills from ever seeing the light of day.  Can Kennedy defeat the
American public?  Solving this problem is up to you.

The Secret FDA Agenda ­ Government Against the People

The FDA is a puppet organization.  Its management is a revolving door with Big 
Pharma, Big Biotech, and Big Agriculture.  The behavior of its management team, 
set by its current leader Andrew von Eschenbach ­ but fully entrenched in its 
long and ugly history, is one of acting as a police-force bully to forward the 
profits of those with money and stamp out all competition (under the false guise
of consumer protection).  The FDA management fully believes it is above any law 
that is in its way or any attempt at Congressional oversight.  It gives lip 
service to its safety mission.  It is a cult unto itself.

The anti-American FDA is actively seeking to undermine U.S. laws and harmonize 
our dietary supplement laws with Mexico and Canada.  This is being done through 
the Trilateral Cooperation Charter ­ an illegal agreement set up with health 
regulatory agencies in Mexico and Canada.  It is part of the campaign towards a 
North American Union, one which would be a catastrophe for health freedom in 
this country as dietary supplement laws in Canada and Mexico are far more 
restrictive than in the U.S.

The FDA would also like to harmonize our dietary supplement laws with the 
evolving international standards set by Codex, thus branding therapeutic 
nutrition as dangerous and risky and needing to be sold by Big Pharma or removed
from the market altogether (if it competes with a blockbuster category of 
drugs).  Codex is planning to use the same proteomics and biomarker technology 
that will be used by the FDA¹s Critical Path Initiative to remove therapeutic 
dietary supplements from the international market and force their policies on 
America, thereby superseding the sovereignty of American law on threat of trade 
sanctions.  The FDA fully supports draconian Codex guidelines to regulate 
dietary supplements and is working with the Germans to concoct technology to 
brand nutrients as drugs.  The FDA management is as bad as any government agency
can get.  Under the leadership of Andrew von Eschenbach it has plummeted to an 
all time low.

What You Can Do

1. Call, fax, phone, and write your Senators and tell them you are opposed to 
bill S1082 - Food and Drug Administration Revitalization Act.  Tell them you 
want no legislation of any kind that will enable the FDA to frivolously attack 
dietary supplements.  Tell them you do not want Big Pharma funding the FDA with 
user fees for drug approvals.  Demand an independent office within the FDA to 
monitor drug safety.  And tell them you want full disclosure by Big Pharma of 
all their clinical trials.  Tell them you support the Grassley legislation (S467
and S468) which offers true reform of the FDA.

2. Tell your Senators you are completely opposed to any law that would enable 
the FDA to act as a drug company, such as S1082, which is proposing the 
formation of the Reagan-Udall Foundation for the FDA.

3. Sign this petition demanding congressional oversight of the FDA¹s Trilateral 
Cooperation Charter ­ a key point the FDA is using to illegally support the 
formation of the North American Union while at the same time undermining health 
freedom.  This is the FDA¹s front line attack that undermines American law and 
seeks to harmonize us with the laws of other countries.  We must win this battle
to stop Codex and preserve our health freedom ­ including access to therapeutic 
dietary supplements and all alternative health options.

If S1082 becomes law and the FDA is allowed to enter relationships with foreign 
countries without any Congressional mandate or oversight we can kiss health 
freedom goodbye ­ as well as our dietary supplements.  It is time for dietary 
supplement companies and trade groups to get their heads out of the sand and 
quit jockeying for position in the New World Order at the expense of the future 
well being of their own customers.

The issue of health freedom is an issue for all Americans who believe in our 
constitution and our founding documents.  America is the last bastion of health 
freedom on earth.  If we fall, the world will be plunged into a Dark Ages of 
health.   Our future health will be dictated by a multinational sickness 
industry driven by profits for drug and biologic companies with little to do 
with real quality of health.  This is a crossroads ­ a moment in time.  Health 
freedom is fundamental to all other freedoms as without health freedom the minds
and bodies of a population are easy to control.

Copyright © 2007  Truth In Wellness, LLC

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