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S1082 -

THE VOICE OF THE PEOPLE IS BEING HEARD

By Byron J. Richards, CCN

May 4, 2007

NewsWithViews.com

http://www.newswithviews.com/Richards/byron26.htm

 

There is still time to stop FDA, Inc.

 

Bill S1082 is a bill that helps fund the FDA with Big Pharma money. It is

known all over Capital Hill as Big Pharma-designed legislation. It is running

into all sorts of credibility problems. A vote is likely on Monday – delayed

due

to all the opposition flooding the Senate by “we the people.â€

 

Major Problem #1 – A Fair Price for Drugs.

 

Realizing that meaningful FDA reform legislation is not likely again for ten

years numerous Senators are backing the Dorgan amendment to S1082. The

amendment enables U.S. citizens to buy drugs from Canada and other

industrialized

nations. This will save us at least 50 billion dollars over the next ten years

and cut the price of many drugs in half. Those opposing the amendment, which

includes most of the major proponents of S1082 and the Bush administration, are

the ones clearly on the payroll of Big Pharma. Their excuse for not supporting

it is flimsy – that it will cause safety problems. The majority of Senators

are not buying this transparent cover-up. Dorgan won Round 1 of the voting on

his amendment yesterday (63-28), showing that he has the power to hit Big Pharma

where it hurts – in the pocketbook. A final vote on the Dorgan amendment is

expected Monday (keep up support for the Dorgan amendment).

 

Major Problem #2 – A Fake Safety Bill.

 

Last year’s Institute of Medicine report labeled FDA management as

dysfunctional causing FDA reform to pick up momentum. To deflect public outrage

S1082

was created by Kennedy and Enzi, in close consultation with the FDA and Big

Pharma. As you might expect from such a meeting of the minds, the bill is really

a

Big Pharma-sponsored con job and it actually increases the power of

dysfunctional FDA management.

 

Unfortunately for Big Pharma and the FDA, Charles Grassley (R-IA), a man

concerned with true and meaningful safety reform, has gone through S1082 with a

fine tooth comb. He has proposed 11 amendments

http://grassley.senate.gov/index.cfm?FuseAction=PressReleases.Detail & PressReleas\

e_id=5369 to close the Big

Pharma loopholes that Kennedy, Enzi, the FDA, and Big Pharma built into this

legislation. Big Pharma and the FDA hate all 11 Grassley amendments and Big

Pharma

has its legion of lobbyists trying to defeat them as you read this. Support

the Grassley amendments for true and meaningful safety reform.

 

Major Problem #3 – A Sneak Attack on Dietary Supplements.

 

As I have been reporting for the last week, language relating to the

Reagan-Udall Foundation for the FDA creates a new regulatory category and

broadens FDA

power in a way that can be used to attack dietary supplements. In response to

this devious threat, Jonathan Emord, our nations leading health freedom

attorney, prepared amendment language to nullify the threat – an amendment we

now

call The People’s Amendment. Many of you flooded the Senate with your

objections – AND YOUR VOICE IS BEING HEARD.

 

I have obtained an e-mail message from David Taylor, the president of the

Natural Products Association, which went out to various heads of nutrition

companies – in an effort to get companies not to protest S1082 (dietary

supplement

trade groups are not the friends of health freedom). It contained an attachment

with a transcribed conversation between Hatch, Harkin, Kennedy, and Enzi

about all the phone calls you’ve been making. It shows that Hatch and Harkin

don’

t really understand what the Reagan-Udall foundation is, that Kennedy and Enzi

are lying about what it will do, AND THAT WE ARE GETTING THROUGH.

 

Here is the text:

 

SEN. HATCH:

My office has been inundated by calls from people throughout the country who

believe that this legislation, specifically the provision establishing a

Reagan-Udall Institute, will overturn the Dietary Supplement Health and

Education

Act of 1994. That has not been my reading of the bill, but I wonder if other

Senators have heard similar concerns?

 

SEN. HARKIN:

Yes, I have received a good many calls as well. And, I have to say that I

would be very concerned, as I know the Senator from Utah is, if anything in the

bill we are considering, S. 1082, would overturn DSHEA, a law we fought

side-by-side to see enacted.

 

SEN. ENZI:

It might be helpful if I explained the provision you are discussing, as my

office has received many calls as well and I believe the callers are not

informed about this matter. Subtitle B of Title II of S. 1028, establishes the

Reagan-Udall Foundation for the Food and Drug Administration. That simple

purpose of

that non-profit Foundation is to lead collaborations among the FDA, academic

research institutions and industry designed to bolster research and

development productivity, provide new tools for improving safety in regulated

product

evaluation, and in the long-term make the development of those products more

predictable and manageable.

 

SEN. KENNEDY:

That is exactly the purpose of the Foundation, which was included in the drug

safety legislation Senator Enzi and I introduced last year. The Foundation

will be financially supported by industry and philanthropic donated funds. A

Chief Scientist at FDA will promote intramural research and coordinate it with

efforts at the Foundation.

 

SEN. HATCH.:

That explanation is very helpful. What, specifically, would the role of the

Foundation be with respect to dietary supplements?

 

SEN. KENNEDY:

Let me make absolutely clear that the Reagan-Udall Foundation will in no way

override, overturn or conflict with the Dietary Supplement Health and

Education Act. Nothing in this bill would have that effect.

 

SEN. ENZI:

Yes, we took great pains to make certain there would be no conflict with

DSHEA. Regarding foods, and dietary supplements are generally regulated as

foods,

the general directive of the Foundation is to identify holes in the evaluation

of food safety and identify ways to address those deficiencies through

collaborative research with industry.

 

SEN. HARKIN:

So, to make this absolutely clear, what you are saying is that the bill we

are debating would in no way interfere with consumers’ access to dietary

supplements?

 

SEN. HATCH:

To add to that point, it seems that the language could, in fact, help dietary

supplement consumers, because it would allow collaboration between government

and industry to conduct research on issues that might be helpful to

supplement consumers?

 

SEN. KENNEDY:

Yes, that is the case.

 

SEN. ENZI:

I agree with Chairman Kennedy’s assessment.

 

SEN. HATCH:

I thank you for those assurances and that clarification.

 

SEN. HARKIN:

This has been a very helpful discussion, because Senator Hatch and I could

never support legislation that would interfere with DSHEA and we are glad to

receive the assurances of the Chairman and the Ranking Republican on the

Committee.

 

This is a major breakthrough – Kennedy and Enzi are now on record stating

this will in no way affect our dietary supplements. And Hatch and Harkin are on

record as being concerned. There are still two problems. 1) Kennedy and Enzi

are hard to trust, based on all the Big Pharma loopholes built into their bill.

2) The FDA and its lawyers get to interpret what S1082 means once it becomes

law. The FDA could care less what Kennedy or Enzi intended to say. Until the

language is fixed it is a problem of magnitude.

 

Major Problem #4 – The Creation of FDA, Inc.

 

As you can see from the Kennedy and Enzi comments above, they are portraying

the Reagan-Udall Foundation for the FDA as a benevolent and friendly group

that will facilitate collaboration between the FDA, academia, and private

industry – receiving funding from industry and philanthropic donations – and

oh yes,

let’s not forget the foundation may even help with safety. Do you really

think the FDA needs to create a whole organization to do that? And why

wouldn’t

such duties just be the function of a few people or a department within the FDA?

 

 

It is my opinion that the primary reason for bill S1082 is to create FDA,

Inc. by using the Reagan-Udall Foundation for the FDA. The FDA wants to be in

the

drug development and marketing business and is looking for a way to do it.

Most of the issues in S1082 are a smokescreen, keeping Senators like Grassley

busy fighting all the Big Pharma loopholes. So far Kennedy and Enzi have

skillfully created so much diversion that nobody is paying attention to the FDA

becoming a drug company.

 

In a nutshell, Andrew von Eschenbach, M.D, head of the FDA, has a long

history of involvement with the cancer-for-profit industry. His resume includes

being head of the National Cancer Institute, where he routinely diverted funding

from solid cancer science into the pockets of his friends in Big Bio Tech. He

was also a lead player in an old boy network called C-Change, a group of the

most powerful vested interests in biotechnology and cancer research – which is

headed by George Bush Sr. and his wife, Barbara. It is not surprising that the

current president backs Big Pharma and Big Biotech as he does – his family

wealth depends on it. Drug research and development performed at the

Reagan-Udall

Foundation will undoubtedly be paid for, in large part, by companies who have

grants from the National Cancer Institute (taxpayer funds).

 

Von Eschenbach took over the helm of the FDA to create his dream of a cancer

sickness industry wherein nobody actually gets well – they just live

indefinitely in a sick condition on really expensive biotech drugs. This project

is

called the Critical Path Initiative. The FDA has created highly sophisticated

software that can identify protein-molecule changes at the cellular level. The

FDA wants to use this computer software to design the entire next generation of

powerful biological medicines – making all of private industry use its

software technology. The Reagan-Udall foundation is the tool that FDA plans to

use

for patent protection and licensing arrangements of its technology with private

industry – and thus the creation of FDA, Inc. Von Eschenbach is on record as

stating that the Critical Path Initiative is the FDA’s top priority (not drug

safety or food safety).

 

The Critical Path Initiative has been repeatedly attacked because it would

expose patients to drugs with far less testing for safety and effectiveness

compared to drugs already on the market. Furthermore, these biologic drugs will

be

far more powerful because they throw gene switches in cells – meaning the

risk for adverse events skyrockets. Initially, just patients with no other

medical hope will be the guinea pigs. The FDA wants to run this technology in

all

doctor’s offices around the country – which will require your DNA in an

FDA-owned government database. This is not science fiction – this is what the

FDA is

on public record as wanting to do.

 

Keep Taking Action – Revised letter

 

Anti S.1082 Food and Drug Revitalization Act

 

May 5, 2007

 

The Honorable (Senator First and Last Name)

 

Address Address

 

Dear Senator Last Name;

 

The issue of drug safety and access to drugs at a fair price is of the utmost

importance to myself and all Americans. In general, I am opposed to Senate

bill S1082: Food and Drug Administration Revitalization Act, as it does not go

far enough to protect myself and my family from the dangers of drugs. If it is

to be passed I want all 11 Grassley amendments which are true safety reform

added to the bill. I am also in favor of the Dorgan amendment that enables

Americans to get a fair price on prescription medication.

 

As one of the 150 million Americans that rely on dietary supplements to keep

myself and my family well, I am especially concerned that this legislation

broadens FDA regulatory power to harass functional foods and dietary supplements

–

which has nothing whatsoever to do with drug safety. While Senator’s Kennedy

and Enzi are telling us not to be concerned – we simply don’t trust the FDA

and want language that protects dietary supplements in this legislation.

 

It is vital that the terms “food†and “food ingredients†be removed from

this legislation. There must be no confusing the safety of drugs and the safety

of food and food ingredients – which are governed by different laws. This bill

authorizes the creation of a new regulatory category that enables the FDA and

the Reagan-Udall Foundation for the FDA to attack dietary supplements and

functional foods. This problem in the wording can be corrected with this simple

amendment – so as to be sure this legislation is about drugs and drug safety

only.

 

Amendment to Bill S1082

 

Purpose of the amendment: The bill, S1082: The Food and Drug Administration

Revitalization Act, is hereby amended to eliminate any reference to the terms

food or food ingredients, such that food and food ingredients will not be

subject to any jurisdiction or control by the Reagan-Udall Foundation for the

Food

and Drug Administration.

 

Intent of amendment: To eliminate from the bill any possibility that food or

food ingredients would be treated like drugs either for safety review purposes

or for assessment of their efficacy. It is a fundamental tenet of food and

drug law that foods and food ingredients are presumed to be safe and have to be

established to be adulterated only if they present a significant or

unreasonable risk of illness or injury.

 

Sincerely,

 

 

To get information on contacting your Senators,

http://www.senate.gov/general/contact_information/senators_cfm.cfm

 

 

 

Related articles:

 

1, Senators Bribed by Big Pharma vs. Senators not Bought Off 5-2-07

2, Dietary Supplements Threatened, Freedom in Danger 4-30-07

3, U.S. Health Freedom on Verge of Collapse 4-25-07

 

 

 

© 2007 Truth in Wellness, LLC -

 

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--

 

Byron J. Richards, Founder/Director of Wellness Resources, is a

Board-Certified Clinical Nutritionist and nationally-renowned health expert,

radio

personality, and educator. He is the author of Mastering Leptin, The Leptin

Diet, and

Fight for Your Health: Exposing the FDA's Betrayal of America.

 

Richards encourages individuals to take charge of their health, stand up for

their health rights, and not blindly succumb to propaganda from the

vested-interests who profit from keeping Americans sick. As founder of Wellness

Resources, Inc. of Minneapolis, MN, an independently-owned fine-quality dietary

supplement company since 1985, he has personally developed 75 unique

nutraceutical-grade nutritional formulas. www.wellnessresources.com

 

E-mail: byron

 

 

 

 

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