Codex OT

[Guest guest]

For all you people in a hurry, please just read the bold lines,

and act, if you would like supplements and herbs to remain freely

accessible and reasonably priced.

The legal drug pushers are noticing we are shifting to the way of

Nature,

and they are trying to take over. All under the banner of " protection " .

Funny, aspartame is still legal.

Please spread far and wide.

 

NONE of our witnesses will be allowed to present oral testimony at the

Codex

Vitamin Oversight hearing on Feb 28 unless MORE people sign the

petitions

at http://www.garynull.com/issues/Codex/AboutCodex.htm

and at http://www.laleva.org/petizione/english/intro_eng.html

Please forward Ed's article to more people.

 

 

International Advocates for Health Freedom - http://www.iahf.com

 

IAHF Webmaster: Breaking News, Codex Oversight, All Countries

 

IAHF List: Ed Fry's well written article below highlights the MAIN thing

to

understand about

the Pharma Cartel's dietary supplement takeover campaign: the whole

thing

boils down to the fact that they're trying to falsely define vitamin

safety.

 

This false definition of vitamin safety is the KEY THING we must expose.

 

Ed focuses on the late Dr.Brian Leibovitz expose of the pseudoscience of

 

John Hathcock, formerly with FDA, now with CRN.... and the ARCHITECT

of the pseudoscience being used to SET US UP. After you read Ed's

article,

I encourage you to go to http://www.iahf.com to see NAS Paper and

Rebuttals.

 

NONE of our witnesses will be allowed to present oral testimony at the

Codex

Vitamin Oversight hearing on Feb 28 unless MORE people sign the

petitions

at http://www.garynull.com/issues/Codex/AboutCodex.htm

and at http://www.laleva.org/petizione/english/intro_eng.html

Please forward Ed's article to more people.

 

 

Protecting People from Nutrients: Pseudo-Science In the Service of BIG

Money

 

by Edward Fry edfry

 

The myth of " Lowest Observable Adverse Event Levels " (LOAEL) for

vitamins and minerals is about to insinuate itself into our lives via a

forum called Codex, a UN underwritten trade summit without citizen

representation. The outcome of this gathering of the high and mighty is

still pending.

 

People still have time to examine the roots of the

so-called science that various " health policy " groups will use to argue

for limits on essential nutrients, which they deem inherently dangerous

.. What is the source of their alleged safety concerns? Are morgues

filled with vitamin poisoned corpses? Or is this part of a stealthy

strategy to turn supplements into de facto drugs?

 

LOAEL is " risk " terminology in the U.S. Food and Drug Administration's

(FDA) latest effort to restrict consumer access to nutrients. It is to

be accomplished this time by the indirect invention of international

trade standards.

 

FDA is assisting the birth of WTO-orchestrated rules

that will invariably put pressure on U.S. law and regulations. By

accentuating " risks, " and subordinating, indeed, repressing potentially

life saving information about nutrients, the FDA at Codex is extending

practices dating back over forty years.

 

As will be seen, the

" scientific " underpinnings of the FDA proposal are rife with arbitrary

assumptions and criteria. FDA's Codex agenda focused on supplement

" risk " serves, as it always has, the interests of ever-more-powerful

drug multinationals, not those of citizens.

 

In 1999, the FDA, abetted by the National Academy of Sciences (NAS),

borrowed from methods for identifying toxic chemical risk to define the

" risks " of life-giving, essential nutrients.

 

By making " safety " the

core issue for consideration in setting global standards, the FDA has

helped to exclude discussion of optimal nutrient intake, disease

prevention, and a broad range of nutritional research. Citizens remain

largely uninformed, blind to the huge, moneyed forces that influence the

 

actions of paternalistic bureaucracies in their respective countries,

ostensibly seeking to " protect " them by official policy.

The FDA's proposal to define supplements in terms of risk (pleasing drug

 

multinationals, whose dangerous technologies become obscured when more

benign products are scapegoated) uses scientific sounding language and

alphabetic gibberish to argue for dosage limits, despite the fact that

supplements have a better safety record than food. If limiting risk

were indeed the the NAS' or FDA's utmost concern, there long ago would

have been an initiative to upgrade policies for " approved as safe "

drugs, which when " properly prescribed and administered, " kill over

100,000 Americans each year.

The framework for this NAS/ FDA Risk Assessment Proposal for Dietary

Supplements germinated from a paper titled " Safety Limits for Nutrient

Intakes: Concepts and Data Requirements, " published in Nutrition Reviews

 

(51: 278-285, 1993). The premise of the present NAS/FDA proposal, and

the contagion of incongruencies generated by it, can be traced directly

to this paper, written by John Hathcock, then of the FDA's Center for

Food Safety and Applied Nutrition. Not surprisingly, Hathcock today is

a vice president at the Council for Responsible Nutrition, a trade

organization dominated by drug multinationals <www.crnusa.org>.

A valuable analysis of the paper by Brian Leibovitz, Ph.D. was published

 

in the Journal of Optimal Nutrition (JON). With a prodigious knowledge

of nutrition, including molecular details, Leibovitz worked for years as

 

a post doctoral fellow at one of the world's premier biological sciences

 

research centers at the University of California at Davis. (Recently

deceased, he had become increasingly dismayed by the pursuit of

commercial reward by many in his field, that had displaced an interest

in fundamental nutritional research or even sound science.)

Leibovitz was sufficiently disturbed by the audacity of the Nutrition

Reviews paper that in his editorial subtitled " Acronyms and

Definitions: Arsenal of Confusion " (JON 3[2], 1994), he made it a

candidate for a Bad Science (BS) Award. He said that to the best of his

knowledge this work " introduced the most absurd acronyms and ridiculous

equations in a single article ... with respect to both quality and

quantity " . The paper " introduced novel acronyms as well as toxicology

acronyms adapted for nutrition " . These persist in the current NAS/ FDA

proposal :

>ADI (Acceptable Daily Intake)

>SF (Safety Factor)

>NOAEL (No Observed Adverse Effect Level)

>LOAEL (Lowest Observed Adverse Effect Level)

>RfD (Reference Dose [ " probably will not cause deleterious effects

over a lifetime of exposure " ])

>UFs (Uncertainty Factors)

>MF (Modifying Factor)

>SI (nutrient Safety Index)

>SL (Safety Limit)

[Examples of the paper's equations appended below.]

The FDA's (Hathcock) proposal for assessing supplement " risk " was

elaborated by the private and publicly unaccountable NAS. It has been

embraced by executives of supplement trade groups, who appear to be

cozying up to mainstream medicine's view of nutrients. This view is

underwritten by the participation and revenue of drug conglomerates,

which possess little interest in the advancement of nutritional

knowledge and practices, that might displace a " need " for ultra

profitable, patented drugs.

At the core of the proposal highlighted below is the premise that

essential nutrients are harmful in ways equivalent to chemical toxins,

and should be assessed similarly. (A corollary of such a premise,

suggesting that some amount of chemical poison is good for us, is borne

out in the same document by the NAS/ FDA conclusion that fluoride is

essential and safe at levels shown by earlier government research to

cause skeletal fluorosis and other diseases .)

Official sounding acronyms and obtuse language notwithstanding, the

reader should probe the following definitions first hand, and decide for

 

him or herself whether what is presented is scientific and

methodological sophistication or sophistry. Note: Multiple unknowns and

indeterminate variables follow:

" For the calculation of the RfD, the SF has been refined into multiple

components described as uncertainty factors, UFs, and a modifying

factor, MF. Thus, the RfD is defined by the following equation: RfD =

NOAEL (or LOAEL) / (UF x MF), where UF represents *one or the product of

 

several uncertainty factors* [Dr. Leibovitz' emphasis], generally

tenfold each. An additional factor, the MF, is *used as necessary to

account for areas of uncertainty that are not explicitly addressed by

the usual factors* [emphasis added to highlight the careless assignment

of certainty to a jumble of unknowns ] " .

Expanding this exercise in critical (or creative) thinking:

" To assess the comparative safety of nutrients, a nutrient safety index

(SI) has been defined as a ratio that is analogous in several ways to

the therapeutic index (TI) for drugs. The SI was defined as the minimum

toxic dose divided by the recommended intake: SI = LOAEL / RI. This SI

is useful for comparing the relative hazard posed by over consumption of

 

different nutrients. In this analysis , an SI of 10 does not indicate

that an intake of up to 10 times the RDA is safe. Instead, it indicates

that *such an intake provides no margin of safety* [Dr. Leibovitz'

emphasis] " .

Amidst several tortuous leaps in logic (e.g., that a toxic dose of a

drug is in any scientific sense analogous to that of a nutrient, which

has no toxic dose per se), we learn that the number 10, despite being

called an index, represents neither a co-factor nor a distribution,

where a sequence of increasing or decreasing numbers, indicates a

gradient or range of values. As a quantitative indicator, or modifying

ratio, the " value " of the safety index (SI) is instead mysterious.

" If appropriate and adequate human data are available, a safety limit

(SL) could be calculated as follows:

SL = LOAEL /SF where LOAEL is the lowest-observed-adverse-event level

derived from clinical reports and SF is a safety factor that provides an

 

acceptable margin of safety. The SF could be either fixed or *variable*

[emphasis added to highlight the arbitrariness of this approach] " .

More effort has been spent studying and applying concepts of optimal

nutrient intake for lab animals than for humans. Investigating the

validity of what is today regarded as " appropriate and adequate " human

nutrition would be a noble and worthy starting point, rather than using

arbitrary factors to forge limits. Nutrient levels that " safely "

prevent disease states may be, and likely are, far lower than those

necessary to promote robust health.

The final stop in a landscape of obtuse conclusions is this most

eye-opening remark:

" The confidence in and reasonableness of safety limits, regardless of

the methods to define them [emphasis added], will be enhanced if the

* objectives* [emphasis added], data criteria, and the quantitative

method have been agreed upon ahead of time by *groups responsible for

nutrition and health policy* [emphasis added].

>From this it appears that the throng of abbreviations and equations

offered is little more than an attempt to assure consensus and set

limits in advance of comprehensive research findings. To paraphrase a

worthier exhortation: " Damn the science. Full speed ahead! " . What's

frightening is, more than academic musings, this rationale has emerged

as a means for setting international nutritional policy.

This is bad news for billions of us who would benefit from standards

that would define optimal nutrient levels, a Suggested Optimal Intake

Range [sOIR] for nutrients, instead of LOAEL. Illness and death

resulting from supposedly ungoverned nutrient levels are virtually nil

compared to the death and disease resulting from nutritional

deficiencies. Yet, research into and policies for defining ideal

nutrient levels are sacrificed in the name of a policy (objective) that

seeks to delimit dosage levels. It's a shame the zeal to frame policies

to minimize potencies in the name of safety isn't applied to drugs,

which kill and injure millions.

If the pending Risk Assessment Proposal is the best science available,

as bureaucrats and industry big shots claim, isn't it bewildering that

its prime architect argued that it be developed by policy makers and not

 

nutritional scientists?

Current U.S. laws and regulations make ours one of the few remaining

countries in the world where some supplements products are still made by

 

supplement companies, instead of by drug manufacturers. We in the U.S.

are still free to take higher levels of nutrients than government has

decreed as " adequate " . The FDA, whose mission it is to assure the safety

 

of the U.S. food and drug supply, is proposing standards in

international trade negotiations, that would have the effect of

increasing drug companies' monopolistic hold on nutritional products and

 

the health care delivery worldwide. Under pressure of the trillion and

a quarter dollar a year disease treatment industry, a relative few,

motivated more by greed and power than by any commitment to the public

good, are poised to enhance their stake at all our expense -- " expense "

in all its forms, from the merely economic to the tragic.

 

Appendix:

Safety limits may be calculated by the SUM [square-root method] and

midpoint method as follows:

Midpoint method:

SL = (LOAEL- (LOAEL - RDA) /2, or equivalently,

SL = (LOAEL + RDA) divided by 2 x (the arithmetic mean)

Square-root method:

SL = (LOAEL / SF) = LOAEL /SI0.5, where SI = LOAEL /RDA, or

equivalently,

SL = (LOAEL x RDA)0.5 (the arithmetic mean)

 

 

 

 

____________________

To , write to IAHF-

 

 

 

 

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