Protecting People from Nutrients: Pseudo-Science In the Service of BIG Money
by Edward Fry

The myth of "Lowest Observable Adverse Event Levels" (LOAEL) for vitamins and minerals is poised to insinuate itself into our lives via Codex, an ongoing UN-underwritten trade policy forum without citizen representation. Since the outcome of this gathering of bureaucrats is pending, people whose lives stand to be affected 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 alleged safety concerns? Are morgues filled with vitamin poisoned corpses? Or, could this be 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. Since past, direct attempts to categorise nutrients as drugs have failed, restrictions would be accomplished this time around by the indirect means 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 suppressing, potentially life saving information about nutrients, the FDA at Codex is extending a practice 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, in concert with the National Academy of Sciences (NAS), used methods for identifying toxic chemical risk to define the "risks" of life-giving, essential nutrients. By making "safety" by itself the issue for consideration in setting global standards, the FDA has helped to exclude discussion of optimal nutrient intake and a broad range of nutritional research. Citizens, largely uninformed and blind to the huge, moneyed forces that influence the actions of paternalistic bureaucracies in their respective nations, are said to be "protected" by such official policy.

The FDA's proposal to define supplements in terms of risk (pleasing drug multinationals, whose dangerous technologies become obscured when more benign industries are scapegoated) uses scientific sounding language to argue for dosage limits, despite the fact that supplements have a better safety record than food in countries, like the U.S., which presently enjoys liberal access. 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 W 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 it generates, can be traced directly to this paper, written by John Hathcock, then of the FDA's Center for Food Safety and Applied Nutrition. Hathcock today is a vice president at the Council for Responsible Nutrition, a trade organisation whose membership is dominated by drug interests <www.crnusa.org>.

A valuable analysis of the Hathcock paper by Brian Leibovitz, Ph.D. was published in the Journal of Optimal Nutrition (JON). With a prodigious knowledge of molecular biology, biochemistry and nutrition, 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 commercial agendas of 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 "honored" it with 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 no 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 private and publicly unaccountable NAS, under contract with FDA, expanded upon the Hathcock proposal for assessing supplement "risk". The finished document has been embraced by executives of supplement trade groups, who see it as "rational compromise" to an even more repressive European rationale. Restrictions on supplement potencies appear to be supported by the participation and revenue of drug conglomerates, who would seem to have an interest in assuring that advancements in nutritional knowledge or practice do not displace the "need" for ultra profitable, patented drugs.

At the crux of the proposal highlighted below is the premise that essential
nutrients are harmful in ways comparable to chemical toxins, and deserve comparable assessment. A corollary of this premise -- that some amount of chemical poison is good for us -- is borne out in the same NAS/ FDA document with the 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 u 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 "therapeutic" or 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 study and application of standards for optimal nutrient intake has been extended to lab animals than to human beings. Investigating valid scientific disagreements over the meaning of "appropriate and adequate" human nutrition would be a noble and worthy starting point, rather than using arbitrary factors to forge limits. There is abundant data that nutrient levels which "safely" prevent clinical symptoms of deficiency (disease) 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 frame 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 an academic musing, this rationale has emerged as a means for setting international nutritional policy.

This is bad news for billions who might benefit from standards that define a safe and optimal nutrient intake range, a Suggested Optimal Intake Range [SOIR] for nutrients, not 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 maim millions.

If the pending Risk Assessment Proposal is the best science available, as bureaucrats and industry leaders 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 supplement products are still made by supplement companies, instead of by drug manufacturers. We in the U.S. are 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 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, seem poised to enhance their stake at all our expense -- "expense" in all its forms, from the merely economic to life and death 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)