Fwd: Article By Dr.Gaby: Safe Upper Limits for Nutritional Supplements: One Giant Step BACKWARD

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27 Jan 2004 22:06:13 -0000

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Article By Dr.Gaby: Safe Upper Limits for Nutritional Supplements: One

Giant Step BACKWARD

 

IAHF Webmaster: Breaking News, Whats New, All Countries, Codex, What to Do

 

IAHF List: Alan Gaby, MD just sent me his article (see below) which was just

published in the Special Issue of the Journal of Orthomolecular Medicine on the

Safety and Efficacy of Vitamins. The footnotes are not included, if you require

the footnotes, please order a copy of the original from JOM at

http://www.orthomed.org/jom/jom.htm

 

I just sent this article to Dr.Antoinette Booyzen, South African Codex Delegate

who as things currently stand, appears to be convinced that CRN's views on " Safe

Upper Limits " are " scientific " . This article refutes any such conclusion. Please

forward it to your countries delegate to the UN Codex Alimentarius Commission's

Committee on Nutrition and Food for Special Dietary Uses.

 

There is a very real danger that unless enough vitamin consumers world wide

lobby against it, a grossly unscientific vitamin standard could be rushed

through to completion at the next Codex meeting in November in Bonn, Germany.

 

I am especially concerned that pharma dominated controlled opposition groups CRN

and IADSA have announced their intention to hold a political summit meeting two

days before the next Codex meeting. Unless enough consumers world wide get

behind ANH's legal and lobbying efforts, we won't be able to stop the

pharmaceutical takeover of the natural products industry. (The CRN meeting is

October 24- 27th, the CRN/IADSA Political Summit to screw the dietary supplement

industry is being held October 28-29th, and the Codex meeting is the following

monday, 2 days later, starting November 1st......)

 

Want more help in connecting the dots? Read the Cover story interview Greg Ciola

did with me in the Dec/Jan issue of The Health Crusader Magazine at

http://www.thehealthcrusader.com/pgs/article-0104-ban.shtml Please forward this

like wildfire throughout your up and downlines if you are a network marketing

distributor for any CRN member company: Mannatech, Shaklee, Herbalife, GNLD,

NuSkin.

 

These companies have been lied to by CRN in a press release on CRN's website

which proclaims that a " victory " has been won at Codex due to RDA's being

scrapped in favor of so called " Safe Upper Levels " (allegedly based on

" science " ) but Gaby's article (see below) EXPLODES that contention....

 

I am blown away by the naivete of such people as Sam Caster at Mannatech who has

been flattered by CRN's making him a Board Member so he thinks John Hathcock at

CRN is " his friend " . Sam better wake up, because Hathcock used to work at FDA

and might as well STILL be working at FDA, and he's NOT our friend, Gaby's

article EXPLODES any contention that we can trust Hathcock's so called

" scientific " risk assessment methodology, which was misextrapolated from

toxicological risk assessment methodology originally intended for the evaluation

of toxic pharmaceutical DRUGS and which they're MISAPPLYING to safe vitamins.

 

Never forget that CRN is dominated by Wyeth, Monsanto, Bayer, BASF, and

Pfizer....

 

 

" Safe Upper Limits " for nutritional supplements: one giant step backward

by Alan R. Gaby, M.D.

 

In May, 2003, the " Expert Group on Vitamins and Minerals " (EVM), an advisory

group originally commissioned in 1988 by the then Ministry of Agriculture

Fisheries and Food, and subsequently reporting to the Food Standards Agency in

England, published a report that set " Safe Upper Limits " (SULs) for the doses of

most vitamin and mineral supplements. The establishment of SULs was based on a

review of clinical and epidemiological evidence, as well as animal research and

in vitro studies. For those nutrients for which the available evidence was

judged insufficient to set an SUL, the EVM instead established " Guidance

Levels " , which were to be considered less reliable than SULs.

 

This writer's analysis of the EVM report reveals that the dose limits were set

inappropriately low for many vitamins and minerals; well below doses which have

been used by the public for decades with apparent safety. While the release of

this 360-page document would be of little import, were it to be used solely as a

manifesto for the pathologically risk-averse, preliminary indications are that

it could be used very actively to support the arguments of those who are seeking

to ban the over-the-counter sale of many currently available nutritional

supplements. If the report is used that way, then the public health could be

jeopardized.

 

On May 30, 2002, the European Union adopted Directive 2002/46/EC, which

established a framework for setting maximum limits for vitamins and minerals in

food supplements. The EVM report is seen by the UK government as the basis for

its negotiating position in the process of setting these pan-European limits.

 

The apparent anti-nutritional-supplement, anti-self-care bias that permeated the

process of setting safety limits is evident both in the way in which the SUL was

defined and in the fact that the benefits of nutritional supplements were

purposely ignored. The SUL was defined as the maximum dose of a particular

nutrient " that potentially susceptible individuals could take daily on a

life-long basis, without medical supervision in reasonable safety. " In other

words, it is the highest dose that is unlikely to cause anyone any harm, ever,

under any circumstance. Furthermore, the EVM was specifically instructed not to

consider the benefits of any of the nutrients, and not to engage in risk/benefit

analysis.

 

There is little or no precedent in free societies for restricting access to

products or activities to levels that are completely risk-free. Aspirin causes

intestinal bleeding, water makes people drown, driving a car causes accidents,

and free speech may offend the exquisitely offendable. Politicians and

bureaucrats do not seek to ban aspirin or water or driving or free speech,

because their benefits outweigh their risks. For vitamins and minerals, however,

some authorities seem to believe that unique safety criteria are needed.

 

Moreover, the government's instructions to disregard the many documented

benefits of nutritional supplements introduced a serious bias into the

evaluation process. As the EVM acknowledged, determining safety limits involves

an enormous degree of uncertainty and a fairly wide range of possible outcomes.

The committee might have established higher safety limits than it did, had it

been told to weigh benefits against risks. The government's instructions

appeared to be an implicit directive to err on the side of excluding doses that

are being used to prevent or treat disease. And that is what the EVM did, often

by making questionable interpretations of the data, and doing so in what appears

to have been an arbitrary and inconsistent manner.

 

 

Riboflavin Guidance Level

 

A typical example of the EVM's dubious approach to establishing safety limits is

its evaluation of riboflavin. The committee acknowledged that no toxic effects

have been reported in animals given an acute oral dose of 10,000 mg/kg of body

weight, or after long-term ingestion of 25 mg/kg/day (equivalent to 1,750 mg/day

for a 70-kg human). Moreover, in a study of 28 patients taking riboflavin for

migraine prophylaxis, a dose of 400 mg/day for 3 months did not cause any

adverse effects. Despite a complete absence of side effects at any dose in

either humans or animals, the EVM set the Guidance Level for riboflavin at 40

mg/day. That level was established by dividing the 400 mg/day used in the

migraine study by an " uncertainty factor " of 10, to allow for variability in the

susceptibility of human beings to adverse effects.

 

A more appropriate conclusion regarding riboflavin would have been that no

adverse effects have been observed at any dose, and that there is no basis at

this time for establishing an upper limit. If the EVM's recommendation is used

to limit the potency of riboflavin tablets to 40 mg, then migraine sufferers

will have to take 10 pills per day, in order to prevent migraine recurrences.

 

 

Vitamin B6 Safe Upper Limit

 

Similar reasoning led to an SUL of 10 mg/day for vitamin B6, even though this

vitamin has been used with apparent safety, usually in doses of 50 to 200

mg/day, to treat carpal tunnel syndrome, premenstrual syndrome, asthma, and

other common problems. The SUL for vitamin B6 was derived from an animal study,

in which a dose of 50 mg/kg of body weight/day (equivalent to 3,000 mg/day for a

60-kg person) resulted in neurotoxicity. The EVM reduced that dose progressively

by invoking three separate " uncertainty factors: " 1) by a factor of 3, to

extrapolate from the lowest-observed-adverse-effect-level (LOAEL) to a

no-observed-adverse-effect-level (NOAEL); 2) by an additional factor of 10, to

account for presumed inter-species differences; and 3) by a further factor of 10

to account for inter-individual variation in humans. Thus, the neurotoxic dose

in animals was reduced by a factor of 300, to a level that excludes the widely

used 50- and 100-mg tablets.

 

The decision to base the SUL for vitamin B6 on animal data (modified by a

massive " uncertainty factor " ) was arbitrary, considering that toxicology data

are available for humans. A sensory neuropathy has been reported in some

individuals taking large doses of vitamin B6. Most people who suffered this

adverse effect were taking 2,000 mg/day or more of pyridoxine, although some

were taking only 500 mg/day. There is a single case report of a neuropathy

occurring in a person taking 200 mg/day of pyridoxine, but the reliability of

that case report is unclear. The individual in question was never examined, but

was merely interviewed by telephone after responding to a local television

report that publicized pyridoxine-induced neuropathy.

 

Because pyridoxine neurotoxicity has been known to the medical profession for 20

years, and because vitamin B6 is being taken by millions of people, it is

reasonable to assume that neurotoxicity at doses below 200 mg/day would have

been reported by now, if it does occur at those doses. The fact that no such

reports have appeared strongly suggests that vitamin B6 does not damage the

nervous system when taken at doses below 200 mg/day. As the EVM did with other

nutrients for which a LOAEL is known for humans, it could have divided the

vitamin B6 LOAEL (200 mg/day) by 3 to obtain an SUL of 66.7 mg/day. Had the

committee been allowed to evaluate both the benefits and risks of vitamin B6, it

probably would have established the SUL at that level, rather than the 10 mg/day

it arrived at through serial decimation of the animal data.

 

 

Manganese Guidance Level

 

Chronic inhalation of high concentrations of airborne manganese, as might be

encountered in mines or steel mills, has been reported to cause a

neuropsychiatric syndrome that resembles Parkinson's disease. In contrast,

manganese is considered one of the least toxic trace minerals when ingested

orally, and reports of human toxicity from oral ingestion are " essentially

nonexistent. " The neurotoxicity that occurs in miners and industrial workers may

result from a combination of high concentrations of manganese in the air and,

possibly, direct entry of nasally inhaled manganese into the brain (bypassing

the blood-brain barrier).

 

In establishing a Guidance Level for manganese, the EVM cited a study by

Kondakis et al, in which people exposed to high concentrations of manganese in

their drinking water (1.8-2.3 mg/L) had more signs and symptoms of subtle

neurological dysfunction than did a control group whose drinking water contained

less manganese. The committee acknowledged that another epidemiological study by

Vieregge et al showed no adverse effects among individuals whose drinking water

contained up to 2.1 mg/L of manganese. The EVM hypothesized that these studies

may not really be contradictory, since the subjects in the Kondakis study were,

on average, 10 years older than were those in the Vieregge study, and increasing

age might theoretically render people more susceptible to manganese toxicity.

Based on the results of these two studies, the EVM established a Guidance Level

for supplemental manganese of 4 mg/day for the general population and 0.5 mg/day

for elderly individuals.

 

There are serious problems with the EVM's analysis of the manganese research.

First, the committee overlooked that fact that in the Kondakis study the people

in the high-manganese group were older than were those in the control group

(mean age, 67.6 vs. 65.6 years). Many of the neurological symptoms that were

investigated in this study are nonspecific and presumably age related, including

fatigue, muscle pain, irritability, insomnia, sleepiness, decreased libido,

depression, slowness in rising from a chair, and memory disturbances. The fact

that the older people had more symptoms than did the younger people is not

surprising, and may have been totally unrelated to the manganese content of

their drinking water.

 

Second, the EVM broke its own rules regarding the use of uncertainty factors,

presumably to avoid being faced with an embarrassingly low Guidance Level for

the general population. In setting the level at 4 mg/day, the committee stated:

" No uncertainty factor is required as the NOAEL [obtained from the Vieregge

study] is based on a large epidemiological study. " As a point of information,

the Nurses' Health Study was a large epidemiological study, enrolling more than

85,000 participants. The Beaver Dam Eye Study was a medium-sized epidemiological

study, enrolling more than 3,000 participants. In contrast, in the Vieregge

study, there were only 41 subjects in the high-manganese group, making it a very

small epidemiological study. In its evaluation of the biotin, riboflavin, and

pantothenic acid research, the EVM reduced the NOAEL by an uncertainty factor of

10, in part because only small numbers of subjects had been studied. Considering

that more subjects were evaluated in the

pantothenic acid research (n = 94) than in the Vieregge study (n = 41), it

would seem appropriate also to use an uncertainty factor the for manganese data.

Applying an uncertainty factor of 10 to the Vieregge study would have produced

an absurdly low Guidance Level of 0.4 mg/day for supplemental manganese, which

is well below the amount present in a typical diet (approximately 4 mg/day) and

which can be obtained by drinking several sips of tea. Parenthetically, in a

study of 47,351 male health professionals, drinking large amounts of tea (a

major dietary source of manganese) was associated with a reduced risk of

Parkinson's disease, not an increased risk. In changing its methodology to avoid

reaching an indefensible conclusion, the EVM revealed the arbitrary and

inconsistent nature of its evaluation process.

 

 

Niacin (nicotinic acid) Guidance Level

 

Large doses of niacin (such as 3,000 mg/day) can cause hepatotoxicity and other

significant side effects. The EVM focused its evaluation, however, on the

niacin-induced skin flush, which occurs at much lower doses. The niacin flush is

a sensation of warmth on the skin, often associated with itching, burning, or

irritation that occurs after the ingestion of niacin and disappears relatively

quickly. It appears to be mediated in part by the release of prostaglandins. The

niacin flush is not considered a toxic effect per se, and there is no evidence

that it causes any harm. People who do not like the flush are free not to take

niacin supplements or products that contain niacin. For those who are unaware

that niacin causes a flush, an appropriate warning label on the bottle would

provide adequate protection.

 

Granting, for the sake of argument, that the niacin flush is an adverse effect

from which the public should be protected, the EVM's Guidance Level still is

illogical. The committee noted that flushing is consistently observed at a dose

50 mg/day, which it established as the LOAEL. That dose was reduced by an

uncertainty factor of 3, in order to extrapolate the LOAEL to a NOAEL. Thus, the

Guidance Level was set at 17 mg/day, which approximates the RDA for the vitamin.

The EVM also noted, however, that flushing has been reported at doses as low as

10 mg, so the true LOAEL is 10 mg/day. Applying the same uncertainty factor of 3

to the true LOAEL would have yielded a Guidance Level of a paltry 3.3 mg/day,

which probably is not enough to prevent an anorexic person from developing

pellagra. As with manganese, the EVM applied its methodology in an arbitrary and

inconsistent manner, so as to avoid being faced with an embarrassing result.

 

 

Vitamin C Guidance Level

 

The EVM concluded that vitamin C does not cause significant adverse effects,

although gastrointestinal (GI) side effects may occur with high doses. The

committee therefore set a Guidance Level based on a NOAEL for GI side effects.

It is true that taking too much vitamin C, just like eating too many apples, may

cause abdominal pain or diarrhea. The dose at which vitamin C causes GI side

effects varies widely from person to person, but can easily be determined by

each individual. Moreover, these side effects can be eliminated by reducing the

dose. Most people who take vitamin C supplements know how much they can

tolerate; for those who do not, a simple warning on bottles of vitamin C would

appear to provide the public all the protection it needs. Considering the many

health benefits of vitamin C, attempting to dumb down the dose to a level that

will prevent the last stomachache in Europe is not a worthwhile goal. However,

as mentioned previously, the EVM was instructed to ignore the

benefits of vitamin C.

 

Granting, for the sake of argument, that there is value in setting a Guidance

Level for GI side effects, the EVM did a rather poor job of setting that level.

The committee established the LOAEL at 3,000 mg/day, based on a study of a small

number of normal volunteers. An uncertainty factor of 3 was used to extrapolate

from the LOAEL to a NOAEL, resulting in a Guidance Level of 1,000 mg/day.

However, anyone practicing nutritional medicine knows that some patients

experience abdominal pain or diarrhea at vitamin C doses of 1,000 mg/day or

less, and the EVM did acknowledge that GI side effects have been reported at

doses of 1,000 mg. It is disingenuous to set a NOAEL and then to concede that

effects do occur at the no-effect level. To be consistent with the methodology

it used for other nutrients, the committee should have set the LOAEL at 1,000

mg/day, and reduced it by a factor of 3 to arrive at a NOAEL of 333 mg/day. The

EVM was no doubt aware of the credibility problems it would have

faced, had it suggested that half the world is currently overdosing on vitamin

C. To resolve its dilemma, the committee used a scientifically unjustifiable

route to arrive at a seemingly politically expedient outcome.

 

 

Conclusion

 

These and other examples from the report demonstrate that the EVM applied its

methodology in an arbitrary and inconsistent manner, in arriving at " safety "

recommendations that are excessively and inappropriately restrictive. While the

directive to evaluate only the risks, and to ignore the benefits, of nutritional

supplements created a rigged game, the members of the EVM appeared to be willing

participants in that game.

 

If the EVM report is used to relegate currently available nutritional

supplements to prescription-only status, then millions of people would be

harmed, and very few would benefit. It would be of little consolation that the

higher doses of vitamins and minerals could still be obtained with a doctor's

prescription, because most doctors know less about nutrition than many of their

patients do. Moreover, the overburdened health-care system is in no position to

take on the job of gatekeeper of the vitamin cabinet; nor is there any need for

it to do so.

 

Ironically, as flawed as the EVM report is, its recommendations may ultimately

prove to be " as good as it gets " in Europe. Other European countries are

recommending that maximum permitted levels be directly linked to multiples of

the RDA, which could result in limits for some nutrients being set substantially

lower than those suggested in the EVM report.

 

While some nutritional supplements can cause adverse effects in certain clinical

situations or at certain doses, appropriate warning labels on vitamin and

mineral products would provide ample protection against most of those risks.

 

 

Note: Reprinted with permission from the Journal of Orthomolecular Medicine (in

press), as part of a special issue devoted to clearing up the confusion about

the toxicity of vitamins.

For Health Freedom,

John C. Hammell, President

International Advocates for Health Freedom

556 Boundary Bay Road

Point Roberts, WA 98281-8702 USA

http://www.iahf.com

jham

800-333-2553 N.America

360-945-0352 World

 

 

 

 

 

 

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