Several associations representing consumers and health practitioners were present under the banners of the National Health Federation : Friends of Freedom from Canada, the Europe-based Alliance for Natural Health , Danish MayDay , La Leva from Italy, the US Health Freedom Coalition as well as the Dr. Rath Health Foundation .

The question is really, whether freedom of choice in healthcare will be respected. Although the guidelines are not in themselves restricting supplement sales, they do prohibit information about diseases and nutrition and they call for future dosage restrictions to be set after scientific evaluation of the safety of nutrients contained in pills and capsules. Consumer representatives who attended the meeting are concerned that the guidelines, in conjunction with the European Union’s directive on food supplements, may be a first step towards heavy controls on nutrition that would favor the pharmaceutical approach to disease over active, consumer-driven prevention.

Flaws and some unclear points that should have sent the guideline back to the Nutrition Committee for reconsideration were pointed out by Scott Tips of the National Health Federation . Industry representative David Pineda of IADSA , the International Food/Dietary Supplements Alliance said instead that after more than 10 years of discussion in the Committee, the consensus that was reached was a positive step and should be adopted…

The Codex Alimentarius Commission – 85 members present

After dealing with previously submitted comments by Australia, Brazil, China and Venezuela, the vitamin and mineral supplements guideline was passed by a passive vote – no objections from a full 85-member-assembly – one item on a lengthy list of standards and guidelines to be adopted.

“What now?” was the question of those concerned health freedom advocates who attended the meeting, one of whom answered: “We may have lost a battle, but the war is far from over”. Indeed, much now depends on the discussions recently initiated by FAO and WHO, to work out a proper model to assess the risks inherent in supplements. “But rather than only assessing the risks, they must look at the immense benefits from these nutrients as well as the risks, before they can reach a proper decision”, commented another one of the activists. Agreement is building that risk assessment procedures developed for toxic chemicals cannot be applied to nutrients without making a dog’s breakfast.

So where do we go from here? We must continue working to make sure that the benefits of supplements are not overlooked when deciding whether to limit quantities or composition of supplements, but this also ties in to a much larger issue: Are corporations going to decide how we should take care of our health or will people be free to choose?

There is a tough time ahead. Perhaps what is needed is a real change in health care, a reform that would sweep pharma-dominated medicine, which in the US has become the major cause of death and injury, off its pedestal of exclusive ‘guardian of health’ to allow all kinds of alternatives to fluorish so people may have a meaningful range of choice when it comes to health and well being.

The National Health Federation had argued the guidelines should be re-considered, because they are contravening the World Health Organization’s own procedural rules, alas to no avail:(

1. The guidelines do not state what purpose they serve, although that is required by Codex rules adopted as recently as a year ago, but well before the November 2004 Nutrition Committee meeting that finalized the text.

2. There is no clear definition as to what vitamins and minerals are covered by these guidelines. Although supplements “should contain vitamins, provitamins and minerals recognized by FAO and WHO”, according to the text, there is actually no publication of the FAO or WHO that provides lists of recognized vitamins, provitamins and minerals.

3. Certain countries are exempted from the application of the guidelines. Those countries that consider vitamins and other nutrients should be regulated as drugs are exempted. This means harmonization of different national laws, the goal of all Codex activity, is not being forwarded by the guidelines.

I might add that, while the guidelines ask for restrictions on supplements in the comparatively liberal countries, the really backwards view of “nutrition is really medicine and any of those nutritional supplements are drugs” is acknowledged as being quite acceptable. Indeed, one of the amendments to the guidelines was Australia’s demand to emphasize that “These Guidelines apply only in those jurisdictions where products … are regulated as foods”.

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In this issue, Kaplan and colleagues (1) describe an open trial of the first 14 adults with bipolar disorder treated with this nutritional supplement, which consists of a broad range of minerals and vitamins, plus 3 amino acids and several antioxidants. Symptom reductions were clinically noted within 2 weeks and sustained over 6 months of observation. All outcome measures showed significant improvements (55% to 66% symptom reduction), and a strong effect size (> .80) was observed for ratings of depression as well as mania. Most patients could reduce their doses of psychiatric medications, and some patients became stable without any psychiatric medication. Only 2 patients started on new medications that might conceivably have contributed to their stabilization. Even allowing for the usual overestimation of effects in open-label series, these preliminary findings raise interesting questions about nutrition-behavior interactions.

In view of the 50 years of experience with lithium, the notion that minerals can treat bipolar disorder is unsurprising. However, the nutrient supplement studied by Kaplan and colleagues contains no lithium. Might other dietary nutrients have mood-stabilizer properties?

Some may object that a clinical trial of a mixture of ingredients is inherently unscientific: How can one know which ingredient is the active one, whether a smaller number of ingredients will have the same clinical effect, or whether the same ingredients are active in different patients? These questions will become worth pursuing once it has been formally determined whether the mixture, handed down from animal husbandry as a single entity, works in humans. Kaplan’s open-label report justifies her now ongoing controlled study, whose outcome appropriately precedes pursuing questions of mechanism of action (2) and parsimony.

Even so, it is difficult to avoid speculating about possible mechanisms. Might minerals serve as catalysts for enzymes involved in neurotransmitter metabolism, change drug biotransformation, modify membrane receptors or channels, influence second or third messenger systems, or alter gene expression? Lithium, a single cation, has spawned a minor industry of investigations into mechanisms of action, and the possibilities if there were numerous interacting micronutrients (the collective term for minerals and vitamins) are staggering.

My interest in this nutrient mixture was initially sparked by a case in my clinical practice. A 10-year-old with bipolar disorder was referred for treatment of severe temper tantrums, which had lasted for 2 to 4 hours daily for 4 months. The well-nourished child had no prior psychiatric history or treatment. After 2 days on the Hardy-Stephan nutrient regimen, his tantrums showed significant improvement, with the father-psychiatrist reporting a “complete” absence of outbursts or even irritability at 5 days. After 2 weeks, the available supply of the nutrient supplement was exhausted, and tantrums returned within 48 hours. A similar supplement, containing most of the same ingredients, was then started and produced a moderate improvement, which parents and teachers estimated as 60% of the original effect. When restarted on the original formula, the symptoms were judged to have again responded completely. This naturalistic A-B-A-C-B trial caught my attention because of the full stabilization without psychiatric medications and the absence of observed adverse effects.

I proceeded to cautiously conduct additional trials of the Hardy-Stephan nutrient supplement. Among 22 patients (10 adults, 9 adolescents, 3 preadolescents) who clinically met criteria for bipolar disorder, 19 showed what I judged to be a positive response (2 mild, 7 moderate, 10 marked improvement). Among the 15 patients who were being treated with medications when they began the nutritional supplement, 11 patients have been stable for 6 to 9 months without psychiatric medications. These observations are consistent with Kaplan’s open-label findings, but leave questions of safety unresolved.

Nausea was the main adverse effect in Kaplan’s study. In the larger anecdotal experience of Hardy and Stephan and my limited clinical observations, loose stools and headache were common. Diarrhea, vomiting, flatulence, and agitation were less common. Classical symptoms of mineral or vitamin toxicity were not encountered, but might have emerged with lengthier treatment or more systematic observation.

The Hardy-Stephan supplement contains many nutrients at high doses relative to the Recommended Daily Allowance (RDA), but these RDA levels were primarily established to prevent deficiency disorders in the general population. A broader range of vitamin and mineral functions (3,4) are considered in formulating the newer daily intake standards, which vary widely because of different criteria for adequacy and different health goals. (5) Although most ingredients in the nutrient supplement studied by Kaplan and colleagues appear well within safe limits, any multi – ingredient treatment might have toxic effects that cannot be readily predicted from its individual components. Even though it contains only “natural” ingredients and is not under U.S. Food and Drug Administration (FDA) purview, the Hardy-Stephan nutrient supplement should be examined in controlled empirical research – just as new pharmacologic agents are – to properly assess adverse effects and potential risks.

Psychiatrists do not normally think of vitamins or minerals as modifiers of the effects of psychiatric medications, but the early anecdotal experience with this nutrient supplement suggests that there may be strong micronutrient-medication interactions. This mineral-vitamin supplement seems to generally potentiate the clinical properties of psychiatric drugs. Most patients in the Kaplan et al. study could be managed with less medication after the nutrient supplement was added. To avoid medication toxicity, Hardy and Stephan have suggested to patients’ psychiatrists that the doses of psychiatric medications be rapidly reduced shortly after the nutrient supplement is initiated. In my observations, transitioning patients from medications to micronutrients is exceedingly tricky to manage. Introducing micronutrients too quickly can increase the adverse effects of medications, including agitation, while withdrawing psychiatric medications too quickly can result in symptom exacerbation. Often, both increased adverse effects and symptom resurgence are seen at once. Much more data are needed about how to “transition” patients who are currently taking psychiatric medications. Although it appears less difficult to treat medication-naive patients (such as my 10-year-old patient), the transition from psychiatric medications to micronutrients can require genuine technical savvy-even for patients who have not taken such medications for several weeks or months. Clinicians who mistakenly approach these new findings as encouragement to combine micronutrients with psychiatric medications may find that they have stepped into a serious quagmire.

Although health food advocates have made numerous claims without scientific documentation, nutritional influences on mental illness have received considerable research attention, (6) some of which is quite rigorous and promising. Andrew Stoll’s research on omega-3 fatty acids for bipolar disorder (7,8) and Eugene Arnold’s work on omega-6 fatty acids for attention deficit disorder (9-11) suggest that these nutrients might themselves be therapeutic. Other micronutrients (calcium, chromium) and macronutrients (inositol, amino acids) have also shown some potential for influencing mood disorders. (12-15) Arnold’s recent findings suggest that relative zinc deficiency might explain why some patients with ADHD do not show a more robust response to psychostimulants. (9)

Several large-scale double-blind placebo-controlled studies of RDA or high-dose multivitamin regimens in adults have reported improved scores of mood and cognition (16,17) as well as anxiety and somatic symptoms. (18) A recent review reported that 10 of 12 randomized double-blind placebo- controlled studies found that multi-micronutrient regimens can improve cognitive functioning in children. (19) However, high-dose multivitamin treatments have not been found to be effective in children with ADHD or learning disorders. (11,20)

Speculatively, there is a great deal to learn about minerals and vitamins in psychiatric pathophysiology and psychopharmacology. It is intriguing that many of the enzymes proposed as target sites of lithium action are metalloenzymes that are noncompetitively inhibited by lithium, which probably acts by displacing the divalent cation. (21) Why would supplementation with divalent cations have a therapeutic effect? Do we know enough about complex intracellular regulatory interactions to answer this question? Individual micronutrients will need to be examined in combination with lithium, but it is unlikely that the physiology will be so simplistic and dyadic. The groundbreaking approach of examining several nutrient ingredients at once, while a violation of our usual tenets of investigation, may present an opportunity to examine how micronutrients might operate in concert.

Assessing the safety and efficacy of multinutrient formulas will require considerable research. Developing dose-effect curves for each micronutrient, and examining all possible combinations of micronutrients, will be a horrifically large task. (22) Many years will be required to arrive at a formula that is optimal for the general population, but it is more likely there will eventually be different formulas whose safety and efficacy are optimized to the metabolic requirements of treating different disorders, different individuals, different ages, and different comorbid health situations.

The possibility of a nutritional alternative to drug treatment may raise hope and carry the risk of igniting public interest beyond reasonable bounds. Some patients may find it difficult to wait for nutrient supplements to be examined in humans for both efficacy and safety in controlled trials, and clinicians will need to help patients keep their enthusiasm from pushing usage beyond its scientific basis. Similarly, clinicians will want to think twice if they are tempted to forge ahead with empirical trials of this novel treatment with possible unknown risks and unproven benefit. Some physicians, presuming a low risk of toxicity, may reason that it is judicious to allow some drug-naive patients to proceed with empirical trials of nutrient supplements for a few weeks before committing them to treatment with psychiatric medications. Most clinicians will want the reassurance of systematic safety data before beginning to examine its effects in patients. Clinicians will hopefully minimize risks of nutrient-medication interactions by initially restricting their trials to patients who have not recently used psychiatric medications.

If Kaplan and colleagues’ preliminary findings are confirmed in controlled research, and if safety studies are favorable, what then? What if some psychiatric patients could be treated with inexpensive vitamins and minerals rather than expensive patented pharmaceuticals? or what if some doses of psychiatric drugs could be reduced by the concurrent use of nutrients? The economic implications, for individual patients and for the pharmaceutical industry, are difficult to overlook. For now, micronutrient treatments and other nutritional approaches remain in a very early stage of scientific investigation. Depending on how this line of research develops, clinicians and researchers may need to rethink the traditional bias against nutritional supplementation as a potential treatment for major psychiatric disorders.

Charles W. Popper, M.D.
The Journal of Clinical Psychiatry
Dec 2001

REFERENCES

1. Kaplan BJ, Simpson JSA, Ferre RC, et al. Effective mood stabilization with a chelated mineral supplement: an open-label trial in bipolar disorder. J Clin Psychiatry 2001;62:936-944

2. Shaldubina A, Agam G, Belmaker RH. The mechanism of lithium action: state of the art, ten years later. Prog Neuropsychopharmacol Biol Psychiatry 2001;25:855-866

3. Mertz W. A perspective on mineral standards. J Nutr 1998:128(suppl 2): 375S-378S

4. Cashman KD, Flynn A. Optimal nutrition: calcium, magnesium and phosphorus. Proc Nutr Soc 1999;58:477-487

5. Mertz W. Three decades of dietary recommendations. Nutr Rev 2000;58: 324-331

6. Werbach MR. Nutritional Influences on Mental Illness: A Sourcebook of Clinical Research. 2nd ed. Tarzana, Calif: Third Line Press; 1999

7. Stoll AL, Locke CA, Marangell LB, et al, Omega-3 fatty acids and bipolar disorder: a review. Prostaglandins Leukot Essent Fatty Acids 1999;60: 329-337

8. Stoll AL, Severus E, Freeman MP, et al. Omega 3 fatty acids in bipolar disorder: a preliminary double-blind, placebo-controlled trial. Arch Gen Psychiatry 1999;56:407-412

9. Arnold LE, Pinkham SM, Votolato N. Does zinc moderate essential fatty acid and amphetamine treatment of attention-deficit/hyperactivity disorder? J Child Adolesc Psychopharmacol 2000;10:111-117

10. Arnold LE. Alternative treatments for adults with attention-deficit hyperactivity disorder (ADHD). In: Wasserstein J, Wolfe LE, Lefever FF, eds. Adult Attention Deficit Disorders: Brain Mechanisms and Life Outcomes. New York, NY. New York Academy of Sciences; 2001:310-341

11. Arnold LE. Treatment alternatives for attention-deficit/hyperactivity disorder. In: Jensen PS, Cooper J, eds. Diagnosis and Treatment of ADHD: An Evidence-Based Approach. Washington, DC: American Psychiatric Press. In press

12. Levy NA, Janicak PG. Calcium channel antagonists for the treatment of bipolar disorder. Bipolar Disord 2000;2:108-119

13. McLeod MN, Golden RN. Chromium treatment of depression. Int J Neuropsychopharmacol 2000;3:311-314

14. Chengappa KN, Levine J, Gershon S, et al. Inositol as an add-on treatment for bipolar depression. Bipolar Disord 2000;2:47-55

15. Van der Does AJ. The effects of tryptophan depletion on mood and psychiatric symptoms. J Affect Disord 2001;64:107-119

16. Benton D, Fordy J, Haller J. The impact of long-term vitamin supplementation on cognitive functioning. Psychopharmacology (Berl) 1995; 117: 298-305

17. Benton D, Haller J, Fordy J. Vitamin supplementation for 1 year improves mood. Neuropsychobiology 1995;32:98-105

18. Carroll D, Ring C, Suter M, et al. The effects of an oral multivitamin combination with calcium, magnesium, and zinc on psychological well-being in healthy young male volunteers: a double-blind placebo-controlled trial. Psychopharmacology (Berl) 2000; 150:220-225

19. Benton D. Micro-nutrient supplementation and the intelligence of children. Neurosci Biobehav Rev 2001;125:297-309

20. Arnold LE. Treatment alternatives for attention-deficit hyperactivity disorder (ADHD). J Arm Disord 1999;3:30-48

21. Phiel CJ, Klein PS. Molecular targets of lithium action. Annu Rev Pharmacol Toxicol 2001;41:789-813

22. Pryor WA. Vitamin E and heart disease: basic science to clinical intervention trials. Free Radic Biol Med 2000;28:141-164

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You’d think so.

In modern psychiatry, niacin and schizophrenia are both terms that have been closeted away out of sight. And patients, tranquilized into submission or Prozac-ed into La-La Land, are often idly at home or wandering the streets, where either way it is highly doubtful that they will get much in the way of a daily vitamin intake. Those in institutions fare little better nutritionally. For everyone “knows” that vitamins do not cure “real” diseases.

But Dr Hoffer dissents. For half a century Dr Hoffer has dissented. His central point has been this: Illness, including mental illness, is not caused by drug deficiency. But much illness, especially mental illness, may be seen to be caused by a vitamin deficiency. This makes sense, and has stood up to clinical trial again and again. If you do not believe this, Vitamin B-3 and Schizophrenia will provide you with the references to prove it. And remember that it was Dr. Hoffer who started off those clinical studies in the first place. In 1952.

I personally should have first became aware of a food-brain connection during those all-night, cookie-fired mah-jongg marathons I all-too-regularly indulged in while attending Australian National University. Though arguably somewhat less than psychotic, my mind was nevertheless pretty whacked out on sugar, junk food and adrenalin by 3 am. My mood was destroyed; my mind agitated; unable to sleep, sit still, or smile. Of course, I never entertained even the thought of a nutrition connection. For we’ve all been carefully taught that drugs cure illness, not diet.

And certainly not vitamin supplements!

But the truth will out eventually. Three years later, I first saw niacin work on somebody else. He was a bona-fide, properly-diagnosed, utterly-incurable, State-hospitalized schizophrenic patient. I did not see niacin work in the hospital, of course; the only vitamins given there are what you can filter out of your Jell-O and your Tang. No, the patient was a fellow whose parents were desperate enough try anything, even nutrition. Perhaps this was because their son was so unmanageably violent that he was kicked out of the asylum and sent to live with them. On a good day, his Mom and Dad somehow got him to take 3,000 milligrams of niacin and 10,000 mg of vitamin C. Formally a hyperactive insomniac, he responded by sleeping for 18 hours the first night and becoming surprisingly normal within days. I’d seen him before, and I saw him after. I’d talked to his parents during the whole process. It was an astounding improvement.

Sometime afterward, I tried niacin to see if it would help my own touch of sleeplessness. I found it worked nicely, and it only took a little to do so, perhaps 100 milligrams at most. Any more and I would experience a warm “flush.” But then I found that when I ate junk food or sugar in quantity, I could hold 500 mg or more without flushing a bit. And when I took all that niacin, instead of flipping out, I was calm. In Vitamin B-3 and Schizophrenia , Dr. Hoffer explains why this is so:

1) As a rule, the more ill you are, the more niacin you can hold without flushing. In other words, if you need it, you physiologically soak up a lot of niacin. Where does it all go? Well, a good bit of it goes into making nicotinamide adenine dinucleotide, or NAD. NAD is just about the most important coenzyme in your body. It is made from niacin, as its name implies.

2) Niacin is also works in your body as an antihistamine. Many persons showing psychotic behavior suffer from cerebral allergies. They need more niacin in order to cope with eating inappropriate foods. They also need to stop eating those inappropriate foods, chief among which are the ones they may crave the most: junk food and sugar.

3) There is a chemical found in quantity in the bodies of schizophrenic persons. It is an indole called adrenochrome. Adrenochrome (which is oxidized adrenalin) has an almost LSD-like effect on the body. That might well explain their behavior. Niacin serves to reduce the body’s production of this toxic material.

That Dr. Hoffer can compress a lifetime of research experience into one readable and surprisingly short book is a tribute to how clearly he teaches both layman and physician the essentials of niacin treatment. I have taught nutritional biochemistry to high school, undergraduate, and chiropractic students. To most, it is not an especially gripping subject. But when even a basic working knowledge of niacin chemistry can profoundly change psychotic patients for the better, it becomes very interesting very quickly.

Dr. Hoffer has treated thousands and thousands of such patients for nearly half a century. At 83, he still is in actively practicing orthomolecular (megavitamin) psychiatry. He has seen medical fads come and go. What he sees now is what he’s always seen: that very sick people get well on vitamin B-3.

Review copyright c 2000 by Andrew Saul, 23 Greenridge Crescent, Hamlin, NY 14464 USA.

Vitamin B-3 and Schizophrenia: Discovery, Recovery, Controversy
by Abram Hoffer, MD
Quarry Press, Kingston, Ontario Canada (1998) ISBN 1-55082-079-6
Softcover, 150 pages plus bibliography and two appendices.

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“There are several smaller studies that have found a protective effect from dietary intakes of B6,” said lead researcher Esther K. Wei, an instructor in medicine at Harvard Medical School and Brigham and Women’s Hospital. However, “this is the first large study of women to look at blood levels of B6” and find a protective effect, she added.

Wei and her colleagues evaluated nearly 33,000 women who were participants in the Nurses’ Health study, a long-running study that began in 1976. Since then, researchers have focused on subsets of the original 121,700 participants, all nurses between 30 and 55 years of age when they enrolled, to study various health issues.

Among this subset, Wei and her team analyzed blood samples collected in 1989, looking for levels of a substance called PLP (pyridoxal 5′-phosphate) — the main active form of vitamin B6 in the blood. Then they looked at medical records to determine who contracted cancer of the colon or cancer of the colon and rectum (colorectal).

They found a total of 194 colorectal cancer cases and 410 cases of colon polyps, which often precede colorectal cancer. After dividing the women into four groups, from lowest to highest blood levels of PLP, the researchers found that the highest quartile group had a 44 percent lower risk of colorectal cancer and a 58 percent lower risk of colon cancer. The same associations held for the development of polyps.

The associations between high blood levels and lower risk held even after Wei’s group controlled for other colon cancer risk factors, such as family history of the disease.

Women in the group with the highest blood levels of B6 had about six times the blood levels of the nutrient as those in the lowest group, Wei said.

Dietary intake of Vitamin B6 was also associated with reduced risk. Women in the lowest intake group got a median of 1.6 milligrams a day compared to 8.6 milligrams in the highest intake group. The recommended daily intake of B6 for most adults varies from 1.3 to 1.7 milligrams a day, depending on age and gender. Those in the lowest group were getting close to the recommended amount of daily B6, Wei said, while those in the highest group, which got the most protective effect from colon cancer, were getting about five times the recommended daily intake, but still at a safe level, she said.

According to the Institute of Medicine, 100 milligrams per day of B6 is the upper threshold of a safe intake level.

It’s possible, said Wei, to take in 8.6 milligrams of Vitamin B6 a day by taking a multivitamin and eating vitamin B6-rich food. But she stressed that “you don’t have to take in 8.6 milligrams a day to get a reduced risk,” since reductions in cancer risk started showing up at levels of just 3.3 milligrams a day.

Vitamin B6 is involved in around 100 physiologic reactions and functions in the body, according to Wei, including protein metabolism, red blood cell function and proper functioning of the nervous and immune systems.

The vitamin can be sourced from multivitamins, fortified cereals, beans, meat, poultry, fish and some vegetables and fruits.

Scientists aren’t sure why high blood levels of vitamin B6 protect against colon and colorectal cancer, Wei said, but she noted that “individuals who have high levels of B6 have less chance of having damaged DNA, which can lead to cancer.”

Dr. Durado Brooks, director of colorectal cancer for the American Cancer Society, called the new study “interesting work.” If the finding about blood levels of the vitamin and reduced cancer risk is replicated, he said, “it will be a useful bit of information to give people about lowering their risk of colon cancer.”

Meanwhile, there are a number of measures people can take to lower risk, he said. “Multiple vitamins with folate have been previously shown to reduce risk.” Keeping a healthy body weight and maintaining an exercise program can reduce risk, too, he said. For those at average risk of colon cancer, the Cancer Society recommends formal screening beginning at age 50.

The screening tests include a fecal occult blood test, barium enema or examinations of the colon via a test called a sigmoidoscopy or a colonoscopy.

Colorectal cancer is the third most common cancer in the United States, according to the American Cancer Society. The Society estimates that 104,950 new cases of colon cancer and 40,340 new cases of rectal cancer will be diagnosed in 2005, with about 56,290 deaths linked to the disease. The death rate from colorectal cancer has been declining, however, probably because of early detection and improved treatments.

Source: www.msn.com

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