Bivirkninger fra kosttilskudd har det hittil blitt rapportert lite om. I fjor ble det i USA innført en lov som krever innrapportering av bivirkninger. Nå er FDAs første rapport publisert, for de første seks månedene loven har vært gyldig. Og hva sier FDA? De har mottatt 604 bivirkningsrapporter. Av disse dreier 5 seg om dødsfall og 85 sykehusinnleggelser. Høres skummelt? I lys av at amerikanerne spiser ca. 53 milliarder doser kosttilskudd på et år? Og FDA innrømmer at dødsfallene og innleggelsene kan skyldes "underliggende medisinsk tilstand", altså neppe selve kosttilskuddet. Og sist: FDA vil ikke offentliggjøre hvilke kosttilskudd som har medført bivirkningsrapporter. Så ta det med ro; dette er en erketypisk FDA storm i en tekopp! Kosttilskudd er fortsatt noe av det tryggeste du kan putte i munnen!

Det nye amerikanske rapporteringssystemet (1) har sitt utspring i "The Dietary Supplement and Nonprescription Drug Consumer Protection Act" som reviderte loven om mat, medisin og kosmetikk. Denne gjaldt fra 1. januar 2008.

Nå er ti måneder gått, og tall foreligger for de første seks månedene: 604 bivirkninger er innkommet for kosttilskudd, herunder fem dødsfall og 85 sykehusinnleggelser.

Men som ved all bivirkningsrapportering innebærer dette KUN en korrelasjon mellom en hendelse og inntak av kosttilskudd. Det betyr ikke at hendelsen skyldtes kosttilskuddet.

Som FDA selv innrømmer, dødsfallene og innleggelsene kan skyldes "underliggende medisinsk tilstand", m.a.o. at hendelsen kan skyldes eksisterende sykdom og/eller farmasøytisk medisin som tas for sykdommen. Det er altså neppe grunn til å mistenke kosttilskuddet i første omgang.

Selv om denne loven, og tilhørende rapporteringssystem er nytt, betyr ikke det at det ikke tidligere har vært rapportert om kosttilskudd og bivirkninger. Det har det, og tallene har vært – og er, verden over – så lave at kosttilskudd er samlet den tryggeste gruppe substanser man overhodet kan putte i munnen. Dette har ikke endret seg.

Bakgrunn for kravet om rapportering

Det var blant annet Senator Richard Durbin (D-Ill) som sponset den nye lovendringen. En av grunnene til dette "kravet" om bivirkningsapportering var Efedra-saken. Efedra (eller syntetisk efedrin) anvendtes i slanke- og energitilskudd. I 2001 døde Minnesota Vikings lineman Korey Stringer, og i 2003 døde Baltimore Orioles pitcher Steve Bechler.  I begge tilfellene var efedra implisert. FDA handlet og forbød kosttilskudd med efedra. Saken raste i årevis. Selv om det ble påvist at disse to personene hadde brukt syntetisk efedrin, og i høyere doser enn anbefalt, gjaldt forbudet også naturlig efedra (fra planten). Kosttilskudd fikk altså skylden, selv om det relevante produktet var farmasøytisk fremstilt syntetisk efedrin. Resultatet var at efedra som kosttilskudd ble forbudt, mens reseptfrie medisiner (og andre varer) med syntetisk efedrin fortsatt var tillatt i salg. Forstå det den som vil!

Det er sterke krefter i USA som vil kosttilskudd og naturmedisin til livs. Farmasøytisk industri har enorm politisk påvirkningskraft. Bare i Washington D.C. er det flere lobbyister fra farmasøytisk industri enn det er senatorer og kongressmenn!

Reseptpliktig medisin - til sammenlikning

I 2007 mottok FDA 482 154 bivirkningsrapporter for reseptpliktig medisin, eller ca 240 000 på et halvår. Mot altså ca. 600 for kosttilskudd.

Husk at rapporteringsplikten også gjelder reseptfri farmasøytisk medisin (OTC). For denne gruppen har ikke FHV tall tilgjengelige. Man undres…..

Og som JAMA (Journal of the American Medical Association) skrev allerede i 1998: korrekt foreskrevet og korrekt inntatt farmasøytisk medisin var da den fjerde største direkte dødsårsaken i USA, med 106000 drepte. For ti år siden; siden er det blitt verre.

Hva er en bivirkning (adverse effect)?

Ifølge FDA er en bivirkning hva som helst, fra en bekymring om at et kosttilskudd ikke virker til alvorlig sykdom som følger etter inntak.

Og det er her FDAs talsmann, Michael Herndon innrømmer om de rapporterte fem dødsfall og 85 sykehusinnleggelser: "Some of these deaths were likely due to underlying medical conditions."

Hvilke kosttilskudd gjelder det?

FDA nekter å opplyse hvilke kosttilskudd som har medført disse bivirkningsrapportene.

Vi vet altså ikke. Og her er det viktig å merke seg at kosttilskuddsmarkedet i USA er veldig forskjellig fra det norske, mest i positiv retning. Men det finnes visse negative aspekter.

For, som Orthomolecular Medicine News Service skrev 9. oktober 2008:

"In the absence of FDA disclosure to the contrary, it is likely that the five or fewer deaths attributed to "food supplements" were in fact due to medicinal substances marketed as dietary supplements. FDA acknowledges this in a round-about way at their website (http://vm.cfsan.fda.gov/~dms/mwgblghb.html . There you will find an "Important Message" which asks health professionals to "Report Serious Adverse Events Associated with Dietary Supplements Containing GBL, GHB, or BD . . . a group of products sold as dietary supplements for bodybuilding, weight loss and sleep inducement which have been determined to pose a significant public health hazard. These products are chemically related  to gamma butyrolactone (GBL), gamma hydroxybutyric acid (GHB), and 1,4 butanediol (BD), and can cause dangerously low respiratory rates (intubation may be required), unconciousness/coma, vomiting, seizures, bradycardia and death. GBL, GHB and BD have been linked to at least 122 serious illnesses reported to FDA, including three deaths."

But these substances are not foods. They are not vitamins, and they are not minerals, and they are not amino acids. They should not be considered with or as food supplements."

På norsk:

GBL, Gamma butyrolakton (GBL)

GHB, Gamma-hydroksysmørsyre eller 4-hydroksysmørsyre

BD 1,4-butanediol

Neppe det de fleste av oss erverver oss ved et besøk i helsekostbutikken… men spørsmålet er altså hvor mange av bivirkningsrapportene som skyldes kosttilskudd (i USA) med disse stoffene og andre stoffer, som faller utenfor det man normalt (her hjemme i hvert fall) betrakter som kosttilskudd.

Inntil FDA finner det for godt å fortelle oss det, vet vi ikke. Følgelig er tallet 604 bivirkningsrapporter verdiløst.

Og hvor mye kosttilskudd spiser amerikanerne?

Over halvparten av USAs befolkning tar kosttilskudd hver dag. Hvis hver av disse tok en tablett hver dag, ville det utgjøre 145 millioner doser per dag, eller 53 milliarder doser i løpet av et år.

Konklusjon

Kosttilskudd er ikke farlige. de er faktisk ekstremt trygge – også i USA, hvor utvalget er mye større enn i Norge, og tilgjengelige doser også er mye høyere.

Men det finnes farlige tilskudd. Som dem nevnt ovenfor, kanskje. Eller tilskudd av dårlig kvalitet. Det er funnet kosttilskudd (også) i Norge, som inneholder legemidler.

Dessuten går det å misbruke kosttilskudd, noe som særlig gjelder trenings/dopingstilskudd, hvor ulovlige stoffer noen ganger brukes, og rimelige doser ofte overstiges.

Hvor mange av de rapporterte bivirkningene skyldes misbruk?

Og hvor mange av dem skyldes andre årsaker, som underliggende helseproblemer, og medisiner som vedkommende har tatt?

Alt som skal til for at det skal bli en rapport av det er at noen har hatt en hendelse, og det er kjent at vedkommende har tatt et tilskudd. Ikke nødvendigvis noen årsakssammenheng. ja, og så var det jo FDAs definisjon da, at hvis man opplever at et kosttilskudd "ikke virker", så kan man rapportere det som en "bivirkning".

Spis kosttilskudd med god samvittighet, kjære leser. Helse- og nytteverdien overstiger faren for "farlige bivirkninger" mangfoldige ganger.

Jan Klyve

Fritt Helsevalg

30. oktober 2008

(1) (Dietary Supplement Adverse Event Reporting)

Kilder

Artikkel i USA TODAY 22. September, "Dietary supplements cause 600 ''adverse events"

http://www.usatoday.com/news/health/2008-09-22-supplements-adverse-events_N.htm?csp=34

Pressemelding fra Orthomolecular Medicine News Service, 9. oktober 2008 (gjengitt nedenfor).

Lenker:

The "Dietary Supplement Adverse Event Reporting" webpage, http://www.cfsan.fda.gov/~DMS/ds-rept.html

Dietary Supplement and Nonprescription Drug Consumer Protection Act

http://www.fda.gov/opacom/laws/pl109462.html

Adverse Event Reporting System (AERS)

http://www.fda.gov/cder/aers/default.htm

Pressemelding fra Orthomolecular Medicine News Service

Orthomolecular Medicine News Service, October 9, 2008

FDA Claims "Food Supplement" Deaths; Hides Details from the Public

(OMNS, October 9, 2008) "Dietary supplements cause 600 ''adverse events''", reported USA Today on 22 Sept, 2008. In an article that looks much like an official US Food and Drug Administration press release, it said that "Serious side effects from the use of food supplements resulted in 604 "adverse-event" reports - a list that includes at least five deaths - through the first six months that such accounts have been required by law." (1)

Good grief! Looks like all those supplement-popping health nuts really are nuts after all. Food supplements simply must be dangerous!

Or are they?

Later on in the article, far from the headline, USA Today conceded that "An adverse event can be anything from a concern that a supplement isn''t working to a serious illness that follows consumption." And, FDA spokesman Michael Herndon admitted that of the five deaths and 85 hospitalizations reported, "Some of these deaths were likely due to underlying medical conditions."

FDA''s method of gaining data is suspect at best and biased at worst. Their "Dietary Supplement Adverse Event Reporting" webpage, http://www.cfsan.fda.gov/~DMS/ds-rept.html, states: "FDA would like to know when a product causes a problem even if you are unsure the product caused the problem or even if you do not visit a doctor or clinic." The measure of uncertainty involved in publicly soliciting adverse reports "even if you are unsure that the product caused the problem" is noteworthy.

But most significant of all is that FDA refused to disclose exactly which supplements allegedly were causing problems. Doesn''t the public have a right to know? In the absence of FDA disclosure to the contrary, it is likely that the five or fewer deaths attributed to "food supplements" were in fact due to medicinal substances marketed as dietary supplements. FDA acknowledges this in a round-about way at their website

(http://vm.cfsan.fda.gov/~dms/mwgblghb.html). There you will find an "Important Message" which asks health professionals to "Report Serious Adverse Events Associated with Dietary Supplements Containing GBL, GHB, or BD . . . a group of products sold as dietary supplements for bodybuilding, weight loss and sleep inducement which have been determined to pose a significant public health hazard. These products are chemically related ! to gamma butyrolactone (GBL), gamma hydroxybutyric acid (GHB), and 1,4 butanediol (BD), and can cause dangerously low respiratory rates (intubation may be required), unconciousness/coma, vomiting, seizures, bradycardia and death. GBL, GHB and BD have been linked to at least 122 serious illnesses reported to FDA, including three deaths."

But these substances are not foods. They are not vitamins, and they are not minerals, and they are not amino acids. They should not be considered with or as food supplements. Over half of all Americans safely take nutritional supplements every day. If each of those persons took only one tablet per day, that would be some 145,000,000 individual doses daily, for a total of over 53 billion doses annually. Many healthy people take more. And yet, according to national statistics compiled by the authoritative American Association of Poison Control Centers, there is not even one death per year from vitamins. (2) Look at the reports, which detail each individual vitamin, mineral, amino acid and herb, and see for yourself at http://www.aapcc.org/dnn/NPDS/AnnualReports/tabid/125/Default.aspx.

By comparison, FDA acknowledges that prescription drugs resulted in 482,154 adverse-event reports in the year 2007. That is nearly 400 times as many adverse events from prescription drugs per six-month period. And this much higher number does not include over-the-counter drugs, a striking omission. Many non-prescription drugs, such as Tylenol (acetaminophen), are a long way from safe. Liver toxicity from acetaminophen poisoning is by far the most common cause of acute liver failure in the United States. Acetaminophen accounted for 51% of all acute liver failure cases in 2003. (3) Indeed, the Associated Press previously reported that common drug dangers are so bad that "Harmful reactions to some of the most widely used medicines - from insulin to a common antibiotic - sent more than 700,000 Americans to emergency rooms each year." (4)

Vitamin supplements compete with FDA-sponsored drugs. FDA has been trying to eliminate availability of vitamin supplements for over 45 years. As early as 1962, writes constitutional attorney Jonathan W. Emord, "FDA perceived a competitive threat emerging to drug regulation from the sale of dietary ingredients at above RDA doses." In 1966, "FDA published a rule that any dietary supplement exceeding 150% of the RDA for a vitamin or mineral would automatically be regulated as a drug." In 1976, after a "public outcry," the Proxmire Amendment prohibited FDA from deeming a vitamin or mineral a drug solely because of potency. "Undaunted," continues Emord, "FDA tried yet again to rid the market of vitamins in the 1970s by claiming on a case by case basis that they were adulterated based on their potency." FDA also tried to have supplements declared to be unapproved food additives. "FDA''s position was a logical absurdity: Single ingredient dietary supplements were food additives b! ecause the ingredients were added to a gelatin capsule which was, FDA said with a wink and a smirk, a food. . . The United States Court of Appeals for the Seventh Circuit described FDA''s position as an "Alice in Wonderland" approach." In 1980, FDA tried to get vitamins classified as over-the-counter drugs. . . FDA has repeatedly exceeded the limits of its statutory authority to bring about changes designed to protect drug companies from competition." (5)

Additional evidence comes directly from FDA, whose own Dietary Task Force Report, released June 15, 1993, said: "The task force considered many issues in its deliberations including to ensure that the existence of dietary supplements on the market does not act as a disincentive for drug development." There is also this statement was made by FDA Deputy Commissioner for Policy David Adams, at the Drug Information Association Annual Meeting, July 12, 1993: "Pay careful attention to what is happening with dietary supplements in the legislative arena . . . If these efforts are successful, there could be created a class of products to compete with approved drugs. The establishment of a separate regulatory category for supplements could undercut exclusivity rights enjoyed by the holders of approved drug applications."

FDA wants control of vitamins. Their latest ploy is to frighten the public into thinking vitamin supplements are dangerous, without proof, and without even naming the supplements they accuse. Don''t fall for what Abram Hoffer, M.D., calls "the FDA''s grand lie that, if told over and over again, is accepted as somehow true."

Vitamin supplements are not the problem. Poor eating habits, and too many medicines, are the problem. Food supplements are a solution. They are effective, and vastly safer than drugs. The US Food and Drug Administration knows this full well.

References:

(1) Perez AJ. Dietary supplements cause 600 ''adverse events''. USA Today, Sept 22, 2008: http://www.usatoday.com/news/health/2008-09-22-supplements-adverse-events_N.htm or http://www.usatoday.com/news/health/2008-09-22-supplements-adverse-events_N.htm?POE=click-refer

(2) Annual Reports of the American Association of Poison Control Centers'' National Poisoning and Exposure Database, 3201 New Mexico Avenue, Ste. 330, Washington, DC 20016. Download any report from 1983-2006 at http://www.aapcc.org/dnn/NPDS/AnnualReports/tabid/125/Default.aspx free of charge. The "Vitamin" category is usually near the end of the report. Summary and commentary at: http://www.doctoryourself.com/vitsafety.html

(3) Larson AM et al Acetaminophen-induced acute liver failure: results from a United States multicenter, prospective study. Hepatology 2005;42:1364-1372. See also: http://www.medpagetoday.com/Psychiatry/Depression/tb/2233

(4) Associated Press, Oct 17, 2006. http://www.msnbc.msn.com/id/15305033/

(5) Emord JW. FDA violation of the rule of law. Speech from the Health Freedom Exposition in Richmond, Virginia September 23, 2006. http://www.emord.com/events/speeches/fda_violation.htm

Nutritional Medicine is Orthomolecular Medicine

Orthomolecular medicine uses safe, effective nutritional therapy to fight illness. For more information: http://www.orthomolecular.org

The peer-reviewed Orthomolecular Medicine News Service is a non-profit and non-commercial informational resource.

Editorial Review Board:

Damien Downing, M.D.
Harold D. Foster, Ph.D.
Steve Hickey, Ph.D.
Abram Hoffer, M.D., Ph.D.
James A. Jackson, PhD
Bo H. Jonsson, MD, Ph.D
Thomas Levy, M.D., J.D.
Erik Paterson, M.D.
Gert E. Shuitemaker, Ph.D.

Andrew W. Saul, Ph.D., Editor and contact person. Email: omns@orthomolecular.org