HEALTH AND STRESS T h e Ne w s l e t t e r of

The Ameri can In stitut e of S tress June

2002

SORTING OUT SUPPLEMENT SUPERIORITY AND SAFETY KEYWORDS: N L E A , MedW atch, nutraceutical, L-tryptopha n, contamination, C o e n z y m e Q 1 0 , E P A , D H A , B o d y S o l u t i o n s , E n f o rm a , F e d e r a l T ra d e C o m m is s i o n

"A desire to take medications is, perhaps, the greatest feature which distinguishes man from other animals." Sir William Osler, considered by many the greatest physician who ever lived, wrote this a decade before the advent of aspirin, which sparked the birth of drug companies and the pharmaceutical industry. Popular patent medicines promising miraculous results were readily available at general stores, chemists' shops and even from seed merchants. Some were also sold by traveling salesmen out of the backs of wagons with claims of instant cures backed up by convincing testimonials from paid performers. The contents of these concoctions were jealously guarded secrets and often included hefty concentrations of alcohol. Opium, cocaine and other addictive substances were not uncommon components so it's not too surprising that many customers not only ALSO INCLUDED IN THIS ISSUE

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21st Century Patent Medicines DSHEA & Supplement Safety Concerns PC SPES, SPES, GHB And Lipokinetix Should Ephedra Be Banned? And Now Some Good Supplement News Omega-3 - Another "Super Supplement" Weight Loss Supplement Scams And The Need For Greater Regulatory Powers

experienced relief of their pain and other complaints but also had an urge to keep taking the magical potion. Patent medicines were cheap and plentiful and if one didn't work there was always another to try. A doctor's visit could cost ten times as much and often ended by a prescription for some particular patent medicine anyway. While some countries like Britain had regulations to protect the public from injurious and falsely represented food and drugs, the U.S. made no attempt to establish such safeguards until well into the 20th century. The FDA essentially did not start to function until 1940 and was primarily concerned with food safety. It seems clear that patent medicines were mostly quackery and provided little lasting benefit. Indeed, with the exception of purgatives like Ex-Lax and Phillips Milk of Magnesia, few have persisted. It is doubtful if Osler ever envisaged that a gigantic drug industry would emerge with ready made pills advertised directly to patients in an effort to influence prescribing habits. Nor could he have foreseen that it would be rare to find a physician able to write a prescription listing the amounts of various ingredients tailored to a patient's specific needs, the manner in which they should be compounded and the correct dosage of the final product.

June 2002

The Newsletter of THE AMERICAN INSTITUTE OF STRESS

Th e public's fascination with pharmaceuticals has faded due to the withdrawal of numerous drugs because of serious side effects and fatalities. It is not surprising, therefore, that they are eager to find nutritional supplements that are satisfactory alternativ es since these are presumed to be completely safe. 21st C ent ury Pat ent Medicines? Many feel that some nutritional supplements are essentially the equivalent of patent medicines promoted 100 - 150 years ago because there is nothing to guarantee that they are either effective or safe. With respect to efficacy , supplements may not make claims for curing or treating any disease but there are ways to get around this. Safety has never been viewed as a concern since "natural" supplements are assumed to be harmless when taken as indicated. Recent reports suggest otherwise and many feel that changes in current regulations are urgently needed. Congress has distinguished between what the Food and Drug Administration considers to be a drug as opposed to a dietary or nutritional supplement. Unfortunately, this categorization is not based on biological effects but how the product is promoted or labeled. It is approv ed as a drug when it claims that it can "treat, prev ent, cure, mitigate, or diagnose" a specific disease and satisfies FDA requirements for safety and efficacy . While nutritional supplements can make only "structure/function" claims, such as "maintains a healthy circulatory system" or "promotes comfort", they are not required to prove either safety or efficacy and enjoy other exemptions. How this distinction evolv ed has an interesting history. In 1937 , 107 people died after taking elixir sulfanilamide because of the diethy lene glycol solvent that was used in its formulation. In response to this, Congress enacted the Food, Drug and Cosmetic Act of 1938 , which, for the first time, required proof that a drug was safe before it could be marketed. Several decades later, an epidemic of birth defects associated with thalidomide led to the 196 2 Kefauver-Harris Amendment requiring manufacturers to

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report all adverse events to the FDA and proof of efficacy was now also necessary to receive FDA approval. Efficacy can be established in randomized trials that might require only a few hundred patients to establish the validity of a claim. Safety is much more difficult to prove and usually necessitates exposing thousands to a new drug, doing tests to insure there are no adverse hematological, kidney or liver abnormalities and demonstrating that there are no contraindications during pregnancy or for patients with other disorders, taking other medications, etc. Dietary supplements are not held to similar standards for the following reason. The 1990 Nutrition Labeling and Education Act (NLEA) limited health claims that could be made about the relationship between a nutrient or food and a disease or health-related condition, to these seven categories: • Calcium and osteoporosis • Sodium and hypertension • Dietary saturated fat and cholesterol and risk of heart disease • Dietary fat and cancer • Fiber-containing grain products, fruits, vegetables and cancer • Fruits and vegetables and cancer • Fruits, vegetables and grain products containing fiber, particularly soluble fiber and coronary heart disease Supplement manufacturers complained that these restrictions would severely limit their ability to develop new products. They mounted a very aggressive and successful advertising campaign to convince Congress that there was a growing public demand for nutritional supplements, legislators were besieged by constituents, and the rest is history. DSHEA & Supplement Safety Concerns Since supplements were perceived as being completely safe, passing favorable legislation was not difficult. The Dietary Supplement Act of 1992 exempted supplements from the NLEA restrictions so that essentially they could claim anything they wanted to. However, that was not enough for supplement manufacturers who realized they had enough muscle to gain

June 2002

The Newsletter of THE AMERICAN INSTITUTE OF STRESS

other advantages that would bring in billions of dollars. The Dietary Supplement Health and Education Act (DSHEA) of 1994 was a bonanza allegedly designed to further empower people to actively participate in improving their own health care by providing greater access to dietary supplements. According to DSHEA, a dietary supplement was now defined as any product intended to supplement the diet that bears or contains one or more of the following ingredients: • a vitamin • a mineral • an herb or other botanical • an amino acid • a dietary substance used to supplement the diet by increasing total daily intake • any concentrate, metabolite, constituent, extract or combination of these ingredients Nutraceutical is a term that applies to foods that provide some health benefits as well as products that have medicinal value. Foods and medicines are regulated differently and under DSHEA, a firm has the sole responsibility for determining that the nutraceuticals it manufactures or distributes are safe. A firm also bears the responsibility to insure that any representations or claims made about its products are substantiated by adequate evidence showing that these are not false or misleading. Critics point out that this is like asking the fox to guard the chicken coop. Under DSHEA provisions, dietary supplements do not need FDA approval before they are marketed nor does a manufacturer have to provide the evidence it relies on to substantiate either safety or effectiveness. Even when new ingredients are added to the formulation the only requirement is evidence that the product is "reasonably expected to be safe". Drug manufacturers must notify the FDA when they learn of any adverse reaction that is potentially related to their product. Data on adverse reactions to drugs are collected via direct contact with health care providers, patients and manufacturers or from MedWatch, the FDA's voluntary reporting system. Many drug reactions are not recognized as such because they are attributed to something else. In addition,

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surveys show that probably more than 90 percent of those that are correctly identified are never reported to either the manufacturer or the FDA. Even when such reports are received it may be difficult to prove that a specific drug is the cause of the problem when multiple medications are being taken. Adverse reactions to nutritional supplements don't have to be reported to the FDA or anyone else no matter how severe they are or how compelling the evidence is. Yet, the FDA is obligated to prove that a nutritional supplement is unsafe before it can even request that its use be restricted, much less attempt to have it banned. Most individuals take more than one supplement and possibly prescription and non-prescription drugs as well, which makes the source of a possible drug reaction difficult to pin down. How can the agency possibly prove that a supplement is harmful or potentially dangerous under such circumstances? In some instances the problem may have nothing to do with the supplement itself but rather contamination during its production. There were numerous disabilities and more than three dozen deaths in 1989 due to L-tryptophan, a popular supplement used to treat insomnia and depression. After a lot of detective work these were traced to a contaminant introduced in the manufacturing process which resulted in a rare disorder known as eosinophilic myalgia. Authorities have banned certain calcium supplements derived from animal bones because of high lead concentrations. Other supplements have been withdrawn due to possible contamination with salmonella. Such complications take a long time to trace because nutraceuticals are considered to be quite safe when taken as directed. Recent developments suggest otherwise. PC SPES, SPES, GHB And Lipokinetix PC SPES is a supplement that contains eight herbs and has been found to benefit certain patients with prostate cancer but is sold to "promote prostate health". SPES is another popular herbal that "strengthens" the immune system. Earlier this year, the FDA warned consumers to stop using these supplements because they contained

June 2002

The Newsletter of THE AMERICAN INSTITUTE OF STRESS

prescription drugs that could cause severe side effects. Laboratory analysis of the products by the California Department of Health Services found that PC SPES contained warfarin (Coumadin), a blood thinner, and that SPES had alprazolam (Xanax), a tranquilizer. Both are patented products manufactured by the same company, who voluntarily issued a nationwide recall. Nobody knows how many other supplements may be contaminated since even routine quality-assurance testing would not necessarily detect the presence of impurities. California investigators reported that nearly one-third of 260 imported Asian herbals were either spiked with drugs not listed on the label or contained lead, arsenic or mercury. Five Chinese herbals had significant amounts of potent drugs used to treat diabetes. A pediatrician reported on children from wealthy California families who were actually malnourished from eating snack food spiked with supplements. Dietary supplement companies have begun aggressively targeting children and parents with potent nutraceuticals designed to help kids gain strength, lose weight, or treat colds and flu, depression and attention deficit disorder. As a result, increasing numbers of kids are swallowing supplements, often with the knowledge, urging and even insistence of parents in search of "natural" remedies or "healthy" alternatives for youngsters who eat too many cupcakes or drink too much soda. One survey recently found that almost 20 percent of parents were giving their children supplements. In Long Island, a mother gave her 18-month-old baby a teaspoon of eucalyptus oil last year because a store clerk told her it was good for a fever. The child suffered permanent neurological damage and almost died Supplements designed to improve athletic performance or lose weight are particularly likely to be associated with adverse reactions. The FDA's lack of awareness of the extent of such problems or their severity is disturbing, even though there is little they can do about it. Gammahydroxybutyrate (GHB) and its precursors are popular body building supplements but may cause coma and death. The FDA was

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aware of only 14 episodes and one death from 1993-1998 whereas Florida had recorded 549 in 1998 alone. Because of mounting problems Congress intervened two years later and overrode DSHEA by banning GHB after evidence that it had caused 60 deaths. A recent article in Annals of Internal Medicine described five patients admitted to the same hospital within a six month period for liver failure after taking Lipokinetix, a weight loss supplement. No other drugs were involved, all tests for viral and other forms of hepatitis were negative and jaundice or other manifestations appeared after a few weeks of taking the supplement as directed. Analysis of the product revealed appropriate amounts of norphedrine (phenylpropanolamine), caffeine, yohimbin, diiodothyronine and sodium usinate as listed on the label. None of these alone is associated with liver toxicity but the authors convincingly demonstrated how their combination could cause problems. Further investigation revealed two other cases of liver failure due to Lipokinetix (also sold as Syntrax) reported on MedWatch and it is likely that there are numerous others that have not been diagnosed correctly or reported. This is just the tip of the iceberg with respect to safety problems associated with weight loss supplements and lack of awareness. The FDA's monitoring system implicated dietary supplements in 2,621 adverse events between 1993 and 1998 with 184 deaths. In contrast, the Association of Poison Control Centers received almost 7,000 adverse reports on supplements in 1998 alone. These did not include ephedra products for weight loss, which accounted for the biggest chunk of the FDA's cases, and deserves further discussion. Should Ephedra Be Banned? A recent review of hospital records suggested that almost one in four admissions was due to some complication from a medication. It is estimated that for each statin safety complaint received by the FDA there are probably over ten times as many that are not recorded. The situation is probably much worse with respect to nutritional supplements and it is impossible to accurately estimate how prevalent safety problems are.

June 2002

The Newsletter of THE AMERICAN INSTITUTE OF STRESS

The FDA received 1400 complaints about ephedra between January 1993 and February 2000, most of which were for elevated blood pressure, palpitations or rapid heart rate. However, ephedra containing products were also associated with more deaths, heart attacks, cardiac arrhythmias, hypertension, strokes and seizures than all other dietary supplements combined. Victims tended to range in age from 18 to 45 years old who followed dosage recommendations. Ephedra is believed to have been responsible for the deaths of three football players last year and although it has been banned by the National Football League, National Collegiate Athletic Association, International Olympic Committee and severely restricted in 15 states, sales continue to soar. The FDA took action against drugs containing ephedrine about twenty years ago listing contraindications and dosage warnings. However, it has little if any control over supplements other than to make recommendations or give warnings that manufacturers can accept or ignore. In 1997, because of mounting criticism, the FDA proposed to limit the dose of ephedra in dietary supplements containing caffeine, prohibit unwarranted label claims and require a warning label limiting daily doses as well as duration of treatment. These were all very reasonable suggestions designed to protect the public based on numerous mishaps that had been voluntarily reported. However, industry pressure has been so powerful that several of these suggestions have already been withdrawn. The last report from the agency indicated that nothing will be done until a more thorough investigation is completed later this year or some time in 2003. Ephedra supplements in widely varying doses are being taken by millions to lose weight, increase energy or improve performance in sports and athletic activities. Most contain caffeine, guarana or other botanical products to increase stimulant effects but there is no guarantee that the label identifies all the ingredients or the correct amount of those that are listed. One pharmacologist who has analyzed 150 such weight loss and sport supplements noted "You really don't know what you're getting in these products, or how much."

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Ma ny consu mers are not ev e n aw are th ey 'r e in gest ing ephe dra beca use it is li sted as Ma Huang or si da cordi foli a. Pr oduc ts also ofte n in clud e B vita mins or gr een tea ex tr act to imply the y pr omot e he alth and hav e su gges tiv e nam es lik e M e t a b o lif t , Th e r m a d r o l , Qu adra burn , Ri pper fuel , Zo ne Fat Buste r an d Li pofu el. Co nv i n ci ng pro moti onal ma t e r i a l wi t h g l ow in g te s t i m o n i a l s t ha t incl ude im pres siv e bef ore and afte r pi ctur es em phas iz in g sa fety as well as effi cacy in crea se their app eal. Dat a ob tain ed from P o ison Con trol Cen ters rev eals th a t ad v e rs e ep h e d r a su pple ment rep orts in crea sed from 21 1 in 19 9 7 to 40 7 in 1 9 9 9 bu t th e nu mber s ar e pr obab ly much much hi gher sin ce such faci liti es would cap ture on ly a fra ctio n of tho se affec ted. La st Septe mber , th e Pu blic Cit iz en s he alth adv ocac y gr oup peti tion ed the FDA to ban all ep h e d r a sup plem ents co mpla inin g th at the safet y pr oble ms were mu ch more seri ous and wide spre ad than ap prec iate d. They poin ted out that Te xas re po rt e d 5 0 0 a dv e r s e e ph e d ra e v e n t s in le s s t h a n t w o y e a rs o r o ve r a t h ird m o re t h a n t h e F DA h a d ga t h e re d in 7 ye a rs a n d "t h e f a c t t h a t a s in gle s t a t e co u ld do t h is s pe a k s t o t h e pi t if u l in a de q u a cy o f re po rt s t o t h e c u rre n t FD A sy st em ." Th e pe titi on was signe d by Dr . Ra y mon d Wo osle y , a car diov ascu lar ph arma colo gist and FDA con sult ant on ep hedr a's card iac tox i city . He emp hasi z ed t h a t "J u s t a ddi n g w a rn i n gs t o t h e pr o du c t la be ls is n o t e n o u gh be ca u s e t h e re h a v e be e n t o o m a n y p a t ie n t s w h o f o llo w e d t h e i n s t r u ct i o n s , re a d t h e w a rn in gs a n d s t ill s u f f e re d s t ro k e s or hea rt a t t ac ks." There has bee n no re spon se nor is an y li k ely . And Now Som e Good Supplement News So me suppl emen ts lik e Coen z y me Q1 0 ar e no t on ly compl etel y sa fe, but ha v e been prov en to be nefi t a vari ety of di sord ers in rigor ous scie ntif ic studi es. A do uble -bli nd place bo contr olle d st udy has ag ain conf irme d th e be nefi ts of Co Q1 0 in co nges tiv e hea rt failu re at a dosa ge of 20 0 mg . da ily . Bas ed on th e ex peri ence of ot hers , do ubli ng this amou nt in di v ide d do ses woul d li k ely hav e im prov ed these

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The Newsletter of THE AMERICAN INSTITUTE OF STRESS

re sult s. The abili ty of Co Q1 0 to impr ov e im mune sys tem resp onse s wa s sh own in an othe r do uble bli nd study whe re subje cts v a ccin ated for Hep atit is B rec eiv e d ei ther pl aceb o, 9 0 mg . Co Q1 0 or 18 0 mg. Co Q1 0 da ily . Ant ibod y ti ters one mon th later we re signi fica ntly hig her in the Co Q1 0 re cipi ents (es peci ally at high er doses ) in dica ting bet ter prot ecti on. A chro nic fati gue synd rome cro ss ov er study mea suri ng recov ery time aft er a stan dard bic y cle ex e rcis e ch alle nge fo und 90 % impr ov em ent with 30 0 mg. Co Q1 0 da ily as oppos ed to 50 % on 10 0 mg. da ily , and a retur n to pre trea tmen t va lues af ter the cros s ov er to pl aceb o. This clea r d o se -r e sp o nse rela tion ship str ongl y su ppor ts Co Q1 0 's ther apeu tic effi cacy as op pose d to a place bo respo nse. Co Q1 0 ha s no adv erse sid e or lon g te rm effec ts an d th ere was no ev ide nce of tox ic ity in on e pr omis ing stud y in rec urre nt prost ate ca nce r wh e r e p a t i e nt s rece iv ed 60 0 m g . / d a y f o r a y e a r . In f a c t , t h e N I H h a s fu nded a study of Park inso n's dise ase ba sed on very enco urag ing prel imin ary re sult s in whi ch pa t ien t s w ill rece ive 3 0 0 , 6 0 0 o r 1 2 0 0 m g. o f C o Q 1 0 da i ly fo r up t o 17 m ont h s ! Hu ntin gton 's disea se is a debi lita ting di sord er that also cau ses unco ntro lled mo v eme nts and deme ntia and usu ally st rik e s at an earl y ag e. A rec ent stud y in Ne urol ogy fo und that giv ing 30 0 mg. of Co Q1 0 tw ice a da y fo r 30 mon ths resu lted in si gnif ican t im prov emen t an d fo r th e fi rst ti me rev er sed a bi oche mica l ab norm alit y se en in th is disor der. Ano ther pap er in th e sa me issue rep orte d th at 2 0 0 to 30 0 mg . of Co Q1 0 dail y cu red two teen ager s wi th a rare inh erit ed muscl e di seas e. The m a nuf a ct ur e r ha s a p p l i e d f o r F D A a p p r o v a l of its pro duct as a pr escr ipti on drug for t h is d isor d e r . Th e st ress of an acute hea rt attac k is ass ocia ted with a distu rban ce in gl ucos e me tabo lism tha t in crea ses bloo d in suli n le v els . Th is hy per insu line mia can caus e fu rthe r da mage by prom otin g cl otti ng te nden cies ove r th e ne x t four week s. This pe riod is the time of grea test ris k fo r a re peat hea rt attac k an d as one car diol ogis t no ted, "Th e gr eate r th e re duct ion in ex cess ins ulin the bet ter off a pa tien t

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s ho u ld be . " In one st u dy , he ar t at ta c k p at i en t s who re c ei v ed 12 0 mg . of Co Q1 0 d ai l y e x p e r i e nc e d m or e t h an 10 % r ed u ct i on in fa s ti n g and po s tp r an d ia l i ns u li n le v e l s, si g ni f ic a nt l y les s an gi n a a nd rh y th m di st u rb a nc e s and a low e r rat e o f rec u rr e nt he a rt at t ac k s and fa t al i ti e s. P r o b a b l y t h e mo s t d r a m a t i c e f f e c t s o f Co Q1 0 ar e se en in pa t ie n ts wi t h p er i od o nt a l dis e as e th at ha s fa il e d to r es p on d to co nv e nt i on a l the r ap i es an d a nt i b i o t i c s. A cr e a m co n t a i n i n g Co Q1 0 h as be e n sho w n to red u ce wr i nk l es an d a ge sp o ts be c au s e of its an t io x id a nt e ff e ct s . In a st ud y of pa ti e nt s wi th sk i n w ri n k l e s in the co r ne r s of the ey e s, " cr o ws fe e t" , Co Q1 0 cre a m was ap p li e d o nc e da il y fo r six we e k s to on e ey e and a p l a c e b o c r e a m t o t h e o t h e r . T o me a s u r e w ri n k l e de pt h , sil f lo re p li c as we r e app l ie d , r em o v e d an d mea s ur e d for de p th by la s er a t bas e li n e and af t er si x we ek s . Wri n k l e d ep t h was re d uc e d by 2 7 % in th e tr ea t ed g ro u p com p ar e d to con t ro l s and at 10 w ee k s the r e was a 43 % re d uc t io n in w r i n k l e s. T h e re a s o n C o Q1 0 is e f f e c t ive in h e a rt dis e a s e , m a l ign a n cy a n d s o m a n y o t h e r dif f e re n t d is o r de rs is t h a t it in c re a s e s t h e p ro du ct io n o f A T P (a de n o s in e t ri ph o s ph a t e ), w h ic h is t h e so urce of ener gy f or a ll c ells . As ca n be se en from the abov e st udie s, dosag e re comm enda tion s ca n va ry widel y . When ta k en for prev enti v e purpo ses, dai ly doses ra nge betw een 60 and 2 0 0 mg. eithe r as a si ngle or twic e da ily dose . Co Q1 0 sho uld be tak en with food , pr efer ably con tain ing fa t, since it is not solub le in wa ter. Var ious pr epar atio ns are av ail able but gel atin ca psul es conta inin g Co Q1 0 dis solv ed in oi l se em to at tain hig her bloo d le v els . Pr ices ca n va ry treme ndou sly and do not refle ct qu alit y . Cut rate caps ules may hav e li ttle ac tiv e ing redi ent but one of the best p r o d uc t s is al so one of th e le ast e x p e ns i v e . Omega-3 - Another "Super Supplement" Th e cl aim that fis h is "br ain food " ma y be mor e th an an ol d wi v es' tal e ba sed on rec ent rese arch . Mo re than 60 % of the br ain is compo sed of fatty tis sue deri v ed pr imar ily from the ome ga-3 fat ty acids

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The Newsletter of THE AMERICAN INSTITUTE OF STRESS

fo und in fish. Blo od tests sho w th at most Am eric ans are defi cien t in ome ga-3 fat ty ac ids and 20 % hav e no dete ctab le am ount s. There is good rea son to belie v e th at these ind iv id uals are at incr ease d ri sk fo r be hav i oral , me mory and lea rnin g pr oble ms as we ll as de pres sion and ev e n su icid e . R a t e s o f d e p r e s s i o n a r e lo w in c o u n t r i e s li k e Ja p a n w h e r e t h e a v e r a g e c o n s u m p t i o n of se a f o o d p e r p e r s o n is a r o u n d 1 5 0 lb s . a y e a r . T h e in c i d e n c e of m a j o r d e p r e s s i o n i s ne a r l y 6 0 t i m e s g r e a t e r in N e w Z e a l a n d , w h e r e s e a f o o d c o n s u m p t i o n is a b o u t 4 0 p o u n d s a y e a r . P o s t - p a r t u m de p r e s s i o n , t h e di s o r d e r t h a t ca u s e d A n d r e a Y a t e s t o d r o w n he r f i v e ch i l d r e n , is 5 0 t i m e s m o r e co m m o n i n co u n t r i e s w i t h l o w se a f o o d i n t a k e l e v e l s . S c i e n t i s t s ha v e f o u n d a b n o r m a l l y l o w le v e l s of om e g a - 3 f a t t y a c i d s in t h e b r a i n s of d e p r e s s e d p a t i e n t s a n d m a n y s u s p e c t t h e r e m a y b e a li n k b e t w e e n t h e d e c r e a s e of om e g a - 3 f a t t y a c i d s in t h e A m e r i c a n di e t du r i n g t h e pa s t c e n t u r y and ou r in c r e a s i n g in c i d e n c e of d e p r e s s i o n . Om e g a - 3 le v e l s a r e lo w e r b e c a u s e w e a r e e a t i n g le s s f i s h a n d t h e s a t u r a t e d f a t s in m e a t s a n d d a i r y product s, om e g a - 6 fatty ac i d s in v e g e t a b l e oi l s , a n d t r a n s - f a t s in t e r f e r e w i t h t h e a b i l i t y t o ut i l i z e o m e g a - 3 . T h r o u g h m o s t o f hu m a n e x i s t e n c e t h e r a t i o o f om e g a - 6 t o om e g a - 3 f a t t y a c i d s i n ou r d i e t w a s 1 : 1 or 2 : 1 . T h e ra t i o in t h e cu r r e n t U . S . d i e t is e s t i m a t e d t o b e b e t w e e n t e n a n d t w e n t y t i m e s hi g h e r . The im port ance of th i s wa s un ders core d in a Harv a rd study in whic h r e se a r che r s se para ted rece ntly ho spit aliz ed depre ssed pat ient s in to two gr oups mat ched for sev erit y of sym ptom s. On e wa s pl aced on a di et high in omega -3 fa tty acid s an d th e ot her rece iv ed a high om ega- 6 di et. Afte r th ree mont hs, the im prov emen t in the ome ga-3 gro up was so dr amat ic that in an un usua l mo v e, the Un iv er sity ove rsig ht commi ttee ord ered th e st udy to be st oppe d so tha t al l th e pa tien ts could ben efit fro m om ega- 3 su p p l e m e nt a t i o n. An othe r Un iv er sity stu dy found tha t k i ds low in om ega- 3 fa tty acid s we re si gnif ican tly more lik ely to hav e lear ning

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d i s o rd e r s , hy p e r a c t i v i t y an d ot h e r b e ha vior a l pro b l e m s . To in v e st i g a t e e f f e ct s on lea r n i n g ab i l i t y , ra t s we re r a i s e d on e i t h e r a d ie t d e f i ci e n t in o m e g a- 3 fa t t y ac i d s or on e con t a i n i n g n o r m al am o u n ts . Bo t h gr o u p s in i t i a l l y ha d s i m i la r nu m b er s of sy n a p t i c co n n e c t i on s i n t h e b r a i n b u t a f t e r f o u r we e k s o f a l e a r ni n g p r o g r a m , t h e om e g a - 3 g r o u p h a d co n s i d e r ab l y mo r e an d al so sc o r e d m u c h hi g h e r on te s t s to me a s ur e le a r ni n g s k i l ls . T h e we l l k n o w n c a r d i o p r o t e c t i v e b e n e f i t s of f is h a n d om e g a - 3 w e re c on f ir m ed in a rec e nt re p or t fr om th e o ng o i n g P h y s i ci a ns ' H e a l t h S t u d y sho w i n g t ha t p a r t i ci p a n t s w i t h t h e hi g h e s t o m e g a 3 le v e l s wer e 8 1 pe rc e nt le s s lik e ly to di e s u d d e n l y . An o t h e r I t a l i a n s t u d y o f h e a r t a tt a ck su r v i v or s fo un d th at th o se wh o t o o k f i sh - o i l su p p l e m e nt s ha d o nl y ha l f t he in c id e nc e of su dd e n car d ia c de at h w it h in th e fi rs t fo ur ye a rs of tr e at m en t c om p ar e d to con t ro l s on the sa m e die t w h o to o k v i t a m i n E . T h e l o n g - t e r m N ur s e s ' H e a l t h S t u d y a l s o r e p o r t e d t h a t w om e n who at e fi sh re g ul a rl y ha d nea r ly o ne - th i rd fe w er de a th s fr om he a rt di s ea s e c om p ar e d to wom e n who ra r el y at e fis h . O v e r 2 0 0 0 ot h er st u di e s hav e li nk e d o me g a- 3 d e f i c ie n ci e s to m e m o ry p ro b le m s, dy s le x ia an d a ho s t of dis e as e s r a n g in g f r om ar t hr i ti s , all e rg i es an d c hi l dh o od as t hm a to di ab e te s , bre a st an d c o l o r e c t a l c a n c e r , ec z e m a a n d o t h e r s k i n d is o rd e rs . Th e mos t be ne f ic i al om e ga - 3 a ci d s are EP A (e ic o sa p en t an o ic ac i d) an d D HA (d o co s ah e x a n oi c ac id ) wh ic h ar e f ou n d in fat t y fis h li k e sa l mo n , swo r df i sh , s ar d in e s tun a , blu e fi s h, an d ma ck e re l . P e o p l e wh o d o n ' t l i k e fi s h o r a r e c on c er n ed ab o ut me r cu r y con t am i na t io n c an ta k e col d li v e r oi l but it ' s not ve r y p al a ta b le an d la rg e am ou n ts ar e re qu i re d . F i s h o i l s u p p l e m e n t s r i c h i n o m e g a - 3 fa t t y a ci d s are a muc h be tt e r cho i ce bu t it is i mp o rt a nt to be ce r ta i n tha t th e pro d uc t y ou ch o os e ha s bot h EP A and DH A in s i g n i f i ca n t a m o u nt s a n d li s t s a n e x p i r a t i o n d a t e . S up p l e m e n t s co n t a i n i n g om e g a -6 a nd / or om e ga - 9 fat t y aci d s sho u ld be a v o i d e d si nc e t h e s e a r e r e a d i l y a v a i l a b l e f r o m f o o d s a n d ca n r e d uc e om e g a - 3 u t i l iz a t i o n .

June 2002

The Newsletter of THE AMERICAN INSTITUTE OF STRESS

Weight Loss Supplement Scams And The Need For Greater Regulatory Powers A me r ic a ns sh e ll ou t $ 3 3 bil l io n y ea r ly in wh a t is usu a ll y a fu t il e at te m pt t o she d so me ex t ra po u nd s an d kee p t he m of f. It is ge n er a ll y re co g ni z ed th a t t he on l y way to lo s e wei g ht is to in g es t f e w e r c a l o r i e s t h a n a r e e x p e n d e d , wh i c h m ea n s eat i ng le s s, ex e rc i si n g mor e an d u su a ll y bo th . Wh at mo s t peo p le se e m to b e loo k in g fo r, ho w ev e r, is so m e mag i c p i l l t h a t wi l l d o t h e t r i c k . P h a r m a c e u t i c a l s h av e be en a dis a st e r wit h th e rec a ll of R e d u x a n d th e i m m i n e n t d e m i s e o f M er i di a be ca u se of se v er e he al t h haz a rd s . A si gn i fi c an t po rt i on of th e $ 4 bi ll i on s p e n t a nn u a l l y o n nut r i t i o n a l sup p l e m e n t s i s for we i gh t lo ss pr o du c ts an d pr og r am s a n d th e n u m b e r a n d ty p e s th a t a r e a v a i la b le ar e mi nd bo g gl i ng , as ar e the i r c l a i m s . A n I n t e r ne t se a r c h on " w e i g h t l os s " tur n ed up we l l ov e r 2 mi l li o n hit s in a te nt h of a se c on d , all of wh i ch ar e p r e s u m a b l y s a f e wh e n t a k e n a s d i r e c t e d . I t is cle a r tha t th ey ar e no t, an d ep he d ra a nd Li p ok i ne t ix ar e no t t he on l y o f f e nd e r s . E ff i ca c y is ano t he r pr ob l em an d B o d y S o l u t i o n s i s o n e ex a m p l e o f t h e n um e ro u s sca m s tha t ab ou n d. No ne e d to w or r y abo u t die t or ex er c is e , you ca n " lo s e whi l e you sn o oz e ". Th e ho ok is "Y o u s im p ly dr i nk a tab l es p oo n of th e for m ul a b ef o re be d , sle e p wel l an d los e we ig h t. " W he n y o u r e c e i v e t h e p r o d uc t t h e d ir e ct i on s ar e to dri n k tha t ta bl e sp o on on a n e m p t y s t o m a c h s o t h a t yo u c a n ' t e a t f or th r ee ho u rs be f or e yo u tak e it , and n ot ag a in un t il yo u wa k e up th e ne x t da y . T he i r Pha s e 1 pr og r am co s ts $1 8 0 for a 9 0 day su p pl y an d the n ju mp s to $ 4 8 e v e r y t w o we e k s . T h e p r i m a r y i n g r e d i e n t

i s a hy dr o ly z ed co w co ll a ge n pr ot e in p op u la r iz e d in T he La s t Cha n ce Di e t th a t c au s ed a nat i on a l upr o ar 25 ye a rs ag o b e c a us e i t r e su l t e d i n nu m e r o u s d e a t h s. T he co m pa n y doe s no t off e r a mo ne y b ac k gu ar a nt e e and de s pi t e num e ro u s law s ui t s, is ex t re m el y pr of i ta b le . T he En f or m a Sy s t em cl a im s th at it s " Fa t Tr ap p er " an d "Ex e rc i se in a Bot t le " p ro d uc t s inc r ea s e the bo d y ' s ca pa c it y to b ur n fa t and he l p it bur n mo re ca l or i es w hi l e sle e pi n g, at a cos t of ab ou t $ 7 0 / mo n th . Th ei r in fo m er c ia l s, cl a im i ng t ha t co ns u m e r s co u l d e nj o y f r i e d chi c k e n , p iz z a, et c ., an d st il l lo se we i gh t , tha t w e r e sh ow n 2 3 ,0 0 0 t im e s ov e r e i g h t m o n t hs , r e su l t e d in sa l e s of $ 3 5 m i l l i o n . T h e Fe d e r a l T r a d e C o m m i s s i o n s u e d c h a r g i n g t h a t t h e c l a i m s we r e n o t s up p or t ed an d al th o ug h th e com p an y wa s o rd e re d to pa y a $ 1 0 mil l io n fi ne an d r e f r a i n f r o m ma k i n g f a l s e c l a i m s , th e y a r e s t i l l f l o u r i s hi n g w i t h sl i g h t l y d i f f e r e n t a dv e rt i si n g wor d in g . The r e are nu m er o us o the r sca m s ra n g in g f r om ma g i c m u s h r o o m s , w o n d e r b a r k f r o m Br a z i l , c el l ul i te pi l ls , py ru v at e , cre a ti n e, g ar c in i a c am b og i a an d gr ee n al ga e to "S li m mi n g I ns o le s " wor n in ea ch sh o e tha t ma ss a ge c e r t a i n r e f l e x z on e s ca u s in g t h e b od y t o b ur n st or e d fat an d th e "Fa t -B e Go ne R i n g " t ha t ca n he l p y o u l o s e w e i g h t i n c er t ai n bo dy lo c at i on s by we ar i ng it on a s pe c if i c fin g er . It is ha rd to be l ie v e tha t p eo p le fa l l for sc a ms th a t onl y sl im th e ir w a l l e t s a n d t ha t t h e g o v e r n m e n t is p ow e rl e ss to st o p the m . T he r e are so m e pro m is i ng an d sa fe s up p le m en t s on the ho r iz o n tha t do ha v e p ot e nt i al fo r we ig h t los s as we ll as st r es s r e d u c t i o n th a t w i l l b e d i s c u s s e d i n a f u t u r e Ne w s l e t t e r - s o s t a y tu n e d !

Health and Stress

The Newsletter of

The American Institute of Stress 124 Park Avenue

Yonkers, NY 10703

ANNUAL SUBSCRIPTION RATES: E-MAIL…………………… $25.00 PRINT (DOMESTIC)……. $35.00 PRINT (FOREIGN)……… $45.00

Page 8

ISSN # 1089-148X Paul J. Rosch, M.D., F.A.C.P. Editor-in-Chief www.stress.org e-mail: [email protected]