Bill Sardi on The Dietary Supplement Access and Awareness Act

[Guest guest]

There is just no end to the pharmaceutical industry's attacks on your

health.

Knowledge of Health, Inc.

457 West Avenue #117, San Dimas, CA 91773 Bill Sardi, President

H.R. 3156 The Dietary Supplement Access & Awareness Act

Elected representatives A. (CALIF), D. Dingell (MICH) and

Henry A. Waxman (CALIF) have introduced legislation [hr 3156] before the

House of Representatives, now in committee, that would virtually destroy

the dietary supplement industry.

The legislation is identified as the " Dietary Supplement Access & Awareness

Act, " but it does not address free access and only creates a negative

awareness of these products.

Previous FDA Warning Eliminated One Dietary Supplement

Here is why HR 3156 poses such a threat to the availability of dietary

supplements. Not long ago the Food & Drug Administration (FDA) issued just

a similar warning, asking physicians to report adverse reactions associated

with kava kava supplements, an anti-anxiety herbal product. The public was

also warned to report any side effects and the FDA warning was published in

newspapers and on TV news reports. Later, published studies cleared kava

kava from any suspicion, but the damage had been done. The public backed

away from kava supplements based upon the bulletin issued by the FDA, and

today kava farmers in the South Pacific have plowed up their fields. A $25

million product was destroyed by FDA meddling. The same destruction could

result from the passage of HR 3156.

Guilt By Assumption

This legislation was written without adequate prior evidence that vitamin,

mineral or herbal products pose a mortal or serious risk to humans. HR

3156 requires the public and their physicians to report to federal health

authorities within 15 days of the onset of any serious adverse

reaction. This legislation assumes the industry is hiding product hazards

that have escaped normal monitoring.

Guilt By Association

Every physician who treats a patient that has had a stroke, heart attack,

or experienced sudden death, will now be obligated to report any dietary

supplements after an adverse event. This is guilt by association.

The Dietary Supplement Information Bureau reports that six in ten Americans

(59 percent) report taking dietary supplements on a regular

basis. Subsequent reports will read there is an association between mortal

and near-mortal events and dietary supplements. But there is little if any

evidence of cause and effect.

Imagine the government commissioned a study of hit-and-run auto-pedestrian

accidents and found that 95% of children hit by cars were wearing tennis

shoes. Would we then mistakenly conclude that the tennis shoes caused the

accidents? Such non-scientific association would likely be aired in news

reports to frighten the public away from relatively safe products.

For example, this recently occurred when researchers at Harvard Medical

School published a report showing more lutein in fatty tissues of people

who have heart attacks. The researchers publicly suggested this was a

concern that required more investigation. But lutein accumulates in fatty

tissues to protect them from turning rancid, and individuals with more body

fat will exhibit higher concentrations of lutein in these tissues. There

is simply no evidence that lutein, provided in spinach and from marigold

extracts in dietary supplements, causes heart attacks!

Dietary Supplements Relatively Safe

For many years running the American Association of Poison Control Centers

has reported the mortality and morbidity associated with dietary

supplements to be relatively low, with no mortality associated with

multivitamins for a period of more than 8 years running. Even though

dietary supplements are safer than food (food borne infection strikes

millions annually), safer than table salt, and safer than many

over-the-counter remedies such as aspirin, onerous reporting requirements

would be mandated by HR 3156. The dietary supplement industry has nothing

to hide. These reporting requirements are unjustified.

Mandates Scare Tactics

HR 3156 would require that millions of dollars of public money be spent to

educate the public to report alleged side effects to their physicians. HR

3156 will likely result in labeling that will say " Report any serious

adverse reactions to your physician. " Or imagine listening to the radio

and a government sponsored ad says: " If you or a loved one experience a

serious side effect such as a stroke, heart attack, or even death) that you

believe may be related to a dietary supplement, please notify your

physician. " Such efforts to label products or educate the public in this

manner only serves to create doubt in the public's mind over the relative

safety of these products and assumes serious adverse reactions are a major

but unreported problem.

Timing of Legislation Questioned

HR 3156 appears misdirected. It comes at a time when the side effects

emanating from properly prescribed and ingested prescription drugs result

in the needless death of more than 100,000 Americans annually. Where is

legislation that would adequately protect the public from unsafe

over-the-counter or prescription drugs? Relatively troublesome drugs like

Vioxx and Bextra have been returned to pharmacy shelves with black box

warnings that put the burden on consumers to check for potential side effects.

FDA Inaction Over Unsafe Drugs Has Prompted The Search for Safer Alternatives

Furthermore, the public has become aware the FDA has approved drugs that

have not undergone adequate safety testing, and permitted pharmaceutical

companies to advertise these very same drugs on television, making

unsubstantiated claims of their effectiveness and safety, which resulted in

the demise of thousands of Americans. This has prompted millions of

Americans to search for safer alternatives to unsafe drugs, namely dietary

supplements, to allay symptoms posed by arthritis, headaches, menopause and

other conditions.

Dietary supplements are concentrated foods, just as table salt is

concentrated sodium. Will physicians be required to report strokes induced

by patients who ingest excessive amounts of salt?

Would Patients Be in a Position to Report Serious Side Effects?

Pray tell, how would a patient experiencing a serious side effect (death,

stroke, cardiac arrest, etc.) be in a position to even ascertain their

harmful health event was related to a dietary supplement? The average

older American takes 2.4 prescription drugs in addition to dietary

supplements. Why are the dietary supplements being fingered for reporting

and not the more hazardous drugs?

Drugs and Other Agents Would Be Unreported

For example, a patient taking aspirin therapy to prevent a heart attack,

and steroids to treat arthritis, estrogen replacement therapy for

menopause, along with vitamin E, and experiences a heart attack, would have

to disclose to their doctor they were taking vitamin E pills. Aspirin,

estrogen and steroids deplete the body of vitamin C which weakens blood

vessels, induces their collapse, and can result in blockage of a coronary

artery that produces a heart attack. But the vitamin E might be unfairly

blamed for inducing this event. The patient may also be a smoker and/or

alcohol drinker, which further depletes vitamin C and increases the risk

for a heart attack. But only the vitamin E pills would be reported to the FDA!

No Demonstration Project

Virtually all patients and their physicians would be obligated under HR3156

to report to the FDA such adverse events, at a cost of millions of dollars,

with no demonstration project that proves threats to public health would be

eliminated or the public welfare improved.

HR 3156

Sponsor:

<http://cp.perfora.net:8000/p= & v=0000000002B9C14D091C87AB & t=redir & dest=687474703\

A2F2F74686F6D61732E6C6F632E676F762F6367692D62696E2F626471756572792F3F2644623D643\

1303926717565727962643D404649454C44253238464C443030332B4034253238253238403125323\

85265702B44617669732B2B537573616E2B412E2532392532392B3031363431253239253239>Rep

, A. [CA-53] (introduced 6/30/2005)

Co-Sponsors:

<http://cp.perfora.net:8000/p= & v=0000000002B9C14D091C87AB & t=redir & dest=687474703\

A2F2F74686F6D61732E6C6F632E676F762F6367692D62696E2F626471756572792F3F2644623D643\

1303926717565727962643D404649454C44253238464C443030342B4034253238253238403125323\

85265702B44696E67656C6C2B2B4A6F686E2B442E2532392532392B3030323939253239253239>Re\

p

Dingell, D. [MI-15] - 6/30/2005

<http://cp.perfora.net:8000/p= & v=0000000002B9C14D091C87AB & t=redir & dest=687474703\

A2F2F74686F6D61732E6C6F632E676F762F6367692D62696E2F626471756572792F3F2644623D643\

1303926717565727962643D404649454C44253238464C443030342B4034253238253238403125323\

85265702B5761786D616E2B2B48656E72792B412E2532392532392B3031323039253239253239>Re\

p

Waxman, Henry A. [CA-30] - 6/30/2005

To find out the status of this bill go to:

<http://cp.perfora.net:8000/p= & v=0000000002B9C14D091C87AB & t=redir & dest=687474703\

A2F2F74686F6D61732E6C6F632E676F762F6367692D62696E2F71756572792F7A3F633130393A482\

E522E333135362E4948>http://thomas.loc.gov/cgi-bin/query/z?c109:H.R.3156.IH:

To read the

bill:

<http://cp.perfora.net:8000/p= & v=0000000002B9C14D091C87AB & t=redir & dest=687474703\

A2F2F7777772E616870612E6F72672F30355F303633305F4852333135362E706466>http://www.a\

hpa.org/05_0630_HR3156.pdf

To contact your elected

representative:

<http://cp.perfora.net:8000/p= & v=0000000002B9C14D091C87AB & t=redir & dest=687474703\

A2F2F7777772E686F7573652E676F762F77726974657265702F>http://www.house.gov/writere\

p/

Bill Sardi, Knowledge of Health, Inc, San Dimas, CA. Website:

<http://cp.perfora.net:8000/p= & v=0000000002B9C14D091C87AB & t=redir & dest=687474703\

A2F2F7777772E6B6E6F776C656467656F666865616C74682E636F6D2F>www.knowledgeofhealth.\

com