Bill Sardi, President Knowledge
of Health, Inc. 7-20-5
Be it hereby declared that the
citizenry of the United States is at war with its elected officials over free
access to dietary supplements without interference by federal health agencies
that now distribute misinformation regarding these products.
The threat is posed by HR 3156:
Dietary Supplement Access & Awareness Act
Elected representatives Susan A.
Davis (CALIF), John D. Dingell (MICH) and Henry A. Waxman (CALIF) have
introduced legislation, 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.
Guilt by assumption
That these elected
representatives would write legislation, without prior evidence that vitamin,
mineral or herbal products pose a mortal or serious risk to humans, and
requires the public and their physicians to report to federal health
authorities within 15 days of the onset of any serious adverse reaction,
assumes the industry is hiding product hazards that have escaped normal
monitoring.
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, these representatives have
chosen to draft legislation that would mandate onerous reporting requirements
that 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.
Previous FDA Warning Eliminated
One Dietary Supplement
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 will result from the passage of HR
3156.
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?
FDA inaction over unsafe drugs
has prompted 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?
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 associations 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 who
have 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!
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.
Launch recall efforts
today!
The dietary supplement industry
and the public must launch an all out effort to recall elected representatives
who submit overly onerous, restrictive legislation that assumes all dietary
supplements are unsafe and which will likely frighten the public away from
relatively safe alternatives to problematic prescription drugs.
Therefore, and without hesitation,
American health freedom fighters have resolved to launch an all out recall
effort against representatives Davis, Dingel and Waxman, to begin today!
Furthermore, HR 3156 shall be vigorously opposed from every quarter in
American society!
