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!
Sponsor:
Rep Davis, Susan A. [CA-53] (introduced 6/30/2005)
Co-Sponsors:
Rep Dingell, John D. [MI-15] - 6/30/2005
Rep
Waxman, Henry A. [CA-30] - 6/30/2005
To find
out the status of this bill go to: http://thomas.loc.gov/cgi-bin/query/z?c109:H.R.3156.IH:
To read
the bill: http://www.ahpa.org/05_0630_HR3156.pdf
To
contact your elected representative: http://www.house.gov/writerep/
