Pharmavite LLC Says Vitamin B Study Published in JAMA Is Flawed; Vitamins Meant for...

Pharmavite LLC Says Vitamin B Study Published in JAMA Is Flawed; Vitamins Meant for Prevention, Not Disease Treatment

NORTHRIDGE, Calif.--(Business Wire)--
Pharmavite LLC, maker of Nature Made(R) vitamins, today urged
caution against making final judgment on B vitamins for prevention and
heart health. The most recent study titled "Mortality and
Cardiovascular Events in Patients Treated with Homocysteine-Lowering B
Vitamins After Coronary Angiography," is published in the August 20,
2008 edition of the Journal of American Medical Association (JAMA).

"Vitamins are meant to be taken for preventative measures to
support long-term good health, rather than treat disease," said
Carroll Reider, MS, RD, Pharmavite scientific affairs. "This study is
a Randomized Controlled Trial (RTC), which has become the gold
standard for establishing the efficacy of drugs. Unfortunately, it is
poorly suited to the evaluation of the effects of nutrients. This type
of study is doomed to fail since nutrients and drugs have two
different mechanisms."

Reider identified several major problems in the trial design:

-- Length of Treatment: Nutrients work best in studies that look
at their effect on health over a five to ten year period (and
even longer) to see how they promote good health. They cannot
correct a disease that was caused by lifelong poor health,
especially in a short period of time. Although they work best
in prevention, they can be very effective in diseases that
were caused by the nutrient deficiency, such as people with
cardiovascular disease (CVD) due to high homocysteine, which
is a B vitamin deficiency.

-- Patient Population: This study evaluated the effects of B
vitamins on a population that had existing cardiovascular
heart disease and other health conditions and were on multiple
medications. The intent was to see if the B vitamins would
reduce their homocysteine which would result in a reduction of
future cardiovascular events.

-- Homocysteine Levels: The findings of this study are not
surprising given outcomes of similarly designed RTC studies:
lowering homocysteine in patients with existing cardiovascular
disease does not appear to reduce the risk of subsequent
cardiovascular events. The major criticism of this study was
most of the population did not have high homocysteine to begin
with. The mean homocysteine went from 10.8 nmoles/L (normal)
to 7.6 nmoles/L (normal). Essentially, researchers treated a
population who didn't have high homocysteine (that is, that
was not the cause of their heart disease) with a homocysteine
lowering therapy. Had patients with much higher homocysteine
levels been included in the trial, or they isolated the groups
with high homocysteine, an even greater reduction in
homocysteine levels would likely have been observed.

Previous vitamin B studies are consistent in showing that they can
help lower homocysteine levels and maintain cardiovascular health. For
example, one major study suggests that a 25 percent decrease in
homocysteine is associated with an approximate 10 percent decrease in
the risk of coronary heart disease and a 20 percent decrease in the
risk of stroke(1).

"The bottom line," said Reider. "Eat a healthy diet, exercise and
take your B vitamins as needed. Research shows B vitamins support
heart health cognitive function and provide many other benefits when
taken long-term as part of an overall healthy plan."

Note to Editors: Pharmavite scientific experts are available for
interviews. The Pharmavite News Bureau can also provide research data
on B Vitamins.

About Pharmavite

For more than 35 years, Pharmavite has earned and maintained the
trust of pharmacists, consumers, and retailers by manufacturing
high-quality vitamins, minerals, herbs and other dietary supplements
that are safe, effective and science-based. The dietary supplement
industry is regulated by the U.S. Food and Drug Administration and the
Federal Trade Commission, as well various state and local regulatory
agencies. As a leader in the dietary supplement industry, Pharmavite
swiftly adopted the FDA-released Good Manufacturing Practices (GMPs)
introduced in June 2007, which sets rigorous manufacturing standards
for the supplement industry.

(1) Semin Vasc Med. 2005 May; 5(2): 215-22.

Pharmavite News Bureau
Carol Soudah/Traci Kantowski, 877-866-2539
pnb@carryonpr.com

Copyright Business Wire 2008