Comparative Safety of Drugs and Supplements/Herbs Philip Rudnick
May 19, 2004
The growing use by the public of
supplements and herbs represents a threat to the current very
profitable operation of the Drug Industry. To counter this
threat, the Drug Industry, the FDA and the Medical
Establishment want Congress to believe that under current
legislation supplements and herbs, not drugs, represent a
major source of harm to the public. Documentation from the
medical literature shows unequivocally that the very opposite
is true. Also, the safety of supplements and herbs can be
fully addressed and regulated under the current DSHEA. The
FDA, with its scandalous incestuous ties to the Drug Industry,
simply wants legislation that would enable it to restrict
access of the public to supplements/herbs while permitting the
Drug Industry to carry on its profitable operation. Its goal
is the assurance of a “health-care” system economically based
on the treatment of disease with drugs, not its prevention
through nutrition.
Drug, Herb & Supplement Mortality
Iatrogenic deaths from non-error adverse effects of
medication: ~ 106,000/year
There were two million, two hundred and sixteen thousand
adverse (life threatening) reactions to drugs given in
hospitals. This did not count drug errors. The JAMA report
(below) also listed one hundred and six thousand deaths from
properly prescribed in patient drugs during 1997. Based on
conservative vs. liberal estimates, this placed properly
prescribed drug usage as the 4th - 6th leading cause of death
in the US.
Reference:
Abstract
Incidence of Adverse Drug Reactions in Hospitalized Patients
A Meta-analysis of Prospective Studies
Jason Lazarou, MSc; Bruce H. Pomeranz, MD, PhD; Paul N. Corey,
PhD
JAMA. 1998;279:1200-1205.
Objective.— To estimate the incidence of serious and fatal
adverse drug reactions (ADR) in hospital patients.
Data Sources.— Four electronic databases were searched from
1966 to 1996.
Study Selection.— Of 153, we selected 39 prospective studies
from US hospitals.
Data Extraction.— Data extracted independently by 2
investigators were analyzed by a random-effects model. To
obtain the overall incidence of ADRs in hospitalized patients,
we combined the incidence of ADRs occurring while in the
hospital plus the incidence of ADRs causing admission to
hospital. We excluded errors in drug administration,
noncompliance, overdose, drug abuse, therapeutic failures, and
possible ADRs. Serious ADRs were defined as those that
required hospitalization, were permanently disabling, or
resulted in death.
Data Synthesis.— The overall incidence of serious ADRs was
6.7% (95% confidence interval [CI], 5.2%-8.2%) and of fatal
ADRs was 0.32% (95% CI, 0.23%-0.41%) of hospitalized patients.
We estimated that in 1994 overall 2216000 (1721000-2711000)
hospitalized patients had serious ADRs and 106000
(76000-137000) had fatal ADRs, making these reactions between
the fourth and sixth leading cause of death.
Conclusions.— The incidence of serious and fatal ADRs in US
hospitals was found to be extremely high. While our results
must be viewed with circumspection because of heterogeneity
among studies and small biases in the samples, these data
nevertheless suggest that ADRs represent an important clinical
issue.
From the Departments of Zoology (Mr Lazarou and Dr Pomeranz),
Physiology (Dr Pomeranz), and Public Health Sciences (Dr
Corey), University of Toronto, Toronto, Ontario.
Deaths from consumer use of herbs: 37/year
According to the FDA, between 1993 and 1998, federal, state
and local agencies reported a total of 184 deaths, most of
which were associated with weight-loss formulas.
184 Deaths/5 Years = 37 Deaths/Year
Reference:
Mortality From Herbs:
http://www.emedicine.com/EMERG/topic449.htm
Author: Jon Mark Hirshon, MD, MPH
Mortality/Morbidity: The FDA noted 2621 adverse drug reactions
and 184 deaths due to herbal products over a 5-year period
(1993-1998).
Deaths from Supplements: 0-1/year
DOCTOR YOURSELF Newsletter (Vol. 4, No. 4 January 20, 2004)
Andrew W. Saul
http://www.doctoryourself.com
Contributing Editor,
Journal of Orthomolecular Medicine (http://www.orthomed.org)
In 1998, the American Association of Poison Control Centers'
Toxic Exposure Surveillance System reported the following
fatalities from vitamin supplements:
Adult multiple vitamins: 0
Pediatric multiple vitamins: 0
(And, incidentally, there were no deaths from vitamin C,
vitamin E, folic acid, nor from any other vitamin whatsoever.)
Background: More than 100 million Americans regularly use
vitamins. In the US, consumer spending on vitamins and
minerals has doubled in the last 6 years, reaching $6.5
billion annually. Iron-containing vitamins are the most toxic,
especially in pediatric acute ingestions (see Toxicity, Iron).
Fat-soluble vitamins are more dangerous in acute ingestions.
Frequency:
In the US: Data from the 1998 American Association of Poison
Control Centers' Toxic Exposure Surveillance System document
the total number of exposures for each class of vitamins, the
number of patients with major adverse outcomes, and the number
of fatalities from that ingestion, as follows:
Adult multiple vitamins without iron or fluoride - 2409 total
exposures, 1 major outcome, and 0 deaths
Adult multiple vitamins with iron but without fluoride - 5781
total exposures, 2 major outcomes, and 0 deaths
Pediatric multiple vitamins without iron or fluoride - 7252
total exposures, 0 major outcomes, and 0 deaths
Pediatric multiple vitamins with iron but without fluoride -
16,125 total exposures, 0 major outcomes, and 0 deaths
Vitamin A - 2146 total exposures, 0 major outcomes, and 0
deaths
Niacin - 2244 total exposures, 2 major outcomes, and 0 deaths
Pyridoxine - 355 total exposures, 5 major outcomes, and 0
deaths
Other B complex vitamins - 1439 total exposures, 0 major
outcomes, and 0 deaths
Vitamin C - 2650 total exposures, 0 major outcomes, and 0
deaths
Vitamin E - 1726 total exposures, 1 major outcome, and 0
deaths
Overall, 49,709 exposures to different types of vitamins were
reported to the poison control centers across the US in 1998,
accounting for 14 major adverse outcomes and no deaths. Of the
total exposures, 39,396 exposures occurred in children younger
than 6 years.
Mortality/Morbidity: Morbidity and mortality from pure
vitamins are rare. One study of acute or chronic overdoses,
with more than 40,000 exposures, reported 1 death and 8 major
adverse outcomes.
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