Diet supplements criticized
Journal calls for tighter rules; industry
says law adequate
09/17/98
New York Times News Service
People trying to treat their own
ailments with
remedies from health-food stores have
become
severely ill from pills and powders
sold as "dietary
supplements," according to six separate
reports
being published Thursday in the New
England
Journal of Medicine.
Lead poisoning, impotence, lethargy,
nausea,
vomiting, diarrhea and abnormal heart
rhythms
were among the disorders described,
resulting from
powerful herbs, toxic contaminants or
the presence
of potent drugs or hormones in products
that were
supposed to be "all natural" and free
of drugs.
In addition, several children with
cancer worsened
when their parents rejected
conventional therapy in
favor of alternative methods.
The six reports - three articles and
three letters to
the editor - involved only about a
dozen patients,
but Dr. Marcia Angell, executive editor
of the
journal, said, "I think this is the tip
of the iceberg."
In a sharply worded editorial
accompanying the
reports, she and Dr. Jerome Kassirer,
the editor in
chief of the journal, criticized
supplement makers
and practitioners of alternative
medicine for
advocating unproven and potentially
harmful
treatments. "Alternative treatments
should be
subjected to scientific testing no less
rigorous than
that required for conventional
treatments," they
wrote.
Taken together, the editorial and
multiple case
studies from the medical establishment
amount to a
throwing down of the gauntlet before
the booming
supplement industry. The cases
demonstrate that
consumers can be harmed by seemingly
innocuous
herbs and nutritional supplements and
lend weight
to the argument that the loosely
regulated industry
should be held more accountable for its
products.
Unlike drugs, dietary supplements do
not have to
be proved safe and effective before
they are put on
the market. Dr. Angell said that if
supplements
were held to the same standard as
drugs, "the onus
would be on the manufacturers to prove
safety and
efficacy, and I think most of them
would shut
down."
She was especially critical of the Dietary
Supplement Health and Education Act of
1994,
which weakened the authority of the
Food and
Drug Administration to regulate
vitamins, herbal
remedies and other products classified
as dietary
supplements. The supplement industry
boomed
after the law was passed, from an $8
billion-a-year
business in 1994 to nearly $12 billion
a year in
1997.
Dr. Annette Dickinson, a spokeswoman
for the
Council on Responsible Nutrition, a
Washington,
D.C., trade association representing
supplement
makers, called the editorial an
"unjustified
broadside." She said that the law was
adequate to
safeguard the public and that the
industry had no
more errors or mishaps than food or
pharmaceutical producers.
Dr. William Schultz, deputy
commissioner for
policy at the FDA, said that before
1994, the
agency could order a substance off the
market until
a manufacturer could demonstrate its
safety. After
1994, Dr. Schultz said, new laws
stipulated that the
FDA could not remove a product until it
was
proved unsafe. In practice, he said,
that means that
hazardous products can go undetected until
someone is harmed by them.
In an especially impassioned report in
the journal,
cancer specialists from Alberta
Children's Hospital
in Calgary described two cases in which
parents of
children with cancer decided to forgo
chemotherapy and radiation in favor of
alternative
treatments.
One patient was a 15-year-old boy with
Hodgkin's
disease, a cancer of the lymphatic
system that can
be cured in more than 80 percent of
patients if
standard treatment is begun promptly.
The family
rejected conventional therapy in favor
of an herbal
product. When the family returned to
conventional
therapy, higher doses of chemotherapy were
required and side effects were more
serious.
Doctors also sounded a warning about
herbal
products imported from Asia. A journal
article
reported that 83 of 260 samples tested
by the
California Department of Health
Services contained
poisonous heavy metals such as lead,
arsenic or
mercury, or drugs not listed on the label.
________________________________________________________________
Arthur Hirsch {} [log in to unmask] {} Lewisville, TX {} 972-434-2377
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Always Remember This: Happiness Is Right, So Choose Happiness
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