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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