[MOL] supplements may be toxic [02343] Medicine On Line

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[MOL] supplements may be toxic

I am a strong advocate for alternative medicine, including herbs and
supplements, but found the following article from the NY Times to be a
healthy reminder. (This comes on the heals of a friend ending up in
emergency Sunday, from a reaction to some herbs she was taking.) We just
have to be careful. You can go to the web page, but i have also included the
full article below. Love, joicy 

Dietary Supplements May Test Consumers' Health
    [09/22/98; New York Times (Free Registration Required)]

Growing numbers of Americans are stepping daily into a potential 
minefield of substances loosely referred to as dietary supplements, 
many of which have little or nothing to do with the components of 
foods people normally consume. And increasingly these pill poppers 
are getting into trouble, suffering toxic reactions to deliberate 
or accidental components of these products or sacrificing the 
chance to be helped by conventional medicine.  

[NOTE: Access to articles on 'The New York On The Web' is free *for
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The full article can be found at:



Dietary Supplements May Test Consumers' Health


              Expanded Coverage of Science 

              By JANE

                       Growing numbers of Americans are stepping
daily into a potential minefield of

loosely referred to as dietary supplements, many of which have little or

nothing to do with the components of foods people normally consume. And

increasingly these pill poppers are getting into trouble, suffering toxic
reactions to deliberate

              or accidental components of these
products or sacrificing the chance to be helped by

conventional medicine. 

              Last week in six reports published in
The New England Journal of Medicine, physicians

              described such
reactions as lead poisoning, impotence, blood clots, abnormal heart

              nausea, vomiting, diarrhea and disorientation from
exposure to powerful drugs or toxic

              contaminants in products
deemed to be "all natural" alternatives to established therapies. The

reports are a reminder that consumers who wander recklessly into the world
of herbs and

              other dietary supplements must proceed at their
own risk because no regulatory agency has the

              authority to
assess the safety, purity or effectiveness of these products before they can
be sold

              to the public. 

              Members of the public
may be, in effect, serving as

              guinea pigs in experiments that
don't always have happy

              endings. While the majority of

              manufacturers are scrupulous and use production

techniques that approach pharmaceutical standards,

              others are
less than careful and some are downright

              cheats, filling
capsules with impure substances and

              sometimes with few or none
of the ingredients listed on

              the labels. 

the Law Allows 

              Once upon a time, dietary supplements of all
kinds were

              treated as food additives under the direct
jurisdiction of

              the Food and Drug Administration. Producers
had to

              prove the supplements were safe before they could be

sold, a requirement that doubtless kept hundreds of

off the shelves. Producers also could not claim

              any health
benefits that were not scientifically established

              to the
satisfaction of the F.D.A. 

              But in 1994, under a deluge of
consumer pressure

              instigated by the supplement industry,
Congress changed

              the rules. Dietary supplements -- broadly
defined to

              include herbs, amino acids, botanical extracts,

quasi-vitamins as well as real vitamins and minerals --

be sold without any prior approval of the agency,

              which had
been established decades earlier to safeguard

              the health of
Americans against the onslaught of

              unethical or careless food
and drug producers. 

              Now, under the new law entitled the
Dietary Supplement

              Health and Education Act, it is up to the
F.D.A. to take

              products off the market only after they have

              dangerous to people taking them. Only when a new

ingredient is introduced is the company obliged to provide the drug agency

              documentation of its presumed safety. Furthermore, while
companies cannot make claims of a

              product's ability to treat
or prevent disease, they can make general function, wellness and

nutritional support statements on package labels that imply health benefits,
even though such

              benefits may not be well established by
properly designed scientific experiments. 

              Thus, an herb
called saw palmetto can be said to promote prostate health and ginkgo to

enhance memory. And while people have long used the herb feverfew to help
with migraine

              headaches, producers can only say it helps with
brain function. But not every consumer

              organization supported
the new law. For example, the Washington-based Center for Science

in the Public Interest, a nonprofit consumer advocacy group, called the bill
a "ticking time

              bomb" that would force consumers to "play
Russian roulette when they take a supplement." 

              The center
pointed out that royal jelly, a dietary supplement derived from honey bees,

              already been linked to the death of an 11-year-old girl
with asthma and had caused serious

              asthmatic attacks in nine
other people. 

              In the newly published reports, researchers
described PC-SPES, an unregulated mixture of

              herbs with potent
estrogen-like activity, that caused serious side effects in patients with

prostate cancer. In another report, two previously healthy young women were
said to have

              suffered irregular heart rhythms, lethargy,
persistent nausea and severe vomiting after taking a

dietary supplement that was contaminated with digitalis, a drug that could

              fatal heart rhythms when inappropriately used. 

Another report told of two children with cancer whose parents rejected

              chemotherapy in favor of dietary supplements -- a
botanical said to boost immunity in one

              case and shark
cartilage (a supplement popularized by the 1992 book "Sharks Don't Get

Cancer") in the other. One child died in a few months, the other developed a
more advanced

              cancer requiring more potent therapy. 

In still another report, an analysis of 260 Asian patent medicines sold in
California revealed

              that 32 percent contained a drug not
listed on the label or contaminants like lead, arsenic and


              Caveat Emptor 

              Dr. Lori A. Love and
colleagues at the F.D.A. pointed out in the journal that "there are

currently no federal regulations that establish specific criteria for
purity, identification and

              manufacturing procedures of dietary
supplements." In other words, producers can put in just

anything they want, including no active ingredient at all, and there is no
guarantee that

              what it says on the label is what is in the
bottle. An analysis of ginseng products, for example,

up to a 10-fold difference in the amount of the active ingredient, even
though all were

              labeled as containing the same amount. 

Nor is the producer required to maintain pharmaceutical standards in making
the product,

              which could end up -- and some have ended up --
with all manner of contaminants. In 1990,

              36 people died and
at least 1,500 became seriously ill after taking a popular supplement,

L-tryptophan, which was subsequently found to contain 63 contaminants and
pulled from the


              Furthermore, the drug
agency researchers noted, "there are no requirements for mandatory

reporting to the F.D.A. of adverse events by the manufacturer or distributor
of these

              products," which means it is up to the agency and
physicians to pick them up. This brings up

              a third problem:
Many, perhaps most, people who take over-the-counter dietary supplements

and other alternative remedies never report that fact to their physicians.
Even when patients

              suffer untoward effects, they may be too
embarrassed to tell their doctors what they had been

As a result, doctors sometimes mistakenly attribute supplement-caused
symptoms to

              the illness or the treatment they prescribed,
which can result in unwarranted and hazardous

              changes in the
patient's medical care. 

              In an accompanying editorial, Dr.
Marcia Angell and Dr. Jerome P. Kassirer pointed out that

consumers mistakenly assume that dietary supplements are safer than drugs
even though their

              producers often assert that they are as or
more powerful than conventional medicines. But

              there is no
free lunch. If a substance contains biologically active ingredients, it is
bound to

              have other effects that may be undesirable, even
dangerous. The editors called for rigorous

              testing of all
products, stating, "It is time for the scientific community to stop giving

alternative medicine a free ride." 

              PERSONAL HEALTH is
published weekly, on Tuesdays. Click here for a list

              of links
to other columns in the series. 
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