'Dirty Dozen' of Dietary Supplements
Consumer Reports Issues List of Potentially Dangerous Supplements
April 1, 2004 Despite known
hazards, many potentially dangerous dietary supplements are readily available for purchase in stores & on the Internet,
according to a new report from Consumer Reports.
Today, the magazine released its
"dirty dozen" list of dietary supplements that it says are too dangerous to be on the market.
The list includes yohimbe, bitter orange, chaparral & andro. But researchers say the supplements are sold under
many names, which makes it hard for consumers to know what they're getting.
Many of the supplements that made
the list have already been banned in other countries. But researchers say regulatory barriers created by Congress have prevented
the FDA from taking similar actions to protect consumers in this country.
The announcement coincides w/a report
on supplement safety issued today by the Institute of Medicine, which suggests that the FDA should take action against potentially
hazardous dietary supplements & asks Congress to ease restraints on the agency.
Dirty Dozen of Dietary Supplements
Researchers from the consumer magazine
say the supplements that made its "dirty dozen" list may cause cancer, severe liver or kidney damage, heart problems, or even
For example, they say the herb aristolochia has been conclusively linked to
kidney failure & cancer in China, Europe, Japan
& the US.
Yohimbe, a supplement marketed as a sexual stimulant & herbal Viagra, has been linked to
heart & respiratory problems.
The supplement bitter orange, whose ingredients have effects similar to those of the banned weight-loss
stimulant ephedra, is also on the list of potentially dangerous supplements.
Many of these dietary supplements
are sold in both single & combination products marketed for a wide variety of uses, from building muscle & losing
weight to easing stress & arthritis.
Researchers divided the list into
3 categories based on the amount of available evidence about the dietary supplement:
very likely hazardous
is an antidepressant from the family of drugs known as selective serotonin reuptake inhibitors or SSRI's. Celexa
helps to restore the brain's chemical balance by increasing the supply of a chemical messenger in the brain called
serotonin. Because Celexa appears to relieve depression
by increasing serotonin w/minimal effect on many of the other chemicals in the brain, it may cause relatively few & mild
side effects, which tend to go away w/continued treatment.
EFFEXOR XR is a prescription medication used to treat depression, generalized
anxiety disorder, & social anxiety disorder, allowing you to get back to your life again.
XR is known as an SNRI (serotonin & norepinephrine reuptake inhibitor) & is believed to help treat depression
& the associated symptoms of anxiety by affecting the level of 2 chemicals in the brain
serotonin & norepinephrine.
two chemicals are thought to play a key role in depression & the associated symptoms of anxiety. Correcting the imbalance
of these 2 chemicals may help relieve depression symptoms & the associated symptoms of anxiety, which can be a positive
step toward getting your life back.
Generic name: Clonazepam
is used alone or along with other medications to treat convulsive disorders such as epilepsy.
also prescribed for panic disorder, unexpected attacks of overwhelming panic accompanied by fear of recurrence. Klonopin belongs
to a class of drugs known as benzodiazepines
is an antidepressant that is the newest member of the family of medications known as selective serotonin reuptake inhibitors
was developed by isolating a part of the CELEXA TM (citalopram HBr) molecule, known as an isomer. As a result,LEXAPRO appears
to offer some particular advantages in the treatment of depression:
is the most widely prescribed antidepressant medication in history. Since it's introduction in 1986, prozac has helped over
40 million patients worldwide, including those suffering from depression, obsessive compulsive disorder, bulimia nervosa &
Paxil® (paroxetine HCl) has been approved by the U.S. Food and Drug
Administration as a safe & effective treatment for these conditions:
continued treatment, Paxil can help restore the balance of serotonin (a
naturally occurring brain chemical), which helps reduce the symptoms of anxiety & depression. Depression, GAD, social
anxiety disorder, panic disorder, OCD & PTSD can occur separately. However, many people have an overlap of these conditions.
The good news is Paxil is the first & only medication in the class of antidepressants
known as selective serotonin reuptake inhibitors (SSRIs) approved by the FDA to treat all these conditions.
RISPERDAL® (risperidone) is a medication that treats the symptoms
of schizophrenia. Medications known as conventional antipsychotics were
introduced in the 1950's & are still in use today. RISPERDAL is a newer medication, called an atypical antipsychotic. It's reassuring to know that RISPERDAL has been
around for over 8 years and used by more than 10 million people worldwide. In fact, RISPERDAL is the #1 prescribed antipsychotic.
Symptoms are thought to be caused by imbalances of two chemicals in the brain. These
are called dopamine & serotonin.
how RISPERDAL works is unknown. However, it seems to readjust the balance of dopamine and serotonin. This helps relieve your
symptoms. While it's not a cure, RISPERDAL helps control your symptoms so you can start getting on with your life.
is a medical condition that affects individuals & those who share their lives. Fortunately, Once-Daily WELLBUTRIN XL
can help provide relief for many people who have depression.
because the active ingredient (bupropion HCl) in WELLBUTRIN XL is clinically proven to effectively treat depression w/a
low risk of sexual side effects & a low risk of weight gain.
continued Dirty Dozen List
Since the brand names of the products
containing the dirty dozen supplement ingredients vary widely, researchers say consumers should read ingredient labels carefully
& look for the following:
Aristolochic acid (Aristolochia, birthwort, snakeroot, snakeweed, snagree root, sangrel,
serpentary, wild ginger).They list this as having caused documented human cancers & it's linked to kidney failure.
Very Likely Hazardous -- These are banned in other countries, have an FDA warning, or
show adverse effects in studies:
Comfrey (Symphytum officinale, ass ear, black root, blackwort, bruisewort,
consolidae radix, consound, gum plant, healing herb, knitback, knitbone, salsify, slippery root, symphytum radix, wallwort).
Abnormal liver function or damage, often irreversible; deaths reported.
Androstenedione (4-androstene-3, 17-dione, andro, androstene). Increased cancer risks
& decreases in "good" HDL cholesterol have been reported.
(Larrea divaricata, creosote bush, greasewood, hediondilla, jarilla, larreastat). Abnormal liver function has
been linked to use.
Germander (Teucrium chamaedrys, wall germander, wild germander). Abnormal
liver function has been linked to use.
Kava (Piper methysticum, ava, awa, gea, gi, intoxicating pepper, kao, kavain,
kawa-pfeffer, kew, long pepper, malohu, maluk, meruk, milik, rauschpfeffer, sakau, tonga, wurzelstock, yagona, yangona). Abnormal
liver function has been linked to use.
Likely Hazardous -- These have adverse-event reports or theoretical risks.
Bitter orange (Citrus aurantium, green orange, kijitsu, neroli oil, Seville
orange, shangzhou zhiqiao, sour orange, zhi oiao, zhi xhi). High blood pressure; increased risk of heart arrhythmias, heart
attack & stroke are risks associated w/use.
Organ/glandular extracts (brain/adrenal/pituitary/
placenta/other gland "substance"
or "concentrate"). Theoretical risk of mad cow disease, particularly from brain extracts.
Lobelia (Lobelia inflata, asthma weed, bladderpod, emetic herb, gagroot,
lobelie, indian tobacco, pukeweed, vomit wort, wild tobacco). Difficulty breathing & rapid heart rates are thought to
be associated w/this.
Pennyroyal oil (Hedeoma pulegioides, lurk-in-the-ditch, mosquito plant,
piliolerial, pudding grass, pulegium, run-by-the-ground, squaw balm, squawmint, stinking balm, tickweed). Liver & kidney
failure, nerve damage, convulsions, abdominal tenderness, burning of the throat are risks; deaths have been reported.
Scullcap (Scutellaria lateriflora, blue pimpernel, helmet flower, hoodwort,
mad weed, mad-dog herb, mad-dog weed, quaker bonnet, scutelluria, skullcap). Abnormal liver damage.
(Pausinystalia yohimbe, johimbi, yohimbehe, yohimbine) Blood pressure changes, heart beat irregularities &
heart attacks have been reported.
Experts say it's important to tell
your doctor about any dietary supplement you may be taking. Not only do many supplements have significant side effects, but
they may also interfere w/the effectiveness of prescribed medications, such as birth control pills.
Study Advises Against Drugs for Children in Depression
Pediatricians & family physicians should not prescribe antidepressants for depressed children &
adolescents because the drugs barely work & their side effects are often significant, Australian researchers
The researchers analyzed data from 5 published trials of 3 antidepressants, Prozac, Zoloft & Paxil,
in depressed patients under age 18. They found that the drugs offered only a "very modest" benefit over placebos.
At the same time, the drugs carry significant risks, the researchers
said in their report, published in today's issue of the British medical journal BMJ.
"If the drugs were highly advantageous over placebo, then
you'd live w/the risks," Jon Jureidini, a child psychiatrist in Adelaide & the study's lead author, said in an interview.
"If the drugs were completely safe, then you might argue that
there's nothing wrong w/giving something that's only slightly better than a placebo."
However, Dr. Jureidini said, neither is true, so antidepressants
should not be prescribed for children & adolescents except in extreme circumstances.
"We strongly want to say that non-child-psychiatrists should
not be initiating the prescribing of" the antidepressants known as selective serotonin reuptake inhibitors or S.S.R.I.'s,
a class that includes Eli Lilly's Prozac, Pfizer's Zoloft & GlaxoSmithKline's Paxil, Dr. Jureidini said.
The study is the latest salvo in an increasingly bitter war
over whether prescribing antidepressants to children & adolescents is appropriate.
Dr. Joseph Glenmullen, author of "Prozac Backlash" & a
fierce critic of the pills, said the latest study further vindicated his view that antidepressants can be dangerous. "What
this shows is that, on balance, there is no good reason to prescribe these pills," Dr. Glenmullen said.
However, Dr. Graham Emslie, a professor of psychiatry at the
University of Texas Southwestern Medical Center, who was an author of some of the studies reviewed in the article, said the
study was "illogical."
"I wish the effect size of these drugs was bigger, but at
least there's some effect," Dr. Emslie said. "Some of these kids are severely depressed & we've got to do something."
Dr. Emslie, like many psychiatric researchers, is a consultant
to pharmaceutical companies.
The Australian researchers suggested that psychiatrists offer
children talk therapy in place of the drugs. But Dr. Emslie said that only one study had shown that talk therapy was beneficial.
"If people could offer better treatments than drugs, it'd
be great," Dr. Emslie said.
British drug regulators have cautioned doctors against using
any antidepressant but Prozac to treat depressed children & adolescents because the drugs have not proved effective against
depression & may increase the risk of suicidal thoughts & behavior.
The Food & Drug Administration recently issued a warning
that all patients taking antidepressants should be closely monitored by doctors, especially in the first weeks. But the agency
emphasized that it had not concluded that the drugs caused suicidal thinking or behavior.
Dr. Laurence Greenhill, a professor of clinical psychiatry
at Columbia University, said neither side in the debate had a monopoly on truth.
"I think that these medications are neither as much of a silver
bullet as the advocates would have it nor as terrible as the critics would say," Dr. Greenhill said.
The Altered Human Is Already Here
In the popular imagination, the
technologically altered human being is a cross between RoboCop & the Borg.
The hardware that would make such a mating of humans, silicon
chips & assorted weaponry a reality is, unfortunately, still on back order.
Many people, however, have already made a different kind of
leap into the posthuman future.
Their jump is biochemical, mediated by proton-pump inhibitors, serotonin boosters & other drugs
that have become permanent additives to many human bloodstreams.
Over the past half century, health-conscious, well-insured, educated people in the United States &
in other wealthy countries have come to take being medicated for granted.
More people shift to the pill-taking life every year, to the delight of pharmaceutical manufacturers.
Indeed, drug sales suggest how willing people are to pursue better living through chemistry.
Last year retail drug sales worldwide were $317 billion. In the United States alone, consumers spent
$163 billion on drugs. In North America, the use of drugs that affect the central nervous system, antidepressants & others,
increased 17%. No group has escaped. Last week the Centers for Disease Control & Prevention reported that 10 million children
took prescription medication for 3 months or longer in 2002 & preschoolers, another study found, are now the fastest growing
group of children receiving antidepressants.
This is a social change on the same order as the advent of computers, but one that is taking place
inside the human body. Just 50 years ago, according to a report by IMS Health, a company that tracks the pharmaceutical industry,
the two biggest-selling over-the-counter drugs were Bufferin & Geritol.
The prescription drug business was tiny. In 1954, according to IMS, Johnson & Johnson had $204
million in revenue. Now it is about $36 billion. In 1954, Merck took in $1.5 million in drug sales; in 2002, that figure was
To look at it in another way, Americans take so many drugs that some researchers Dr. Christian G. Daughton
of the Environmental Protection Agency's National Exposure Research Laboratory in Las Vegas, for example are worried about
the effects on the environment.
What does it mean if the sewers run rich with Zoloft? Or to be more precise, what might happen to fish
eggs if the rivers soak up waste water with discarded & excreted pharmaceuticals & personal care products, like shampoo?
No one has the answer yet, but the idea that what runs through our collective bloodstream is a potential
environmental hazard makes you look at your medicine cabinet in a different way.
In short, while the Six Million Dollar Man is still a fantasy, Pharmaceutical Man is already here &
largely unnoticed. Swallowing a pill at a business lunch is likely to elicit little curiosity. A high-powered executive who
did not have blood pressure or cholesterol problems might be suspect. There are concerns about the widespread use of antidepressants,
but they do not seem to have affected sales.
In fact, the group of antidepressants that includes Zoloft is the third biggest class of pharmaceuticals
by sales in the United States, totaling $11 billion in 2003.
Drugs in the top two categories statins to reduce cholesterol levels & proton pump inhibitors to
prevent heartburn, gastritis, ulcers & other digestive problems had sales of about $14 billion & $13 billion, respectively.
Critics of the national medicine cabinet have noted that behaviors & physiological changes that
were once simply aspects of life menopause, the inability to keep still as a child, baldness, decreasing potency in old men
have been medicalized, turned into syndromes or diseases.
Dr. Thomas Szasz, a psychiatrist who in the 1960's defined himself as far outside the mainstream by
arguing that mental illness was a myth, recently wrote a book called "Pharmacracy," about the invasive rule of medicine as
it defines our lives.
Last fall, the President's Council on Bioethics issued a report called "Beyond Therapy: Biotechnology
& the Pursuit of Happiness." The report included material on genetics & embryo selection, but it also addressed performance
enhancement & behavioral drugs. One of its concerns was the way everything in life becomes a medical problem.
When new technologies, including drugs, come through doctors, the report said, many aspects of life
become medicalized, raising concerns that "the pursuit of happiness & self-perfection would become part of the doctor's
The report also cataloged "other aspects of human life that formerly had little to do with doctors
& hospitals: childbirth, infertility, sexual mores & practices, aspects of criminal behavior, alcoholism, abnormal
behavior, anxiety, stress, dementia, old age, death, grief & mourning."
One might argue that any extension of medicine should be welcome. The prevention of heart attacks is
obviously a worthy effort. Antidepressants can ease anguish, which for many people who take them is overwhelming. In many
countries of the world, people would jump at the chance to worry about having too much medicine; they don't have nearly enough
Yet some of the new miracles of the pharmaceutical industry are not intended to save lives, but to
improve & prolong them.
Ana-Maria V. Zaugg vice president of corporate strategic planning for IMS Health, said that there were
two streams of change in pharmaceutical research & use. Acute care is giving way to chronic or preventive care managing
cholesterol levels rather than treating heart attacks, for example. At the same time, disease treatment is being extended
to treatment whose goal is to increase well-being.
Drugs for baldness, incontinence, sexual performance & the effects of menopause may be included
in the latter category. Both trends are expected to increase, Ms. Zaugg said.
Some areas that she is confident will grow are drugs to improve male sexual performance, anti-Alzheimer's
drugs & drugs for incontinence & osteoporosis. If new psychostimulants & anti-obesity drugs appear in the future,
she said, they will quickly take off. Compounds that increase intelligence & greatly improve memory will undoubtedly be
best-sellers as well.
Whether or not the growing use of drugs has altered our essential humanity, there is now almost no
bodily system that cannot be adjusted by them. Blood, respiration, the nervous system, hormonal regulation, muscles &
bones, the cardiovascular system, reproduction, sexuality drugs are available to nudge them all in one direction or the other.
It is not unusual for someone to begin the day with a cocktail of antidepressants, statins & blood pressure medications.
The result does not yet seem to be the epidemic of dull, well-managed emotionless humanity that some
forecasters have worried about. For instance, among professionals in journalism & publishing in the New York metropolitan
area, who no doubt take as much Zoloft per capita as anyone on the planet, it is no small trick to find someone who is either
calm or happy.
Perhaps in the future, stronger drugs will produce the well-sedated zombies that will make the streets
of Times Square disturbingly docile & well mannered, but it has not happened yet.
There are concrete results of the medicated life, however. Dr. Isaac Schiff, chief of obstetrics and
gynecology at Massachusetts General Hospital in Boston, said he found that "most people, men & women who are in their
50's, are taking something every day."
He added, "One of the reasons is that our life expectancy has changed dramatically. Our whole concept
of aging is very different."
Dr. Schiff said that many people in their 40's & 50's "are now taking medication to prevent diseases
in their 70's."
In the case of osteoporosis, for example, the point of taking medication at age 50 is to prevent a
hip fracture at age 75 or 80.
What that means for medicine is that as old problems recede, new ones arise. Dr. Neal L. Benowitz,
professor of medicine & chief of clinical pharmacology at the University of California at San Francisco, said that doctors
had seen a shift in "what you can expect to die from." There are fewer deaths from heart attack, he said & more from congestive
heart failure, cancer & Alzheimer's.
One problem, of course, is that it is the well-off & the well educated who are most likely to take
advantage of the many drugs available. Another is that need can be manufactured by advertising.
Even children know from television that if you are sad & worried, there is a pill for you. If you
have heartburn there is a pill for you. It is a lot harder to find out that there are other ways to feel better, physically &
emotionally, than taking drugs.
By & large, however, the pharmaceutical road is paved with pretty good intentions. The president's
report addressed "the pursuit of happiness." A similar report on the dangers of computers & other hard technology might
have a different subtitle the pursuit of power, perhaps.
Even the dystopian fantasies of cyborgs & the overmedicated are fundamentally different. Drugs
are an easy way to contentment & the absence of pain even if they are ultimately unsatisfying. Hardware is something else.
It enhances the senses, increases strength, adds weapons. As a cyborg, you can be your own telescope, your own computer, your
It may not be so bad that the pharmaceutical human is arriving first.
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