putting quackery to the test

Wall Street Journal - August 7, 2006

No ‘Alternative’ By JEROME GROOPMAN

Some 60 million Americans use supplements, megavitamins, herbs and
other so-called “alternative” treatments. Their out-of-pocket costs
approach $40 billion a year. Their therapies are promoted by a vast
number of self-help books, Web sites and talk shows that feature
thrilling testimonials of benefits for maladies that mainstream
medicine cannot remedy. But we are now learning what happens when the
testimonials are subjected to objective testing. In February, the
results of a large clinical trial of the supplements glucosamine and
chondroitin sulfate for osteoarthritis were released. These data came
on the heels of a rigorous assessment of the herb saw palmetto for
symptoms of an enlarged prostate gland. Both studies failed to show
clinical efficacy. All this should mark a sea change in how the
public views such treatments.


In the first case, some 1,583 patients with symptomatic
osteoarthritis of the knee were randomly assigned to receive
glucosamine, chondroitin sulfate, both supplements, the anti- inflammatory Celebrex, or placebo. The trial was sponsored by the
National Center for Complementary and Alternative Medicine, NCCAM,
and the National Institute of Arthritis and Musculoskeletal and Skin
Diseases. The study found there was no overall statistical benefit
except for Celebrex. Of note, 60% of the patients receiving placebo
reported significant improvement.

This result was greeted without surprise by a colleague of mine who
is a primary care physician. Many of her patients swear by the
benefits of the supplement for their arthritis; and one of them, a
woman in her 70s, never failed to press the physician to take it for
her own aches and pains. When the doctor demurred, the patient eyed
her with some disdain. “You doctors are so close-minded,” she said.
“You won’t accept a treatment that comes from outside of your own
world.” One day, a package arrived at her office. It was a large
container of glucosamine, which still sits in a cabinet, unopened.
“Despite all my patients’ testimonials, it didn’t make sense,” she
told me. “Glucosamine is absorbed from the digestive tract and
rapidly broken down in the body. How could this supplement survive
digestion, travel through the circulation, deposit in worn-down
joints, and rebuild cartilage?”

My colleague is a caring and competent clinician, and I was struck by
the barb from her patient about being “close-minded.” Most physicians
I know feel triangulated in caring for people who pursue alternative
therapies. Pointed questioning of the probity of the treatments casts
the doctor in the role of adversary rather than ally. Glibly
endorsing such therapies may be politically correct but, in essence,
patronizes the patient, since the doctor has no objective basis to
assess the value of the herb or supplement being promoted for the
problem. An honest clinician questions all treatments — ranging from
an antibiotic from a pharmacy to an elixir from a health food store
– and asks if they pose real risks, offer real benefits, or both.
When I was a patient with a serious problem of uncertain outcome, I
felt the powerful temptation to seek a magical solution. Most doctors
are sympathetic to this sensibility. But a good doctor distinguishes
magic from medicine.

The widespread misconception among the public is that what is
“natural” is necessarily salubrious and safe, while in fact, the
natural world is filled with poisons and toxins. Some of those
natural poisons, of course, can be used therapeutically: Two of the
most important chemotherapy drugs, vincristine and taxol, are
derived, respectively, from the periwinkle plant and the Pacific yew
tree.

The patients I care for with cancer or AIDS take multiple
prescription medications, and how these drugs interact with each
other can be no simple matter; throw into the mix an herb of unclear
composition and unknown metabolism, as well as unknown side effects,
and there is a recipe for trouble. I witnessed this as the first
group of pharmaceuticals against HIV were being tested during the
late 1980s. There was a groundswell of demand among understandably
desperate patients for alternatives to medicines like AZT that can
have serious side effects and, as single agents, only modest benefit.
One “natural” alternative was an extract from a Chinese cucumber
termed compound Q. It was imported from Asia and taken by a number of
desperate AIDS patients based on testimonials that it could eradicate
HIV. The fact that the cucumber extract was used as an abortifacent
in China seemed not to register, until several patients developed
severe toxic reactions, including coma. Physicians and researchers
who challenged compound Q were vilified as being ignorant, wed to the
pharmaceutical-medical complex, or envious that a cure had arrived
from outside of “mainstream” medicine.

Then there was St. John’s wort. This popular herb was touted as a
treatment for depression and alleged to have antiviral activity in
people with HIV. It was shown to be no better than placebo for
depression and, most worrisome, to interfere with the activity of the
lifesaving anti-HIV protease drugs.


That alternative therapies are coming under the sharp lamp of science
is of some irony. In 1991, Congress passed a bill to create an Office
of Alternative Medicine within the National Institutes of Health.
Seven years later, this became NCCAM. Sen. Tom Harkin of Iowa was one
of the main drivers behind the legislation. Mr. Harkin was said to
believe that nontraditional potions and procedures were important
therapies, his faith stemming in part from friends and family who
testified to their importance. A collective groan was heard in the
halls of university hospitals and research centers. Precious federal
dollars were being diverted from “real science” to shamanism. Some
alternative medicine gurus also objected, worried that their
therapies would be tested “the NIH way.”

The academic opponents were proven wrong — because the fears of the
gurus came true. The reason for this can largely be attributed to
Stephen Straus, who directs the NCCAM. Dr. Straus is neither a
naysayer nor a believer, but rather a scientist, meaning that he is
agnostic about any particular therapy. Dr. Straus explained that the
same rigorous metrics used to evaluate normal medicine are applied to
the numerous unproven alternative treatments — “the NIH way.” The
justification for spending federal funds is still hotly debated, as
evidenced by an impassioned article in a recent issue of the journal
Science, with a call for the Congress to re-examine the issue. But
rigorous testing of popular alternative therapies is a matter of
public health and informs proper medical practice. On the wall of Dr.
Straus’s office is a framed quote: “The plural of anecdotes is not
evidence.” A billion Chinese cannot be wrong, goes the old saw, but
in fact they can and often are.

But it is not a matter of geography or culture. Until the 19th
century, Western practitioners were badly wrong, attributing diseases
to an imbalance in humors, bleeding patients and prescribing
poultices and purgatives. Modern Western medicine has also embraced
therapies that were later disproven. In the 1960s, surgeons tied off
an artery under the breastbone in patients with angina, believing
this increased circulation to the diseased heart. Many patients swore
by the surgery, but when the procedure was subjected to a clinical
trial, it turned out that the sham operation was equally beneficial.

Placebos are very powerful. Beyond yoga for lower back pain and
acupuncture for analgesia, there has not been a study showing an
unequivocal benefit of an alternative therapy when subjected to the
rigor of an NIH trial. This negative outcome should not be greeted
smugly, because most experimental drugs developed by pharmaceutical
or biotechnology companies fail to fulfill their promise. The
difference is that these companies rely on biological mechanisms to
select candidate drugs for testing, rather than unsubstantiated
testimonials and anecdotes.

Dr. Straus believes the public should acquire an historical
perspective on the urban legends of alternative therapy. Beyond
compound Q and St. John’s wort, he recalled the euphoria around
laetrile, the extract from apricot pits promoted as a cancer cure,
that brought Steve McQueen to Mexico and to his death, and also the
story that shark cartilage caused tumors to melt away because sharks
never develop cancer (not true). On the other hand, one of the most
important new therapies for leukemia is an arsenic derivative
identified in western China as part of traditional practice that
resulted in well-documented remissions; its effects on key molecules
in the malignant cells have been elegantly mapped by scientists. And
qualified researchers are testing components of tumeric and other
spices than can inhibit melanoma and breast cancer cell growth.
Science is enthusiastic when it meets reality.

Still, the failure to prove that so many popular alternative
treatments have any benefit has generated resistance among the
believers. The promoters of saw palmetto objected to the study,
saying that the dose and preparation used in the trial were not
optimal. But, in fact, the most frequently used preparation was the
one studied. The clinical trial of glucosamine and chondroitin
sulfate will be extended, but lacking a scientific rationale for the
treatment should lower expectations about a different outcome.

How long does it take for a false messiah to be abandoned when
redemption does not arrive? “Things that are wrong are ultimately set
aside,” Dr. Straus said, “and things that are right gain traction.
There are the conflicting tides of belief and fact, and each has its
own chronology. Things don’t change quickly, but over time a
cumulative body of evidence becomes compelling.” I reflected on this
when I read that one major vendor of saw palmetto asserted he would
continue to promote the herb despite the new data. As science spreads
in his world, doubt will chip away at blind faith, and he will find a
shrinking group of believers.


Dr. Groopman is the Recanati Professor at Harvard Medical School.

2 Responses to “putting quackery to the test”

  1. JP Saleeby, MD Says:

    Dr. Groopman may have some points here. As I have written before in an article that appears on Enigma Magazine (http://www.enigmaonline.com/gbase/Expedite/Content?oid=oid%3A714) on the very subject. As an allopath (MD) and one who embraces some complementary medicine (but not all) I wear both hats. I can be a critic and often have been (refer to my article about “Forget those crystals.” in (http://www.mountainx.com/opinion/2002/1002saleeby.php), so this subject is nothing new. However, where this doctor is off base is his criticisms of the utility of some of these herbs… after all most pharmaceuticals are derived from plants found in our rain forests. Big Pharma alters them chemically so as to patent a “new” drug and thus profit from their development. Big Pharma is also a significant backer of research at our leading universities and advertisers in our medical journals (JAMA and NEJM). I am sure Dr. Groopman is quoting the recent studies in these journals. He as many other American physicians is guilty of ignoring the plethora of good research studies conducted outside our boarders… reference “The Complete German Commission E Monographs”, a highly regarded tome (twice the size of our PDR) that is evidence based and confirms the usefulness of herbals. Would be glad to provide Dr. G more evidence, as I am first a scientist. In my Adaptogen book, I devote 1/3 of the pages to scientific references that “back up” what I report. I by the way also cringe at those late night infomercials for diet books authors and supplements salespersons. I would honestly like to see the supplement industry a bit more regulated and have herbals appear in the pages of the PDR.

    Respectfully,

    JP Saleeby, MD
    www.saleeby.net

  2. Alternative Medicine Says:

    Alternative Medicine…

    Alternative Medicine…

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