pureheart

As a clinical research tool, a placebo is often referred to
as nothing but a sugar pill - neutral and benign. In
fact, "placebo" comes from the Latin word meaning "I shall
please." Everything about the word would seem to be
guileless. Or that's what the general thinking is anyway.

In last week's e-Alert "Seeing Red" (7/16/03) I told you
about two different studies in which red clover extract was
tested in the treatment of menopausal hot flashes. In both
studies, the group of women who received red clover showed
about the same rates of success in controlling hot flashes.
But the subjects in the placebo group in one study reported
almost no effect at all, while in the other study the placebo
subjects had almost the same results as the red clover group.

How could the results of these two placebo groups be so
different? One strong possibility: The placebos may have been
very different. Because contrary to common thinking, clinical
research trials - especially pharmaceutical trials - bring a
whole new meaning to the old Latin idea of "I shall please."

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The importance of being inert
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There was a time when doctors would prescribe phony
medication - sugar pills - to their patients who they
regarded as hypochondriacs. They called the pills "placebo"
and when the patients reported positive results the idea of
the placebo effect was born.

These days, placebo pills are used in clinical trials to
measure the true effect of a drug or supplement. They are
thought to be made of inert substances designed to have no
effect. But consider this: there's no such thing really as an
inert substance. For instance, placebo pills are still called
sugar pills. Is sugar inert? Far from it, of course. If you
take a sugar pill, your body will have a reaction, especially
if you happen to have an insulin disorder. But if you're
given that same pill as part of a drug research trial, your
reaction becomes a factor in the research.

That may seem like nothing (what real difference could a
little boost of sugar make?) but sugar and other supposedly
inactive ingredients are not the issue. Not in the least.

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A little secret
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When a pharmaceutical company tests its products, where do
you suppose they get placebo pills? Do they place an order
with a placebo pill manufacturer? Or does Nestle's candy
company run a little side business to supply researchers with
sugar pills?

The fact is, drug companies make their own placebo pills for
research purposes, and for each individual study they create
a unique placebo formula - sometimes purposely including
ingredients that match ingredients in the drugs being tested.
But at no time do the contents of the placebos have to be
revealed.

Does that sound "inert" or "inactive" to you? Suddenly the
idea of a "sugar pill" doesn't seem so innocent anymore.

Before conducting human trials for drugs, pharmaceutical
companies are often fully aware of many of the side effects
of the products they're testing. So, for instance, if a drug
is known to cause dizziness and nausea, the drug company
running the test wants the placebo to have the same side
effects. And they have an explanation for this. They say the
placebo should mimic the drug being tested so that the
control group of the experiment will have side effects
similar to the placebo group. Without that, they claim, the
results of a blind study would be compromised.

There are plenty of gray areas to debate in that logic, but
for the moment let's focus on the idea of what they call
an "active placebo," designed to mimic the side effects of a
tested drug. And with that in mind let's look at an
advertising campaign for the allergy medication called
Claritin. In the Claritin TV spots, when it comes to the
moment to list the side effects, the voice-over says, "The
most common side effects with Claritin, including headache,
drowsiness, fatigue and dry mouth, occurred about as often as
they did with a sugar pill."

A sugar pill? Really? Just what kind of "sugar pill" were the
researchers using that caused headache, drowsiness, fatigue
and dry mouth? Sounds to me like a sugar pill with a little
something added. But they want us to believe that this
medication will produce side effects no more serious than
what you'd get with a TicTac.

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The whistle blower
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Dr. Beatrice Golomb, MD, PhD, is an assistant professor of
medicine at the University of California, San Diego, and has
been actively fighting the research establishment's claim
that placebos are inactive substances. Dr. Golomb wants
scientists to provide a list of placebo ingredients so trial
results can be properly evaluated.

To level the playing field, Dr. Golomb suggests that drug
companies start divulging all placebo ingredients. She also
recommends that a standardized set of placebos be developed
that would have known and predictable side effects. This
would go a long way toward eliminating the pharmaceutical
industry's cynical manipulation of test data.

As you might suspect, the drug companies are not very
receptive to Dr. Golomb's idea of letting go of this aspect
of product testing that they have full control over.

Meanwhile, what about physicians and researchers who work
independently from the pharmaceutical giants - do they know
the truth about placebos supplied by drug companies? Right
now it's hard to tell just how widespread this knowledge is.
According to the National Center for Complementary and
Alternative Medicine at the National Institutes of Health
(NIH), the placebo effect is defined as "desirable
physiological or psychological effects attributable to the
use of inert medications." From that statement it would
appear that NIH officials either believe that placebos are
genuinely inactive, or they're not admitting that they know
better.

Or maybe they're just feeling drowsy, dizzy, irritable and
nauseous from a sugar pill someone gave them.

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