[SSRI-Research] placebo gained approval for prescription use from the Food and D

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Wed, 2 Feb 2005 19:50:27 -0500

 

 

[sSRI-Research] placebo gained approval for prescription use

from the Food and Drug Administration Monday

 

After more than four decades of testing in tandem with other drugs,

placebo gained approval for prescription use from the Food and Drug

Administration Monday.

 

" For years, scientists have been aware of the effectiveness of placebo

in treating a surprisingly wide range of conditions, " said Dr.

Jonathan Bergen of the FDA's Center for Drug Evaluation and Research.

" It was time to provide doctors with this often highly effective option. "

 

Those two paragraphs are the opening of a satirical report fabricated

by the staff of The Onion, a humorous " news " web site. (For the entire

spoof, see the e-alert " Wonder Drug " 10/23/04.) The sly joke here, of

course, is that placebos used in clinical trials are completely inert

- just " sugar pills. "

 

Most people would never think to question the contents of a placebo.

After all, everyone knows that placebos have no active ingredients.

But if a placebo could talk, it would respond just like any con man

caught with his hand in your pocket: " Who ME? Would I lie to you? "

 

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Sugar coating

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There was a time when doctors sometimes prescribed phony medication to

their patients who they regarded as hypochondriacs. They called the

pills " placebo " (a Latin word meaning " I shall please " ), and when the

patients reported positive results the concept 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 commonly called sugar pills. But 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 tiny boost of

sugar make?), but a little sugar is not the issue here. Far from it.

 

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A little secret

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When a pharmaceutical company tests a product in a placebo-controlled

trial, 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 side business that supplies 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 including ingredients that match ingredients in

the drugs being tested. But the contents of placebos are never 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 may want 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 a popular allergy

medication. In the TV ads, when the moment arrives to list the side

effects, the voice-over says, " The most common side effects -

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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Inertia standardized

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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

standardized placebos should be developed so that side effects will be

uniform and predictable. 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

the NIH either believes that placebos are genuinely inactive, or

they're not saying.

 

Or maybe they're just feeling drowsy, dizzy, irritable and nauseous

from a sugar pill someone gave them.