After more than four decades of testing in tandem with other drugs, placebo gained approval for prescription use from the Food and Drug Administration.

"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. 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?"

Sugar coating

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.

A little secret

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.

Inertia standardized

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.

Sources:Chemistry and Industry, Vol. 21, Pg. 900

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