The Poor Misunderstood Placebo

By Janet Starr Hull, PhD, CN

Placebos - not your everyday topic of conversation. Yet, placebos affect everyone in a very dramatic way. In my aspartame and artificial sweetener work, the part placebos play in the research on the safety of these sweeteners is very important, but the importance of the poor, misunderstood placebo is ignored, especially when the research is unfavorable for the sweeteners.

Most people would never think to question the contents of a placebo. After all, everyone thinks that placebos have no active ingredients. But if a placebo could talk, it would sound very insecure because it is burdened with some serious issues: "Who am I to YOU?" it might say. "I don't count. I am a "nobody." I'm just used and ignored. I am so misunderstood."

Dr. Beatrice Golomb, MD, PhD, assistant professor of medicine, University of California, San Diego, is one of many research scientists actively advocating that the "establishments" provide a list of placebo ingredients used in their laboratory research. Label her a placebo activist.

In order to properly evaluate product safety trial results, Dr. Golomb has requested that the drug companies be forced to divulge all placebo ingredients used in their studies. To level the playing field, she recommends that standardized placebos be developed so that side effects are uniform and predictable. This would go a long way toward eliminating the pharmaceutical industry's influences and manipulation of test data, such as in the aspartame and sucralose corporate research studies, in silicon breast implant developmental research, and in the research on the various toxic pharmaceuticals like Vytorin ® (see February 2008 Healthy Newsletter Feature Article). All these drugs were FDA approved, yet corporate test results showed health dangers. The problem here - in research experiments, these drugs did show to be dangerous to human health, and these corporate studies were flawed and skewed. Shoddy and bad science, maybe? That subject is for another article...let's get back to our poor placebo.

As you might suspect, the drug companies are not very receptive to Dr. Golomb's ideas (or anyone else's recommendations for that matter) of letting go of their full control over their own product testing. And remember that placebos used in clinical trials are completely inert "sugar pills."

There was once a time when doctors commonly prescribed phony, sugarcoated medication to patients they regarded as hypochondriacs. They called the pills "placebos", a Latin word meaning, "I shall please." When some patients reported positive health results, the concept of the placebo effect was born.

Today, placebo pills are used in clinical trials to measure the true effect of a drug or supplement. They are assumed to be inert substances designed to have no effect. But there's really no such thing as an inert substance in a pharmaceutical experiment because the human body will activate -placebo or not. If a placebo is a sugar pill, your body will have a reaction to it, especially if you are diabetic or have any form of a blood sugar issue. If given a sugar pill as part of a drug research trial, any reaction becomes a factor in the research. Particularly when testing artificial sweeteners, a sugar pill cannot be inert.

When a pharmaceutical company tests a product in a placebo-controlled trial, where do you suppose they get the placebo pills? An interesting fact not well known is the drug companies make their own placebo pills for their own 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.

Before conducting human trials for drugs, pharmaceutical companies are often fully aware 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 this logic, but for the moment let's focus on the "active placebo" designed to mimic the side effects of the drug being tested. Let's look at the advertising campaign for a popular anti-depressant medication as a good example. Thanks to the "Public Right To Know Act", a list the side effects must be provided, hence the long list of side effects mentioned at the end of each ad, which typically sound like: "The most common side effects include headache, drowsiness, fatigue and dry mouth, blurred vision, and suicidal tendencies - also occurring about as often with a placebo effect."

What kind of placebo or "sugar pill" causes headache, drowsiness, fatigue and dry mouth, blurred vision and suicidal tendencies? Dr. Golomb and other professional research scientists believe that something else was added to that placebo, yet by law, the manufacturer performing the research does not have to disclose that information. What they want consumers (and the FDA) to believe is that this new drug or artificial sweetener produces side effects no more serious than what you'd get with a sugar pill.

In the past, placebos may have been genuinely inactive, and the extent of the chemicals they were matched against was neither as toxic nor as prolific as the modern drugs and food additives of today.

The poor misunderstood placebo.

Posted March 2008 | Permanent Link

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