Placebos are complex and cloaked in mystery — far from inert

Enigma in a mystery

“It’s nothing”

That would probably be the response if you asked a clinical researcher what goes into a placebo pill. Most of them would likely stick to the script: “It’s inert. Nothing. A sugar pill.”

That last part gives you a clue to the truth.

Sugar is not inert. Far from it. But more importantly, a placebo should NEVER be thought of as a sugar pill. Far from it.

In fact, placebos are specially designed for every single trial that uses them. Which is why they often contain active ingredients that are included for a specific purpose. So by creating the right placebo, you can create a very different outcome for how the drug being tested stacks up. And that’s why mainstream medicine’s insistence that placebo-controlled studies are the “gold standard” of research is a complete myth.

Those placebos are full of secrets that rarely get told.

Easter Bunny, unicorns, and the Tooth Fairy

Last week we learned that many trials that tested the antiviral flu medication Tamiflu used placebos that contained chemicals not found in the Tamiflu capsules.

I’m sure some were shocked by that revelation. I know I was shocked, years ago, the first time I realized that placebos aren’t nearly as innocent as we’ve been led to believe.

Think of all the times we’ve seen drug companies hide harmful data, or manipulate numbers, or pay prestigious doctors to lend their names to research they didn’t do.

Think of all that, and then consider that those same drug companies get to design the “recipes” for their own placebos. These are the “sugar pills” they use for trials of drugs they’ve invested millions (or hundreds of millions) of dollars to produce.

When a placebo has something extra, it’s called an “active placebo.”

Researchers claim an active placebo is sometimes needed so the placebo group will have side effects similar to the intervention group. This helps convince subjects in the placebo group that they may be getting an actual drug, which helps keep placebo subjects from dropping out of studies.

Okay — sounds like a major rationalization but let’s go with it for a minute. It still leaves HUGE ethical gray areas. For instance, think of how placebo results are used in advertising…

A few years ago, there was a drug ad running on TV with this voiceover: “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? When a “sugar pill” causes headache, drowsiness, fatigue, and dry mouth, something is deeply rotten in Denmark!

The 90% unknown

More than 10 years ago I first told you about the work of Dr. Beatrice Golomb. For many years Dr. Golomb has actively fought the research establishment’s claim that placebos are inactive substances. As she’s pointed out, “There are no known substances that are completely physiologically inert.”

Dr. Golomb led a placebo investigation that appeared in the Annals of Internal Medicine a few months ago. After analyzing all the studies that appeared in four major medical journals over two years, Dr. Golomb and her team reported that only about 8% of the studies disclosed placebo pill ingredients.

So in more than nine out of 10 studies, the contents of the placebo pill is top-secret drug company research.

Dr. Golomb notes one instance where a placebo contained lactose. This was in a trial for a drug designed to help keep cancer patients from losing weight. But cancer patients are inclined to be lactose intolerant, so gastrointestinal problems in the placebo group were on the high side, which obviously made the drug look better than it was.

Placebos are one of the last little dirty secrets of drug company research. The companies design them, they don’t have to disclose what’s in them, and then they tout the results like some tiny little sugar pill had the same negatives.

The next time you hear “side effects were the same as with a placebo,” think about the last time that you added some sugar to your coffee and ended up with headache, drowsiness, fatigue, and dry mouth.

Sources: 
“What’s in Placebos: Who Knows? Analysis of Randomized, Controlled Trials” Annals of Internal Medicine, Vol. 153, No. 8, 10/19/10, annals.org

“When is a Placebo Not Really a Placebo? Maybe More Often Than You Think” Katherine Hobson, Wall St. Journal Health Blog, 10/18/10, blogs.wsj.com

“No Standard for the Placebo?” ScienceDaily, 10/18/10, sciencedaily.com