Placebos? In my wildest dreams, I never thought I’d write even a tenth of a post about placebos…I mean, what do I care about those “innocuous” sugar pills that cause no side effects? 

But then yesterday I read a recently-published, interesting “Science Daily” article on how placebos can reduce pain: http://goo.gl/OrVGq And, for some obscure reason, it started me wondering…what exactly is inside a placebo?

And so my Google search began…

One of my first hits was an October 2010 paper published in the “Annals of Internal Medicine” and titled: “What’s in Placebos: Who Knows?”: http://goo.gl/ONkdz

Aha. Bingo. 

The first sentence of the abstract tells us that No regulations govern placebo composition. Saywhatwhatwhat??? No FDA standards? Not even the  itsiest bitsiest precept stuck way in the back of a forgotten set of FDA guidelines? Nope. Nothing. 

That’s what the paper’s main author, Dr. Beatrice Golomb, states (see this 2010 “Science Daily” report): http://goo.gl/n6e2p): “…there isn’t anything actually known to be physiologically inert. On top of that, there are no regulations about what goes into placebos, and what is in them is often determined by the makers of the drug being studied, who have a vested interest in the outcome. And there has been no expectation that placebos’ composition be disclosed. At least then readers of the study might make up their own mind about whether the ingredients in the placebo might affect the interpretation of the study.”

Why do I find this disturbing? I mean, I’ve read some really gross stuff about what drug companies do in order to achieve their goals…trial data manipulation and so on… 

And that leads us right to a thorny issue: how can we really trust the results of studies and trials that don’t even disclose what’s in their placebos? I have to admit, if I’d never come across the 2010 Golomb study, I wouldn’t have thought it a relevant issue…but now…hmmm. 

Let’s see. First point: placebos have to LOOK A LOT LIKE (even the way they smell and feel, apparently) the drug being tested in the “controlled” clinical trial. Second point…a much more important one!: the drug companies are making their own placebos. And here let me think out loud: doesn’t it make sense that the drug companies would at least be tempted to use special, uhm, fillers or whatnotsies that might make their drug look better and seem more effective than it really is…? It’s certainly a possibility…

Dr. Golomb and her team found that only 8.2% of placebo-controlled clinical trials revealed what exactly was inside the placebo. They also found that earlier trials of cancer and HIV treatments used placebo pills composed of lactose sugar and found relatively few gastrointestinal problems in the experimental group: AIDS and cancer patients can be at an increased risk for lactose intolerance (from: http://goo.gl/esIf2). In this case, the placebo probably made the experimental drug look better…Of course, the opposite might also occur…

Dr. Golomb adds: “We can only hope that this hasn’t seriously systematically affected medical treatment,” noted Golomb. But she and her team suggest that it is a very real possibility, with potentially serious consequences. “An ineffective treatment might appear effective, or an effective treatment might appear ineffective in trials,” senior researcher Jeremy Howick of the University of Oxford, in England, told Reuters Health in an email. “This is obviously harmful for public health since it could lead to use and payment for ineffective treatments, or failure to recognize effective ones.“

Yesterday one thing led to another, and I also read about “active” placebos: http://goo.gl/UyL3y Active placebos? Wait a sec, aren’t placebos supposed to be INACTIVE? Well, no, not really. Active placebos are designed to give patients a few minor (?) side effects similar to those caused by the actual experimental drug. That way, they are fooled into thinking they’re receiving the real deal, not an “innocuous” substitute. Patients in studies and trials talk to one another, you see, which means that those who don’t suffer from any side effects whatsoever would probably get suspicious.

Food for thought. I mean, there might be more to the old “placebo effect” than we thought…

Well, whatever…One thing is for sure: I’m all in favor of DISCLOSURE! DISCLOSURE! DISCLOSURE!!! I mean, tell us what’s really inside those “sugar” or “starch” pills! If I were in a trial, I’d certainly want to know…