When a Placebo WORKS, is it Still a Placebo?

It’s a fun question… Almost a joke. Yes, the mugshot is me, myself and I, in the smugness of youth. I loved the Mad Magazine guy. His ears matched mine.

The standard definition of a placebo effect can be summarized as “an improvement caused by a treatment that cannot cause the improvement”. A “placebo effect” is a paradox, an oxymoron, impossible. It can’t possibly work.

There’s only one small problem. Placebo effects exist. They are not just documented by many medical authorities, they are an essential part of the so-called “Gold Standard” of modern medicine. The double-blind placebo-controlled clinical trial cannot function without placebo effects.

How can this be? It’s complicated. First of all, there are three different definitions of placebo. Merriam-Webster:

1. a usually pharmacologically inert preparation prescribed more for the mental relief of the patient than for its actual effect on a disorder
2. an inert or innocuous substance used especially in controlled experiments testing the efficacy of another substance (such as a drug)
3. something tending to soothe

The definitions provided by Webster are not very accurate but useful enough to understand our issue.

First, it is important to understand the INTENT of each definition. Let’s call them placebo-1, placebo-2, and placebo-3 for reference.

Placebo-1 is a real placebo in medical practice. It is prescribed by a doctor for the “relief” of a patient when the doctor has no recommended treatment option available from the medical bureaucracy. If it “works”, doctor and patient are happy. If it fails, there is generally no problem, nothing could be done. When a doctor’s recommendation doesn’t work, it’s just the wrong medicine, not a placebo. It happens a lot. In theory, a placebo-1 can’t work, so it can’t cause any damage. Placebo-1 “works”. We can debate theory all we want – in medical practice, placebos work. There is no debate.

But, what if Placebo-1 didn’t cause the observed effect? Well then, the medical profession might be interested, perhaps even obliged to investigate and learn what did cause the positive effect, in the interests of science, medicine, and of their patients. But the medical profession does not want to investigate, so it’s called placebo effect. Case closed.

Placebo-2 is a clinical placebo, administered in a clinical study to prove the effectiveness of a drug. The intent of placebo-2 is to provide NO IMPROVEMENT in the condition of the patient. The intent of the study is to test a drug. Patient consequences are of little importance except for guidelines to protect the patient from exposure to harm. When the placebo-2 “works”, the placebo arm of a clinical study shows more improvement than the drug arm and the study fails. Sometimes a placebo-2 works too well. When this happens there is seldom, if ever, a rush to test placebo-2 as a medicine, the study is simply abandoned. Most placebos cannot be patent medicines. In practice, placebo-2 works, but not too well. Researchers can argue that, in theory, the improvement was not caused by the placebo – but theory and practice are not the same.

But, what if Placebo-2 didn’t cause the observed effect? It’s the same. The medical profession might be interested, perhaps even obliged to investigate and learn what did cause the positive effects, in the interests of science, medicine, and of their patients. But that would be outside of the bounds of the clinical study. Not paid for by the people or companies funding the clinical study. They don’t want to investigate, so it’s called placebo effect. Case closed.

Placebo-3 needs some clarification. When does placebo-3 “something tending to soothe” exist? Placebo-3 exists when placebo-1 and placebo-2 are not present, but someone calls a successful treatment a placebo. There is no requirement for any medical authority.  Your grandmother, spouse, or child can call it a placebo. No proof is required either. In fact, if proof of cause is available – it’s not a placebo. A common example: someone takes an alternative medicine and observes an improvement. They tell someone, maybe a conventional medical doctor, who says “it’s probably just a placebo” or “it’s probably just a placebo effect“. Placebo-3 is a “probably just a placebo” placebo. Does placebo-3 “work”? It has to work to exist. If there is no improvement, placebo-3 doesn’t exist. Placebo-3 works. It works in practice, it just doesn’t work in the theory of the person who calls it a placebo.

But, what if Placebo-3 didn’t cause the observed effect? Same, same. The person who is claiming it is “probably just a placebo effect” might be might be interested, perhaps even obliged to investigate and learn what did cause the positive effect, in the interests of science, medicine, and of their patients. That’s not the objective, the object is to dismiss the treatment, not to understand the benefit, so it’s called placebo effect. Case closed.

When a treatment works, in theory, it’s a drug, a medicine. When a natural product, like chicken soup, or Vitamin C works in practice, the FDA considers it an unapproved medicine, but not a drug.  If you want to sell chicken soup as a “treatment for the common cold”, you need to have it approved by the FDA as a drug. Otherwise? It’s “probably just a placebo” – placebo-3. There is no official proof that it works. The medical bureaucracies have a weasel clause. If you want to claim that your Vitamin C product is a treatment for scurvy (as recommended by all major medical texts) you can do so only if you also provide labelling that clearly states scurvy the frequency of scurvy in the population.

When a treatment fails in theory and fails in practice, it’s a failure. But nobody cares.

When a treatment works in theory and fails in practice, it’s also a failure. But it might still be a medicine. Most medicines fail in practice most of the time.  The requirements for approval by the US/FDA are a very low (but very expensive) bar. The treatment must work “better than a placebo works” – which again validates that placebos work. If the placebo only worked 10 percent of the time, a medicine might be approved by working 15 percent of the time. A clinical trial is required for approval, and the clinical trial was either tested against a different drug, or against a placebo that “worked”.

When a treatment fails in theory and works in practice, it’s a placebo. The theory is wrong. Get over it. There’s no mystery as long as we separate theory and practice.

A placebo is a treatment that works in practice but does not work in theory.

If it doesn’t work, it’s not a placebo. Q.E.D.

But… but… but… how is this possible? It’s possible because we don’t understand everything, and certainly not when we use the word placebo. We might define a placebo effect more accurately as:

“A positive effect where we do not understand the cause but we believe the effect was NOT caused by the treatment”. A claim of placebo effect is dependent on the belief of the claimant – it has nothing to do with the beliefs of the patient.

Every effect is a real effect, with a real cause. There are no placebo effects, in theory, by definition. Placebo effects only exist in practice. As soon as we understand the cause, it’s no longer a placebo effect, it’s a real effect, with a real cause.

Sometimes, when we don’t understand the cause we admit that we don’t understand the cause. We don’t know why chicken soup helps the common cold, but we know it does. Sometimes we say “placebo effect”. Sometimes we do both, we admit we don’t understand, and we name it placebo effect.

There is no proof of placebo effect. No proof is possible. As soon as we prove the cause, placebo effects disappear. There are sometimes claims that placebo effects are caused by the belief of the patient – and Oxford’s dictionary makes this claim.  However, this claim cannot be proven. As soon as the cause is proven, it can be manipulated to cause the effect, in which case it no longer a placebo effect.

Webster: Placebo effect: “improvement in the condition of a patient that occurs in response to treatment but cannot be considered due to the specific treatment used”.

With theory and practice added:

“improvement in the condition of a patient that occurs in response to treatment (in medical practice) but cannot be considered due to the specific treatment used (in medical theory)”

As soon as we understand the cause of an improvement caused by a placebo in both practice and theory – it’s not a placebo any more. The improvement had a real cause.

But that doesn’t make the so-called placebo treatment a medicine.

One final, and important question: what happens when a placebo cures? Surely that’s an important question? But no.  Cured is not defined in many medical dictionaries, not scientifically or medically defined in any medical reference.  There is no definition of, and no test for cured for any non-infectious disease, nor any chronic disease, nor any mental disorder, nor any disease cured by health.  There are over 70,000 codes for different diagnoses of disease. There are no codes for cured.  None. When cures occur, cures are lost.  Placebo cures? Same same.  Placebo cure is not in the dictionary.

Most patient improvements come from health, not from medicines, not from placebos. Health is the best treatment, the best cure, and the best preventative – the Healthicine Creed. But there are no studies of healthicine.

To your health, Tracy
Founder: Healthicine

Note: this post was written based on my answer to the Quora question: https://www.quora.com/If-a-placebo-fails-is-it-still-considered-a-placebo/answer/Tracy-Kolenchuk