In Healthcare, It's Placebos [Almost] All the Way Down

Kim BellardTwo remarkable articles -- one on placebos, one on informed consent -- caught my attention.  To set them up, a famous, perhaps apocryphal, story:

A scientist tried to explain the solar system to a lay audience.  When he finished, a skeptical woman told him he was wrong: the earth was flat, and rested on the back of a giant turtle. The scientist asked her what the turtle rested on.  "Another turtle," she replied confidently.  He then asked what that turtle was on.  The woman would have none of it.  "You can ask all you want, sir, but it's turtles all the way down."

Faith is a funny thing.  Especially in health care.

Let's start with placebos.

Brian Resnick wrote an in-depth look on them for Vox.  Simply put, the placebo effect is that a patient's belief or expectation that something will remedy their symptoms often does, in fact, help -- often as much as "legitimate" treatments.  Placebos are more effective than many realize.

He cities 2015 research that found not only solid evidence that the placebo effect exists, but is actually growing stronger -- although, curiously enough, only in the U.S.  The research focused on pain control medicine, but there are similar trends with antidepressants and anti-psychotic drugs as well.

As Mr. Resnick says, "belief is the oldest medicine known to man."  Every culture has had some sort of healer, in whom great faith was placed.  For most of history, the treatments that such healers had in their bag of tricks was fairly limited.  We like to think that modern medicine is more sophisticated, more based on science, but consider the following:

Nature

That science thing doesn't look so good now, does it?

Ted Kaptchuk, a Professor at Harvard Medical School, told Mr. Resnick: "The placebo effect is a surrogate marker for everything that surrounds a pill. And that includes rituals, symbols, doctor-patient encounters.”  Let's keep in mind that the placebo effect is not limited to pills.  For example, some studies suggest that "fake surgeries" -- where the patient thinks he/she had a surgery but only got an incision -- may have an even more powerful placebo effect than pills do.

Indeed, in Salon, Dr. Ronald P. Grelsomer said:

The bigger the treatment, the more expensive the pill, the more well-known the doctor, the more impressionable the patient, the greater becomes the placebo effect. What bigger treatment is there than surgery?

Mr. Resnick lists several types of placebo effects, which I'll summarize as follows:

1. Regression to the mean: Most people get better over time anyway.
2. Confirmation bias: When we expect to get better, we often do.
3. Expectations and learning: we've learned over time that doctors and medicine help us, and we expect that they will again.
4. Pharmacological conditioning: our brains can mimic the effects of many drugs, if it thinks it is getting them.
5. Social learning: if others get better from something, so should I.
6. A human connection: "usually intangible traits like warmth and empathy help make patients feel better."

Mr. Resnick cautions that placebos, for the most part, work on symptoms, not underlying causes.  E.g., they don't improve lung function, but they can make people think their lung function is better.  Still, researchers now are saying that placebos can work even for how strenuous exercise seems, so it is clear they are powerful.

It makes one wonder if we really understand what a placebo really is.  Indeed, there is research that suggests that even when patients are told they're getting a placebo, it can still work.

In this context, Dr. Grelsomer brings up the issue of informed consent.  There's a dual problem: if the patient is unknowingly given a placebo, where's the informed consent?  And if the risks of a treatment are fully explained, patients may be scared, leading to a "reverse placebo" effect that can comprise their recovery.

Which leads to the second article, Richard Gunderman, M.D., and James Lynch, M.D., writing about "The Decline and Fall of Informed Consent."  Millions of people have to sign informed consent forms in health care settings every year in order to receive treatment.  However, "The only problem: it is often neither informed nor a real consent."

They cite, for example, a professor who had a chance to enroll in a clinical trial, for which a thirty page informed consent document had to be signed.  After trying to make sense of it, he finally said: 

I am pretty smart, but I have enough to worry about with my diagnosis, and this informed consent form is so overwhelming that I simply can’t tell the difference between what is important and what is just legalese.

The authors conclude that such forms now often resemble "a monstrosity," not protecting patients but, rather, doctors, researchers, and institutions.  In their opinion, the example of the thirty page form is not an outlier, but is routine.  They note:

"One of the most important goals of informed consent is to protect patient autonomy, but the complexity of the forms makes patients more reliant than ever on doctors, researchers, and institutions to explain the risks and benefits.

Ironically, informed consent leads to more reliance on trust, which just leads back to placebos.  It's good for us to trust our caregivers, but that trust itself shouldn't be the basis for the care we get.

Both Mr. Resnick and Dr. Grelsomer bring up the possibility that, since they can be so effective, perhaps we should make placebos part of "mainstream medicine."  Dr. Grelsomer asserts: "We are winning the battle over conditions that require science and losing out on those that just need a little placebo."

Maybe. For all we talk about patient-centered care, patient autonomy, and informed patients, when most of us get sick we want that all-knowing healer -- usually a physician, but sometimes a chiropractor, an acupuncturist, a dispenser of supplements, etc.

Still, if all we want is healers, well, sugar pills don't cost $3 trillion.

Dr. Kaptchuk sees placebos as "basically the water that medicine swims in."  That water is murky, impure, full of tides and eddies.  He'd like to see the art of medicine truly turn into the science of medicine, and so should we all.  It's hard to decide which is worse: placebos, mainstream treatments that have no empirical evidence, treatments still given even though shown not to work, or treatments that are just unnecessary.

It may not be placebos all the way down, but they and their ilk go much further down than we'd like to admit.