Answering Our Critics, Part 2 of 2: What’s the Harm?

Last week I posted a list of 30 rebuttals to many of the recurrent criticisms that are made by people who don’t like what we say on SBM. I thought #30 deserved its own post; this is it. At the end, I’ve added a few items to the original list.

What’s the harm in people trying CAM? Science-based medicine has been criticized for being too rigid and intolerant. Why do we insist on randomized placebo-controlled trials to prove that a treatment is safe and effective? Isn’t it enough that patients tell us they feel better? Isn’t that what we all want, for our patients to feel better? Even if the treatment only works as a placebo, isn’t that a good thing? What’s the harm in that?

The albuterol/placebo study

I would argue that we don’t just want our patients to think they are better, we want them to actually be better. A study that illustrates that principle has been discussed on this blog before, here and here.

A group of patients using an effective albuterol asthma inhaler was compared to 2 placebo groups (a placebo inhaler group and a sham acupuncture group), and to a group that got no treatment at all. Patients reported the same relief of symptoms with each of the two placebo controls as with the albuterol inhaler; all three groups reported feeling significantly better than the no-treatment group. It could be argued that placebos are an effective treatment for the subjective symptoms of asthma.

But when they used an objective measure, improvement in lung function, airflow only increased in the albuterol group. The placebo groups were indistinguishable from the no-treatment group. So here you have patients who feel better and think they are better but who aren’t actually better, who might not recognize the severity of an asthma attack in time to get to the ER and avoid a fatal outcome. As Peter Lipson said, we have effective, lifesaving treatments for asthma, and treating an asthma attack with a placebo is folly.

An accompanying editorial was very misguided. It said:

What is the more important outcome in medicine: the objective or the subjective, the doctor’s or the patient’s perception? This distinction is important, since it should direct us as to when patient-centered versus doctor-directed care should take place… For subjective and functional conditions — for example, migraine, schizophrenia, back pain, depression, asthma, post-traumatic stress disorder, neurologic disorders such as Parkinson’s disease, inflammatory bowel disease and many other autoimmune disorders, any condition defined by symptoms, and anything idiopathic — a patient-centered approach requires that patient-preferred outcomes trump the judgment of the physician.

Should the patient run the show?

Some of those conditions are not just defined by symptoms: they also have physical findings and laboratory abnormalities. Admittedly, only the patient can tell us whether he is experiencing pain, depression, etc. and we should always listen and believe him. But things like changes in behavior, medication use, and Parkinsonian tremor can be observed by others, and autoimmune disorders can be followed with blood tests.

Should patient-preferred outcomes be our goal? Do we really want to offer any treatment that makes the patient feel better? Penn Jillette famously said, “If all you want is to feel better, take heroin.” What if you carry the patient-centered concept to its extreme? What if a patient prefers high doses of heroin for headaches, or antibiotics for a cold, or demands unnecessary surgery? Apotemnophiliacs will be happy with the outcome if a normal, healthy limb is amputated. Heroin makes people feel euphoric, patients who get a prescription for antibiotics feel better than if they become angry because their wishes are thwarted, and a patient might feel reassured if an unnecessary exploratory laparotomy finds nothing wrong. Should that trump the judgment of the physician? I think not!

Doctors are consulted because they have expert knowledge. They have a responsibility to educate and advise patients and to work with them, taking their personal preferences into account, to do what’s in their best interest, not just what they think they want. Medicine is not like a retail store where the customer is always right. Placebos are unethical, and deception tends to undermine the doctor/patient relationship.

Just how powerful is the placebo?

The placebo has been highly over-rated. One writer even said it was proof that God exists. It has been claimed that one-third of all illnesses can be cured with placebo, but that’s not true. It’s a misunderstanding of a 1955 study by Henry Beecher. He looked at studies with a placebo arm and found that on average, one-third of subjects in the placebo arm reported improvement. But those subjects were not all experiencing placebo effects; some of them would have reported improvement with no treatment, due to the natural course of the disease or other factors.

Two later studies by Hrobjartsson and Gotzsche in 2001 and 2010 looked at studies that included both a placebo arm and a no treatment arm and concluded that:

We did not find that placebo interventions have important clinical effects in general. However, in certain settings placebo interventions can influence patient-reported outcomes, especially pain and nausea, though it is difficult to distinguish patient-reported effects of placebo from biased reporting. The effect on pain varied, even among trials with low risk of bias, from negligible to clinically important. Variations in the effect of placebo were partly explained by variations in how trials were conducted and how patients were informed.

In their opinion, there is no place for the use of placebos outside of clinical research studies. Placebos may relieve headaches, but they can’t cure cancer or pneumonia. Antibiotics work just as well if the patient is asleep or in a coma; placebos only work if the patient is awake and knows he has been given something.

There’s not just one placebo effect, but a number of different placebo responses that work by different mechanisms including anxiety reduction, expectation, activation of the brain’s reward centers, conditioning, and learning. Fabrizio Benedetti has been doing exciting research on placebos, studying the physiological changes that occur when someone responds to a placebo. He also believes there is no place for placebos in clinical practice.

The stages in CAM reasoning

CAM advocates tend to pass through these stages:

1. They accept testimonial evidence and see no need for scientific testing.
2. They recognize that the scientific community will not accept their claims without scientific testing.
3. They do some studies.
4. When flaws in the studies are pointed out, they try to do better studies.
5. A systematic analysis of all studies fails to support their claims.
6. They are forced to admit that there is no convincing scientific evidence that their treatment works better than placebo.
7. They argue that even if the treatment is only a placebo, it should be used for its placebo benefit.
8. They argue that placebos are “effective” and that it is acceptable to lie to patients.

What’s the harm?

Val Jones coined the word “shruggie” to denote doctors who think alternative medicine is harmless and is not worth fighting. We think the “shruggies” are wrong.

Is there any harm in telling a patient that an ineffective treatment has real objective benefits? I would argue that this constitutes lying, is unethical, and undermines the doctor/patient relationship. If a patient finds out that the doctor has fooled him with a sugar pill, he won’t be able to trust the doctor again.

What if the patient is already using an ineffective treatment and believes it is helping him? We should ask if it is exposing the patient to a significant likelihood of harm. We should ask if the patient is using it instead of other treatments that have been proven to work or that might be lifesaving. If the answers to both questions are “no,” it is kinder and more humane not to challenge the patient’s belief.

We should have firm rules about evidence-based medicine and ethical principles, but there are times when the rules should be broken in the name of common sense and empathy. What if an 80-year-old woman has been getting monthly B12 shots for 40 years and is convinced she needs them, even though science tells us there is absolutely no legitimate medical indication for her to get them? It’s very unlikely that we could say anything that would change her belief. Challenging her belief will only cause her distress. If we deny her request, she will get the shots elsewhere. It’s not likely that the shots will harm her, and getting the shots is comforting to her and makes her feel better. In that case, I would break the rules and let her have the shots. I would feel a small twinge of guilt for breaking the rules, and we should feel that guilt whenever we break the rules, to minimize the chances of getting on a slippery slope and breaking them when we shouldn’t. We should break them only with very good reasons with which other reasonable people would likely agree.

So in individual, select cases, belief in ineffective treatments is relatively harmless and need not be confronted. But in general, false beliefs can do a lot of harm. There is a whole website, What’s the Harm, devoted to the harm that false beliefs can do. So far, it has compiled reports of 368,379 people killed, 306,096 injured and over $2,815,931,000 in economic damages. Please go there and look at some of the accounts of patients who have died or suffered serious consequences because of false medical beliefs about everything from acupuncture to vitamin megadoses.

The concept of comfort measures

What does “effective” mean? It’s important to understand the difference between objective outcomes and patient perceptions. We can conclude from the evidence that acupuncture is merely a theatrical placebo. We can conclude that it would be unethical for us to recommend it. But if a patient is already using acupuncture and feels it is effective in relieving his symptoms, that falls into the category of comfort measures, where the patient is deriving a degree of comfort from a procedure with no objective effects. Things like backrubs, fluffing pillows, and spending time listening to patients don’t cure disease, but they do provide comfort. No one wants to deny patients that kind of comfort. If the patient asks us about acupuncture or another objectively ineffective treatment, we can answer honestly with the negative scientific evidence while also acknowledging that some patients think they derive subjective comfort from it and that there is little chance of harm.

Conclusions

• Placebos don’t really do much.
• Placebos have no place in clinical practice. They are unethical.
• Accepting false beliefs can harm and even kill. Using ineffective treatments can delay or interfere with effective conventional treatment.
• Science-based medicine is the only reliable basis of establishing the safety and effectiveness of a treatment and developing rules for clinical practice, but we can sometimes justify bending those rules in the interests of patient comfort. Rigorous science can be tempered by common sense, benevolence, and empathy.
• We can offer the patient comfort measures that will not change the course of the illness, as long as they are clearly identified as comfort measures with no false promises of therapeutic benefit.
• We shouldn’t offer placebos, but we can sometimes condone them.
• There is a fine line to walk between doing what patients think they want and what is in their best interests in the long run.

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Additions to the list in Part 1

31. X is officially approved by…so it must work.
They cite some organization or authority. It may be Medicare, insurance companies, state licensing boards for acupuncture/chiropractic/naturopathy, the WHO, the courts, specific hospitals/clinics, individual doctors or experts. Also: the NCCAM is studying it, so there must be something to it.

This is similar to #7, the argument from popularity. It is a logical fallacy called the argument from authority. These organizations are not authorities when it comes to scientific truth; often they are not even experts in science. They are influenced by factors like politics, expediency, customer demand, economics, lobbyists, legal maneuvering, etc. No matter how many authorities approve of a treatment, it must still be properly tested to determine safety and efficacy.

32. I can’t afford conventional medicine; CAM costs less.
If it costs less but doesn’t work, that’s false economy.

33. Studies show it doesn’t work, but what if it only works for me and a small minority of people like me?
That’s possible, but not very probable. If it worked for a significant minority of people, that would have shown up in the data, would have affected the statistics, and would have changed the outcome of the study. If the minority was too small to affect the study outcome, what’s the likelihood that you would be one of the special few that it actually worked for? The odds are against it, and there is no rational way to choose the one that might work for you out of all the various treatments that have been tested and shown to be ineffective.

34. My doctor said nothing was wrong with me, but my CAM provider did a test conventional medicine doesn’t do, and found a condition that needed to be treated.
How do you know it’s not one of the many bogus tests and bogus diagnoses that abound in the world of CAM?

35. Conventional medicine doesn’t have an effective treatment for my disease.
CAM doesn’t either. They may tell you they do, but they will only offer false hope and waste your time and money. Maybe it’s time to accept that there is no effective treatment and concentrate on finding ways to cope and improve your quality of life.

36. Why do you concentrate so obsessively on CAM instead of attacking the abuses of conventional medicine and Big Pharma?
This is sometimes phrased as “why don’t you put your own house in order before you criticize others?” We do frequently write about Big Pharma and about conventional medical practices. We don’t emphasize that, because conventional medicine is constantly criticizing and policing itself. Current practices are continually being re-evaluated and discarded if they are found ineffective. We concentrate on CAM because there is no such tradition of self-criticism in CAM, because they never reject any treatment when the evidence shows it doesn’t work, and because hardly anyone is writing critically about CAM.

This criticism amounts to saying “Why don’t you blog about what I consider to be important?” And the easy answer is: it’s not your blog, it’s ours. We get to decide.