Seeking nursery school teachers like Barbara

Photo credit: Donnie Ray Jones ‘Silly Things’

The first one we visited was called Oak School (real name withheld). The manager gave us a tour, and something didn’t feel right. The staff seemed robotic and tired. The manager also spoke about assessments for their toddlers (some as young as 6 months old!) That made me cringe. What if my toddler didn’t do so well in the assessment? Might he be stigmatized, or eventually be (over) diagnosed and medicated? Or, what if the assessment showed that he was better average? Would I subconsciously be tempted to place burdensomely high expectations on his little shoulders?

How do you assess the progress of a toddler anyways? I got a hint out of the corner of my eye during our tour. One of the teachers had a toddler on her lap, and they were sitting at a table that had two blocks of wood about a foot apart. The teacher then (appeared to me to) guide the child’s right hand to place one of the blocks on top of the other. The teacher then took a picture, presumably to send to the parent as evidence that the child had passed an assessment.

We need nurseries to be safe, but what else should inspections do?

The next day we visited another nursery that was much better. I’ll call it Happy Days (again not a real name). At Happy Days the staff were bubbly, playful, and visibly enjoyed playing with the children. Happy Days was our first choice. But before paying the deposit, I went online to see what Ofsted (the UK Government’s ‘Office for Standards in Education, Children’s Services and Skills’) said about the nurseries we visited. I was surprised. Oak School got top marks, but Happy Days was ranked as ‘inadequate’. Their report confirmed my impression that the staff seemed to like children, that the children seemed happy, and that it was safe, they claimed problems included:

• • Managers didn’t monitor staff well enough to ensure they assessed progress adequately.

• Children were not well prepared for school.

But what is ‘adequate progress’ for a toddler? And if formal preparation is needed for school, why aren’t nurseries compulsory?

A closer look at the process for inspecting nurseries gave me a clue about why Oak School fared better. To prepare for inspections, managers have to study 164 pages of documentation, including a 5-page self-assessment form (which has 12 pages of guidance). I suspect that Oak School got better ‘grades’ because management got their staff to fill out forms and performing assessments for the inspections.

This is not a rant against Ofsted. On the contrary. Any sensible parent wants nurseries to be inspected for safety, so I’m sincerely grateful for their safety inspections. I’d also like to know if my child is falling way behind in some area of development. But any major developmental abnormality would either be obvious or need a medical professional rather than an Ofsted inspector to diagnose. Beyond safety, I want to know whether the teachers like children, and whether my child has fun. Playing, after all, is what Europe’s best schools say children are supposed to do. The problem is that it is hard to measure whether children are having fun playing or whether staff is like Barbara.

Photo credit: 3rd Marine Division

Deprescribe heavy-handed inspections?

The solution to too much inspection might be found in one of the solutions to too much medicine. Just as medicine is good up to a point and harmful beyond that point, 90% of teachers surveyed think that Ofsted inspections have no impact or a negative impact. It may also contribute to burnout, as a national survey suggest high turnover among nursery school staff. The inspections also require additional layers of management, time, and money. (Is this why childcare in the UK is among the world’s most expensive?)

In medicine one way to solve the problem of ‘too much medicine’ is to ‘deprescribe’. ‘Deprescribing’ trials require some people who take lots of pills have a ‘medication review’, which usually leads to removing some of their pills. Others carry on taking all their pills. The trials usually find that people are just as well off or better with fewer pills. It also costs less money. We should try the same thing with nursery inspections. Let some nurseries carry on with the heavy-handed inspections, while others get a very light touch inspection where only safety is checked (very well). Then, we could ask parents and teachers how happy they are with the nurseries, how much money was saved, and even how well the toddlers ‘progressed’.

I can already hear many of my colleagues say they want a nursery that does lots of assessments, recommends additional ‘home’ learning, and challenges their children to prepare for school. If you are one of these parents, you should be free to find a nursery that does those things even though the evidence doesn’t suggest it’s beneficial. In the same way, I should be free to choose a nursery that doesn’t burden staff with too much paperwork, and that is cheaper because it doesn’t require management to implement complex procedures. Until a ‘deprescribing’ of the heavy-handed nursery school inspections happens, I’m going with the one that has staff like Barbara, inspection results be damned.

I received a lot of questions from people who watched the BBC Horizon documentary about placebos and back pain. Some even asked: ‘Where can I get those placebos I saw on TV?’ The placebos we used in the documentary aren’t available commercially. But the placebo effect is caused by more than the placebo pill. The placebo pill doesn’t cause anything by itself. If it was just the pill, I could easily tell people to go online and buy placebos (for example here).

The placebo effect is complex, and is caused by different things. We can also harness the placebo effect for our own benefit. For the next 7 days I’m going to talk about one aspect of the placebo effect per day. One of the things people mean when they say ‘placebo effect’ is ‘Hawthorne effect’, and I’ll start with that here. I’ll share the remaining 6 on Medium.com and social media.

1^st of 7 things you need to know about placebo effects: Hawthorne effects

In a series of experiments between 1924 and 1933, scientists fiddled with the lighting in parts of the Hawthorne works belonging to the Western Electric Company factory near Chicago. When they turned the lights up in one part of the factory, they found that productivity went up. Then they tried turning the lights down: productivity went up again. Since productivity increased whether the lights were turned up or turned down, they reasoned that the factory worker performance went up because workers knew they were being watched. They called the effect of being observed the ‘Hawthorne effect’.

Scientists are finding that Hawthorne Effects could occur in medicine too. For example, one study looked at rates of hand washing in hospital staff. When staff knew they were being observed, they were more likely to wash their hands than when they didn’t know they were being observed. Researchers in Denmark looked at what happened to 3000 people in trials who weren’t taking an intervention or a placebo (for example they were on waiting lists). These patients were simply being observed. In spite of not taking anything, their symptoms improved by 24%. Most of us can relate to this. If we knew we were being carefully observed as part of a trial, we might do things that are good for our health, like exercise more, eat healthier, drink less alcohol, or expect to recover. All of these could have health benefits.

In any study like the BBC back pain documentary, participants knew they were being watched. This could have caused them to be more optimistic about trying to do things like move more, or expect to recover. Being optimistic and moving more (as I’ll describe in later posts) can reduce back pain.

Some evidence shows that we can use (something like) the Hawthorne effect to improve our own health. For example, some trials show that people who weigh themselves regularly lose weight. Weighing yourself regularly is called ‘self-monitoring’ and basically means observing (a measurement of) yourself. I also find Hawthorne-like effects helpful for reaching my fitness goals. At the moment I’m trying to improve my running endurance. I share how far and fast I run via social media with the group I sometimes run with. Sharing my scores with a group means I’m observing the records of my training, and it also makes me ‘accountable’ to the group. This motivates me to train a bit more and a bit harder. Clinical trials show that ‘accountability’ improves physical fitness.

Hawthorne effects don’t occur in everyone, and they are different in different people. The best way to find out how powerful they are for you is to try. Monitor something you’d like to improve (like your weight or fitness level) and make yourself accountable to others. Then, observe any improvements.

#pain #placebo #DoctorYou #exercise

@DrMichaelMosley @OxEmCare

Two true stories motivated me to do the review. Archie Cochrane reports the first. He was the only doctor in a prisoner of war camp during World War II. One night the Germans dumped a young Soviet prisoner in his ward. The soldier had pleurisy (holes in his lungs) and was screaming. Cochrane didn’t want to wake up the other prisoners, so took him to his private room. He had no morphine, just aspirin, which wasn’t working. He felt desperate. He knew very little Russian and there was no one in the ward who did. He finally instinctively sat down on the bed and took the soldier in his arms. The screaming stopped and the prisoner died peacefully in Cochrane’s arms a few hours later. It was not the pleurisy that caused the screaming but loneliness. He was ashamed of his misdiagnosis and kept the story secret.

A doctor friend called Anne (real name withheld) told me the a more recent story about her experience. Anne was teaching three smart medical students who were told to diagnose a woman complaining of severe pain in her left shoulder. After 20 minutes of questions, the students wrote seven pages of notes and

recommended two drugs: an anti-inflammatory and a painkiller. Anne looked at what the students did and agreed that it was evidence-based. But something told her there was more to the story. She sat beside the patient, asked general question

s, and listened carefully. After a few minutes, the woman broke down in tears and told her about a personal tragedy involving one of her children. After some comforting, the tears and shoulder pain both vanished. Anne’s empathy and understanding prevented the woman from unnecessary painkilling drugs. This is significant because Jane Ballantyne from the University of Washington School of Medicine worries that even milder painkilling drugs may contribute to the current opioid crisis, as patients may subsequently seek stronger and stronger treatments.

Our review suggests Cochrane and Anne’s empathy aren’t just the stuff of stories. Empathic and positive communication seems to improve conditions ranging from lung function and length of hospital stay, to pain, patient satisfaction, and quality of life. From related research, we also understand more and more about how positive empathic communication works. First, you need empathy to make the right diagnosis. Without it patients may not share symptoms, especially embarrassing ones. Next, an empathic practitioner will help put a patient at ease and reduce their stress. Dozens of trials suggest that relaxation reduces pain, depression and anxiety, and even lowers the risk of heart disease. Also, by being positive (which is part of empathy), activates the patient’s brain in such a way that the patient makes his or her own painkilling endorphins.

Our review had some limitations. For example the studies in the review were small and blinding is hard to achieve, since doctors know if they have been trained to provide additional empathy. Another limitation is that the effect was small: for example empathic and positive communication reduced pain by an average of half a point on a 10-point scale. However this small effect is important, especially if we take harms and drug options into account. Many commonly used over the counter drugs, on the other hand, barely outperform placebos for back pain, cancer pain, and many chronic conditions, yet can have serious side effects. By contrast, a key finding of the study was that positive empathic communication does not seem to harm patients.

Whether or not doctors prescribe drugs for pain, adding a dose of empathy will probably boost the drug’s effect without risking any harm to the patient. And for some patients a dose of empathy is all they need.

Postscript

Since publishing the paper some people have asked: how can I use empathy to help me? The answer to that goes beyond the evidence in the trial. However there is one way I think we can extrapolate the evidence in a scientific way. Few people would deny that they sometimes (even often) have negative, unconstructive thought patterns. Evidence suggests that these are bad for our mental health. Empathy involves understanding, then acting on the understanding. So being empathic with ourselves—at a high level—means understanding that we’re human and make mistakes, then moving on to deal with whatever needs to be dealt with in a constructive way.

A version of this newsletter was published on the Huffington Post on 24 April 2018

The answer depends on which version of the World Medical Association (WMA) ethical guidelines (codified in the ‘Declaration of Helsinki’) we look at. The original Declaration was published in 1964 as a response to the horrific Nazi experiments with humans in World War II. According to this original version, it was unethical to give people placebos if there was an established treatment. This makes sense to doctors and patients. If doctors could have provided a treatment they knew worked, they risk doing relative harm by prescribing placebos, and harming patients is unethical. And most patients want to know which treatment option is the best one, not whether a new treatment is better than a placebo.

It’s not that the original Declaration banned placebos in trials altogether—they were allowed if there was no alternative. For instance there is no cure for the common cold. So testing a new treatment for the common cold against a placebo would be okay. There were also two other kinds of cases where they could be okay.

1. The first is in a ‘placebo add-on’ trial. In these trials, all patients in the trial receive the best existing treatment. Then, some receive the new treatment as an ‘add-on’ to the existing treatment, while others receive a placebo in addition to the existing therapy. This type of trial is useful in some cases. But when people talk about placebo controlled trials they usually don’t mean add-on trials.
2. The second is placebo trials in developing countries, where people wouldn’t be able to afford the standard drug. If someone invented a new cheaper drug that they could afford in the developing country, then it might be okay to compare that new drug against a placebo. I don’t agree with this point because the new drug could generate large profits, so I think the manufacturers owe the people in the trial the chance of getting something that we already know works. It turns out that it doesn’t matter whether you agree with me, because in 2000 the Declaration of Helsinki was revised to allow placebo trials in developed countries too.

The revised Declaration states:

a placebo controlled trial may be ethically acceptable even if proven therapy is available … Where for compelling and scientifically sound methodological reasons its use is necessary to determine … efficacy or safety

A problem was that they didn’t explain what the ‘compelling and scientifically sound methodological reasons’ are. I searched for them and found two, and neither makes much sense. The first is that placebo controlled trials are supposedly better at telling us whether a new treatment works or not. The geek word for this is ‘assay sensitivity’. Promoters of placebo controlled trials use the example of selective serotonin reuptake inhibitors (SSRI) antidepressants to make this point. While SSRI antidepressants are quite effective for people with severe depression, they barely beat placebos for people with mild depression.

This means that (at least in trials) SSRI antidepressants are not always better than placebos for people with mild depression. So if we compared a new antidepressant drug against an SSRI in people with mild depression. If the new drug were just as good as the SSRI we wouldn’t know if the new one was better than a placebo or not.

But if the reason we need a placebo-controlled trial is because the old drugs aren’t that good, then why not demand that the new drug be better than the old one? Many promoters of placebo controlled trials think it is okay for a new drug to be as good as an old one, rather than better. You might believe this is okay if the new drug has fewer side effects. But the best way to prove that the new drug has fewer side effects than the old one is to do a trial in which we compare the new drug with the older one. (An option is to conduct a trial that has three groups: one group would get a placebo, the other would get the new drug, and the third would get the old drug.) Financial interests could also play a role here. If we compare the new drug with an older one, the new one might come out as a loser even if both are better than placebo. This could explain why Eggermont’s placebo controlled trial was funded by industry, whereas trial funded by the National Cancer Institute is currently underway that compares the new drug (ipilimumab) with the old one (interferon alpha).

The second ‘methodological and scientific’ reason to prefer placebo controlled trials is that they supposedly give us a measure of ‘absolute effect size’. Basically this means that if we compare a new drug with an old one, we don’t know how much better the new one is compared to a placebo. But why does this matter? Patients and doctors want to know how the new one compares to what they already have, not what it does compared with a placebo. There is another reason why this is wrong: placebos don’t provide a ‘baseline’ against which an ‘absolute’ measure can be obtained. For example in ulcer drug trials, the placebo effects ranged from 0% and 100% of the drug effect. Like with ‘real’ drugs, we don’t always know why placebo effects vary, but they do.

Besides not making much sense, our recent study suggests that real doctors or patients don’t agree with them. If real doctors and patients believed there were good ‘methodological’ or ‘scientific’ reasons, then we would expect to see lots of placebo controlled trials used where there was an established therapy. But we don’t. We found that just four (6% of our sample) of trials used placebo controls even though they could have used an established treatment. The Eggermont trial of ipilimumab described above was one of them.

I’ve tried contacting Eggermont to ask whether patients in the trial knew about the existence of interferon alpha but haven’t had a response. And our study shows that real doctors and patients don’t seem to agree with the WMA revision to the Declaration of Helsinki. The confusing arguments about the supposed ‘methodological’ advantages of placebo controls seem controversial at best. This makes the WMA’s policy on the ethics of placebos in trials is unethical. Anyone enrolling in a trial beware!

A version of this was published by the BMJ Journal of Medical Ethics here.

I saved the money for the NHS because I live in the UK, but I would have saved the money for whoever was footing my health bills in any country. If I lived somewhere where I paid my own medical bills I would have saved the money myself.

I was proud of this because rising costs are making the NHS and similar organizations around the world unsustainable. You might think I saved the money by running for a charity, but I ran the full 26 miles (42 kilometers) for myself. So how did I do it? The answer takes us back to three years ago when I twisted my knee playing volleyball. It swelled up so much that it hurt to walk and I couldn’t bend it past 90 degrees. I waited weeks and it didn’t heal, so I got a scan, and they found pretty serious bone and cartilage damage. (I had an old injury in the same knee from my college days—that’s another story.) The hospital doctors recommended a kind of knee surgery called arthroscopy. About 40,000 of these are done in the UK and a million in the US are done each year. At a cost of £1681 in the UK and $5000 in the US, this means that £67,000,000 in the UK and 5 billion dollars in the US are spent each year on knee arthroscopies. That doesn’t include the costs of treating side effects.

I was tempted to get surgery because I could see the damage to my knee. However I was just writing my book about self-healing and thought it would be hypocritical for me to get surgery. I asked my general practitioner if there were other options and he referred me to a physiotherapist.

The physiotherapist gave me some simple exercises (like one leg squats), which I did 3 or 4 times per week. Slowly my knee started to heal, and eventually I started running again. I ran more and more each month. Then six months ago I gathered the courage to sign up for a full marathon. On October 22^nd I completed it without stopping in just under four hours. My legs and body were very stiff for a few days, but my knee was okay.

Clearly, I was offered the option of surgery too quickly (doctors are not supposed to offer knee surgery too quickly, and many don’t). Curious, I did a little digging to see what the evidence said. A systematic review of randomized trials suggests that knee surgery is no better than simpler, cheaper, and safer options like exercise or physiotherapy. Surgery can also have serious side effects. Four in 1000 people who have the surgery experience deep venous thrombosis (basically a blood clot that blocks circulation), which can in exceptional cases lead to deadly complications such as pulmonary embolism (blockage of an artery). Surgery also carries the risk of infections. This means that tens of millions of pounds and dollars, and a lot of unnecessary suffering could be saved if we opted for less invasive, safer options like physiotherapy.

Since the evidence says it’s no better than physiotherapy, why would anyone demand surgery? One reason is laziness—some people don’t like exercise. But if people were clearly explained that physiotherapy was as good with fewer risks, I know some people who would be happy to get off their butts and try physio. Another reason is that we live in a culture of ‘too much medicine’ where we tend to (wrongly) believe that new fancy treatments are better than old ones when in fact old treatments are better than new ones about half the time. I’ve also spoken to people who say that since the problem with their knee is mechanical, they need a mechanical solution like surgery. That’s not quite right. At a basic level, the exercises strengthen the muscles around the knee, which stabilize the joint and allow you to function better, so physio is a mechanical solution. Physiotherapy can also work via other more complex mechanisms that reduce how much pain you feel.

A final objection is that people complain that they have to wait weeks to see a physiotherapist, especially in publicly funded healthcare settings like the UK. I agree this is frustrating. But if we reduced the number of knee arthroscopies by just 10%, we could pay for about 150,000 additional physiotherapist appointments in the UK and over 6,000,000 in the US each year. This would reduce physio waiting times.

This doesn’t mean you should never have surgery. I myself would consider it if nothing simpler and safer worked. But evidence suggests that most of us are probably better off going for the less invasive options before going under the knife.

Choosing a less invasive and cheaper treatment helped me last a full 26 miles. If more people choose these types of treatments, maybe the NHS (or your healthcare provider) can go the distance too.

Written with input from Liz Morris @Lmo_Ox and Mackenzie Fong

This newsletter was first published by Medium.com on 21 November 2017: https://medium.com/@jhhowick/i-ran-my-first-marathon-and-saved-the-nhs-2000-6cbdfeb8f6c.

You can teach an old dog new tricks, and this old dog wants to learn – Thomas P. O’Neill

In February 1983, my grandmother had a stroke that paralysed the right side of her body. The doctors, physiotherapists and family members focused on helping her learn to live with just her left side. They succeeded: she lived another 30 years, mostly without help. She was a tough woman who grew up on a ranch where there was no running water or time to complain. According to conventional medical thinking at the time, she was a success story.

Trying to get her to use her right hand would have been pointless (they thought), since the part of her brain that operates the right side of the body was damaged by the stroke. At the time they believed that the brain was ‘hard wired’: one part of the brain to control the right hand, one for the left hand, and so on. If one part of the brain was damaged, that was it. Yet unbeknownst to my grandmother’s therapists (science can move at a frustratingly slow pace), researchers had already discovered that the brain wasn’t completely hard wired.

It all started in 1958, when University of Wisconsin Professor Paul Bach-Y-Rita‘s father Pedro suffered from a stroke. Like my grandmother, half of Pedro’s body was paralysed. Pedro also lost his ability to speak. But Paul’s brother George refused to believe his father would spend the rest of his days in that condition. Instead of ignoring the paralyzed side, George encouraged Pedro to try and use it. He tried again and again (and again), and after a lot of hard work, he succeeded. Pedro got to the point where he could walk and hike normally. After he died, scientists did an autopsy and were surprised by what they found.

The part of Pedro’s brain that was damaged during the stroke, was still damaged. Instead, other parts of the brain had reorganised itelf so that he could use both sides of his body. Eventually, Bach-y-Rita’s (and other scientists‘) research was adapted for stoke victims in a kind of treatment called Constraint Induced Movement Therapy (CIMT). CIMT involves restricting the limb that can be used by placing it in a sling or splint for 90% of the patient’s waking hours for about two weeks. The therapy has helped people who suffered a stroke to regain use of their ‘paralysed’ limb. Had the therapy been available to my grandmother when she had her stroke, I have no doubt that with her determined character she would have recovered most of the use of her right side.

This kind of research developed into a new field called ‘neuroplasticity‘, which means the science of how the brain can change (‘neuro’=brain, ‘plastic’=changeable). Neuroplasticity is pretty sexy so it shouldn’t surprise you that some commercial programs claim to use neuroplasticity ‘techniques’ that help you think yourself into becoming a new and improved person. These commercial programs are rarely based on good evidence. What good science has shown is that the brain can generate new neurons (albeit in a limited way), even in elderly people. These brain changes can occur faster than was previously believed. Scans on medical students before and after they studied for exams found the volume of grey matter in their brains increased significantly in a just a few months.

Basically, you can teach old dogs new tricks.

This is good news for our health because the biggest cause of death in developed nations is heart disease. Changing the way we eat, think, and exercise can reduce the risks of heart disease. Learning about neuroplasticity is even motivating me to try (again!) to stop eating chocolate cake.

This and other ideas discussed in Jeremy Howick’s latest book Doctor You

To prepare the trial, Thomas took a stack of cards and wrote positive on half of them and negative on the other half. He shuffled the cards and put them in a drawer beside his desk. As patients came to visit, he first checked to see whether they had a life-threatening illness that needed referral to a specialist or an ambulance. If they did, he referred them or called an ambulance. Otherwise, he drew a card from the drawer.

• If he drew a ‘positive’ card he said he knew exactly what was wrong with them. If they didn’t need any medicine, he told them confidently that they would be better in a few days. If they needed medicine, he said it would definitely make them feel much better very soon.
• If he drew a ‘negative’ card, he told patients, ‘I cannot be certain what is the matter with you.’ If no treatment was prescribed he added, ‘and therefore I will give you no treatment.’ If a treatment was prescribed he said, ‘I am not sure that the treatment I am going to give you will have an effect.’

As a back up plan, he told patients to call him if anything changed. He treated 100 patients with a negative consultation and 100 with a positive consultation. In the end he found that 64% of the patients who received positive consultations got better within two weeks whereas only 39% of the patients with negative consultations got better. He published his results in a 1987 article called ‘General practice consultations: is there any point in being positive?’

There were problems with the trial, especially lack of blinding. Since Dr. Thomas knew which patients got the positive consultations, this could have influenced the results. But since Thomas’ study, dozens of higher quality studies have been done with many different kinds of outcomes, and it has become difficult to doubt the results. Our recent mega-study with 12 randomized trials confirmed that doctors who use positive language reduce patient pain by a similar amount to drugs. Other trials show that positive messages can:
• help Parkinson’s patients move their hands faster,
• increase ‘peak flow’ (a measure of how much air is breathed) in asthma patients,
• improve the diameter of arteries in heart surgery patients, and
• reduce the amount of pain medication patients use.

The way a positive message seems to help is biological. When a patient anticipates a good thing happening (for example that their pain will go away), this activates parts of the brain that help the body make its own drugs like endorphins. A positive doctor may also help a patient relax which can also improve health.

To be sure, even positive messages can be bad if overdone. Some serious illnesses don’t get better, so telling patients with these illnesses they will get better is a lie. However even in these cases, patients like to be offered hope. In fact palliative care doctors who work with dying patients dying emphasize how important it is to communicate in an honest yet hopeful way. This means being honest about the disease, and at the same time help them plan for the things that they can accomplish, such as a last visit with their grandchildren.

Overdoing positive messages can be done but the opposite—negative language—may be just as bad.

Harm caused by negative messages

When doctors say negative things it can increase pain. In one study of patients about to receive an injection, doctors either gave a negative message (‘your arm may sting a little’) or a neutral message (‘your arm may feel tingly’). The pain was 10% higher in the patients who received a negative message. Harms caused by negative messages has been demonstrated in numerous other trials.

In the end…

… George Lewith was right: there is a point in being positive. For doctors, communicating optimism will benefit most patients. If you’re not a doctor then being positive (and avoiding negative thoughts) can also benefit you. Studies show that learning to see our problems in a more positive light can improve well being. Just the other day I recommended a positive thinking exercise to a friend. My friend was sceptical and asked: ‘How sure are you this stuff works?’
‘I’m positive,’ I replied.

*Sadly, Professor Lewith passed away peacefully soon after I wrote the first draft of this newsletter. He was happy that I wrote it, and his surviving immediate family have given me permission to publish this.

This newsletter was published on 11 July by the Huffington Post (see here).

Lying to patients is almost always unethical. But, in order for placebos to work, we have to believe they are “real” treatments, which means the doctor would have to lie to us and say that the placebo was actually a real treatment. Or, in the case of a clinical trial, that it might be a real treatment. After all, if a doctor handed you a pill and said, “this is just a sugar pill”, you’d probably assume it wouldn’t work. But sometimes our assumptions are mistaken.

I led a team that recently conducted a systematic review – considered to offer the highest quality evidence – containing data from five trials of open-label placebos (placebos that patients know are placebos). We found that open-label placebos seem to benefit patients with back pain, depression, allergic rhinitis, irritable bowel syndrome (IBS) and attention deficit hyperactivity disorder (ADHD).

The history of open-label placebos can be traced back to at least 1965 when Baltimore doctors, Lee Park and Uno Covi, gave open placebos to 15 neurotic patients. They told the patients: “Many people with your kind of condition have been helped by what are sometimes called sugar pills and we feel that a so-called sugar pill may help you too.” Many of the patients got better. Paradoxically, since these were neurotic patients, they thought that the doctors had lied to them and given them real drugs.

Since Park and Covi’s pioneering study, many more rigorous ones have been undertaken. In a typical recent study that was included in our review, Ted Kaptchuk of Harvard Medical School randomly allocated 80 patients with severe IBS to receive either placebo pills presented as “placebo pills made of an inert substance, like sugar pills, that have been shown in clinical studies to produce significant improvement in IBS symptoms through mind-body self-healing processes” or no treatment (the control group). After three weeks, the researchers found that the open-label placebo group improved by 15% more than those in the control group.

One of the participants in the trial, Linda Buannono, had been suffering from IBS for years and nothing had helped. On some days she was in so much pain she could barely leave the house. The open-label placebo had a big effect on her, so much so that she said: “I never felt better in my life.” But, at the end of the trial, she stopped receiving the placebos and her IBS became worse again. She went to her pharmacist to ask for some open-label placebos, but he told her it would be unethical for him to do so.

The trials in our systematic review were all quite small and weren’t “blinded”. (Blinding is where the participants and/or the researchers don’t know who’s getting what.) In these types of trials, participants and researchers need to know who is getting the open-label placebo and who isn’t, so it’s not possible to blind them. Trials that are not blinded are considered to be somewhat biased. However, the trials were consistently positive and we also know a bit about how open-label placebos work, suggesting that bias cannot explain away these results.

Lifting the lid on open-label placebos
Open-label placebos probably work in two ways. The first is expectation. Open-label are usually given with a positive suggestion (the doctor will tell the patient the pill is just a placebo but adds that it “produces significant improvement for patients like you”. This positive suggestion creates a positive expectation, which can activate the reward mechanisms in the brain and help the body produce its own substances, such as painkilling endorphins.

The second is conditioning. Just as Pavlov’s dogs learned to associate the sound of a bell with food and began salivating whenever they heard the bell, most of us have been conditioned to expect a positive outcome when a trusted doctor gives a treatment. So even though we know a pill is a placebo, our bodies may react in a way that helps us heal. There have been several studies, including one in humans, showing that the immune system can be activated much in the same way that Pavlov’s dogs salivated at the mere sound of a bell.

Since open-label placebos work, does this mean doctors should start handing them out like Smarties? That may be unwise because it would support a pill-popping, overmedicalised culture. Fortunately, our review of open-label placebos demonstrates something more general: placebo effects are real for many common conditions. And we can benefit from placebo effects without actually using placebo pills. Doctors who give positive messages and take time to communicate with enhanced empathy to patients can have positive benefits whether or not they give pills. Far from being unethical, since placebo effects can benefit many patients it is probably unethical not to exploit them.

This newsletter was published by TheConversation on 5 May 2017.

The funny thing is that cytisine isn’t used much in the UK because doctors here can’t prescribe it. Why not? My brother in law likes conspiracy theories and insists the reason is something to do with capitalism and corruption. I’m not into conspiracy theories so I looked for the truth. This took me into the La La Land of drug regulation that is worse than a conspiracy …

The reason doctors in the UK can’t prescribe this cheap effective drug is that it hasn’t been licensed, and drugs that haven’t been licensed can’t be prescribed. The main reason a drug company won’t apply for a licence is that the licensing process is expensive. Since cytisine can’t be patented (it’s not new), the company would not be able to recover the costs of licensing. But since smokers and taxpayers would benefit, why doesn’t the Department of Health commission the licensing process? The UK the government spends 13.9 billion pounds per year on treating smoking related illnesses. If cytisine could reduce these costs by just 1% it would save UK taxpayers 14 million pounds per year. I contacted the Department of Health the to ask (I got the same answer from the EU), and they passed the buck. They said their role is to review applications, not make them. According to a colleague (who wishes to not be named) this isn’t true because there is a provision buried somewhere for the Department of to commission a licence, but I couldn’t confirm this. What the Department of Health does do is fund private/public collaborations, and such a partnership could help a company absorb the cost of licensing. They haven’t done that either.

What other reasons might the Department of Health use for not finding a way to let doctors prescribe cytisine? I have heard three and they don’t add up to a good excuse.
1. Although trials show cytisine works, some might say we need more trials. With the trials and decades of observations I find this difficult to accept but if someone in the Department of Health really believes this, they could commission a trial. Publicly commissioned trials are common for other (less deadly) problems like prophylactic antibiotics for children with colds.
2. If doctors are suddenly able to prescribe cytisine, patients would not be able to buy it because nobody in the UK currently produces or supplies enough. But his can’t be right. If no company would be willing to produce it although it had been licensed, I’m pretty sure a company already producing it in Eastern Europe would be delighted to scale up their operation. (Refusal of a UK drug company to produce a licensed drug would also show that the patent system is not just a reward for research and development but a warrant to overcharge — that’s another point).
3. It could just be inertia — the Department of Health may not be used to doing these kinds of things. This is no excuse because millions are being wasted and smokers need help quitting. It’s time for someone in the Department of Health to follow my colleague’s advice to transcend the “Alice in Wonderland world of regulation” to find a way let doctors prescribe cytisine. Until that happens I’ll have to suffer through my brother in law’s conspiracy lectures. Cytisine may be cheap way to help people quit quit smoking but it doesn’t stop them from buying into conspiracy theories.

Additional reporting and writing by Robert West and Paul Aveyard

Jeremy Howick is a medical researcher and philosopher, look him up on Facebook, Twitter, or LinkedIn to read more.

Some say placebos are so powerful they cure almost anything, while others say they barely work. To sceptics, believing in placebos is as irrational as filling the gas tank of your car with Earl Grey tea“ and thinking it will run. In spite of this controversy many doctors give placebos to their patients. So it’s important to know the truth: if placebos work we might like to use them more, otherwise let’s stop fooling ourselves.