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The need to deliver ethical placebos

Dr Placebo
Last edited 13th September 2012

Clinical practice demands doctors provide the best available care. Some patients have non-specific complaints and there is no proven ‘active’ treatment. Placebos might benefit these patients. In other cases such as relieving pain placebos are known to have beneficial effects, while ‘active’ treatments have known side-effects. A problem is regulations all but forbid placebo use. But this is perverse – why would regulations prevent doctors from helping their patients?

Fortunately there other solutions. The reason placebos are considered unethical is they supposedly involve lying to patients. For example a doctors might tell their patient “this is a real treatment” when in fact it is a sugar pill. However placebos have been known to have effects even when doctors tell patients they are mere placebos. Hence doctors could simply inform patients that the treatment they prescribe is a placebo, and avoid the ethical problem. However it is likely that telling a patient that a treatment is a ‘placebo’ will reduce its effect.

But some patients may not care whether the treatment they are going to receive is a ‘placebo’, especially if such knowledge might reduce the benefit. These patients will undoubtedly want to know the treatment is safe, but have no interest in the ingredients or the label we place on the treatment. So, doctors could ask patients how much information they wish to receive about the treatment. The doctor could say, "Good morning Mrs Jones, my name is Dr Smith. This treatment has helped people with symptoms like yours, and it is known to be safe. We don't know exactly how it works, although some studies suggest it induces the body to produce various chemicals that can have benefits. Some patients like to know a lot about the treatments they use, while others don’t care and are willing to try and judge for themselves. If you would like to know more about the treatment I’m going to depend on you to prompt me. Does that seem like an acceptable way of proceeding?” Then, if the patients prefer to know more, the doctor might say that the treatment is sometimes referred to as a ‘placebo’, and add that much confusion surrounds the term. Or, if the patient doesn’t care, the doctor could refrain from revealing any further information.

This situation is familiar to us. Some Olympic athletes may wish to know everything about their opponents and the conditions, while others will find such information distracting.

As a patient, the amount of information you wish to receive about your treatments must be taken into account. Sometimes you will want to know everything, and at other times you may merely wish to know your treatment is safe.

It is impossible to avoid the outrage and scandal of the News of the World if you were in the UK this week. One media organisation went too far in its pursuit of sensitive data by tapping phones, and there have been hourly revelations since then, revealing a much greater system problem. Has the media lost its way? Yes it has. The “big scoop” has become more important than respect for individuals and their lives, and the right to know has trumped the right to privacy.

As the scandal crosses the Atlantic and more people lose their jobs, the last few days made me reflect about analogies between the media and medical research, and possible lessons for EBM. Like the news headline writers, data is the major part of what medical research is about as well. It is sensitive data because the content is health information of patients. Thankfully, medical research has to go through multiple levels of ethical review before it is carried out and perhaps the rather lame Press Complaints Commission needs to be replaced with a proper code of ethics for journalism and a body that can enforce it.

The history of medical research has had plenty of ethical issues and scandals which have largely led to improvements in guidelines and the way in which research is conducted. Perhaps most importantly, the involvement of Nazi doctors in unethical research during the Holocaust led to the establishment of the Nuremberg code: ten principles of ethical conduct in medical research in 1949. The World Medical Association developed the Declaration of Helsinki to guide the medical research community regarding human experimentation. But scandals still continue to happen. The impact of Andrew Wakefield’s bogus Lancet paper about MMR has led to huge consequences for childhood immunisation across several countries. Conflicts of interest in research and clinical practice have led to inappropriate regulation of medical devices.

Medical researchers have the privilege of working in fields where their findings can genuinely impact human lives, and ethical research can be done in every area of medicine to make treatment and the patient experience better, even in end-of-life decisions in the intensive care unit.

As a researcher with an interest in epidemiology, a lot of my work involves using patient databases to formulate and test hypotheses. The aim is not “to publish or perish” and get as many papers from the data as possible, and nor is it financial reward. We as researchers should always remember why we are doing what we do: to discover more about health and disease in order to improve outcomes for patients.

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