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The placebo effect has recently returned to centre stage with numerous studies showing that some physicians are administering placebos to treat their patients through the beneficial placebo effect. However according to the World Medical Association (WMA) the deceptive use of placebos is considered unethical as it violates patients' autonomy and breaches trust. This article argues that placebos are safe, provide therapeutic benefit, sometimes necessary and when administered under certain ethical guidelines set forth in this article they do not violate patients' autonomy or trust. Therefore, even though deception is generally ethically prohibited in medicine, the use of deceptive placebos could be an exception. The deceptive placebo should thus be endorsed by the WMA and their ethical and responsible use in clinical practice should be promoted.
With the ever growing public and research interest in alternative medicine the placebo effect has recently returned to centre stage (Vallance, 2006). Contrary to its use in research, where it is thought to provide no therapeutic benefit and act as a control; in clinical practice the placebo is prescribed by the physician with the intention of producing a therapeutic benefit (Lichtenberg et al., 2004). Therefore the ethical implications of the two scenarios are different and need to be considered separately. I will focus on the use of the placebo in clinical practise as a therapeutic treatment.
The practice of physicians prescribing 'inert' agents that lacked any specific pharmacologic potency but presented as real medicine to patients, was once a routine practise to relieve patients' discomfort (Shapiro AK, 1997, Miller and Colloca, 2009). However, with the introduction of modern therapeutics and as the law and medical ethics embraced respect for patient autonomy and informed consent, the practise began to fall out of favour (Brody, 1982). Even so, according to recent surveys, physicians are still treating patients by prescribing placebos to promote the beneficial placebo effect (Shermon and Hickner, 2008, Tilburt et al., 2008, Miller and Colloca, 2009). But is this practice ethical? Not according to the American Medical Association (AMA) and the World Medical Association (WMA) (2002) Declaration of Helsinki. Which, have policies against the use of deceptive prescription of placebos by physicians (Bostick et al., 2008, Foddy, 2009).
However, this commentary will offer an argument against this, in favour of allowing the deceptive use of placebos to be used in clinical practice. I will do this on the ground that they provide beneficence and are safe (non-maleficence) and can be utilized for clinical use without violating a patient's autonomy.
Before launching into this article it is worthwhile clarifying some of the terminology in relation to placebos for this commentary. A placebo is an inert substance or procedure that lacks a specific pharmacological or physiological efficacy for a patient's condition. A pure placebo generally entails an 'inert' intervention such as a sugar pill which is typically presented as a real medication deceptively. Impure placebos however do consist of biologically 'active' treatments that have specific efficacy for some conditions but not for the condition it is prescribed (Miller and Colloca, 2009). The term placebo will be used to identify the former, as actual harm may result from the latter and is therefore considered an unethical form of therapy (Rorty and Frankel, 2009). Any therapeutic benefit that is gained by the context of the clinical encounter, rather than the by the efficacy of the placebo itself is defined as the 'placebo effect' (Finniss et al., 2010). The use of placebos, like all treatments prescribed by physicians are only ethical if they elicit a favourable benefit to-risk ratio compared with other available treatments. So, can placebos actually provide a therapeutic benefit?
The placebo has been found to provide therapeutic benefit in a number of fields of medicine, including psychiatry, general practise and cardiology (Bienenfeld et al., 1996, Laporte and Figueras, 1994, Thomas, 1994). It was also scientifically documented by Beecher (1955), who found that, soldiers experienced an analgesic effect with saline. The study however failed to account for other confounding variables such as the effect of natural recovery or regression towards the mean making his results unreliable (Foddy, 2009). However, since then numerous laboratory experiments addressed these methodological problems and have produced robust and consistent evidence for placebos providing therapeutic treatment for pain, anxiety and depression (Benedetti, 2008). Further support for the placebo comes from new neuroimaging techniques that have shown that the same neural pathways that are activated by active painkiller medications are activated by placebos. The neurobiological mechanisms across various medical conditions through which the placebo effect exerts its beneficial effect are also being elucidated (Finniss et al., 2010). This demonstrates that the placebo effect is a real phenomenon and can provide potential benefit to patients. Therefore the placebo can be ethically justifiable on the grounds of beneficence as it provides benefit to certain patients.
There are some commentators that will argue that it is an ethical requirement that further solid evidence of benefit be provided before they can be used clinically. However even if there was only suggestive data for the beneficial effects of placebo treatment, what is wrong with prescribing a placebo which can cause no harm? Placebos are inert by their nature and therefore unlike active medicines which can frequently cause unwanted side effects they are harmless in this respect. There is however the belief that as it is possible for placebos to elicit a potentially beneficial response they also have the capacity to have ill effects. A number of studies have even been successful in demonstrating that a harmful so called 'nocebo' effect can be generated (Barsky et al., 2002). In these studies subjects were given the placebo and given an expectation of harm, however this does not relate to placebos in clinical use where the doctor will give an expectation of benefit. There is thus no reliable evidence that the beneficent use of placebos in a therapeutic context could be unsafe or cause harm.
But how necessary are placebos with modern therapeutics? Placebos would of course be unnecessary and certainly unethical if it were possible to give patients an effective active treatment. However there are a number of cases where efficacious treatments are unavailable or useless and placebos are suitable alternatives. Such examples include disorders such as irritable bowel syndrome (IBS) where there is no effective cure but significant recovery effects (43%) have been found through the use of placebos as treatment. Therefore for the 30-50% of patients who do not respond to active treatment, the use of placebos may be the best treatment available (Dorn et al., 2007, Foddy, 2009). As placebos provide potential benefit to some patients in certain cases at low to no risk at all and when used in good faith in a therapeutic context they need not violate a physician's obligation to heal. It can therefore be argued that it is ethically defensible to allow the use of placebos for treatment on the grounds of their beneficence and non-maleficence, provided there is no other more effective treatment available. However, the main ethical concern about placebos is that they involve a level of deception.
Is Deception Necessary?
The AMA suggests that a placebo can only be administered by a doctor when full consent is obtained form the patient beforehand (Bostick et al., 2008). But the data from studies on the clinical effectiveness of so called 'revealed' placebos where placebos are not administered deceptively is not particularly compelling (Park and Covi, 1965, Pollo et al., 2001, Foddy, 2009). Though some potential benefit was found for 'revealed' placebos the studies had many limitations and so not much faith can be put into the use of 'revealed' placebos. Further evidence to debunk 'revealed' placebos are findings including: larger placebo pills work better than small ones and placebo injections are more useful than placebo pills (Chaput De Saintonge and Herxheimer, 1994, de Craen et al., 1999). These results support the notion that the magnitude of the placebo effect is dependant on the patient's expectation of benefit. To reveal the inert nature of the placebo would certainly reduce its effectiveness and therefore if placebos are to be used in clinic to provide benefit to patients they ought to be used deceptively.
It was argued by Kant (1999) that our duty to tell the truth or not to deceive should require us to tell a would-be murder that his intended victim is hidden in our house. However I am not certain that many people would agree that our duty not to deceive is so demanding (Kant, 1999). There are all aspects of life where there are special circumstances in which we accept deception. It seems fair to argue then that the deceptive use of placebos in clinical practice may be such a circumstance. However generally deception is not ethical in medicine, so should the deceptive use of placebos have a place in medicine? They would certainly violate a patient's autonomy, or would they?
What about autonomy?
In medical practise deception is prohibited on sound ethical grounds, as if the doctor is able to withhold information from the patient about there treatment or diagnosis this would effectively control the choices that the patient is able to make. This would certainly then limit the patients right of self-government or autonomy. There is a sense then that placebos may diminish a patient's autonomy for which there two main arguments (Foddy, 2009).
Firstly it is argued that by deceptively administering a placebo, the patient is led falsely into believing what is put into their body. This may affect a patient's autonomy as it can limit the choices that are available to them and thereby diminishes their ability to determine their medical future. But if placebos were administered within certain ethical guidelines this argument begins to weaken. Placebos should only be administered when there is no other effective available treatment that the patient can or is willing to take. Therefore no other worthwhile choices are available to the patient, protecting their autonomy and health. It can still be said that the patient is denied the choice to take no treatment at all. However the patient goes to the doctor with the desire to get better. Therefore if the placebo is administered to do just that then it is still bidding by the patient's wishes and does not affect their autonomy (Harris, 1989).
The placebo should also be characterized as a temporary treatment of symptoms. The patient being aware of this would then be able to seek other 'ineffective' treatments available such as homeopathy if they choose to. It also then does not prevent the patient from benefiting from new effective therapies that may become available, only further protecting the patient's autonomy.
In the case where a doctor does give a placebo when there is an alternative more effective therapy then this can be seen as negligence and not deception. In such a case, it is the misdiagnosis of the doctor and not the deception of the placebo that affects the patient's optimal care and autonomy. If placebos were unavailable the same doctor may still prescribe an ineffective active medicine which in some cases may be just as bad or even worse. Therefore just like any other therapy placebos will be open for abuse and it is essential that doctors prescribe them in a way that does not diminish a patient's autonomy or health (Miller and Colloca, 2009).
Another strong argument is that if a patient is given a placebo deceptively they are being coerced by the doctor that the placebo is the best treatment. But is the patient's autonomy being violated by this coercion? The patient may indeed if informed fully disagree with the doctor that the placebo is the best treatment available to them, something that is impossible in the use of deceptive placebos. Coercion thus violates the patient's autonomy as the doctor is able to force the patient to accept a treatment that they may well prefer not to have. However even though placebos provide therapeutic benefit it is worth noting that they don't actually counteract the symptoms of a disorder like an active medication does. Thus they are not classified as a treatment as the placebo itself has no specific 'pharmaceutical' effect on the condition (Rorty and Frankel, 2009). In fact placebos are probably more closely related to a form of suggestion such as encouraging words or good bedside manner.
It has been found that psychological placebos such as verbal reassurance operate by the same mechanism of a placebo pill or injection (Hrobjartsson, 2001). If one decides that a pharmacological placebo reduces autonomy then it should also be true that a psychological placebo such as encouragement also then reduces autonomy as well. Would one suggest then that a doctor should seek consent before giving a reassuring word to his patient or offer a smile for comfort? If a similar level of coercion is already justifiable in what is regarded as 'good' bedside manner then it is reasonable to justify deceptive placebos ethically by the same merit. Deceptive placebos can thus be used with certain ethical guidelines that do not violate a patient's autonomy suggesting that the general prohibition of deception in medicine need not include placebo use.
There is another element to deceptive placebos that can be argued renders them ethically unacceptable in clinical use; which is the breach of trust it may incur. For the placebo to be effective the doctor has to have a relationship with the patient whereby the patient trusts that the placebo being given is a real medication (Kleinman et al., 1994). The breach of this trust can be detrimental and there is always a risk that the patient will discover that they are being administered a placebo. If this occurs then it may lead to the patient losing their trust in their doctor and becoming sceptical of all other doctors. This could have serious adverse effects to the patient and the medical profession. The patient may not seek advice for an illness in the future or may not comply with advice that is given as they no longer trust doctors. Meaning the use of placebos has the potential to cause harm to that patient in the future. The practice of medicine itself depends on the trusting relationship between doctor and patient, therefore the quality of care would certainly be reduced if patients became sceptical of their doctors honesty.
Perhaps the fact that the use of placebos is prohibited by the AMA and WMA makes it more likely that patients will see them as undesirable and abusive if discovered. If however they were to endorse the use of placebos in clinical practice it may foster a response that the deception was harmless and they are unlikely to hold the doctor at fault, potentially reducing the risk of breach of trust.
Additionally, a patient could be recommended a placebo honestly without disclosing it is a placebo and diminishing its effectiveness. For example a doctor could say to a patient with lower back pain "You can take this pill if you like, I am not sure how it works but there has been evidence from studies that it reduces symptoms in some patients with your condition." This is a completely honest statement which perhaps should be said with many active treatments that doctors prescribe currently. The way in which the placebo is presented to the patient and prescribed could be done in a manner that would limit its infringement on autonomy and breach of trust.
For the placebo to be the best service for physicians in clinical practice then they should be used deceptively. I have shown that the prescription of a placebo is beneficial in a variety of disorders and poses little to no risk of harm to the patient and in certain cases it is the best or only available treatment. Therefore both beneficence and non-maleficence is served by advocating the use of placebos. The only possible justification against their use deceptively is that it violates patient autonomy and trust. But as I have argued, the administration of placebos within certain ethical guidelines as outlined in this article is never a threat to patient's autonomy or breach of trust.
Therefore benefits of deceptive placebo use should be advocated to patients to help remove any damaging social stigmas that placebos currently have. Patients could then be made active in the decision making of placebo use and could be asked to select whether they would be willing if ever in the future to be prescribed a placebo. This would certainly end the argument that deceptive placebos infringe on a patient's autonomy or causes breach of trust. I conclude that deceptive placebos have a legitimate and ethically sound place in clinical practice once administered in accordance with the guidelines set forth in this article
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