anyone got insomnia? here what the doc prescribes
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The Greek philosopher Epictetus once remarked, “Man is not disturbed by events, but by the view he takes of them…”- that is to say, a stimulus has no innate meaning except the personal significance we attach to it. The placebo (Latin for “I shall be pleasing) is a modern example of this very concept. Known to laymen as the ‘sugar pill’, doctors throughout the last century have hotly debated the mechanisms by which placebos appear to elicit a physical response from the patient. Some skeptics dismiss it as medical ‘quackery’ whilst others swear by its effectiveness. Ben Wyld in “If pain persists consult your doctor for swift, sweet relief” is so bold as to suggest that “Placebos may one day have a legitimate place in medical treatment”. Whether a miracle cure or diabolical scam, we must be able to consider four key domains in any given article (authority, accuracy, objectivity and currency) in order to evaluate its value in relation to other sources of contemporary literature. Throughout the course of this discussion I shall critically evaluate the wealth of attitudes towards placebos from different textual media in relation to each other, and the prescribed newspaper article in establishing a personal informed opinion.
The ‘placebo’ could be defined as medical treatment which has no proven clinical effect but produces comparably favourable outcomes in patients with certain conditions. “A placebo could be pharmacological (e.g., a tablet), physical (e.g., a manipulation), or psychological (e.g., a conversation)” (Hrobjartsson & Gotzsche, 2001) . Two mechanisms that have been proposed for explaining this seemingly perplexing phenomenon are the “conditioning model” (biological) and the “expectancy model” (psychological) .
According to the conditioning model, previous participation in medical treatment and their outcomes (it might be a swift recovery or negative associations of doctors in white coats) strongly influences how they are likely to react in future encounters. The reaction is not unlike the Russian physiologist Pavlov’s notable experiment in which dogs learnt to associate a bell with feeding over time and therefore developed a conditioned response of salivation upon hearing a bell (Rathus, 1997) . Likewise, if a patient consistently experienced favourable outcomes after being treated by a particular physician, then s/he might make a recovery on subsequent occasions where placebo was used. This is because the patient has a reasonable belief that the physician will solve the problem (Jones, 2003) .
A subtly different theory is that of the “expectancy model”. In short, the patient will experience outcomes in accordance with his or her initial expectations since the body works synergistically with the mind. In a certain experiment, 80 percent of volunteers who were given plain water vomited after they were told they were instead given an emetic (Fields, 1997) . This is in accordance with one quote in the article, which maintains that “The belief or expectation that an individual has, that they will experience pain relief [when given treatment], initiates biological action”.
The American Food and Drugs Administration (FDA) website claims “Today's brain imagery techniques do lend support, though, to the theory that thoughts and beliefs not only affect one's psychological state, but also cause the body to undergo actual biological changes…” . The precise interaction between psychological states and biological effect if the focus of a newly developing field in medicine- that of “psychophysiology” .
Whereas medicine once considered the mind and body to be separate entities, they are now inalienable to another in maintaining the health of an individual. Consider this analogy- the body is like a car under the influence of the driver (mind). One cannot function properly in isolation from the other (Hassed, 2003) . It is therefore simple to imagine how a psychological intervention such as a placebo could eventuate tangible, physical benefits despite appearing spurious initially.
Statistical data is used on a single occasion to promote the newspaper article’s main assertion- “…patients taking placebo experienced 80 per cent of the benefits measured in people taking drugs such as Prozac and Efexor”. It is not entirely clear whether this means “patients taking placebos experienced fewer benefits as those taking drugs” or “patients taking placebos did not find them as efficacious as those taking drugs”. Nevertheless, the statistic is impressive and in itself, puts forward a good case for customers to utilize placebos.
The aforementioned figure could have been enhanced by verification from other peer-reviewed sources and more statistics (especially one comparing efficacy of placebo treatment to no treatment). Another statistic which could be included to enhance the author’s promotion of placebos could be something along the lines of “about 70% of patients respond to placebo for depression…” . Instead, the article prefers to draw upon circumstantial ‘expertise’ of several researchers in this field to provide their experiences and impressions.
Despite the seemingly objective language used throughout the article, it is biased in that it raises the readers’ hopes without validating claims with solid research data. Furthermore, Wyld does not take into consideration the various opinions of other researchers that the placebo effect is exaggerated. Where there are voices of dissent, they are usually in regards to the ethics and morality of administering placebo treatments. Not a single source actually denies the efficacy of placebos, leading us to the conclusion that Wyld has already accepted it as fact. Consequently, the reader becomes inclined to the suggestion and accepts it.
A brief review of contemporary literature will reveal that while the overwhelming majority place confidence in the placebo effect, a minority are not convinced by it- citing flawed experimental methodology and incomplete knowledge as the most common reasons.
In a recent journal article , Hrobjartsson & Gotzsche (2001) evaluated the range of double –blinded, randomized placebo controlled trials in popular literature. They identified 114 of 727 trials which were in accord with their selection criteria. In short, they compared the placebo outcomes of each trial against the non-intervention group and they “found little evidence in general that placebos had powerful clinical effects…”. Furthermore, they found that the placebo effect was greatest with small groups but diminished as more cases were introduced, concluding that “The reported large effects of placebo could therefore, at least in part, be artifacts of inadequate research methods”.
Hrobjartsson & Gotzsche pointed out that in many of the trials they examined, many of the patients in the non-treatment would have recovered regardless of whether they had received treatment or placebo. This idea is supported by the American Chemical Society website , which notes that there are many inherent confounding factors in trials whilst utilizing placebo controls. However, they were equally quick to point out that blinded evaluation was not possible in any of the trials because patients not receiving treatment would be aware of this whilst the placebo controls would be inclined to believe that they were receiving treatment.
The authors of the paper, Drs. Hrobjartsson & Gotzsche were originally from a medical background, which promotes confidence in their abilities to evaluate placebo effectiveness. Their study was sponsored by the Nordic Cochrane Centre in Copenhagen. The centre itself is a subsidiary of the ‘Cochrane Collaboration’ whose explicit mission is “making up-to-date, accurate information about the effects of healthcare readily available worldwide….” . Since the Cochrane Collaboration is a non profit organization, we can be certain that their article is trustworthy as there are no commercial or political interests present to further their respective agendas.
All research has been confirmed by reference to other journals where applicable. In all, there is reference to 134 other sources, which indicates that the authors have applied diligent research into the field and are aware of the contemporary ideas regarding placebo treatment. The journal is ‘peer reviewed’ so this gives further basis for us to put our faith in the article’s academic integrity. Additionally, the article is quite recent, having been written in 2001 and so the ideas expressed within it are in accord with current research.
Alternatively, an article published by W. Wyat. Gibbs in the ‘Scientific American’ magazine produced a counter-argument against Hrobjartsson and Gotzsche’s original findings. He noted that their meta-analysis was fundamentally flawed as only 27 of the 114 trials involved subjective pain analyses, with the remaining 87 trials involving ‘39 other maladies’. He says, “For each of these problems the number of patients was too small to allow any firm conclusion except that placebos do much more for some illnesses than for others”. Furthermore, he includes quotes elicited from interviewing other academics (including Irving Kirsch, a psychologist and himself a noted researcher in the field). Kirsch maintains, “It makes no sense to evaluate the magnitude of the placebo effect in general”, explaining that some ailments cannot be treated even with an active drug, much less a placebo because of physiological limitations (for example, osteoarthritis)- therefore absence of evidence does not necessarily equate to evidence of absence in regards to the placebo effect.
As a reader, we have two reasons to place our faith in the article’s informational content. Firstly, it was published in the ‘Scientific American’ magazine which is a popular magazine aiming to make current scientific research and ideas accessible to the general public population. Secondly, Gibbs is a senior staff writer for the magazine and a quick search will reveal that he has written numerous articles covering disciplines ranging from robotics to genetics. This would undoubtedly afford him a broader perspective on scientific issues and how they relate to each other. His experience is reflected in wining honorable mentions twice from the ‘Evert Clark Award for Science Journalism’ .
There are several instances where Gibbs cites journal studies and other researchers in order to add credence to his argument. Although not explicitly referenced in a bibliography, all references are cited so the reader can verify that his ideas are in accord with contemporary literature. A reader would be able to use a database or even a standard search engine to look for the relevant articles as they are all recent.
Since no major studies have been undertaken since the time of the article, we can be fairly sure that the article, being published in 2001 is in accord with current ideas regarding placebo efficacy. However, despite appearing objective in citing several sources and viewpoints, the article overwhelmingly include research advocating placebo efficacy. At times, it appears as though Gibbs’ stance is in defence of previously established research in light of Hrobjartsson and Gotzche’s recent suggestions. Therefore a more thorough investigation of popular literature is warranted.
The third source evaluated managed a comprehensive and objective investigation into the mechanisms of perceived placebo benefits. “The Mysterious Placebo Effect” by Carol Hart , confirmed Hrobjartsson and Gotzsche’s findings that “Any therapeutic meeting between a conscious patient and a doctor has the potential of initiating a placebo effect…” , explaining that any interaction between a doctor and a patient are likely to produce some therapeutic benefit as the act of attending to and interviewing a patient constitute a placebo (known commonly as the “Hawthorne Effect” ). Further to this, Hart examines the various mechanisms whereby confounding factors could be introduced into placebo-controlled trials. Therefore Hart’s work is a watershed in the history of placebo research in that it is the first to look past the issue of placebo effectiveness and examine how its administration could potentially skew experimental results.
Hart does give a thorough consideration to how the placebo could produce a response, the most prominent of these being the expectancy and conditioning models explored earlier. These establish further grounds for Wyld’s proposal that “placebos may one day have a legitimate place in medical treatment…”.
In contrast to the previous two articles, Hart manages a truly objective overview of the placebo effect in that she explores how it operates in depth, and contrasts this knowledge with other popular studies in contemporary literature (both for and against). This is maintained by the use of strictly objective language throughout. Indeed, it would be in her interests to remain impartial as she mentions in the introduction, “Understanding the basis of placebo effects, however, can help in filtering out noise and avoiding flawed study designs”. Furthermore, one will notice that all references to other resources are cited where applicable and that these are representative of the various views in contemporary literature. There are no hidden agendas or advertising as such to introduce biases into the article.
As a reader, we have many grounds to respect the article’s authority as it is written by Carol Hart, whose research interests include neurological disorders, psychology and pharmacology , which would all contribute to her understanding and appreciation of this subject. She has published numerous works in journals, books and magazines and lectured at the University of Pennsylvania (an ‘Ivy League’ institute particularly renowned for international relations, economics and biomedical sciences).
The article has been commissioned and edited by the ‘American Chemical Society’, whose explicit mission statement is “to encourage in the broadest and most liberal manner the advancement of chemistry in all its branches…” . Most probably, the article has been commissioned by this organization so that biochemists can understand how to correctly utilize placebo controls in experimental situations. It would thus be in the society’s best interests to explain the details in depth and provide a comprehensive overview within the article. In addition, we have grounds to believe that the ideas expressed within the article will be consistent with the other research articles as it has been written fairly recently (1999).
Wyld raised only two potential legal issues relating to placebo administration. The first was in administering placebos without obtaining adequate informed consent. Second was the potential for pharmaceutical corporations to deliberately mislead health consumers with a ‘false product’- somewhat similar to displaying a ‘fake’ painting in an art gallery.
“The Ethics of Placebo-Controlled Trials- A Middle Ground” (Emanuel & Miller, 2001) is an essay which was recently published for the ‘National Institutes of Health’ (NIH) in America. The essay delivers a thoughtful insight into the ethical issues surrounding placebo delivery in clinical and research settings and delivers a conclusion which aims to strike a compromise between the two opposing schools of thought.
In short, physicians face a dilemma as placebos are required to establish a reliable baseline in clinical trials, which new treatments are compared with. On the flipside, the current “active-control orthodoxy” deems that methodological considerations render the placebo invalid. Furthermore, the “placebo orthodoxy” maintains that the placebo is deceitful and necessarily puts the interests of medical research and the greater population ahead of individual rights- the so-called “utilitarian ethics” (Zion, 2004) , which holds that the end justifies the means.
However, to inform the patient that s/he was taking a placebo would defeat the purpose of a double-blinded test. The essay complements an idea raised in Wyld’s article- “…but the knowledge that that the pill was a placebo might diminish it’s effectiveness”- proposing that a viable compromise between this dilemma would be to explain to the patient the ‘possibility’ of receiving a placebo and its consequences, or explain the same without direct reference to the word ‘placebo’ except where directly enquired (Brown, 1998) . The essay recognizes that placebo controls are particularly unethical where “…withholding an effective treatment might be life-threatening or might cause serious morbidity”. Indeed, this was the case in original zidovudine (AZT) drug trials, where researchers were sufficiently convinced of the experimental drug’s efficacy that the experiment was immediately ceased and the patients administered treatment (Crouch & Arras, 1998) .
Emanuel & Miller forward the argument that despite the fact that placebos are medicinally inert, if they are proven to equal or exceed the efficacy of conventional treatments then their use should be justified as they elicit improvement in patient outcomes, but only where conventional treatments have failed and where informed consent is elicited.
For adequate informed consent, a patient must satisfy three criteria (Breen et al., 1997) :
1) the patient must be mentally competent to make a rational decision;
2) the patient must be informed in broad terms of the nature and possible risks of treatment;
3) the patient must consent voluntarily, that is, not under the influence of suggestion or coercion.
Regardless of the possibility of decreased placebo effectiveness if a patient is informed, patients must nevertheless be informed in clinical or experimental settings that they may receive placebo.
The nocebo effect (closely related to the placebo effect) is where patients experience unpleasant side-effects due to taking placebo and works in precisely the same way . It is the doctor’s ethical duty to consider the patient’s reaction to placebo according to his/her expectancy. For example, a patient may have experienced a paternalistic physician or contra-indications to a certain drug in their past.
The “Victorian Wrongs Act” of 1958 (Breen et al., 1997) maintains that a doctor is not negligent if his/her actions are comparable to that of the “ordinary skilled person exercising and professing to have that special skill” and/or a respected body of medical opinion. In today’s litigious era, it is highly unlikely that placebos will hold a “legitimate place in medical treatment” anytime soon (as Wyld proposes) simply because the placebo effect is not yet fully understood nor accepted, and doctors are not willing to take the risk.
The journal was written by Dr. Ezekiel J. Emanuel and Dr. Franklin G. Miller. Dr. Emanuel received his M.D. and Ph.D. (majoring in political philosophy) degrees from Harvard University. He is currently the “Chair of the Department of Clinical Bioethics at the Warren G. Magnuson Clinical Center at the National Institutes of Health” and served on the ethics committee of the Clinton administration’s “Health Care Task Force” . Dr. Miller graduated with B.A. and Ph.D. degrees from Columbia University, majoring in philosophy. He currently serves in the ethics committee in the National Institutes of Health and the editorial board of the “American Journal of Bioethics” publication .
Clearly, both authors have had extensive experience in the field of medical ethics and coming from philosophy-oriented backgrounds, are aware of the various schools of thought and how we derive our ethical ideas.
The article is peer-reviewed so we can conclude that its contents are help in high esteem by academics. The article is also reviewed by an editorial board to ensure that the four aforementioned criteria are fulfilled. Indeed, an article must be of particular significance and quality to be accepted for publication in a journal as prestigious as the “New England Journal of Medicine”.
There is no attempt on the authors’ part to advertise any product or organization, and has in fact been sponsored by the National Institutes of Health (a government organization) in order to address the glaring inconsistencies regarding the ethics of placebo administration. Furthermore, extensive research has produced a list of contemporary studies which are drawn upon in order to advance certain arguments. Therefore, all information is current and in accord with current knowledge, thereby holding relevance for the reader in the present day and age.
Altogether, the article is “swift and sweet”, providing a stimulating (albeit brief) introduction into the controversy surrounding placebo usage. The article is useful in that it catches and maintains the readers interest through introducing a drug completely redefining the current medical paradigm. The biological and physiological foundations prompt the reader to reflect upon placebo’s significance and accept it as a treatment with real potential. The article is disadvantageous to the patient in that it provides unsubstantiated claims which may well have been fabricated. Furthermore, there is not enough consideration of literature exploring the possibility that placebos are not so effective. There is insufficient discussion to explore the plethora of ethical and legal issues surrounding placebo usage and so the patient would be unlikely to fully comprehend its implications.
In conclusion, one may appreciate the article at face value, but a thorough consideration of ideas in contemporary literature is required to truly arrive at a personal informed decision. Placebos are not so simple so as to be promoted in a single newspaper article- contemporary literature will reveal that, is anything, placebo mechanisms are still poorly understood and that they must be used with discretion.
phew finished at last
now i have to cut 600 words off it somehow
