Mental Health: A Philosophical Analysis (International Library of Ethics, Law, and the New Medicine)
Especially if the allocation is done by a medical researcher who has a stake in the matter for instance because she has developed the new treatment , allocation decisions may consciously or subconsciously be influenced by expectations about who will profit from the intervention and thus create unbalanced groups. Allocation by a random process helps to control this source of bias. No one denies that RCTs are powerful experimental designs—and that their power stems from the ability to control numerous sources of bias and confounding.
Specifically, one may be led to assume that RCTs are necessary for reliable causal inference or that RCTs are guaranteed to deliver reliable results. A number of philosophers of medicine have in the past decade or so argued that these stronger claims do not hold to scrutiny. A final but very important issue is that of the external validity of the RCT results.
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Even under ideal conditions i. Typical test populations differ from the target populations i. For example, many RCTs will exclude elderly patients or patients with co-morbidities but the treatment will be marketed to these patients. For financial reasons, many RCTs are nowadays conducted in developing countries whereas the treatments are mainly or exclusively marketed to patients in developed countries. Whereas the protocols for conducting an RCT are very strict and detailed, there are no good guidelines how to make treatment decisions when the patient at hand belongs to a population that differs from the population in which the RCT was conducted e.
There are in fact two problems of external validity in the application of RCT results. On the one hand there is the population-level problem of making an inference from test to target population. On the other hand, there is the problem of making an inference from population to individual.
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For this claim to be true, the treatment must be on average effective, which allows the effectiveness to vary among the individuals in the population. Indeed, it is possible that the intervention is effective and beneficial on average but ineffective or positively harmful in some individuals i. Evidence-Based Medicine Working Group John Worrall argues that, at the end of the day, RCTs are a powerful means to control selection bias, but no more than that Worrall , a,b.
As he uses the term, selection bias occurs when treatment and control group are unbalanced with respect to some prognostic factors because a medical researcher has selected which patients will receive which treatment. Selection bias in this sense obviously cannot occur in an RCT because in an RCT the allocation is made by a random process. But it is also clear that randomization is at best sufficient but not necessary to achieve the result. A large number of alternative designs may be used to the same effect: allocation can be made by a strict, albeit non-random protocol; allocation is made by non-experts who are unrelated to the treatment development and therefore have no expectations concerning outcomes; treatment and control groups are deliberately matched again by persons who have nothing at stake or according to some protocol ; and so on.
A controversial issue is the role of mechanistic knowledge, that is, knowledge about the biological and physiological mechanisms responsible for medical outcomes and thus treatment efficacy should play in EBM. Nevertheless, a number of philosophers of medicine have pointed out that mechanistic knowledge is in fact important in EBM or that it should receive more attention.
Federica Russo and Jon Williamson have, for instance, argued that causal claims need both statistical evidence as well as evidence about the mechanisms that connect an intervention with the outcome variable in order to be established Russo and Williamson Others disagree Reiss or qualify the claim Gillies ; Howick a; Illari Further, it has been pointed out that mechanistic knowledge plays an important role in the design and preparation of an RCT, as well as in the interpretation and application of RCT results La Caze ; Solomon Especially when it comes to extrapolating research results from a test to another population, mechanistic knowledge is supposed to be vital Steel ; see also next section.
On the other hand, knowledge about mechanisms is often highly problematic and should not be relied on too heavily in applications Andersen New therapies are often trialed using animal models before they are tested on humans in a randomized trial. Animal models also play important roles in establishing whether or not a substance is toxic for humans. The International Agency for Research on Cancer IARC , for example, classifies substances with respect to the quality of the evidence for their carcinogenicity into five groups.
Evidence from animal models is referred to in the characterization of each group IARC This raises questions about how such extrapolations from animal models to humans work, and how reliable they are. Animal models are widely used in biomedical research because experimental interventions on animals are easier to conduct and cheaper than experiments on humans. Both kinds of experiments involve ethical dilemmas, but animal experimentation is usually regarded as less problematic from an ethical point of view than experimentation with humans.
At any rate, the number of animals killed, maimed, or made sick in biomedical research is much higher than the number of humans adversely affected in this research. The problem is essentially this. What is true of a model can be presumed to be true of the target only to the extent that the model is similar to the target in relevant respects. The reason we experiment on models in the first place is, however, that the model differs in important respects from the target if animals were just like humans, we would not find experiments on the former to be ethically less problematic than experiments on the latter.
Extrapolation—the inference from model to target—is therefore only worthwhile to the extent that there are significant limitations in our ability to study the target directly. If so, there can be no good grounds to decide whether a model is a good one for the target. To do so, we would have to investigate whether the target is relevantly similar to the model; but if we could do so, there would be no reason to study the model in the first place. This inferential problem has led some commentators to maintain highly skeptical views concerning our ability to use animals as models for humans in biomedical research.
Hugh LaFollette and Niall Shanks argue that animal models cannot be reliably used for extrapolation at all, but at best only heuristically, as sources of hypotheses that have to be tested on humans LaFollette and Shanks The former can be used to make reliable predictions about target populations of interest; the latter only heuristically. The main premise in their argument that animal models in biomedical research are at best HAMs but not CAMs is that for a model to be a CAM there cannot be causally relevant disanalogies between model and target—a condition which is rarely if ever met by animal models again, this is why we study animals in the laboratory in the first place.
Daniel Steel ch. Whether a claim about a model can be extrapolated depends, he argues, also on the strength of the claim to be exported. It is one thing, say, to reason from. He assumes that causes C such as medical interventions or the ingestion of toxic substances bring about their effects E such as the appearance of symptoms or improvements or deteriorations of symptoms through a series of steps or stages.
To trace a causal process means to investigate through what set of stages C brings about E. Process tracing is comparative when the set of stages through which C brings about E in one species or population is compared to the set through which it does so if it does so indeed in another. Comparative process tracing would be futile if, in order to know that C causes E in the target species or population, we would have to compare all the stages of the process between model and target.
This is because in order to do so, we would have to know all stages of the process through which C causes E , but if we did, we would already know that C causes E. Thus, if we compare an intermediate stage of the process which obtains in the model with that stage in the target and find them to be relevantly similar, then the only differences that may still obtain will be downstream from this stage.
How useful comparative process tracing is as a method for extrapolation for the biomedical sciences depends on how reliable the assumption that only downstream differences matter to extrapolation is, the reliability with which stages where there might be differences between model and target can be identified and the reliability of our mechanistic knowledge more generally.
If, say, our reasons for supposing that C causes E through a series of stages X , Y , Z in the model, or that X and Z are the stages where model and target are likely to differ, are not very strong, then the method does not get off the ground. This is an issue that depends on the quality of the existing knowledge about a given case and cannot be addressed for the biomedical sciences as a whole.
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There are certainly some examples of well-established causal claims where it is known only that C causes E but the details of the causal process are entirely beyond our current grasp Reiss forthcoming-a. An alternative to comparative process tracing that has been proposed is extrapolation by knowledge of causal capacities. If C has a causal capacity to bring about E , then C causes E in a somewhat stable or invariant manner.
Specifically, C will then continue to contribute to the production of E even when disturbing factors are present Cartwright And therefore, if C causes E in a model species or population and C has the causal capacity to bring about E , then there is some reason to believe that C causes E also in the target species or population for a defense, see Cartwright The usefulness of the method of extrapolation by causal capacities depends, among other things, on the extent to which biomedical factors can be characterized as having capacities.
Many biomedical causes do indeed have some degree of stability. These figures suggest a reading along the lines of,. Reiss b: But there is a high degree of interaction with other factors as well. Whether or not a substance is toxic for an organism depends on minute details of its metabolic system, and unless the conditions are just right, the organism may not be affected by the substance at all. To what extent this method will be successful therefore similarly case-dependent as comparative process tracing.
As we can see, there is no general answer to the question whether or not animal studies are valuable from a purely epistemic as opposed to ethical, economic, or combined view. Other authors have developed a practice-based taxonomy of animal modes to allow more accurate assessment of the epistemic merits and shortcomings, and predictive capacities of specific modeling practices Degeling and Johnson There is much evidence that species differ enormously with respect to their susceptibility to have toxic reactions to substances.
Thus, while it is very likely that for any one toxin, there is some species that is predictive of the human response, it is often hard to tell which one is most appropriate for any particular toxin. A species that predicts the human response well for one substance may be a bad model for another. However, some authors suggest that extrapolations from animal models have been made successfully in at least some cases Steel discusses the extrapolation of claims concerning the carcinogenicity of aflatoxin from Fisher rats to humans; see Reiss a for a critical appraisal and Steel for a response.
Frequently, in the biomedical sciences, reliable animal or other non-human models are not available and RCTs on humans are infeasible for ethical or practical reasons. In these and other cases, biomedical hypotheses can be established using observational methods. As we have seen in Section 5 , evidence-based medicine regards observational methods as generally less reliable than RCTs and other experimental methods.
This is because observational studies are subject to a host of confounders and biases that can be controlled when the hypothesis is tested by a—well-designed and well-conducted—RCT. But it is not the case that observational methods cannot deliver reliable results. In fact, it is well possible that the medical knowledge that has been established observationally by far exceeds the knowledge that comes from RCTs.
Here are some examples of medical interventions that are widely accepted as effective but whose effectiveness has not been tested using RCTs: penicillin in the treatment of pneumonia, aspirin for mild headache, diuretics for heart failure, appendectomy for acute appendicitis and cholecystectomy for gallstone disease Worrall a: ; automatic external defibrillation to start a stopped heart, tracheostomy to open a blocked air passage, the Heimlich maneuver to dislodge an obstruction in the breathing passages, rabies vaccines and epinephrine in the treatment of anaphylactic shock Howick b, Observational studies often begin by reporting a recorded correlation between a medical outcome of interest and one or a set of independent variables: lung cancer rates are higher in groups of smokers than in groups of non-smokers, liver cancer rates are higher in populations that tend to consume food that has been contaminated with aflatoxin than in populations whose food is uncontaminated, to give a few examples.
That smoking causes lung cancer, or aflatoxin cancer of the liver, would indeed account for the observed correlations. But so would a variety of other hypotheses. Ronald Fisher famously proposed that it may be the case that early stages of bronchial carcinoma cause an individual to crave cigarettes, and he provided some evidence that both smoking behavior and susceptibility to lung cancer have a common genetic basis Fisher Selection bias is normally understood as the bias that obtains when individuals self-select into the observed population and the reasons for which they do so are correlated with the outcome variable.
If an observational study examines only hospitalized patients and smokers are more likely to be in hospital for reasons that have nothing to do with lung cancer, then smoking and lung cancer can be correlated in the data even if the variables are independent in the general population. Mismeasurement and diagnostic error provide another account of spurious correlation. Suppose tuberculosis was on the rise a generation or so after many people traded pipe smoking for cigarette smoking. Then, if it was difficult to distinguish a death from tuberculosis from a death from lung cancer because necropsy techniques were not sufficiently well developed, the data might again show a correlation even though the population variables are uncorrelated.
Retrospective observational studies work by ruling out alternative hypotheses such as these ex post rather than controlling for them ex ante as RCTs do Reiss a. In an RCT, mismeasurement should not obtain because the protocol specifies measurement procedures for the outcome variables in great detail in advance.
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Selection bias should not obtain because patients are randomized into treatment groups. Once allocated to a group, they are prevented from obtaining another treatment elsewhere, and researchers make sure that patients comply with the treatment regime. But there are equivalent means to rule out these possibilities in observational settings. While it may well be the case that early stages of cancer cause a craving for cigarettes, this hypothesis cannot explain the protective effect that stopping smoking has.
However, it could be shown that in order to account for the observed rise in lung cancer incidence, the diagnostic error at autopsy among older people would have to have been an order of magnitude higher than the diagnostic error among younger people Gilliam Mismeasurement could therefore also be ruled out. Similar considerations helped to rule out other alternative hypotheses Cornfield et al. Even if one were to believe, with the proponents of EBM, that observational studies are generally less reliable than RCTs, medicine could—fairly obviously—not do without them. There are large numbers of pressing questions that could not be addressed by an RCT for ethical, financial and other practical reasons.
This is not merely because of the straightforward ethical issues involved in deliberately exposing humans to a potential carcinogen for the sake of medical progress. It is also because exposure to low levels of aflatoxin can take many years or even decades to produce symptoms. The ability of researchers to control food intake in a large group of experimental subjects for a very long has evident practical financial and limitations. Moreover, it is not clear that RCTs are always more reliable than observational studies to answer questions both methods are able to address.
Whether or not a study is reliable depends on whether or not confounders and biases have in fact been eliminated, not by which method they have been eliminated. Issues concerning the reliability of a method can be entangled with issues concerning its ability to address the research question the biomedical scientist seeks to answer.
Both RCTs and observational studies in the biomedical sciences are typically employed to test rather complex hypotheses about the safety and efficacy of medical interventions. It may well be that some of the issues are more reliably treated by one method and others by the other. A famous controversy in which the results from observational studies and those from RCTs conflicted was that over the benefits and safety of hormone replacement therapy HRT in the early s Vandenbroucke HRT seemed protective for coronary heart disease in observational studies, whereas RCTs indicated an increase in the first years of use.
For breast cancer, combined hormone preparations showed a smaller risk in an RCT than in observational studies. In the end it turned out that the timescale of the effects was responsible, and that because of the way they are typically run, observational studies got some issues right and RCTs others:. The observational studies had picked up a true signal for the women closer to menopause.
In the randomised trial, that signal was diluted because fewer women close to menopause were enrolled… The randomised trials had it right for coronary heart disease but failed to sufficiently focus on women close to menopause for breast cancer. The main reasons for the discrepancies were changes of the effects of HRT over different times… Vandenbroucke Case reports remain extremely popular in medicine both as publications to communicate within the field and for pedagogical purposes.
In short, a case report describes a medical problem experienced by one or more patient, usually involving the presentation of an illness or similar that in some way difficult to explain or categorize based on existing understandings of disease or understandings of physiology and pathology. Cases in medicine take highly standardized forms of presentation which are inculcated in health care professionals during their education, and many have commented on their highly standardized narrative structure and its epistemic and other implications Hunter ; Hurwitz Cases typically provide details on the presentation of the disease, diagnosis, treatment, and outcomes for the patient, with a focus on practice-based observations and clinical care rather than the results of randomized controlled trials or other experimental methodologies.
One of the purposes of cases is to gather detailed information including facts that may not be immediately relevant, but that could prove to be Ankeny Thus the information contained in the case and the case itself can be useful over the long term particularly if it can be systematically combined with other cases into larger datasets.
Single cases are seen by some as problematic as a form of evidence particularly in the era of EBM, because they often focus on highly unusual manifestations of illness and disease, rather than typical or repeatedly observed conditions that might support generalizable rules. However standard accounts of EBM include the case series as a type of evidence, which involves the aggregation of individual cases of patients with similar attributes e.
EBM does place the case series quite low in its hierarchy of evidence but nonetheless it is acknowledged that cases have potential usefulness especially where forms of evidence that rate more highly are not available, as may often be the case where human patients are concerned due to practical or ethical reasons, or where the available evidence at higher levels has been produced in a manner that is methodologically or otherwise flawed.
Cases can serve other purposes: for instance analyses of cases can provide working hypotheses about casual attribution that can ground further tests of causal relations Ankeny , which in turn allows use of more traditional methodologies such as RCTs, cohort studies, and so on to explore these causal hypotheses.
In the context of clinical care, cases can allow health care providers to identify a cause that can be manipulated to cure or prevent the condition in question, in order to treat ill patients, even in the absence of more rigorous forms of evidence. Diagnosis is the process through which a clinician determines what is wrong with a patient who is ill or ailing in some way. Although a critical part of the practice of medicine, it has been relatively neglected in the literature of philosophy of medicine particularly in comparison to more statistically-based methods for evaluating evidence in other fields Stanley and Campos The key philosophical issues that arise in this context relate to how such determinations can be made in a manner that is accurate given the high amount of uncertainty and complexity often associated with the human condition, and hence involve logical, epistemological, and ontological issues.
The usual way of proceeding in a clinical setting is to ask the patient to articulate what is ailing him or her, and thus to use a standardized reporting format to detail various symptoms which represent subjective manifestations of the illness or disease. In addition, clinicians perform various tests and examinations that allow more objective manifestations or signs to be recorded, such as heart rate, blood pressure and count, reflexes, and so on. A perennial debate in the philosophy of medicine is what constitutes symptoms and signs and whether they are in fact distinct, which relates to deeper issues about the realism of disease conditions as discussed above Section 2.
The tricky part of the process is to find a means for mapping these symptoms and signs onto a particular disease condition. Some would advocate that this process is no different than usual methods in philosophy of science for hypothesis generation and testing based on evidence, and this type of model fits with what is termed differential diagnosis.
Differential diagnosis involves a set of hypothetical explanations for a particular condition which come to be ruled in or out based on the evidence together with additional data that is collected, hence relying on a form of reasoning via decision nodes or algorithmic pathways Stanley and Campos However this approach can be dangerous particularly among novices, given the large number of similar patterns among common diseases. Some have claimed that the making of a diagnosis is both a deontic act and computable, and that diagnoses are relative only inasmuch as they occur in a complex context which in turn makes them a social practice Sadegh-Zadeh Computer-assisted diagnostic techniques have improved and are used increasingly in clinical settings; Kenneth Schaffner provided an early analysis of the criteria which an ideal diagnostic logic would need to satisfy for updated discussions see Schaffner , , and for arguments about the limitations of such types of diagnosis see Wartofsky The epidemiologists who initiated the formal EBM movement in the early s had good reason to be skeptical about expert opinion.
When therapies are subjected to systematic tests, tradition and expert opinion are sometimes shown to be flawed. John Worrall discusses three examples: grommets for glue ear, ventricular ectopic beats repressing substances such as encainide or flecainide for cardiac arrest, and routine fetal heart rate monitoring to prevent infant death Worrall a: In each case we have a procedure the effectiveness of which is indicated by common sense and knowledge about the patho-physiological pathways—glue ear is a condition produced by a build-up of fluid in the middle ear that is unable to drain away because of pressure differentials, grommets act by letting air into the middle ear and thereby equalizing pressure, for instance—but which, when tested by a randomized trial, turns out to be ineffective at best and positively harmful in the worst case.
Misjudgments concerning the efficacy of therapies for purely epistemic reasons are not the only worry that one might have about expert opinion. Medical experts and patients are in what economists call a principal-agent relationship. The principal—in this case, the patient—desires the delivery of a certain good or service—in this case, his health. He instructs an agent—in this case, the doctor—with it, because he lacks the expertise to produce the good himself.
The doctor may not always choose the optimal therapy for a patient we can suppose that it takes some effort to select the optimal therapy for a patient , and any therapy can be implemented sloppily. Moreover, lacking expertise, the patient cannot observe the level of effort a doctor puts in.
In our world, neither patients nor doctors are particularly rational, nor are they motivated purely by self-interest, there are ethical codes such as the modern form of the Hippocratic Oath, and the health sector is one of the most regulated industries of all.
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All this does not, however, change the incentive structure in which doctors and other providers of health services operate. There is a further complication. Many, probably most, doctors have connections to the pharmaceutical industry in one form or another. Even if we suppose that doctors do not prescribe a therapy because they are paid to do so, marketing efforts directed at them will influence treatment recommendations, if only because they know certain pills better than others, or because some treatments are at the top of their heads.
For all these reasons, the EBM principle that treatment decisions should be based on the best available evidence from systematic research does not come out of nowhere. However, while these are all bad reasons to recommend Y over X in the light of the study result, there may be a variety of good reasons. As discussed in Section 5 , RCTs and many observational studies are population-level studies, which produce average results that are not straightforwardly applicable to individuals.
Instead, the RR may vary dramatically among the subpopulations of p , and it may well be the case that Y is more effective than X for some subpopulations. The same is true of side effects. Tonelli discusses a case where a patient who suffers from multiple sclerosis receives a treatment that does seem to alleviate her symptoms, but since she has started taking it, she has been plagued by severe episodes of depression.
Clinical trial results indicate that the drug is effective in treating multiple sclerosis, and no adverse psychiatric effects have been reported. Her GP and her psychiatrist now debate whether to continue the treatment. This is another reason why clinical judgment must be exercised in the derivation of a treatment recommendation. Unfortunately, experts—like all humans—are notoriously bad decision makers. Cognitive psychologists have established a large number of cognitive biases to which human experts are subject: they suffer from overconfidence e.
Better numeracy and statistical training at universities can help to eliminate some cognitive biases Gigerenzer Computer-aided medical diagnosis and decision making may alleviate others. No training or computer program can make normative judgments, however, and neither will help with adverse incentive structures and financial interests. These difficulties also beset committees of medical experts to which we are turning next.
One way to help overcome expert bias is by making medical decisions not dependent on individual expert judgments but instead have groups of experts coming to some form of aggregate judgment. The U. National Institutes of Health, for instance, used to organize so-called consensus conferences designed to resolve scientific controversy.
Panel members are chosen from clinicians, researchers, methodologists and the general public. Federal employees are not eligible, nor are researchers who have published on the subject at hand or have financial conflicts of interest Solomon These exclusions are intended to contribute to controlling government influences as well as any biases due to financial or intellectual interests. Consensus conferences and other mechanisms for reaching group judgments are clearly no panacea.
More important in the present context is the observation that while these conferences possibly help to control some forms of partiality, they are ineffective in reducing others and may be responsible for the introduction of new biases. One concern is that panel members may read the existing evidence selectively, for instance, because of weighing salient studies or studies that are available to them more heavily.
Another is that phenomena such as groupthink Janis and peer pressure may influence results. In an NIH consensus conference panel members have to come to a verdict after only two days of hearings and deliberations. Under these conditions it is certainly possible that more outspoken panel members or those who perform well under extreme pressure have a undue influence on results. Moreover, it is not clear that excluding clinicians who have published on the issue at hand is always such a good idea.
After all, it is not implausible to maintain that those scientists who actively work on a research topic are those who best understand it and therefore can make the best informed judgments. For these and other reasons, Solomon , explores the consequences of judgment aggregation. In this process group members typically do not deliberate but instead cast their opinions which are then aggregated using some pre-determined procedure.
The majority rule would be a simple example of such a procedure. Coming to a group judgment using a mechanical procedure such as majority vote has a number of advantages. Under these conditions, then, a committee of experts is likely to make a better judgment than a single expert. Moreover, in the absence of deliberation and pressure to come to a unanimous results, and when voting is secret, the influence of groupthink, peer pressure etc. When conditions a — c do not hold, results are more ambiguous or even negative. When experts are not reliable, i.
When the outcome can have more than two values, inconsistent results can obtain. This can easily be demonstrated with an example in which there are three possible outcomes and three experts. Suppose, for instance, that a panel has to decide which of three treatments A , B and C is the most effective in treating some disease. The individual panel members have the following individual rankings:.
The majority rule is of course only one way to aggregate judgments. The Delphi method e. Experts answer questionnaires in several rounds. During this process the range of the estimate will often decrease, and it is hoped that the group will converge towards the correct answer. The process is stopped after a pre-determined stopping criterion such as number of rounds, achievement of consensus, stability of results, and an average of the estimates of the final round is used as result.
Solomon , raises a fundamental issue concerning group judgments that is entirely independent of the specific method used. She argues that we do not often find group judgment methods to determine the truth of scientific hypotheses or estimates of variables in the natural sciences though see Staley If there is uncertainty about, say, which of two alternative hypotheses is true or what value a natural constant has, scientists go out and test, experiment, measure.
Controversies, in other words, are settled on the basis of evidence, not individual or group opinion. Consequently, she recommends more widespread use of mechanical techniques for amalgamating evidence such as meta-analysis in lieu of consensus conferences and the like. The frequency of NIH consensus conferences has indeed markedly declined in recent years Solomon , But this is of course no reason to maintain that group judgments are no longer needed.
Consensus conferences may be the wrong tool for the purposes of the NIH, or the NIH may have a mistaken view about the ability of evidence to settle disputes adequately. Indeed, there are at least two reasons to believe that group judgment procedures are here to stay. The first reason is that, as we have seen above, medical decisions are always in part decisions about normative matters. No treatment is entirely without side effects and so if judgments about efficacy are to be of practical guidance, they must include a weighing of benefit alleviation of disease symptoms against cost suffering from side effects —even if economic costs and benefits are not to be taken into consideration.
Second, government agencies such as the U. Food and Drug Administration FDA have to decide whether new treatments should be licensed to be marketed. These decisions often have significant consequences, and democracies tend to prefer to be able to hold someone accountable for making them. Drug approval therefore cannot be determined on the basis of evidence according to some mechanical algorithm. Biddle discusses epistemological and moral issues of drug approval in the context of a case study on Vioxx, an analgesic. Vioxx was approved by the FDA in but five years later pulled from the market by its manufacturer Merck due to safety concerns.
It is estimated that some 55, people died from taking the drug Harris Biddle observes that the FDA is not sufficiently independent of the pharmaceutical industry to make unbiased decisions likely. To solve these problems of conflicts of interests, Biddle proposes to institute an adversarial system in which two groups of advocates, a group of representatives of the manufacturer and a group of independent scientists, would argue before a panel of judges over whether a drug should be allowed on the market.
The panel of judges in this model also consists of independent FDA or university scientists. He argues that the adversarial system would better acknowledge the fact that an increasing number of medical researchers have financial ties to the pharmaceutical industry by treating them as advocates rather than disinterested experts. See also Reiss and Wieten , Reiss forthcoming-b.
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There is no doubt that medical research is shaped by various external values, in ways similar to the value ladeness that is well-recognized in other areas of science see entry on scientific objectivity. Many of these values create a variety of ethical dilemmas relating to equity of access to health care and similar. Even in recent years once medical research has been made more inclusive, this trend has introduced a host of additional philosophical and ethical issues Epstein For our purposes, we will focus on the implications of the systematic exclusion of certain types of individuals, groups, or diseases from research for future research as well as clinical medical practice in terms of the validity of evidence produced and decisions made based on that evidence.
What would be the reasons for abolishing it? Who should bear the burden of proof? Furthermore, the book discusses the impact neurosciences may have on psychiatric and psychological evaluations of defendants as well as on legal decisions about insanity. Show all. Herron, Doody's Book Reviews, March, Show next xx. Recommended for you.
How does the fact that autism is a heterogeneous concept affect the answers to these questions? Who has the authority or knowledge to speak on behalf of people with autism? In this paper, we describe a cluster of research topics which should be on the agenda of the emerging field of autism ethics. These topics include the very concept of autism itself, the question whether autism is primarily an identity or a disorder, the ethical questions that parents of autistic children face, metaethical questions, the ethical consequences of epistemological questions, and a cluster of questions related to social justice, stigma, and paternalism.
Should autism be detected as early as possible, even prenatally, to prevent its development? Perhaps, we should instead seek to accommodate neurological difference. There is no consensus on the question of what society owes to people with autism, and whether that is different from what society owes to nonautistic people. One key reason is that those labels do not always convey how well a person is able to function, or how severe the challenges are that they face in their daily lives Silverman, ; p. Autism is now considered a spectrum condition, but no agreement has been reached about even the most basic issues, such as what causes or even constitutes it Waltz, To what ontological category does it belong?
On one view, it is first and foremost a psychiatric diagnosis used in clinical practices. Second, autism as a term is also used to refer to a neurocognitive reality. Several theories have been suggested to explain in neurological terms the behavior defined in the diagnostic manuals Frith, However, there are several competing explanatory models. The weak executive function thesis hypothesizes that individuals with autism have problems planning, organizing, and keeping track of several activities, hence, the restricted or repetitive patterns of behavior or interests.
Mottron and colleagues have proposed that autistic people have enhanced perceptual functioning, and hence a visual type of intelligence Mottron et al. This means that every deviation from the expectation draws attention and is taken seriously. It is hypothesized that people with autism spectrum disorder ASD are less flexible in processing violations to their expectations Van de Cruys et al.
He maintains that the common perception that the diagnostic criteria of autism have widened is not accurate: In fact, the diagnostic criteria have often shifted so that it is unclear what is actually meant by autism. But individuals who experience communicative problems and individuals who have a specific cognitive style may not share the same neurology, and not everyone with those characteristics satisfies the diagnostic criteria for ASD. Autism as an umbrella term may wrongly suggest that it is a phenomenon that is expanding rather than shifting in meaning over time, and the idea that we can find one biological reality underlying everything which is called autism may be misguided.
Having sketched as background some of the scholarship on autism, we will proceed to describe the research questions that are currently being asked, or that we think should be asked in the emerging field of autism ethics. The first such question flows directly from the background discussion just mentioned and concerns the social metaphysics of autism.
When empirical autism researchers investigate what autism is, they do not always stop to ask fundamental, conceptual, and ontological questions. Clearly, discussions of autism and disagreements among autistic people, parents, and professionals on whether autism should be cured or treated, have different outcomes depending on what conception of autism is being assumed. If one focuses on the fact that autism is a psychiatric diagnosis based on certain behavior associated with dysfunction, one is fundamentally arguing on a different level than if autism is seen as a neurological reality , possibly with a genetic basis.
Under the first approach, the person with autism becomes analogized to someone who seeks help during a difficult period in their life. If, however, one assumes that a diagnosis of autism reflects a neurological or cognitive identity, the need for help depends on whether one considers this identity a problem, and if so, what kind of problem. Some argue that autism should be confirmed through medical practice, as only those with medical training can accurately identify autism. This also relates to an issue we shall discuss later on in this paper, namely, who can speak for the autistic community.
Whether one assumes that autism is primarily a deficit in social functioning as for example in the theory of mind hypothesis or a deficit in information processing as for example in the intense world hypothesis has immediate consequences for which treatment options are the best for autistic people. For example, if one adheres to the intense world theory or similar theories that stress sensorial or informational overload, treatment and support should first of all focus on relieving sensory processing issues rather than on trying to mold acceptable behavior through behavioral therapy.
As we have described above, the idea that autism constitutes a natural kind may be misguided, as there is something fundamentally social and historical in the way autism is defined and diagnosed. Moreover, there is great heterogeneity among the people diagnosed with autism.
For example, how should it be interpreted that about three out of four autism diagnoses are given to boys and men? This may imply that it is a condition that affects men more than women, or it may imply that autism manifests itself differently in women or in a way that society perceives differently. As mentioned earlier, it is commonly assumed that the rise in diagnoses is due to a widening of diagnostic criteria, so that people who are less severely affected but still share the same fundamental characteristics have access to support and services.
Or ought it instead be revised or modified? Maybe this means that the use of autism is only justified in certain circumstances. But can a concept that is abandoned in research still work in the clinic, for example, as a gateway to access to services? Hence, although we may question whether there will ever be one explanation of the origin of autism or a consensus about its ontological status, the concept as such seems to work as an explanation in a therapeutic sense for at least a subset of those diagnosed.
Indeed, how autism is framed in the media may influence how people conceive of autism and what direction autism research takes. Another topic related to the concept of autism is the globalization of the term. Would implementing Western screening and treatment programs for autism in developing countries count as improving health care?
Or would it be to impose Western standards on other cultures?
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Finally, but importantly, there is the autistic experience itself. Although autism as an idea may be heterogeneous, complex, and even ambiguous people with autism tell us about their very real experiences of being different. In order to arrive at a nuanced understanding of autism, these aspects contribute to the complexity of the concept of autism and should not be ignored. The field of autism ethics should also investigate whether autisms heterogeneity has ethical consequences. Perhaps, however, there are undesirable consequences of being given a diagnosis that may not reflect one single underlying biological reality.
In developing this part of the autism ethics agenda, philosophers may be able to build on similar work that has been done in related areas, such as the theory of physical disabilities developed by Barnes Another cluster of questions concerns the idea that autism is an identity or a personality trait rather than a disease or disorder that should be cured or prevented. But others, often parents of autistic children with severe behavioral problems or suffering, have challenged this view and have claimed that those who are advocating it cannot speak for all those diagnosed with autism Ortega, This line of moral reasoning seems to assume that there is a common definition of what constitutes happiness and harm.
Being autistic is seen by many people with autism as an integral part of their identity. From this perspective, a cure is an option which a large group of autistic people do not want to consider, as a cure would fundamentally change who they are—and they want to keep their autistic identity as it is.
Such organizations have sometimes spoken as if autism is a disorder that should be cured, and have tended to steer research and research funding toward finding a biological explanation and hence it is assumed a cure.